While you often hear about automobile and food recalls, you may be less aware of drug recalls. However, they do happen. Health Canada is responsible not only for authorizing which drugs can be sold in Canada, but also to do the reverse, that is, to recall drugs from the Canadian market.
To understand drug recalls, you need to be aware of how sales of a drug are allowed in the first place, which begins when a drug manufacturer applies to Health Canada for authorization to sell its drug here.
Canadians are often surprised that it isn’t researchers or health professionals who start the process, but rather drug manufacturers. Included in the submission is information about the drug such as its intended use, safety, effectiveness, adverse reactions, and contraindications. Research studies that support the drug’s use are also provided, as well as samples of its label and the suggested product monograph.
Scientists at Health Canada review the material, although there are no timelines set out for this process. Rather, the quality and quantity of the submitted material play a role, as does the workload of staff at Health Canada. However, if the drug is for what is considered a critical illness like cancer, Alzheimer’s disease or AIDS, times may be faster just because there are few treatments for these types of diseases.
Finally, a notice of compliance is issued and the drug can be sold in Canada. But a certificate doesn’t necessarily mean that the drug will in fact be sold. If you check out Health Canada’s database you will see a listing for notices of compliance (i.e. those drugs approved for sale) and a listing called the drug product database, that is, the drugs that are actually being sold in Canada.
Thus, a drug may be approved but still not be available on our market. The drug manufacturer may sell it in other countries, but decide, perhaps for financial reasons, against selling it in Canada.
Licensed natural health products like vitamins, minerals, herbs, and traditional medicines, also undergo a process to be sold in Canada, but their approval focuses on safety and labelling.
Drug recalls occur when a drug is defective or potentially harmful. For example, the drug may be mislabelled, poorly packaged, subtherapeutic, more potent than labelled, or contaminated. Every drug manufacturer is required to have quality control and safety procedures, and to also have recall mechanisms in place. Ideally problems are prevented, but when a problem does occur the manufacturer is obligated to contact everyone to whom it has sold the drug. Health Canada must be notified within 24 hours of a manufacturer making a recall decision. If a licensed natural health product is involved, the manufacturer has three days to contact Health Canada.
So if you take a prescription drug, how do you as a patient find out about the recall? For a recall that involves a batch or lot of a drug, memos are faxed to all Canadian wholesalers and pharmacies which then check their stock on hand. A response to the fax is required, and the drug manufacturer will ensure they receive one. It is the pharmacy’s obligation to contact you, although if your prescription was for 20 capsules three months ago, your pharmacist will know you have completed your prescription and not contact you. For recalls that involve a newly discovered adverse effect or contraindication, the recall information is disseminated more widely and you may even hear about it in the news.
Sometimes a drug is removed completely from the market, for example the pain reliever rofecoxib or Viox, which was associated with serious cardiovascular problems. Not only did the drug manufacturer contact all their customers, but pharmacists also contacted all their clients with the aim that ALL tablets be returned.
Sometimes, however, there may be new information that is important enough to be communicated to prescribers and pharmacists, but not serious enough to warrant a recall, for example, the use of atypical antipsychotics like risperidone for behaviour problems in elderly dementia patients. Risperidone is indicated for psychosis, but it can be prescribed “off label” for other reasons with the prescriber deciding its appropriate use. However, new research has linked the use of these drugs in elderly patients to an increased incidence of cardiovascular deaths. A warning, not a recall, was issued by both Health Canada and drug manufacturers, with prescribers and pharmacists checking their patient profiles for any patients who might be at increased risk.
Health Canada’s recalls and warnings are available on its website, and you can even subscribe to the service. If you take a recalled medication, you certainly want to know about it!