Pharmaceutical Recycling: When 1st World Liability Means 3rd World Shortages

My  wife and I received a mail about a $500-something dollar epipen having reached its expiration date.  It made me curious whether the "obsolescence" of the pharmaceuticals equated to actual risk.

I found a decent 2012 Science-Based-Medicine journal article by Scott Gavura, seeking answers to the question, and found once-again that medical ethics are rich in direction for environmental ethics.  Human Health has been a concern for longer than Environmental Health.

So basically the article says that there is very little risk that expired medicine is bad for you.  It doesn't turn into poison (there was one possible case of that from a medicine that was long ago banned from the market... think of the liability if people died from not reading the date on your label).

When a new medicine is approved by FDA, no Pharma company can afford to then test it by putting it on the shelf for several years to determine its expiration date.  They do run tests on exposure to moisture and light, and use those to predict shelf life.  But like food, an open can of stuff doesn't stay good for as long as a closed can of stuff, so the expiration date is majorly affected by whether it is pre-consumer (unopened at a pharmacy) or post-consumer (excess from a once opened bottle).

And this is hot topic in Waste Policy... see all the national pharma take-back day events this month.

So the next most fascinating thing in the article is that most of the "expired" pharmaceuticals turned in for recycling, by far, are pre-consumer pills.  Pharmacies - understandably - are cautious about selling drugs to patients with "expired" or even "soon to expire" dates.

SpongeTransferred from en.wikipedia, CC BY-SA 3.0
So the drugs don't turn into poison.   But some of them may be less effective.  Aspirin, for example, breaks down into less effective form when exposed to moisture, yielding a slight "vinegary" odor.  And in the case of an epi-pen, "less effective" is certainly a concern if you can afford a new one.  But if my kid starts to suffer a life-threatening peanut allergy reaction, I'm not going to check the date on his epi-pen.

And as the FDA points outA small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed.  Of course, that's also true if I donate a brand new can of peanut butter to a food shelf.

Commercial interests put warnings on labels that protect them from liability lawsuits, but don't risk closing the sale.  They want us to buy new jars of peanut butter, but they don't have an interest in us donating free peanut butter.  And the same can be said of bottles of aspirin and epi-pens.

People are advised to electively upgrade their epi-pens, and pharmacists diligently replace them when the dates are out.  But someone who faces dying without an epi-pen shouldn't have their expired epi-pens taken away from them.

This seems to me analogous to electronics second hand markets.

If there is a very poor illiterate person in a very poor country who has no hope of ever affording the drug, and a doctor who has access to the expired medicine has no realistic concern over being sued by the poor illiterate person, what are the ethics of sending those "expired" drugs into a secondhand market?

As I immediately realized while composing my LinkedIn policy question, just suggesting that "rich countries give expired medicine to poor countries" may ring alarm bells.  I felt my reputation could be at risk just because I suggested it.

And who would have the muscle to oppose this "Gray Market"?  Big Pharma.

How does Big Pharma benefit?

Well, I'm not sure how pre-consumer drugs - those which never sold - are affected.  Most large retailers have agreements with original equipment manufacturers that they don't get paid if the inventory doesn't sell - shelf space is sold almost like real estate, with OEMs being the tenant because they have so much risk from losing cost of goods sold under Big Box Store agreements.

So if MOST of the expired drugs, by far, are pre-consumer, is that where public policy directs us?

No.  Pharma benefits more from disposal or obsolescence of drugs that have already been sold.  The aspirin makers got their money from the bottle of aspirin on grandma's shelf.  So they are not in "planned obsolescence mode".

To be fair, the two probably balance out one another.  Big Pharma wouldn't want a date that expires so soon that pharmacists pull it from the shelf before sale... that's like shredding brand new computers that don't sell.

But back to the ethics question, should pre-consumer expired meds be made available to Doctors Without Borders?

If you answer "no", you are putting our nation's honor and reputation above the lives of the poor.

If you answer "yes", you are guilty of advocating for expired meds to be sold to the poor.

"It's a false choice, I believe they should get new medicine"

The third is a "let them eat cake" non-response in my opinion.  Someone in Africa may need an epi-pen right now, and if they die without it while we shred our pre-consumer pens, then White guilt trumps African lives.

Or we can make up a statistic.  80-90% of pre-consumer meds sent to Third World Nations are X.  Get a law passed based on the made up statistic, and create a real liability answer to a moral question.

So as we shred up our used computers and send Africans into coltan mines to get the strategic minerals to make new ones, which the Africans can't afford, and we call that "Stewardship" and "Ethical Recycling".... should we do the same with pre-consumer expired meds?

My position is that Africans should be making the decision, and be fully informed, but should do the risk analysis and cost-benefit analysis without the burden of Colonialist Power Liability Concerns.

Of course, the real public interest is in getting the Opiods out of the market.  My father passed away after suffering stage 4 cancer, which got into his spine and bones, in late February (he was 82).  People with painful cancer, like my dad, should get the meds they need to sleep and not be in agony.  But those meds need to be "recycled" in a good way.  And that's why Drug Enforcement DEA, not FDA or Big Pharma or EPA, runs the pharmaceutical recycling programs.

1 comment:

Josh Lepawsky said...

Really like this post. The best questions are tough ones and I like that the answers aren't 'easy'.

Was thinking there is an analogous ethical situation around 'f-waste' [food waste] that could be used to explore comparisons of comfort/discomfort with such choices. Came up in a recent conversation with a waste public policy-maker who was wondering whether there really is such a huge legal liability with food past best before dates or fresh food not sold being given to food banks and similar organizations. It would be interesting to ask those who feel uncomfortable with pharmaceutical recycling whether they feel similarly about giving unsold food or food past best before date to their local food bank.