Return and reuse of rx meds

[ZakMeister]

I know the general consensus is to NOT take sold rx behind the counter items. But let's say if you have Mrs Jones who have been a loyal customer for the last 5 years and one day she picked up Sulfacetamide drops and decided that it wasn't the right manufacturer. Would you take it back if she hasn't opened the bottle yet? How about if it was an insulin pen that she opened from the package and realized she doesn't want it?




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[Niosh]

What makes the wrong manufacturer? That's a dumb reason to return something. So is "I don't want it". I wouldn't reuse either, I might return the drops if they were cheap and just eat the cost for a good customer.

 

[ZakMeister]

What makes the wrong manufacturer? That's a dumb reason to return something. So is "I don't want it". I wouldn't reuse either, I might return the drops if they were cheap and just eat the cost for a good customer.

Wrong from the customer perspective, we see it as a "different" manufacturer. So are you saying that if there was a good reason for anything you can think of, you might consider returning it to stock for reuse? I am just not clear if it's against a Federal law and my state isn't totally clear about it. But like I said it's generally discouraged


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[Litha]

It's not allowed in my state (ID). The law says,
"Once removed from the premises from which it was dispensed, a drug or prescription device must only be accepted for return under the conditions permitted by this rule or pursuant to the Legend Drug Donation Act and rules."

Exceptions are patient's in a hospital that have received unit dose medication, or those in a facility which received deliveries that aren't accessible to patients.

For your example, a lady that takes a box of insulin pens and later wants to bring it back because it's the "wrong ones...". Technically can't verify the pens were kept in correct, temperature controlled conditions and fit to restock. That's why we couldn't take them back and dispense to another patient.

Unless she hadn't left the pharmacy area after the med had been sold. If she remained in sight, or within the immediate area, I would consider taking it back. If she left the store and went to the parking lot or wherever else, then no. Pharmacist judgement is important.

 

[zelman]

Wrong from the customer perspective, we see it as a "different" manufacturer. So are you saying that if there was a good reason for anything you can think of, you might consider returning it to stock for reuse? I am just not clear if it's against a Federal law and my state isn't totally clear about it. But like I said it's generally discouraged


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It is 100% federally illegal to dispense a product that has not been in the custody of your pharmacy since it was delivered by your wholesaler. The legal definition of "adulterated product" is "any product which may have been adulterated". If you cannot prove that the storage conditions were appropriate, then it is adulterated (even if the storage conditions were appropriate).

 

[Niosh]

My state allows it with restrictions:

657—6.15(124,126) Return of drugs and other items. For the protection of the public health and safety, prescription drugs and devices, controlled substances, and items of personal contact nature may be returned to the pharmacy for reuse or resale only as herein provided:
6.15(1) Integrity maintained. Prescription drugs and devices may be returned, exchanged, or resold only if, in the professional judgment of the pharmacist, the integrity of the prescription drug has not in any way been compromised.
6.15(2) Controlled substances. Under no circumstances shall pharmacy personnel accept from a patient or a patient’s agent any controlled substances for return, exchange, or resale except to the same patient.
6.15(3) Unit dose returns. Prescription drugs dispensed in unit dose packaging, excluding controlled substances, may be returned and reused as authorized in 657—subrule 22.1(6).
6.15(4) Personal contact items. Pharmacy personnel shall not accept for reuse or resale any items of personal contact nature that have been removed from the original package or container after sale.

I don't think federal law explicitly makes it illegal, but zelman makes a good point above about dispensing adulterated products.

I say wrong manufacturer is a dumb reason because they should all be near identical and it should be explained to the patient as such. If they still don't want that manufacturer for whatever reason, then depending on my mood and relationship with the patient I might eat the cost on the item. The integrity maintained clause above is what limits me from reusing any returned medications. If they didn't leave my pharmacy I'd probably return and reuse. If they were gone a few hours and came back same-day, I might return and reuse. If they came back the next day, it's doubtful I would return and reuse.

 

[BidingMyTime]

If they were gone a few hours and came back same-day, I might return and reuse.

Seriously? Especially capsules, remember the Tylenol deaths? Even tablets, how do you know they didn't open the bottle over some e-coli laden surface they had been cutting raw meat on, before deciding they didn't want the tablets? It might be a remote risk, but its not a risk I would take (especially considering its illegal, and this is why its illegal.)

 

[Niosh]

Seriously? Especially capsules, remember the Tylenol deaths? Even tablets, how do you know they didn't open the bottle over some e-coli laden surface they had been cutting raw meat on, before deciding they didn't want the tablets? It might be a remote risk, but its not a risk I would take (especially considering its illegal, and this is why its illegal.)

We primarily dispense sealed full bottles, so that's how I would know they have or haven't opened it. I don't want to spell out every scenario where I would or would not re-dispense. The point is use good judgement and keep the patients safe.

Illegal in Illinois?

 

[zelman]

We primarily dispense sealed full bottles, so that's how I would know they have or haven't opened it. I don't want to spell out every scenario where I would or would not re-dispense. The point is use good judgement and keep the patients safe.

Illegal in Illinois?

Illegal in the entire USA.

 

[Ackj]

We primarily dispense sealed full bottles, so that's how I would know they have or haven't opened it. I don't want to spell out every scenario where I would or would not re-dispense. The point is use good judgement and keep the patients safe.

Illegal in Illinois?

Opened or not, can you ensure the meds haven't spent the last 2 hours in a 130 degree car? It's a business issue whether or not to offer a customer a refund, but if you do accept the return, you absolutely cannot re-dispense.

 

[Dred Pirate]

Opened or not, can you ensure the meds haven't spent the last 2 hours in a 130 degree car? It's a business issue whether or not to offer a customer a refund, but if you do accept the return, you absolutely cannot re-dispense.

exactly - not worth the risk - this is the one advantage if it is a chain - at least it doesn't come out of your bottom line

 

[Niosh]

Illegal in the entire USA.

That is not what I was taught and not what my state law says. I don't believe state laws can be more lenient than federal law?

Opened or not, can you ensure the meds haven't spent the last 2 hours in a 130 degree car? It's a business issue whether or not to offer a customer a refund, but if you do accept the return, you absolutely cannot re-dispense.

If I can't then I wouldn't re-dispense.

 

[HouTX]

That is not what I was taught and not what my state law says. I don't believe state laws can be more lenient than federal law?


If I can't then I wouldn't re-dispense.

follow the stricter law! can't believe u were not taught that

 

[lord999]

Illegal in the entire USA.

I hope you pharmacists all remember that the FD&C Act still applies here. Zelman has the correct interpretation and it's straightforward. If a chain of custody cannot be objectively determined for a product that is considered a "drug" under FD&C (and you should know the nuances as a matter of pharmacy practice), that "drug" is considered to not be dispensable and is to either be sent back for destruction or destroyed right there. (Technically, you are allowed to use USP's guidelines and instrumental analysis tests on the meds to redetermine adulteration, but hardly anyone uses that criteria in the present day.)

Whether or not you just give the money back is a business decision, it's not a pharmacy practice matter. If this was Walgreens, I'd just accept it back and refund the money as it's cheaper in the long run then getting someone pissed off. BUT tell the customer that this is a one-time exception as I can't reuse this not because I don't trust you but there's this public safety act that guarantees that you and everyone else gets pure (FD&C 1906), safe (1938), and effective (Kefauver 1962) and I can't guarantee this with a return. I'm giving you the money back because I understand your situation, but I'm going to either fill out paperwork to destroy it (or destroy it in front of them).

And, you're actually responsible for the entire chain of custody due to the law originating from the time where pharmacies bought direct from manufacturers due to that adulteration problem (I'm old enough to remember when pharmacies arranged the shelves by manufacturer/wholesalers, this predates even organizing by generic or by alpha). If you're buying from some "wholesaler" that sold stuff from the back of their van (happened quite a bit in the late 1990s and early 2000s for shortage drugs, you get what you deserve if you don't have the invoice chain of custody. And you're professionally held responsible for the chain of custody, which is why most pharmacy only deal with reputable wholesalers with a indemnity clause.

Save yourself a lawsuit risk and just toss whatever comes back (unless it's controls, in which case you have to do whatever your state does or CII's where it has to be 222'ed to an approved destruction agent or 41'ed and done yourself). For my money, I have tossed drugs where the patient had left my sight but not left the store yet as one fill isn't enough to risk adulteration as a charge.

 

[Niosh]

I don't believe what I've said falls outside of the federal laws, but maybe I haven't been very clear. If I can't guarantee the integrity of a drug, I will not re-use it. And no other pharmacist should either.

Side note: I've never done it.

 

[FarmD711]

How would you guarantee the integrity if it's left the pharmacy?


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