Factsheet on Drug Shortages

What Drug Makers do:

When its production and distribution of medically necessary drugs is interrupted, a drug maker is the first to know that a shortage is about to happen.  They advise their health care customers in advance what drugs are affected and how long they may be in shortage.   They've also committed to providing information on current and potential drug shortages on the  Canadian Drug Shortage Database. This allows health care providers time to adjust treatment plans as needed.

Drug makers also identify alternative supplies that can make up the shortfall to customers. This may be found from other companies who make similar drugs in other countries. The drug maker is also coming up with a plan to solve the problem that interrupted production and created the shortage.

What Provincial and Territorial Health Authorities do:

Provincial and territorial health authorities have set up bulk buying groups to purchase medically necessary drugs for patients.  These groups sign supply contracts with drug makers.  They determine who the supplier is, how many suppliers they need, and establish penalties for non-delivery.

When supplies are interrupted, hospitals, clinics and health professionals implement strategies to ensure the most efficient use of existing supplies and to minimize impacts on patients.  They keep patients advised of the supply situation in each facility and community, and adjust treatment schedules and procedures if required.  If a shortage is significant and long in duration, alternative supplies may be sought from drug makers within Canada or in other countries.  

How the Health Portfolio can Help:

Information and Communication

In a time of shortage or potential shortage of medically necessary drugs, our top priority is patients. We work hard to help ensure that the right information gets in the right hands at the right time. This means doctors, pharmacists and patients getting enough advance notice from manufacturers so that treatment plans can be smoothly adjusted, if needed.

Through the various networks supported by the Health Portfolio, we can bring together provinces, territories, health care professionals and companies to exchange the latest information on supply and to ensure that our collective efforts to address shortages are coordinated.

Health Canada's collaborative work with industry and health professional stakeholders has resulted in a commitment by Canada's Research-Based Pharmaceutical Companies and the Canadian Generic Pharmaceutical Association to collect information from member companies on current and impending drug shortages, and to communicate this information to Canadians via the  Canadian Drug Shortage Database. Here, health professionals can learn what drugs are, or are expected to be in short supply so they can plan treatments accordingly.

First Nations and Inuit Support

As a front line health service provider to First Nations and Inuit, Health Canada works with health professionals to ensure First Nations living on-reserve have access to the drugs they need.

Access to Supply Alternatives:

Health Canada has a variety of tools available to help minimize the impact of any shortages. Through the collaborative efforts of different programs within the department, we will work to help maintain a supply of high quality, safe and effective drugs by:

• Working closely with companies so they can quickly resolve manufacturing, quality and distribution issues;
• working with manufacturers to ensure alternate suppliers, changes in manufacturing process or location can be reviewed and market authorized on a priority basis;
• ensuring all necessary licensing requirements are met;
• working with our international counterparts, such as the U.S. Food and Drug Administration, to identify additional sources of supply and to share needed safety and quality information; and,
• providing priority access to alternatives on an emergency basis.

We will use the right tool for the situation at hand. The time required for each will depend on the specific request. Canadians can be assured that Health Canada is ready to respond on a priority basis.

We also strongly encourage provincial and territorial health authorities to source drugs from multiple suppliers so that they are not vulnerable to production interruptions from a sole supplier

If a supply source for a medically necessary drug is found outside of Canada and you want to know how you can bring certain drugs into to the country, contact Health Canada at:

SIPDMail@hc-sc.gc.ca
Telephone: 613-941-7281
Fax: 613-941-0825

If you want help confirming whether the manufacturing quality standards of a new source of supply are acceptable in Canada, contact Health Canada at:

Drug Establishment Licences:
E-mail: del_questions_leppp@hc-sc.gc.ca
Telephone: 613-954-6790
Fax: 613-957-4147

Drug Good Manufacturing Practices:
E-mail: gmp_questions_bpf@hc-sc.gc.ca
Telephone: 613-957-1492
Fax: 613-957-6709

If you're a physician and have a patient with a serious or life-threatening condition and you need urgent access to a limited quantity of a drug not authorized for sale in Canada, contact Health Canada's Special Access Program at:

SAPdrugs@hc-sc.gc.ca
Telephone: (613) 941-2108
Fax: (613) 941-3194

Alternative therapies may be available in Canada. To determine if a specific drug is approved for use in Canada, visit Health Canada's online Drug Product Database