Domperidone compounding/use in inpatient hospital

[vash1012]

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We have a doctor who wants to use domperidone that is compounded in a local pharmacy. When these patients come into our hospital, he wants to continue this. According to the FDA website, it is illegal to compound and dispense domperidone unless it is under an IND application. My question is, how/why are compounding pharmacies able to compound this if this is clearly stated to be illegal? Also, if this or similar situations have come up in other hospitals, what did your institution do about this? Our current stance is that we definitely cannot provide it for the patients and we are not currently allowing them to use their own since, by relabeling it for inpatient use, we are technically dispensing an unapproved product illegally.

Thanks!

 

[Trent Steele]

Post partum women came in droves for this stuff at a compounding pharmacy I was at... Does your institution forbid patients from bringing their own dietary supplements as well?

 

[Pharmavixen]

Where I practice, it's legal to compound prescriptions for patients who bring their scripts directly to your pharmacy, but if you want to compound and sell to another institution, that requires a manufacturer's licence.

But pharmacists can compound and dispense to individual patients because that's within our scope of practice. Like that.

Is that what you meant?

 

[vash1012]

I am specifically refer to the legality of compounding a medication that is not approved for use in humans, especially one that was withdrawn from the market for safety concerns (whether or not those concerns were valid). I can't think of any other examples of things that are compounded often that were withdrawn from the market for this reason. I called my state board of pharmacy's legal officer today and he was completely unaware that compounding pharmacies were doing this but also did not seem particularly concerned. He did state that for us to get it from a compounding pharmacy for in hospital use would require a license on their part and may subject them to FDA jurisdiction. And in response to the other question, yes, my institution restricts patients from using most dietary supplements and herbals in the hospital.

 

[spacecowgirl]

If a patient brings in a supplement we cannot identify by its markings or is not in a sealed bottle from a manufacturer we don't relabel it for inpatient use. We tell the doctor something to the effect that we cannot guarantee the safety of the product and if s/he wants a patient to use it, they are assuming all responsibility for any problems. To be honest, I don't know if that is adequate. It hardly ever comes up.

 

[owlegrad]

If a patient brings in a supplement we cannot identify by its markings or is not in a sealed bottle from a manufacturer we don't relabel it for inpatient use. We tell the doctor something to the effect that we cannot guarantee the safety of the product and if s/he wants a patient to use it, they are assuming all responsibility for any problems. To be honest, I don't know if that is adequate. It hardly ever comes up.

Yeah we do basically the same thing, but like you say it doesn't come up often. I know my pharmacists hate home meds because they figure even if it is in a bottle, it still is not always possible to know if the product inside is what the bottle claims. Is that why it has to be sealed? I admit that seems pretty strict to me. So you guys only accept new, unopened bottles?

 

[vash1012]

My place doesn't accept any herbals/supplements outside of some vitamins, period. I don't think its harsh because most of the stuff doesn't do jack diddly anyway so it really is all risk no benefit, IMO. I keep expecting someone to raise a stink about it, but no one has yet. The only one that bothers me is fish oil, as it clearly has a defined use that is beneficial. I think the whole "we can't verify the contents" thing is a crutch we use to save us the time of having to relabel things, but in reality, we spend about as much time writing orders to dc all the stuff.

 

[Pharmavixen]

I didn't realize you didn't have domperidone stateside. We've had it in Canada since 1985. I've dispensed a fair bit of it, and I'm a bit puzzled by the FDA's stance. Certainly there are nastier drugs they have approved.

 

[vash1012]

I completely agree, Pharmavixen.

 

[Pharmavixen]

That said, if you are dispensing a drug that is illegal except in certain restricted circumstances, seems that you are put into a vulnerable position, liability-wise, if a patient has a negative outcome, even if it isn't connected to the domperidone.

 

[Socrates25]

I didn't realize you didn't have domperidone stateside. We've had it in Canada since 1985. I've dispensed a fair bit of it, and I'm a bit puzzled by the FDA's stance. Certainly there are nastier drugs they have approved.

You can get domperidone in the USA, but you have to go thru a special training program and be a special "authorized prescriber" in order to write a script for it.

In med school we had a pt with extreme diabetic gastroparesis and domperidone is one of the last line of therapies used to treat it. One of our GI docs got his special license to prescribe just for this one patient.