Transforming and Supporting Patient Care - Health Professions ...

84Chapter 3 - A New Drug Approvals Framework For OntarioDespite the restrictions stated in the Food and Drugs Act and theRegulations, the regulation of health professionals remains a provincialresponsibility, and if permitted in provincial regulation, health professionalsare permitted to provide drug samples according to the applicableprovincial legislation and regulations.The CPSO and the OCP have interpretations and guidelines on dispensingdrug samples.The CPSO policies apply to all physicians and outline their obligations withrespect to drug samples. They include:• Medication samples (clinical evaluation packages) should only bedistributed to patients in order to allow physicians to evaluate theclinical performance of the medication outside of the context of postmarketingsurveillance studies, to initiate therapy, or for a similarpurpose. Any departure from this must be justifiable in terms ofprinciples of ethical medical practice (for example, where the normalmeans of obtaining drugs or other medical products would result inan excessive financial burden or other hardship to the patient).• The distribution of samples should not involve any form of materialgain for the physician or for the practice with which he or she isassociated.• Physicians must not participate in the trading, selling, or bartering ofdrug samples for cash or other goods. The use of drug samples is tobe restricted to the purpose for which the samples were provided.• Physicians who accept samples and similar devices are responsiblefor ensuring their age-related quality and security. They are alsoresponsible for the proper disposal of unused samples. Physiciansmust document all samples provided to patients in the patienthealth record. 51In this review, HPRAC considered whether distributing drug samplesfalls within the scope of practice of those health professions who makesamples available to patients and whether distributing samples constitutesdispensing, in which case it should only occur pursuant to a prescription.A number of health professions, nursing in particular, cited economicconsiderations as one reason for dispensing samples to patients.HPRAC observes that the distribution of prescription drugs currentlyrequires two separate acts. The drugs must be: (a) prescribed; and (b)dispensed. In some cases, both acts may be completed by one person.Physicians, for example, are authorized to prescribe and dispense drugs.51College of Physicians and Surgeons of Ontario, Policy #2-02;www.cpso.on.ca/policies/policies/default.aspx?ID=1828.HPRAC Critical Links January 2009