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Teva’s Budesonide
Inhalation Suspension
AN Rated and Bioequivalent to Pulmicort Respules®*
ly
Available Exclusive
from Teva
To place your order,
call your wholesaler
or distributor today.
Please see brief summary
of prescribing information on
adjacent page.
Budesonide Inhalation Suspension
STRENGTH
SIZE
NDC#
0.25 mg/2 mL
2 mL x 30
00093-6815-73
0.5 mg/2 mL
2 mL x 30
00093-6816-73
Intended for inhalation use only with compressed air
driven nebulizer systems, also known as jet nebulizers.
*Pulmicort Respules® is a registered trademark of AstraZeneca.
©2011, Teva Pharmaceuticals USA
1090 Horsham Road • North Wales, PA 19454
800.545.8800 • www.tevausa.com
10147
BRIEF SUMMARY
BUDESONIDE INHALATION SUSPENSION
CLINICAL PHARMACOLOGY
Pharmacokinetics
Special Populations
Nursing Mothers
The disposition of budesonide when delivered by inhalation from a dry powder
inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was
studied in eight lactating women with asthma from 1 to 6 months postpartum.
Systemic exposure to budesonide in these women appears to be comparable
to that in non-lactating women with asthma from other studies. Breast milk
obtained over eight hours post-dose revealed that the maximum concentration
of budesonide for the 400 and 800 mcg doses was 0.39 and 0.78 nmol/L,
respectively, and occurred within 45 minutes after dosing. The estimated oral
daily dose of budesonide from breast milk to the infant is approximately 0.007
and 0.014 mcg/kg/day for the two-dose regimens used in this study, which
represents approximately 0.3% to 1% of the dose inhaled by the mother.
Budesonide levels in plasma samples obtained from five infants at about 90
minutes after breast-feeding (and about 140 minutes after drug administration
to the mother) were below quantifiable levels (< 0.02 nmol/L in four infants and
< 0.04 nmol/L in one infant) (see PRECAUTIONS, Nursing Mothers).
Pharmacodynamics
The effects of budesonide inhalation suspension on the hypothalamic-pituitaryadrenal (HPA) axis were studied in three, 12-week, double-blind, placebocontrolled studies in 293 pediatric patients, 6 months to 8 years of age, with
persistent asthma. For most patients, the ability to increase cortisol production
in response to stress, as assessed by the short cosyntropin (ACTH) stimulation
test, remained intact with budesonide inhalation suspension treatment. In a
subgroup of children age 6 months to 2 years (n = 21) treated with a total daily
dose of budesonide inhalation suspension up to 1 mg or placebo, the mean
change from baseline in ACTH-stimulated cortisol levels showed a decline in
peak stimulated cortisol at 12 weeks compared to an increase in the placebo
group. These mean differences were not statistically significant compared to
placebo. Another 12-week study was conducted in 141 pediatric patients 6
to 12 months of age with mild to moderate asthma or recurrent/persistent
wheezing. All patients were treated with a total daily dose of either 0.5 mg or
1 mg of budesonide inhalation suspension or placebo. A total of 28, 17,
and 31 patients in the budesonide inhalation suspension 0.5 mg, 1 mg, and
placebo arms respectively had an evaluation of serum cortisol levels post-ACTH
stimulation both at baseline and at the end of the study. The mean change
from baseline to Week 12 ACTH-stimulated minus basal plasma cortisol
levels did not indicate adrenal suppression in patients treated with budesonide
inhalation suspension versus placebo. However, 7 patients in this study (4
of whom received budesonide inhalation suspension 0.5 mg, 2 of whom
received budesonide inhalation suspension 1 mg and 1 of whom received
placebo) showed a shift from normal baseline stimulated cortisol level (≥ 500
nmol/L) to a subnormal level (< 500 nmol/L) at Week 12. In 4 of these patients
receiving budesonide inhalation suspension, the cortisol values were near the
cutoff value of 500 nmol/L.
CLINICAL TRIALS
Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical
trials of 12-weeks duration each were conducted in 1018 pediatric patients,
6 months to 8 years of age, with persistent asthma of varying disease duration
(2 to 107 months) and severity. Doses of 0.25 mg and 0.5 mg administered
twice daily were compared to placebo to provide information about appropriate
dosing to cover a range of asthma severity. A Pari-LC-Jet Plus Nebulizer (with
a face mask or mouthpiece) connected to a Pari Master compressor was used
to deliver budesonide inhalation suspension to patients in the 3 U.S. controlled
clinical trials. The co-primary endpoints were nighttime and daytime asthma
symptom scores (0 to 3 scale). Each of the doses discussed below were
studied in one or two, but not all three of the U.S. studies.
Results of the 3 controlled clinical trials for recommended dosages of
budesonide inhalation suspension (0.25 mg to 0.5 mg twice daily, up to a total
daily dose of 1 mg) in patients, 12 months to 8 years of age, are presented
below. Compared to placebo, budesonide inhalation suspension significantly
decreased both nighttime and daytime symptom scores of asthma at doses
of 0.25 mg twice daily, and 0.5 mg twice daily. Symptom reduction in
response to budesonide inhalation suspension occurred across gender and
age. Budesonide inhalation suspension significantly reduced the need for
bronchodilator therapy at all the doses studied.
Improvements in lung function were associated with budesonide inhalation
suspension treatment in the subgroup of patients capable of performing lung
function testing. Significant improvements were seen in FEV1 [budesonide
inhalation suspension 0.5 mg twice daily] and morning PEF [budesonide
inhalation suspension 0.25 mg twice daily and 0.5 mg twice daily] compared
to placebo.
A numerical reduction in nighttime and daytime symptom scores (0 to 3 scale)
of asthma was observed within 2 to 8 days, although maximum benefit was not
achieved for 4 to 6 weeks after starting treatment. The reduction in nighttime
and daytime asthma symptom scores was maintained throughout the 12 weeks
of the double-blind trials.
CONTRAINDICATIONS
Budesonide Inhalation Suspension is contraindicated as the primary treatment
of status asthmaticus or other acute episodes of asthma where intensive
measures are required.
Hypersensitivity to budesonide inhalation suspension or any of the ingredients
of this preparation contraindicates the use of budesonide inhalation suspension.
WARNINGS
Particular care is needed for patients who are transferred from systemically
active corticosteroids to inhaled corticosteroids because deaths due to adrenal
insufficiency have occurred in asthmatic patients during and after transfer from
systemic corticosteroids to less systemically available inhaled corticosteroids.
After withdrawal from systemic corticosteroids, a number of months are
required for recovery of hypothalamic-pituitary-adrenal (HPA)-axis function.
Patients who have been previously maintained on 20 mg or more per day of
prednisone (or its equivalent) may be most susceptible, particularly when their
systemic corticosteroids have been almost completely withdrawn.
During this period of HPA-axis suppression, patients may exhibit signs and
symptoms of adrenal insufficiency when exposed to trauma, surgery, infection
(particularly gastroenteritis) or other conditions associated with severe
electrolyte loss. Although budesonide inhalation suspension may provide
control of asthma symptoms during these episodes, in recommended doses it
supplies less than normal physiological amounts of corticosteroid systemically
and does NOT provide the mineralocorticoid activity that is necessary for
coping with these emergencies.
During periods of stress or a severe asthma attack, patients who have
been withdrawn from systemic corticosteroids should be instructed to
resume oral corticosteroids (in large doses) immediately and to contact their
physicians for further instructions. These patients should also be instructed
to carry a warning card indicating that they may need supplementary systemic
corticosteroids during periods of stress or a severe asthma attack.
Patients requiring oral corticosteroids should be weaned slowly from systemic
corticosteroid use after transferring to budesonide inhalation suspension. Lung
function (FEV1 or AM PEF), beta-agonist use, and asthma symptoms should be
carefully monitored during withdrawal of oral corticosteroids. In addition to
monitoring asthma signs and symptoms, patients should be observed for signs
and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness,
nausea and vomiting, and hypotension.
Transfer of patients from systemic corticosteroid therapy to budesonide
inhalation suspension may unmask allergic or other immunologic conditions
previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis,
conjunctivitis, eosinophilic conditions, eczema, and arthritis (see DOSAGE
AND ADMINISTRATION).
Patients who are on drugs which suppress the immune system are more
susceptible to infection than healthy individuals. Chicken pox and measles,
for example, can have a more serious or even fatal course in susceptible
pediatric patients or adults on immunosuppressant doses of corticosteroids.
In pediatric or adult patients who have not had these diseases, or who have not
been properly vaccinated, particular care should be taken to avoid exposure.
How the dose, route, and duration of corticosteroid administration affects the
risk of developing a disseminated infection is not known. The contribution
of the underlying disease and/or prior corticosteroid treatment to the risk is
also not known.
The clinical course of chicken pox or measles infection in patients on inhaled
corticosteroids has not been studied. However, a clinical study has examined
the immune responsiveness of asthma patients 12 months to 8 years of age
who were treated with budesonide inhalation suspension (see PRECAUTIONS,
Pediatric Use).
If a patient on immunosuppressant doses of corticosteroids is exposed to
chicken pox, therapy with varicella zoster immune globulin (VZIG) or pooled
intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If
exposed to measles, prophylaxis with pooled intramuscular immunoglobulin
(IG) may be indicated (see the respective package inserts for complete VZIG
and IG prescribing information). If chicken pox develops, treatment with
antiviral agents may be considered.
Budesonide inhalation suspension is not a bronchodilator and is not indicated
for the rapid relief of acute bronchospasm or other acute episodes of asthma.
As with other inhaled asthma medications, bronchospasm, with an immediate
increase in wheezing, may occur after dosing. If acute bronchospasm
occurs following dosing with budesonide inhalation suspension, it should
be treated immediately with a fast-acting inhaled bronchodilator. Treatment
with budesonide inhalation suspension should be discontinued and alternate
therapy instituted.
Patients should be instructed to contact their physician immediately when
episodes of asthma not responsive to their usual doses of bronchodilators
occur during treatment with budesonide inhalation suspension.
Hypersensitivity Reactions Including Anaphylaxis
Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis,
urticaria, angioedema, and bronchospasm have been reported with use
of budesonide inhalation suspension . Discontinue budesonide inhalation
suspension if such reactions occur (see CONTRAINDICATIONS and ADVERSE
REACTIONS).
PRECAUTIONS
General
During withdrawal from oral corticosteroids, some patients may experience
symptoms of systemically active corticosteroid withdrawal, e.g., joint and/
or muscular pain, lassitude, and depression, despite maintenance or even
improvement of respiratory function (see DOSAGE AND ADMINISTRATION).
Because budesonide is absorbed into the circulation and may be systemically
active, particularly at higher doses, suppression of HPA function may be
associated when budesonide inhalation suspension is administered at doses
exceeding those recommended (see DOSAGE AND ADMINISTRATION), or
when the dose is not titrated to the lowest effective dose. Since individual
sensitivity to effects on cortisol production exists, physicians should consider
this information when prescribing budesonide inhalation suspension.
Because of the possibility of systemic absorption of inhaled corticosteroids,
patients treated with budesonide inhalation suspension should be observed
carefully for any evidence of systemic corticosteroid effects. Particular care
should be taken in observing patients post-operatively or during periods of
stress for evidence of inadequate adrenal response.
It is possible that systemic corticosteroid effects such as hypercorticism,
reduced bone mineral density, and adrenal suppression may appear in a
small number of patients, particularly at higher doses. If such changes occur,
budesonide inhalation suspension should be reduced slowly, consistent with
accepted procedures for management of asthma symptoms and for tapering
of systemic corticosteroids.
Orally inhaled corticosteroids, including budesonide, may cause a reduction in
growth velocity when administered to pediatric patients. A reduction in growth
velocity may occur as a result of inadequate control of asthma or from use
of corticosteroids for treatment. The potential effects of prolonged treatment
on growth velocity should be weighed against the clinical benefits obtained
and the risks associated with alternative therapies. To minimize the systemic
effects of orally inhaled corticosteroids, including budesonide inhalation
suspension, each patient should be titrated to his/her lowest effective dose
(see PRECAUTIONS, Pediatric Use).
Although patients in clinical trials have received budesonide inhalation
suspension on a continuous basis for periods of up to 1 year, the long-term
local and systemic effects of budesonide inhalation suspension in human
subjects are not completely known. In particular, the effects resulting
from chronic use of budesonide inhalation suspension on developmental
or immunological processes in the mouth, pharynx, trachea, and lung are
unknown.
In clinical trials with budesonide inhalation suspension, localized infections
with Candida albicans occurred in the mouth and pharynx in some patients.
The incidences of localized infections of Candida albicans were similar between
the placebo and budesonide inhalation suspension treatment groups. If these
infections develop, they may require treatment with appropriate antifungal
therapy and/or discontinuance of treatment with budesonide inhalation
suspension.
Inhaled corticosteroids should be used with caution, if at all, in patients with
active or quiescent tuberculosis infection of the respiratory tract, untreated
systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes
simplex.
Rare instances of glaucoma, increased intraocular pressure, and cataracts have
been reported following the inhaled administration of corticosteroids.
Information for Patients
Patients being treated with budesonide inhalation suspension should receive
the following information and instructions. This information is intended to
aid the patient in the safe and effective use of the medication. It is not a
disclosure of all possible adverse or intended effects. For instructions on the
proper use of budesonide inhalation suspension and to attain the maximum
improvement in asthma symptoms, the patient or the parent/guardian of the
patient should receive, read, and follow the available patient information and
instructions carefully.
z Patients should take budesonide inhalation suspension at regular intervals
twice a day as directed, since its effectiveness depends on regular use. The
patient should not alter the prescribed dosage unless advised to do so by
the physician.
z The effects of mixing budesonide inhalation suspension with other
nebulizable medications have not been adequately assessed. Budesonide
inhalation suspension should be administered separately in the nebulizer.
z Budesonide inhalation suspension is not a bronchodilator, and its use is not
intended to treat acute life-threatening episodes of asthma.
z Budesonide inhalation suspension should be administered with a jet
nebulizer connected to a compressor with an adequate air flow, equipped
with a mouthpiece or suitable face mask. The face mask should be
properly adjusted to optimize delivery and to avoid exposing the eyes to
the nebulized medication (see DOSAGE AND ADMINISTRATION).
z Ultrasonic nebulizers are not suitable for the adequate administration of
budesonide inhalation suspension and, therefore, are not recommended
(see DOSAGE AND ADMINISTRATION).
z Rinsing the mouth with water after each treatment may decrease the risk
of development of local candidiasis. Corticosteroid effects on the skin can
be avoided if the face is washed after the use of a face mask.
z Improvement in asthma control following treatment with budesonide
inhalation suspension can occur within 2 to 8 days of beginning treatment,
although maximum benefit may not be achieved for 4 to 6 weeks after
starting treatment. If the asthma symptoms do not improve in that time
frame, or if the condition worsens, the patient or the patient’s parent/
guardian should be instructed not to increase the dosage, but to contact
the physician.
z Patients should not stop the use of budesonide inhalation suspension
abruptly without consulting with their prescribing physician.
z Patients whose chronic systemic corticosteroids have been reduced or
withdrawn should be instructed to carry a warning card indicating that they
may need supplemental systemic corticosteroids during periods of stress
or an asthma attack that does not respond to bronchodilators.
z As always, care should be taken to avoid exposure to persons with
chicken pox and measles. If exposure to such a person occurs, and the
child has not had chicken pox or been properly vaccinated, a physician
should be consulted without delay (see WARNINGS and PRECAUTIONS,
Pediatric Use).
z Long-term use of inhaled corticosteroids, including budesonide, may
increase the risk of some eye problems (cataracts or glaucoma). Regular
eye examinations should be considered.
z Patients or their parents/guardians considering use of budesonide
inhalation suspension should consult with their physician if they are allergic
to budesonide or any other orally inhaled corticosteroid.
z Physicians should be informed of other medications patients are taking
as budesonide inhalation suspension may not be suitable in some
circumstances and the physician may wish to use a different medicine.
z Budesonide inhalation suspension should be stored upright at controlled
room temperature 20º to 25ºC (68º to 77ºF) and protected from light.
Budesonide inhalation suspension should not be refrigerated or frozen.
z When an aluminum foil envelope has been opened, the shelf life of the
unused vials is two weeks when protected from light. The date the
envelope was opened should be recorded on the front of the envelope in
the space provided.
z After opening the aluminum foil envelope, the unused vials should be
returned to the envelope to protect them from light. Any individually
opened vials must be used promptly.
z For proper usage of budesonide inhalation suspension and to attain
maximum improvement, the available Patient’s Instructions for Use
should be read and followed.
Drug Interactions
In clinical studies, concurrent administration of budesonide and other
drugs commonly used in the treatment of asthma has not resulted in an
increased frequency of adverse events. The main route of metabolism of
budesonide, as well as other corticosteroids, is via cytochrome P450 (CYP)
isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a potent
inhibitor of CYP3A4, the mean plasma concentration of orally administered
budesonide increased. Concomitant administration of other known inhibitors
of CYP3A4 (e.g., itraconazole, clarithromycin, erythromycin, etc.) may inhibit
the metabolism of, and increase the systemic exposure to, budesonide. Care
should be exercised when budesonide is coadministered with long-term
ketoconazole and other known CYP3A4 inhibitors. Omeprazole did not have
effects on the pharmacokinetics of oral budesonide, while cimetidine, primarily
an inhibitor of CYP1A2, caused a slight decrease in budesonide clearance and
a corresponding increase in its oral bioavailability.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies were conducted in rats and mice using oral administration
to evaluate the carcinogenic potential of budesonide.
In a two-year study in Sprague-Dawley rats, budesonide caused a statistically
significant increase in the incidence of gliomas in male rats at an oral dose
of 50 mcg/kg (less than the maximum recommended daily inhalation dose
in adults and children on a mcg/m2 basis). No tumorigenicity was seen in
male and female rats at respective oral doses up to 25 and 50 mcg/kg (less
than the maximum recommended daily inhalation dose in adults and children
on a mcg/m2 basis). In two additional two-year studies in male Fischer and
Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of
50 mcg/kg (less than the maximum recommended daily inhalation dose in
adults and children on a mcg/m2 basis). However, in the male Sprague-Dawley
rats, budesonide caused a statistically significant increase in the incidence of
hepatocellular tumors at an oral dose of 50 mcg/kg (less than the maximum
recommended daily inhalation dose in adults and children on a mcg/m2 basis).
The concurrent reference corticosteroids (prednisolone and triamcinolone
acetonide) in these two studies showed similar findings.
In a 91-week study in mice, budesonide caused no treatment-related
carcinogenicity at oral doses up to 200 mcg/kg (less than the maximum
recommended daily inhalation dose in adults and children on a mcg/m2 basis).
Budesonide was not mutagenic or clastogenic in six different test systems:
Ames Salmonella/microsome plate test, mouse micronucleus test, mouse
lymphoma test, chromosome aberration test in human lymphocytes, sex-linked
recessive lethal test in Drosophila melanogaster, and DNA repair analysis in
rat hepatocyte culture.
In rats, budesonide had no effect on fertility at subcutaneous doses up to 80
mcg/kg (less than the maximum recommended daily inhalation dose in adults
on a mcg/m2 basis). However, it caused a decrease in prenatal viability and
viability in the pups at birth and during lactation, along with a decrease in
maternal body-weight gain, at subcutaneous doses of 20 mcg/kg and above
(less than the maximum recommended daily inhalation dose in adults on
a mcg/m2 basis). No such effects were noted at 5 mcg/kg (less than the
maximum recommended daily inhalation dose in adults on a mcg/m2 basis).
Pregnancy
Teratogenic Effects
Pregnancy category B
As with other corticosteroids, budesonide was teratogenic and embryocidal in
rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and
skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (less than
the maximum recommended daily inhalation dose in adults on a mcg/m2 basis)
and 500 mcg/kg in rats (approximately 4 times the maximum recommended
daily inhalation dose in adults on a mcg/m2 basis). In another study in rats,
no teratogenic or embryocidal effects were seen at inhalation doses up to 250
mcg/kg (approximately 2 times the maximum recommended daily inhalation
dose in adults on a mcg/m2 basis).
Experience with oral corticosteroids since their introduction in pharmacologic,
as opposed to physiologic, doses suggests that rodents are more prone to
teratogenic effects from corticosteroids than humans.
Studies of pregnant women, however, have not shown that inhaled budesonide
increases the risk of abnormalities when administered during pregnancy. The
results from a large population-based prospective cohort epidemiological
study reviewing data from three Swedish registries covering approximately
99% of the pregnancies from 1995 to 1997 (i.e., Swedish Medical Birth
Registry; Registry of Congenital Malformations; Child Cardiology Registry)
indicate no increased risk for congenital malformations from the use of inhaled
budesonide during early pregnancy. Congenital malformations were studied in
2014 infants born to mothers reporting the use of inhaled budesonide for
asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual
period), the period when most major organ malformations occur. The rate
of recorded congenital malformations was similar compared to the general
population rate (3.8% vs. 3.5%, respectively). In addition, after exposure
to inhaled budesonide, the number of infants born with orofacial clefts was
similar to the expected number in the normal population (4 children vs. 3.3,
respectively).
These same data were utilized in a second study bringing the total to 2534
infants whose mothers were exposed to inhaled budesonide. In this study, the
rate of congenital malformations among infants whose mothers were exposed
to inhaled budesonide during early pregnancy was not different from the rate
for all newborn babies during the same period (3.6%).
Despite the animal findings, it would appear that the possibility of fetal harm is
remote if the drug is used during pregnancy. Nevertheless, because the studies
in humans cannot rule out the possibility of harm, budesonide inhalation
suspension should be used during pregnancy only if clearly needed.
Non-Teratogenic Effects
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids
during pregnancy. Such infants should be carefully observed.
Nursing Mothers
Budesonide, like other corticosteroids, is secreted in human milk. Data with
budesonide delivered via dry powder inhaler indicates that the total daily
oral dose of budesonide in breast milk to the infant is approximately 0.3%
to 1% of the dose inhaled by the mother (see CLINICAL PHARMACOLOGY,
Pharmacokinetics, Special Populations, Nursing Mothers). No studies
have been conducted in breastfeeding women with budesonide inhalation
suspension; however, the dose of budesonide available to the infant in breast
milk, as a percentage of the maternal dose, would be expected to be similar.
Budesonide should be used in nursing women only if clinically appropriate.
Prescribers should weigh the known benefits of breastfeeding for the mother
and the infant against the potential risks of minimal budesonide exposure
in the infant.
Pediatric Use
Safety in pediatric patients six months to 12 months of age has been evaluated.
Safety and effectiveness in pediatric patients 12 months to 8 years of age have
been established (see CLINICAL PHARMACOLOGY, Pharmacodynamics,
CLINICAL TRIALS and ADVERSE REACTIONS).
It has been reported a study in pediatric patients 6 to 12 months of age
with mild to moderate asthma or recurrent/persistent wheezing. All patients
were randomized to receive either budesonide inhalation suspension or
placebo. Adrenal axis function was assessed with an ACTH stimulation test
at the beginning and end of the study, and mean changes from baseline in
this variable did not indicate adrenal suppression in patients who received
budesonide inhalation suspension versus placebo. However, on an individual
basis, 7 patients in this study (6 in the budesonide inhalation suspension
treatment arms and 1 in the placebo arm) experienced a shift from having
a normal baseline stimulated cortisol level to having a subnormal level at
Week 12 (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Pneumonia
was observed more frequently in patients treated with budesonide inhalation
suspension than in patients treated with placebo, (N = 2, 1, and 0) in the
budesonide inhalation suspension 0.5 mg, 1 mg, and placebo groups,
respectively.
A dose dependent effect on growth was also noted in this 12-week
trial. Infants in the placebo arm experienced an average growth of 3.7
cm over 12 weeks compared with 3.5 cm and 3.1 cm in the budesonide
inhalation suspension 0.5 mg and 1 mg arms respectively. This
corresponds to estimated mean (95% CI) reductions in 12-week growth
velocity between placebo and budesonide inhalation suspension 0.5 mg of
0.2 cm (-0.6 to 1) and between placebo and budesonide inhalation suspension
1 mg of 0.6 cm (-0.2 to 1.4). These findings support that the use of budesonide
inhalation suspension in infants 6 to 12 months of age may result in systemic
effects and are consistent with findings of growth suppression in other studies
with inhaled corticosteroids.
Controlled clinical studies have shown that inhaled corticosteroids may cause
a reduction in growth velocity in pediatric patients. In these studies, the mean
reduction in growth velocity was approximately one centimeter per year (range
0.3 to 1.8 cm per year) and appears to be related to dose and duration of
exposure. This effect has been observed in the absence of laboratory evidence
of hypothalamic-pituitary-adrenal (HPA)-axis suppression, suggesting that
growth velocity is a more sensitive indicator of systemic corticosteroid
exposure in pediatric patients than some commonly used tests of HPA-axis
function. The long-term effects of this reduction in growth velocity associated
with inhaled corticosteroids, including the impact on final adult height, are
unknown. The potential for “catch up” growth following discontinuation of
treatment with inhaled corticosteroids has not been adequately studied.
In a study of asthmatic children 5 to 12 years of age, those treated with
budesonide administered via a dry powder inhaler 200 mcg twice daily
(n = 311) had a 1.1-centimeter reduction in growth compared with those
receiving placebo (n = 418) at the end of one year; the difference between these
two treatment groups did not increase further over three years of additional
treatment. By the end of four years, children treated with the budesonide dry
powder inhaler and children treated with placebo had similar growth velocities.
Conclusions drawn from this study may be confounded by the unequal use
of corticosteroids in the treatment groups and inclusion of data from patients
attaining puberty during the course of the study.
The growth of pediatric patients receiving inhaled corticosteroids, including
budesonide inhalation suspension, should be monitored routinely (e.g., via
stadiometry). The potential growth effects of prolonged treatment should be
weighed against clinical benefits obtained and the risks and benefits associated
with alternative therapies. To minimize the systemic effects of inhaled
corticosteroids, including budesonide inhalation suspension, each patient
should be titrated to his/her lowest effective dose.
An open-label non-randomized clinical study examined the immune
responsiveness of varicella vaccine in 243 asthma patients 12 months to 8
years of age who were treated with a total daily dose of budesonide inhalation
suspension up to 1 mg (n = 151) or non-corticosteroid asthma therapy
(n = 92) (i.e., beta2-agonists, leukotriene receptor antagonists, cromones).
The percentage of patients developing a seroprotective antibody titer of
≥ 5 (gpELISA value) in response to the vaccination was similar in patients
treated with budesonide inhalation suspension (85%) compared to patients
treated with non-corticosteroid asthma therapy (90%). No patient treated
with budesonide inhalation suspension developed chicken pox as a result of
vaccination.
Geriatric Use
Of the 215 patients in 3 clinical trials of budesonide inhalation suspension in
adult patients, 65 (30%) were 65 years of age or older, while 22 (10%) were 75
years of age or older. No overall differences in safety were observed between
these patients and younger patients, and other reported clinical or medical
surveillance experience has not identified differences in responses between the
elderly and younger patients.
ADVERSE REACTIONS
The following adverse reactions were reported in pediatric patients treated with
budesonide inhalation suspension.
The incidence of common adverse reactions is based on three double-blind,
placebo-controlled, US clinical trials in which 945 patients, 12 months to
8 years of age, (98 patients ≥ 12 months and < 2 years of age; 225 patients
≥ 2 and < 4 years of age; and 622 patients ≥ 4 and ≤ 8 years of age) were
treated with budesonide inhalation suspension or vehicle placebo. The
incidence and nature of adverse events reported for budesonide inhalation
suspension was comparable to that reported for placebo. The following
table shows the incidence of adverse events in US controlled clinical trials,
regardless of relationship to treatment, in patients previously receiving
bronchodilators and/or inhaled corticosteroids. This population included a total
of 605 male and 340 female patients.
Adverse Events With ≥ 3% Incidence Reported
By Patients On Budesonide
Budesonide
Vehicle
Total Daily Dose
Placebo
1 mg
0.5 mg
(n = 227) (n = 223) (n = 317)
Adverse Events
%
%
%
Respiratory System Disorder
35
38
36
Respiratory Infection
11
12
9
Rhinitis
9
8
5
Coughing
Resistance Mechanism Disorders
11
9
11
Otitis Media
5
3
3
Viral Infection
3
4
2
Moniliasis
Gastrointestinal System Disorders
5
5
4
Gastroenteritis
4
4
3
Vomiting
4
2
2
Diarrhea
2
3
2
Abdominal Pain
Hearing and Vestibular Disorders
4
5
4
Ear Infection
Platelet, Bleeding, and Clotting Disorders
4
3
1
Epistaxis
Vision Disorders
4
2
2
Conjunctivitis
Skin and Appendages Disorders
4
2
3
Rash
The above table shows all adverse events with an incidence of 3% or more
in at least one active treatment group where the incidence was higher with
budesonide inhalation suspension than with placebo.
The following adverse events occurred with an incidence of 3% or more in
at least one budesonide inhalation suspension group where the incidence
was equal to or less than that of the placebo group: fever, sinusitis, pain,
pharyngitis, bronchospasm, bronchitis, and headache.
Incidence 1% to ≤ 3% (by Body System)
The information below includes all adverse events with an incidence of 1 to ≤
3%, in at least one budesonide inhalation suspension treatment group where
the incidence was higher with budesonide inhalation suspension than with
placebo, regardless of relationship to treatment.
Body as a Whole
Allergic reaction, chest pain, fatigue, flu-like disorder
Respiratory System
Stridor
Resistance Mechanisms
Herpes simplex, external ear infection, infection
Central & Peripheral Nervous System
Dysphonia, hyperkinesia
Skin & Appendages
Eczema, pustular rash, pruritus
Hearing & Vestibular
Earache
Vision
Eye infection
Psychiatric
Anorexia, emotional lability
Musculoskeletal System
Fracture, myalgia
Application Site
Contact dermatitis
Platelet, Bleeding & Clotting
Purpura
White Cell and Resistance
Cervical lymphadenopathy
The incidence of reported adverse events was similar between the 447
budesonide inhalation suspension-treated (mean total daily dose 0.5 to 1 mg)
and 223 conventional therapy-treated pediatric asthma patients followed for
one year in three open-label studies.
Cases of growth suppression have been reported for inhaled corticosteroids
including post-marketing reports for budesonide inhalation suspension (see
PRECAUTIONS, Pediatric Use).
Less frequent adverse events (<1%) reported in the published literature,
long-term, open-label clinical trials, or from worldwide marketing experience
with any formulation of inhaled budesonide include: immediate and delayed
hypersensitivity reactions including anaphylaxis, rash, contact dermatitis,
urticaria, angioedema, and bronchospasm (see WARNINGS, Hypersensitivity
Reactions Including Anaphylaxis ); symptoms of hypocorticism and
hypercorticism; glaucoma, cataracts; psychiatric symptoms including
depression, aggressive reactions, irritability, anxiety, and psychosis; and bone
disorders including avascular necrosis of the femoral head and osteoporosis.
DOSAGE AND ADMINISTRATION
Patients Maintained on Chronic Oral Corticosteroids
Initially, budesonide inhalation suspension should be used concurrently
with the patient’s usual maintenance dose of systemic corticosteroid. After
approximately one week, gradual withdrawal of the systemic corticosteroid
may be initiated by reducing the daily or alternate daily dose. Further
incremental reductions may be made after an interval of one or two weeks,
depending on the response of the patient. Generally, these decrements
should not exceed 25% of the prednisone dose or its equivalent. A slow
rate of withdrawal is strongly recommended. During reduction of oral
corticosteroids, patients should be carefully monitored for asthma instability,
including objective measures of airway function, and for adrenal insufficiency
(see WARNINGS).
During withdrawal, some patients may experience symptoms of systemic
corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and
depression, despite maintenance or even improvement in pulmonary function.
Such patients should be encouraged to continue with budesonide inhalation
suspension but should be monitored for objective signs of adrenal insufficiency.
If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses
should be increased temporarily and thereafter withdrawal should continue
more slowly. During periods of stress or a severe asthma attack, transfer
patients may require supplementary treatment with systemic corticosteroids.
A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a
Pari Master compressor was used to deliver budesonide inhalation suspension
to each patient in 3 U.S. controlled clinical studies. The safety and efficacy
of budesonide inhalation suspension delivered by other nebulizers and
compressors have not been established.
Budesonide inhalation suspension should be administered via jet nebulizer
connected to an air compressor with an adequate air flow, equipped with a
mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the
adequate administration of budesonide inhalation suspension and, therefore,
are NOT recommended.
Manufactured In England By:
IVAX PHARMACEUTICALS UK
Runcorn, Cheshire WA7 3FA England
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 10/2009
®
EDITORIAL ADVISORY BOARD
Philip P. Burgess, RPh, MBA
Mary E. Inguanti
RPh, MPH, FASCP
Chairman
Community Pharmacy Foundation
Illinois Board of Pharmacy
Chicago, Ill.
Gene Memoli Jr., RPh, FASCP
Director
Customer Development, Omnicare
Cheshire, Conn.
Senior Vice President, Operations
Charter Oak Health Center
Hartford, Conn.
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James A. Jorgenson
RPh, MS, FASHP
The Pharmacy Group LLC
Glastonbury, Conn.
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Chief Pharmacy Ofﬁcer, VP
Clarian Health
Indianapolis, Ind.
Pharmacy manager and co-owner
The Medicine Shoppe/
Pharmacy Solutions Inc.
Two Rivers, Wisc.
David J. Fong, PharmD
Frederick S. Mayer, RPh, MPH
Jack Rosenberg, PharmD, PhD
Former community chain store
senior pharmacy executive
Danville, Calif.
President
Pharmacists Planning Service Inc.
San Rafael, Calif.
Professor Emeritus
Pharmacy Practice and Pharmacology
Long Island University
Brooklyn, N.Y.
Anna Garrett
PharmD, BCPS
Christina Medina, PharmD
Stephen W. Schondelmeyer
PharmD, PhD
Manager
Professional and College Relations
CVS Caremark
Hollywood, Fla.
Manager
Outpatient Clinical Pharmacy Programs
Mission Hospital
Asheville, N.C.
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DrugTopics .c om
Februar y 2011
DRUG TOPICS
3
CONTENTS
F E B R U A R Y 2 011
VO L . 1 5 5 N O . 2
DrugTopics.com
COVER STORY
Medicare Part D Audits
With federal agencies
taking a long, hard look at
Medicare transactions, now’s
a good time to make sure
your pharmacy is ready for
its close-up. PAGE 30
Pharmacy abroad PAGE 16
Melissa Corrigan, RPh
PRESCRIBED READING
22
Mike LaRosa, PharmD cand.
Phoning it in PAGE 28
Should PBMs put the moves on Medicaid?
A new report claims it’s a no-brainer for the bottom line. NCPA
disagrees.
27
Part D rules change may jar LTC
Long-term care may have to retool for 7-day ﬁlls — with 30-day bills.
Pharm techs step up
In towns without pharmacists, necessity is the mother of invention.
Pamela Schweitzer, PharmD
A five-star success PAGE 32
SPECIAL REPORT
32
A place for mail-order
A collaboration between the VA and Indian Health Services is
making life a little easier for many American Indians.
Ken Baker, BS Pharm, JD
Monthly safety audits PAGE 48
Sign up for your own Drug Topics E-newsletter
Take your pick of Drug Topics’ 2 weekly e-newsletters:
Community Pharmacists’ Report and
Hospital Pharmacists’ Report
To sign up, visit DrugTopics.com/enewssignup
Dennis Miller, RPh
Efficiency at any cost PAGE 56
4
DRUG TOPICS
Februar y 2011
DrugTopics .c om
GETTY IMAGES/PHOTOGRAPHER’S CHOICE RF/SNAP DECISION (PILL BOTTLE), GETTY IMAGES/PHOTODISC/
MEDIOIMAGES (NUMBERS, LEFT), GETTY IMAGES/THE IMAGE BANK/DAVID GOULD (REDLINE NUMBERS)
28
Meet the face
of health care in
the community.
Now meet the pharmaceutical company
dedicated to helping her do her best.
Today’s pharmacist does so much more than dispense medications. She’s
an immunizer, health condition screener, patient counselor, and basic
medical advisor. That’s why, at Takeda, we do everything we can to give
pharmacists the tools and time they need to use their expert knowledge
to beneﬁt patients. From industry-leading patient education materials to
medication adherence programs, we believe in the importance of strong
partnerships with the pharmacist community—and all the communities
they serve.
For product information, visit www.tpna.com/products
CONTENTS
F E B R U A R Y 2011
VO L . 1 5 5 N O . 2
CONTINUING EDUCATION
What’s happening now at
Medication errors
What you need to know:
• Why they happen
• How to prevent them
• Who may be liable
• How to apologize PAGE 36
DT BLOG
No fries with that
“How long can it take to put some
pills in a bottle?”
One pharmacist who has heard
all the questions spends her
drive home polishing answers
she’ll never give.
CLINICAL
10 GUEST EDITORIAL
E-tracking is not the answer
35 ANTICOAGULATION
The latest info on VTE in HIV;
intracerebral hemorrhage;
and antiplatelet/warfarin
combinations
13 LETTERS
How many pharmacists does it
take to ﬁll a prescription?
14 JP AT LARGE
Some things you don’t forget
16 IN MY VIEW
A student reports on pharmacy
practice in Turkey
56 VIEWPOINT
When efﬁciency is the only thing
that counts
ISSUES & TRENDS
18 UPFRONT
A new pharmacy school takes a
hands-on approach to learning
REGULATORY & LEGAL
48 RISK MANAGEMENT & CQI
Two success measures that
every pharmacy should post
49 LEGAL COMPLIANCE
Have state laws caught up with
telepharmacy?
Is she thinking what you’re
thinking? To ﬁnd out, visit the
DT blog at our homepage at
DrugTopics.com.
WEB EXCLUSIVES
ASHP lobbies for laws to ease
drug shortage
DrugTopics.com/shortage
USP wants new Rx labels
DrugTopics.com/labels
ACIP updates antiviral
guidelines for ﬂu treatment
DrugTopics.com/acip
DIGITAL EDITION
PRODUCT UPDATES
50 OTC
Foot-care products
53 NEW PRODUCTS
Alsuma preﬁlled auto-injectors for
migraine and cluster headaches
Subscribe to the monthly digital
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Go to DrugTopics.com/digital
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Februar y 2011
DrugTopics .c om
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INSTRUCTIONS ON PILL BOTTLE); PHOTODISC/SETH JOEL (MEDICINE CABINET WITH PRESCRIPTION BOTTLES)
COUNTER POINTS
Indication: Metformin hydrochloride tablets are indicated
as an adjunct to diet and exercise to improve glycemic
control in adults and children with type 2 diabetes mellitus.
Adverse reactions: The most common adverse reactions,
reported in > 5% of metformin-treated patients, are:
diarrhea, nausea/vomiting, flatulence, asthenia, indigestion,
abdominal discomfort, and headache.
Contraindications and precautions:
Metformin hydrochloride tablets are contraindicated in
patients with:
Mylan Metformin is
Berry Nice.
1. Renal disease or renal dysfunction (e.g., as suggested
by serum creatinine levels * 1.5 mg/dL [males],
* 1.4 mg/dL [females] or abnormal creatinine clearance)
which may also result from conditions such as
cardiovascular collapse (shock), acute myocardial
infarction, and septicemia.
2. Known hypersensitivity to metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic
ketoacidosis, with or without coma. Diabetic ketoacidosis
should be treated with insulin.
Metformin should be temporarily discontinued in patients
undergoing radiologic studies involving intravascular
administration of iodinated contrast materials, because
use of such products may result in acute alteration of
renal function.
Before initiation of metformin therapy and at least annually
thereafter, renal function should be assessed and verified
as normal. In patients in whom development of renal
dysfunction is anticipated, renal function should be
assessed more frequently and metformin discontinued
if evidence of renal impairment is present.
WARNINGS: LACTIC ACIDOSIS
Lactic acidosis is a rare but serious, metabolic
complication that can occur because of metformin
accumulation. Reported cases have occurred primarily
in diabetic patients with significant renal insufficiency,
including both intrinsic renal disease and renal
hypoperfusion, often in the setting of multiple
concomitant medical/surgical problems and multiple
concomitant medications. The risk of lactic acidosis
may, therefore, be significantly decreased by regular
monitoring of renal function and by use of the minimum
effective dose. Other conditions that increase the risk
of lactic acidosis include: sepsis, dehydration, excess
alcohol intake, hepatic insufficiency and acute
congestive heart failure.
When lactic acidosis occurs, it is fatal in approximately
50% of cases. The reported incidence of lactic acidosis
in patients receiving metformin is very low
(approximately 0.03 cases/1000 patient-years, with
approximately 0.015 fatal cases/1000 patient years).
The onset is often subtle, accompanied only by
nonspecific symptoms such as malaise, myalgias,
respiratory distress, increasing somnolence and
nonspecific abdominal distress. Laboratory
abnormalities include low pH, increased anion gap,
and elevated blood lactate. If acidosis is suspected,
metformin should be discontinued and the patient
hospitalized immediately.
Metformin treatment should not be initiated in
patients ≥ 80 years of age unless measurement of
creatinine clearance demonstrates that renal function
is not reduced, as these patients are more susceptible
to developing lactic acidosis.
Please see adjacent Brief Summary of Prescribing
Information, including BOXED WARNING with complete
details about lactic acidosis.
©2010 Mylan Pharmaceuticals Inc. MYNMET003
A metformin tablet that doesn’t smell like fish.
• A blackberry-scented formulation designed to mask the
“fishy smell” associated with some metformin tablets1
• Therapeutically equivalent to Glucophage®*
• Available in 500 mg, 850 mg and 1000 mg tablets
*Registered trademark of Bristol-Myers Squibb.
Reference: 1. Pelletier AL, Butler AM, Gillies RA, et al. Metformin Stinks, Literally. Ann Intern Med. 2010;152:267-268.
METFORMIN HYDROCHLORIDE TABLETS, USP
500 mg, 850 mg and 1000 mg
Rx Only
BRIEF SUMMARY: Please see package insert for full prescribing information.
INDICATIONS AND USAGE: Metformin hydrochloride tablets are indicated as an adjunct to diet
and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
CONTRAINDICATIONS: Metformin hydrochloride tablets are contraindicated in patients with:
1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels
≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females] or abnormal creatinine clearance)
which may also result from conditions such as cardiovascular collapse (shock),
acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).
2. Known hypersensitivity to metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without
coma. Diabetic ketoacidosis should be treated with insulin.
Metformin should be temporarily discontinued in patients undergoing radiologic studies
involving intravascular administration of iodinated contrast materials, because use of
such products may result in acute alteration of renal function. (See also PRECAUTIONS.)
WARNINGS:
Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that
can occur due to metformin accumulation during treatment with metformin; when it
occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in
association with a number of pathophysiologic conditions, including diabetes mellitus,
and whenever there is signiﬁcant tissue hypoperfusion and hypoxemia. Lactic acidosis
is characterized by elevated blood lactate levels (> 5 mmol/L), decreased blood pH,
electrolyte disturbances with an increased anion gap, and an increased lactate/
pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin
plasma levels > 5 mcg/mL are generally found.
The reported incidence of lactic acidosis in patients receiving metformin
hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with
approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patientyears exposure to metformin in clinical trials, there were no reports of lactic acidosis.
Reported cases have occurred primarily in diabetic patients with signiﬁcant renal
insufﬁciency, including both intrinsic renal disease and renal hypoperfusion, often in the
setting of multiple concomitant medical/surgical problems and multiple concomitant
medications. Patients with congestive heart failure requiring pharmacologic
management, in particular those with unstable or acute congestive heart failure who
are at risk of hypoperfusion and hypoxemia are at increased risk of lactic acidosis.
The risk of lactic acidosis increases with the degree of renal dysfunction and the
patient’s age. The risk of lactic acidosis may, therefore, be signiﬁcantly decreased by
regular monitoring of renal function in patients taking metformin and by use of the
minimum effective dose of metformin. In particular, treatment of the elderly should be
accompanied by careful monitoring of renal function. Metformin treatment should not
be initiated in patients ≥ 80 years of age unless measurement of creatinine clearance
demonstrates that renal function is not reduced, as these patients are more susceptible
to developing lactic acidosis. In addition, metformin should be promptly withheld in the
presence of any condition associated with hypoxemia, dehydration or sepsis. Because
impaired hepatic function may signiﬁcantly limit the ability to clear lactate, metformin
should generally be avoided in patients with clinical or laboratory evidence of hepatic
disease. Patients should be cautioned against excessive alcohol intake, either acute or
chronic, when taking metformin, since alcohol potentiates the effects of metformin on
lactate metabolism. In addition, metformin should be temporarily discontinued prior
to any intravascular radiocontrast study and for any surgical procedure (see also
PRECAUTIONS).
The onset of lactic acidosis often is subtle, and accompanied only by nonspeciﬁc
symptoms such as malaise, myalgias, respiratory distress, increasing somnolence and
nonspeciﬁc abdominal distress. There may be associated hypothermia, hypotension
and resistant bradyarrhythmias with more marked acidosis. The patient and the
patient’s physician must be aware of the possible importance of such symptoms and
the patient should be instructed to notify the physician immediately if they occur (see
also PRECAUTIONS). Metformin should be withdrawn until the situation is clariﬁed.
Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels
and even blood metformin levels may be useful. Once a patient is stabilized on any dose
level of metformin, gastrointestinal symptoms, which are common during initiation of
therapy, are unlikely to be drug-related. Later occurrence of gastrointestinal symptoms
could be due to lactic acidosis or other serious disease.
Levels of fasting venous plasma lactate above the upper limit of normal but less
than 5 mmol/L in patients taking metformin do not necessarily indicate impending
lactic acidosis and may be explainable by other mechanisms, such as poorly controlled
diabetes or obesity, vigorous physical activity or technical problems in sample handling.
(See also PRECAUTIONS.)
Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis
lacking evidence of ketoacidosis (ketonuria and ketonemia).
Lactic acidosis is a medical emergency that must be treated in a hospital setting. In
a patient with lactic acidosis who is taking metformin, the drug should be discontinued
immediately and general supportive measures promptly instituted. Because metformin
hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good
hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis
and remove the accumulated metformin. Such management often results in prompt
reversal of symptoms and recovery. (See also CONTRAINDICATIONS and PRECAUTIONS.)
PRECAUTIONS: General: Macrovascular Outcomes: There have been no clinical studies
establishing conclusive evidence of macrovascular risk reduction with metformin
hydrochloride tablets or any other anti-diabetic drug.
Monitoring of Renal Function: Metformin is known to be substantially excreted by the
kidney, and the risk of metformin accumulation and lactic acidosis increases with the
degree of impairment of renal function. Thus, patients with serum creatinine levels
above the upper limit of normal for their age should not receive metformin. In patients
with advanced age, metformin should be carefully titrated to establish the minimum dose
for adequate glycemic effect, because aging is associated with reduced renal function. In
elderly patients, particularly those ≥ 80 years of age, renal function should be monitored
regularly and, generally, metformin should not be titrated to the maximum dose (see
WARNINGS and DOSAGE AND ADMINISTRATION in full prescribing information).
Before initiation of metformin therapy and at least annually thereafter, renal function
should be assessed and veriﬁed as normal. In patients in whom development of renal
dysfunction is anticipated, renal function should be assessed more frequently and
metformin discontinued if evidence of renal impairment is present.
Use of Concomitant Medications That May Affect Renal Function or Metformin Disposition:
Concomitant medication(s) that may affect renal function or result in signiﬁcant hemodynamic
change or may interfere with the disposition of metformin, such as cationic drugs that are
eliminated by renal tubular secretion (see PRECAUTIONS: Drug Interactions), should be used
with caution.
Radiologic Studies Involving the Use of Intravascular Iodinated Contrast Materials
(for example, intravenous urogram, intravenous cholangiography, angiography, and
computed tomography (CT) scans with intravascular contrast materials): Intravascular
contrast studies with iodinated materials can lead to acute alteration of renal function
and have been associated with lactic acidosis in patients receiving metformin (see
CONTRAINDICATIONS). Therefore, in patients in whom any such study is planned, metformin
should be temporarily discontinued at the time of or prior to the procedure, and withheld for
48 hours subsequent to the procedure and reinstituted only after renal function has been
reevaluated and found to be normal.
Hypoxic States: Cardiovascular collapse (shock) from whatever cause, acute congestive
heart failure, acute myocardial infarction and other conditions characterized by hypoxemia
have been associated with lactic acidosis and may also cause prerenal azotemia. When such
events occur in patients on metformin therapy, the drug should be promptly discontinued.
Surgical Procedures: Metformin therapy should be temporarily suspended for any surgical
procedure (except minor procedures not associated with restricted intake of food and ﬂuids)
and should not be restarted until the patient’s oral intake has resumed and renal function
has been evaluated as normal.
Alcohol Intake: Alcohol is known to potentiate the effect of metformin on lactate
metabolism. Patients, therefore, should be warned against excessive alcohol intake, acute
or chronic, while receiving metformin.
Impaired Hepatic Function: Since impaired hepatic function has been associated with
some cases of lactic acidosis, metformin should generally be avoided in patients with
clinical or laboratory evidence of hepatic disease.
Vitamin B12 Levels: In controlled clinical trials of metformin of 29 weeks duration, a
decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical
manifestations, was observed in approximately 7% of patients. Such decrease, possibly due
to interference with B12 absorption from the B12-intrinsic factor complex, is, however, very
rarely associated with anemia and appears to be rapidly reversible with discontinuation of
metformin or vitamin B12 supplementation. Measurement of hematologic parameters on an
annual basis is advised in patients on metformin and any apparent abnormalities should
be appropriately investigated and managed (see PRECAUTIONS: Laboratory Tests).
Certain individuals (those with inadequate vitamin B12 or calcium intake or absorption)
appear to be predisposed to developing subnormal vitamin B12 levels. In these patients,
routine serum vitamin B12 measurements at 2- to 3-year intervals may be useful.
Change in Clinical Status of Patients with Previously Controlled Type 2 Diabetes: A
patient with type 2 diabetes previously well controlled on metformin who develops laboratory
abnormalities or clinical illness (especially vague and poorly deﬁned illness) should be
evaluated promptly for evidence of ketoacidosis or lactic acidosis. Evaluation should
include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate,
pyruvate and metformin levels. If acidosis of either form occurs, metformin must be stopped
immediately and other appropriate corrective measures initiated (see also WARNINGS).
Hypoglycemia: Hypoglycemia does not occur in patients receiving metformin alone
under usual circumstances of use, but could occur when caloric intake is deﬁcient, when
strenuous exercise is not compensated by caloric supplementation, or during concomitant
use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol.
Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufﬁciency
or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be
difﬁcult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs.
Loss of Control of Blood Glucose: When a patient stabilized on any diabetic regimen is
exposed to stress such as fever, trauma, infection, or surgery, a temporary loss of glycemic
control may occur. At such times, it may be necessary to withhold metformin and temporarily
administer insulin. Metformin may be reinstituted after the acute episode is resolved.
The effectiveness of oral antidiabetic drugs in lowering blood glucose to a targeted level
decreases in many patients over a period of time. This phenomenon, which may be due to
progression of the underlying disease or to diminished responsiveness to the drug, is known
as secondary failure, to distinguish it from primary failure in which the drug is ineffective
during initial therapy. Should secondary failure occur with either metformin or sulfonylurea
monotherapy, combined therapy with metformin and sulfonylurea may result in a response.
Should secondary failure occur with combined metformin/sulfonylurea therapy, it may be
necessary to consider therapeutic alternatives including initiation of insulin therapy.
Information for Patients: Patients should be informed of the potential risks and beneﬁts of
metformin and of alternative modes of therapy. They should also be informed about the
importance of adherence to dietary instructions, of a regular exercise program, and of regular
testing of blood glucose, glycosylated hemoglobin, renal function and hematologic parameters.
Page 1 of 2
The risks of lactic acidosis, its symptoms, and conditions that predispose to its
development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to
patients. Patients should be advised to discontinue metformin immediately and to promptly
notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual
somnolence or other nonspeciﬁc symptoms occur. Once a patient is stabilized on any dose
level of metformin, gastrointestinal symptoms, which are common during initiation of
metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal
symptoms could be due to lactic acidosis or other serious disease.
Patients should be counselled against excessive alcohol intake, either acute or chronic,
while receiving metformin.
Metformin hydrochloride tablets alone do not usually cause hypoglycemia, although it
may occur when metformin is used in conjunction with oral sulfonylureas and insulin. When
initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment,
and conditions that predispose to its development should be explained to patients and
responsible family members. (See Patient Information in full prescribing information.)
Laboratory Tests: Response to all diabetic therapies should be monitored by periodic
measurements of fasting blood glucose and glycosylated hemoglobin levels, with a goal
of decreasing these levels toward the normal range. During initial dose titration, fasting
glucose can be used to determine the therapeutic response. Thereafter, both glucose and
glycosylated hemoglobin should be monitored. Measurements of glycosylated hemoglobin
may be especially useful for evaluating long-term control (see also DOSAGE AND
ADMINISTRATION in full prescribing information).
Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/hematocrit
and red blood cell indices) and renal function (serum creatinine) should be performed, at
least on an annual basis. While megaloblastic anemia has rarely been seen with metformin
therapy, if this is suspected, vitamin B12 deﬁciency should be excluded.
Drug Interactions (Clinical Evaluation of Drug Interactions Conducted with Metformin):
Glyburide: In a single-dose interaction study in type 2 diabetes patients, coadministration of
metformin and glyburide did not result in any changes in either metformin pharmacokinetics
or pharmacodynamics. Decreases in glyburide AUC and Cmax were observed, but were highly
variable. The single-dose nature of this study and the lack of correlation between glyburide
blood levels and pharmacodynamic effects, makes the clinical signiﬁcance of this interaction
uncertain (see DOSAGE AND ADMINISTRATION: Concomitant Metformin Hydrochloride Tablet
and Oral Sulfonylurea Therapy in Adult Patients in full prescribing information).
Furosemide: A single-dose, metformin-furosemide drug interaction study in healthy
subjects demonstrated that pharmacokinetic parameters of both compounds were affected
by coadministration. Furosemide increased the metformin plasma and blood Cmax by 22%
and blood AUC by 15%, without any signiﬁcant change in metformin renal clearance. When
administered with metformin, the Cmax and AUC of furosemide were 31% and 12% smaller,
respectively, than when administered alone, and the terminal half-life was decreased by 32%,
without any signiﬁcant change in furosemide renal clearance. No information is available
about the interaction of metformin and furosemide when coadministered chronically.
Nifedipine: A single-dose, metformin-nifedipine drug interaction study in normal healthy
volunteers demonstrated that coadministration of nifedipine increased plasma metformin
Cmax and AUC by 20% and 9%, respectively, and increased the amount excreted in the
urine. Tmax and half-life were unaffected. Nifedipine appears to enhance the absorption of
metformin. Metformin had minimal effects on nifedipine.
Cationic Drugs: Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine,
quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by
renal tubular secretion theoretically have the potential for interaction with metformin by
competing for common renal tubular transport systems. Such interaction between metformin
and oral cimetidine has been observed in normal healthy volunteers in both single- and
multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak
metformin plasma and whole blood concentrations and a 40% increase in plasma and
whole blood metformin AUC. There was no change in elimination half-life in the single-dose
study. Metformin had no effect on cimetidine pharmacokinetics. Although such interactions
remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment
of metformin and/or the interfering drug is recommended in patients who are taking cationic
medications that are excreted via the proximal renal tubular secretory system.
Other: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic
control. These drugs include the thiazides and other diuretics, corticosteroids,
phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid,
sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are
administered to a patient receiving metformin, the patient should be closely observed for
loss of blood glucose control. When such drugs are withdrawn from a patient receiving
metformin, the patient should be observed closely for hypoglycemia.
In healthy volunteers, the pharmacokinetics of metformin and propranolol and metformin
and ibuprofen were not affected when coadministered in single-dose interaction studies.
Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact
with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and
probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term carcinogenicity studies
have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of
91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively.
These doses are both approximately four times the maximum recommended human daily
dose of 2000 mg based on body surface area comparisons. No evidence of carcinogenicity
with metformin was found in either male or female mice. Similarly, there was no tumorigenic
potential observed with metformin in male rats. There was however, an increased incidence
of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
There was no evidence of a mutagenic potential of metformin in the following
in vitro tests: Ames test (S. typhimurium), gene mutation test (mouse lymphoma cells),
or chromosomal aberrations test (human lymphocytes). Results in the in vivo mouse
micronucleus test were also negative.
Fertility of male or female rats was unaffected by metformin when administered
at doses as high as 600 mg/kg/day, which is approximately three times the maximum
recommended human daily dose based on body surface area comparisons.
Pregnancy: Teratogenic Effects. Pregnancy Category B: Recent information strongly
suggests that abnormal blood glucose levels during pregnancy are associated with a higher
incidence of congenital abnormalities. Most experts recommend that insulin be used during
pregnancy to maintain blood glucose levels as close to normal as possible. Because animal
reproduction studies are not always predictive of human response, metformin should not
be used during pregnancy unless clearly needed.
There are no adequate and well controlled studies in pregnant women with metformin.
Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This
represents an exposure of about two and six times the maximum recommended human daily
dose of 2000 mg based on body surface area comparisons for rats and rabbits, respectively.
Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Nursing Mothers: Studies in lactating rats show that metformin is excreted into milk and
reaches levels comparable to those in plasma. Similar studies have not been conducted in
nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a
decision should be made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother. If metformin is discontinued, and if
diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.
Pediatric Use: The safety and effectiveness of metformin for the treatment of type 2
diabetes have been established in pediatric patients ages 10 to 16 years (studies have not
been conducted in pediatric patients below the age of 10 years). Use of metformin in this
age group is supported by evidence from adequate and well controlled studies of metformin
in adults with additional data from a controlled clinical study in pediatric patients ages 10
to 16 years with type 2 diabetes, which demonstrated a similar response in glycemic control
to that seen in adults. (See CLINICAL PHARMACOLOGY: Pediatric Clinical Studies in full
prescribing information.) In this study, adverse effects were similar to those described in
adults. (See ADVERSE REACTIONS: Pediatric Patients.) A maximum daily dose of 2000 mg
is recommended. (See DOSAGE AND ADMINISTRATION: Recommended Dosing Schedule:
Pediatrics in full prescribing information.)
Geriatric Use: Controlled clinical studies of metformin did not include sufﬁcient numbers
of elderly patients to determine whether they respond differently from younger patients,
although other reported clinical experience has not identiﬁed differences in responses
between the elderly and younger patients. Metformin is known to be substantially
excreted by the kidney and because the risk of serious adverse reactions to the drug is
greater in patients with impaired renal function, metformin should only be used in
patients with normal renal function (see CONTRAINDICATIONS, WARNINGS, and CLINICAL
PHARMACOLOGY: Pharmacokinetics in full prescribing information). Because aging is
associated with reduced renal function, metformin should be used with caution as age
increases. Care should be taken in dose selection and should be based on careful and
regular monitoring of renal function. Generally, elderly patients should not be titrated to
the maximum dose of metformin (see also WARNINGS and DOSAGE AND ADMINISTRATION
in full prescribing information).
ADVERSE REACTIONS: In a U.S. double-blind clinical study of metformin in patients with
type 2 diabetes, a total of 141 patients received metformin therapy (up to 2550 mg per
day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of
the metformin patients, and that were more common in metformin- than placebo-treated
patients, are listed in Table 1.
Table 1. Most Common Adverse Reactions (> 5%) in a
Placebo-Controlled Clinical Study of Metformin Monotherapy*
Metformin Monotherapy
Placebo
(n = 141)
(n = 145)
Adverse Reaction
% of Patients
Diarrhea
53.2
11.7
Nausea/Vomiting
25.5
8.3
Flatulence
12.1
5.5
Asthenia
9.2
5.5
Indigestion
7.1
4.1
Abdominal Discomfort
6.4
4.8
Headache
5.7
4.8
* Reactions that were more common in metformin- than placebo-treated patients.
Diarrhea led to discontinuation of study medication in 6% of patients treated with
metformin. Additionally, the following adverse reactions were reported in ≥ 1 to ≤ 5%
of metformin patients and were more commonly reported with metformin than placebo:
abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating
increased, taste disorder, chest discomfort, chills, ﬂu syndrome, ﬂushing, palpitation.
Pediatric Patients: In clinical trials with metformin in pediatric patients with type 2
diabetes, the proﬁle of adverse reactions was similar to that observed in adults.
OVERDOSAGE: Overdose of metformin hydrochloride has occurred, including ingestion
of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10%
of cases, but no causal association with metformin hydrochloride has been established.
Lactic acidosis has been reported in approximately 32% of metformin overdose cases
(see WARNINGS). Metformin is dialyzable with a clearance of up to 170 mL/min under
good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of
accumulated drug from patients in whom metformin overdosage is suspected.
Manufactured in India by:
Matrix Laboratories Limited
Secunderabad — 500 003, India
Code No.: MH/DRUGS/25/NKD/89
Manufactured for:
MYLAN®
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
REVISED JANUARY 2010
BS:MX:METB:R1ppt
Page 2 of 2
Counter Points
As part of our ongoing initiative to encourage dialogue on issues
of interest to pharmacists, each month Drug Topics will present
an editorial by a guest columnist writing on a subject of his or
her choice. Send us your feedback; we look forward to sharing it
in an upcoming issue.
DISPENSED AS WRITTEN
Kent Shaw
Let’s eliminate meth labs, not ﬁnd
more of them
I write this in response to the recent Drug Topics editorial
r titled “E-tracking is the right prescription for U.S.
meth
problems”[January 2011]. The notion that an
m
e-tracking system is a better solution for our nation’s meth-lab
crises rather than returning pseudoephedrine (PSE) to its prescription status ignores one simple fact: E-tracking systems are
incapable of reducing meth labs. In fact, e-tracking systems are
fueling our PSE smurﬁng epidemic.
Meth incidents increase in e-tracking states
The latest twist with e-tracking is a Meth Offender Registry
that attempts to prevent criminals from buying PSE. The reality is that meth cookers don’t need to buy PSE — there are
hordes of people willing to make a quick buck by purchasing
the PSE for them. Coupled with the rampant availability of
false identiﬁcations, anyone can buy PSE as often as they
choose. This is why states with e-tracking systems continue
to have increasing numbers of meth labs.
According to a recent AP investigation, since 2008 meth incidents have increased the most in the 3 states that have e-tracking
systems. Meth incidents rose a combined 67% in those states —
34% in Arkansas, 65% in Kentucky, and 164% in Oklahoma.
Tennessee developed its own tracking system and has arrested
large numbers of meth cookers, but in 2010 Tennessee had another record-setting year for meth-lab seizures (an average of
5 meth labs a day were seized — a 41% increase compared to
seizures in 2009). Clearly this is not a problem we can arrest our
way out of, nor can we afford to keep trying to do so.
eliminating PSE smurﬁng and reducing the number of meth labs
from several hundred to 13 in 2010. Mississippi passed a similar
law in July of 2010 and has already experienced a 70% reduction
in meth-related cases statewide.
Drug-endangered children need protection
There is another important topic not discussed in the editorial.
This debate isn’t just about people making meth and ruining their
own lives. It’s also about drug-endangered children. In the 4½
years since Oregon passed its law, Oregon has removed only 2
children from meth labs, instead of the approximately 40 children
it used to rescue each year. Since passing its law, Mississippi has
seen a 75% reduction in the number of children removed from
meth labs. What is a child’s safety worth to our society?
Who in good conscious can advocate for e-tracking when the
facts show that it is reactive at best, has proved ineffective, and is
only exasperating a problem that costs us lives and a great deal of
money? I say shame on those who are proﬁting from this misery
and thwarting attempts to implement a real solution.
Prescription PSE is important for all Americans, not just for
a select few who think they must have PSE, a product that by
all medical standards is considered to be a nonessential medication that doesn’t cure anything and for which there are plenty
of alternatives.
The opinions expressed by guest editorial writers are their own
and do not necessarily represent the views of Drug Topics’ staff or
the staff of Advanstar Communications.
Kent Shaw is the assistant chief of the California Department of
Prescription PSE the only viable solution
The facts clearly dictate that prescription PSE is our only viable
solution if we want to eliminate PSE smurﬁng and greatly reduce
meth labs. In 2006, Oregon returned PSE to its prescription status,
10
DRUG TOPICS
Februar y 2011
Justice, Bureau of Narcotic Enforcement. He is a 25-year lawenforcement veteran. He is also a member of the advisory board of
the National Methamphetamine and Pharmaceutical Initiative.
He can be reached at 916-319-8292.
DrugTopics .c om
First and only FDA-approved, single-ingredient colchicine
TOUGH, BUT GENTLE
COLCRYS® (colchicine, USP) is a modern standard of
care for gout ﬂares.
Help your patients save money on COLCRYS at www.COLCRYS.com.
Important Safety Information
COLCRYS (colchicine, USP) tablets are indicated taking colchicine. Rhabdomyolysis has been
for prophylaxis and the treatment of gout ﬂares.
occasionally observed, especially when colchicine
COLCRYS is contraindicated in patients with renal is prescribed in combination with other drugs
or hepatic impairment who are concurrently known to cause this effect. Monitoring is
prescribed P-gp inhibitors or strong inhibitors of recommended for patients with a history of blood
CYP3A4 as life-threatening or fatal toxicity has dyscrasias or rhabdomyolysis.
been reported. Dose adjustments of COLCRYS
may be required when co-administered
with P-gp or CYP3A4 inhibitors. The most
common adverse events in clinical trials for
the prophylaxis and treatment of gout were
diarrhea and pharyngolaryngeal pain. Rarely,
myelosuppression, thrombocytopenia, and
leukopenia have been reported in patients
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1.800.
FDA.1088.
You may also report negative side effects to
the manufacturer of COLCRYS by calling
1.888.351.3786.
Please see brief summary of full Prescribing Information on adjacent page.
Distributed by AR Scientiﬁc, Inc. A URL Pharma company.
Philadelphia, PA www.urlpharma.com
©2011 URL Pharma, Inc.
All rights reserved.
COL-359
Jan 2011
Printed in USA.
www.COLCRYS.com
1.888.351.3786
24 hours, and occurring in up to 20% of patients given therapeutic
doses. Typical symptoms include cramping, nausea, diarrhea,
abdominal pain, and vomiting. These events should be viewed
as dose-limiting if severe as they can herald the onset of more
signiﬁcant toxicity.
®
COLCRYS (colchicine, USP) tablets for oral use
Brief Summary of full Prescribing Information
The following is a brief summary only. Please see full Prescribing
Information for complete product information.
INDICATIONS AND USAGE
COLCRYS® (colchicine, USP) tablets are indicated for prophylaxis and
the treatment of gout ﬂares.
Prophylaxis of Gout Flares: COLCRYS is indicated for prophylaxis of
gout ﬂares.
Treatment of Gout Flares: COLCRYS is indicated for treatment of
acute gout ﬂares when taken at the ﬁrst sign of a ﬂare.
Familial Mediterranean fever (FMF): COLCRYS is indicated in adults
and children 4 years or older for treatment of familial Mediterranean
fever (FMF).
CONTRAINDICATIONS
Patients with renal or hepatic impairment should not be given COLCRYS
in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all
protease inhibitors, except Fosamprenavir). In these patients, lifethreatening and fatal colchicine toxicity has been reported with
colchicine taken in therapeutic doses.
WARNINGS AND PRECAUTIONS
Fatal Overdose: Fatal overdoses, both accidental and intentional, have
been reported in adults and children who have ingested colchicine.
COLCRYS should be kept out of the reach of children.
Blood Dyscrasias: Myelosuppression, leukopenia, granulocytopenia,
thrombocytopenia, pancytopenia, and aplastic anemia have been
reported with colchicine used in therapeutic doses.
Drug Interactions: Colchicine is a P-gp and CYP3A4 substrate.
Life-threatening and fatal drug interactions have been reported in
patients treated with colchicine given with P-gp and strong CYP3A4
inhibitors.
If treatment with a P-gp or strong CYP3A4 inhibitor is required in
patients with normal renal and hepatic function, the patient’s dose of
colchicine may need to be reduced or interrupted [see DRUG
INTERACTIONS]. Use of COLCRYS in conjunction with P-gp or strong
CYP3A4 inhibitors (this includes all protease inhibitors, except
Fosamprenavir) is contraindicated in patients with renal or hepatic
impairment [see CONTRAINDICATIONS].
Monitor for toxicity and if present consider temporary interruption or
discontinuation of COLCRYS.
Neuromuscular Toxicity: Colchicine-induced neuromuscular toxicity
and rhabdomyolysis have been reported with chronic treatment in
therapeutic doses. Patients with renal dysfunction and elderly
patients, even those with normal renal and hepatic function, are at
increased risk. Concomitant use of atorvastatin, simvastatin,
pravastatin, ﬂuvastatin, gemﬁbrozil, fenoﬁbrate, fenoﬁbric acid, or
benzaﬁbrate (themselves associated with myotoxicity) or cyclosporine
with COLCRYS may potentiate the development of myopathy [see
DRUG INTERACTIONS]. Once colchicine is stopped, the symptoms
generally resolve within 1 week to several months.
ADVERSE REACTIONS
Prophylaxis of Gout Flares: The most commonly reported adverse
reaction in clinical trials of colchicine for the prophylaxis of gout
was diarrhea.
Treatment of Gout Flares: The most common adverse reactions
reported in the clinical trial with COLCRYS for treatment of gout ﬂares
were diarrhea (23%) and pharyngolaryngeal pain (3%).
FMF: Gastrointestinal tract adverse effects are the most frequent
side effects in patients initiating COLCRYS, usually presenting within
DRUG INTERACTIONS
COLCRYS is a substrate of the efﬂux transporter P-glycoprotein
(P-gp). Of the cytochrome P450 enzymes tested, CYP3A4 was mainly
involved in the metabolism of colchicine. If COLCRYS is administered
with drugs that inhibit P-gp, most of which also inhibit CYP3A4,
increased concentrations of colchicine are likely. Fatal drug
interactions have been reported. Physicians should ensure that
patients are suitable candidates for treatment with COLCRYS and
remain alert for signs and symptoms of toxicities related to increased
colchicine exposure as a result of a drug interaction. Signs and
symptoms of COLCRYS toxicity should be evaluated promptly and, if
toxicity is suspected, COLCRYS should be discontinued immediately.
See full Prescribing Information for a complete list of reported
potential interactions.
USE IN SPECIFIC POPULATIONS
s In the presence of mild to moderate renal or hepatic impairment,
adjustment of dosing is not required for treatment of gout ﬂare,
prophylaxis of gout ﬂare, and FMF but patients should be
monitored closely.
s In patients with severe renal impairment for prophylaxis of gout
ﬂares the starting dose should be 0.3 mg/day, for gout ﬂares no
dose adjustment is required but a treatment course should be
repeated no more than once every 2 weeks. In FMF patients, start
with 0.3 mg/day and any increase in dose should be done with
close monitoring.
s In patients with severe hepatic impairment, a dose reduction may be
needed in prophylaxis of gout ﬂares and FMF patients; while a dose
reduction may not be needed in gout ﬂares, a treatment course
should be repeated no more than once every 2 weeks.
s For patients undergoing dialysis, the total recommended dose for
prophylaxis of gout ﬂares should be 0.3 mg given twice a week with
close monitoring. For treatment of gout ﬂares, the total
recommended dose should be reduced to 0.6 mg (1 tablet) x 1 dose
and the treatment course should not be repeated more than once
every two weeks. For FMF patients the starting dose should be 0.3
mg per day and dosing can be increased with close monitoring.
s Pregnancy: Use only if the potential beneﬁt justiﬁes the potential risk
to the fetus.
s Nursing Mothers: Caution should be exercised when administered to
a nursing woman.
s Geriatric Use: The recommended dose of colchicine should be based
on renal function.
Manufactured for:
AR SCIENTIFIC, INC. Philadelphia, PA 19124 USA
by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA
Rev 04, May 2010
Distributed by AR Scientiﬁc, Inc.
A URL Pharma company.
Philadelphia, PA
www.urlpharma.com
COL-272
Counter Points
Letters
Re: “Single, poor, and
desperate” [JP at Large,
January 2011]:
I remember when I worked
retail and folks would come in
to ﬁll prescriptions for their sick
children. I’ve seen the looks on
their faces when they found out
how much their prescriptions
cost. Some parents would turn
around and try to leave without
antibiotics a sick child needed because they couldn’t afford them.
I would take the time to call the doctor and switch the
drug to something else that was just as effective (more effective, in some instances) and cost a lot less.
It’s hard for some patients when they have to choose between food on the table, rent, getting to work, and paying for
doctors and meds.
GETTY IMAGES/PHOTODISC/MATTHIAS TUNGER
Making the call
Debbie Bair, PharmD
TACOMA, WASH.
Coping with shortages
Follow the money
Q: How many pharmacists does it take to ﬁll a
prescription? A: Four. One to call the manufacturer, another to call the wholesaler, a third to
call the doctor and ask for therapeutic substitution, and a fourth to put whatever is left on the
shelf into a bottle!
The drug shortage problem is growing
worse. The “Drug Shortages Summit Report,” based on the Nov. 10, 2010, meeting in Bethesda, Md., is featured in the
January 19th, 2011, e-mail from ASHP
Advocacy. The report suggests reasons for
the shortages and strategies for coping with
them; we all need to get involved with this.
Every patient deserves a good pharmacist, and the patients who don’t get one
are going to feel it until we all ﬁgure out
a way through this crisis.
Susan J. Bliss, RPh, MBA
The article by Kathryn Foxhall about
counterfeit drugs [“Counterfeit drug war
continues,” December 2010] is right on
target. What is bafﬂing is the way pharmaceutical companies continue to ﬂock
to the countries that make the counterfeit
drugs. China is known to be the counterfeit capital of the world, yet companies
like Pfizer (Viagra) and Hoffmann-La
Roche (Tamiﬂu) insist on staying despite
the counterfeiting and contamination of
their products.
Also, it would be nice to have a law
that requires a pharmaceutical product to
indicate where that product was actually
manufactured. The pharmaceutical companies do not want this as proﬁt is more
important to them than patient safety.
Robert S. Katz, RPh
PORTLAND, ORE.
STAMFORD, CONN.
DrugTopics .c om
A little list with a big agenda
I can think of 3 things that would help
with the counterfeit drug problem.
1. Return drug manufacture to the
United States. (FDA would have oversight and it would help the unemployment problem.)
2. Big pharma should go back to
charging reasonable prices for drugs instead of what the market will bear.
3. Place a tariff on imported drugs
(raw materials or processed).
J. Davis, RPh
WAXAHACHIE, TEXAS
R2D2 as RPh
Your article on Plan B [DT blog: DrugTopics.
com] was biased and did not represent my
beliefs on the use of the product. It was a
real disappointment.
The premise that a pharmacist could be
required to dispense product is deprofessionalizing to pharmacy, the profession you
purport to promote. Just as a prescriber has
the “right” to prescribe the drug he considers the proper drug for a patient, based on
his knowledge and preferences, so should
a pharmacist have the ability to decide
whether to dispense. Otherwise pharmacy
professionals are merely vending machines.
Bob Wilbanks, RPh
CLEVELAND, MISS.
Editor’s note: The DT blog is a forum for expression of reader opinion. All contributions that
respect the limits of civil discourse are welcome.
We want to hear from you
Printed and e-mailed letters should be brief
and include the writer’s name, address,
daytime phone number, and date of the
issue you are referencing: Editor,
Drug Topics, 24950 Country Club Blvd., Suite
200, North Olmsted, OH 44070-5351.
E-mail address: drugtopics@advanstar.com.
Letters may be edited for length, style,
content, and clarity at our discretion.
Februar y 2011
DRUG TOPICS
13
Counter Points
JP AT LARGE
Jim Plagakis, RPh
Pharmacy moments remembered
Snapshot. I was walking out front when I saw a young man in his mid-teens staring at
the label of an OTC pain medicine. He was very well dressed. His shoes were well made,
probably by hand, probably in Italy.
“Alfonso,” I said, “You’re back.” I offered a few blocks from the drugstore where I
work. Shriners hospital is the preeminent
my hand.
“Señor Pharmaceutico,” he smiled. burn center for children in the western
“¡Hola. It has been a long time.” His smile hemisphere. It is a charity hospital, but
Alfonso’s parents pay full price for his care.
was luminescent. His eyes bright.
Alfonso was back in town for another
“Are you back for a short visit?” In a
way, I was uncomfortable. I was hoping round of surgeries. He was staying at a
that he did not have to stay for months. It halfway house for teenagers. There’s a
girl from Peru he likes a lot, he said, but
was the Christmas season.
What frightens me the most is what she would be leaving after the bandages
I do not know and how that ignorance come off and the docs make sure there is
can cause me to act in a way that I am no infection.
“Es difícil,” he shrugged. “I have that
not proud of.
The ﬁrst time I met Alfonso, I asked if Latin blood and I am in love, Senor. Es
I could help him and then looked away muy difícil. She is my ﬁrst love.” His eyes
quickly. When I returned my gaze to sparkled. “I am just a boy.”
I asked Alfonso if he would see her
him, he was smiling. I must have looked
stunned. Patient care is the cornerstone again and he sadly told me that her many
of my practice of pharmacy, and at ﬁrst surgeries were complete. “My parents are
I couldn’t even look at this kid. I did not pleased. They want to protect me like I
was still a niño. They
expect his appearance,
believe that she would
and I still cringe when
I did not expect
only be heartache beI remember how JP’s
his appearance,
cause she is beautiful,
famous patient-centric
and I still look like
viewpoint crashed.
and I still cringe
this.”
He spoke in heavily
when I remember
“Perhaps someday.”
accented English. “It’s
how JP’s famous
Why didn’t I just keep
okay,” he said. “I am
patient-centric
quiet?
used to it.” Alfonso is
viewpoint
“Mañana,” he spat
a shopper who wants
crashed.
and then rattled off
to be informed about
something in Spanish.
the OTC drugs he may
He paused, “Always
want to use. He comes
from a country that does not have a nan- mañana, but Señor, tomorrow never
ny government. He knows that he is on comes.”
Snapshot. There are times when I go
his own. He asks lots of questions.
The Shriners Hospital for Children is through my days on automatic. I do my
associated with UTMB (University of Texas job like a robot and do not really keep my
Medical Branch at Galveston) and is only head in the game. There is a man whom
14
DRUG TOPICS
Februar y 2011
I have decided I don’t like very well. He
is way too mouthy for my tastes and has
the nerve to call me buddy, as if we’re best
friends. I am polite, but I can be polite and
chilly at the same time.
He came in with 3 prescriptions the
other day. He looked a bit out of sorts. His
hair was greasy and his clothes were wrinkled. His prescriptions were for Vicodin,
Soma, and a new one for him: alprazolam. Of course, in my head, I labeled him
a drug-seeker and even made a comment
to the technician about what a loser he is.
When I took his prescriptions to the
register, I noticed that a little boy, perhaps
4 years old, was holding his hand. “Your
boy?” I asked.
“He’s all mine now,” he said. “My wife
left us last month, and I’ll be raising him
all by myself.
I thought of the alprazolam and felt a
chill of shame for judging him so harshly.
This was 2 weeks before Christmas.
Snapshot. This week, I saw 2 teenage girls looking at cosmetics. They were
all giggly, the way teenage girls can get. It
sort of irritated me that they were handling the lipsticks. Then I saw their faces.
They were from Shriners hospital, and I
could see that each had many surgeries to
go. They were happy, though, and when
they smiled and their eyes sparkled, I saw
beauty. They were gorgeous.
Jim Plagakis is a community pharmacist
in Galveston, Texas. You can e-mail him
at jpgakis@hotmail.com and cc us at
drugtopics@advanstar.com. You can also check
out his website at jimplagakis.com.
DrugTopics .c om
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cyan
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20611030304R1_1-1.pgs 03.04.2011 18:03
ADVANSTAR_PDF/X-1a
Counter Points
IN MY VIEW
Mike LaRosa, PharmD candidate
Through the eyes of a student:
Pharmacy practice in Istanbul, Turkey
This summer I observed pharmacy practice as few in the United States have seen it. I
was entering my third year of professional study and interested in a practice experience
abroad. In this country, while avenues of practice keep expanding, most would agree
that
of pharmaceutical care is familiar and standardized. I wanted to see how that would
th t delivery
d li
change in a country characterized by different politics, beliefs, and attitudes. In July I headed to
Istanbul, Turkey.
My experience began amid a surging, immensely crowded
population of 12 million people, 98% of whom are Muslim.
The community practice I was going to was located right
off Istiklal Avenue in Taksim Square, in the Beyoglu district
— perhaps the most diverse and progressive sector of a city
steeped in rich tradition.
interactions are very direct. Chairs in which waiting patients may
sit are arranged around the walls, facing into the center of the
room. Overall, in a Turkish pharmacy one sees an emphasis on
the intimate nature of a patient encounter.
Patient expectations
When you understand the structure of a Turkish pharmacy,
even if it’s from the point of view of community pharmacy only,
Routes to professional practice
I quickly learned that for pharmacists in Turkey, primary pro- you can understand the quality of care provided in such a pharfessional options are in either industry or community phar- macy as well as what patients expect from their pharmacists.
My pharmacist made the point that patients are looking
macy, speciﬁcally independent pharmacy. This is in notable
for remedies to illness, not monitoring of outcontrast to the status quo in America, where
comes. In this regard community pharmacists
most career paths lead to either retail chains or
in Turkey feel somewhat frustrated, since they
hospitals and health systems.
Patients are
have the pharmaceutical knowledge and see
Conversations with Turkish pharmacy students
looking for
enough patients to know which medication is
gave me the impression that industry offered
remedies to
associated with the most favorable outcomes.
attractive beneﬁts, including the opportunity to
illness, not
However, in the view of most patients, the docbalance reimbursement (i.e., work) with quality
monitoring of tor is the only individual responsible for betof life, a major concern of new pharmacists. This
tering their health. The pharmacist is simply a
issue drives career decisions and ultimately the
outcomes.
means to an end.
way the profession evolves. I also observed that
I think the most valuable lesson I learned
the training students receive is designed almost
exclusively along the lines of industrial practice. In Turkey we during my visit to Turkey was just how much pharmacy is
won’t ﬁnd the clinically focused care model we’re used to; the evolving. Both my pharmacist and the students I worked with
were extremely generous with their time and knowledge.
incentives for practitioners are simply not there.
I feel that the experience of living in such a culturally diAlmost all medications in Turkey can be obtained without
prescription. Those medications requiring a prescription are paid verse region has added tremendously to my outlook on my
for almost entirely through government insurance. In Turkey, career and taught me the importance of tolerance in a pharmedications are mostly the same as those available in the United macy practice conducted among people of different cultures,
States, but they are kept behind the counter and organized in beliefs, and expectations.
glass cabinets according to disease state. All tablets and capsules
come in unit-of-use boxes of varying amounts. In addition, al- Mike LaRosa is a third-year pharmacy student at Jefferson School
most half the cabinet space is devoted to vitamin and herbal sup- of Pharmacy, Thomas Jefferson University, in Philadelphia. To read
plements. Patients are received in the center of the pharmacy at more about his experience, visit http://istanbulpharmacy.blogspot.
a waist-level counter that runs along the entire pharmacy. Many com. He can be reached at michael.larosa@jefferson.edu.
16
DRUG TOPICS
Februar y 2011
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Up front
INDUSTRY NEWS & ANALYSIS
Boutique focuses on needs of breast-cancer patients
An independent drugstore recently expanded its boutique section
for breast-cancer patients to include a wide variety of medical
products and clothing.
Lehan Drugs and Home Medical Equipment in DeKalb, Ill.,
now includes a 2,500-square-foot Women’s Health Department
and Boutique that boasts 3 private dressing rooms and 3 certified
lymphedema garment fitters.
The Lehan family, which includes owners Tim and Ann
Lehan; their daughter-in-law and pharmacist son; Tim’s brother,
Patrick; and his sister, Terri Lehan Hettel, first added women’s
health products to the drug- and medical-equipment store 7 or
8 years ago, after cancer patients visiting the store asked for
lymphedema compression socks. “We wanted to be certified fitters
in lymphedema garments, and it became obvious to us that we
needed to start looking into being a mastectomy fitter,” said Lehan
Hettel, who manages the store. Many specialized products followed.
Today’s expanded Women’s Health Department and Boutique
features products for all women. “We do bra fittings for everyone,
and we have everything from ‘hot flash pajamas’ to scarves to
hats with built-in sun protection,” Lehan Hettel said.
More than 90 area doctors refer their breast-cancer patients to
Lehan’s. And because it is the only drugstore in the community to
offer this service, new patients consistently seek out Lehan Drugs.
— Christine Blank, Contributing Editor
A family affair: Four generations have served Lehan’s since the ﬁrst store opened its doors in 1964.
BIOTECHNOLOGY
Flu vaccine patch to get 5-year test; beats
traditional injection for effectiveness in animals
A revolutionary ﬂu vaccine patch is likely to be developed in
the course of an upcoming 5-year clinical trial.
The National Institutes of Health (NIH) recently awarded
$10 million to the Georgia Institute of Technology, Emory
University, and PATH, a nonproﬁt organization in Seattle,
Wash., to test and reﬁne the inﬂuenza vaccine patch.
The technology allows for the painless self-administration
of ﬂu vaccine by means of tiny microneedles that dissolve into
the skin. The 5-year grant will advance the microneedle patch
through a Phase 1 clinical trial and compare the effectiveness of
traditional intramuscular injection of ﬂu vaccine to that of microneedle patches. In animals, vaccination with the dissolving
microneedles has been
shown to have greater
effectiveness than vaccination with hypodermic needles, according
to researchers.
“We have seen
evidence that the vaccine works even better
18
DRUG TOPICS
Februar y 2011
when administered to the skin because of the plethora of antigenpresenting cells which reside there. This study will allow us to
determine how we can optimize the vaccine to take advantage
of those cells that are important in generating the body’s immune
response,” said Ioanna Skountzou, co-principal investigator for
the project and assistant professor in Emory University’s Department of Microbiology and Immunology.
The technology will also increase the number of people
being vaccinated — especially susceptible populations such as
children and the elderly — and reduce healthcare costs, according to Mark Prausnitz, the project’s principal investigator
and a professor in the Georgia Tech School of Chemical and
Biomolecular Engineering.
“We believe a self-administered vaccine patch could reduce
healthcare costs in 2 ways. First, self-administration removes
the need to visit a clinic and use the precious time of a doctor or nurse. Second, the convenience of self-administration
should increase the number of people getting vaccinated,
which will reduce the number of people getting sick with inﬂuenza,” Prausnitz said.
Although the patch would initially be available by prescription only, it could become over-the-counter at some point in
the future, Prausnitz said.
— Christine Blank, Contributing Editor
Continued on pg. 20
DrugTopics .c om
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Up front
U
Continued from pg. 18
HANDS-ON LEARNING
New pharmacy school offers unique
3-calendar-year PharmD program
This fall, Saint Joseph College School of Pharmacy will open
the doors of its new 35,000-square-foot facility in the heart of
downtown Hartford, Conn., to its ﬁrst class of students. With
an expected enrollment of 68, the new school will offer a
unique 3-calendar-year doctoral degree program in pharmacy
(PharmD), which represents the ﬁrst doctoral program in the
college’s 78-year history.
Modeled after curriculum employed at the University of
Southern Nevada College of Pharmacy (Henderson), the program
emphasizes a student-centered, active learning environment. The
curriculum is organized in blocks, allowing students to concentrate on 1 course at a time through a variety of learning activities,
rather than in the traditional lecture format.
“We have student-centered, small-group learning. Professors
are not expected to walk into a large lecture
room and give a lecture where students learn
passively. Instead, our classrooms are designed in the round, with the professor at the
center, so that students are engaged and able
to participate in the educational experience,”
said Joseph R. Ofosu, PharmD, RPh, dean of
Saint Joseph College School of Pharmacy.
Joseph R. Ofosu
Once a week, beginning in the ﬁrst semester, pharmacy students will be introduced to practice experiences in community and institutional pharmacy settings.
“Community sites range from small independent pharmacies
to the largest chain pharmacies. Various institutional rotations
include large medical centers, small community hospitals, longterm-care pharmacies, and home IV pharmacies. This will allow
the students plenty of time to experience all that pharmacy has to
offer. In the third year, the students will have an even larger choice
of locations for more advanced rotations,” said John Parsi, RPh,
CDE, the pharmacy school’s director of experiential education.
The new pharmacy school provides students hands-on learning in patient care, dispensing, and all the other areas that a pharmacist can pursue.
“Pharmacists have many career pathways open to them beyond dispensing, including health insurance, home-care services,
government sectors, research, and teaching,” said Dr. Ofosu, who
most recently served as associate dean for Academic Affairs at
Howard University College of Pharmacy, Nursing and Allied
Health Sciences.
“This is a profession that will continue to do well. The need
for drug or medication specialists is going to grow, due to the
aging population and the new approach to healthcare. Nurses,
pharmacists, and other healthcare professionals are going to play
key roles. The new healthcare law and society are expecting more
from the pharmacy profession,” Dr. Ofosu said.
— Julia Talsma, Editor-in-Chief
20
DRUG TOPICS
Februar y 2011
HEALTHY OPTIONS
Walgreens brings fresh produce to “food deserts”
In addition to its role as a pharmacy provider, Walgreens seems
to be morphing into a supermarket in some U.S. cities.
In 10 of its Chicago-area stores, Walgreens is piloting a program to provide healthy food options such as fresh fruits and
vegetables, frozen meats and ﬁsh, eggs, and whole-grain cereals
and pastas in its stores. In fact, it is carrying 750 new food items
in each of the 10 stores, which are primarily in the south and
west sides of Chicago.
Walgreens’ executives chose those locations to pilot food
stores because they are in urban areas where there are no supermarkets or other retail locations selling healthy food, leaving
neighborhood residents few options beyond high-calorie fast
foods or processed food products sold by convenience stores.
“Last year, we were approached by Chicago’s mayor, Richard
M. Daley, about ﬁnding ways to address ‘food deserts.’ Because
we are the city’s most accessible retailer, we decided to look at
how we could help in places where there was limited or no
access to healthy food options,” said Don Whetstone, senior
director, new format development, Walgreens.
Walgreens started
rolling out the redesigned Chicago stores
last year. “We are focused on health and
wellness, and this is one
more way we can help
improve the health outcomes of customers and
patients in the area,”
Whetstone said.
In an increasingly competitive big-chain marAccording to Whetketplace, Walgreens’ act of social service may
also help its bottom line.
stone, the biggest chal(Photo courtesy of Walgreens)
lenge connected with
adding fresh and frozen food to drugstores is determining the
right product mix to serve the community.
“So far, we are hearing very positive feedback from customers about the offerings, and they are pretty vocal about letting
our store managers know what items they would like to see
more of,” Whetstone said.
While Walgreens’ executives are considering adding the full
line of “healthy foods” to other Walgreens’ stores, they have not
yet announced locations in other cities. “The concept of a food
desert is not exclusive to Chicago … [but] Chicago is the only
city with this pilot at this time,” Whetstone said.
However, that may soon change. According to a recent
Reuters report, at the company’s annual meeting in January,
Walgreens executives announced a plan to bring similar initiatives to some 300 to 500 stores in the company’s chain of more
than 7,600.
— Christine Blank, Contributing Editor
DrugTopics .c om
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Issues & Trends
Up front
In Depth
Fred Gebhart, Contributing Editor
New report advocates replacing Medicaid FFS with
managed pharmacy benefit
A
new report urges states to replace
Medicaid fee-for-service pharmacy
programs with the kind of managed drug beneﬁts used in Medicare Part
D plans, Medicaid managed care organizations, and some commercial health plans.
Why drop FFS? Optimal pharmacy
benefit management could save $30
billion over the next decade, the report
claimed. In the near term, savings of $12
per member per month in 2011 can be
expected.
The claim comes in an analysis of
Medicaid drug spending commissioned
by the Pharmaceutical Care Management
Association (PCMA) and conducted by
The Lewin Group, healthcare and human services consultants. The projected
savings include a combination of reduced
dispensing fees, reduced ingredient-cost
reimbursement, increased generic use,
and decreased drug utilization. The key
message in the report is that pharmacy
beneﬁt managers (PBMs) can cut Medicaid expenditures.
PBMs can cut Medicaid costs
“We, like every other health-related
group, have been looking for ways to
save money in Medicaid without cutting
benefits or harming patients,” PCMA
President and CEO Mark Merritt told
Drug Topics. “Medicaid is not a traditional
PBM space, but this is a space legislators
are going to look into. This report is intended to spark discussion so policymakers don’t start slashing without seeing the
larger picture.”
Merritt said the key audience for the
report is governors and state legislators
around the nation. PCMA hit the same
22
DRUG TOPICS
Februar y 2011
audience with a telephone survey of registered voters suggesting that respondents
preferred to cut expenditures for prescription-drug coverage rather than cutting
payments to physicians or hospitals. There
was no immediate reaction from state ofﬁcials, but at least one pharmacy group
said PCMA was using Medicaid spending
to build support for its PBM membership.
Flawed assumptions
The National Community Pharmacists Association (NCPA) criticized the underlying
policy assumptions in the Lewin report,
starting with the lack of distinctions drawn
between Medicaid and Medicare program
requirements and populations as well as
the lack of attention given to differences
between state Medicaid programs and the
ﬁnancial dependence of PBMs on rebates
from brand-name drug manufacturers.
“The point we want to highlight is really the PBM track record when it comes
to a serious cost-cutting mechanism —
generic drugs — which is obviously undercut by their brand-name drug rebates,”
said NCPA spokesman John Norton.
Overlooked impact
NCPA also said the report failed to recognize the potential impact of reduced reimbursement on pharmacy access, the pending expansion of the Medicaid population
base, the likelihood that reducing drug utilization and drug treatments would boost
overall medical expenditures, the lack of
prescribing controls in the Lewin model,
widely different generic dispensing rates
among states, and controls on nongeneric
products needed to reduce expenditures to
the projected levels.
Lewin analysts concluded that FFS
programs account for 73% of all Medicaid pharmacy benefit spending. Dispensing fees, ingredient costs, and benefit management are directed by state
ofﬁcials who are subject to local political
pressures, Merritt said.
Medicare Part D, Medicaid managed
care organizations, and state employee
plans typically use private-sector PBMs to
set dispensing fees, ingredient reimbursement, and generic dispensing goals, and
other plan parameters.
“Medicaid is the last large unmanaged
pharmacy beneﬁt in the country,” Merritt
said. “Medicaid dispensing fees are double
the fees paid under Medicare.”
Merritt said PCMA wants to bring the
same kind of management to Medicaid
pharmacy benefits that Medicare and
other drug programs employ. NCPA suggested that states could provide more effective care at lower cost by focusing on
generic drug substitution and use than by
bringing PBMs into Medicaid.
Generics ﬁrst
“All plans, including state Medicaid FFS
plans, will realize signiﬁcant savings by
implementing a ‘generics ﬁrst’ plan design,” NCPA said in a written statement.
“PBMs are not a critical component of
implementing these plan designs. Recent
generic dispensing rates from the big 3
PBMs demonstrate that the retail channel effectively drives generics across all
types of plans. In 2009, all of the PBMs
had signiﬁcantly lower generic dispensing
rates associated with their mail pharmacies where they were solely responsible for
generic dispensing.”
DrugTopics .c om
See the effect of LEXAPRO
Proven efﬁcacy in MDD in adolescents aged
12 to 17, and in MDD and GAD in adults1-5
In adolescents aged 12 to 17 with
Major Depressive Disorder (MDD)*1
In adults with MDD and Generalized
Anxiety Disorder (GAD)1
LEXAPRO and citalopram are not the same1,6,7
• LEXAPRO is approved for MDD and GAD1;
citalopram is not approved for GAD.6
• LEXAPRO is approved for MDD in adolescents
aged 12 to 17 years1; citalopram is not.6
There is no generic available for LEXAPRO
*LEXAPRO is indicated as an integral part of a total treatment program for MDD.
Drug treatment may not be indicated for all adolescents with this syndrome.
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and
young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of
Lexapro or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term
studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was
a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy
should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use
in pediatric patients less than 12 years of age.
Contraindications
• Lexapro is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). There have been reports of serious, sometimes
fatal, reactions with some cases resembling neuroleptic malignant syndrome (NMS) and serotonin syndrome. Features may include
hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid ﬂuctuations of vital signs, and mental status changes
that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have
recently discontinued SSRI treatment and have been started on an MAOI. Serotonin
syndrome was reported for two patients who were concomitantly receiving linezolid,
an antibiotic which has MAOI activity. Lexapro should not be used in combination with
an MAOI or within 14 days of discontinuing an MAOI. MAOIs should not be initiated within
14 days of discontinuing Lexapro.
• Lexapro is contraindicated in patients taking pimozide
or with hypersensitivity to escitalopram or citalopram.
Please see additional Important Safety Information on adjacent page.
Visit the LEXAPRO website at www.lexapro.com
There is no generic available
for LEXAPRO
Lexapro (escitalopram oxalate) is indicated for the acute and maintenance treatment of major depressive disorder (MDD) in adults
and adolescents aged 12-17 years. Lexapro is also indicated for the acute treatment of generalized anxiety disorder (GAD) in adults.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
• All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening,
suicidality and unusual changes in behavior, especially within the ﬁrst few months of treatment or when changing the dose.
Consideration should be given to changing the therapeutic regimen, including discontinuing medication, in patients whose
depression is persistently worse, who are experiencing emergent suicidality or symptoms that might be precursors to worsening
depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting
symptoms. Families and caregivers of patients treated with antidepressants should be alerted about the need to monitor patients
daily for the emergence of agitation, irritability, unusual changes in behavior, or the emergence of suicidality, and report such
symptoms immediately. Prescriptions for Lexapro should be written for the smallest quantity of tablets, consistent with good
patient management, in order to reduce the risk of overdose.
• A major depressive episode may be the initial presentation of bipolar disorder. In patients at risk for bipolar disorder, treating
such an episode with an antidepressant alone may increase the likelihood of precipitating a mixed/manic episode. Prior to
initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar
disorder. Lexapro should be used cautiously in patients with a history of mania or seizure disorder. Lexapro is not approved for
use in treating bipolar depression.
• The concomitant use of Lexapro with other SSRIs, SNRIs, triptans, tryptophan, antipsychotics or other dopamine antagonists
is not recommended due to potential development of life-threatening serotonin syndrome or neuroleptic malignant syndrome
(NMS)-like reactions. Reactions have been reported with SNRIs and SSRIs alone, including Lexapro, but particularly with drugs
that impair metabolism of serotonin (including MAOIs). Management of these events should include immediate discontinuation
of Lexapro and the concomitant agent and continued monitoring.
• Patients should be monitored for adverse reactions when discontinuing treatment with Lexapro. During marketing of Lexapro and
other SSRIs and SNRIs, there have been spontaneous reports of adverse events occurring upon discontinuation, including dysphoric
mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias), anxiety, confusion, headache, lethargy, emotional
lability, insomnia and hypomania. A gradual dose reduction rather than abrupt cessation is recommended whenever possible.
• SSRIs and SNRIs have been associated with clinically signiﬁcant hyponatremia. Elderly patients and patients taking diuretics or
who are otherwise volume-depleted appear to be at a greater risk. Discontinuation of Lexapro should be considered in patients
with symptomatic hyponatremia and appropriate medical intervention should be instituted.
• SSRIs (including Lexapro) and SNRIs may increase the risk of bleeding. Patients should be cautioned that concomitant use of
aspirin, NSAIDs, warfarin or other anticoagulants may add to the risk.
• Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain
that Lexapro does not affect their ability to engage in such activities.
• Lexapro should be used with caution in patients with severe renal impairment or with diseases or conditions that alter metabolism
or hemodynamic responses. In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma
concentrations were increased. The recommended dose of Lexapro in hepatically impaired patients is 10 mg/day.
• For pregnant or nursing mothers, Lexapro should be used only if the potential beneﬁt justiﬁes the potential risk to the fetus or child.
Adverse Reactions
• In clinical trials of MDD, the most common adverse reactions in adults treated with Lexapro (approximately 5% or greater
and at least twice the incidence of placebo) were nausea (15% vs 7%), insomnia (9% vs 4%), ejaculation disorder (9%
vs <1%), fatigue (5% vs 2%), somnolence (6% vs 2%), and increased sweating (5% vs 2%). In pediatric patients, the overall
proﬁle of adverse reactions was similar to that seen in adults; however, the following additional adverse reactions were
reported at an incidence of at least 2% for Lexapro and greater than placebo: back pain, urinary tract infection, vomiting, and
nasal congestion.
• In clinical trials of GAD, the most common adverse reactions in adults treated with Lexapro (approximately 5% or greater and at
least twice the incidence of placebo) were nausea (18% vs 8%), ejaculation disorder (14% vs 2%), insomnia (12% vs 6%), fatigue
(8% vs 2%), decreased libido (7% vs 2%) and anorgasmia (6% vs <1%).
References: 1. LEXAPRO [package insert]. St. Louis, Mo: Forest Pharmaceuticals, Inc.; 2009. 2. Emslie GJ, Ventura D, Korotzer A,
Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial.
J Am Acad Child Adolesc Psychiatry. 2009;48:721-729. 3. Burke WJ, Gergel I, Bose A. Fixed-dose trial of the single isomer SSRI
escitalopram in depressed outpatients. J Clin Psychiatry. 2002;63:331-336. 4. Davidson JRT, Bose A, Korotzer A, Zheng H. Escitalopram
in the treatment of generalized anxiety disorder: double-blind, placebo controlled, ﬂexible-dose study. Depress Anxiety. 2004;19:234240. 5. Wade A, Lemming OM, Hedegaard KB. Escitalopram 10 mg/day is effective and well tolerated in a placebo-controlled
study in depression in primary care. Int Clin Psychopharmacol. 2002;17:95-102. 6. Celexa [package insert]. St. Louis, Mo: Forest
Pharmaceuticals, Inc.; 2009. 7. Mork A, Kreilgaard M, Sanchez C. The R-enantiomer of citalopram counteracts escitalopram-induced
increase in extracellular 5-HT in the frontal cortex of freely moving rats. Neuropharmacology. 2003;45:167-173.
Please see accompanying brief summary of Prescribing Information
for LEXAPRO, including Boxed Warning.
© 2010 Forest Laboratories, Inc.
Printed in U.S.A.
41-1017601r
5/10
Visit the LEXAPRO website at www.lexapro.com
LEXAPRO® (escitalopram oxalate) TABLETS/ORAL SOLUTION
Brief Summary: For complete details, please see full Prescribing Information for Lexapro.
Rx Only
WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and
young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of
Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term
studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was
a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant
therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not
approved for use in pediatric patients less than 12 years of age. [See Warnings and Precautions: Clinical Worsening and Suicide Risk,
Patient Counseling Information: Information for Patients, and Used in Specific Populations: Pediatric Use].
INDICATIONS AND USAGE: Major Depressive Disorder-Lexapro (escitalopram) is indicated for the acute and maintenance treatment of major
depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies]. A major depressive episode (DSM-IV) implies a
prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight
and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed
thinking or impaired concentration, a suicide attempt or suicidal ideation. Generalized Anxiety Disorder-Lexapro is indicated for the acute
treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies]. Generalized Anxiety Disorder (DSM-IV) is characterized by
excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It
must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty
concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
CONTRAINDICATIONS: Monoamine oxidase inhibitors (MAOIs)-Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is
contraindicated [see Warnings and Precautions]. Pimozide-Concomitant use in patients taking pimozide is contraindicated [see Drug
Interactions]. Hypersensitivity to escitalopram or citalopram-Lexapro is contraindicated in patients with a hypersensitivity to escitalopram or
citalopram or any of the inactive ingredients in Lexapro.
WARNINGS AND PRECAUTIONS: Clinical Worsening and Suicide Risk-Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in
behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a
known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There
has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of
suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant
drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and
young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase
in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive
compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients.
The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials
(median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among
drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of
suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively
stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per
1000 patients treated) are provided in Table 1.
TABLE 1
Age Range
Drug-Placebo Difference in Number of Cases
of Suicidality per 1000 Patients Treated
Increases Compared to Placebo
<18
14 additional cases
18-24
5 additional cases
Decreases Compared to Placebo
25-64
1 fewer case
65
6 fewer cases
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However,
there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the
recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed
closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy,
or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric
patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal
impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should
be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently
worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially
if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with
certain symptoms [see Dosage and Administration]. Families and caregivers of patients being treated with antidepressants for major depressive
disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of
agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report
such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers [see also
Patient Counseling Information]. Prescriptions for Lexapro should be written for the smallest quantity of tablets consistent with good patient
management, in order to reduce the risk of overdose. Screening Patients for Bipolar Disorder-A major depressive episode may be the initial
presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of
the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients
with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a
detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Lexapro is not approved
for use in treating bipolar depression. Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions-The development of a
potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and
SSRIs alone, including Lexapro treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which
impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may
include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of
serotonin syndrome or NMS-like signs and symptoms. The concomitant use of Lexapro with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Lexapro with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of
the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of Lexapro with serotonin precursors
(such as tryptophan) is not recommended. Treatment with Lexapro and any concomitant serotonergic or antidopaminergic agents, including
antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Discontinuation of Treatment with Lexapro-During marketing of Lexapro and other SSRIs and SNRIs (serotonin and norepinephrine reuptake
inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt,
including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there
have been reports of serious discontinuation symptoms. Patients should be monitored for these symptoms when discontinuing treatment with
Lexapro. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur
following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose but at a more gradual rate [see Dosage and Administration]. Seizures-Although
anticonvulsant effects of racemic citalopram have been observed in animal studies, Lexapro has not been systematically evaluated in patients
with a seizure disorder. These patients were excluded from clinical studies during the product’s premarketing testing. In clinical trials of Lexapro,
cases of convulsion have been reported in association with Lexapro treatment. Like other drugs effective in the treatment of major depressive
disorder, Lexapro should be introduced with care in patients with a history of seizure disorder. Activation of Mania/Hypomania-In placebocontrolled trials of Lexapro in major depressive disorder, activation of mania/hypomania was reported in one (0.1%) of 715 patients treated with
Lexapro and in none of the 592 patients treated with placebo. One additional case of hypomania has been reported in association with Lexapro
treatment. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with
racemic citalopram and other marketed drugs effective in the treatment of major depressive disorder. As with all drugs effective in the treatment
of major depressive disorder, Lexapro should be used cautiously in patients with a history of mania. Hyponatremia-Hyponatremia may occur as
a result of treatment with SSRIs and SNRIs, including Lexapro. In many cases, this hyponatremia appears to be the result of the syndrome of
inappropriate antidiuretic hormone secretion (SIADH), and was reversible when Lexapro was discontinued. Cases with serum sodium lower than
110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk [see Geriatric Use]. Discontinuation of Lexapro should be considered
in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia
include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and
symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Abnormal Bleeding-SSRIs and SNRIs, including Lexapro, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal
anti-inflammatory drugs, warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological studies (case-control and
cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to
life-threatening hemorrhages. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Lexapro and
NSAIDs, aspirin, or other drugs that affect coagulation. Interference with Cognitive and Motor Performance-In a study in normal volunteers,
Lexapro 10 mg/day did not produce impairment of intellectual function or psychomotor performance. Because any psychoactive drug may impair
judgment, thinking, or motor skills, however, patients should be cautioned about operating hazardous machinery, including automobiles, until
they are reasonably certain that Lexapro therapy does not affect their ability to engage in such activities. Use in Patients with Concomitant
Illness-Clinical experience with Lexapro in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using Lexapro
in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. Lexapro has not been systematically
evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were generally excluded from clinical studies during the product’s premarketing testing. In subjects with hepatic impairment, clearance of racemic citalopram was
decreased and plasma concentrations were increased. The recommended dose of Lexapro in hepatically impaired patients is 10 mg/day [see
Dosage and Administration]. Because escitalopram is extensively metabolized, excretion of unchanged drug in urine is a minor route of elimination. Until adequate numbers of patients with severe renal impairment have been evaluated during chronic treatment with Lexapro, however, it
should be used with caution in such patients [see Dosage and Administration]. Potential for Interaction with Monoamine Oxidase InhibitorsIn patients receiving serotonin reuptake inhibitor drugs in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of
serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital
signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in
patients who have recently discontinued SSRI treatment and have been started on an MAOI. Some cases presented with features resembling
neuroleptic malignant syndrome. Furthermore, limited animal data on the effects of combined use of SSRIs and MAOIs suggest that these drugs
may act synergistically to elevate blood pressure and evoke behavioral excitation. Therefore, it is recommended that Lexapro should not be used
in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after
stopping Lexapro before starting an MAOI. Serotonin syndrome has been reported in two patients who were concomitantly receiving linezolid,
an antibiotic which is a reversible non-selective MAOI.
ADVERSE REACTIONS: Clinical Trials Experience-Because clinical studies are conducted under widely varying conditions, adverse reaction
rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect
the rates observed in practice. Clinical Trial Data Sources; Pediatrics (6 -17 years)-Adverse events were collected in 576 pediatric patients
(286 Lexapro, 290 placebo) with major depressive disorder in double-blind placebo-controlled studies. Safety and effectiveness of Lexapro in
pediatric patients less than 12 years of age has not been established. Adults-Adverse events information for Lexapro was collected from 715
patients with major depressive disorder who were exposed to escitalopram and from 592 patients who were exposed to placebo in double-blind,
placebo-controlled trials. An additional 284 patients with major depressive disorder were newly exposed to escitalopram in open-label trials. The
adverse event information for Lexapro in patients with GAD was collected from 429 patients exposed to escitalopram and from 427 patients
exposed to placebo in double-blind, placebo-controlled trials. Adverse events during exposure were obtained primarily by general inquiry and
recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of
the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized
event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify
reported adverse events. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a
treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened
while receiving therapy following baseline evaluation. Adverse Events Associated with Discontinuation of Treatment; Major Depressive
Disorder; Pediatrics (6 -17 years)-Adverse events were associated with discontinuation of 3.5% of 286 patients receiving Lexapro and 1% of
290 patients receiving placebo. The most common adverse event (incidence at least 1% for Lexapro and greater than placebo) associated with
discontinuation was insomnia (1% Lexapro, 0% placebo). Adults-Among the 715 depressed patients who received Lexapro in placebo-controlled
trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed-dose studies,
the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro was not significantly different from the rate of discontinuation for adverse events in patients receiving placebo. The rate of discontinuation for adverse events in patients assigned to a fixed dose of
20 mg/day Lexapro was 10%, which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day
Lexapro (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro,
and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients). Generalized Anxiety
Disorder; Adults-Among the 429 GAD patients who received Lexapro 10-20 mg/day in placebo-controlled trials, 8% discontinued treatment due
to an adverse event, as compared to 4% of 427 patients receiving placebo. Adverse events that were associated with the discontinuation of at
least 1% of patients treated with Lexapro, and for which the rate was at least twice the placebo rate, were nausea (2%), insomnia (1%), and
fatigue (1%). Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials; Major Depressive Disorder; Pediatrics (6 -17 years)-The
overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies, as shown in Table 2. However, the
following adverse reactions (excluding those which appear in Table 2 and those for which the coded terms were uninformative or misleading)
were reported at an incidence of at least 2% for Lexapro and greater than placebo: back pain, urinary tract infection, vomiting, and nasal
congestion. Adults-The most commonly observed adverse reactions in Lexapro patients (incidence of approximately 5% or greater and approximately twice the incidence in placebo patients) were insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased,
fatigue, and somnolence. Table 2 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred
among 715 depressed patients who received Lexapro at doses ranging from 10 to 20 mg/day in placebo-controlled trials. Events included are
those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than
the incidence in placebo-treated patients.
TABLE 2
Treatment-Emergent Adverse Reactions Observed with a Frequency of 2%
and Greater Than Placebo for Major Depressive Disorder
Adverse Reaction
Autonomic Nervous System Disorders
Dry Mouth
Sweating Increased
Central & Peripheral Nervous System Disorders
Dizziness
Gastrointestinal Disorders
Nausea
Diarrhea
Constipation
Indigestion
Abdominal Pain
General
Influenza-like Symptoms
Fatigue
Psychiatric Disorders
Insomnia
Somnolence
Appetite Decreased
Libido Decreased
Respiratory System Disorders
Rhinitis
Sinusitis
Urogenital
Ejaculation Disorder1,2
Impotence2
Anorgasmia3
Lexapro
(N=715)
Placebo
(N=592)
6%
5%
5%
2%
5%
3%
15%
8%
3%
3%
2%
7%
5%
1%
1%
1%
5%
5%
4%
2%
9%
6%
3%
3%
4%
2%
1%
1%
5%
3%
4%
2%
9%
3%
2%
<1%
<1%
<1%
1Primarily ejaculatory delay.
2Denominator used was for males only (N=225 Lexapro; N=188 placebo).
3Denominator used was for females only (N=490 Lexapro; N=404 placebo).
Generalized Anxiety Disorder; Adults-The most commonly observed adverse reactions in Lexapro patients (incidence of approximately 5% or
greater and approximately twice the incidence in placebo patients) were nausea, ejaculation disorder (primarily ejaculatory delay), insomnia,
fatigue, decreased libido, and anorgasmia. Table 3 enumerates the incidence, rounded to the nearest percent of treatment-emergent adverse
events that occurred among 429 GAD patients who received Lexapro 10 to 20 mg/day in placebo-controlled trials. Events included are those
occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the
incidence in placebo-treated patients.
TABLE 3
Treatment-Emergent Adverse Reactions Observed with a Frequency of 2%
and Greater Than Placebo for Generalized Anxiety Disorder
Adverse Reactions
Lexapro
Placebo
(N=429)
(N=427)
Autonomic Nervous System Disorders
Dry Mouth
9%
5%
Sweating Increased
4%
1%
Central & Peripheral Nervous System Disorders
Headache
24%
17%
Paresthesia
2%
1%
Gastrointestinal Disorders
Nausea
18%
8%
Diarrhea
8%
6%
Constipation
5%
4%
Indigestion
3%
2%
Vomiting
3%
1%
Abdominal Pain
2%
1%
Flatulence
2%
1%
Toothache
2%
0%
General
Fatigue
8%
2%
Influenza-like Symptoms
5%
4%
Musculoskeletal System Disorder
Neck/Shoulder Pain
3%
1%
Psychiatric Disorders
Somnolence
13%
7%
Insomnia
12%
6%
Libido Decreased
7%
2%
Dreaming Abnormal
3%
2%
Appetite Decreased
3%
1%
Lethargy
3%
1%
LEXAPRO® (escitalopram oxalate) TABLETS/ORAL SOLUTION
Adverse Reactions
TABLE 3
Treatment-Emergent Adverse Reactions Observed with a Frequency of 2%
and Greater Than Placebo for Generalized Anxiety Disorder (continued)
Lexapro
(N=429)
Respiratory System Disorders
Yawning
Urogenital
Ejaculation Disorder1,2
Anorgasmia3
Menstrual Disorder
LEXAPRO® (escitalopram oxalate) TABLETS/ORAL SOLUTION
Placebo
(N=427)
2%
1%
14%
6%
2%
2%
<1%
1%
1Primarily ejaculatory delay.
2Denominator used was for males only (N=182 Lexapro; N=195 placebo).
3Denominator used was for females only (N=247 Lexapro; N=232 placebo).
Dose Dependency of Adverse Reactions-The potential dose dependency of common adverse reactions (defined as an incidence rate of 5% in
either the 10 mg or 20 mg Lexapro groups) was examined on the basis of the combined incidence of adverse events in two fixed-dose trials.
The overall incidence rates of adverse events in 10 mg Lexapro-treated patients (66%) was similar to that of the placebo-treated patients (61%),
while the incidence rate in 20 mg/day Lexapro-treated patients was greater (86%). Table 4 shows common adverse reactions that occurred in
the 20 mg/day Lexapro group with an incidence that was approximately twice that of the 10 mg/day Lexapro group and approximately twice that
of the placebo group.
Adverse Reaction
Insomnia
Diarrhea
Dry Mouth
Somnolence
Dizziness
Sweating Increased
Constipation
Fatigue
Indigestion
TABLE 4
Incidence of Common Adverse Reactions in Patients with Major
Depressive Disorder
Placebo
10 mg/day
(N=311)
Lexapro
(N=310)
4%
7%
5%
6%
3%
4%
1%
4%
2%
4%
<1%
3%
1%
3%
2%
2%
1%
2%
20 mg/day
Lexapro
(N=125)
14%
14%
9%
9%
7%
8%
6%
6%
6%
Male and Female Sexual Dysfunction with SSRIs-Although changes in sexual desire, sexual performance, and sexual satisfaction often occur
as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests
that SSRIs can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving
sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss
them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.
Adverse Event
Ejaculation Disorder
(primarily ejaculatory delay)
Libido Decreased
Impotence
Libido Decreased
Anorgasmia
TABLE 5
Incidence of Sexual Side Effects in Placebo-Controlled Clinical Trials
Lexapro
In Males Only
(N=407)
12%
6%
2%
(N=737)
3%
3%
In Females Only
Placebo
(N=383)
1%
2%
<1%
(N=636)
1%
<1%
There are no adequately designed studies examining sexual dysfunction with escitalopram treatment. Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about
such possible side effects. Vital Sign Changes-Lexapro and placebo groups were compared with respect to (1) mean change from baseline in
vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated
with Lexapro treatment. In addition, a comparison of supine and standing vital sign measures in subjects receiving Lexapro indicated that
Lexapro treatment is not associated with orthostatic changes. Weight Changes-Patients treated with Lexapro in controlled trials did not differ
from placebo-treated patients with regard to clinically important change in body weight. Laboratory Changes-Lexapro and placebo groups were
compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence
of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically
important changes in laboratory test parameters associated with Lexapro treatment. ECG Changes-Electrocardiograms from Lexapro (N=625),
racemic citalopram (N=351), and placebo (N=527) groups were compared with respect to (1) mean change from baseline in various ECG
parameters and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These
analyses revealed (1) a decrease in heart rate of 2.2 bpm for Lexapro and 2.7 bpm for racemic citalopram, compared to an increase of 0.3 bpm
for placebo and (2) an increase in QTc interval of 3.9 msec for Lexapro and 3.7 msec for racemic citalopram, compared to 0.5 msec for
placebo. Neither Lexapro nor racemic citalopram were associated with the development of clinically significant ECG abnormalities. Other
Reactions Observed During the Premarketing Evaluation of Lexapro-Following is a list of treatment-emergent adverse events, as defined in the
introduction to the ADVERSE REACTIONS section, reported by the 1428 patients treated with Lexapro for periods of up to one year in doubleblind or open-label clinical trials during its premarketing evaluation. The listing does not include those events already listed in Tables 2 & 3, those
events for which a drug cause was remote and at a rate less than 1% or lower than placebo, those events which were so general as to be
uninformative, and those events reported only once which did not have a substantial probability of being acutely life threatening. Events are
categorized by body system. Events of major clinical importance are described in the Warnings and Precautions section. Cardiovascular - hypertension, palpitation. Central and Peripheral Nervous System Disorders - light-headed feeling, migraine. Gastrointestinal Disorders - abdominal
cramp, heartburn, gastroenteritis. General - allergy, chest pain, fever, hot flushes, pain in limb. Metabolic and Nutritional Disorders - increased
weight. Musculoskeletal System Disorders - arthralgia, myalgia jaw stiffness. Psychiatric Disorders - appetite increased, concentration impaired,
irritability. Reproductive Disorders/Female - menstrual cramps, menstrual disorder. Respiratory System Disorders - bronchitis, coughing, nasal
congestion, sinus congestion, sinus headache. Skin and Appendages Disorders - rash. Special Senses - vision blurred, tinnitus. Urinary System
Disorders - urinary frequency, urinary tract infection. Post-Marketing Experience; Adverse Reactions Reported Subsequent to the Marketing
of Escitalopram-The following additional adverse reactions have been identified from spontaneous reports of escitalopram received worldwide.
These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal
connection to escitalopram and have not been listed elsewhere in labeling. However, because these adverse reactions were reported voluntarily
from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug
exposure. These events include: Blood and Lymphatic System Disorders: anemia, agranulocytis, aplastic anemia, hemolytic anemia, idiopathic
thrombocytopenia purpura, leukopenia, thrombocytopenia. Cardiac Disorders: atrial fibrillation, bradycardia, cardiac failure, myocardial
infarction, tachycardia, torsade de pointes, ventricular arrhythmia, ventricular tachycardia. Ear and Labyrinth Disorders: vertigo Endocrine
Disorders: diabetes mellitus, hyperprolactinemia, SIADH. Eye Disorders: diplopia, glaucoma, mydriasis, visual disturbance. Gastrointestinal
Disorders: dysphagia, gastrointestinal hemorrhage, gastroesophageal reflux, pancreatitis, rectal hemorrhage. General Disorders and
Administration Site Conditions: abnormal gait, asthenia, edema, fall, feeling abnormal, malaise. Hepatobiliary Disorders: fulminant hepatitis,
hepatic failure, hepatic necrosis, hepatitis. Immune System Disorders: allergic reaction, anaphylaxis. Investigations: bilirubin increased,
decreased weight, electrocardiogram QT prolongation, hepatic enzymes increased, hypercholesterolemia, INR increased, prothrombin
decreased. Metabolism and Nutrition Disorders: hyperglycemia, hypoglycemia, hypokalemia, hyponatremia. Musculoskeletal and Connective
Tissue Disorders: muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis. Nervous System Disorders: akathisia, amnesia, ataxia,
choreoathetosis, cerebrovascular accident, dysarthria, dyskinesia, dystonia, extrapyramidal disorders, grand mal seizures (or convulsions),
hypoaesthesia, myoclonus, nystagmus, Parkinsonism, restless legs, seizures, syncope, tardive dyskinesia, tremor. Pregnancy, Puerperium and
Perinatal Conditions: spontaneous abortion. Psychiatric Disorders: acute psychosis, aggression, agitation, anger, anxiety, apathy, completed
suicide, confusion, depersonalization, depression aggravated, delirium, delusion, disorientation, feeling unreal, hallucinations (visual and
auditory), mood swings, nervousness, nightmare, panic reaction, paranoia, restlessness, self-harm or thoughts of self-harm, suicide attempt,
suicidal ideation, suicidal tendency. Renal and Urinary Disorders: acute renal failure, dysuria, urinary retention. Reproductive System and Breast
Disorders: menorrhagia, priapism. Respiratory, Thoracic and Mediastinal Disorders: dyspnea, epistaxis, pulmonary embolism, pulmonary
hypertension of the newborn. Skin and Subcutaneous Tissue Disorders: alopecia, angioedema, dermatitis, ecchymosis, erythema multiforme,
photosensitivity reaction, Stevens Johnson Syndrome, toxic epidermal necrolysis, urticaria. Vascular Disorders: deep vein thrombosis, flushing,
hypertensive crisis, hypotension, orthostatic hypotension, phlebitis, thrombosis.
DRUG INTERACTIONS: Serotonergic Drugs-Based on the mechanism of action of SNRIs and SSRIs including Lexapro, and the potential
for serotonin syndrome, caution is advised when Lexapro is coadministered with other drugs that may affect the serotonergic neurotransmitter
systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John’s Wort [see Warnings
and Precautions]. The concomitant use of Lexapro with other SSRIs, SNRIs or tryptophan is not recommended. Triptans-There have been rare
postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Lexapro with a triptan is clinically
warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Warnings and
Precautions]. CNS Drugs- Given the primary CNS effects of escitalopram, caution should be used when it is taken in combination with other
centrally acting drugs. Alcohol-Although Lexapro did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other
psychotropic medications, the use of alcohol by patients taking Lexapro is not recommended. Monoamine Oxidase Inhibitors (MAOIs)-[see
Contraindications and Warnings and Precautions]. Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)-Serotonin release
by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an
association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have
also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased
bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully
monitored when Lexapro is initiated or discontinued. Cimetidine-In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and Cmax of 43% and 39%, respectively. The
clinical significance of these findings is unknown. Digoxin-In subjects who had received 21 days of 40 mg/day racemic citalopram, combined
administration of citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.
Lithium-Coadministration of racemic citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the
pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium
dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of escitalopram, caution should
be exercised when Lexapro and lithium are coadministered. Pimozide and Celexa-In a controlled study, a single dose of pimozide 2 mg coadministered with racemic citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately
10 msec compared to pimozide given alone. Racemic citalopram did not alter the mean AUC or Cmax of pimozide. The mechanism of this
pharmacodynamic interaction is not known. Sumatriptan-There have been rare postmarketing reports describing patients with weakness,
hyperreflexia, and incoordination following the use of an SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g.,
fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram) is clinically warranted, appropriate observation of the patient is advised.
Theophylline-Combined administration of racemic citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose
of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not
evaluated. Warfarin-Administration of 40 mg/day racemic citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown. Carbamazepine-Combined administration of
racemic citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing
properties of carbamazepine, the possibility that carbamazepine might increase the clearance of escitalopram should be considered if the two
drugs are coadministered. Triazolam-Combined administration of racemic citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4
substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam. KetoconazoleCombined administration of racemic citalopram (40 mg) and ketoconazole (200 mg), a potent CYP3A4 inhibitor, decreased the Cmax and AUC of
ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram. Ritonavir-Combined administration of a single dose of ritonavir (600 mg), both a CYP3A4 substrate and a potent inhibitor of CYP3A4, and escitalopram (20 mg) did not affect
the pharmacokinetics of either ritonavir or escitalopram. CYP3A4 and -2C19 Inhibitors-In vitro studies indicated that CYP3A4 and -2C19 are the
primary enzymes involved in the metabolism of escitalopram. However, coadministration of escitalopram (20 mg) and ritonavir (600 mg), a
potent inhibitor of CYP3A4, did not significantly affect the pharmacokinetics of escitalopram. Because escitalopram is metabolized by multiple
enzyme systems, inhibition of a single enzyme may not appreciably decrease escitalopram clearance. Drugs Metabolized by Cytochrome
P4502D6-In vitro studies did not reveal an inhibitory effect of escitalopram on CYP2D6. In addition, steady state levels of racemic citalopram
were not significantly different in poor metabolizers and extensive CYP2D6 metabolizers after multiple-dose administration of citalopram,
suggesting that coadministration, with escitalopram, of a drug that inhibits CYP2D6, is unlikely to have clinically significant effects on escitalopram metabolism. However, there are limited in vivo data suggesting a modest CYP2D6 inhibitory effect for escitalopram, i.e., coadministration
of escitalopram (20 mg/day for 21 days) with the tricyclic antidepressant desipramine (single dose of 50 mg), a substrate for CYP2D6, resulted
in a 40% increase in Cmax and a 100% increase in AUC of desipramine. The clinical significance of this finding is unknown. Nevertheless, caution
is indicated in the coadministration of escitalopram and drugs metabolized by CYP2D6. Metoprolol-Administration of 20 mg/day Lexapro for
21 days in healthy volunteers resulted in a 50% increase in Cmax and 82% increase in AUC of the beta-adrenergic blocker metoprolol (given in a
single dose of 100 mg). Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of Lexapro
and metoprolol had no clinically significant effects on blood pressure or heart rate. Electroconvulsive Therapy (ECT)-There are no clinical
studies of the combined use of ECT and escitalopram.
USE IN SPECIFIC POPULATIONS: Pregnancy; Pregnancy Category C-In a rat embryo/fetal development study, oral administration of
escitalopram (56, 112, or 150 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased fetal body weight and
associated delays in ossification at the two higher doses (approximately 56 times the maximum recommended human dose [MRHD] of
20 mg/day on a body surface area [mg/m2] basis). Maternal toxicity (clinical signs and decreased body weight gain and food consumption), mild
at 56 mg/kg/day, was present at all dose levels. The developmental no-effect dose of 56 mg/kg/day is approximately 28 times the MRHD on a
mg/m2 basis. No teratogenicity was observed at any of the doses tested (as high as 75 times the MRHD on a mg/m2 basis). When female rats
were treated with escitalopram (6, 12, 24, or 48 mg/kg/day) during pregnancy and through weaning, slightly increased offspring mortality and
growth retardation were noted at 48 mg/kg/day which is approximately 24 times the MRHD on a mg/m2 basis. Slight maternal toxicity (clinical
signs and decreased body weight gain and food consumption) was seen at this dose. Slightly increased offspring mortality was also seen at
24 mg/kg/day. The no-effect dose was 12 mg/kg/day which is approximately 6 times the MRHD on a mg/m2 basis. In animal reproduction
studies, racemic citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects,
when administered at doses greater than human therapeutic doses. In two rat embryo/fetal development studies, oral administration of racemic
citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and
survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose. This dose was also
associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental no-effect dose was 56 mg/kg/day. In a rabbit
study, no adverse effects on embryo/fetal development were observed at doses of racemic citalopram of up to 16 mg/kg/day. Thus, teratogenic
effects of racemic citalopram were observed at a maternally toxic dose in the rat and were not observed in the rabbit. When female rats were
treated with racemic citalopram (4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first
4 days after birth and persistent offspring growth retardation were observed at the highest dose. The no-effect dose was 12.8 mg/kg/day. Similar
effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses 24 mg/kg/day.
A no-effect dose was not determined in that study. There are no adequate and well-controlled studies in pregnant women; therefore, escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy-Nonteratogenic Effects
Neonates exposed to Lexapro and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included
respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia,
hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs
or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome
[see Warnings and Precautions]. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension
of the newborn (PPHN). PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal
morbidity and mortality. In a retrospective, case-control study of 377 women whose infants were born with PPHN and 836 women whose infants
were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation
compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the
risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. The study did not include
enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk. When treating a pregnant woman
with Lexapro during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment [see Dosage
and Administration]. Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were
euthymic at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience
a relapse of major depression than women who continued antidepressant medication. Labor and Delivery-The effect of Lexapro on labor and
delivery in humans is unknown. Nursing Mothers-Escitalopram is excreted in human breast milk. Limited data from women taking 10-20 mg
escitalopram showed that exclusively breast-fed infants receive approximately 3.9% of the maternal weight-adjusted dose of escitalopram and
1.7% of the maternal weight-adjusted dose of desmethylcitalopram. There were two reports of infants experiencing excessive somnolence,
decreased feeding, and weight loss in association with breastfeeding from a racemic citalopram-treated mother; in one case, the infant was
reported to recover completely upon discontinuation of racemic citalopram by its mother and, in the second case, no follow-up information was
available. Caution should be exercised and breastfeeding infants should be observed for adverse reactions when Lexapro is administered to a
nursing woman. Pediatric Use-Safety and effectiveness of Lexapro has not been established in pediatric patients (less than 12 years of age) with
Major Depressive Disorder. Safety and effectiveness of Lexapro has been established in adolescents (12 to 17 years of age) for the treatment of
major depressive disorder [see Clinical Studies]. Although maintenance efficacy in adolescent patients with Major Depressive Disorder has not
been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients. Safety and effectiveness of Lexapro has not been established in pediatric patients less than
18 years of age with Generalized Anxiety Disorder. Geriatric Use-Approximately 6% of the 1144 patients receiving escitalopram in controlled
trials of Lexapro in major depressive disorder and GAD were 60 years of age or older; elderly patients in these trials received daily doses of
Lexapro between 10 and 20 mg. The number of elderly patients in these trials was insufficient to adequately assess for possible differential
efficacy and safety measures on the basis of age. Nevertheless, greater sensitivity of some elderly individuals to effects of Lexapro cannot
be ruled out. SSRIs and SNRIs, including Lexapro, have been associated with cases of clinically significant hyponatremia in elderly patients,
who may be at greater risk for this adverse event [see Hyponatremia]. In two pharmacokinetic studies, escitalopram half-life was increased by
approximately 50% in elderly subjects as compared to young subjects and Cmax was unchanged [see Clinical Pharmacology]. 10 mg/day is the
recommended dose for elderly patients [see Dosage and Administration]. Of 4422 patients in clinical studies of racemic citalopram, 1357 were
60 and over, 1034 were 65 and over, and 457 were 75 and over. No overall differences in safety or effectiveness were observed between these
subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger
patients, but again, greater sensitivity of some elderly individuals cannot be ruled out.
DRUG ABUSE AND DEPENDENCE: Abuse and Dependence; Physical and Psychological Dependence-Animal studies suggest that the abuse
liability of racemic citalopram is low. Lexapro has not been systematically studied in humans for its potential for abuse, tolerance, or physical
dependence. The premarketing clinical experience with Lexapro did not reveal any drug-seeking behavior. However, these observations were not
systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Lexapro patients for history of drug abuse and follow such
patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
OVERDOSAGE: Human Experience-In clinical trials of escitalopram, there were reports of escitalopram overdose, including overdoses of up
to 600 mg, with no associated fatalities. During the postmarketing evaluation of escitalopram, Lexapro overdoses involving overdoses of over
1000 mg have been reported. As with other SSRIs, a fatal outcome in a patient who has taken an overdose of escitalopram has been rarely
reported. Symptoms most often accompanying escitalopram overdose, alone or in combination with other drugs and/or alcohol, included
convulsions, coma, dizziness, hypotension, insomnia, nausea, vomiting, sinus tachycardia, somnolence, and ECG changes (including QT
prolongation and very rare cases of torsade de pointes). Acute renal failure has been very rarely reported accompanying overdose. Management
of Overdose-Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of
activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general
symptomatic and supportive care. Due to the large volume of distribution of escitalopram, forced diuresis, dialysis, hemoperfusion, and exchange
transfusion are unlikely to be of benefit. There are no specific antidotes for Lexapro. In managing overdosage, consider the possibility of
multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any
overdose.
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045 USA
Licensed from H. Lundbeck A/S
© 2009 Forest Laboratories, Inc.
Rev. 05/09
Issues & Trends
Up front
In Depth
Fred Gebhart, Contributing Editor
Proposed Part D rules for short-cycle dispensing roil LTC
P
roposed rules designed to cut
waste in Medicare Part D could
create problems for long-termcare (LTC) pharmacy. LTC facilities and
pharmacies that serve them will have to
adjust their care and business models for
short-cycle dispensing. Most LTC facilities
currently dispense 30-day ﬁlls. The proposed rules require 7-day or shorter ﬁlls
for Part D prescriptions.
“The proposed rule requires LTC pharmacies to be up and running with shortcycle dispensing by January 1, 2012,” said
Lynne Batshon, director of policy and advocacy, American Society of Consultant Pharmacists (ASCP). “We have some concerns
about pharmacies’ ability to be in place
within that time frame. We don’t have a
sense of how many pharmacies might not
be able to continue to provide services.”
Short-cycle dispensing is designed to
reduce the waste associated with 30-day
ﬁlls in the LTC setting. The Affordable Care
Act of 2010 requires Part D plan sponsors
to use speciﬁc, uniform dispensing techniques such as weekly, daily, or automated
dose dispensing.
The proposed rules cover all pharmacies that dispense to LTC facilities, including mail-order pharmacies, Batshon noted.
And while the draft rules apply only to
brand name products, many observers expect the Centers for Medicare and Medicaid Services to extend the same requirement to generic products.
Tip of the iceberg
Short-cycle dispensing is only the tip of
the iceberg. Not only do LTC facilities and
pharmacies have to work out the mechanics of a new dispensing cycle, they
also have to work out financial details
with Part D plans. Without some accommodation, pharmacies could be dispensing
four 7-day scripts and getting paid for one
30-day ﬁll.
DrugTopics .c om
Another provision requires unused
medications dispensed short-cycle to be
returned to the pharmacy. Some states allow redispensing of returned medications
under some circumstances; some do not,
said Marissa Schlaifer, director of pharmacy
affairs, Academy of Managed Care Pharmacy. The Drug Enforcement Administration restricts returns of narcotics.
Despite the conﬂicts, LTC facilities must
return unused medications and LTC pharmacies must deal with the returns. Pharmacies must also report returns to Part
D plans, which will report to CMS. Little
thought has been given to the mechanics of handling returned medications, and
the National Council for Prescription Drug
Programs (NCPDP) is still developing the
needed communication protocols.
“These are pretty signiﬁcant changes,”
Schlaifer said. “We need a new standard
for electronic communications along with
all the other details. A 1-year time frame
is very short.”
Not much time
Pharmacy and LTC groups are discussing
implementation dates with CMS, Schlaifer
said, but pharmacy must proceed on the
assumption that the new procedures will
take effect as scheduled next January.
The impact of short-cycle dispensing will be uneven, said Carla McFaddin, ASCP director of professional affairs.
Larger facilities already using automated
dispensing will have few problems adapting. Retail pharmacies serving only 1 or 2
LTC facilities can probably adjust to shorter
ﬁll cycles without major additional costs.
“It is the in-between pharmacies that
could have problems,” McFaddin said. “It
comes down to what extent facilities are
willing to share the costs involved.”
The outlook could be clear in June,
when Part D plans assemble bids for
2012. All parties, including LTC facilities,
LTC pharmacies, NCPDP, and Part D plans,
must agree to new dispensing cycles with
the required hardware and software investments, new handling procedures and
communications protocols for return of
unused medications, and new fee structures to support the new programs.
CMS could delay implementation
of the medication-return requirement,
Schlaifer added, but short-cycle dispensing is explicitly required by legislation and
cannot be deferred.
“CMS says the data show that shortcycle dispensing will save money overall,”
she said. “I have not seen those numbers
myself. Short-cycle dispensing may cut
waste, but it may also increase the costs
of dispensing. The jury is still out on the
overall impact on patient care.”
Extension requested
CMS accepted comments on the proposed
rules through January 21, 2011. In comments responding to the Federal Register notice of November 22, 2010, ASCP
requested the extension of the proposed
implementation date by 1 year to January 1, 2013.
“Pharmacies, nursing homes, and prescription drug plans all need more time to
implement short-cycle dispensing,” said
ASCP President Albert Barber, PharmD,
CGP, FASCP, in a released statement. “An
additional year to create systems and invest in new technology and training gives
pharmacists a chance to make this transition without negatively impacting care for
seniors.”
ASCP also requested that CMS consider adding controlled substances to its
list of drugs exempted from the rule because of the stringent record-keeping associated with these substances. Also, there
are high risks of diversion with controlled
substances as the number of times a drug
is handled increases.
Februar y 2011
DRUG TOPICS
27
Chains & Business
Fred Gebhart, Contributing Editor
Technicians key to telepharmacy
success in North Dakota
Pharmacy technicians have emerged as key players in the growth of telepharmacy in
both inpatient and outpatient settings. That’s the view from North Dakota, which relies
heavily on telepharmacy to bring pharmacy services to communities and hospitals that
don’t
a pharmacist.
d ’t have
h
Telepharmacy would never have
been as successful as it has been
without technicians,” said Barbara E. Lacher, BS, RPh Tech, CPhT, assistant
program director, pharmacy technician
program, and associate professor, North
Dakota State College of Science. “Techs
are key to everything we do.”
The college regularly updates its tech
training program to reﬂect current practice needs. One of the latest curriculum
updates is additional information on overthe-counter medications. That helps techs
answer basic patient questions and, more
importantly, helps techs recognize when
to bring the pharmacist into the loop.
More education makes techs more effective, especially in telepharmacy sites where
the pharmacist isn’t in the next room.
No argument from the Pharmacy
Technician Certiﬁcation Board (PTCB).
PTCB has certiﬁed about 80,000 techs
nationwide.
Only the beginning
“North Dakota is a
good example to
model,” said PTCB
Executive Director
and CEO Melissa
M. Corrigan, RPh.
“They are very
forward-thinking.
They are looking at Melissa Corrigan
telepharmacy and
technicians as a way to bring pharmacy
services to rural communities. But that is
only the beginning.”
Pharmacy chains are using technicians to provide patient services by telephone, Corrigan said. The military is using telepharmacy to dispense around the
28
DRUG TOPICS
Februar y 2011
world. Hospitals are using telepharmacy in
sterile prep rooms and across large campus
settings. Technicians are the common element keeping all these systems working.
“Pharmacy techs are the people at the
actual remote site,” said National Pharmacy Technician Association Chairman
and CEO Mike Johnston, CPhT. “The
telepharmacy role is very different from
working as a tech in a traditional setting.
You don’t have the in-person supervision. Telepharmacy techs are more independent and need to be better trained.”
Licensing and cross-training
North Dakota agrees. Technicians who
want to work in telepharmacy must have
at least 12 months of certiﬁcation in the
state. The hands-on experience is a plus.
“Technicians like telepharmacy,”
Lacher said. “It gives them a little more
scope than working with a pharmacist
on-site, and telepharmacy wages are
higher. We wouldn’t have telepharmacy
without technicians.”
North Dakota began licensing telepharmacies in 2001 to extend pharmacy
services to rural areas. Some rural hospitals without a pharmacist are using
telepharmacy to provide inpatient pharmacy services. A few are even crosstraining nurses as technicians.
“If you don’t have a pharmacist and
don’t have a tech, the nurses end up making a lot of decisions they aren’t trained
for,” said Shelley Doherty-Johnsen, RPh,
director, ePharmacist Direct, Fargo, N.D.,
which provides telepharmacy services to
more than a dozen rural hospitals around
the state from a central facility in Fargo. “If
they can cross-train some of their nurses
as techs, they can add pharmacy services
without adding staff.”
That makes sense from the commercial side of telepharmacy.
“Pharmacy technicians are ideally
suited to telepharmacy,” said Michael E.
Coughlin, president and CEO of telepharmacy provider ScriptPro. “Nurses don’t
have the experience in claims processing,
inventory, and other areas. A pharmacy
tech already knows that universe.”
A variety of universes
Technicians already know a variety of
pharmacy universes. That’s why hospitals and health systems have emerged as
key players in the telepharmacy world,
Coughlin said. One of the newest wrinkles
is sterile-preparation telepharmacy. Techs
prepare chemotherapy and other IV medications in a typical sterile facility; the supervising is pharmacist linked electronically.
“Even if the pharmacist is sitting in the
next room, telepharmacy can give you a
higher level of oversight than you have
with a traditional sterile-prep situation,” he
said. “Telepharmacy gives you clear, visual
records of drugs, bar codes, syringes — every step of the preparation process.”
That kind of remote veriﬁcation is also
ﬁnding favor with the Department of Defense. The U.S. Navy is using telepharmacy to verify dispensing by technicians
around the globe, Coughlin said.
“Telepharmacy allows pharmacies to
provide expertise and oversight anywhere
in the world with a video link,” he said.
“We see huge growth in telepharmacy,
with more technicians becoming involved
in drug preparation, in dispensing, in
working with patients. Telepharmacy allows you to bring the pharmacist into the
loop at precisely the right moment.”
DrugTopics .c om
Cover Story
Angela Watkins
Medicare Part D Audits
Is your pharmacy prepared?
W
ith the opening of the 112th Congress, there is
considerable uncertainty on how healthcare reform will progress. However, there is one thing
of which you can be certain: With Medicare Part D plan
sponsors under scrutiny from the Centers for Medicare &
Medicaid Services (CMS), which has oversight of all aspects of the program’s administration, pharmacy audits will
continue and possibly even increase in the future. Is your
pharmacy prepared?
The Medicare program cost $509 billion in 2009 and
had 46.3 million beneﬁciaries, according to the most recent Medicare Board of Trustees Report, issued on August
5, 2010. It is the nation’s largest federally funded healthinsurance program. Controlling the cost of the program is
an ongoing concern of both the Obama administration and
Congress. Therefore, any Medicare provider can expect an
audit. According to statistics captured in 2009 and released
in 2010, 44% of audits targeted hospital pharmacy records;
29% targeted long-term-care facilities; and 21% targeted
community pharmacies.
“All sponsors are required to have a comprehensive plan
to detect, correct, and prevent fraud, waste, and abuse.
Medicare Part D audits help ensure that procedures and
reimbursement mechanisms are consistent with contractual and regulatory requirements,” said Daniel B. Frier, Esq.,
founding partner, Frier Levitt, LLC, located in New York
and New Jersey.
Different types of audits
Pharmacies participating in the Medicare Part D program
should be aware of 2 types of possible audits: Desk audits
and ﬁeld audits.
Desk audits use automated means to review pharmacy
claims and encounter data. This type of audit can include
reviews of payment reports, drug utilization, physician prescribing patterns, and geographic prescribing reports.
Field audits are performed onsite at the pharmacy and
involve physical observations, prescription reviews, and checks
for compliance with Part D regulations and procedures.
Field auditors will typically review the following:
• Prescription records
• Computerized dispensing records
30
DRUG TOPICS
Februar y 2011
• Patient signature logs
• Quality control plans
“In general, auditors are looking at the validity of a
prescription for legal and regulatory compliance, and conﬁrming that the prescription corresponds with the claim
submission,” said Rena Bielinski,
PharmD, AHFI, Chief Pharmacy Ofﬁcer, National Audit, Miramar, Fla.
National Audit (www.nationalaudit.
com) works with various healthinsurance providers in performing
audits nationwide.
Bielinski said that onsite audits include general physical observations.
Rena Bielinski
Among other things, these observations check for and review:
• Compliance with Health Insurance Portability and
Accountability Act (HIPAA) guidelines
• Display of Medicare Part D posters
• General safety conditions and cleanliness
• Security of controlled substances as required by law
• Pharmacists’ licenses
• Presence of nonpharmacy employees in pharmacy
area
• Refrigerator temperatures
Bielinski noted a trend in some general ﬁndings in recent
years. These ﬁndings include:
• Incorrect use of DAW (“dispensed as written”) codes
• Missing proof of drug deliveries
• Unauthorized or undocumented reﬁlls
• Absence of hard copies of prescriptions
• Missing prescriber signatures
Be audit-ready
Each health-insurance provider or pharmacy beneﬁt manager (PBM) may have a different set of guidelines on how
pharmacies in its network should ensure that Medicare Part
D regulations are being met and on how they should comply with an audit.
However, Timothy J. Davis, PharmD, owner of Beaver
Health Mart Pharmacy in Beaver, Penn., noted that a successful audit begins before the letter conﬁrming an impending
DrugTopics .c om
GETTY IMAGES/PHOTOGRAPHER’S CHOICE RF/SNAP DECISION (PILL BOTTLE), GETTY IMAGES/PHOTODISC/
MEDIOIMAGES (NUMBERS, LEFT), GETTY IMAGES/THE IMAGE BANK/DAVID GOULD (REDLINE NUMBERS)
audit even arrives. Employees at Beaver Health Mart have a
clear roadmap that outlines their speciﬁc duties, especially for
those employees who play a role during an audit.
“Each employee knows what is expected of them even
before an audit. We’ve taken the time to communicate
expectations, deliverables, and time
frames with all functional departments and employees managing a
delegated function,” said Davis. “It
takes a little extra effort to plan upfront. But the staff is better prepared
with regard to their particular involvement in the audit process.”
Davis said his pharmacy is “auditTimothy J. Davis
ready” year-round. “We review materials regularly and monitor actions on
an ongoing basis,” he said. “We are quick to take action in
areas where we ﬁnd noncompliance.”
Software identiﬁes audit triggers
Davis also uses technology as a quality-control mechanism.
He said, “Technology that helps integrate workﬂow also
helps staff proactively prepare for any audit.”
A software program helps Beaver Health Mart Pharmacy
staff track patient signatures, physician prescriptions, electronic notes that can ﬂag speciﬁc item alerts, day supply
calculations, and signature prompts. It can also generate
reports sorted by total sales price, drug names, and drug
serial numbers.
“The right software can help identify audit triggers and
provides safeguards to protect your bottom line,” Davis
added.
Davis extends use of that technology to his customers
by allowing them to register online (www.BeaverHealthMart.
com) for a variety of services, including prescription reﬁlls.
Once a pharmacy has been through an audit, is the business exempt from another one? Bielinski warned pharmacists not to think that Medicare Part D audits are a one-time
event.
“Audits are an ongoing responsibility to ensure effective
oversight and management,” he said.
Keys to a successful audit
Bielinski offered a number of tips for pharmacies faced with
upcoming audits. Communicate and be forthright with the
audit vendor. The vendor has some ﬂexibility in rearranging audit dates, but, once a date is conﬁrmed, it is difﬁcult
for the vendor to make another change. “Don’t be afraid to
contact the audit vendor as many times as necessary to ask
DrugTopics .c om
any questions you might have about the audit,” she added.
Bielinski also suggested that pharmacies:
• Send requested materials to the vendor in a timely
fashion. If you cannot meet the deadline, ask for an
extension well in advance of the due date. Vendors use
automation to manage from hundreds to thousands
of pharmacies, so it is crucial that you respond by the
due date.
• Make sure that all the documents requested are in
the ﬁle and in chronological order. Proactively maintain records in organized ﬁles so that when you are
notiﬁed of an audit there will be less time needed for
preparation.
• Review the ﬁle to make sure that you are aware of
any deﬁciencies that CMS will discover.
• Be familiar with the language regarding audits in
your plan or PBM contract; this tells you what your
rights are during an audit and what rights the plan
or PBM has.
Attorney Frier and his partner, Jonathan E. Levitt, add
that receiving payment from CMS is no assurance that a
provider has billed or coded correctly for a service.
“CMS has the [right] to reopen any individual claim
within 12 months of payment to the provider and may reopen a claim for an additional 36 months for good cause,”
said Frier. The company website (www.frierlevitt.com) outlines
various scenarios that might cause CMS to reopen a claim.
Because contract language and standards set forth vary from
contract to contract, Levitt and Frier suggest that pharmacists
read those documents before signing them.
In the ﬁnal analysis, Davis said, while Medicare Part D
audits can be time-consuming for pharmacies, audits are
quality-control mechanisms that lead to improved customer
care — the true bottom line.
Angela Watkins is a freelance writer in Massillon, Ohio.
Februar y 2011
DRUG TOPICS
31
Special Report
Barbara Hesselgrave
Partnership improves prescription
delivery to American Indians
32
DRUG TOPICS
Februar y 2011
ans and other IHS patients requesting
the service in the Rapid City area.”
The back story
Michael A. Valentino, RPh, MHSA,
chief consultant in Pharmacy Beneﬁts
Management Services, Veterans Health
Administration, Department of Veterans Affairs, said that the mail-order
pharmacy program, which was conceived almost 2 decades ago, was the
result of “some very insightful pharmacy leadership in the VA who understood manual processing was not
a viable process in the long run.” The
VA, he added, was probably the ﬁrst to
break ground and pioneer mail-order
automation in both the public and private health-sector markets. “We were
2 years ahead of Kaiser.”
In describing the considerations that
led to CMOP, Valentino said that the
lack of space and the cost and inefﬁciency of the labor-intensive process of
ﬁlling so many prescriptions manually
“just wasn’t going to serve us.”
He added, “We knew we’d never
have enough pharmacists or space or
technicians, so we built this highly costeffective, efﬁcient, and quality product.” With the fast turnaround time of
CMOP’s electronic mail fulﬁllment, it
takes only a few days from the time a
prescription is entered until the patient
receives the medication. According to
Valentino, patients are very happy with
the service, and pharmacy staffers have
more time to spend with the patients.
Creating the relationship
Pamela Schweitzer, PharmD, BCPS, a
pharmacy consultant with Phoenixarea IHS, is a former pharmacy director with the VA. Her
experience with the
VA was invaluable,
she said, and she
envisioned bringing
the same efficiencies to IHS. But it
was not until “all
Pamela Schweitzer the stars were lined
DrugTopics .c om
GETTY IMAGES/DIGITAL VISION/STEFANO SALVETTI
I
magine a government health program that serves millions earning the highest excellence rating
awarded by J.D. Power and Associates.
Has it happened?
Indeed it has. The 5-star-rated mailorder pharmacy program of the Department of Veteran Affairs (VA) was
the ﬁrst of its kind in this country to
receive the rating. Today it continues to
set a benchmark for innovation and efﬁciency, and now the VA is partnering
with the Indian Health Services (IHS)
to improve prescription delivery to the
federally recognized tribes of IHS, a
population of about 2 million people.
On October 21, 2010, IHS announced a pilot program between its
Rapid City PHS Indian Hospital in Rapid City, S.D., and the VA’s Consolidated
Mail Outpatient Pharmacy (CMOP)
program in Leavenworth, Kan. According to an agency statement, “The pilot
program will improve safety and cost
effectiveness by providing prescription
reﬁlls by mail to support care for veter-
Special Report
up” that the transition from manual to
centralized fulﬁllment could take place
for IHS.
“In the early 2000s new laws enabled us to bill a third party; then early
in 2003 we had a big initiative for electronic health records,” said Schweitzer.
But what really got the process going, she
added, were high gas prices. Schweitzer
noted that it was costly for patients to
travel long distances to come to pharmacies every 30 days to ﬁll prescriptions.
Two years ago she began “planting
the seeds of the idea,” talking personally with the tribes and promoting the
idea within the ranks of IHS, and “all
the negativity went away,” she said.
She was able to sell the project to area
leaders who recognized the potential
beneﬁts and would help champion the
idea of switching from a manual to
centralized fulﬁllment system.
Besides patient-access problems,
Schweitzer said, the IHS pharmacists
were burning out. They were spending
most of their time ﬁlling prescriptions
rather than focusing on patients who
needed counseling and extra care. Job
retention and satisfaction were down.
In the remote IHS service areas, she
said, several facilities, including the
Rapid City test site, were having a hard
time recruiting pharmacists.
Less restock, more patient time
Todd Warren, PharmD, BCPS, director
of pharmacy at Rapid City PHS Indian
Hospital, said that his facility ﬁlls approximatelly 900 prescriptions a day, of
which “roughly 45% are reﬁlls, which
can be mailed.”
Warren said that all of Rapid City’s
constituents were asked whether they
wanted to participate in the mail-order
program. Not surprisingly, some did
not wish to receive mailed prescriptions. Several elders believed their
medications would be stolen, he said.
Other patients feared that they would
DrugTopics .c om
LCDR Peter Juve, PharmD (left), counsels a patient opting to obtain a prescription in person at the hospital
pharmacy. Mail-order is also available for all patients. (Photo courtesy of Rapid City PHS Indian Hospital.)
The CMOP program has given pharmacists such as LCDR Todd Campbell, PharmD (left), more time to spend
with individual patients. (Photo courtesy of Rapid City PHS Indian Hospital.)
not remember to call in for prescription
reﬁlls, and some simply liked to come
into the pharmacy.
Since the August 2010 inception of
Rapid City’s reﬁll service with CMOP,
Warren said, the hospital has signed up
about 50% of its constituents.
The process begins when a patient
visits the IHS provider, who asks which
prescription needs reﬁlling. The provider
then reviews and renews the prescription. The patient’s next stop is to the IHS
pharmacist, who asks whether the patient would like to have the prescription
mailed. If the patient agrees to mail-order,
the pharmacist puts the prescription into
a queue going to CMOP. The prescription
is ﬁlled and mailed to that patient from
the Leavenworth facility. The total turnaround time is about 35 hours plus an
additional 2.5 days in transit from Leavenworth to the Rapid City member.
Continued on pg. 34
Februar y 2011
DRUG TOPICS
33
Special Report
Continued from pg. 33
In addition to patients’ satisfaction,
Warren said, the pharmacy staff is very
pleased with the service. “The nice thing
for us is that before, we were returning
to stock a large number of prescriptions
within the 7-day window; [now] once
they’re gone, they’re out,” he said.
Improved adherence
Valentino said that medication adherence is a signiﬁcant issue for the VA, and
CMOP plays an important role. “I can
tell you, if you don’t have the drug in
your possession, you can’t be adherent.”
He added that the VA is trying to ﬁnd
additional ways to communicate with
patients taking chronic medication and
is in the process of designing an iPhone
app and a system to send text messages
to cell phones.
Schweitzer is also pleased with
the results of the partnership. She
remembers how she wanted to institute this process for many years after
her tenure at the VA, where she observed models that allowed pharmacists important interaction and clinical time with patients. Now, that her
vision is becoming reality, Schweitzer
said that she is seeing the real-time
beneﬁts at Rapid City and couldn’t be
more enthusiastic about the program.
With centralized ﬁlling and packaging of prescriptions, pharmacists gain
time to interact more often with patients, said Schweitzer. This beneﬁts the
hospital and medical staff, she pointed
out. In 2011, the hospital will have its
ﬁrst pharmacy resident, she added.
Future CMOP rollouts are planned
for IHS facilities in Phoenix and Minnesota. Over the next few years,
Schweitzer said, all of IHS will be
included in the CMOP program.
Barbara Hesselgrave is a freelance writer
A short primer on First Nation healthcare
The lands, education, health, and lives of the federally recognized people of the First Nation — their
preferred nomenclature — are directly affected by the federal government. The distinction between
federally recognized and state-recognized American Indians harks back to historical events of the
late 1780s, when special government-to-government relationships between the federal government
and Indian tribes were established by the U.S. Constitution.
The federal government granted American Indians reservation land, under their sovereignty, to compensate for the lands taken from them. However, the lands “granted” as “Federal Reserves” were
generally undesirable, being far removed from centers of commerce and unsuitable for productive
farming and pasturage. Moreover, the forcible removal from traditional lands also meant a separation from the plants and animals that were an integral part of traditional practices and American
Indian medicine.
The BIA takeover
In 1926, the Bureau of Indian Affairs (BIA) was formed. It is the oldest bureau of the U.S. Department of the Interior. The BIA’s mission concerns administration and management of American Indian
land. This includes matters pertaining to natural resources, building, school funding, and social
issues affecting the nearly 2 million people living on the reservations. Today, there are 565 federally
recognized American Indian tribes and Alaska Natives in 35 states.
The Indian Health Services (IHS) provides direct health services to American Indians. This agency,
which was organized within the Department of Health and Human Services during the 1950s,
arose from the national push for prevention in public health when vaccines for polio, diphtheria,
and whooping cough emerged.
The situation today
With little or no access to public transportation and few opportunities to earn a living, most American
Indians are at or below the federal poverty level and must often travel long distances to access an
IHS facility. If patients require tests or services not available through their local IHS facility and must
travel to other state-run facilities, despite their citizenship of that state they may be referred back to
IHS and turned away, once they disclose that they are American Indian.
This state of affairs contributes to an abysmal reality. A July 2003 report by the U.S. Commission
on Civil Rights, “A Quiet Crisis: Federal Funding and Unmet Needs in Indian Country,” stated that
American Indians have a lower life expectancy than any other racial/ethnic group. In addition, the
commission found that American Indians experience some of the highest rates of chronic diseases
such as diabetes, HIV, tuberculosis, and alcoholism.
Permanent funding
The Obama administration has made efforts to boost funding for IHS. In addition, when President
Obama signed into law the Patient Protection and Affordable Care Act (PPACA), it permanently
reauthorized the Indian Health Care Improvement Act (IHCIA), which created the framework for
the IHS. Prior to PPACA, the continuation of IHCIA was dependent on an annual reauthorization.
— Barbara Hesselgrave
based in Virginia.
34
DRUG TOPICS
Februar y 2011
DrugTopics .c om
Clinical
ANTICOAGULATION THERAPIES
Anna D. Garrett, PharmD, BCPS
Anticoagulation update
Risk factors for VTE in HIV
The frequency of venous thromboembolism (VTE) in patients
with HIV ranges from 0.19% to 7.63% per year. This frequency
correlates to an approximate 10-fold increase in risk over that of
the general population. Despite this, national guidelines do not
address VTE prevention and treatment for patients with HIV.
According to the literature, a higher rate of VTE occurs in
patients with HIV who are younger than 50 years (3.31% vs.
0.53% in age-matched healthy controls), have a CD4+ cell count
less than 200 cells/mm3, or have a diagnosis of acquired immunodeﬁciency syndrome. Both protein S and C deﬁciencies
are considered risk factors. These deﬁciencies are thought to be
secondary to immunosuppression. In addition, the use of protease inhibitors (speciﬁcally indinavir and saquinavir) and the
presence of active opportunistic infections or antiphospholipid
antibodies may be associated with VTE in HIV.
The mechanism of the increased risk relative to use of protease inhibitors is unclear but several hypotheses have been
suggested. These include interference with hepatic metabolism,
generation of endothelial or platelet dysfunction, or effects of fat
redistribution on the coagulation proﬁle (although data have
not supported this).
Many cases of VTE are preventable. In light of the expense
associated with VTE cases, it is imperative that all VTE risk factors
be identiﬁed and incorporated into medical decision-making for
high-risk patients, including those with HIV, in order to decrease
the burden on the healthcare system. Risk factors associated with
HIV are not well understood; therefore, long-term prospective
studies assessing these are needed.
Source: Kiser KL, Badowski ME. Risk factors for venous thromboembolism in patients with human immunodeﬁciency virus infection.
Pharmacotherapy. 2010;30(12):1292–1302.
Previous antiplatelet therapy results in poorer
outcomes in cases of intracerebral hemorrhage
A recent meta-analysis of patients with intracerebral hemorrhage who were taking antiplatelet drugs showed a modest but
signiﬁcantly higher mortality rate in those who were receiving
these agents.
Researchers performed a meta-analysis of 25 cohort studies
comprising 9,900 patients with intracerebral hemorrhage; 23%
of patients had been taking antiplatelet drugs (usually aspirin) at
the time of the hemorrhage. In a multivariable-adjusted pooled
analysis, previous antiplatelet therapy was associated with signiﬁcantly higher mortality (odds ratio, 1.27; P=.001) but not worse
functional outcomes (OR, 1.10).
In this analysis, too few patients were taking nonaspirin antiplatelet drugs or dual antiplatelet therapies to allow conﬁdent
DrugTopics .c om
conclusions about different antiplatelet regimens. The authors
commented that this report serves to remind us that antiplatelet
drugs, including aspirin, are not necessarily benign and should
be prescribed only if the beneﬁt outweighs the risk of treatment.
Source: Thompson BB, Béjot Y, Caso V, et al. Prior antiplatelet
therapy and outcome following intracerebral hemorrhage: A systematic
review. Neurology. 2010;75:1333–1342.
Risk of combination therapy with warfarin/
antiplatelet agents may not outweigh beneﬁt
Many patients with new-onset atrial ﬁbrillation receive anticoagulation with warfarin to decrease their risk of ischemic stroke.
They may also have co-existing vascular conditions that may
require platelet inhibition with aspirin or clopidogrel in addition
to warfarin.
A Danish study of 119,000 patients hospitalized with atrial
ﬁbrillation examined the safety of these therapies relative to
the decrease in stroke risk. Nearly 83,000 patients were discharged on warfarin, aspirin, clopidogrel, or a combination of
these agents. The most common therapies were warfarin alone
(43%), aspirin alone (40%), or warfarin plus aspirin (16%).
Nonfatal bleeding occurred in 12,191 patients (10%) and fatal
bleeding occurred in 1,381 patients (1.2%). The risk for fatal or
serious nonfatal bleeding was 3.7 times higher for patients who
received triple therapy (warfarin plus clopidogrel plus aspirin)
versus warfarin alone; 3.1 times higher for patients who received
warfarin plus clopidogrel; and 1.7 to 1.8 times higher for patients
who had aspirin added to either of the other 2 drugs (clopidogrel
or warfarin). The most common location of bleeding was in the
gastrointestinal system. Stroke risk was not lowered for patients
receiving triple therapy or warfarin plus clopidogrel.
The outcome of this analysis makes a strong argument for
much greater care in the use of antiplatelet drugs with warfarin
even when there is a strong indication for both. For example, if a
patient receiving warfarin requires one or more stents, the baremetal type may be preferable to the drug-eluting type in order
to decrease the required duration of therapy with clopidogrel. If
possible, combination therapy should be avoided since the risks
of bleeding outweigh the beneﬁts of reduced stroke incidence.
Source: Hansen ML, Sørensen R, Clausen MT, et al. Risk of bleeding
with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel
in patients with atrial fibrillation. Arch Intern Med. 2010;170:1433–1441.
Anna D. Garrett is manager, Outpatient Clinical Pharmacy Programs,
Mission Hospital, Asheville, N.C., and president and founder of the
National Association of Women in Health Care (www.nawhc.com).
She also is a Drug Topics board member. She can be reached at anna.
garrett@msj.org.
Februar y 2011
DRUG TOPICS
35
Continuing Education
AN ONGOING CE PROGRAM OF THE UNIVERSITY OF FLORIDA
COLLEGE OF PHARMACY AND DRUG TOPICS
Medication errors:
Causes, prevention,
liability, and the
apology
Virgil Van Dusen, RPh, JD
REGIONAL DEAN
TTUHSC SCHOOL OF PHARMACY
TEXAS TECH UNIVERSITY — ABILENE, TEXAS
W. Steven Pray, PhD, DPh
BERNHARDT PROFESSOR
COLLEGE OF PHARMACY
SOUTHWESTERN OKLAHOMA STATE UNIVERSITY
M
edication errors are a serious problem for pharmacists
and society. Pharmacists ﬁll the vast majority of
prescriptions or drug orders correctly, but even in
the best-managed pharmacies errors still occur. Although
medication errors are small in number, they may have a
devastating effect on the patient and pharmacist. Fortunately,
policies can be implemented and technology used to reduce
the error rate. This article explores the common causes of
medication errors, error-prevention strategies, and possible
liability, as well as how the pharmacist should respond to the
patient after an error.
Medication error deﬁned and identiﬁed
Medication errors are caused by a number of “wrongs.” The wrong
drug may have been prescribed or dispensed, the wrong strength
dispensed, or wrong directions placed on the label. A provider may
fail to give a medication or the patient may be noncompliant, failing
to take a medication when prescribed. The deﬁnition of an error is
any incorrect event occurring during the process of medication use.1
The National Coordinating Council for Medication Error Reporting and Prevention deﬁnes a medication error as “any preventable
event that may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related
to professional practice; healthcare products, procedures, and systems, including prescribing; order communication; product labeling;
packaging; nomenclature; compounding; dispensing; distribution;
administration; education or monitoring; and use.”2
36
DRUG TOPICS
Februar y 2011
GETTY IMAGES/BLEND IMAGES/TERRY VINE (SENIOR HISPANIC WOMAN LOOKING AT MEDICATION BOTTLE); OJO IMAGES/ TOM MERTON
(MAN READING INSTRUCTIONS ON PILL BOTTLE); PHOTODISC/SETH JOEL (MEDICINE CABINET WITH PRESCRIPTION BOTTLES)
WEATHERFORD, OKLAHOMA
W W W.D R U GTO P I C S .C O M
CREDIT:
2.0
EARN CE CREDIT FOR THIS ACTIVITY AT WWW.DRUGTOPICS.COM
EDUCATIONAL OBJECTIVES
Goal: To educate pharmacists and pharmacy technicians on medication errors, including causes, mitigation techniques, and how to address the patient after
the error.
After participating in this activity, pharmacists
and pharmacy technicians should be able to:
● Relate the history of medication errors and
current rates of errors
● Identify causes of medication errors in
pharmacy practice and costs associated
with those errors
● List speciﬁc methods for reducing
medication errors
● Explain how pharmacists should respond to a
patient who has experienced medication error
The University of Florida College of Pharmacy is accredited
by the Accreditation Council for Pharmacy Education
as a provider of continuing pharmacy education.
ACPE # 0012-9999-10-147-H05-P (K)
ACPE # 0012-9999-10-147-H05-T (K)
This lesson is not valid for CE credit after 02/28/2013.
To obtain immediate CE credit, take the test online at
www.drugtopics.com. Click on the “Continuing Education” box on the Drug Topics home page, which will take
you to the CE site. Log in, find and click on this lesson,
and follow the three simple steps. Test results will be
displayed immediately and you can print the certificate showing your earned CE credits.
For questions concerning PRINT CEs, call 352-273-6275.
For questions concerning ONLINE CEs, call 877-252-7711.
W W W.D R U GTO P I C S .C O M
Month 2011
DRUG TOPICS
37
MEDICATION ERRORS
Continuing Education
TABLE 1
Adverse drug event. In contrast, an adverse drug event
(ADE) is a medication-induced injury. Some ADEs are not
Sixth Canon, 1848 Code of Ethics
medication errors (e.g., an allergic reaction in a patient with
Philadelphia College of Pharmacy
no history of allergy is an ADE). Other ADEs, however, are
Apothecaries are likewise liable to commit errors in
caused by errors.3 ADEs are common in hospitals, nursing
compounding prescriptions:
homes, and outpatient/community settings.
Firstly — from the imperfect handwriting of the physicians;
Experts estimate that 1.5 million preventable ADEs occur
Secondly — owing to the various synonyms of drugs in use, and
4
yearly in the United States. A recent report from the Departtheir imperfect abbreviations;
ment of Health and Human Services indicates that among
Thirdly — from the confusion which even in the best-regulated
hospitalized Medicare beneﬁciaries, adverse events related to
establishments may sometimes occur, arising from the press of
medication account for 31% of total events.5 In these patients,
business; and
events involving temporary harm were related to medication
Fourthly — from deficient knowledge or ability of one or more of
the assistants in the shop, or of the proprietor.
most commonly at 42%. Finally, medication-related preventable events were assessed at 50%.5
Source: Ref 7
Audit methods. Audits of completed pharmacy orders
can identify medication errors. Researchers conduct random
thorized a new and separate incentive program for eligible
inspections of prescriptions in community pharmacies awaitprofessionals who are electronic prescribers.8
ing patient pickup. The actual contents of the vial are comeRx. The Electronic Prescribing (eRx) Incentive Program
pared with the drug and strength listed on the label to discover
went into effect on January 1, 2009. Electronic prescribers
whether an incorrect medication or an incould earn a 2% incentive payment during
correct strength of the correct medication
2010. Paying physicians to prescribe elecwas wrongly dispensed. Researchers also
tronically on their Medicare Part B claims
Medication errors
compare the patient’s name on the label
may encourage them to also prescribe and
have always plagued
to the identifying information on the outer
transmit non-Medicare prescriptions elecpharmacy.The 1848
bag to help detect wrong-patient errors.
tronically, thereby reducing errors caused
Code of Ethics of
Comparing information entered into
by handwriting. E-prescribing participation
the Philadelphia
the computer with the vial label using
is now voluntary for physicians and pharthese methods is a powerful tool for deCollege of Pharmacy macies, but a penalty may begin in 2012
termining the accuracy with which pharfor prescribers who do not e-prescribe for
identifed 4 specific
macist and technician enter data and for
Medicare and Medicaid patients.8
errors often still
reducing errors. When these investigative
Abbreviations. Finally, errors can ocsignificant today.
methods were employed in an outpatient
cur through the use of abbreviations. Bemedication-error prevention program at a
cause of this problem, most abbreviations
Veteran’s Administration outpatient pharshould be avoided.
macy, the error rate decreased from 0.6% to 0.1% in just 12
Certain abbreviations are misinterpreted today as easily as
months.6
they were 150 years ago. The Institute for Safe Medication
Practice (ISMP) has identiﬁed several easily misinterpreted
History of errors
abbreviations, some of which have resulted in patient harm.9
The Institute of Medicine (IOM) has lately focused much
attention on medication errors, but medication errors have
Automation and dispensing systems
always plagued pharmacy. The 1848 Code of Ethics of the
The pressure to ﬁnish one’s tasks in a busy pharmacy has alPhiladelphia College of Pharmacy identiﬁed 4 speciﬁc reasons
ways been a source of errors. New dispensing systems and
for errors (e.g., bad handwriting) often still signiﬁcant today
automated prescription-ﬁlling technologies can increase ef(Table 1).7 To combat bad handwriting, a 2007 IOM study
ﬁciency, however, and can provide several error-prevention
checkpoints.
suggested that individual “states should enact legislation consistent with and complementary to the Medicare ModernizaCommunicating with patients to prevent errors
tion Act’s electronic prescribing provisions and remove existing
Pharmacists must understand the purpose of each prescription,
barriers to such prescribing.”4
its route of administration, and its frequency of use. DiscussHandwriting vs. e-prescribing. In 2005, the Centers for
ing these points with the patient can prevent possible errors.
Medicare and Medicaid Services (CMS) published regulations
Communication discouraged. As recently as 3 decades
establishing standards to discourage handwritten prescriptions
ago (before passage of the Omnibus Budget Reconciliation Act
and encourage e-prescribing.8
of 1990 [OBRA-90]), pharmacists rarely discussed medication
MIPPA. Addressing the issue of handwriting from a feduse with patients, and patients seldom knew the purpose for
eral perspective, legislation known as the Medicare Improvewhich the medication was prescribed. It was considered unments for Patients and Providers Act of 2008 (MIPPA) au-
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seemly for patients to know too much about the medicines
Error rates
their physicians prescribed.10
Estimates of error rates vary widely across a variety of pharmacy-care settings.
The 1952 American Pharmaceutical Association Code of
Methods. Exact error rates often disagree because of the
Ethics stated, “The pharmacist does not discuss the therapeutic
different methodologies used to identify and quantify them.
effect or composition of a prescription with a patient. When
Four studies examining dispensing errors in community pharsuch questions are asked, he suggests that the qualiﬁed pracmacies employed the same method of error detection, ﬁnding
titioner is the proper person with whom such matters should
errors rates of 1.7% to 24%.13
be discussed.”10
Projections. Extrapolating error rates to potential daily
By suppressing patient interaction, APhA prevented pharprescription volumes provides projections of the numbers of
macists from understanding patient needs, concerns, and other
patients who are potentially affected. For instance, an error
issues related to medication use or misuse. However, patient
rate of 1.7% equals approximately 4 errors per 250 prescripinteraction is now mandatory. Pharmacists who understand
tions per pharmacy per day. On a national scale, perhaps 51.5
patients’ medical conditions and medications will more easily
million errors occur during the ﬁlling of 3 billion prescriptions
recognize inappropriate drug therapy.
annually in the United States.13
A better process. The pharmacist’s routine could include
conﬁrming patient knowledge of their medication regimens;
Deﬁnitions. The fundamental deﬁnition of an error also
checking for appropriate individualized dosing for the patient
determines error rates. One investigator may deﬁne an error
based on age, weight, and drug elimination; and conductas any inappropriate use of a drug, regardless of whether
ing follow-up after new medications are added to a patient’s
harm resulted. Another researcher may deﬁne an error as
regimen. This approach to therapy would
only those situations with the potential to
also help avoid several common types of
cause harm or to be viewed as “clinically
medication errors.11
An error rate of 1.7% signiﬁcant.”14
Error reporting may also be limited in
Case law. Evidence of the magnitude
equals approximately
some studies to speciﬁc types of errors or
of medication errors over a century ago is
4 errors per 250
to errors occurring at 1 or more speciﬁc
unavailable. Case law does provide some
prescriptions per
locations in the dispensing process.15
evidence of the history of errors, however,
pharmacy per day.
Telephone prescriptions. For examand their effect on the public.
In the 1932 case of Jones v. Walgreen Co.,
Perhaps 51.5 million ple, a 2003 study focused on errors created
as a result of telephoned prescriptions. In
a physician-signed prescription for “Stronerrors occur during
that study, 12.4% of all telephoned pretium Salicylate four ounces (Wyatt), teathe filling of 3 billion
scriptions contained an error in the inforspoonful in water four times a day” was
prescriptions per year. mation provided by the person calling in
presented to a graduate pharmacist.12 The
the prescription.16
pharmacist ﬁlled it with pure Parke-Davis
Children. Another area of research
strontium salicylate powder rather than the
focuses on errors in children. Children are particularly vuleffervescent “Wyatt” (actually Wyeth) brand.
nerable to medication errors because their smaller body size
The plaintiff suffered severe injury from the adverse effects
and incomplete/immature organ function affect medication
of the overdose. The pure strontium provided 720 grains in
distribution and metabolism. Further, children seldom if ever
16 hours when the usual oral dose of the medication should
double-check their caregiver’s procedure for errors. One study
have been between 60 and 100 grains daily.
found that approximately 15% of children were dispensed
A judgment was rendered in favor of the patient in the
a medication with a potential dosing error.17 Another study
amount of $20,000. The pharmacy appealed, but the judgment was afﬁrmed on appeal. The court ruled that a phardiscovered that 22% of acetaminophen doses ordered for
macist who does not consult with a physician regarding an
children were outside the 10 to 15 mg/kg safe dosage recobvious overdose may be guilty of negligence.
ommendation.18
The court stated that “in applying his knowledge and exVenues. Other medication error studies have focused on
ercising care and diligence, the druggist is bound to give his
speciﬁc venues, such as nursing homes, psychiatric facilities,
patrons the beneﬁt of his best judgment…” In this case the
chemotherapy units, and hemodialysis units. The multitude
court referenced the pharmacist’s responsibility to use “ordiof factors used in identiﬁcation of medication error and the
nary skill and care” toward patients, deﬁning such care as “the
uniqueness of areas investigated cause serious challenges in
highest degree of prudence, thoughtfulness, and diligence, and
accurate error-rate determination.
is proportioned to the danger involved.”12
Cost of errors
Thus, dispensing a poisonous dosage would be viewed as
Medication errors can be ﬁnancially and emotionally devasa breach of the duty owed the patient and as negligence on
tating. Errors that cause patient harm can generate ﬁnancially
the part of the pharmacist, rendering the pharmacist liable for
crippling malpractice actions and affect pharmacy goodwill
the resulting injuries.
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Continuing Education
TABLE 2
Sources of pharmacist medication errors
•
•
•
•
•
•
•
•
•
•
•
Wrong drug dispensed
Wrong strength dispensed
Calculation error
Abbreviation or symbol misinterpreted
Illegible handwriting
Disruption in workﬂow
Sound-alike drug names
Look-alike drug names
Failure to verify verbal orders
Ambiguous orders
Lack of drug knowledge
errors per year, each creating approximately 20 minutes of
extra work for the healthcare workers (mainly nurses and
pharmacists), thus diverting hundreds of hours from direct
patient care.1
Causes of errors
Errors may occur at any step of the medication-use process
(Table 2).24
Overdose. Dispensing an overdose is among the most
serious medication errors. Overdoses can result from the
administration of excessive single doses or the too-frequent
administration of correct doses. Many medications are available in a variety of dosage forms and strengths. When it is
not clear which is intended, the prescriber must be consulted
Source: Ref 24
for clariﬁcation. Even dispensing the wrong form of the drug
can have serious consequences.
when adverse publicity escalates. Costs include additional
Errors may be mechanical or intellectual.25
healthcare expenditures to care for the injured patient, which
can be overwhelming. A 2000 study estimated the national
Mechanical. Mechanical errors occur when the pharmaannual cost of preventable outpatient pharmacy ADEs for
cist errs with respect to the prescription itself, e.g., dispensing
Medicare enrollees aged ≥65 years at $887 million ($1,983
the wrong drug or the wrong strength, or labeling incorrectly.
per ADE).19
Intellectual. An intellectual error occurs when the pharHospital costs. Hospital-based errors are even more
macist fails to act in a manner to prevent harm in connection
costly. The cost of additional inpatient care for a preventwith the medication, dosage, frequency, or any other use of
able ADE incurred while in the hospital
the medication by the patient that would
is $5,857.20 This study, published in 1997,
be foreseeable based on the pharmacist’s
One study found
training and/or professional background.
reﬂected ﬁgures for 1993 that excluded
that 28% of patients
any healthcare costs outside of the hosError prevention
pital. If one assumes an annual incidence
who presented
Error prevention (risk management) is
of 400,000 in-hospital preventable ADEs
to an emergency
a set of activities designed to reduce the
(each incurring extra hospital costs of
department did so
incidence of errors. Errors cannot be com$5,857), however, the annual cost of hosbecause of an ADE.
pletely eliminated, as the risk of a misﬁll
pital errors is $2.3 billion in 1993 dollars
More than 70% of
will always be present.
(almost $4 billion in 2010 dollars).
Methods. Pharmacies must develop
ER visits. Another method used to essuch ADEs were
and
maintain appropriate methods for entimate medication-error costs is to exampreventable.
tering orders and ﬁlling prescriptions.
ine emergency-room visits and subsequent
Risk management. Every pharmacist
hospitalizations. One study made in a tershould view his/her role as that of a risk
tiary care hospital determined that 1.4%
manager, because every pharmacist action is subject to postof admissions were due to an ADE, perhaps preventable in
hoc review.
28% of cases.21 The estimated cost per ADE was $10,375,
Communication. Verbal communication and written
with an estimated annual hospital cost of $1.2 million for all
documentation are important in reducing risk. Adequate
preventable ADEs. Another study found that 28% of patients
patient communication is critical.
presenting to an emergency department did so because of
Documentation. Documenting events or interventions
an ADE, and over 70% of such ADEs were preventable. The
is equally important in demonstrating due diligence on the
average institutional cost was approximately $1,444 for each
part of the pharmacist to prevent errors.
preventable medication-related visit.22
Counseling. Although it is time-consuming, establishing
Nursing homes. Nursing homes also experience costs
a pattern of counseling patients about medications demonassociated with medication errors, which is highly signiﬁcant
strates compliance with OBRA-90, thereby allowing pharmain light of the number of medications taken by nursing-home
cists to discover and address medication errors.
residents. The U.S. General Accounting Ofﬁce reported in
Common errors. Pharmacists should also identify com2000 that preventable errors in a single nursing home cost
mon medication errors, taking action to prevent these errors
up to $340,942 over a 2-year period.23
before they can occur. The ISMP’s Medication Safety Alert newsDiverted work hours. Addressing medication errors
letter, the US Pharmacopeia (USP) MedMARx data reports,
creates extra work, and the costs may be substantial. For
and case studies from the Agency for Healthcare Research
example, a 700-bed hospital may have 300,000 medication
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TABLE 3
Examples of error-prone abbreviations
Term
Mistaken for:
AD, AS, AU
(right ear, left ear, each ear)
OD, OS, OU
(right eye, left eye, each eye)
BT (bedtime)
BID (twice a day)
HS (half-strength)
BT (bedtime)
o.d., OD (once daily)
OD (right eye)
OJ
(orange juice)
OD or OS
(right eye, left eye)
Per os (orally)
OS (left eye)
q.d. or QD
(daily)
qid or QID (four times daily)
especially if the period after
the “q” or tail of the “q”
appears to be an “i”
qhs (each bedtime)
qhr (every hour)
qn (each night)
qh (every hour)
q.o.d. or QOD
(every other day)
mistaken for q.d. (daily)
or QID (four times daily)
q1d (daily)
qid (four times daily)
U or u (unit)
the numerals 0 or 4,
causing a 10-fold overdose
or more (e.g., “4U” seen as
“40” or “4u” seen as “44”)
U or u (unit)
cc, so dose is given in
volume instead of units
(e.g., “4u” seen as “4cc”)
Source: Ref 26
and Quality’s web M&M (http://www.webmm.ahrq.gov) are
excellent resources in understanding issues associated with
medication errors.4
ISMP list. FDA and ISMP have launched a campaign to
eliminate use of ambiguous medical abbreviations that are
frequently misinterpreted and lead to mistakes that result in
patient harm. As part of the campaign, FDA recommended
that healthcare professionals consider ISMP’s “List of ErrorProne Abbreviations, Symbols, and Dose Designations” whenever medical information is communicated. Table 3 provides
some examples.26
Toolkit. In addition, FDA and ISMP have provided a toolkit of resource materials, known as “ISMP and FDA Campaign to Eliminate Use of Error-Prone Abbreviations.”27
Technology. Technology may help reduce errors. Barcode technology and automated medication-dispensing devices help personnel choose the correct medications.
Mindfulness. Nontechnological interventions may also
provide an opportunity for reduced errors. Examples of
such practices include improved communication practices
(e.g., always resolving medication discrepancies), creating
a culture of safety, and reducing fatigue in the workplace
through careful scheduling.
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Patient education
Patients and family play an integral role in preventing medication errors if they have the necessary information.
• Pharmacists should provide the name of each medication when counseling patients.
• Pharmacists should allow patients to visualize the medications and explain that the medication should always look
the same.
• Patients should be encouraged to speak to the pharmacist if the prescription’s color differs to ensure that it is a
different generic rather than the wrong medication.
• Patients should be instructed on storage requirements
and special instructions to ensure correct use.
• Patients should be encouraged to question any discrepancy (e.g., the label name differs, the directions differ, the
medication appears different).
• Patients should be informed about possible side effects,
the risk of their occurrence, what action to take if they occur,
short- and long-term side effects of taking the medication
(including the risk of dependency), and the importance of
self-observation in assessing these effects.
• The effects of the medication, both minor and more
profound, should be discussed, including how each will affect
day-to-day functioning, what to do if they occur, and when
a pharmacist or physician should be consulted.
Counseling patients on the use of their medications can
also prevent medication errors related to the time of administration, route of administration, and noncompliance.
Obra-90. OBRA-90 greatly changed pharmacists’ responsibilities regarding patient counseling and the associated potential for errors.28 Pharmacists must “offer to discuss” with
each patient or caregiver matters that in the pharmacist’s
professional judgment are signiﬁcant, including the name
and description of the medication, its dosage form, route of
administration, and duration of therapy.
Providing patients information, as required under this
federal provision for Medicaid patients, may conceivably result in better therapeutic outcomes, fewer medication-error
problems, and patients’ greater understanding of their medications.
State provisions. In recognition of its beneﬁts, every
state has extended counseling provisions to all patients (not
just Medicaid patients) thereby giving more patients the opportunity to have better understanding of medication usage.
Reporting of errors
Pharmacy organizations. Pharmacy organizations often
monitor self-reported medication errors. This system detects
only a small percentage of errors, but it is one of the few
options available. Pharmacy organizations should pursue a
better method to identify error patterns and allow for early
intervention when an error has occurred.
Self-reporting and prevention. Error reporting and
review may also provide valuable information regarding error trends so that prevention efforts may achieve maximum
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MEDICATION ERRORS
Continuing Education
TABLE 4
ISMP error reporting form
1. Describe the error or preventable adverse drug reaction.
What went wrong?
2. Was this an actual medication error (reached the patient) or
are you expressing concern about a potential error or writing
about an error that was discovered before it reached the
patient?
3. Patient outcome.
4. Type of practice site (hospital, private office, retail pharmacy,
drug company, long-term care facility, etc.)
5. The generic name (INN or official name) of all products
involved.
6. The brand name of all products involved.
7. The dosage form, concentration, strength, etc.
8. How was the error discovered/intercepted?
9. Please state your recommendations for error prevention.
boards have legal authority to address errors, however, and
can take appropriate action.
In recent years boards have become more vigilant in addressing medication errors. Pharmacy boards have included
regulations stating that misﬁlling a prescription may be considered unprofessional conduct and subject to board oversight.
For example, the Oklahoma State Board of Pharmacy
included in its regulations: “Violations of the rules of professional conduct … include … [the] 1) failure to establish and
maintain effective controls to prevent prescription errors or
misﬁlls, or 2) misﬁlling of a prescription that departs from the
standards of care ordinarily exercised by a pharmacist with
proof of actual injury not having to be established.”32
Pharmacy boards can employ similar regulations to take
action against a pharmacy and/or pharmacy involved in a
medication error.
Liability associated with errors
Pharmacists who act in a careless manner or who are inattentive to detail can be considered legally negligent, even if
their actions result in unintended patient harm. (This is in
impact. If pharmacists refuse to voluntarily report medication
contrast to a criminal event, which typically requires intent
errors, important epidemiologic and preventive information
on the part of the responsible party.)
is unavailable to the medical community.
Four factors. In malpractice actions, 4 elements must
Medwatch. The MedWatch program is the FDA’s sysbe met for the pharmacist to be legally liable: a duty owed
tem for reporting errors and ADEs.29 It is composed of volby the pharmacist, a breach of that duty,
untary reports from medical professioncausation, and damages. If any of these
als and mandatory reports submitted by
Pharmacists who
elements cannot be proven, the court can
manufacturers (i.e., reports received by
dismiss the case. It is important to review
the manufacturer from patients and cliact in a careless
these elements in detail:
nicians). About 250,000 such reports are
manner or who are
Duty. Responsible, ethical pharmacists
received annually via FDA Form 3500.
inattentive to detail
have always attempted to provide the best
Unfortunately, it is believed that many ercan be considered
possible care. Caring for patients may be
rors and ADEs are not reported, owing to
natural, but the pharmacist/patient relaa combination of time pressures, fear of lilegally negligent,
tionship establishes the legal duty. Once a
ability, and lack of perceived beneﬁt from
even if their actions
pharmacist provides patient care, the ensureporting the incident.30
result in unintended
ing relationship requires that care to meet
MERP. ISMP is a federally certified
patient harm.
professional pharmacy practice standards.
patient-safety organization that provides
Many courts have addressed the stanlegal protection and confidentiality for
dards of care owed to patients. In French
any submitted report. Identity, afﬁliation,
Drug Co. v. Jones, the court stated, “All courts have held that
and location remain conﬁdential in any reports submitted to
a druggist is required to use a high standard of care in disgovernment agencies or manufacturers.
pensing drugs on prescriptions of physicians, and when he
The ISMP Medication Errors Reporting Program (MERP)
negligently supplies a drug other than the drug requested, he
is a conﬁdential national voluntary reporting program similar
is liable for resulting harm to the purchaser.”33
to MedWatch. MERP provides an expert analysis of the causes
of medication errors, subsequently disseminating recomIn the case of Speevy v. United States, the court held, “In
mendations for their prevention. Published case studies alert
ﬁlling and reﬁlling prescriptions, a pharmacist is required to
healthcare professionals and others about recommendations
exercise that high degree of care which a very prudent and
to prevent errors. ISMP notiﬁes manufacturers and regulacautious person would exercise under the same or similar
tory agencies (eg, FDA) of recommended changes to increase
circumstances.”34 From these and other cases it is clear that
safety. In addition to actual errors, near-errors and hazardous
courts have high expectations of pharmacists when it comes
conditions may also be reported. Completion of the form is
to care provided to patients.
simple and it can be submitted electronically (Table 4).31
Breach of duty. Once a plaintiff establishes that a speciﬁc
duty of care existed, the next element in the negligence claim
State boards of pharmacy. Reporting medication eris determining whether that duty was breached.
rors to state pharmacy boards is generally not required. These
Abbreviation: INN, international nonproprietary name
Source: Ref 31
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Medication error: Case study
A highly agitated physician enters your clinic pharmacy. Her
ofﬁce is a few doors down the hall from your pharmacy.
She asks to speak to you privately. She has a bottle from
your pharmacy in her hand. It was ﬁlled 4 days ago, and
your label states that it contains tramadol 50 mg, to be
taken 3 times daily.
The patient, currently in her ofﬁce, complained of nausea
and anorexia beginning 3 days ago. He also noticed dizziness, sleepiness, malaise, and tremor. He was afraid he
had the ﬂu, even though it was not ﬂu season.
In taking his history, the physician asked to see his current
medications. Your prescription is the only medication he is
currently taking. She used a search engine to investigate
whether the correct strength had been dispensed and discovered that the product in the container is trazodone 50 mg.
Out of a sense of professional respect, she is asking how
the error occurred and what you expect her to tell the patient.
Several courses of action are open to you, including:
●
Ask her to give the bottle to you and send the patient
to you. Empty the bottle and place tramadol in the
bottle, telling the patient to continue taking it 3 times
daily. Do not inform the patient about the misﬁll.
●
Substitute tramadol 50 mg for the trazodone, and
ask her to give it to the patient, telling the patient
A breach of duty is typically based on some established
standard of practice with which the pharmacist failed to comply. Applicable standards are found in provisions of national
organizations, state or federal laws or regulations, or even the
pharmacy’s own standards as published in its policy and/or
procedure manual.
A common breach of duty is failure to place the right
medication in the right container. This breach is fairly simple
to establish, as any evidence of a misﬁlling is virtually sufﬁcient for a presumption of negligence.35 Expert testimony
may establish a breach of duty, but the obviousness of the
error in a misﬁll may make expert testimony unnecessary.
State provisions (e.g., laws or regulations) regarding errors
as unprofessional conduct establish the duty for accuracy and
the resulting breach when the lack of accuracy is shown. This
is why many pharmacy malpractice actions never reach a jury
verdict. Out-of-court settlements are common if it is clear that
there was a breach of duty owed by the pharmacist and no
defense against the liability is present.
Causation. Pharmacists owe patients a duty to follow set
standards; the element of causation requires proof that the
pharmacist’s action or inaction caused the alleged patient
damage. Causation provides a means of connecting conduct
with a resulting effect, typically an injury.
DrugTopics .c om
●
●
that you made an error, but that you have corrected
the situation.
Request that she send the patient to you, discard
the old bottle, ﬁll the prescription correctly, and give
the patient a full refund. Do not describe the misﬁll.
Request that she send the patient to you, apologize
to the patient, and ﬁll the prescription correctly.
Consider the potential consequences of each and decide
which is best for the patient and yourself:
●
Correcting the misﬁll is commendable, but refusing
to inform the patient about the misﬁll is deceptive,
compounding the problem. Either the physician or
the patient may discover the misﬁll.
●
Correcting the misﬁll and asking the physician to explain the situation allows the pharmacist to give the
patient the correct medication and also to avoid a
confrontation, but avoids the opportunity to accept
responsibility and tender an apology. The patient
may ﬁle a lawsuit out of lingering resentment and
mistrust.
●
Correcting the misﬁll and refunding the purchase
price are both commendable, but not informing the
patient about the misﬁll is deceptive, compounding
the problem. Either the physician or the patient may
discover the misﬁll.
●
Of the options presented, this apology and reﬁlling
the prescription correctly appears best. It allows you
to accept blame, while correcting the misﬁll.
The pharmacist may be held responsible if no new intervening act severs the link between the pharmacist’s action and the patient’s injury. For example, if a pharmacist
dispenses 5 mg of warfarin when the physician prescribed 1
mg of warfarin and the patient immediately suffers a stroke,
causation is readily apparent.
However, suppose in the same misﬁll situation the patient
ingested the incorrect warfarin 5 mg for only 2 days before
noticing the error and obtaining the correct 1-mg tablets. In
this case, if the patient suffered a stroke 2 months later, establishing the causal link between the original breach and the
injury would be very difﬁcult.
Damages. The ﬁnal element requiring proof in a malpractice action is that of damages. Without some form of damages
no recovery is permitted. Damages fall into the categories of
actual damages and punitive damages.
• Actual damages compensate injured patients for any
direct loss based on the pharmacist’s negligence. The intent
of payment for actual injuries is to restore the patient to the
condition he or she experienced before the negligent action
of the pharmacist. Some are easily calculated, such as medical costs or lost wages as a result of time away from work.
Other actual damages are more difﬁcult to calculate, such
as loss of vision or hearing, emotional injuries, pain and sufFebruar y 2011
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MEDICATION ERRORS
Continuing Education
fering, and other physical injuries. The ﬁnancial payment may
not fully restore the patient, but it does help ease the pain and
make the harm more bearable. Tort reform in some states limits
ﬁnancial compensation by capping the award at a preset ﬁgure,
thereby preventing excessively large awards and giving insurance companies the ability to better estimate losses.
• Punitive damages, in contrast to actual damages, are
intended to punish the individual causing the harm. They
have no connection with actual damages. Typically, punitive
damages can be assessed if it is found that the pharmacist
acted with reckless disregard for the patient’s life. Examples
include the pharmacist allowing technicians to ﬁll prescriptions without oversight, watching television while filling
prescriptions, or attempting to cover up a prescription error.
Failure to follow stated manufacturer guidelines addressing
the need to observe automated equipment might also result
in punitive damages.36
If pharmacists fail to admit an error or to express sorrow
out of fear of litigation, it limits their ability to manage or
mitigate harm caused by the error.
Medication errors may be discovered by the patient, a physician, a poison center, the pharmacist who made the error, or
another pharmacist.39 Once an error is discovered, the pharmacist must determine what, if anything, will be said to the
patient. Unfortunately, pharmacy educators often fail to address
this inevitable patient interaction, thereby leaving the pharmacist little direction in formulating an appropriate response.
Apology laws. In order to allow medical professionals,
including pharmacists, to apologize without fear of it being
construed as an admission of guilt, many states have enacted
relevant legislation. As of 2008, 34 states had passed laws banning the introduction of some forms of apologies in litigation.38
Partial apology. Approximately two-thirds of existing state
apology laws protect only the expression of regret, not accompanying information related to fault. This type of legislation
Defenses to liability
provides for partial apology protection.
Even if an injured patient can prove all 4
Thus, if the pharmacist says, “I am sorry
elements, defenses for the pharmacist may
for
your
pain,” no liability arises. If, however,
An authentic
exist. For instance, if the patient could have
the pharmacist says, “I am sorry for misﬁllapology has the
avoided harm caused by the pharmacist’s
ing your prescription and your pain,” liability
capacity to inspire
negligence, liability may be partly or tocould occur based on that statement.40
tally avoided under a legal theory known
These ﬁne-line distinctions between a
a unique kind of
as contributory negligence.
manifestation
of sympathy and an admishealing, both for the
Contributory negligence. Patients
sion of fault are confusing; pharmacists
party who inﬁicted
may contribute to their harm by failure to
should clearly understand the distinction
the harm and the
comply with directions, follow the pharand determine what protection may be
patient who suffered provided by their individual states.
macist’s instructions, or recognize apparent
risks and take action.
Healing effect. An apology may mitithe harm.
For example, if the pharmacist instructgate potential damages, but it also provides
ed the patient to always expect to receive a
emotional healing, both for the party who
green capsule, yet the patient consumed a prescription misinﬂicted harm and the patient who suffered harm.
ﬁlled with a white tablet, contributory negligence could be
The apology acts as a healing agent for the party who has
attributed to the patient. Thus, pharmacist counseling can
erred because giving an apology demonstrates moral courage
make patients more responsible for recognizing risks and takby speaking a truth that carries potentially grave consequencing action to minimize those risks.
es.40 It also provides the opportunity to demonstrate moral
Comparative negligence. Statutes or doctrines concernintegrity and to restore the relationship with the harmed paing comparative negligence have replaced contributory neglitient. Finally, offering an apology allows the pharmacist to
gence in many jurisdictions. In this case, negligence is measured
regain self-respect in light of the pharmacist’s imperfection
as a percentage, and damages are diminished in proportion to
and failure that resulted in the medication error.
the amount of negligence attributable to the person for whose
Studies have shown that in the aftermath of an error,
injury, damage, or death recovery is sought. Juries can make
“….professionals often feel shame, humiliation, agony, anthe determination of percentage of negligence.
guish, devastation, panic, guilt, remorse, sadness, anger,
self-doubt, and self-blame.”40 Yet the authentic apology has
Importance of issuing an apology
the capacity to inspire a unique kind of healing and has the
The purpose of an apology is to recognize responsibility for
potential to bring emotional healing to both the pharmacist
an act that may have had negative consequences and allow
and the patient.
the responsible party to express remorse.
Psychologists have discovered that one of the most sigThe professional pharmacist has many opportunities to say
niﬁcant factors inﬂuencing the granting of forgiveness is re“I’m sorry” or “I apologize,” yet may never do so.37 Patients
pentance by the party who has erred. Thus, a heartfelt and
have a right to know what went wrong when an error ocsincere apology may reduce liability by invoking the patient’s
curs, and pharmacy practitioners should be able to disclose
forgiveness. A culture of disclosure and apology may be benerrors without fear of repercussion.38
eﬁcial in mitigating liability.
44
DRUG TOPICS
Februar y 2011
DrugTopics .c om
CONTINUING EDUCATION
Conclusion
Patients expect safe, error-free medication distribution by
pharmacists. However, pharmacists involved with medication distribution occasionally misﬁll or mislabel a prescription. Systems can be created to greatly decrease the risk of
errors and injuries to a patient. Pharmacists must be mindful
of the possibility of errors and continue to take steps to identify errors and correct them before they reach the patient.
References
1. Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. Relationship between medication errors and adverse drug events. J Gen
Intern Med. 1995;10:199–205.
2. National Coordinating Council for Medication Error Reporting
and Prevention. NCC MERP: The First Ten Years. December 2005.
http://www.nccmerp.org/pdf/reportFinal2005-11-29.pdf. Accessed January 20, 2011.
3. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug
events and potential adverse drug events. Implications for prevention.
ADE Prevention Study Group. JAMA. 1995;274:29–34.
4. Institute of Medicine. Preventing Medication Errors. Quality Chasm
Series. Washington, DC: National Academies Press; 2007.
5. Department of Health and Human Services. Ofﬁce of Inspector
General. Adverse events in hospitals: National incidence among Medicare beneﬁciaries. November 2010. http://oig.hhs.gov/oei/reports/oei-0609-00090.pdf. Accessed January 20, 2011.
6. Boneberg RF, Kellick KA, Pudhorodsky TG, Vitell SJ, Jones GE.
Results of a retrospective outpatient medication error prevention
program at a Department of Veterans Affairs Medical Center. ASHP
Midyear Clinical Meeting. 1991;26:325E.
7. Smith DB, Ellis C, Troth SF. A code of ethics adopted by the Philadelphia College of Pharmacy. Am J Pharm. 1848;20:148–151.
8. U.S. Department of Health and Human Services. Centers for
Medicare and Medicaid Services. Electronic Prescribing (eRx) Incentive Program. http://www.cms.gov/ERXincentive/. Accessed January
20, 2011.
9. Institute for Safe Medication Practices (ISMP). ISMP’s list of errorprone abbreviations, symbols, and dose designations. ISMP Medication
Safety Alert! Washington, DC: ISMP;2001:6.
10. Buerki RA, Vottero LD. Ethical Responsibility in Pharmacy Practice.
2nd ed. Madison, WI: American Institute of the History of Pharmacy;2002.
11. Cohen MR. Causes of medication errors. In: Cohen MR, ed.
Medication Errors. Washington, DC: American Pharmaceutical Association;1999:1.1–1.8.
12. Jones v. Walgreen Co. 265 Ill. App. 308 (Ill. App. 1932).
13. Flynn EA, Barker KN, Carnahan BJ. National observational study
of prescription dispensing accuracy and safety in 50 pharmacies. J Am
Pharm Assoc. 2003;43:191–200.
14. Allan EL, Barker KN, Malloy MJ, Heller WM. Dispensing errors
and counseling in community practice. Am Pharm. 1995;NS35:25–33.
15. Lesar TS, Lomaestro BM, Pohl H. Medication-prescribing errors in a teaching hospital. A 9-year experience. Arch Intern Med.
1997;157:1569–1576.
16. Camp SC, Hailemeskel B, Rogers TL. Telephone prescription errors in
DrugTopics .c om
two community pharmacies. Am J Health Syst Pharm. 2003;60:613–614.
17. McPhillips HA, Stille CJ, Smith D, et al. Potential medication dosing errors in outpatient pediatrics. J Pediatr. 2005;147:761–767.
18. Losek JD. Acetaminophen dose accuracy and pediatric emergency
care. Pediatr Emerg Care. 2004;20:285–288.
19. Field TS, Gilman BH, Subramanian S, Fuller JC, Bates DW, Gurwitz JH. The costs associated with adverse drug events among older
adults in the ambulatory setting. Med Care. 2005;43:1171–1176.
20. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug
events in hospitalized patients. Adverse Drug Events Prevention Study
Group. JAMA. 1997;277:307–311.
21. Jha AK, Kuperman GJ, Rittenberg E, Teich JM, Bates DW. Identifying hospital admissions due to adverse drug events using a computer-based monitor. Pharmacoepidemiol Drug Saf. 2001;10:113–119.
22. Tafreshi MJ, Melby MJ, Kaback KR, Nord TC. Medication-related
visits to the emergency department: A prospective study. Ann Pharmacother. 1999;33:1252–1257.
23. GAO. Adverse drug events: The magnitude of health risk is uncertain because of limited incidence data. Washington, DC: US General
Accounting Ofﬁce;2000.
24. Chisholm-Burns MA, Vaillancourt AM, Shepherd M, eds. Pharmacy Management, Leadership, Marketing, and Finance. Sudbury, MA:
Jones & Bartlett;2011:122.
25. Fink JL, Vivian JC, Keller Reid K, eds. Pharmacy Law Digest. 35th
ed. St. Louis, MO: Facts and Comparisons;2000;265.
26. Institute for Safe Medication Practices. ISMP’s list of error-prone
abbreviations, symbols, and dose designations. http://www.ismp.org/
tools/errorproneabbreviations.pdf. Accessed January 20, 2011.
27. Institute for Safe Medication Practices. ISMP and FDA campaign
to eliminate use of error-prone abbreviations. http://www.ismp.org/tools/
abbreviations/. Accessed January 20, 2011.
28. Omnibus Reconciliation Act of 1990. 42 U.S.C. §1396r–8(g)(2)
(A)(ii)(I).
29. FDA. MedWatch: The FDA Safety Information and Adverse Event
Reporting Program. http://www.fda.gov/Safety/MedWatch/default.htm. Accessed January 20, 2011.
30. Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance — lack of vigilance, lack of trust. JAMA. 2004;292:2647–2650.
31. Institute for Safe Medication Practices. ISMP Medication Errors
Reporting Program (MERP). https://www.ismp.org/orderForms/reporterrortoISMP.asp. Accessed January 20, 2011.
32. Oklahoma Administrative Code. §535: 10–3–1.2 (17), (18).
33. French Drug Co. v. Jones, 367 So.2d 431 (Miss. 1978).
34. Speevy v. United States, 512 F.Supp. 670 (N.D. Texas 1981).
35. Abood RR. Pharmacy Practice and the Law. 6th ed. Sudbury, MA:
Jones & Bartlett;2011:372.
36. Schroeder v. Lester E. Cox Medical Ctr., Inc. 833 S.W.2d 411 (Mo.
App. S.D. 1992).
37. Van Dusen V, Spies A. Professional apology: dilemma or opportunity? Am J Pharm Educ. 2003;67:813-818.
38. Vivian JC. Legal effect of an apology. US Pharm. 2008;33:68–72.
39. Van Dusen V. Legal and practical aspects of the professional’s apology. Pharmacy Times. 2008;74:82–92.
40. McCormick DW. Whatever you do, don’t say you’re sorry. Okla
Bar J. 2001;72:2357.
Februar y 2011
DRUG TOPICS
45
MEDICATION ERRORS
Continuing Education
TE ST QU E S TIO NS
Write your answers on the form appearing on page 47 (photocopies of the answer form
are acceptable) or on a separate sheet of paper. Mark the most appropriate answer.
1. A medication error would include which of the following?
a. Wrong date on label
c. Child-resistant container utilized
b. Wrong drug dispensed
d. Failure to counsel
2. An adverse drug event (ADE) is considered to be:
a. A state board of pharmacy (BOP) action taken because a drug was
dispensed by the pharmacy without the pharmacist’s ﬁnal check
b. The loss of a medication in transit between origination site and destination
c. An injury due to medication, which can include an error
d. A recall implemented by the manufacturer at the request of the FDA
3. It is estimated that at least ________preventable ADEs occur each year.
a. 400,000
b. 1.5 million
c. 51.5 billion
d. 3 billion
4. When community pharmacies are audited for prescription errors, which of
the following is appropriate?
a. Comparing vial contents to the drug and strength listed on the label
b. Comparing physician name to authorization date
c. Comparing pharmacist’s initials on label to work schedule
d. Calling patients at home to verify vial contents
5. The 1848 Philadelphia College of Pharmacy Code of Ethics identiﬁed which
of the following reasons for medication errors?
a. Lack of manufacturer-provided medications c. Lack of oversight by state BOPs
b. Inferior quality of compounding ingredients d. Busy nature of the pharmacy
6. What legislation has been used as an incentive to encourage physicians to
e-prescribe for medications?
a. Omnibus Reconciliation Act
b. The Robinson-Patman Act
c. The FDA Modernization Act
d. Medicare Improvements for Patients and Providers Act
7. Historically (pre-1990) the counseling of patients on the use of the
medication was performed by the:
a. Pharmacist b. Physician c. Physician’s nurse d. Pharmacy clerk
8. Pharmacy medication error rates in the community pharmacy setting:
a. Routinely range from 0.1%-0.5%. c. Routinely range from 1%-5%.
b. Routinely range from 0.5%-1%. d. Vary greatly due to differing research methods
9. If a pharmacy has a medication error rate of 1.7% and ﬁlls 250 prescriptions
per day, 6 days per week, approximately how many errors would occur annually?
a. 42
b. 130
c. 420
d. 1300
10. Errors resulting from the telephoning of prescriptions to the pharmacy have
been reported at a rate of:
a. 1.3%
b. 5.9%
c. 12.4%
d. 18.1%
11. Preventable ADEs in hospitalized patients are generally:
a. Almost 3 times as costly as outpatient errors
b. Less costly than outpatient errors, because the institution provides care at
no cost to the patient
c. Less costly than outpatient errors, because errors can be detected more
quickly and resolved before injury
d. As costly as outpatient errors, because both require signiﬁcant intervention
12. Errors resulting in medication overdoses may be caused by:
a. Administration of an excessive single dose
b. Omission of regularly scheduled medications
c. Mislabeling of a prescription dosing schedule from 3 times daily to twice daily
d. Providing a drug strength less than that prescribed by the physician
46
DRUG TOPICS
Februar y 2011
13. Which of the following is an example of an intellectual error?
a. Dispensing trazodone 150 mg when the prescription was for trazodone
50 mg, but labeling the prescription correctly
b. Dispensing trazodone 150 mg when the prescription was for trazodone
50 mg, and also labeling the prescription incorrectly
c. Filling an amantadine prescription as ordered for a child, knowing that the
dose falls within the toxic range
d. Filling 2 prescriptions at once and accidentally switching the labels
14. A pharmacist receives a prescription for the following: “Rx: Combigan Ophth.
Drops 0.2%/0.5% 10 mL, Sig: 1 drop OD daily in am; 1 drop OU daily in
pm.” According to the ISMP, which element of this prescription is most likely
to cause a medication error?
a. The percentage strengths of the ingredients c. Using “OD” and “OU”
b. Using “mL” to designate volume
d. Using “am” and “pm”
15. Pharmacists informing ISMP about an error can be assured that:
a. Their names will remain conﬁdential
b. The pharmacy for which they work will be disciplined for factors such as
not hiring sufﬁcient help
c. The state’s board of pharmacy will be informed
d. Local news sources will receive information for creation of a public alert
16. State BOP regulations often include language stating that misﬁlling a
prescription may be considered:
a. Part of the normal press of business and subject to board oversight
b. Unprofessional conduct and subject to board oversight
c. Human error and not subject to board oversight
d. Regrettable, but only subject to board oversight if the patient suffers harm
17. A pharmacist ﬁlling a prescription for doxazosin accidentally placed doxepin
in the bottle. Which element of liability has he created before the product
even reaches the patient?
a. Intentional inﬂiction of harm b. Breach of duty c. Causation d. Damages
18. A pharmacist came to work hung over and told his technicians to ﬁll Rxs and
only bother him if they had a “bad problem.” He slept in the break room for 4
hours while the technicians ﬁlled 250 prescriptions. A misﬁll occurred and a
patient was hospitalized. In this case, the pharmacist will probably incur:
a. Punitive damages only
c. Neither punitive nor actual damages
b. Actual damages only
d. Both punitive and actual damages
19. After receiving a prescription for eyedrops, a patient noticed that the bottle
had a green cap and was opaque. Previous prescriptions had always had
an orange cap, with a milky suspension visible in the bottle. He used the
product and suffered damage. What can be said about this situation?
a. The pharmacist may be somewhat protected under the concept of
contributory negligence
b. The pharmacist has no defense to liability as the product is clearly misﬁlled
c. Damages incurred as a result of a misﬁll in such situations are always
attributed to the patient
d. Damages will be split between the patient and the pharmacist, and are
virtually always given a 50/50 division by a judge
20. Which of the following apologies made to a patient for a misﬁlled
prescription could incur liability?
a. “I regret deeply that your child was admitted to the hospital last night.”
b. “I’m sorry that you were forced to visit the emergency room to deal with
the vomiting.”
c. “We were so busy, I made a mistake, but I am most sincere in my
sympathy for your distress.”
d. “When you are free, please come by and I’ll let you know how bad I feel.”
DrugTopics .c om
CONTINUING EDUCATION
EVALUATION OF CE
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ANSWER FORM
ACPE # 0012-9999-10-147-H05-P (K)
ACPE # 0012-9999-10-147-H05-T (K)
Medication errors CE quiz answers February 2011
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Test questions start on page 46
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Not valid for CE credit after 02/28/2013
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date you sign up
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Submit your check (payable to The University of Florida) and form to:
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Februar y 2011
DRUG TOPICS
47
Regulatory & Legal
RISK MANAGEMENT AND CQI
Kenneth R. Baker, BS Pharm, JD
Is it working?
Monthly Rx safety audits
A
few years ago I was asked to participate in what was at that time
a unique study to determine the
effect on medication errors if telepharmacy were introduced in the state of North
Dakota. The project was conducted in cooperation with the North Dakota Board
of Pharmacy, The North Dakota Pharmacists Association, and North Dakota State
University College of Pharmacy. These 3
pharmacy organizations were pioneers in
telepharmacy. The question was whether
there would be more medication errors
if telepharmacy were made a permanent
part of the practice.
I was asked to participate in training
pharmacy personnel in medication safety
and continuous quality improvement
(CQI). In addition, we were to institute a
method of measuring quality in participating pharmacies and telepharmacy sites.
Is it working?
In essence, we wanted to know whether
the CQI plan we instituted at each of these
sites was working.
If a pharmacy, be it community, longterm care, or hospital, cannot answer that
question, its CQI program of medication
error reduction is not complete. The ﬁnal
step in continuous quality improvement
is to monitor progress and use that information to analyze and look for lingering
vulnerabilities in its workﬂow.
No matter how sophisticated a pharmacy’s quality system is, risk of error will
still exist. There will always be vulnerabilities to ﬁx and there will always be changes
that need to be made to further reﬁne the
system. While the goal in a CQI system is
“perfection,” it will never be reached. The
system will never be complete.
48
DRUG TOPICS
Februar y 2011
Measuring success
There are 2 measures of success every
pharmacy should post on its wall. I refer to these measurements collectively as
“Monthly Safety Audits.” Both should be
posted each month and compared with
results for prior months.
The best way to compare is to draw
a month-to-month graph using error and
near-miss information as the graph point
for each month. It should be a simple
graph and, hopefully, the line of success
should be going up.
Quality-related events
The first graph develops its point each
month by subtracting the number of
quality-related events (QRE: a combination of all near-misses and errors) from
the number of prescriptions ﬁlled for the
month. This gives the number of prescriptions ﬁlled correctly, which is divided by
the total number of prescriptions ﬁlled.
This ﬁgure is converted into a percentage.
This percentage of prescriptions free of error (even one that was corrected before it
reached the patient — i.e., 98%) is plotted
on the vertical (y) axis. Time in months is
on the horizontal (x) axis. QRE is a better
measurement than errors, because nearmisses can expose a problem before it becomes an error or a claim. The best way
to prevent errors is to prevent the mistakes
that can lead to them.
Effectiveness of CQI
The second graph is a measurement of the
percentage of QREs that are caught before
reaching the patient. While the ﬁrst graph
shows success in avoiding mistakes, this
second graph shows how successful the
CQI system is at catching mistakes before
they become errors. The hope is that every
month both graphs will have lines that go
up, meaning that the system is working
and improving.
In the North Dakota study, it was determined that by implementing a CQI
system along with adequate training and
measures of success, medication errors
could be reduced, although not eliminated, in both the telepharmacy locations
and the central pharmacies. The study
did not show a signiﬁcant difference in
the number of errors in the 2 workplaces.
The systems used, although not perfect,
were working.
The combination of the 2 graphs outlined here helps in efforts to constantly improve the workﬂow. Posting both graphs
emphasizes to staff the pharmacy’s commitment to success and quality. They give
answers to essential questions: “How are
we doing quality-wise?” and “Is the system working?”
How do you track your pharmacy’s
success, errors, and near-misses? How do
you use the information collected?
To see the Quality Manager system,
visit www.pqc.net, the website of the Alliance for Patient Medication Safety.
This article is not intended as legal advice
and should not be used as such. When legal
questions arise, pharmacists should consult
with attorneys familiar with pharmacy law
in their states.
Ken Baker is a pharmacist and an attorney.
He consults in the areas of pharmacy
error reduction, communication, and risk
management. Mr. Baker is an attorney of
counsel with the Arizona law ﬁrm of Renaud
Cook Drury Mesaros, Pa. Contact him by
e-mail at ken@kenbakerconsulting.com.
DrugTopics .c om
Regulatory & Legal
LEGAL COMPLIANCE
Ned Milenkovich, PharmD, JD
Telepharmacy opportunities:
New horizons in patient care
T
echnology is providing ever-greater
convenience in the pharmacy marketplace, so it should come as no
surprise that one of the next new frontiers
available to pharmacists, in their expansion of patient care, will be telepharmacy.
Technology systems for telepharmacy,
using bar-coding and other secure automation, have been in the works for quite
some time now.
Telepharmacy relates to the operation
of a remote site located at a significant
distance from the “home pharmacy.” The
remote site is staffed by trained nonpharmacist personnel and serves as a pharmacy and a convenient meeting point
for patients in isolated areas who do not
have easy access to a pharmacist. In other
words, the remote site serves as a surrogate for the home pharmacy, while the
pharmacist is still able to interact with the
patient and provide healthcare.
How it works
The remote site contains medication and
electronic systems in the same way that
a traditional pharmacy does. Ideally, the
remote site should be staffed by a welltrained nonpharmacist who is able to
serve a patient’s needs under the supervision of a remote pharmacist.
When a patient comes to the remote
site, a prescription is processed using technology that provides the pharmacist with
visual access to the prescription itself as
well as to the drug product as it moves
through the fulﬁllment process. Once the
prescription has been ﬁlled, the pharmacist
communicates with the patient by video
feed and provides appropriate clinical
counseling. The trained nonpharmacist
DrugTopics .c om
staffer assists the process by ensuring that
the technology supporting the fulﬁllment
of the prescription is functioning properly.
In addition, the staffer assists the pharmacist and patient by enabling the communication through the video feed at the
remote site.
Through telepharmacy,
a pharmacist is able
to serve segments of a
population that would
otherwise not have
ready access to such a
healthcare provider.
State laws lag
Technology systems achieve near flawless
accounting and accuracy, and they provide
the pharmacist with tools never before
available to simultaneously enhance patient
care and increase business opportunity.
Through implementation of telepharmacy,
a pharmacist is able to serve segments of a
population that would otherwise not have
ready access to such a healthcare provider.
Nevertheless, many state pharmacy
laws and regulations are devoid of language
regulating this area. Telepharmacy is still a
novelty, and there is a lag in implementation of new laws after professional and
technological innovations are deployed.
Moreover, in the few states where
telepharmacy laws exist, there is a lack of
uniformity among the various states’ measures. Implementation of comprehensive
and uniform state laws and regulations
would provide a more certain medium
for telepharmacy for the marketplace and
patient population.
With regard to state laws and regulations in the telepharmacy arena, establishing requirements that any technology
used must be able to electronically link
drug product at the remote site back to the
original packaging from the drug manufacturer would ensure patient safety and
offer a de minimus chance of medication
dispensing error. By electronically sending
the drug product’s bar-code information
from the remote site back for comparison
with the manufacturer’s bar code, the
electronic indicia of the drug can be conﬁrmed without human intervention.
Similarly, laws and regulations should
require that captured images of the drug
product and prescription that are labeled
and dispensed at the remote site must be
retrievable and reviewable by the pharmacy and pharmacist at all times.
Finally, telepharmacy laws and regulations should provide for proper counseling
by means of video technology that enables
pharmacist and patient to interact directly.
Technology in telepharmacy is making
dramatic gains. It is incumbent on the states
to ensure that its safe and effective use enables patient care to move forward.
This article is not intended as legal advice and
should not be used as such. When legal questions
arise, pharmacists should consult with attorneys
familiar with pharmacy law in their states.
Ned Milenkovich is a member at McDonald
Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also a member of
the Illinois State Board of Pharmacy. Ned can
be reached at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com.
Februar y 2011
DRUG TOPICS
49
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toenails, hurting feet present a huge
public health concern, according
to the American Academy of Orthopaedic Surgeons (AAOS), which states that
43.1 million U.S. residents suffer from foot
problems — 1 in every 6 people.
The National Institute on Aging also
warns us to be kind to our feet: “Years of
wear and tear can be hard on them. So can
disease, bad circulation, poorly trimmed
toenails, and wearing shoes that don’t fit.”
To prevent problems or to soothe already aching feet, many will welcome
these new or repackaged foot-care aids.
Moisture support
Winter weather can be especially tough on
feet, causing cracked heels and split skin.
To introduce its foot cream to a national
audience, the O’Keeffe’s Company recently instituted several changes. New packaging, a more user-friendly website, and a
nationwide advertising campaign will tell
customers that O’Keeffe’s for Healthy
Feet provides guaranteed relief for dry
feet that crack and split. The special formulation penetrates the rough, thick skin
50
DRUG TOPICS
Februar y 2011
of soles and heels, bringing in moisture to
begin the skin’s natural healing process.
Antifungal
WellSpring Pharmaceutical Corp. is now
shipping a rebranded Micatin Antifungal Cream carton that features English/
Spanish text and full Spanish drug facts
inside, in a move to support compliance
and education for the fastest-growing segment of the U.S. population.
“The UPC will not change as it is a rolling change from our current package,” a
company spokesperson told Drug Topics.
Nerve-pain relief
Topical BioMedics recently expanded distribution to include The Vitamin Shoppe
and Pharmaca Integrative Pharmacy
stores. The all-natural Topricin Foot
Therapy Cream now comes in 2 sizes
— a convenient 4-oz. jar and a 2-oz. tube.
Completely safe for diabetics, Topricin
soothes the burning, throbbing nerve pain
in the feet, as well as treating dry, cracking skin of the feet. In addition to relieving
foot and ankle pain, Topricin Foot Therapy
Cream helps to prevent damage resulting
from use of high heels. It is used pre- and
post-performance by professional dancers
who really have to “stay on their toes.”
Ceremides
Kao Brands Co. has reformulated its
Curél lotions and repackaged them into
white bottles, a change from the original
blue bottles. With the addition of ceremides complex, Curél lotions replenish
the ceremides lost to the elements. These
lipid molecules are crucial to maintaining
the skin’s protective barrier and locking in
moisture.
Shea butter
Curél Foot Therapy Cream is formulated with shea butter to deeply moisturize dry skin, healing cracked heels
and smoothing tough soles. Urea helps
to remove the thickened, callused skin
that can develop on dry feet in the cold
winter months, while vitamin E helps reduce dryness and ﬂaking. Coconut milk,
known for its anti-inﬂammatory beneﬁts,
soothes and softens.
Continued on pg. 52
DrugTopics .c om
PHOTOS COURTESY OF THE O’KEEFFE’S COMPANY/WELLSPRLING PHARMACEUTICAL/TOPICAL BIOMEDICS
DANA K. CASSELL
Use as directed.
FOR YOUR
PATIENTS WITH
HYPERTENSION
RECOMMEND COLD MEDICINE
WITH A HEART.
Tell your patients about the only
cold brand that won’t raise their
blood pressure: Coricidin® HBP.
Like many of your patients, S. Epatha Merkerson has hypertension. Since decongestants are
contraindicated for hypertensive patients, they need to be careful when they get a cold. So assure
your patients that Coricidin HBP is the smart choice because it’s decongestant-free and specially
made to relieve cold symptoms without raising blood pressure.
Recommend the full line of products from Coricidin HBP. Powerful cold medicine with a heart.
®
Schering-Plough, maker of Coricidin HBP,
sponsors the AHA High Blood Pressure website.
©2011 Schering-Plough HealthCare Products, Inc.
FOOT CARE
Continued from pg. 50
Healthifeet has added
several new products to its
line of footcare treatments.
Collagen
Available through Wound Care Innovations, LLC, CellerateRX activated
collagen products are now being sold
in retail pharmacies. The products previously had been used in healthcare settings such as the Veterans Health Administration.
In addition to providing the skin structural support, collagen can actively assist in
wound-healing processes — especially in
diabetic foot ulcers and skin tears. Collagen
has been proven to trigger every critical
process involved in the body’s healing of
diabetic wounds and helps establish balance in the patient’s wound bed.
The patented collagen in CellerateRX
products immediately provides the properties of activated collagen to the body.
Although the RX in the name may be a
bit disconcerting, CellerateRX is an OTC
product line, available in powder and gel
forms, and FDA-cleared for all wound
types except for third-degree burns.
The transparency of the GlacierGel
dressing enables monitoring of the healing process without the necessity of removing the dressing, avoiding unnecessary wastage and preventing possible
external contamination.
The GlacierGel plasters can also be
used in the prevention of blisters when
placed on hotspots or areas of the foot
where blisters typically develop. Featuring an enhanced adhesive, the GlacierGel
dressings will stay in place for 3 to 4 days.
Gel dressings
One of 6 new products Tender Corp. is
adding to its HealthiFeet brand of footcare treatments in 2011, HealthiFeet
GlacierGel Advanced Blister & Burn
Dressings give consumers the ability
to eliminate the nagging pain of blisters
and burns on contact. Soft, cooling, and
absorbent, the oval-shaped dressings contain 50% water (hydrogel) and provide an
immediate and highly effective cushion
against friction to sensitive skin.
52
DRUG TOPICS
Februar y 2011
Moleskin
HealthiFeet’s new softer and more adhesive Moleskin blister treatment is
also easier for consumers to use, with
pre-cut shapes and sizes eliminating the
need for scissors.
A Moleskin pack includes 22 dressings with 5 unique anatomical shapes
for easy application on hard-to-ﬁt areas. The new Moleskin is useful for applying on hot spots to prevent further
rubbing or as protection and pain relief
from a fully developed blister.
Blister kit
HealthiFeet’s Blister Medic combines
GlacierGel, Moleskin, antiseptic towelettes, and alcohol wipes into one complete ultralight foot care kit. Packages
include 13 dressings and 15 wipes.
Corn salve
The new HealthiFeet Corn Salve safely
removes unsightly corns overnight. The
24/7 Plantar Fasciitis
Support offers a brace for
day and a splint for
night use.
company says to “Apply the topical treatment to the affected area at night and
wake up corn-free!”
Heel balm
HealthiFeet Heel Balm is formulated to
moisturize severely dry cracked skin occurring in and around the heel area.
Exfoliation
HealthiFeet Exfoliating Moisturizer
offers a one-step therapy for treating dry
skin. The Exfoliating Moisturizer’s dual
action formula acts to smooth and hydrate the skin.
Tea tree oil
Among several package changes for
2011, Health Enterprises is repackaging
its 100% Tea Tree Oil, an antifungal
product for toenails and athlete’s foot.
Spa therapy
Health Enterprises is also launching a
line of new spa therapy items for feet,
including the new TheraPED and
TheraTOES, which help pamper and
soothe sore feet.
Plantar relief
The 24/7 Plantar Fasciitis from Health
Enterprises is the only product offering
day (arch brace) and night (night splint)
treatment for painful plantar fasciitis.
Dana K. Cassell, a frequent contributor to
Drug Topics, lives in North Stratford, N.H.
DrugTopics .c om
PHOTOS COURTESY OF WOUND CARE INNOVATIONS/TENDER CORP./HEALTH ENTERPRISES
CellerateRX activated
collagen products are now
available in retail
drugstores.
Product Updates
RX & OTC
New indication
FDA has approved a once-daily dose of Tibotec Therapeutics’ Prezista (darunavir) to
be used in combination with ritonavir for
treating HIV-1 in treatment-experienced
adults with no darunavir resistance-associated mutations. Dosing recommendations are the same as those already
approved for treatment-naive patients.
(www.prezista.com / 877-732-2488)
2
1
3
RX CARE
New drugs
Available from Meridian Medical: Alsuma
(6 mg/0.5 mL sumatriptan) 2-pack singledose preﬁlled auto-injector for acute treatment of migraine and cluster headaches.
(www.alsuma.com / 877-770-8796)
Novartis has announced FDA approval
of Amturnide (aliskiren/amlodipine/hydrochlorothiazide tablets in 5 dosage strengths:
150/5/12.5 mg, 300/5/12.5 mg, 300/5/25
mg, 300/10/12.5 mg, 300/10/2 mg), a
ﬁxed-dose combination hypertension therapy for patients not adequately controlled
by any 2 drugs in the following classes:
direct renin inhibitors, calcium channel
blockers, and diuretics. (www.pharma.
us.novartis.com / 800-693-9993)
FDA approved Bayer HealthCare’s
21/7-day Safyral (drospirenone 3 mg/
ethinyl estradiol 30 μg/levomefolate calcium 451-μg tablets plus levomefolate
calcium 451-μg tablets), an oral contraceptive that raises folate levels in women.
(www.safyral.com / 800-288-8371).
FDA approved Watson’s Ella (ulipristal
acetate 30 mg), an oral emergency contraceptive tablet available by prescription for
the prevention of unintended pregnancy
for up to 5 days after unprotected intercourse or a known contraceptive failure.
(www.ella-rx.com / 800-272-5525)
FDA has approved Endo Pharmaceuticals’ Fortesta, a Schedule III controlled
substance. The clear, odorless gel delivered
by metered-dose pump treats hypogonadDrugTopics .c om
ism (low testosterone) in men ≥18 years.
(www.endo.com / 800-462-ENDO)
FDA approved Warner Chilcott’s Lo
Loestrin FE (norethindrone acetate and
ethinyl estradiol tablets, ethinyl estradiol
tablets, and ferrous fumarate tablets) for
the prevention of pregnancy. With 10 μg
of estrogen, Loestrin FE offers the lowest
estrogen dose of any oral contraceptive on
the U.S. market. (973-442-3200)
OTC
Wyeth Consumer Healthcare has expanded the Caltrate product line with the
launch of Caltrate Soft Chews in chocolate
truffle and vanilla crème flavors. Each
supplement contains 600 mg of calcium
carbonate and 400 IU of Vitamin D3.
(www.caltrate.com / 888-797-5638)
From TriDerma MD: 2 new skin-care/
repair products. TriDerma MD Spot and
Wrinkle Erasing Cream Anti-Aging Complex
helps to reduce the appearance of brown
spots, age spots, and scars, while smoothing out ﬁne lines and wrinkles. TriDerma
MD Pore Reducing Anti-Age Serum helps to
hide imperfections while improving the
overall appearance of pores and skin texture. (www.triderma.com)
From Valeant: Dr. LeWinn by Kinerase
[2], a line of 10 cleansers, moisturizers,
and daily treatments designed to extend
skin’s youth by improving cell health.
(drlewinnbykinerase.com)
From Perio: Pure Silk Moisturizing Shave
Cream Sensitive Skin Formula [3], infused
with aloe, papaya, thyme, and willow
bark. (www.pure-silk.com)
New generics
Glenmark Generics received ﬁnal FDA
approval for 2 products, indomethacin
capsules in 25-mg and 50-mg strengths
and sulfamethoxazole and trimethoprim
tablets in double and single strengths.
Indomethacin is used in treating arthritis; sufamethoxazole and
trimethoprim tablets are
Advertiser
indicated for urinary tract
BUDESONIDE
infections. (Fax: +91-22COLCRYS
4018-9988)
CORICIDIN HBP
Perrigo announced
CORPORATE
that its licensor and supplier Synthon has received
CORPORATE
ﬁnal FDA approval for leCORPORATE
vocetirizine [1] tablets (geCORPORATE
neric for Xyza, UCB/SeCORPORATE
pracor), marketed in the
LEXAPRO
United States by SanofiMETFORMIN
Aventis and indicated for
PRADAXA
the treatment of indoor
PRILOSEC
and outdoor allergies.
RID
(www.perrigo.com)
Index
Teva Pharmaceuticals
CV2-2
URL Pharma Inc.
11-12
Schering-Plough
51
QS/1 Data Systems Inc.
21
Takeda Pharmaceuticals
5
Actavis Inc.
Mylan Pharmaceuticals Inc.
Roxane Laboratories
Forest Laboratories Inc.
17
CV4
CV3
23-26
Mylan Pharmaceuticals Inc.
7-9
Boehringer Ingelheim Ltd.
15
Proctor & Gamble
29
Bayer Corporation
19
PHOTOS COURTESY OF PERRIGO/VALEANT/PERIO
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DRUG TOPICS
55
Final Word
VIEWPOINT
Dennis Miller, RPh
When efﬁciency is all that matters
W
When
I was in college, I used to think “efﬁciency”
was an unequivocal good. I was attracted by the chain
w
drugstore model because I bought into the concept
d
thatt chains
th
h i are efﬁcient. Even though I am often critical of
chains today, I admit that they try hard to cut their unit cost
for ﬁlling each prescription.
A bald-faced lie
The chains enthusiastically embrace the latest technology to improve efﬁciency. Very few pharmacists would elect to go back to
using typewriters, ﬁguring clerk timecards by hand, or using a
bulky order book for the weekly Rx order. But technology can
have a downside. For example, many pharmacy computers now
have the ability to transmit data to our bosses about our speed
and efﬁciency in ﬁlling prescriptions.
Many pharmacists feel that the chains care more about their
technology than they do their employees. Pharmacists have
been told routinely that improvements in technology will allow
us more time to spend with customers. This has always been a
bald-faced lie. The fundamental reason the chains introduce the
latest technology is to cut stafﬁng. Stafﬁng levels are cut commensurate with each technological advance.
A major drag
Efﬁciency is what the chains are all about. The chain concept is
meant to facilitate economies of scale. Mass purchasing of products allows lower unit costs. Chainwide computerization means
that stores can be run more efﬁciently.
Conversely, the foundation of the independent drugstore is
customer service. The chains want the public to think that they
offer customer service that’s as good as that of the independents,
but that’s very often untrue. I’ve had bosses who ridicule pharmacists behind their backs for spending too much time talking
with customers. The chains say they want us to speak with
customers, but most pharmacists realize quickly that the chains
don’t really mean it. The chains have always viewed patient
counseling as a major drag on productivity that adds nothing
to the bottom line.
Huge cost
The chains’ narrow focus on efﬁciency comes at a huge cost
to customers, to employees, and to society. Equating health
56
DRUG TOPICS
Februar y 2011
with the efﬁcient delivery of products comes at a tremendous
price that the chains don’t want to discuss.
Search Google for “pharmacy mistakes” for one illustration of
the many costs of placing speed and efﬁciency above everything
else. Many pharmacists feel that the chains have made the cold
calculation that it is more proﬁtable to sling out prescriptions at
lightning speed and pay customers harmed by mistakes than it
is to provide adequate stafﬁng so that mistakes are a rarity rather
than a predictable occurrence. I’d love to see a study that compares the per store error rate at chains versus independents.
Employees as robots
When efﬁciency is all that matters, employees are viewed as
machines rather than human beings and as a necessary evil to
be barely tolerated until the chain can ﬁgure out a way to automate their jobs. Chain management is endlessly disappointed
that it can’t remake the genomes of store employees so that those
employees are robots. Employees may resent this and take their
resentment out on customers. Thus rudeness toward customers
is not surprising in the chain model.
The narrow focus on efﬁciency carries a cost far beyond that
of disillusioned employees. Pharmacists don’t have time to do
much more than throw a few words at customers. Our customers
end up not understanding their medications. The consequences
of this can be grave.
Assembly-line model
Our entire healthcare system is based on quantity rather than
quality. Society pays a heavy price for this assembly-line model,
which says that human health is directly proportional to the
per capita consumption of products. In this model of healthcare, the concept of prevention becomes a quaint dream of the
distant past.
Americans remain ignorant of the nonpharmacological
determinants of human health. This model based on
efficiency promotes a quick-fix pill for every ill rather than
a fundamental understanding of those lifestyle choices
that can have a profound effect on one’s health.
Dennis Miller is a retired chain store pharmacist living in Delray Beach,
Fla. He is working on a book about pharmacy practice “in the real world”
and welcomes feedback sent to DMiller1952@aol.com.
DrugTopics .c om
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