Progress in Addressing Drug Shortages
Health Canada works collaboratively with provinces and territories, as well as industry stakeholders and health care practitioners to address drug shortages and to build a more open and secure drug supply system. Important progress on a number of key initiatives has been made.
Public Notification Drug Shortages
In response to direct calls for action from the Minister of Health, industry associations launched in 2012 www.drugshortages.ca - a publicly available website providing notification and information on drug shortages, drug discontinuances, and therapeutic alternatives.
In 2016, Health Canada introduced new regulations which require drug manufacturers to report actual and anticipated drug shortages as well as discontinuations on a new third party website. The launch of the third party reporting website is expected in March 2017. Once launched, the third party reporting website will replace www.drugshortages.ca. For more information on drug shortage notification, please visit the Information on Drug Shortages section of the Health Canada Website.
Multi-Stakeholder Steering Committee on Drug Shortages (MSSC)
In 2012, Health Canada, together with the Province of Alberta, launched a Multi-Stakeholder Steering Committee on Drug Shortages (MSSC) made up of industry and health care representatives, to work towards a more rigorous and coordinated approach to drug shortages. The MSSC, endorsed by provincial and territorial Ministers of Health, is collaborating to improve the communication of drug shortage information to the public, and developing enhanced strategies for the prevention and mitigation of drug shortages. The MSSC has developed a number of key tools, as outlined below.
For a list of MSSC members, visit the Protocol for the Notification and Communication of Drug Shortages.
Protocol for the Notification and Communication of Drug Shortages
The MSSC has developed the Protocol for the Notification and Communication of Drug Shortages. The Protocol sets clear expectations in anticipation of, or in response to a drug shortage. This protocol is premised on the early notification of drug shortages or discontinuations by manufacturers/importers and was updated in 2017 in response to the introduction of the regulations on mandatory drug shortage and discontinuation reporting by the Government of Canada, as well as the launch of a new reporting website Drug Shortage Canada. It also clarifies the roles and responsibilities of key actors across the supply chain in response to an impending or actual shortage.
In June 2013, the MSSC has also developed a Multi-Stakeholder Toolkit. The Toolkit describes the Canadian drug supply chain, clarifies roles and responsibilities of key players, and identifies the tools and strategies available to address drug shortages at specific stages of the supply chain. The Toolkit is a reference to support coordinated multi-stakeholder efforts to identify, mitigate, resolve and prevent drug shortages in Canada. The Toolkit was updated in 2017 to reflect the Government of Canadas introduction of the Regulations on Mandatory Drug Shortage and Discontinuation Reporting
Guidance Document to Mitigate Drug Shortages through Contracting and Procurement
In June 2012, the House of Commons Standing Committee on Health tabled a report: Drug Supply in Canada: A Multi-Stakeholder Responsibility, in which they noted the numerous causes of possible shortages, while singling out sole source contracting as the most avoidable cause of drug supply disruptions.
To address the role of contracting practices in drug shortages, the MSSC developed a Guidance Document to Mitigate Drug Shortages through Contracting and Procurement. The guidance document outlines best practice contracting guidelines, procurement strategies, and tools to address common drug supply chain shortage vulnerabilities. These guidelines, strategies, and tools can be applied by and negotiated between various supply chain stakeholders to better prevent and mitigate shortages. The document was updated in 2017 to reflect the Government of Canada’s introduction of the Regulations on Mandatory Drug Shortage and Discontinuation Reporting.
Preventing Drug Shortages: Identifying Risks and Strategies to Address Manufacturing-Related Drug Shortages in Canada
Globally, manufacturing issues are the most commonly cited cause of drug shortages. Acknowledging this reality the MSSC, in collaboration with drug manufacturers, has developed Preventing Drug Shortages: Identifying Risks and Strategies to Address Manufacturing-Related Drug Shortages in Canada. This report seeks to identify, analyze, and propose strategies to reduce and prevent the manufacturing-related causes of drug shortages in Canada. The document was updated in 2017 to reflect the Government of Canadas introduction of the Regulations on Mandatory Drug Shortage and Discontinuation Reporting.
Health Canada and the MSSC are committed to working with drug manufacturers to implement the recommendations outlined in this report into their current business architecture, with the goal of preventing drug shortages from happening in the first place.
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