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CPSO POLICY STATEMENT Drugs and Prescribing- Drug Samples (Clinical Evaluation Packages) APPROVED BY COUNCIL: February 2002 TO BE REVIEWED BY: February 2005 PUBLICATION DATE: March/April 2002 KEY WORDS: Clinical evaluation packages REFERENCE MATERIALS: CMA Guidelines on the Relationship between Physicians and the Pharmaceutical Industry; A Guide to Current Medical Record-Keeping Practices, CPSO, March 2001 RELATED TOPICS: COLLEGE CONTACT: Policy #5-1, Prescribing Practices Physician Advisory Service COLLEGE OF PHYSICIANS AND SURGEONS OF ONTARIO POLICY # 2-02 CPSO POLICY STATEMENT Drugs and PrescribingDrug Samples (Clinical Evaluation Packages) PURPOSE The purpose of this policy is to clarify for physicians their obligations with respect to drug samples. SCOPE This policy applies to all physicians. COLLEGE POLICY Medication samples (clinical evaluation packages) should only be distributed to patients in order to allow physicians to evaluate the clinical performance of the medication outside of the context of postmarketing surveillance studies, to initiate therapy, or for a similar purpose. Any departure from this must be justifiable in terms of principles of ethical medical practice (for example, where the normal means of obtaining drugs or other medical products would result in an excessive financial burden or other hardship to the patient). The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated. Physicians must not participate in the trading, selling, or bartering of drug samples for cash or other goods. The use of drug samples is to be restricted to the purpose for which the samples were provided. Physicians who accept samples and similar devices are responsible for ensuring their age-related quality and security. They are also responsible for the proper disposal of unused samples. Physicians must document all samples provided to patients in the patient health record. For more information, see Policy #5-01, Prescribing Practices. See also A Guide to Current Medical Record-Keeping Practices.1 1 CPSO, March 2001. COLLEGE OF PHYSICIANS AND SURGEONS OF ONTARIO 80 College Street, Toronto, Ontario M5G 2E2