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Rx and the Law: Drug Recalls

08/03/2021 9:09 AM | Anonymous member (Administrator)

By Don R. McGuire Jr., R.Ph., J.D.
Pharmacists Mutual Insurance Company

As a young pharmacist, I experienced my first recall when the drug Oraflex (benoxaprofen) was taken off the market in 1982. The drug was effective in treating arthritis, but had some serious side effects. What I remember were patients telling us this was the only drug that worked for them and asking us to sell it to them rather than returning the drug to the manufacturer. Ultimately, we decided to send it back to the manufacturer. The recent recall of ranitidine and other products for nitrosamine impurities caused me to reflect on how little I understood recalls in 1982.

Drug recalls are voluntary actions taken by a manufacturer to remove a defective product from the marketplace. A recall can be initiated by the manufacturer or the Food and Drug Administration (FDA) can request a recall. Recalls are almost always voluntary by the manufacturer and FDA rarely requests a recall. FDA's role in a drug recall is the same as in the recall of other FDA regulated products; e.g. medical devices, cosmetics, food, etc. The agency's role is to classify the recall, to oversee the manufacturer's strategy, and assess the adequacy of the recall.

Recalls are classified by their severity. Class I recalls involve a dangerous or defective product that could cause serious health problems or death. Class II recalls involve products that could cause a temporary health problem or a slight threat of serious harm. Products involved in Class III recalls are unlikely to cause adverse health reactions, but the products violate labeling or manufacturing laws. You will not hear about every recall on the news. Public notification of a recall usually occurs when the product has been widely distributed or poses a serious health hazard, such as in a Class I recall. However, all recalls are posted weekly on the FDA website through their Enforcement Reports page.

You can also register to receive email notifications of new and updated recalls. Familiarizing yourself with current recalls will be beneficial when your patients contact you with a question about a recall. FDA recommends patients talk to their pharmacists about recalled medications. Class I recalls generally provide information specifically for patients, but other Class recalls do not. Being informed about current recalls will assist you in helping your patients get replacement therapies.

The ranitidine recall applied to both prescription and over-the-counter (OTC) versions of the drug. The recall notice advised patients to stop taking OTC ranitidine immediately, but to consult with their health care professional about other treatment options before discontinuing prescription ranitidine. These types of instruction will generate questions from your patients. Besides being aware of the recommendations for your patients, the recall notice will advise the pharmacy on the removal of the drug from stock and the return procedures.

From a liability perspective, you should follow the procedures outlined in the recall notice. Remove items from stock as instructed. Some recalls will advise you to contact patients currently taking a prescription product. Verify that you have or had the affected lots and notify your patients who received the affected lots as soon as practical. Keeping your computer system updated with current lot numbers and expiration dates of prescription products is crucial to being able to identify those who have received the recalled product. If you receive a new prescription after the recall notice, use the opportunity to help educate prescribers in your area. Be ready to suggest alternatives that are not affected by the recall. Needless to say, it is not a good idea to sell or dispense recalled products at the patient's request instead of following the return process in the recall notice. Another bad idea is compounding the recalled medication when the manufactured product isn't available due to a recall.

Rather than being a passive recipient of information, going online to regularly review recall notices will allow you to be proactive with you patients' therapies. Your patients will see you as a trusted partner in their healthcare. Follow the recall procedures, make sound professional judgments when necessary, and your patients will value your services even more.

©Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.

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