Expired Medications: Not Good Enough For Us But Good Enough For Them?

by

Like most people I know, I’ll drink out of a milk carton and eat packaged food beyond the recommended expiration date, as we all know that these food items are good for a period of time beyond their expiration date. I’ve also done this with over the counter medications and even with prescribed medications such as antibiotics, as in college I ended up hoarding away a whole arsenal of remedies just in case I fell ill away from home.

So you might ask, what is the big deal of taking expired medications especially if they are still effective.  The big deal is that here in the U.S., expired medications cannot be sold or given away legally by health providers.  However, many organizations use them in other countries where there is a shortage of these medications.  Proponents of this usage may argue that discarding expired medications that are still efficacious is extremely wasteful.  Opponents would argue that donating or even selling expired medications is unethical and illustrates a double or lower standard for other countries than our standard here in the U.S.

The WHO in 1999 published Drug Donation Guidelines in its attempt to regulate international drug donations.  Its guidelines are a compromise between these two stances and are based on four core principles.  Specifically, “after arrival in the recipient country all donated drugs should have a remaining shelf-life of at least one year.”  However, though many organizations such as the FDA, UN, and Medecins Sans Frontieres support the WHO guidelines, consistent compliance with these guidelines is lacking.

Our goals are to increase awareness and implement international policy with monetary repercussions to both donor and recipient countries to ensure compliance with the WHO guidelines and to decrease the dastardly dumping of donated drugs into vast landfills around the world.  Between 1992 to 1996, 27,800 to 34,800 tons of drugs and medical supplies (339 to 425 million U.S. dollars) were donated to Bosnia and Herzegovina with over half deemed inappropriate and unusable.

Advertisements

8 Responses to “Expired Medications: Not Good Enough For Us But Good Enough For Them?”

  1. bdsteven Says:

    Very interesting – thanks for the great post. I can definitely see why it would appear that there is a double standard with the administration of “expired” therapeutics in other populations. Like most of the food products you mention, however, a lot of drugs are likewise completely safe and useable far beyond their “expiration date”. Likewise there are those drugs, such as certain biologics and antimicrobials, that have very limited lifetimes or possess considerable risks at even marginally reduced potencies. If there is any way to make this paradigm work, I think it serves to the benefit of all of the stakeholders – there must be careful consideration in the case of each specific treatment, however, as these issues of drug stability and therapeutic window will have much greater ramifications in certain instances more than others.

  2. glmurphy Says:

    Nice posting to highlight another problem associated with such well-meaning humanitarian efforts! At a remote military location, we are constantly battling expired drugs. We simply cannot get our shipments of drugs delivered in a timely fashion to keep everything on our shelves pre-expiry. There are various reasons for the shipping delays; the most common and annoying is the host-nation customs (but that is a story for another class…). We are frequently faced with decisions about which drugs are safe to administer after their expiration dates; and we typically have to rely on our best medical educational guess. On a larger scale, though, as described in this post, management of massive volumes of various drugs would be an astronomical task. If there were no marketing risks associated with disclosure of such information, it would be great if the pharmaceutical companies could provide information on their products regarding the longest possible efficacious use of their drugs; but, of course, this information would cause paying customers to hoard their drugs even longer. A touchy subject for sure, and certainly one that will continue to be difficult to manage safely and effectively.

  3. sbfphc Says:

    The recommended malaria drug category – artemisinin-based combination therapy – ACT – presents a particular challenge for expiry. The active ingredient from the herb artemisia annua does expire/loose potency within 2 years of manufacture. Given that it may take up to six months from manufacture to arrival at point of service, we have a really tight deadline to use these medicines correctly and in a timely fashion.

  4. drlizkim Says:

    Thank you sbfphc, glmurphy and bdsteven for your insightful comments. Thanks for sharing about the problems you had to deal with glmurphy, would like to hear more about the customs of the host-nation that cause/contribute to shipping delays. Are you also having to deal with chemotherapy drugs at your base? I am curious who the major donators are for chemo drugs to your military base? The delay in transport is a huge issue given that the active ingredients t-half life is time dependent. Also, appropriate storage/handling is another huge issue, in that some drugs need to be maintained in certain temperature for timely use. Thank you for responding to our post and sharing your thoughts. EK

  5. MMClancy Says:

    Too true that so often we keep drugs on the shelf far beyond their expiry date because that’s what we have–the biggest category of these I can think of is antivenom. Nearly all of the supplies I can think of consist of at least 1/2-2/3 expired product due to manufacturing changes, shortages and other extrinsic factors.
    Expiration dates can be fashioned partly out of true knowledge of lack of potency or change in compound/concern of risks, but also out of sheer time. Who wants to run a drug trial for 10 years?
    Drug disposal though–that is a tricky topic, and I’m so glad you posted about it. A very interesting view of misguided “charity” indeed.

  6. chenjo Says:

    Thanks everyone for all your comments. I think it is also important to point out the difference between expiration date and shelf life. “Drug manufacturers are required by the FDA to label their products with expiration dates based on real time or estimated, that is, accelerated, testing data(1)…A drug’s shelf life is defined by the period of time where pharmaceutical potency is greater than 90%. The date of expiration marks when a drug’s stability has no longer been tested for safety and efficacy(2). The subtle difference is in the testing. A drug labeled to expire 5 years after manufacture is so labeled because it only had stability testing up to that point. Unless further testing is done, its true shelf life is unknown, and the drug may retain its potency for many more years(3).

    The 1999 WHO Drug Donation Guidelines state that “after arrival in the recipient country all donated drugs should have a remaining shelf-life of at least one year.” From the definition above, the shelf-life of many drugs is unknown depending on the duration of stability testing. Thus, when treating certain diseases and ailments where potency is paramount (infectious diseases, cancer, animal bites as stated above), knowing the true shelf life of a medication is vital. I agree that a stratification paradigm for drug donations should be created to distinguish drugs where high drug potency is critical to the efficacy of treatment of certain diseases (as stated above) to drugs where the lack of its potency isn’t as critical, as in the treatment of non life-threatening illnesses.

    1. Food and Drug Administration. Stability testing and expiration dating. Code of Federal Regulations, 21, Sec. 211.136 and 211.137. 2011. http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.
    2. Culbertson NT. What can be done with expired pharma- ceuticals? A review of literature as it pertains to Special Operations Force’s medics. J Spec Oper Med. 2011;11(2):1-6.
    3. Coffey KC. Is There a Role for Expired Medications in Developing Countries? Clin Pediatr. 2012; 20(10)1-3.

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s


%d bloggers like this: