Download drugs-samples #2-02 - College of Physicians and Surgeons of Ontario

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