August 2018: Addressing Product Recalls

The Rural Pharmacist: Addressing Product Recalls

-Devon Myers, Pharmacist & Owner

“Several drugs containing valsartan being recalled due to contamination with a potential carcinogen”. This was the title of an article recently released by Health Canada, the regulatory body overseeing the safe and effective use of prescription medications in Canada. This article was released on July 9, 2018 and was quickly jumped on by mainstream media. “Health Canada recalls blood pressure drug valsartan after carcinogenic ingredient detected” announced The Globe and Mail. CBC warned that “Some heart, high blood pressure drugs containing valsartan recalled due to cancer risk”. It wasn’t long before posts began appearing on Facebook, Twitter and other social media platforms. In response to this Health Canada advisory, there were several people who contacted our pharmacy to get more information about the product recall. As such, we will use this opportunity to shed some light on the issues surrounding product recalls and to explain what community pharmacists routinely do to protect their patients!

Not only can product recalls affect prescription medications but they can also affect over-the-counter medications. In most circumstances, the recall is conducted because an impurity or contamination is detected in the manufactured product. Incorrect concentrations of ingredients can also result in a product being recalled. In the case of the recent Health Canada advisory, several valsartan-containing products were determined to contain N-nitrosodimethylamine (NDMA). As per Health Canada, “NDMA is a potential human carcinogen, which means it could cause cancer with long-term exposure”. Yikes! Just by reading that warning it becomes easy to understand why so many people contacted their pharmacies to check if their medications had been affected.

The advice from Health Canada, as well as from the manufactures producing the affected drugs, was for patients to continue taking their medications as prescribed. Although it was considered safe to continue taking these medications, many community pharmacists preferred a proactive approach to medication therapy management. Recalls can quickly lead to distribution and availability problems! When pharmacies are notified about product recalls our first action is to contact each and every individual who may have been affected. Once our patients are aware of the situation we then proceed to contact physicians and nurse practitioners to provide recommendations for alternative medications. It is through teamwork and communication with prescribers that pharmacists are able to ensure that patients do not have a gap in their drug therapy management. In the case of the valsartan recall, our pharmacists were able to successfully switch the majority of our patients to another medication within a few days.

As information becomes available regarding drug recalls, your community pharmacist provides a great resource for advice. If you have not been contacted by your pharmacy, chances are that you’re in the clear. However, pharmacists are readily available if you want to double check. Sometimes ease of mind can go a long way especially if you are trying to control your blood pressure!