The Myth of Drug Expiration Dates • Hacker News Board

Re: The Myth of Drug Expiration Dates

#241

Post by r00fus » Wed, Jul 19, 2017, 5:48 AM UTC

Florin_Andrei wrote: post #52

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…

> What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured" Relax, this is the real world, not a computer based series of 0s and 1s. Any such compound begins drifting off from the original specs as soon as it leaves the factory - and in a very real sense it's not exactly at 100% at any time post the moment of manufacture. The question is what kind of deviation can be tolerated.

Offtopic, but even the world of 1's and 0's is subject to real-world constraints - learned in my 90s computer hardware class as I spent weeks in summer after semester debugging why my "basic 8-bit processor" kept crashing after only a few hours of uptime: faulty silicon that periodically read median-voltage differentials cascaded eventually into bad instructions.

The world of logic is built on the shifting ground of reality. Only redundancy and checksums keep it from crashing down in compounded errors.

Re: The Myth of Drug Expiration Dates

#242

Post by Allyssa99 » Wed, Jul 19, 2017, 5:49 AM UTC

perseusprime11 wrote: post #220

kbenson wrote: post #219

Earlier quoted context omitted.

The point is we don't necessarily know, or know to the degree of certainty the FDA requires, how many of these things degrade. Perhaps in certain conditions, they degrade at one rate, but in other conditions (such as a temperature difference), they degrade at a different rate. Testing how drugs perform years after production in multiple different scenarios is necessarily time consuming, because it takes at least that…

I see medicines in foreign countries wrapped in some kind of aluminum foil. Will that prolong the life of the medicine given there is no oxygen to react? Given the amount of money spent on medicines, I really think there is a good moral business case to identify the correct expiration dates and save money for people. We just went through the Health care ordeal. Money saved anywhere is money saved for people who despe…

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Re: The Myth of Drug Expiration Dates

#243

Post by AstralStorm » Wed, Jul 19, 2017, 5:59 AM UTC

pilsetnieks wrote: post #59

Reason077 wrote: post #42

"Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It’s being rationed because there’s so little available." Huh? US hospitals have a shortage of Baking Soda ?

Medical grade baking soda, yes: https://arstechnica.com/science/2017/05/baking-soda-shortage... You can't just take a box from the baking supplies shelf in Walmart.

You could but shouldn't outside of battlefield or other critical conditions. Direct solutions have been used some hundred years ago, prepared on place by a chemist. (They tended to use better than food grade, but not much better.)

Re: The Myth of Drug Expiration Dates

#244

Post by r00fus » Wed, Jul 19, 2017, 5:59 AM UTC

jessriedel wrote: post #125

learn_more wrote: post #80

Earlier quoted context omitted.

The cost model is like a time limited software license. If there is some new trick to extend the license, the drug companies would likely just charge more up front.

Exactly. The price is set by the willingness to pay (the demand curve), which accounts for the fraction of purchased pills that will actually be consumed.

Pharma companies get the benefit of near-perfect inelasticity in demand, i.e., if you don't get your meds means you die or have extreme pain, you will likely be willing to pay inordinate prices.

Re: The Myth of Drug Expiration Dates

#245

Post by AstralStorm » Wed, Jul 19, 2017, 6:13 AM UTC

jinglebells wrote: post #141

tzs wrote: post #110

Earlier quoted context omitted.

For prescription drugs in the hands of consumers, as opposed to hospitals and pharmacies, I would be concerned about consumers misusing drugs. For example, suppose someone goes to their doctor with certain symptoms and are diagnosed with a specific condition. They are prescribed a drug to treat it. They use up half the prescription, and the condition goes away. A couple years later they develop similar symptoms. Inst…

> and cost of a doctor visit. And we've nailed the problem. I don't pay to see the doctor so I have no reason to stockpile the drugs.

Oh but you do. Even in socialized care there are taxes and opportunity cost of time to visit.

It sometimes gets hilariously bad as a patient is supposed to get out of bed very ill to go get a sick leave paper...

Re: The Myth of Drug Expiration Dates

#246

Post by Ashlynn99 » Wed, Jul 19, 2017, 6:27 AM UTC

ekianjo wrote: post #224

techthroway443 wrote: post #202

Earlier quoted context omitted.

Nobody said they need to find the absolute last day the drug expires before they can get it to market. If it's a new drug and they can only say for sure that it lasts 6 months then put that on the label and ship it out. But assuming the drug will be out for 10+ years they should be continually testing the expiration date and updating as they've had more time to make that determination. But like I said initially (and…

> If it's a new drug and they can only say for sure that it lasts 6 months then put that on the label and ship it out. But assuming the drug will be out for 10+ years they should be continually testing the expiration date and updating as they've had more time to make that determination. This needs regulatory work. And this bring very little returns, so your regulatory resources are better spent somewhere else. There…

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Re: The Myth of Drug Expiration Dates

#247

Post by paublyrne » Wed, Jul 19, 2017, 6:33 AM UTC

perseusprime11 wrote: post #220

kbenson wrote: post #219

Earlier quoted context omitted.

The point is we don't necessarily know, or know to the degree of certainty the FDA requires, how many of these things degrade. Perhaps in certain conditions, they degrade at one rate, but in other conditions (such as a temperature difference), they degrade at a different rate. Testing how drugs perform years after production in multiple different scenarios is necessarily time consuming, because it takes at least that…

I see medicines in foreign countries wrapped in some kind of aluminum foil. Will that prolong the life of the medicine given there is no oxygen to react? Given the amount of money spent on medicines, I really think there is a good moral business case to identify the correct expiration dates and save money for people. We just went through the Health care ordeal. Money saved anywhere is money saved for people who despe…

There may be other ways to approach this from a moral point of view. High prices for medicines are defended on the basis of high research costs, not high manufacture costs.

A case could be made for legislation that obliges free replacement of out of date medication for the original purchaser, perhaps with a small surcharge.

Re: The Myth of Drug Expiration Dates

#248

Post by Tuna-Fish » Wed, Jul 19, 2017, 6:38 AM UTC

r00fus wrote: post #236

ekianjo wrote: post #221

Earlier quoted context omitted.

I worked on expiration dates studies in pharma. It's well known that you could probably always extend the shelf life to 3-4 years for most drugs that are supposed to expire within 2 only, because tablets for example tend to be very stable. But nobody wants to run long stability studies, because that costs a lot of money (i.e. several batches that have to be analyzed in regular basis, documented, reported, QA'ed, insp…

How did they come to an expected shelf-life of 2 years in the first place? Some medication that expires quickly can be extended simply by refrigerating it. I wonder what other environmental controls could extend the shelf life of common, expensive medication?

> How did they come to an expected shelf-life of 2 years in the first place?

By storing it for 2 years and testing it after.

> I wonder what other environmental controls could extend the shelf life of common, expensive medication?

Common, expensive is an oxymoron. The vast majority of all medication in use is practically free to produce. The packaging of drugs typically costs more than the drugs themselves. Drug discovery has long concentrated on small-molecular-weight drugs that can be mass-produced for a pittance. The reason drugs cost so much is that proving that they are safe and that they work costs so much. Because of this, there is little economic sense in trying to preserve drugs for longer (which would require more extremely expensive trials), when you can just trash the drugs and order up a new batch that has a combined msrp of $100M for $5k.

In their economics, small molecular weight drugs share more with software than with, say, bread. That is, practically all of the economic cost is upfront investment and the replication cost is non-existent.

Re: The Myth of Drug Expiration Dates

#249

Post by GordonS » Wed, Jul 19, 2017, 6:42 AM UTC

seehafer wrote: post #227

mechnesium wrote: post #222

Earlier quoted context omitted.

I'm a test engineer. Highly accelerated life testing (HALT) can probably be used to closely approximate the shelf life of medicine. You need to look at the parameters that cause degradation (humidity, temperature, light exposure, etc). HALT the samples at different temperature/humidity/lighting extremes and use mass spectrometry to check purity. Use the data to create an algorithm that approximates the product lifeti…

Unfortunately, ALT is not a solution, because it's not accepted by FDA, except as a temporary measure. Any drug submission that supports shelf life via ALT data will be expected to also say "and we're doing real time testing to support this", and FDA will expect the follow up real-time data.

Then perhaps the solution is for the FDA to allow HALT testing. Having said that, I imagine there is little incentive for pharma companies to willingly extend the shelf life of their products - perhaps the real solution is for the FDA to actually require HALT testing.

Re: The Myth of Drug Expiration Dates

#250

Post by ekianjo » Wed, Jul 19, 2017, 6:49 AM UTC

r00fus wrote: post #236

ekianjo wrote: post #221

Earlier quoted context omitted.

I worked on expiration dates studies in pharma. It's well known that you could probably always extend the shelf life to 3-4 years for most drugs that are supposed to expire within 2 only, because tablets for example tend to be very stable. But nobody wants to run long stability studies, because that costs a lot of money (i.e. several batches that have to be analyzed in regular basis, documented, reported, QA'ed, insp…

How did they come to an expected shelf-life of 2 years in the first place? Some medication that expires quickly can be extended simply by refrigerating it. I wonder what other environmental controls could extend the shelf life of common, expensive medication?

> expensive medication

Apart from biologic drugs, most small molecule compounds are dirt cheap to produce. So cheap that nobody is even striving to produce them in a cheaper, more efficient way. If you compare this kind of industry with chemical specialty industries, where the mindset is to increase yield as much as possible, in pharma the production cost is not much of a consideration. So, what you pay for your drugs has almost no relationship to how much it costs to produce. You are paying for patents, market exclusivity and the whole system that goes with it (the pharma companies are not the only ones benefiting from it).

> How did they come to an expected shelf-life of 2 years in the first place?

Stability studies supporting 2 years data (submission to approval takes one year, and compiling all data before submission for filing is a 6 months process, so you can start submission with 1 year stability data in your hands, and tell the regulatory agencies you will provide the 2 years data during the second half of the regulatory review to get 2 years).

Because that's good enough for most drugs. 3 years is usually ideal, but not always necessary. If your drug is used in high volume most patients won't get batches that are produced long ago anyway.