Vague recall process poses potential harm
Drug recall, a rarity 10 years ago, has become an almost daily occurrence in today’s drug distribution system.
A system for recalling drugs after they have become available to the public is important when the drugs subsequently have been deemed “unsafe.” Recently, the influx of recalls related to NDMA contaminations such as with valsartan, ranitidine and the latest, metformin, have raised questions as to how such an interruption of drug supply translates into potential harm at the patient level.
Health Canada’s 59-page document outlining how to recall a drug suggests evaluating the risk to the health of Canadians before a recall. However, this can lead to confusion as to who should actually conduct this risk assessment as the risk is subjective and contextual and may be different among patient populations.
In addition, there is no regulatory body to direct how clinicians should review, discuss, communicate and manage these drug recalls with patients.
If you review communications from Health Canada, here are some key messages they will provide to the public:
- Do not stop taking the medication unless you have discussed with your health care provider.
- Contact your pharmacist to determine if the recall is applicable to you.
- If therapy change is necessary, this discussion should occur with your health care provider.
While these recommendations seem reasonable, they are vague and translate into unclear process for execution. As our healthcare system is already heavily burdened, where do any of us find time to address these recalls: the influx of phone calls to physicians’ offices and pharmacies; the demands to meet with healthcare providers for discussion; the additional appointments and follow-ups if therapy change is necessary.
And the most frustrating part is that Health Canada doesn’t issue any communication if a recall is resolved or not. Presumably, a drug will be available again in the market once it meets all the quality assurance standards. But unclear communications mean patients may remain on suboptimal therapies that may translate into worse outcomes. An example is when a patient with GERD is switched from ranitidine to a proton pump inhibitor and maintained for years to come, only to develop osteoporosis or other potential long-term complications unnecessarily. Or switching patients with diabetes from affordable metformin to more expensive oral hypoglycemics, leading to non-compliance and worsening of diabetes and long-term complications.
In addition, community pharmacies often have an unpredictable drug supply and inventory. They cannot send out routine communications to inform physicians if and when a drug has become available again as this can change from day to day.
Drug recall may be deemed necessary if the drug is “unsafe.” But a drug recall without a clear process on how it can be managed at the patient level can be harmful. A more clear process is necessary as the harm must not be dismissed lightly.