Canada: New protocol and toolkit for managing drug shortages hinge on voluntary reporting by manufacturers

Health Canada recently announced the release of the Protocol for the Notification and Communication of Drug Shortages (PDF) (the "National Protocol") and the Multi-Stakeholder Toolkit(PDF) (the "Toolkit") developed by the Multi-Stakeholder Steering Committee on Drug Shortages.[1]  The National Protocol and Toolkit were published amid increasing concern over the ongoing issue of drug shortages in Canada. 

Both documents are available on the Drug Shortages website, which was launched and is maintained by Canada's Research-Based Pharmaceutical Companies (Rx&D), the Canadian Generic Pharmaceutical Association (CGPA), and the Canadian Pharmacists Association.

The National Protocol
Drug shortages occur when a manufacturer/importer anticipates that they cannot, or in fact cannot, supply a drug to meet projected demand.  Shortages may be due to a number of possible causes, including surges in market demand, difficulties obtaining raw supplies, equipment malfunctions, plant shutdowns ordered by regulators, transport delays, or natural disasters.

The National Protocol establishes a "Tiered Notification and Communication Framework", which is a flexible case-by-case approach to reporting drug shortages and disseminating relevant information based on whether the shortage is anticipated (Tier 1), actual (Tier 2), or actual with the potential for significant impact on patient care (Tier 3).  The document sets out clear expectations for when and how stakeholders across the drug supply chain (e.g., manufacturers, group purchasing organizations, wholesalers, distributors, healthcare professionals and regional/local health authorities) are expected to share information about shortages of human pharmaceutical and biological drugs (including vaccines) authorized for sale and marketed in Canada.  This coordinated involvement of multiple stakeholders is intended to provide the healthcare system with an opportunity to react quickly to shortages and safeguard the health and safety of patients.

The National Protocol also establishes notification and communication expectations with respect to drug discontinuances.  In particular, manufacturers are expected to provide six months advance notification of a drug's discontinuance on the Drug Shortages website.

Note that the National Protocol does not address distribution channel disruptions which may occur at the local, regional, or provincial/territorial levels that are unrelated to manufacturing issues, such that these types of supply chain disruptions may not be posted on the Drug Shortages website.

The Toolkit
Along with the National Protocol, the Toolkit aims to mitigate the impact of drug shortages in Canada by providing an overview of the Canadian drug supply chain, clarifying the roles and responsibilities of various stakeholders, and identifying steps that can be taken to prevent and reduce the impact of drug shortages.

The Toolkit sets out the most common reasons for shortages at each step in the supply chain (e.g., drug approvals, manufacturing, procurement and distribution, and front-line delivery) and suggests tools to avoid or manage the impact of shortages at that step.  At the manufacturing stage, for example, suggestions include:

• identification and utilization of alternate sources of raw material supply;
• increased use of back-up manufacturing sites, packing and packaging components;
• maintenance of a reserve stock of products with a higher risk of shortage;
• increased coordination between sales and operation departments to better forecast sales and product volumes; and
• requiring that all manufacturing partners (e.g., vendors, distributors) have a Business Continuity Plan.

Commentary
The National Protocol sets out a Tiered Notification and Communication Framework which defines the roles of stakeholders in the drug supply chain.  The Toolkit canvases the causes of drug shortages at each level of the supply chain and provides recommendations to various stakeholders as how to prevent or manage drug shortages.  Although the National Protocol adopts an industry approach through the inclusion of stakeholders throughout the supply chain, its success hinges on the timely and accurate disclosure of anticipated or actual shortages by manufacturers.

The recent focus on the drug shortage issue in Canada follows increased attention on this issue in the United States, where mandatory drug shortage reporting obligations for manufacturers were broadened significantly with the passing of the Food and Drug Administration Safety and Innovation Act (FDASIA) last year.[2]

The tools and processes set out in the National Protocol and Toolkit are not legally binding; rather, they are guidelines intended to mitigate negative patient outcomes by facilitating the effective communication of pertinent information throughout the drug supply chain in the event of anticipated or actual drug shortages.

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