Roles and Responsibilities to Address Drug Shortages
The drug supply chain is highly integrated and interdependent. All stakeholders have important roles to play when it comes to addressing drug shortages.
Stakeholders in the drug supply chain
There are a number of key players in the drug supply chain that have distinct but complementary roles in addressing drug shortages. For example:
- Manufacturers provide updated information to the health care system on the supply disruption and are responsible for understanding and meeting the needs of the market. As of March 2017, new mandatory reporting regulations require manufacturers to publicly notify of all anticipated and actual shortages, as well of discontinuations on the Canadian Drug Shortage Website [www.drugshortagescanada.ca]. Manufacturer previously reported on www.drugshortages.ca an industry-administered voluntary reporting system.
- Group purchasing organizations negotiate with manufacturers on behalf of buyers, conduct ongoing market research and support collaboration among stakeholders during a shortage. Group purchasing organizations also support ongoing engagement among key stakeholders in preventing and managing drug shortages.
- Distributors/wholesalers/importers help monitor and communicate drug stock levels and manage equitable distribution of drugs to pharmacies through the proportional allocation of remaining stocks.
- Provinces and territories coordinate action and the flow of information between manufacturers, distributors and regional health authorities during a drug shortage. Provinces and territories may also act as an intermediary with industry associations and health professional associations.
- Regional Health Authorities have the ability to reallocate stock amongst facilities within the region or province in times of shortage.
- Hospital pharmacists consult with healthcare providers and other stakeholders to identify alternative drug treatments for patients, if necessary, or to develop conservation strategies to manage remaining drug supply.
- Community pharmacists communicate with various sources to identify available products, consult with physicians to identify alternative treatments and counsel patients on substitute drug therapies.
- Health care professionals are a critical source of safety information and key contributors to the evolving knowledge of a product's risks and benefits. This is particularly imperative during a shortage, where health professionals may determine suitable alternatives for patients.
These stakeholders are brought together within the Multi-Stakeholder Steering Committee on Drug Shortages (MSSC) to work collaboratively, with Health Canada, on addressing drug shortages.
Health Canada is playing its part as the federal regulator, responsible for reviewing the safety, quality, and efficacy of drugs and for authorizing their sale in Canada. Health Canada has a number of tools and strategies available to assist companies and manufacturers in identifying or accessing alternatives in the event of a drug shortage.
Mandatory drug shortage and discontinuation reporting enables Health Canada to provide timely, reliable and accurate information to the public as well as to provide healthcare professionals, patients, drug supply stakeholders, and Provincial/Territorial governments with the information they require to mitigate and manage effects of drug shortages.
In addition, as part of its regulatory responsibilities, Health Canada is responsible for compliance and enforcement activities in order to verify that regulatory requirements are being applied appropriately.
During a drug shortage, Health Canada works with stakeholders across the drug supply chain to determine the details and status of the drug shortage, coordinate information sharing, and identify collaborative mitigation strategies.
On a case-by-case basis, Health Canada may work with manufacturers to review alternate suppliers, changes in manufacturing processes, or changes in manufacturing locations, when necessary. Health Canada may also:
- work with international counterparts to identify additional sources of supply and to share needed safety and quality information;
- provide the health system with priority access to alternatives on an emergency basis. For example, while not intended to address drug shortages, in exceptional circumstances, the Special Access Programme (SAP) can be used to provide access to non-marketed, medically necessary drugs when the approved supply is at zero or alternatives are not available; and
- Health Canada can employ an expedited review process to expedite the review of a drug.
Other federal departments
A number of other federal departments play a role in supporting the health system in times of shortage. For example:
- Public Health Agency of Canada (PHAC): To supplement the needs of provinces and territories in times of critical emergency - such as a mass casualty event or a pandemic - PHAC maintains a limited supply of select drugs in the National Emergency Stockpile System (NESS). When provincial/territorial healthcare systems cannot meet urgent medical supply needs, PHAC can enable emergency access to products or alternatives. PHAC also co-chairs the Vaccine Supply Working Group (VSWG) - a multi-jurisdictional group that monitors vaccine supply and prices, and develops principles, guidelines and strategies for addressing vaccine supply issues, including shortages. In the event of a vaccine shortage, PHAC may also help to coordinate federal, provincial and territorial responses to address the shortage.
- Public Services and Procurement Canada (PSPC): On behalf of federal, provincial and territorial governments, PSPC manages the Federal/Provincial/Territorial Bulk Purchasing Program (BPP) for Vaccines. The BPP works with provinces and territories, as well as other federal departments and agencies to acquire a safe supply of vaccines (and some drugs) for Canadians. The BPP purchases the annual influenza vaccine, approximately 50 other vaccines, and a variety of drugs, including antivirals. Contracting decisions are overseen by the VSWG.
More information on the roles and responsibilities of key stakeholders in response to a drug shortage, including Heath Canada, can be found in the Multi-Stakeholder Toolkit.
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