Gave experimental UK drugs

[*Posh*]

I worked Wed & Thurs 12's. I had a pt that had meds ordered that I had no clue what they were for. She and her husband insist they be given at exactly 9, 15, & 18. Not during the allotted 30 min before/after time we have. There's even an order stating this now. Anyway, I have to crush the pills because she has a peg and give them along with her other meds. I find out from her husband that one is to stabilize b/p (hypo or hyper) and the other is for Parkinson's. That's all I could learn. The drugs are experimental in the UK where they have to order them from. Of course, I kept missing the pharmacist to talk to him about it and sitting down to actually look online to find out is laughable. I really don't know what question I want to ask here, but I feel weirdly uncomfortable with this. Not just because I don't know anything about it, but also because of the status of the drugs in the UK & US. The husband dolls them out to the pharmacist a few at a time and he places them in rx bottles marked "home meds". Thoughts?

[MunoRN, RN]

This question came up where I work, our pharmacist didn't know the answer so we went to our state's BON. We had patient who was taking multiple drugs she mail ordered from Canada and Europe. One of the drugs was in clinical trials in the US and the BON said this one was an absolute no-no for us to give since the use of drugs in clinical trials is highly regulated. Giving it without being part of the trial when the patient did not qualify for the exemption (terminal illness with no other options) was considered a Federal Felony and the BON stated they would have little choice but to take away the license of a nurse who was guilty of a Felony related to med administration.

The BON said that drugs that weren't approved by, or in trials by the FDA were a little less clear, but that giving these drugs, even with an MD order, could potentially put your license in jeapordy as was probably not worth the risk.

I would hope your pharmacist is not approving "home meds" without them being identified (by med name and dose), and therefore should be aware of the status of the Drug in the US.

[caroladybelle, BSN, RN]

You are crushing meds that you have no knowledge about. If they are hazardous, that could pose danger to others through aerosolization.

This situation needs to be clarified quickly.

[*Posh*]

We have the drug name and dose info. But one of the concerns I had was about crushing them. I found out that the patient is enrolled in a clinical trial for one of the drugs in the UK. The other one is just recommended by her neurologist. I'm definitely going to say something tomorrow when I go back to work. Even if she's been discharged, this is something that needs to be clarified before the nurses are put into this situation again. Thanks, guys! I wanted to make sure I wasn't overreacting. I've just started this job and just on my 2nd week off orientation so didn't want to make waves for nothing!

[Boog'sCRRN246, RN]

It seems like it's a little too easy to administer home meds where you work. At my facility, in order for us to give home meds, the physician has to write an order stating it's okay to continue patient's own meds, then the meds have to be taken from the patient, sent down to pharmacy with a form for verification, then returned to the patient specific drawer in the Pyxis for administration. This prevents the patient from self-medicating (as long as they're honest). There's no way a patient (or patient's family member) would be "doling out pills a few at a time" to the pharmacist.

[Rob72, ASN, RN]

We have the drug name and dose info. But one of the concerns I had was about crushing them. I found out that the patient is enrolled in a clinical trial for one of the drugs in the UK.

Okay, from a Research Coord/RN- if they are not approved in the US, your pharmacy (and you) should not be handling them. If they are investigational, the physcian/Investigator in GB needs to be contacted, and a copy of the protocol needs to come across the pond to your attending, along with a copy of the consent.

"Investigational" means an incomplete profile. The company is unsure of the safety, efficacy and or interactions with the meds, more so with them being crushed.

The Code of Fed Regulations basically dictates that you cannot administer investigational products without approval and training, along with criteria for reporting adverse events. Your State Board of Pharmacy definitely has a statement to that effect.

[Rob72, ASN, RN]

Working in research:

Neither you nor the pharmacist(s) should be handling or administering the investigational med. CFR (Code of Fed Regulations) is very clear- without a protocol, approval, training and a mechanism for reporting adverse events, you cannot dispense or administer investigational meds (this does not include indicated "off-lable" prescribing). Your State Board of Pharm will have a similar statement.

"Investigational" means that there is an undefine drug profile, in safety, efficacy, and/or interaction(s). This is exacerbated by crushing the med, as that would not appear to be an intended dosing profile, increasing chances of toxicity and/or altered metabolism.

Don't.

[Rob72, ASN, RN]

Double-tap....

[NurseVoldemort, BSN, RN]

It seems like it's a little too easy to administer home meds where you work. At my facility in order for us to give home meds, the physician has to write an order stating it's okay to continue patient's own meds, then the meds have to be taken from the patient, sent down to pharmacy with a form for verification, then returned to the patient specific drawer in the Pyxis for administration. This prevents the patient from self-medicating (as long as they're honest). There's no way a patient (or patient's family member) would be "doling out pills a few at a time" to the pharmacist.[/quote']

That's exactly how we do it too!