Over the past 48 hours there has been a significant amount of discussion surrounding an NPR story that says that most pharmaceuticals are safe and effective long after the manufacturer’s expiration date. For those of us who have worked in any retail setting that deals in product freshness and sell-by dates (e.g. supermarkets or pharmacies) this should come as no surprise. There have been numerous reports over the years about the astounding waste that results from a marketplace obsessed with expiration dates. What most people fail to appreciate is that, at least in the case of food, expiration dates are generally left to the whims of manufacturers and packers. Corn flakes have no intrinsic quality or feature that renders them toxic or inedible the day after the best-by date. A chocolate bar doesn’t suddenly become poisonous the moment the sell-by date is passed. Most of the factors that determine freshness have nothing to do with the product and everything to do with how it’s packed, shipped and stored. A box of crackers might have a sell-by date of August 15th, but if the box remains unopened and stored out of the damp, I would feel perfectly confident eating them October 15th. If pressed, I might even open them up as a New Years snack.
Of course the line we are given is that this is all about safety, and I certainly respect that concern. There are some products that probably should be discarded by or very soon after an arbitrary expiration date (fresh meats come to mind). However, the demand for strict safety precautions becomes even greater in the case of medications. Again, this is not to discount the need for some sort of guidelines on how long a drug can actually last. Part of the FDA approval and regulatory process involves drug makers testing and documenting the stability of drugs over time. They do not however require drugs to be potent and safe for any particular length of time and this is where the aforementioned NPR report steps in. Because drug companies only have to demonstrate their products are safe and effective to a point of their choosing, there is no real incentive for those companies to test beyond a few years. Short dating drugs, at least in relation to their likely lifespan, is an effective way to ensure a constant demand for new product. This becomes even more imperative in the case of large pharmaceutical companies producing products still under patent. There is a window of about 8 years where a drug is only available under the trade name (i.e. brand name) before it becomes eligible to “go generic”. This means companies like Pfizer, Astra-Zeneca, Merck and GlaxoSmithKline need to really drive sales before lower cost alternative generics become available. A brand drug sitting on a pharmacy shelf with a two year expiration date means even if that drug is never dispensed, the manufacturer has already made money off it and will make more money off it when that pharmacy has to dispose of it and replace it. It’s kind of like leaving a balance on a gift card: the merchant has already made their money, so any expired balance is basically bonus revenue.
Pharmacies are put in the awkward position of balancing three plates at once: the interests of drug manufacturers, the expectations of patients and the pharmacies own financial interests. This becomes an epic battle with pharmacies trying to return unused (and unexpired) drugs back to wholesalers for credit while ensuring their own stock of drugs is within an acceptable range of “freshness”, if you will. This acceptable range can vary, but many chain pharmacies will discard drugs 3 to 4 months before the manufacturer’s printed expiration date. This we might call an abundance of caution. This abundance of caution generates untold amounts of wasted product, much of which could be used for months if not years beyond. This does little more than enrich drug companies and send billions of dollars worth of still potent and safe medications to be incinerated or otherwise destroyed.
A personal anecdote: a chain retail pharmacy in a small but growing town pulls medications three months out from expiration. It is not unusual for the salvage value of the medications to exceed $5000. If there are some HIV/AIDS or niche products on the list, that salvage value may double or triple. These are drugs that, according to FDA rules, are still considered safe and potent but, because of liability concerns as well as the perceptions of the healthcare consumer, they must be removed from stock.
As the NPR story highlights, there is no real secret that many meds are good for well beyond their official expiration date. Unofficial testing and official testing done by government entities on federal stockpiles show this to be true. However, until regulators require manufacturers to test their products’ shelf-life for much longer periods of time or consumers curb their fear of expiration dates, we will continue to ship tons of pills, capsules and injections for disposal, a strange thing to be doing in an environment that is supposedly all about making healthcare accessible and affordable for government and patients.