Valsartan Recall – A Wake Up Call for Pharmacy

The recent Valsartan recall from Health Canada as well as other regulatory bodies around the world has caused quite a stir-up for the  distribution channel within the pharmacy community.  While medication recall isn’t uncommon and a necessary component in the quality control process, the grand scale of this recall is unprecedented.

Valsartan is a common medication used for various conditions such as hypertension and heart failure. The reason for the recall is that an impurity known as N-nitrosodimethylamine (NDMA) is found in several generic brands. NDMA is a potential carcinogen, so there is a concern with cancer risk from long term exposure. It is still unknown how long this impurity has been detected in the affected lots of valsartan and what it means for patients who have been exposed.

Over the last two weeks, everyone is trying as quickly as possible to address the recall. Patients need to seek further guidance from pharmacists and physicians. Community pharmacists need to determine if their inventory is affected and assess options for their patients.

As a primary care pharmacist, I am able to witness how community pharmacists have addressed this recall in different ways.  Here are few of my observations:

  1. Many pharmacies cannot provide valsartan in an alternate brand that isn’t affected by the recall.  While the recall from Health Canada has only cited few specific brands of valsartan that are affected, many pharmacies don’t stock an alternate brand that isn’t affected. Or perhaps every single pharmacy has rushed to order the non-affected brands from their wholesalers; this unexpected increase in demand has effectively cleared out any inventory, instantly putting the non-affected brands in drug shortage.  There is also the option to switch to other treatment alternative(s).  The Canadian Pharmacists Association has developed the following tool to help clinicians determine appropriate treatment options.
  2. Our collaborative skills vary greatly in the community. While a recall at this scale is disruptive to the day-to-day pharmacy operations, it is a perfect opportunity to illustrate how pharmacists can collaborate with physicians and other health care providers.  From my observations, some pharmacists have done a superb job in identifying which patients may be affected by the recall and provide patient specific recommendations for options to consider. Other pharmacists have reached out to physicians to seek their guidance, without offering any support or recommendation at all. And I have heard some pharmacists  have made no attempt to explain the recall to patients, or at times, have confused them or provided them no specific guidance on what to do.  
  3. Our profession is in a crisis. I don’t come to this conclusion lightly and many may be quick to disagree. But  our profession has a distinct role to serve our society. For pharmacies and pharmacists, we must be prepared to dispense medications and offer sound advices to the public about them.  This recall has illustrated how inconsistent we are able to provide the medications to the public as well as offering sound advice to manage the recall.

Over the last few years, pharmacies have faced many challenges with cut backs and changes to the funding models. They are haunted everyday by drug shortages of essential medicines that demand additional resources without necessarily any financial return. There is a lot of pressure to do more with less. Last time when I visited a pharmacy, there was no smile and everyone seemed to be overworked and stressed.

The valsartan recall has highlighted how pharmacies cannot reliably procure medications for the public anymore. This is often due to factors that are beyond their control. Some pharmacists are also not able to advice their patients on possible treatment alternatives.

If we can’t provide the medication and we can’t suggest an appropriate treatment alternative, what is the purpose of our profession?

We must not forget we are here to serve the public.  We must somehow continue to serve a purpose in our society and this purpose must be transparent to the public.

Do you have any comments about the valsartan recall? Thank you for reading my post.

 

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drugopinions

My name is Cynthia Leung and I am a practicing pharmacist in Kingston Ontario, Canada. This blog is for me to share my ideas, opinions and perspectives on how medications are used in our health care system. Note that these posts are my own opinions and do not represent the opinions of my current or former employers and / or organizations that I may belong to. Any possible case scenarios described in my posts would be modified to maintain patient confidentiality. This blog is not a platform for professional advise for patients or health care providers and the content is not meant to support any clinical decisions or replace professional opinions. Also the images are either taken or created by the author, or adapted with permission. I hope you will enjoy reading my posts!

3 thoughts on “Valsartan Recall – A Wake Up Call for Pharmacy”

  1. A good number of patients were started on an ARB (angiotensin receptor blocker) as a first choice over what i believe is first choice an ACE inhibitor. So this remains a possible choice of drug to turn to for patients taking Valsartan. The Canadian Diabetic Journal recently had 2 articles, one extolling ARBs in in CAD prevention and one disparaging it, but I still believe ACE’s do have an edge. Of course the main side effect is cough for an ACE, but often the ACE is stopped for unrelated cough. A measure I have used successfully in at least one patient, is concomitant iron to reduce cough in ACE patients. Years later when the ACE had been stopped for other reasons, I had to think hard why the patient was on iron before discontinuing it,

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