Do pharmacists have discretion to dispense expired drugs?

[robert_columbia]

The question is pretty self-explanatory. In whatever jurisdictions you are aware of, can a pharmacist use his professional discretion to dispense a drug that, according to the label from the factory, is expired, if the pharamacist and/or the prescribing physician feel that the drug is still reasonably potent and that the danger of harm is minimal, and if the patient gives informed consent? I.e. Joe the Pharmacist is filling a prescription for a short-term course of antibiotics. He has some on the shelf that were manufactured 3 years ago and that “expired” yesterday. He knows that this drug is very stable, and he calls the prescribing physician, who doesn’t see any significant risk that the “expired” meds will be ineffective or harmful, so he’s ok with it. The pharmacist asks the patient, and the patient feels that the expiration dates are a moneymaking scheme by the drug manufacturers to make people buy new drugs, so he’s fine.

1. Would the pharmacist be breaking any laws?
2. Would the pharmacist be in breach of professional ethics?

I know a pharmacy technician in the US, and they said that under no circumstances can an expired drug be dispensed.

[Saint_Cad]

From a practical standpoint, the point is moot. No pharmacist would do such a thing for fear of a lawsuit.

From a legal viewpoint (IANAL) I suspect it would fall under consumer protection laws.

From an ethical viewpoint that question may be better asked of the APhA

[Tim_T-Bonham.net]

My Uncle & Aunt are both pharmacists, and they would never, ever do this.

Because:

• there is a risk, even if small, of a bad reaction from the patient.
• any bad reaction by the patient would likely be blamed on the expired drug, and on them for selling it.
• their insurance would not cover them, because they sold an expired drug.
• and on most drugs, their expired supply could be returned to the maker for credit.

So besides any legal & ethical issues, they would be taking a big risk, for no additional profit – why would they want to do that?

[Hirka_T_Bawa]

I don’t know of any pharmacist or pharmacy that would do this, while I’m not aware of any particular rule that says this can’t be done, it would be against my ethics as a pharmacist.

Besides, I doubt this case would actually ever have a chance to happen. At every pharmacy I’ve worked at, we pull drugs off the shelf about 2 months before the expiration date, package them up, and ship them off to get credit for them. I have pulled drugs out of the shipment to use to fill a script before, but then they were still over a month from the expiration date (and I made sure to tell the patient they were about to expire).

[TriPolar]

A pharmacist would do it only in an emergency situation, where unexpired drugs are not available, and a person is in dire need. Otherwise, what legitimate reason would they have for doing so? The patient’s desire to use the expired medication is irrelevant, and the pharmacist would take great on great risk. They have enough problems with filling prescriptions with current medications these days, it doesn’t make sense that they would complicate their jobs even further.

[Profound_Gibberish]

It is illegal to knowingly dispense or administer expired drugs. Doing so can get you in big trouble with the FDA and the Joint Commission. One could easily lose their license as an RPh, MD, RN, RT, etc by doing so.

[mnemosyne]

@robert_columbia

if the pharamacist and/or the prescribing physician feel that the drug is still reasonably potent and that the danger of harm is minimal… he calls the prescribing physician, who doesn’t see any significant risk that the “expired” meds will be ineffective or harmful, so he’s ok with it.

While the on-the-shelf expiration date has some built in buffer time compared to the stability of the drug as established by stability studies, the fact that there is no data whatsoever beyond the date of the end of a stability protocol and that any data that does exist is not provided to pharmacists or physicians by the manufacturer or the FDA pretty much means that what they “feel” or “think” is completely irrelevant. Beyond the approved drug expiration date, no one knows what happens to the drug, not even the manufacturer.

Obviously it’s not a time bomb, but just like food, sooner or later drugs go bad, and no one knows what that length of time (sooner or later) is, and no one knows what the effect is on the patient. It wasn’t studied and won’t be studied beyond changes made to drug approval regulations.

the patient feels that the expiration dates are a moneymaking scheme by the drug manufacturers to make people buy new drugs, so he’s fine.

The patient is wrong, and further is not qualified to make this decision for him or herself. If expirations were based on manufacturer’s wishes, they would not be measured in years; they’d be much shorter as a butt-load of money and time doing stability would be saved and there’d be no need to make drug formulations as stable as they are. Giving 5mg of a drug is simple. Making that dose still be 5mg after sitting for 6 months pr 2 years in a bathroom cabinet is the hard part.

[Hirka_T_Bawa]

mnemosyne, do you have that whole spiel in a text document waiting to be copy & pasted? How many times have I seen you post that now?

[Kent_Clark]

Too bad. I can see a whole new market for pharmacy thrift stores selling day-old antibiotics, demo brands that failed their market testing, and some reconditioned items (“Sure, Darvon killed 2,000 patients, but that was out of 10 million prescriptions. The savings are big and the odds are on your side!”)

[mnemosyne]

@Hirka_T_Bawa

mnemosyne, do you have that whole spiel in a text document waiting to be copy & pasted? How many times have I seen you post that now?

No, but I kind of know it by heart - I have been on here over a decade (though it’s been since 2007 that I haven’t even worked in the industry!) I figure about 90% of my posts are about hockey (Go Habs Go!), the rest are this one, in various condensed forms! Maybe a few about kittens or Montreal or something. I could just ignore these threads but I figure if people keep asking these questions, it means they haven’t read the older ones, right?
I had occasion to read one of my older posts (c. 2004) about stability testing not too long ago… it’s amazing how much I’ve forgotten…and how much I taught myself! Give it another decade, it will reduce to “Don’t drink spoiled milk, don’t take expired drugs”. :smack:

[rbroome]

@mnemosyne

While the on-the-shelf expiration date has some built in buffer time compared to the stability of the drug as established by stability studies, the fact that there is no data whatsoever beyond the date of the end of a stability protocol and that any data that does exist is not provided to pharmacists or physicians by the manufacturer or the FDA pretty much means that what they “feel” or “think” is completely irrelevant. Beyond the approved drug expiration date, no one knows what happens to the drug, not even the manufacturer.

Obviously it’s not a time bomb, but just like food, sooner or later drugs go bad, and no one knows what that length of time (sooner or later) is, and no one knows what the effect is on the patient. It wasn’t studied and won’t be studied beyond changes made to drug approval regulations.

The patient is wrong, and further is not qualified to make this decision for him or herself. If expirations were based on manufacturer’s wishes, they would not be measured in years; they’d be much shorter as a butt-load of money and time doing stability would be saved and there’d be no need to make drug formulations as stable as they are. Giving 5mg of a drug is simple. Making that dose still be 5mg after sitting for 6 months pr 2 years in a bathroom cabinet is the hard part.

I agree that the patient isn’t qualified to make that decision by himself, but OTOH, perhaps the FDA and DoD are?:
http://www.terrierman.com/antibiotics-WSJ.htm

still trying to find the original article, but I have read this before. Note that the testing program is ongoing as of the date of the article.

[rbroome]

@rbroome

I agree that the patient isn’t qualified to make that decision by himself, but OTOH, perhaps the FDA and DoD are?:
Antibiotics and Expiration Dates - Wall Street Journal

still trying to find the original article, but I have read this before. Note that the testing program is ongoing as of the date of the article.

This is a better (more authoritive) cite:
http://www.ama-assn.org/ama/no-index/about-ama/13652.page

[mnemosyne]

As I’ve said many times, it’s not a time bomb, and clearly if something passes assay criteria after 3 years of stability (that’s generally 100% of label +/- 2.0%, IIRC?) then there’s lots of reason to believe that it’s going to stay within that range for considerable time more. On the other hand, I have tested things with impurity criteria that were something like no more than 0.5% of some degradation product, and on day 1 it’s at 0.001% and after 3 years it’s at 0.35% or somesuch. How to predict when it hits that 0.5% mark? Just like you know your milk is still drinkable a day or two after it’s “best before” or expiry date, but there’s nothing to say exactly when it will turn bad, you know?

The stability protocols don’t require more than what is currently done, and these things are pretty much internationally agreed upon. If the FDA, TPD, etc want to change and extend the requirements in order to have longer expiration dates and longer shelf lives, they are free to do so (provided the stability data supports it), but then we’d simply be asking if the drugs are safe after 5 years instead of after 3. Consumers will still question it, without thinking about where the date on the package actually comes from.

Of course manufacturers want to make a profit, of course they want to have a drug on the shelves for less time so they can sell more…but also, of course, they want that drug to stay safe over it’s shelf life, because the fallout from a recall can be damaging. And so the dates on the packages reflect both the balance of safety and the balance of profit.

The point, though, is that stability past what is currently required by regulatory bodies simply isn’t being tested. Why would a manufacturer test more than is required by law? No matter how long the FDA changed these requirements to, the fact is there would still be no data whatsoever to support stability beyond the end of the required protocol length. Aspirin could be proven to be stable for 30 years…there would be no data to support whether it’s stable for 31.

And your own cite mentions testing of the military stockpiles, and says that while “many” of the products were stable longer than labelled, many were not, even when stored under optimal conditions, which pretty much never happens in pharmacies or patient homes. Temperature variations, humidity variations, etc will cause unpredictable effects on stability and degradation.

So at the end of all this, you’re back where you started. Some drugs could have a longer shelf life, some might not, and that data is collected according to internationally recognized regulations. A day after that, though, no data exists, and someone will still be asking this question on a message board.

[rbroome]

@rbroome

I agree that the patient isn’t qualified to make that decision by himself, but OTOH, perhaps the FDA and DoD are?:
Antibiotics and Expiration Dates - Wall Street Journal

still trying to find the original article, but I have read this before. Note that the testing program is ongoing as of the date of the article.

@mnemosyne

As I’ve said many times, it’s not a time bomb, and clearly if something passes assay criteria after 3 years of stability (that’s generally 100% of label +/- 2.0%, IIRC?) then there’s lots of reason to believe that it’s going to stay within that range for considerable time more. On the other hand, I have tested things with impurity criteria that were something like no more than 0.5% of some degradation product, and on day 1 it’s at 0.001% and after 3 years it’s at 0.35% or somesuch. How to predict when it hits that 0.5% mark? Just like you know your milk is still drinkable a day or two after it’s “best before” or expiry date, but there’s nothing to say exactly when it will turn bad, you know?

The stability protocols don’t require more than what is currently done, and these things are pretty much internationally agreed upon. If the FDA, TPD, etc want to change and extend the requirements in order to have longer expiration dates and longer shelf lives, they are free to do so (provided the stability data supports it), but then we’d simply be asking if the drugs are safe after 5 years instead of after 3. Consumers will still question it, without thinking about where the date on the package actually comes from.

Of course manufacturers want to make a profit, of course they want to have a drug on the shelves for less time so they can sell more…but also, of course, they want that drug to stay safe over it’s shelf life, because the fallout from a recall can be damaging. And so the dates on the packages reflect both the balance of safety and the balance of profit.

The point, though, is that stability past what is currently required by regulatory bodies simply isn’t being tested. Why would a manufacturer test more than is required by law? No matter how long the FDA changed these requirements to, the fact is there would still be no data whatsoever to support stability beyond the end of the required protocol length. Aspirin could be proven to be stable for 30 years…there would be no data to support whether it’s stable for 31.

And your own cite mentions testing of the military stockpiles, and says that while “many” of the products were stable longer than labelled, many were not, even when stored under optimal conditions, which pretty much never happens in pharmacies or patient homes. Temperature variations, humidity variations, etc will cause unpredictable effects on stability and degradation.

So at the end of all this, you’re back where you started. Some drugs could have a longer shelf life, some might not, and that data is collected according to internationally recognized regulations. A day after that, though, no data exists, and someone will still be asking this question on a message board.

good points. thanks