Drug Recalls: What Gives?
I don't know how closely you follow the news, but some recent drug recalls have come across my radar. It is kind of terrifying to me that the manufacturing process that I trust to produce lifesaving medications has had some recent slip ups. I'm not sure if I would be more or less concerned were it preventative rather than rescue medications being recalled. Understandably, there are stringent quality standards imposed by the Food and Drug Administration (FDA) and similar international regulatory authorities. After all lives like mine hang in the balance.
In the last year or two they've recalled several different batches of epinephrine autoinjectors from both AuviQ and Epipen. It is completely terrifying to find out that the autoinjector that goes with you everywhere is being pulled from the market.1 To only turn around a year or so later to carefully check lot numbers on Epipens you were prescribed to replace the AuviQ.2 Next a recall of Ventolin from suppliers is issued. I am slightly less alarmed by the rescue inhaler recall. The defect isn't so severe that they are requesting the inhalers back from patients, just taking them off pharmacy shelves.
What to do if you have a recalled drug?
My experience of drug recalls as a patient have been as follows: Start off with a call the doctor's office and get them to send a script to the pharmacy. This may or may not lead to a chat with insurance to explain why I'm refilling the medication sooner than normal or some other hoops to jump through to get them to cover it. From there it's just the regular pharmacy process. After that I follow the recall instructions to submit the defective medication back to the company. Fill out the paperwork they ask for to reimburse out of pocket costs. From there its just a waiting game to hopefully get a check to cover my cost of the replacement medications. Basically it's a bunch of paperwork and waiting. Certainly not my favorite pastime but a necessary one to get medications that work as intended.
All of this got me wondering how the FDA decides to recall a drug and what differences lead to some products being pulled from everywhere while others are just recalled from pharmacies. There are 4 different kinds of recalls. The FDA ranks recalls from Class I to Class III where Class I is the most likely to result in a bad health outcome or death. Whereas Class III is not likely to cause a bad health outcome.3 Below the threshold of FDA legal action is a Market Withdraw which can occur if a lot is tampered with.4 Recalls can be forced by the FDA or voluntarily started by a manufacturer depending on the circumstances. From all this news about drug recalls, I learned that it's important to have a good pharmacist on my health care team who can reassure me over the phone when I see the headline Ventolin inhalers have been recalled. Drug recalls are scary but a level headed phone call or series of phone calls to your healthcare team helps sort out what to do next in my experience.
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