14 replies to this topic

[Applepi]

So as some of you may be aware already, there is an increasing number of medications that are in shortage due to a variety of reasons (increased demand, manufacturer delays, etc) and there has been some controversy over what pharmacists should be doing with whatever supply they do have. Some pharmacists are still following the current laws that dictate when to dispose of medications (according to manufacturer stability data) even if there is clinical evidence that says the drugs can be used for much longer. Normally I wouldn't really think too much about this, but the fact is some of these medications that are being disposed are important treatments for cancer and the like. These are potentially life-saving drugs that are being poured down the drain because some law says so. What are your thoughts??

List of drugs on shortage: http://www.fda.gov/D...s/ucm050792.htm
Article about disposal of shortage meds: http://vitals.msnbc....sh-scarce-drugs

[Sweeney]

I don't see any reason why someone couldn't purchase out of date drugs if they sign a liability waiver. I'm sure prbm will be able to give us some more insight into the situation, though, being a pharmacy lass herself.

[Applepi]

I'm in pharmacy school right now (2nd year so by no means am I an expert) but I just finished my hospital rotation where we learned that liability waivers don't mean anything. For example, my hospital site refused to allow herbal treatments to be administered regardless of whether or not the patient signed the waiver. A few years ago, they got sued by a patient who had something go wrong even though the guy signed a waiver saying he as asked for an herbal treatment, knew that he was getting it, and was aware of the possible consequences (which included his problem). The hospital had proper documentation of everything and they still ended up paying a decent amount of money.

I guess my biggest problem with this whole situation is that there are some drugs that have clinical data that says that they have a longer stability than the manufacturer dictates in the package insert. I think if pharmacists can find evidence that the drug can be used for longer than the manufacturer states, they should be allowed to do so without fear of legal ramifications (ie. legislation regarding this needs to be changed/updated/overhauled and replaced with something that healthcare providers come up with not politicians in the pocket of drug manufacturers)

[Sweeney]

Then what on earth is the point of a liability waiver?!
Your legal system (and possibly ours) is utterly ridiculous.

[Nymh]

I hope that by "some" you mean "all"

Dispensing expired medications is a liability that I am sure most pharmacies would not be willing to assume. Though when it comes to a lot of things we as the consumer have no way to know the expiration date, because that is on whatever container it came out of at the pharmacy.

I think if pharmacists can find evidence that the drug can be used for longer than the manufacturer states, they should be allowed to do so without fear of legal ramifications (ie. legislation regarding this needs to be changed/updated/overhauled and replaced with something that healthcare providers come up with not politicians in the pocket of drug manufacturers)

The problem is that because it is stated as an expiry date, no matter whether it would still be considered safe and effective, if something adverse happened and some dingbat bankrolled doctor comes and testifies that it "could" be related to the expired medication, the pharmacy could be found at fault. Not to mention the legal fees that they would have to pay just for the lawsuit itself whether they win or lose, and the negative publicity.

You said yourself that liabilities mean nothing - the longer you work in healthcare the more you will realize that this is true. If something happens people will sue regardless of previous consent. Fine print in America has become little more than a technicality that is overlooked by the consumer and often disregarded in legal cases.

I think this is something that should be handled from the top-down instead of the bottom-up.

[Applepi]

Then what on earth is the point of a liability waiver?!
Your legal system (and possibly ours) is utterly ridiculous.

Agreed X100. My understanding of the situation was that the patient pretty much argued that he wasn't adequately informed about herbal medicine. The pharmacist and documentation showing that he spent time educating the patient of what the herbal treatment was, how it was thought to work, that it wasn't an FDA approved medication for his disease, possible side effects, and even other prescription medications that would have been able to do the job amongst other things. The judge ruled that it wasn't enough... I dont really know how much more he could have told the guy. I also know that this isn't an isolated case, many hospitals have to deal with this sort of thing on a regular basis and most of them also refuse to treat with herbals regardless of any liability waivers.

I hope that by "some" you mean "all"

Dispensing expired medications is a liability that I am sure most pharmacies would not be willing to assume. Though when it comes to a lot of things we as the consumer have no way to know the expiration date, because that is on whatever container it came out of at the pharmacy.



The problem is that because it is stated as an expiry date, no matter whether it would still be considered safe and effective, if something adverse happened and some dingbat bankrolled doctor comes and testifies that it "could" be related to the expired medication, the pharmacy could be found at fault. Not to mention the legal fees that they would have to pay just for the lawsuit itself whether they win or lose, and the negative publicity.

You said yourself that liabilities mean nothing - the longer you work in healthcare the more you will realize that this is true. If something happens people will sue regardless of previous consent. Fine print in America has become little more than a technicality that is overlooked by the consumer and often disregarded in legal cases.

I think this is something that should be handled from the top-down instead of the bottom-up.

I guess I should have clarified a bit more, I'm not talking about using drugs months or years past their expiration date. I was mostly taking about some of the cancer treatments used in hospitals that have labels to discard after 2 weeks but have published data or even information in Trissels (a book of stabilities) that say that they can be used for 3-4 weeks. Of course I disagree with pharmacists trying to stretch medications in an unethical manner (read: dilute, use much much longer than any data suggests as appropriate). However I do think in light of current shortages of cancer treatments and the like there should be some sort of legislation in place that allows pharmacists to use drugs a little bit past their expiration date as long as data from legitimate sources says that stability (thus the character of the drug) is unaffected.

As for handling the problem from the "top down," I would normally agree but as stated in the article CMS (centers for medicare services) are the ones who place these sanctions on drug disposal. They need some push from the healthcare community to rethink this rule and read up on the literature that extends stability of the drugs in question. (and hopefully update the current rules)

[iargue]

I don't see any reason why someone couldn't purchase out of date drugs if they sign a liability waiver. I'm sure prbm will be able to give us some more insight into the situation, though, being a pharmacy lass herself.

In the US, the courts have determined that humans do not have the capacity to make informed situations when their health is at risk, or when faced with death. Thus it is out of their control to take unapproved medicine. Even if they sign a waver.

[Sweeney]

In the US, the courts have determined that humans do not have the capacity to make informed situations when their health is at risk, or when faced with death. Thus it is out of their control to take unapproved medicine. Even if they sign a waver.

No, they haven't. Shush, now.

Agreed X100. My understanding of the situation was that the patient pretty much argued that he wasn't adequately informed about herbal medicine. The pharmacist and documentation showing that he spent time educating the patient of what the herbal treatment was, how it was thought to work, that it wasn't an FDA approved medication for his disease, possible side effects, and even other prescription medications that would have been able to do the job amongst other things. The judge ruled that it wasn't enough... I dont really know how much more he could have told the guy. I also know that this isn't an isolated case, many hospitals have to deal with this sort of thing on a regular basis and most of them also refuse to treat with herbals regardless of any liability waivers.

The legal system desperately needs to stop pandering to the lowest common denominator in society. It's ruinous.

[Applepi]

Actually Sweeney, Argue is kinda right on this one. Especially in a hospital setting, a waiver means nothing if the patient can prove that they weren't in the right state of mind to make any decision about their health. This doesn't necessarily even have to be a life-threatening situation... doesn't matter how much information they have.

Edited by Applepi, 15 February 2012 - 01:26 PM.

[Sweeney]

Actually Sweeney, Argue is kinda right on this one. Especially in a hospital setting, a waiver means nothing if the patient can prove that they weren't in the right state of mind to make any decision about their health. This doesn't necessarily even have to be a life-threatening situation... doesn't matter how much information they have.

That's not what he said. He said "humans do not have the capacity to make decisions when their health is at risk", which is not the same as "humans may not have the capacity to make decisions if they can prove that they were not in the right frame of mind to make a decision at the time the decision was made regardless of whether their life was in danger".

[elkid27]

Expiration dates on medicine simply mean that the medication is still 90% viable. Now very rarely you have to be careful because what the medication decomposes into could be dangerous, but in all reality they picked a nice round number and said yea lets not dispense anything after it becomes 10% degraded. So I guess the question becomes how bad do you need/want the drug. If this is a life threatening condition, we have a shortage, and we have some drug thats down to 70% viability, then lets face it 70% viability is better than 0%.

Its impossible to make a blanket law affecting this though because every single medication would have to be looked at in almost all disease states. You would never want to give an antibiotic that isnt 90+% viable to a patient because then you are asking to promote for resistance. Conditions involving psych/blood thinning medications are another example where this wouldnt work. Very minute changes in drug concentrations can cause wildly different outcomes in the body. Basically any narrow therapeutic range drugs would be special cases.

The real issue that should be debated is, in situations where drug shortages occur, should companies be allowed to buy up and stockpile drugs and then charge a higher price for them. That is something that is going on now to some extent and I personally think should be illegal. Its unfortunately playing the medication world like the stock market. Looking for trends, buying up meds, and then making a profit. When the H1N1 scare happened pharmacists who saw that happen and ordered extra Tamiflu before there could have been a shortage were much better off than those who hadnt. Luckily though these pharmacists were still dispensing the drug when needed and at the regular cost, mainly because its pretty much illegal to try to mark up too much. But a company owned by Joe Soap could theoretically order up a couple hundred pallets of an electrolyte solution (I think it was a calcium one over the summer that was in a shortage) and make a nice little profit off it if he could play the pharmacy market well enough.

[Applepi]

Expiration dates on medicine simply mean that the medication is still 90% viable. Now very rarely you have to be careful because what the medication decomposes into could be dangerous, but in all reality they picked a nice round number and said yea lets not dispense anything after it becomes 10% degraded. So I guess the question becomes how bad do you need/want the drug. If this is a life threatening condition, we have a shortage, and we have some drug thats down to 70% viability, then lets face it 70% viability is better than 0%.

Its impossible to make a blanket law affecting this though because every single medication would have to be looked at in almost all disease states. You would never want to give an antibiotic that isnt 90+% viable to a patient because then you are asking to promote for resistance. Conditions involving psych/blood thinning medications are another example where this wouldnt work. Very minute changes in drug concentrations can cause wildly different outcomes in the body. Basically any narrow therapeutic range drugs would be special cases.

The real issue that should be debated is, in situations where drug shortages occur, should companies be allowed to buy up and stockpile drugs and then charge a higher price for them. That is something that is going on now to some extent and I personally think should be illegal. Its unfortunately playing the medication world like the stock market. Looking for trends, buying up meds, and then making a profit. When the H1N1 scare happened pharmacists who saw that happen and ordered extra Tamiflu before there could have been a shortage were much better off than those who hadnt. Luckily though these pharmacists were still dispensing the drug when needed and at the regular cost, mainly because its pretty much illegal to try to mark up too much. But a company owned by Joe Soap could theoretically order up a couple hundred pallets of an electrolyte solution (I think it was a calcium one over the summer that was in a shortage) and make a nice little profit off it if he could play the pharmacy market well enough.

From an economical standpoint it makes sense... as a future pharmacist, I shudder at the idea
Also, I wasn't referring to a blanket statement, just a provision that says if you can provide proof that the medication is still usable (safe and effective) after a manufacturer decided expiration date you can use it. That proof would serve as documentation that would protect the pharmacist from lawsuits (or at least help their case). This would also have to be cleared with the patient before starting said drug. However, I think most patients would welcome it if it was the difference treatment and no treatment for a possibly debilitating condition.

[luvsmyncis]

It wouldn't be practical for a retail pharmacist to dispense medication like that.
1- where I work, it is company policy to send back medications expiring within 6 months. (As in.. this is what our company wants us to do) I'm in charge of inventory and returns at my store, I don't actually do that, because that's retarded. We check our expired every month and pull 3 months out. We get nothing on medications that have already expired, but we do receive credit for sending in medication BEFORE they expire.

2 - we have no way of knowing what there will be a shortage on until we find we can't order it... when someone actually needs it. See Voltaren gel on that list? We haven't been able to get it for more than two weeks, but it wasn't added to that FDA's list until February 8th. There is no telling when this medication will come in. (Actually received 9 tubes yesterday. All sold out already) Will some come in on Thursday truck? Who knows?

3 - our pharmacists are expected to review and verify hundreds of prescriptions a day, speak to countless idiotic doctors/nurses/patients, call insurance, ring up patients, mandatory consult on all new medications, give flu shots and other immunizations, and check patient's blood pressure upon request. I swear if I told my pharmacist he had to also look up and see how long medications are good after the expiration date, he'd rip his hair out.

We typically don't have any onhands on these medications that are on back order. Usually, when there's a shortage, we are left with none before they reach their expiration date. I want to get credit on anything I can, so I send it back before it expires without knowing if there's a shortage or if there WILL BE a shortage within the next three months. But hypothetically, if we had 1 tube of Voltaren on the shelf that expired 12/11, and if the pharmacist took the time to read that it's still good for 3 months after it expires, then I'd still send it back, even though I won't get credit. Because at the end of the day, the patent isn't going to want that tube that says it expires last month. Hell, the patient wouldn't want one that says 02/12, even though that date means it's good until the end of this month. Even more, the patient doesn't want it because the box is all mashed from shipping, nevermind the tube inside is untouched. Even if you told them this was the last tube in the world. They'd claim it's not as good as the previous tube they got, and would demand a refund even if they signed a waiver before purchase. That's how people are. Ridiculous assholes. Best to just avoid this scenario and get yelled at for not having it in the first place.

I don't know if it would work in a hospital situation either. "Hello, Mrs Jones, here's an injection your 4 year old daughter desperately needs. It is my professional duty to alert you it has a manufacturer expiration date of last month, quite frankly it's the last bottle and I found it in the way back of the top shelf where no one else could see it, but if you read the tiny print on this leaflet, you'll discover it's still good despite the date. I am unable to order a new bottle because who knows when more will come in. Please sign right here to permit me to inject your only child with this expired medication that is still good." Then the patient dies of whatever and the waiver means what exactly? YOU GAVE MY DAUGHTER BAD MEDICATION! Yes, I signed whatever, but you should have known better!!!
Hospital pays the price.

The best options for these patients is to either wait until it becomes available again, or, if they cannot wait, have their doctor change the prescription to something similar that is still available. And getting the doctor to call you back is a whole other problem I just won't get into. It sucks, but that's life.

[Applepi]

I agree that its definitely not feasible in a retail setting, there's already so much stuff going on that pharmacists would probably flip a shit if this was added. I do understand where you're coming from regarding the legality of it but the idealist pharmacy student in me cringes that people can come to that level. I think a pharmacist who bends to rule to help someone (with their consent) should be applauded not shunned. And the conversation doesn't necessarily have to play out the way you said it either, with a little bit of empathy and full discretion, I feel like the patients that need the medications the most will understand that the pharmacist is just trying to help.

I think there's a little bit more room to play around in a hospital setting as there is usually a head pharmacist that does very little filling/checking meds and more research and admin type stuff such as dealing with formulary and the like (just based on comparisons between the two environments). Normally I'd agree that patients should just be switched to something else or wait but I've seen cases where Drug A IV was on shortage so hospitals switched to Drug A Oral. Then b/c the oral formulation was in such high demand there was a shortage of that so hospitals had to switch to drug B (and so on) until patients were getting suboptimal treatment because it was all that was available. Waiting it out is possible in some cases but how do you tell a mother who's 8 year old has leukemia that he needs to wait to get treatment b/c the drugs aren't available right now.

The problem is that the FDA doesn't do much in terms of foresight, when they shut down manufacturing at one company, they need to realize that this is going to cause some problems. A lot of these problems could be avoided if they make announcements sooner and find alternative ways of getting the medications before the situation becomes dire.

[elkid27]

While ideally all those are things we wish could happen they will never happen that way. The FDA is underfunded and understaffed. They are doing all they can to just keep their head above water with their current workload. And unfortunately in pharmacy school they teach you high ethics but its just not like that in the real environment. Being a retail pharmacist is a far cry from being a healthcare professional mainly because corporations dont care about treatments they care about profits. Thats the reason like punkrock was saying they pull things that will expire in 6 months. The corporation would rather be able to send it back to get some reimbursement than take the risk that it will expire and they will have to toss it.

On a lighter note if you want some good laughs look up The Angry Pharmacist. Good blog for anybody who works in a pharmacy.