Hospitals forced to discard scarce drugs?

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http://vitals.msnbc.msn.com/_news/20...h-scarce-drugs

Thoughts?

Yes, we've brought it up at this week's staff meeting in the hospital I am on clerkships for administration. CMS will not accept storage/stability from otherwise trusted drug references.

And I believe in the latest ISMP newsletter, there is a push for one patient, one vial. And considering because of the drug shortages, many drugs are only available in multidose units.

What a load of BS. I triple dog dare CMS to come and cite a facility for this. The government needs to pull its head out of its ass.

They are totally stuck between a rock and a hardplace and it's going to take 1 person getting hurt with out of date drugs being even remotely responsible and there will be hell to pay on all ends. so in the end, YAY CAPITALISM!

Sucks, but I understand both sides of the argument. Most beyond use dating is based off of old data, but what else are we supposed to do? If we start overstepping our bounds and using out of date medications we are putting our licenses at risk.

Originally Posted by npage148

They are totally stuck between a rock and a hardplace and it's going to take 1 person getting hurt with out of date drugs being even remotely responsible and there will be hell to pay on all ends. so in the end, YAY CAPITALISM!

Originally Posted by kvl1027

Sucks, but I understand both sides of the argument. Most beyond use dating is based off of old data, but what else are we supposed to do? If we start overstepping our bounds and using out of date medications we are putting our licenses at risk.

I don't understand both sides. How many drugs are actually dangerous past their expiration date vs less potent? Where do these beyond-use dates even come from? A drug isn't going to turn into a pumpkin after 30 days out of the fridge. Why aren't things labeled for 53 days or 17.72 hours? What makes a single-dose PF vial turn bad after 24 hours? If I had to choose between getting potentially less potent chemo or no chemo, I would obviously choose the chemo. How would you prove harm in a lawsuit? Get the consent of the patient, let them be part of the decision process. It's part of the benefit risk analysis made with literally every drug you put in your body every time. Where did this drug come from? Was in manufactured properly? Transported and stored properly, prepared aseptically? Is the pump working right, did the nurse swab the site correctly? Is the port-a-cath clear of contaminants? There are hundreds of potential risks in the pathway and I don't see why this is more of a risk than all of those other things. Manufacturers are no help at all in this either.

We have used things beyond their expiration date with approval from P&T. If there is no alternative and no other treatment, what are you going to do?

Originally Posted by spacecowgirl

I don't understand both sides. How many drugs are actually dangerous past their expiration date vs less potent? Where do these beyond-use dates even come from? A drug isn't going to turn into a pumpkin after 30 days out of the fridge. Why aren't things labeled for 53 days or 17.72 hours? What makes a single-dose PF vial turn bad after 24 hours? If I had to choose between getting potentially less potent chemo or no chemo, I would obviously choose the chemo. How would you prove harm in a lawsuit? Get the consent of the patient, let them be part of the decision process. It's part of the benefit risk analysis made with literally every drug you put in your body every time. Where did this drug come from? Was in manufactured properly? Transported and stored properly, prepared aseptically? Is the pump working right, did the nurse swab the site correctly? Is the port-a-cath clear of contaminants? There are hundreds of potential risks in the pathway and I don't see why this is more of a risk than all of those other things. Manufacturers are no help at all in this either.

We have used things beyond their expiration date with approval from P&T. If there is no alternative and no other treatment, what are you going to do?

I agree. The patient should be given the choice. As long as all the information is given to them and they understand, what's the problem? A drug with 90% potency versus no drug? This is common sense.
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Where do we draw the line on when to not give a drug, if not the expiration date/beyond use date?

There is actually an FDA study commissioned by the DOD to study extended stability in drugs. Turns out the army didn't want to throw away perfectly good doses that have been sitting in storage. Focus was mostly PO though, haven't looked at it in a while.

Originally Posted by owlegrad

Where do we draw the line on when to not give a drug, if not the expiration date/beyond use date?

When it become available again. At least that's what we're doing for some single use injectable products.

Originally Posted by rxlea

I agree. The patient should be given the choice. As long as all the information is given to them and they understand, what's the problem? A drug with 90% potency versus no drug? This is common sense.
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For one thing, some drugs form toxic compounds when broken down in the storage form. So that's an issue.

I think the pharmacist is right to throw them away. The NUMBER ONE RULE of pharmacy is ALWAYS PROTECT YOUR LICENSE. Dispensing knowingly expired drugs that is against the law is NOT protecting your license.

Originally Posted by Carboxide

For one thing, some drugs form toxic compounds when broken down in the storage form. So that's an issue.

But those are pretty few and far between. Aside from the tetracyclines, I'm not aware of any.

Even without direct toxicity, it can be problematic since you're not making a completely informed decision. If you know one drug is far superior to another, you'd use the superior one. Now what if that superior one is expired? Is it still superior, or does the loss of potency tip the scale so that you should use the other one?

Spacecowgirl mentions the risk/benefit analysis. Does the same conclusion to that analysis at 100% potency still hold true at 80%? Does the efficacy drop, while ADRs remain the same? At what point do we stop and say that it is more harmful than good? The fact is we cannot answer these questions right now, and we can't take a guess while we claim to practice evidence based medicine.

Originally Posted by Carboxide

For one thing, some drugs form toxic compounds when broken down in the storage form. So that's an issue.

I think the pharmacist is right to throw them away. The NUMBER ONE RULE of pharmacy is ALWAYS PROTECT YOUR LICENSE. Dispensing knowingly expired drugs that is against the law is NOT protecting your license.

I'm certain that a practicing pharmacist would know which are safe and which are not. I get that part. But as others have mentioned, what's the harm giving it a month or two after the expiration date? It's a tough situation and I believe it is within our scope to be a part of those decisions with the best interest of the patient in mind. In a hospital setting, you're not going to be the only one involved in the decision...so I'm not sure the fear of lost license has basis. As long as the patient is aware and agrees, I can't see us denying a life saving therapy.


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Originally Posted by rxlea

I'm certain that a practicing pharmacist would know which are safe and which are not. I get that part. But as others have mentioned, what's the harm giving it a month or two after the expiration date? It's a tough situation and I believe it is within our scope to be a part of those decisions with the best interest of the patient in mind. In a hospital setting, you're not going to be the only one involved in the decision...so I'm not sure the fear of lost license has basis. As long as the patient is aware and agrees, I can't see us denying a life saving therapy.


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Any time you knowingly violate state laws - within company policy or outside of them - your license is at risk. If someone died because a drug was improperly used or was seriously injured, your license would be gone so fast you wouldn't even get to kiss it goodbye.

You only get one license. One. Once it's gone, it's gone forever. My goal: to not **** that up.

Originally Posted by rxlea

I'm certain that a practicing pharmacist would know which are safe and which are not. I get that part. But as others have mentioned, what's the harm giving it a month or two after the expiration date? It's a tough situation and I believe it is within our scope to be a part of those decisions with the best interest of the patient in mind. In a hospital setting, you're not going to be the only one involved in the decision...so I'm not sure the fear of lost license has basis. As long as the patient is aware and agrees, I can't see us denying a life saving therapy.


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Oh, I don't know. I'm a practicing pharmacist and I couldn't tell you whether specific drugs are safe past their expiration date because there is no data about it. Some things I know aren't safe. Most things, we're somewhat guessing.

I don't advise patients to take expired drugs. Ever. But I work outpatient and we are not talking about chemo or other lifesaving scarce drugs. That makes it easier for me.

What would hold up best in court or in a hearing with the Board of Pharmacy? Hard to say, isn't it? Anything we do something outside of established practice, we're taking a risk.

Originally Posted by All4MyDaughter

Oh, I don't know. I'm a practicing pharmacist and I couldn't tell you whether specific drugs are safe past their expiration date because there is no data about it. Some things I know aren't safe. Most things, we're somewhat guessing.

I don't advise patients to take expired drugs. Ever. But I work outpatient and we are not talking about chemo or other lifesaving scarce drugs. That makes it easier for me.

What would hold up best in court or in a hearing with the Board of Pharmacy? Hard to say, isn't it? Anything we do something outside of established practice, we're taking a risk.

I'm not talking about doxycycline here. I'm talking about things like chemo. I know theres no data. We've done many things procedure wise at my institution where there is zero data. Zippo. I'm just wondering, how much does one day, one week, one month make a difference? Maybe there should be data. I realize it's your ass on the line and that scares me but what if a patient releases the institution from liability? Just a thought. I realize that being a student and not in the hot seat makes my view limited but I'm just thinking to myself...if I wad that patient, wouldI take the week or month old chemo if I'd die otherwise. yep I would...


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Im a little confused here. why are hospitals forced to throw drugs away?

The drugs start the 24 hr expiration once opened even then they are good 7 to 14 days if properly prepared andrefrigerated. or dont prepare until ready to use. If pharmacy and oncology work togeher to schedule the patients accordingly to correctly stagger the patients and batch the meds, wastage can be minimized.

This article seems nothing more than a sensatiinal journalism with lazy ass pharmacy crying foul. Sorry.....stewardship to optimize reaource is why we get paid the big dollars.

Originally Posted by Carboxide

For one thing, some drugs form toxic compounds when broken down in the storage form. So that's an issue.

I think the pharmacist is right to throw them away. The NUMBER ONE RULE of pharmacy is ALWAYS PROTECT YOUR LICENSE. Dispensing knowingly expired drugs that is against the law is NOT protecting your license.

My #1 rule is to act in the best interest of the patient. Any time I would give out a "loaner" drug in the retail world, I'm doing something that's not exactly within the scope of the laws but is in the best interest of the patient. When you get out and practice, you'll see that things are not so black and white.

Originally Posted by Ackj

But those are pretty few and far between. Aside from the tetracyclines, I'm not aware of any.

The fact is we cannot answer these questions right now, and we can't take a guess while we claim to practice evidence based medicine.

Aspirin turns into zit treatment.

I kind of have to laugh about evidence-based medicine. Plenty of things we do are not EBM.

Originally Posted by All4MyDaughter

Oh, I don't know. I'm a practicing pharmacist and I couldn't tell you whether specific drugs are safe past their expiration date because there is no data about it. Some things I know aren't safe. Most things, we're somewhat guessing.
I don't advise patients to take expired drugs. Ever. But I work outpatient and we are not talking about chemo or other lifesaving scarce drugs. That makes it easier for me.

What would hold up best in court or in a hearing with the Board of Pharmacy? Hard to say, isn't it? Anything we do something outside of established practice, we're taking a risk.

We are guessing. And manufacturers are guessing too. I sincerely doubt they test potency at a whole bunch of time periods.

I don't tell people to take expired drugs in retail either. But like Lea said, I'm not talking about that. I'm talking about the naloxone shortage we had a year or so ago. We literally could not get a single dose of naloxone. Do you give a dose that expired based on a somewhat arbitrary date? What is the risk of that vs giving nothing because it's just sitting in your expired meds bin? What about the expired drugs given to medical missions? Is it ok to give other people "unsafe" drugs because they aren't living in the U.S.?

Originally Posted by rxlea

. We've done many things procedure wise at my institution where there is zero data. Zippo.

True story.

Or if the drugs are expiring on the shelf the inventory management sux. if theyre buying short dated drugs...use it up or transfer the inventory to a facility that needs it. drug shortage and inventory have to be proactively managed. It aint going to take care of itself.

Originally Posted by Carboxide

Any time you knowingly violate state laws - within company policy or outside of them - your license is at risk. If someone died because a drug was improperly used or was seriously injured, your license would be gone so fast you wouldn't even get to kiss it goodbye.

You only get one license. One. Once it's gone, it's gone forever. My goal: to not **** that up.

Not me. Patient care first.....then rules and provisions 2nd. Havent lost my license in 21 years.

Do pharmacists usually know when the supply of a scarce drug will be replenished?

I don't know what's going on in these other hospitals, but our supplies generally aren't expiring. We just can't get any more in to replace what we're using. I'm referring to the chemo shortages. And some of these shortages aren't coming out of nowhere. We've been trying to conserve our PF methotrexate for a couple months now. Others have been on and off shortage. Some of the regimens that contain an unavailable drug have alternatives that are equally effective that we can use. Of course this isn't the case with everything, but being aware of what's going on in the pharmacy world, communicating with other pharmacists, diligent inventory control, and evaluation of the literature for alternative dosing/regimens can help some. Working with oncologists to schedule patients getting the same drug the same day can certainly help conserve supply, and is frequently done for expensive medications anyway.

Also, patients first, license second in my world.

Originally Posted by Skawty

Do pharmacists usually know when the supply of a scarce drug will be replenished?

The wholesalers and manufacturers can give you an estimate but I generally take it with a grain of salt.