Summary

Federal Health Minister Rona Ambrose and Fred Horne, Minister of Health for Alberta, have announced an initiative to prevent and reduce the impact of drug shortages in Canada. The initiative is outlined in two documents: Protocol for the Notification and Communication for Drug Shortages (“Protocol”) and Multi-Stakeholder Toolkit for Improved Understanding and Transparency of Drug Shortage Response in Canada (“Toolkit”). The Protocol and Toolkit were developed by a Multi-Stakeholder Steering Committee on Drug Shortages, which includes representation from industry and health care professional associations as well as the federal, provincial and territorial governments.

Together, the Protocol and Toolkit facilitate information sharing and serve as an important resource for those in the Canadian drug supply chain to prevent, manage and resolve drug shortages. It should be noted however that the rules are not set in regulation.

Protocol for the Notification and Communication of Drug Shortages

The Protocol sets out the expectations upon suppliers to provide the earliest possible notification and communication of anticipated and actual drug shortages.

Manufactures in particular are expected to post up-to-date and comprehensive information on actual or anticipated drug shortages to the Canadian Drug Shortage Database (www.drugshortages.ca ). The information is also expected to be communicated to key stakeholders across the drug supply chain in order to mitigate or manage the effects of any shortage, especially any negative impact on the health of patients. The Protocol applies to all human pharmaceutical and biological drugs, including vaccines, which have received market authorization in Canada.

Multi-Stakeholder Toolkit for Improved Understanding and Transparency of Drug Shortages Response in Canada

The Multi-Stakeholder Toolkit describes the roles, responsibilities and relationships of key stakeholders in the Canadian drug supply chain. Further, the Toolkit identifies the expectations of each stakeholder in the event of, or in anticipation of a drug shortage, and provides some guidance as to appropriate strategies to address shortages.

Link

The Protocol can be found here.

The Toolkit can be found here.