Could conditional release of new drugs

The Health Protection Branch (HPB) of Health Canada could be responsible for ensuring that adequate data on effectiveness and safety were collected and appropriately evaluated, but preferably this would be done by an independent organization associated with but not directed by the HPB. However, because an independent organization would probably need legislative revision to change the approval process initially, it would have to operate closely with the HPB.

The pharmaceutical industry, and the federal and provincial governments should financially support the monitoring organization. In return, the pharmaceutical industry would receive benefits from earlier marketing in terms of earlier revenue and longer effective patent time, and the federal and provincial governments would receive better cost effectiveness and safety data on which to base their final decisions about the listing of Canadian drugs.

HOW WOULD PATIENTS BE IDENTIFIED AND WHO WOULD REGISTER THEM?

Unlike in the United Kingdom, in Canada prescriptions are not processed by one organization but by several, and only then those prescriptions that are subsidized entirely or in part are generally recorded. If the patient pays the total cost and there is no other potential payer, it is unlikely that the prescription is recorded and may be destroyed soon after. This leads to the conclusion that the appropriate individual to register the patient is the dispensing pharmacist.

The identification by pharmacists of patients dispensed the new drugs would eliminate the prescribing and patient selection biases inherent in schemes in which physicians register patients. Furthermore, if pharmacists identify the patients from pharmacy registers or databases, patients will be unaware that they were being given a new drug that is being monitored and, thus, compliance should not be compromised. The growing number of pharmacy-based provincial drug databases increases the feasibility and practicality of this method of identifying patients. The pharmacist would also record the prescribing physician so that follow-up clinical information could be obtained.

Pharmacists registered patients in Borden and Lee’s postmarketing surveillance scheme devised in the early 1980s. More recently, this method hasbeen used to study drug utilization in the Pharmacy Medication Monitoring Program at McMaster University, Hamilton, Ontario . Pharmacists also identify patients in the New Zealand Intensive Medicines Monitoring Programme , which has been running successfully for over 20 years.