MICHIGAN STATE UNIVERSITY MSU HEALTH TEAM POLICIES AND PROCEDURES SUBJECT: Sample Drugs SCOPE: All HT Clinics AUTHOR: Susan Dolby, Risk Manager FINAL APPROVAL: 12/2008 EFFECTIVE DATE: 12/1/2008 REVIEW/REVISE DATE: 12/2010 NO: CP - 4 Page: 1 of 4 Policy An effective and safe medication management process for receipt, storage and dispensing of sample pharmaceuticals will be maintained. A practice may accept only those pharmaceuticals that are routinely or reasonably used within that practice. No schedule II, III, IV, or V medications will be accepted as samples. Exceptions may be allowed if Governing Board approval is received in advance. Samples may be provided to patients as a starter or trial supply. Supplying a complete course of a medication is allowed if deemed necessary by the provider based on cost or availability. The use of samples is restricted to patients of licensed independent practitioners of the HealthTeam. Definitions Adverse Drug Reaction: An unintended, undesirable, or unexpected effect of a prescribed medication that requires discontinuing the medication or modifying the dosage and results in a patient outcome of any of the following:  Initial or prolonged hospitalization  Disability in body function, structure, physical activities or quality of life.  Treatment with a prescription medication to prevent damage or impairment  Life-Threatening  Death  Offspring with congenital anomalies Process 1. Receipt: a. Before any medications are accepted, a staff physician is required to approve all medication samples. A licensed staff person of the HealthTeam will sign for receipt of samples. b. Pharmaceutical company representatives may stock and record delivered samples if assisted by a designated nursing staff member or pharmacist. c. The Sample Drug Log (attachment #1) Section A will be completed at the time of delivery of samples. 2. Storage: Revised 9/2009 a. Samples will be stored appropriately with regard to light, temperature, and humidity in a locked area accessible only to authorized staff. b. Medications that look-alike or the names sound-alike will be physically separated as much as possible in the secure storage area. 3. Labeling: a. Sample medications are to be labeled with pertinent information if not displayed on packaging. i. Drug name ii. Strength iii. Amount iv. Drug expiration date v. Patient name vi. Written administration instructions vii. Provider name 4. Dispensing: a. Dispensing is controlled by the licensed independent practitioner. b. Should be in amounts to minimize diversion yet consistent with patient needs. c. Will be in ready-to administer form from the manufacturer if feasible or unit dose if repackaged by pharmacist or a licensed repackager. d. Dispense package inserts if required. e. The Sample Drug Log (attachment #1) Section B will be completed when a sample is distributed to a patient. For clinics not utilizing the electronic prescribing, they should handwrite the necessary information. For clinics utilizing electronic prescribing, a weekly report of samples dispensed may be attached to the log sheet. f. The Sample Drug Log (attachment #1) will note items sent back to pharmacy for disposal. g. Written administration instructions are given and reviewed with the patient or caregiver. 5. Documentation: a. Documentation in the patients medical record is standard in both the paper and electronic record and will include drug, strength, lot number, amount dispensed and the prescribing method will be noted as ‘samples given’. For clinics utilizing electronic prescribing, the lot # of the sample must be entered into the area for instructions. b. The patient’s medical record shall reflect appropriate instructions provided. c. Maintain log sheets for ten years. 6. Quality Control a. Samples will be inspected monthly for expiration date, damage and or contamination. Cross check with the log book will be done to ensure accurate inventory. The day of the monthly inspection will be determined by the clinic. b. Samples that have expired, appear damaged, or contaminated will be removed from storage and sent to the clinical center pharmacy for disposal per ORCBS regulations. Revised 9/2009 i. Removal of expired medications will necessitate updating in log to note ‘expired’ and disposition of medications. ii. Transport of expired medications will be via the courier system, c. Adverse reactions to sample medications should be reported to the clinic medical director and clinical center pharmacy for review and follow up. Page 2 of 4 Removal of samples for safety reasons from clinical areas based on pharmacy review is under the direction of the chief pharmacist in consultation with the clinical medical director. A decision to report to the FDA MedWatch will be made by the clinical medical director. d. Adverse drug reactions and medication errors will be reported to risk management using the occurrence reporting system (see Policy ADM-16) Revised 9/2009 ATTACHMENT #1 Sample Drug Log Section A Medication Brand Name: Lot Number: Medication Generic Name: Expiration Date: Date Received: Manufacturer Name: Rep. Name/Phone # Section B Date MRN Patient Name Strength: Quantity Received: Provider Name Do Not Discard. Maintain a copy of drug log in department Revised 9/2009 Amount dispensed