Paul Davis From: Sent: To: Subject: Tshp@Tshp.Org <messages=console.production.membersuite.com@membersuite.com> on behalf of tshp@tshp.org <messages@console.production.membersuite.com> Monday, May 28, 2012 4:00 AM paul.davis@tshp.org TSHP E-News, May 28, 2012 May 28, 2012 Vol. 41, No. 19 NEWS HIGHLIGHTS The TSHP Office will be closed on Monday, May 28 for the Memorial Day holiday. Please drop us a note or contact us on or after Tuesday. We hope that you and your family have a peaceful holiday weekend. "Like" TSHP on Facebook! ON THIS DATE On May 28, 1830 President Andrew Jackson signed the Indian Removal Act, which began relocation of Native Americans to federal land west of the Mississippi River. In 1937, the National Socialist Party of Germany formed a new state-owned automobile company, Geselischaft zur Vorbereitung des Deutschen Volkswagens mbH, later renamed to simply Volkswagenverk or “The People’s Car Company.” In 1957, National League Baseball owners voted unanimously to allow the New York Giants and Brooklyn Dodgers to move to San Francisco and Los Angeles, respectively. In 1965, methane gas caused a mine explosion near Dharbad, India that killed 375 people and injured hundreds more. In 1983, Irene Cara hit #1 for the 2nd time on the pop charts. Today’s Birthdays: Ia n Fleming (1908-1964, English author); Hunter “Patch” Adams (1945, American physician and social activist); John Fogerty (1945, Singer/songwriter). Today’s Trivia: 1. What was the hit Irene Cara had on May 28, 1983? 2. What group is John Fogerty associated with? PRACTICE & PROFESSION Nix the PSA Testing. According to a final recommendation from the United 1 States Preventive Services Task Force (USPSTF), healthy men should no longer have PSA measurements as a screening test for prostate cancer. The recommendation applies to men of all ages, but does not apply to the use of PSA testing for monitoring patients after a prostate cancer diagnosis or treatment. The task force cited a lack of evidence that PSA testing has an impact on reducing prostate cancer deaths. According to an article published in the Annals of Internal Medicine, “there is adequate evidence that the benefit of PSA screening and early treatment ranges from 0 to 1 prostate cancer deaths avoided per 1,000 men screened.” Psychological harm from false-positive tests and additional testing, including one or more biopsies, more than outweigh the likelihood of finding a case of prostate cancer, and increased adverse events possibly resulting in hospitalization. Critics of the report noted that the USPSTF included no urologists or cancer specialists. The American Cancer Society weighed in on the issue, and generally supported the recommendation. Test All Baby Boomers for Hep C. The CDC estimates that about 2 million Americans born from 1945 to 1965 are infected with Hepatitis Virus C (Hepatitis C) and consequently recommends that everyone ages 47 to 67 be tested for the infection. The recommendation is made mainly because it may be years before noticeable symptoms develop, and due to the potential exposure of that generation to causative factors for the disease such as illegal injected drugs, blood products or organ transplants before HVC testing and patients with HIV. The recommendation is open for public comment until June 8 after which CDC will release a final version. Want to be Healthier? Get more Education and Money! Health, United States, 2011 is the 35th annual report prepared by the National Center for Health Statistics. It includes a compilation of health data through 2010 from a number of sources within the federal government and in the private sector. The report indicates that people with higher levels of education and higher income have lower rates of many chronic diseases, compared to those with less education and lower income levels. Obesity was tied to households with less than a high school education, and in women over 25 with less than a bachelor’s degree. Life expectancy at age 25 was lower for men and women without a high school diploma then those with a bachelor’s degree or higher. Beyond these conclusions, the report contains a wealth of data on other health conditions of the American public. ACPE Moves to Paperless MyCPE Monitor Requirement. Effective January 1, 2013, all pharmacists and technicians seeking continuing education credit from any ACPE-approved provider will be required to provide their NABP e-Profile ID # and date of birth for issuance of CPE Statements of Credit through the “My CPE Monitor” web site. Providers will be required to provide ACPE credit for participants through the online service, and will be unable to send statements to individuals that do not provide this information. For full details visit: http://www.nabp.net/programs/cpemonitor/cpe-monitor-service/index.php Are You Losing your Integrity to a Silent Killer? According to Mary Jo Asmus, unethical behavior is a slippery slope. A small transgression, which appears harmless, can soon snowball into major ethical tangles that make it 2 harder to do your job effectively. “(L)oss of integrity is a silent leadership killer.. . The erosion of this value may happen very slowly over time without much notice of integrity violations on the part of those who participate in questionable practices,” she writes in SmartBrief/SmartBlog on Leadership. Back To Top NEW DRUGS & DEVICES FDA Panel Nixes Xarelto. An FDA advisory panel voted 6-4 against expanding the use of Xarelto® (rivaroxaban) to reduce the risk of potentially lethal clots in people with acute coronary syndrome. The decision was somewhat of a surprise, due to a lack of data on potential side effects and some trial data showing there was an increased risk of potentially fatal bleeding. A final decision from FDA is expected June 29. Back To Top RECALLS, WARNINGS & SHORTAGES Safety Communication: Dialysate Concentrates Used in Hemodialysis. FDA has issued a safety communication for healthcare providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription. The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. Dialysate acid concentrate can contain acetic acid, acetate or citrate, and these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis. These substances typically are found in acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate. It is recommended that health care providers review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient’s overall bicarbonate levels. The levels of acetate, citrate and/or acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients. For more details, see the FDA MedWatch safety alert. Hospira Carpuject Recall Update. FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira, Inc. The pre-filled cartridges containing the products listed in the Drug Alert may be overfilled by at least twice the expected amount, resulting in potential overdose. Because pharmacists and other healthcare providers can 3 visually identify the presence of an overfilled Carpuject pre-filled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products would result in an immediate shortage. Subsequent inspection of retained product by Hospira found additional overfilled Carpuject pre-filled cartridges. The manufacturing problem thought to be responsible for this overfilling has resulted in the risk for overfilled Carpuject pre-filled cartridges for as many as 280 lots of 15 different Carpuject pre-filled cartridge products. FDA is advising healthcare providers to follow the instructions provided with the medication and visually inspect and confirm that the Carpuject pre-filled cartridge contains the labeled fill volume before dispensing and again before administering to patients. Back To Top LEGISLATIVE & REGULATORY UPDATE Senate Passes PDUFA. The Senate voted 96-1 last week to pass the bill reauthorizing the FDA user fee program (PDUFA). The legislation also creates new user fees for generic and biologic drugs. The House must now pass its version, which could occur as early as May 30. The bill also contains a provision that would require drug manufacturers to give FDA early warning if they foresee a potential for drug shortages, one portion of legislation that was being sought by pharmacy groups to deal with the drug shortage situation. The one vote of dissent on the bill was Sen. Bernie Sanders (I-VT). In adopting the bill, the Senate rejected several amendments including one from Sen. John McCain (R-AZ) that would have allowed Americans to buy cheaper drugs from Canada; and one from Sen. Dick Durbin (D-IL) that would have required manufacturers of dietary supplements, including energy drinks, to register their products with FDA. Federal Bill Calls for Elimination of Drug Patents. Almost as if to prove that things can always get weirder, Sen. Bernie Sanders (I-VT) has introduced S 1138, the “Prize Fund for HIV/AIDS Act,” which would de-link R&D incentives from drug prices, specifically for new HIV/AIDS medicines, and create a $3 billion annual prize fund to reward the discover of new treatments. Calling the current system of awarding patents to drug companies “monopolies,” Sanders called for elimination of that system which he believes would be replaced by the power of the competitive marketplace, making more products available at lower cost. Sanders believes the patent system drives up the cost of new drugs, and the hearing he called of a subcommittee of the Senate Health Education, Labor and Pensions Committee last week to hear th e bill, is “the first Congressional hearing ever held to discuss the possibility of ending monopolies for medicines and offering a serious proposal to replace our broken system with one that would accelerate innovation while providing virtually universal access to life-saving medicines.” He primarily focused his attention on Atripla® from Gilead which costs more than $25,000 per person per year, but which generically (unavailable in the U.S.) costs less than $200 per patient per year. The generic version is being purchased from a competitive supplier by the Presidents’ Emergency Plan for AIDS Relief for distribution in developing countries. Sanders acknowledge that the legislation isn’t going anywhere anytime soon – he is the sole sponsor – and a number of opposing 4 forces are lined up against the legislation. Federal/State Law Info Online. George Washington University has initiated a new website to help providers understand federal and state health information laws. HealthInfoLaw.org contains information on current health information laws, offering insights in to legislation including HIPAA, the HITECH Act and the Affordable Care Act. For details, see the announcement online. Back To Top STATE, NATIONAL AND INTERNATIONAL There’s Gotta be a Health Story in Here Somewhere!? New Delhi, capital of India, is increasingly home to more than its notorious bands of monkeys, as urbanization and wildlife collide. Wild boar, mongoose, snakes and cattle are also competing for space with the monkeys, which are seen as living representatives of the Hindu god Hanuman, and fed Tuesdays and Saturdays in accordance with Hindu tradition. “They bring whole cars full of food and feed the monkeys. They do not give a care about the hungry children on the street, but will feed the monkeys,” said the city’s wildlife warden, D.M Shukla. “They get what even human beings in India don’t get,” according to the article in the New York Times. Docs’ Average Pay Exceeds $100K. The national average salary for family and general practitioners is $177,330, according to a new report from the U.S. Bureau of Labor Statistics. The agency has also found that the salaries average above $100,000 in 256 metropolitan areas within the U.S. except for 2. The highest incomes are in Waterloo, Iowa ($249,950) and Ogden, Utah ($243,150). The lowest average occurred in Columbia, MO ($73,150). The average in Texas for family docs and GPs was $182,270. Click here for information about the pay scales for a wide range of health-care jobs in 2009 and 2010. International Pact Inked. The U.S. and Mexico have adopted a set of technical guidelines that will outline how information will be shared during public health events and “emergencies of mutual interest,” the U.S. Department of Health & Human Services announced last week. HHS also announced that Mexico joined the Centers for Disease Control and Prevention’s Laboratory Response Network, which links national and international labs to enhance responses to public emergencies. Texas Medicaid Rx Transfer Issue. CMS has recently observed an increase in beneficiary complaints related to the transfer of prescriptions from retail pharmacies to either mail-order or specialty pharmacy without their explicit consent. The agency issued a memorandum to review the requirements related to the transfer of prescriptions. Specifically: Any prescription transfer from one pharmacy to another, initiated by the Part D Plan, would require release of the model notice and permission by the beneficiary. The model notice should only be used when the transfer of the prescription is not initiated by the beneficiary (or someone on their behalf). The beneficiary can initiate the request by 5 contacting the plan or pharmacy or can mail/fax the permission form to the plan. Unsolicited phone calls made by the Part D Plan or pharmacy seeking permission from beneficiaries to transfer a prescription are not permitted. The 2012 Model Prescription Transfer Letter can be found at: www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Part-D-Marketing-ModelMaterials.html. The use of other mechanisms, such as Prior Authorization forms, to steer a beneficiary into a mail-order pharmacy is against CMS requirements and should be discontinued immediately. The choice of which network pharmacy to use is at the sole discretion and convenience of the beneficiary. Back To Top TSHP/ASHP/LOCAL CHAPTERS TSHP New Practitioner Section Recognized. Recently, the ASHP New Practitioners Forum Membership and Outreach Advisory Group coordinated a state affiliate outreach project to spotlight state affiliates that are providing exceptional services or unique programming and membership events to new practitioners. The following states have developed various types of programs to encourage new practitioner involvement and interaction. The states spotlighted on the ASHP website include: California, Illinois, Minnesota, Missouri, North Carolina, Texas and Wisconsin. Information on each state appears online. Back To Top PEOPLE & PLACES TSHP member Tammy S Cohen, Pharm.D., MS, FASHP has accepted the position of System Director of Pharmacy for the Baylor Healthcare System in Dallas Texas. She had been serving as Interim System Director and Clinical Coordinator for Baylor. Tammy continues to serve TSHP as Chair of the Council on Organizational Affairs. TSHP Member Michael Piñón has accepted a position as a Medical Science Liaison with the U.S. Medical Affairs division of Affymax, Inc. Piñón, a member of the TSHP R&E Foundation Board of Directors, had been with Novartis as Regional Scientific Associate Director in the Cardiovascular, Metabolic and Inflammatory Disease division for several years. TSHP member Monica Puebla, has completed requirements for her MBA and MHA degrees from Texas Woman’s University. She will be serving as Chair of the TSHP Council on Professional Affairs in 2012-13. Jeanne D. Waggener, R.Ph., President of the Texas State Board of Pharmacy, has been elected to a 3-year term as a member of the National Association of Board of Pharmacy District 6 Executive Committee. 6 Christus Santa Rosa Health System has announced that it will permanently close Christus Santa Rosa Hospital-City Centre in downtown San Antonio by August 13. In its notification of May 21, the system said that the closure will result in the elimination of all departments and units at City Centre and a ”permanent employment loss for the majority of associates” who currently work at the hospital, which includes approximately 400 individuals. Some City Centre employees will have an opportunity to transfer to other hospitals within the organization. The Board of Regents of Texas Tech University System has accepted a gift of $2.3 million designated for the exclusive use of establishing the Department of Immunotherapeutics and Biotechnology as part of the School of Pharmacy. The new department will be housed on the Abilene campus. The new department is expected to become operational on September 1, 2012. Four students from The University of Texas College of Pharmacy have been awarded pre-doctoral fellowships by the American Foundation for Pharmaceutical Education (AFPE). They include Kelly Daniels, Christine Dao, Michael Sandoval and Neha Thakore. A total of 42 fellowships were awarded nationally, chosen from among 119 applications. The Board of Regents of The University of Texas have agreed to invest in a new medical school that will be located in Austin. The Regents agreed to allocate up to $30 million a year from the State’s Available University Fund to establish a school. That, along with a pending $250 million commitment from the Seton Healthcare Family for a new teaching hospital, brings the hospital one step closer to reality. Parkland Update. The Dallas Morning News reports that Parkland Memorial Hospital’s governing board has agreed to extend the contract of its interim chief executive office by 90 days. Dr. Thomas Royer will remain on board for a while longer as the construction continues on a new facility and CMS investigators and oversight teams remain in place monitoring the hospital’s changes. The hospital has reorganized its nursing structure to address problems found in the federal inspections. Texas Health has launched a new program to transform care within its facilities. The program will dramatically change the way healthcare is accessed and delivered to North Texas, according to Douglas D. Hawthorne, CEO of Arlington-based Texas Health. The system has reached a 10-year agreement with Franklin, TN-based Healthways which will offer weight-loss, smoking cessation and other health programs as well as cell phone reminders to people to eat better, exercise more and make other health changes. Texas Health and Healthways will provide technology and management tools and population health experts to assist physicians in tracking evolving patient populations and guide their patients’ health. Back To Top RESEARCH 7 UTMB to Collaborate on New Drugs. The University of Texas Medical Branch at Galveston and the University of Washington have received an $8.1 million biodefense grant, along with Seattle-based Kineta, Inc. to develop new drugs to treat some of the world’s most dangerous diseases. The funding to advance next-general antiviral therapeutics comes from the National Institute of Allergy and Infectious Diseases. The grant is designed to increase the number of disease targets to include Ebola and Nipah viruses, along with Yellow Fever, Marburg, plague and others for which there is a lack of effective drug therapy. Diabetes Drug Wins Orphan Status. Andromeda Biotech Ltd. has obtained orphan drug status from FDA for its DiaPep277 drug for the treatment of type 1 diabetes. The company is currently conducting a Phase III clinical trial of the product, which reportedly can prevent the destruction of insulin secreting beta cells. The drug is designed to treat type 1 patients with residual insulin secreting cells in order to preserve their function. Probiotics May Prevent Antibiotic Diarrhea. An article published in the Journal of the American Medical Association (May 9) reports on a metaanalysis of 62 trials that concluded that probiotic administration significantly reduced the incidence of diarrhea associated with administration of antibiotics. Probiotic administration was associated with a 42% reduced relative risk of antibiotic-associated diarrhea. “Restoration of the gut’s microbiology through receptor competition, competition for nutrients, inhibition of epithelial and mucosal adherence of pathogens, introduction of lower colonic pH favoring the growth of nonpathogenic species, stimulation of immunity, or production of antimicrobial substances,” are all mechanisms proposed for the beneficial role of probiotics. The study was reported by MedPage Today. Pfizer Drug Effective in Some Childhood Tumors. Reuters and Bloomberg News report that Pfizer’s Xalkori® (crizotinib), has been found to be successful in treating children with cancers similar to non-small-cell cancer tumors with ALK gene abnormalities (for which Xalkori is currently approved). The therapy was successful in 70 children with a variety of cancers, but most dramatic with anaplastic large-cell lymphoma, a cancer known to have ALK rearrangements in some patients. The Phase I trial was reported at the American Society of Clinical Oncology annual meeting. Back To Top EDUCATIONAL OPPORTUNITIES The ASHP-Accredited Austin Community College (ACC) Pharmacy Technician Program has announced that is has been approved as an ACPE provider. ACC will be offering a wide range of Continuing Pharmacy Education (CPE) activities including: Sterile Compounding and Aseptic Technique; Extemporaneous Compounding; Pediatric Preparations; TPN Compounding; and Chemotherapy Compounding. ACC is also excited to offer the Instructor’s Course: Teaching Sterile Compounding and Aseptic Technique 8 to Pharmacy Technicians, a course for pharmacists, pharmacy technicians, and pharmacy technician educators who train, instruct, and/or supervise pharmacy personnel who prepare compounded sterile preparations (CSPs). For more information about ACC Pharmacy Technician Program ACPE continuing pharmacy education activities, including date, cost, format, and location of CPE activities; information on course prerequisites, course objectives, and course instructors, contact ACC Pharmacy Technician Program CPE Administrator – Lisa McCartney, BAAS, CPhT, PhTR at: 512-223-5949 or at: lmccartn@austincc.edu Back To Top ANSWER TO TODAY'S TRIVIA 1. Irene Cara’s song “Flashdance (What a Feeling)” from the Flashdance movie soundtrack was her #1 single 29 years ago. She had previously (1980) recorded “Fame” and “Out Here on my Own” from the movie “Fame.” 2. Although John Fogerty and his brother started the group “The Golliwogs,” the band was largely ignored. After renaming themselves, the group ‘Creedence Clearwater Revival” took off from 1967 to 1972 with a number of hits in their “swamp rock” style. Back To Top Copyright 2012 TSHP All Rights Reserved TSHP E-Newsletter If you no longer wish to receive these emails, click on the following link: Unsubscribe This message was sent by Texas Society of Health-System Pharmacists using MemberSuite, Inc. Texas Society of Health-System Pharmacists 3000 Joe Dimaggio Blvd Ste 30A Round Rock, TX 78665-3920 9