Expired meds--patient query

[buckley]

Hi! I thought this would be the appropriate place to ask.

A patient of mine told me that her drug rep friend told her that it's okay to use expired meds because these dates are meant to label the drug batches and are not really "expiry" dates. I said I thought that the drug loses potency if it's expired. She asked me if it just meant losing potency or are there any toxic effects. I ended it with a "dont take chances--just buy a new steroid inhaler for your asthma" (she was complaining of several unopened steroid inhalers she had lying in the house). I hope I will have a better anser next time around, so here is me asking--I did a search and no avail, perhaps i am keying in the wrong search tags. i put "expired meds":

1. Do certain drugs expire? Or are they really just tags (which I doubt because why in the world are they called expiration dates?)

2. If there is an expiry date, is it safe to still use them (safe meaning at worst, they're just placebo)? If it's case to case, can you name which drugs are which? More importantly, which drugs should NEVER be used beyond their expiry dates?

3. I just realized I don't have basis for drugs losing their potency after the expiration date. Any help would be nice.

My patient seemed really convinced about how expiration dates are just propaganda of the drug companies. I found this very disturbing.

If these questions seem really dumb, I am sorry. I just hate the feeling of knowing I should know this but find myself being convinced by a patient, whenit should be the other way around. Thanks in advance for your help!

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[Aznfarmerboi]

Off the record, most drug's expiration dates are very conservative. You can have a drug with 90 percent potency after years pass its expiration date. The drug's potency depends on how well you stored the medication. If you store a medication inside your bathroom cabinet, next to your heater, unprotected against light, cold areas, its potency will degrade a lot faster. The basis for that is most of your drugs exisit in a polymorphic state for better absorption into your body.

A drugs expiration date can be due to many reasons from a change in potency to the looks of the medication.

To summarize it, if your friend is taking an expired cream that was taken out of the pharmacy for more than a year, it is okay. However for medications like nitroglycerin. . . I would flush it down the toilet and get a new refill.

 

[tussionex]

some drugs are toxic when outdated!
hello, tetracycline!

 

[PharmDstudent]

some drugs are toxic when outdated!
hello, tetracycline!

Fanconi Syndrome

 

[Old Timer]

First of all some facts.

• Expiration dates mean something. That's why some drugs have 3 year expiration dates and some drugs always have short expiration dates. Check out an Epi-pen the next time your at work. They always have a short expiration date as epinephrine is a heat and light sensitive compound.
• I believe the official definition of expiration date is the drug must have 90% potency at expiration date.
• The storage environment of the drug and the container it is stored in effect the expiration date.
• Some drugs are toxic after expiration date as Tussionex pointed out.
• Every time you open the container you allow air and moisture to enter and that has an effect on the stability of the drug.

So the drug rep is wrong. Expiration dates mean something. My basic rule of thumb is if you won't drink expired milk, don't take expired drugs.

 

[tussionex]

Fanconi Syndrome

 

[PharmDstudent]

Thanks! There's nothing better than positive reinforcement.

I rarely see expired meds where I work.
It was much harder to check the expiration dates of medications when I worked at a hospital. Unit-dosing is killer! (actually a lifesaver when they have barcodes).

 

[DrugDealer]

Tetracycline is the only drug I've heard of that can become toxic when degraded. In my knowldge (which is limited!!), everything else just becomes subtherapeutic. But, I've also read that the TCN cases that caused the Fanconi-like kidney problems were from the 1960s and 70s, and that newer formulations use better fillers that prevent/minimize degradation. So, I'm not sure this is really an issue anymore, but I would still never recommend taking expired TCN.

I guess you could argue that sterile preps, like eye drops, can become "toxic" and dangerous when they are old if the preservative fails and you get growth.

I think everything else just becomes less effective, although some drugs--like the oral reconstituted antibiotics--proceed to a placebo-like state much, much faster. We also learned in our med chem class that the expiration date on thyroid hormones should be considered a true expiration date due to efficacy, not toxicity, reasons. I think it's hydrolyzed pretty easy.

 

[Farmercyst]

I certainly wouldn't want to be stuck with an expired EpiPen after a bee sting or peanut allergy anaphylaxis. Expired insulin is pretty much worthless, though less life-threatening. Most biologics I would think are that way. It really depends on what the patient was referring to. You certainly don't want them thinking that it's universal even if they think it may be true for some drugs.

 

[Chiyo]

I would flush it down the toilet and get a new refill.

A little bit off topic, but we should start educating patients that flushing down unused or expired meds is not a good way of disposing drugs. There are increased concerns about prescription drugs ending up in our water supply because the water treatment systems can't filter them... NG is not as bad as say hormones/antibiotics, but I'd get in a habit of not flushing down the drugs down...

http://www.epa.gov/ppcp/basic2.html

 

[DrugDealer]

A little bit off topic, but we should start educating patients that flushing down unused or expired meds is not a good way of disposing drugs. There are increased concerns about prescription drugs ending up in our water supply because the water treatment systems can't filter them... NG is not as bad as say hormones/antibiotics, but I'd get in a habit of not flushing down the drugs down...

http://www.epa.gov/ppcp/basic2.html

I agree with you....and the FDA agrees with you....for MOST drugs. The FDA actually has a list of medications that SHOULD be flushed: http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf.

 

[Alby]

I currently work in the pharmaceutical industry (sterile injectibles), I have also worked with creams, lotions, aerosols and suspensions. Part of my job involves stability testing, which is what is used to determine the expiration date.

These dates are not just pulled out of a hat... a lot of work and studies go into determining exp dates. In fact, my company has altered expiry dates in the past due to our stability testing.

A common problem with injectibles is crystallization (esp Testosterone cypionate and Testosterone enanthate) and degradation. Some of the degradants can be toxic therefore resulting in decreased potency and increased toxicity. For example tretinoin (cream) degrades rapidly into isotretinoin upon exposure to light.

The industry standard is to use ICH guidelines in stability testing and determination; the FDA monitors this stability testing very closely. The ICH states that "Stability studies should include testing of those attributes of the drug product that are suscpetible to change during storage and are likely to influence quality, safety and/or efficacy." The drug products are evaluated under storage conditions that test its termal stability, sensitivity to moisture or potential for solvent loss. These studies take into account storage, shipment and subsequent use.

The products are tested for the following (in general):

• A significant change (5-10% usually) in assay from its initial value, or failure to meet the acceptance criteria for potency when using biological or immunological procedures.
• Any degradation product's exceeding its acceptance criterion.
• Failure to meet the acceptance criteria for appearance, physical attributes, and functionality test (e.g. color, phase separation, resuspendibility, caking, hardness, dose delivery per actuation).
• Failure to meet the acceptance criterion for pH.
• Failure to meet the acceptance criteria for dissolution for 12 dosage units.

See ICH Harmonised Tripartite Guideline: Evaluation for Stability Data, Q1E for more information...


I hope you are all still awake

 

[confettiflyer]

Expired insulin is pretty much worthless, though less life-threatening.

Try telling that to a type 1 diabetic who starts seeing spots because of bum insulin

 

[SoccerCoach10]

I currently work in the pharmaceutical industry (sterile injectibles), I have also worked with creams, lotions, aerosols and suspensions. Part of my job involves stability testing, which is what is used to determine the expiration date.

These dates are not just pulled out of a hat... a lot of work and studies go into determining exp dates. In fact, my company has altered expiry dates in the past due to our stability testing.

A common problem with injectibles is crystallization (esp Testosterone cypionate and Testosterone enanthate) and degradation. Some of the degradants can be toxic therefore resulting in decreased potency and increased toxicity. For example tretinoin (cream) degrades rapidly into isotretinoin upon exposure to light.

The industry standard is to use ICH guidelines in stability testing and determination; the FDA monitors this stability testing very closely. The ICH states that "Stability studies should include testing of those attributes of the drug product that are suscpetible to change during storage and are likely to influence quality, safety and/or efficacy." The drug products are evaluated under storage conditions that test its termal stability, sensitivity to moisture or potential for solvent loss. These studies take into account storage, shipment and subsequent use.

The products are tested for the following (in general):

• A significant change (5-10% usually) in assay from its initial value, or failure to meet the acceptance criteria for potency when using biological or immunological procedures.
• Any degradation product's exceeding its acceptance criterion.
• Failure to meet the acceptance criteria for appearance, physical attributes, and functionality test (e.g. color, phase separation, resuspendibility, caking, hardness, dose delivery per actuation).
• Failure to meet the acceptance criterion for pH.
• Failure to meet the acceptance criteria for dissolution for 12 dosage units.

See ICH Harmonised Tripartite Guideline: Evaluation for Stability Data, Q1E for more information...


I hope you are all still awake

I also work w/ stability of hospital drugs (controlled drugs), and I agree with your post. Some drugs show very little decrease in potency years after the supposed expiration date. It's difficult though for a normal person to keep tabs on what drug is good long after the expiration date and which have a significant decrease in potency over a short amount of time. It's a better practice to NOT used expired product.

 

[buckley]

Thank you everyone for your responses I believe I did ask it at the right place after all! My patient was referring specifically to her steroid inhaler, but she proceeded to lecture me about antacids, antibiotics, etc.

It is HARD to tell which drugs are still "okay" after the expiration date. I wish they taught us this in medical school.

I did not know about the harm in flushing down the toilet. Personally, I just throw them in the trash. I open them up and then crush them in the trash. Is this bad?

 

[buckley]

Alby, is there a site where we can have access to such practical data? thanks

 

[greatdeals225]

I did not know about the harm in flushing down the toilet. Personally, I just throw them in the trash. I open them up and then crush them in the trash. Is this bad?

I think throwing them in the trash would just create problems if you have trash-pickers... especially on narcs... also I wouldn't advise a patient to throw them in the trash at home.. especially with children and pets.. I don't know who looks and fishes thru their trash! to be safe, tell them to bring them back to the pharmacy the next time they come in for their refills!

 

[txpharm2b]

I think throwing them in the trash would just create problems if you have trash-pickers... especially on narcs... also I wouldn't advise a patient to throw them in the trash at home.. especially with children and pets.. I don't know who looks and fishes thru their trash! to be safe, tell them to bring them back to the pharmacy the next time they come in for their refills!

The link DrugDealer posted (http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf) has some good info and its a quick read. There are apparently drugs the FDA is still saying to flush, but aside from that, they are now saying to toss them out with the kitty litter or coffee grounds, or something else that people would find equally obnoxious to dig through. I'm thinking chicken parts that you pull off before cooking might keep someone from thinking they've found a treasure.

 

[greatdeals225]

The link DrugDealer posted (http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf) has some good info and its a quick read. There are apparently drugs the FDA is still saying to flush, but aside from that, they are now saying to toss them out with the kitty litter or coffee grounds, or something else that people would find equally obnoxious to dig through. I'm thinking chicken parts that you pull off before cooking might keep someone from thinking they've found a treasure.

I think aged coffee would be better.. smells like someone had bad heartburn and just threw up...

 

[Quiksilver]

There is one important fact that i don't think anyone touched. The expiration date on a bottle for a drug is the expiration date of the UNOPENED product under IDEAL CONDITIONS (NOT YOUR BATHROOM, OR KITCHEN). So in reality, we may not all be conservative on expiration dates. That is why NTG is dispensed in original packaging!!! And let us not forget our friends the antibiotics, which don't seem to last much longer then elliot spitzer on one of his stays in washington (ba-bam).

Currently the practice in NY says that expiration date is one year after dispensing unless noted otherwise. It makes sense, don't want to get sued? Stick to that date i guess.

 

[Pianopooh]

At my pharmacy if the drug is going to expire in the year we're in, we write the month/year on the bottle. About two months before the bottle will expire we pull it off shelves and do return inventory. This applies to all medications, you wouldn't want to use expired medicines right? So why would a patient want to take expired meds. However, once dispensed they are good from one year after dispense date and this comes down to whether or not you have an awesome pharmacy or a terrible one. I wouldn't use bottles that are going to expire this year knowing the patient wouldn't use up the medication in time, but at floating pharmacies I've been in they don't care so, it really depends with your store.

 

[FallingStar1717]

There is one important fact that i don't think anyone touched. The expiration date on a bottle for a drug is the expiration date of the UNOPENED product under IDEAL CONDITIONS (NOT YOUR BATHROOM, OR KITCHEN). So in reality, we may not all be conservative on expiration dates. That is why NTG is dispensed in original packaging!!! And let us not forget our friends the antibiotics, which don't seem to last much longer then elliot spitzer on one of his stays in washington (ba-bam).

Currently the practice in NY says that expiration date is one year after dispensing unless noted otherwise. It makes sense, don't want to get sued? Stick to that date i guess.

I disagree. I work in the pharmaceutical industry doing validation work and they always give us expired material to test. In my experience, the potency values of most compounds don't go down that much. More significantly, impurity values don't increase a lot and therefore the drug won't become harmful. FDA and pharm companies build in huge safeguards on their tox testing. If the FDA says the harmful limit is say 1% the pharm company is going to set their allowable sepc at half that. So its going to take a lot of deg to get to harmful levels. And antibiotics (at least pen/cef) are some of the most stable I've come across. I'm talking YEARS-unless you dunk them in acid or bleach or something.

That being said, I still wouldnt take expired drugs. Maybe a few months but that's about it. My knowledge only extends to a handful of products, its impossible to know enough about everything to make it safe.

 

[Farmercyst]

Try telling that to a type 1 diabetic who starts seeing spots because of bum insulin

Sorry, I should have clarified. I was going based on the need of an EpiPen being more of an urgent nature vs insulin injections generally being timed and not emergency use only.

 

[Norm66]

after the expiration date? I know of someone that may have used 5+ yr old allergy drops (BAK) in their eye. Now that eye has been red, burning, itching. He has been to Dr's that say it just becomes less potent, but I have to wonder. Thanks for any advice in the matter that might help him. It's caused him much anxiety.

 

[Praziquantel86]

after the expiration date? I know of someone that may have used 5+ yr old allergy drops (BAK) in their eye. Now that eye has been red, burning, itching. He has been to Dr's that say it just becomes less potent, but I have to wonder. Thanks for any advice in the matter that might help him. It's caused him much anxiety.

The red, burning, itching feeling is allergies. Hence, the eyedrops.

Not the place for medical advice.

 

[FarscapeGirl]

I'm currently in a biology lab, and we use a lot of stuff after their expiration dates. We've found that even kits where things are only supposed to be used through one freeze-thaw cycle are still fine after two. Some things with expiration dates are absolutely ridiculous, like certain solutions. I can see them being contaminated after being opened, but sterile salt solutions should still be sterile and salt solutions after their expiration dates if they're not opened.

After being in labs for almost a decade now, I can tell you that I honestly believe companies are way conservative with their expiration dates, in part so you'll buy more things. I imagine that pharmaceutical companies are rather conservative on their end for expiration dates, both for safety and to encourage people to re-buy compounds.

For that reason, I usually use OTC pain medicines and allergy medication even if it's a little past its expiration date. If it doesn't work, it'll just be like not taking it, which is certainly far from life-threatening. However, for something like an Epi-Pen, antibiotics, and insulin, I'd definitely not use it after the expiration date.

 

[confettiflyer]

I'm currently in a biology lab, and we use a lot of stuff after their expiration dates. We've found that even kits where things are only supposed to be used through one freeze-thaw cycle are still fine after two. Some things with expiration dates are absolutely ridiculous, like certain solutions. I can see them being contaminated after being opened, but sterile salt solutions should still be sterile and salt solutions after their expiration dates if they're not opened.

After being in labs for almost a decade now, I can tell you that I honestly believe companies are way conservative with their expiration dates, in part so you'll buy more things. I imagine that pharmaceutical companies are rather conservative on their end for expiration dates, both for safety and to encourage people to re-buy compounds.

For that reason, I usually use OTC pain medicines and allergy medication even if it's a little past its expiration date. If it doesn't work, it'll just be like not taking it, which is certainly far from life-threatening. However, for something like an Epi-Pen, antibiotics, and insulin, I'd definitely not use it after the expiration date.

Add in any ophthalmic solutions for me. I'll use up to the expiry date for sealed solutions and once it's open, 30 days and it's out for me (ie contact lens fluid).

I guess I didn't post in this thread before...but the DoD contracted with the FDA to do a study on drugs they've been keeping in the desert (135+ degrees F) that were about to expire. Turns out, stuff approaching 18 years past expiration were still 90%+ potent. I'm too lazy to dig it out, but it's pretty easy to find. Saved the DoD tons of $$$. I was in charge of creating a quasi-triage formulary for the free clinic I was at last semester and one of the things I had to do was figure out when to throw things out, I cited that study to back up my decision.

We settled on 3 years past expiration, 5 if it was something we couldn't get readily, sealed liquids got 1 year past expiration. Reformulated items (we had old TriCor) were immediately tossed. Another thing I saw was that the literature was likely to be modified, hence why you'd want consumers throwing out drugs after 3-4 years anyway. One example in my head is Tylenol and recent recommendation changes for peds, if you have APAP that's 4 years old, it may not reflect current recommended doses.

 

[catalyzt]

Pardon me for bringing this zombie thread back from the dead, but I ran across this (very small) study that I thought was interesting and other might be interested as well:

Stability of Active Ingredients in Long-Expired Prescription Medications
Stability of Active Ingredients in Long-Expired Prescription Medications

'Eight long-expired medications with 15 different active ingredients were discovered in a retail pharmacy in their original, unopened containers. All had expired 28 to 40 years prior to analysis...In our data set, 12 of 14 medications retained full potency for at least 336 months, and 8 of these for at least 480 months.'

The citation for the study is:

Arch Intern Med. 2012;172(21):1685-1687. doi:10.1001/archinternmed.2012.4501.

 

[zelman]

Pardon me for bringing this zombie thread back from the dead, but I ran across this (very small) study that I thought was interesting and other might be interested as well:

Stability of Active Ingredients in Long-Expired Prescription Medications
Stability of Active Ingredients in Long-Expired Prescription Medications

'Eight long-expired medications with 15 different active ingredients were discovered in a retail pharmacy in their original, unopened containers. All had expired 28 to 40 years prior to analysis...In our data set, 12 of 14 medications retained full potency for at least 336 months, and 8 of these for at least 480 months.'

The citation for the study is:

Arch Intern Med. 2012;172(21):1685-1687. doi:10.1001/archinternmed.2012.4501.

It’s pretty obvious that the amounts remaining are somewhat meaningless without knowing the starting values. Unless methaqualone expires by reproducing, that could be a small percentage of its initial potency. The chlorpheniramine in that combo product is at over triple where it was supposed to have started, so I don’t trust the manufacturing standards.

 

[beautifulrobot]

It’s pretty obvious that the amounts remaining are somewhat meaningless without knowing the starting values. Unless methaqualone expires by reproducing, that could be a small percentage of its initial potency. The chlorpheniramine in that combo product is at over triple where it was supposed to have started, so I don’t trust the manufacturing standards.

Yeah, apparently the manufacturing standards were (maybe still are?) a bit looser 40 years ago. Also, I wonder if measured amount truly equals bioavailable amount. It probably is with these older drugs, but any drugs with fancy controlled release matrices or buffers may not be as straightforward.

 

[Apotheker2015]

Hi! I thought this would be the appropriate place to ask.

A patient of mine told me that her drug rep friend told her that it's okay to use expired meds because these dates are meant to label the drug batches and are not really "expiry" dates. I said I thought that the drug loses potency if it's expired. She asked me if it just meant losing potency or are there any toxic effects. I ended it with a "dont take chances--just buy a new steroid inhaler for your asthma" (she was complaining of several unopened steroid inhalers she had lying in the house). I hope I will have a better anser next time around, so here is me asking--I did a search and no avail, perhaps i am keying in the wrong search tags. i put "expired meds":

1. Do certain drugs expire? Or are they really just tags (which I doubt because why in the world are they called expiration dates?)

2. If there is an expiry date, is it safe to still use them (safe meaning at worst, they're just placebo)? If it's case to case, can you name which drugs are which? More importantly, which drugs should NEVER be used beyond their expiry dates?

3. I just realized I don't have basis for drugs losing their potency after the expiration date. Any help would be nice.

My patient seemed really convinced about how expiration dates are just propaganda of the drug companies. I found this very disturbing.

If these questions seem really dumb, I am sorry. I just hate the feeling of knowing I should know this but find myself being convinced by a patient, whenit should be the other way around. Thanks in advance for your help!

I say this respectfully, if a drug's expiration date deems the drug expired, then the drug is expired. Would you dispense an expired drug? No. Right?
Patients are always asking these things and it's annoying as hell. It's expired and you need a refill or a new prescription or better insurance if your co-pay is too high or whatever.
Don't forget that when you tell someone it is OK to take an expired drug, you are blessing that with your license. So that should be the end of that dilemma for you right there. Same when someone asks you if it's OK for their ROBUST 3 1/2 year old to take X medication whose label states "consult a physician if under 4 years old". I don't care how fat your child is. The label says no. You can call your prescriber and ask, or hey, there's always "doctor on demand".