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The Myth of Drug Expiration Dates

propublica.org

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Re: The Myth of Drug Expiration Dates

#61

Post by pacaro »

13of40 wrote: post #47
civilitty wrote: post #25

Earlier quoted context omitted.

When working with biological systems, most of the time your acceptable error margin is between 10-25%. There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. The ones where it does matter are tightly controlled and clinically applied by a professional with active monitoring. The only…

Any idea whether the chemicals they decompose into are ever more harmful than the original?

Aspirin is a bad actor in this regard. It tends to revert back to salicylic acid, which is ok for some specific topical uses, but has potential to be pretty harmful orally. Sniffing an old bottle of aspirin will tell you whether they're still good enough

Re: The Myth of Drug Expiration Dates

#62

Post by mherdeg »

I have a lot of respect for this kind of reporting from ProPublica. It's a really good public service to report news that isn't actually new.

In this case, part of the news is that the FDA's 1986 Shelf-Life Extension Program ( https://www.fda.gov/EmergencyPreparedness/Counterterrorism/M... ) has been working fine for decades. This is important for people to know and it's worth re-publishing from time to time as a reminder.

They had another great article like this last month, https://www.propublica.org/article/hundreds-of-judges-new-yo... , which basically reported "local courts in New York state had terrible problems according to an in-depth 2006 New York Times report and are still terrible in 2017". Great stuff.

Likewise a lot of the reporting on "civil forfeiture continues to happen and continues to be unfair, here are more examples" provides a valuable civic service.

I know it can be tough in a news organization to re-report something that everyone already knows is true. It can certainly be tempting to pass over truly important stuff in favor of seeking out brand-new news -- a fair amount of science reporting is driven by "what's in the journals this week" -- but this kind of long-term focus on "what's still true that needs your attention" is equally valuable and great work.

Re: The Myth of Drug Expiration Dates

#63

Post by nathancahill »

jessriedel wrote: post #45

This article has some shoddy logic. For the vast majority of drugs, the actual marginal manufacturing price per pill is essentially zero. That means that when the expired pills are thrown away and new pills are manufactured, there is no true economic loss. Rather, all that potentially happens is a transfer between the consumer and the manufacturer. If pill prices were set by some external force, this could at least b…

I had exactly that thought when listening to the NPR interview this morning. Unfortunately, the value was taken for granted (even extrapolated x4000 to estimate total value loss across all hospitals in the US).

Re: The Myth of Drug Expiration Dates

#64

Post by civilitty »

sevenfive wrote: post #50
civilitty wrote: post #25

Earlier quoted context omitted.

When working with biological systems, most of the time your acceptable error margin is between 10-25%. There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. The ones where it does matter are tightly controlled and clinically applied by a professional with active monitoring. The only…

> There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. Wrong. Therapeutic ratio, not dosage.

Wrong. LSD and fentanyl have polar opposite therapeutic indexes - the therapeutic index is specific to toxicity whereas I'm talking about clinical outcomes in general. There are drugs that have threshold doses below which there is essentially no effect on the patient but aren't toxic until 10-1000x that threshold dose. Fentanyl just happens to have an effective threshold dosage that is dangerously close to its LD50.

Re: The Myth of Drug Expiration Dates

#65

Post by civilitty »

maxerickson wrote: post #58
criley2 wrote: post #56

Earlier quoted context omitted.

This is completely wrong. Dosage studies happens between Phase 2 and Phase 3 trials (and Phase 4 "post marketing" too) and are the most expensive, longest and most scientific process that arguably any business engages in in the entire world. Phase 1 is a safety test in healthy ~men. These seek to find the maximum dose before adverse effects appear in the healthiest humans. Phase 2 is a safety/dosage test in a much la…

Do all 10,000 attempts go through all the testing? Or are many weeded out before $1 billion has been spent?

The $1 billion dollar cost per drug is risk adjusted, so it includes all failed attempts at clinical trials and compounds that didn't make it through pre-trial screening.

Edit: The $1 billion number is meaningless outside the context of large pharmaceutical companies. The cost for phase 3 trials is in the tens or hundreds of millions of dollars so the floor is a wide range and there have been instances of companies getting incredibly lucky and developing a drug for much less than a full billion.

Re: The Myth of Drug Expiration Dates

#66

Post by slr555 »

This issue is a conundrum. Most drugs don't fall off a cliff of efficacy when they reach their expiration date.

There are drugs such as tetracyclines that should never be used past their expiration dates because they degrade into toxic compounds. Certain classes of drugs such as anti-arrhythmics or drugs like warfarin are dosing critical to the point where I would not want them if they were out of date.

I worked in pharmaceuticals in a medically underserved community for a couple of years. At that time when drug samples expired, sales representatives had to return them to their companies for destruction. One doctor in the area made sure that all the drug reps knew he would accept short dated (but not outdated, which would have been against policy for reps) samples for a free clinic he ran. Everyone I knew participated when they had short dated samples. While reps could not distribute outdated samples, doctors had much more latitude in how they dealt with them. It was one of those rare and wonderful situations that was good for patients, created good will for reps and was all completely within regulations.

I should say this was some years ago and regulations may have changed since then.

Re: The Myth of Drug Expiration Dates

#67

Post by JshWright »

The "extended use dates" that Pfizer published mean that we now have 'older' drugs with expiration dates that are past the expiration dates of newer batches. They didn't just say "add 1 year to all expiration dates" they said "for these specific lot #'s, the new expiration date is: XYZ".

They only published extended dates for some lots, since they expect more recent lots to still be in date by the time the shortage is addressed.

I may have spent the better part of a day a couple weekends ago relabeling a bunch of vials with a sharpie...

Re: The Myth of Drug Expiration Dates

#68

Post by agumonkey »

slr555 wrote: post #66

This issue is a conundrum. Most drugs don't fall off a cliff of efficacy when they reach their expiration date. There are drugs such as tetracyclines that should never be used past their expiration dates because they degrade into toxic compounds. Certain classes of drugs such as anti-arrhythmics or drugs like warfarin are dosing critical to the point where I would not want them if they were out of date. I worked in p…

I wonder if a single rule 'no consumption past date' is a safeguard to insure simple behavior from population. If people started to think some drugs can and some cant they might indulge into trying random stuff.

Re: The Myth of Drug Expiration Dates

#69

Post by bcook »

mikestew wrote: post #32
bcook wrote: post #8

I always assumed that the expiration date was partly legal, in the way that you only have 1 year within which you can legally have the drug in your system. I mean, if I am prescribed oxycontin, can I legally have the drug in my system for the rest of my life?

I always assumed that the expiration date was partly legal, in the way that you only have 1 year within which you can legally have the drug in your system. Are you implying that you still hold this assumption and are looking for someone to convince you otherwise? If so, I can't even conceive of where you got this idea in the first place, let alone argue against it. Let's slap a little Occam's Razor on this: how would…

According to my research, in America it's mostly an unknown (unenforced or depends on the state's sometimes conflicting verdicts) whether having a drug in your system means you are in possession of said drug. There are other laws that relate but I cannot pretend to understand the intricacies of which laws might apply to this situation.

But yes, I am interested in a definitive answer.

Laws around prescription pills are sometimes unexpected, like every prescription pill in your Mon-Tues-Wed-etc pill box (outside their prescription container) being a felony. So my grandma has numerous unexpected felonies in her purse.

Re: The Myth of Drug Expiration Dates

#70

Post by vilhelm_s »

harshreality wrote: post #4

> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…

The paper discusses this, they say that 90%-110% is the usual range which is allowed when the drug is sold new. The FDA can set limits on a per-drug basis, and there are some where they require 95-105%, but 90-110% is the most common. (C.f. https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4228B1...)

Several of the drugs they tested were > 100%, so it seems reasonable to assume that a lot of this is due to variation in manufacturing rather than to the drug degrading.

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