In response to a request from the federal Minister of Health, a web-based voluntary notification system was created by industry in 2012 to provide public notification of drug shortages. While the voluntary system has received shortage and discontinuation notifications since its inception, not all companies may be posting shortage notifications to the website. In addition, while drug manufacturers are required to notify Health Canada within 30 days of discontinuation of a market-approved drug assigned a drug identification number (DIN), the information to be provided as part of such notification is not specified. As the Canadian government considers information gaps for drugs that are actively being sold on the Canadian market -- including unreported drug shortages -- as potential health and safety risks for patients, amendments to the Food and Drug Regulations have been proposed that create a mandatory reporting scheme for drug manufacturers to report shortages and discontinuations of drugs.
The proposed amendments mandate reporting of drug shortages and discontinuations by authorization holders to a third-party web site for categories of drugs that have the potential, in a shortage or discontinuation situation, to adversely affect the health of Canadians and the health system, such as:
- drugs on Schedules I to V of the Controlled Drugs and Substances Act;
- drugs on the Prescription Drug List;
- biologic drugs on Schedule D to the Food and Drugs Act;
- radiopharmaceutical drugs listed on Schedule C to the Food and Drugs Act; and
- drugs permitted to be sold without a prescription, but administered only under supervision of a practitioner.
Mandatory reporting of drug shortages and drug discontinuations
In the case of a shortage, authorization holders would be required to report: (a) the actual or anticipated start date of the shortage; (b) the anticipated end date of the shortage; and (c) the actual or anticipated cause of the drug shortage.
In the case of discontinuation, authorization holders would be required to report: (a) the date on which the sale of the drug will be discontinued; and (b) the reason for discontinuation.
For both scenarios, the information would be required to be posted six (6) months prior to the anticipated shortage or discontinuation. If, however, the shortage or discontinuation is known less than six months in advance, then the information would be required to be posted within two (2) days of the authorization holder becoming aware of the shortage or discontinuation and within two (2) days of the authorization holder making the decision to discontinue the drug.
In addition to the above, the mandatory information to be provided by the authorization holder would include: (a) the name and contact information of the authorization holder; (b) the brand name and proper name of the drug (and, if assigned, the DIN); (c) the medicinal ingredients contained in the drug; (d) the therapeutic classification of the drug; (e) the strength, dosage form and package size; and (f) the drug's route of administration.
Notification of zero sales to Health Canada
The proposed amendments also set out an obligation for an authorization holder to notify the Minister when a drug that has received market authorization has not been sold on the Canadian market for a period of twelve (12) consecutive months, and to notify the Minister once the sale of the drug has recommenced. This new obligation would not affect the licensed status of a drug, but allow Health Canada to distinguish between products that have been granted a licence to be sold in Canada but are not actively being sold.
The proposed amendments continue Health Canada's recent trend of increasing public transparency of the drug regulatory process in Canada. While the proposed regulations heighten the regulatory reporting obligations of authorization holders, Health Canada believes that the amendments will address information gaps in the current voluntary drug shortage reporting system created by drug supply disruptions and ensure the accuracy, timeliness and reliability of publicly available drug shortage and discontinuation information for Canadians and health care practitioners.
Interested persons may make representations to Health Canada concerning the proposed Regulations by September 3, 2015.