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Drug Recalls and Withdrawals
a challenge for pharmacists, doctors and patients
Late on Friday afternoon, the fax machine spits out a notice from Health Canada listing a new drug recall or withdrawal. Ensuring that these are properly acted upon to protect the health of their customers is an important, and sometimes frustrating, responsibility of a pharmacist.
Pharmacists are often asked about the difference between drug recalls and drug withdrawals. For a health care professional, the difference is significant. To a member of the public, it may be confusing. To the media, both can be the source of a story.
The main difference between drug recalls and withdrawals involves the degree of risk to patients and who initiates the notice.
Medication withdrawals
Manufacturers initiate drug withdrawals.
- A specific batch of product is voluntarily removed because of a minor manufacturing issue. For instance, the colour, shape or consistency of a tablet might be affected.
- All affected product is voluntarily taken from the market. This is done because of a suspicion that it may have some potentially harmful effect.
Medication recalls
Recalls are initiated by Health Canada and involve varying degrees of risk to patient safety.
- A recall may affect a specific batch of medication. For instance, an error may have been made in the strength of the medication, or medication may have been put in the wrong bottle.
- There may be a general product recall of a specific medication, such as the recall for Vioxx™ a few years ago.
- These recalls are initiated if Health Canada feels that there is enough scientific evidence indicating that a drug creates a risk to public safety.
When we look at the difference between a withdrawal and a recall, it is clear that a wide range of potential issues and responses can result.
Public expectations
Consumers will have questions for pharmacists, including
- How does this withdrawal or recall affect me?
- Am I at risk?
- Will I be able to get a refund?
- What do I do next?
To answer these questions, the pharmacist needs information regarding the problem with the medication and any processes that should be followed. The medication manufacturer will provide pharmacists with information regarding the recall or withdrawal. As well, a toll-free number may be available for patients to call. Consumers receive direct and concrete information on how to deal with their medication.
Media involvement
A withdrawal or recall usually involves press coverage. Bad news and dramatic negative commentaries sell newspapers and lead television broadcasts. Many people believe everything that they hear, and expect the worst from drug manufacturers. A lack of concrete information and sensationalist reporting can create many questions and concerns for the public.
The pharmacy and the patient
To deal with patient concerns and relieve stress on pharmacy staff, almost every pharmacy has a process for handling high-risk drug recalls. Most pharmacies search their files to identify patients who have received the recalled medication in the past 100 to 150 days. Patients are phoned to advise of the recall and to suggest that they should contact their doctor. Many pharmacies offer the patient a refund on the remaining medication.
Currently, the Canadian Association of Chain Drug Stores is arranging to have a knowledgeable third party evaluate the severity of medication recalls. Pharmacies will receive appropriate information from this source and pass it on to the consumer.
Consumers are truly affected by the recall. Now, a useful medication is no longer available. This may create many concerns. It is important to to discuss concerns with your doctor and pharmacist.
A drug recall can be difficult for all involved. Patients, pharmacists, manufacturers, and the health care system all face challenges for different reasons.
In spite of enormous efforts made by government agencies and drug development watchdogs, recalls will always happen. We all want effective drugs that can fight disease with little or no risk to the patient. The reality is that all drugs have some level of risk associated with them. The more complex the disease or therapy, the higher the potential risk. No magic bullet can solve this problem. Still, pharmaceutical companies, Health Canada, physicians, pharmacists and other health care professionals all do their utmost to protect the health and safety of Canadians.
FAMILY HEALTH is written with the assistance of |
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FAMILY HEALTH is written with the assistance of |
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