Administration of non approved FDA drugs

Published

Is it legal for an RN to administer non FDA drugs to patients if ordered by an MD?

Sooo, this is my GREAT delima.... I am a nursing supervisor for a home health agency and have a client with a M.D. order for a drug that is not FDA approved yet, they are getting it from Canada. Is it legal for an RN to administer this drug? I am not able to find any documentation on the rules and regulations for administering non FDA approved drugs in the U.S.A. But yet I do understand that as an RN administering any medication, you are required to be able to determine if the patient is experiencing any adverse side effects and must know in detail the full spectrum of any and all adverse effects any drug may have to protect each individual patient. How is this possible if it is not FDA approved?

There are drug books that list homeopathic medications and have you tried doing a drug search?

I would be very surprised if your pharmacist could not provide you with guidance. I know at least my pharmacy provides me with info on drugs that they do not dispense.

More than once we had to consult the pharmacy for meds the patients would bring from home, usually some Ju Ju root or something.

Everytime they simply said, "Here is the info and as long as its ok with the primary, its ok with us."

Up Vote Up Vote ×
Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.

Yes the FDA defines a drug by it's intended use in the diagnosis, cure, treatment, etc., which the example you gave specifically denies that is intended for any of these purposes, meaning it is not a drug.

A drug in trials has FDA approval to be in trials, and it can be administered but only with informed consent establishing the patient is aware of the approval status of the drug.

Up Vote Up Vote ×
Specializes in home health, dialysis, others.

This is a dicey subject, and very interesting. You say you are from a home health agency - do you have people doing actual in-home shifts who administer meds to the pt.?

Many years ago, my husband took part in a drug trial, and the med really helped him. It was not yet FDA-approved, but was being sold in Canada already.

We lived in Michigan, and Windsor, Ontario was just an hour away. The doc who ran the study got my husband a letter from the FDA stating that he could bring enough of this med back from Canada for his 'personal' use.

With a letter from this doc, he made an appt w/a Canadian doc to get an Rx, took it to a local pharmacy, and got a 6 month supply. We were not stopped at the border!!!

I might be concerned if there are drugs already on the market here for whatever ails this pt. Technically, this could be looked on as an illegal drug.

Cloudy area.

Up Vote Up Vote ×
Specializes in multispecialty ICU, SICU including CV.
Being a RN vs LPN makes no difference unless your Nurse Practice Act is very very unique. What State are you in? I have many different States NPAs and SoPs, never come across administration of FDA approved vs non.

This has less to do with FDA approval than the scope of practice of the LPN. Medications in clinical trials may have effects that have not been determined yet. It requires a patient assessment to determine if and how the patient is reacting to the medication administration. In my state, LPNs can essentially not work in drug research for this reason, nor can they administer trial meds in an inpatient/outpatient setting.

Up Vote Up Vote ×
Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.

US residents are allowed to import a 90 day supply of an FDA approved drug from Canada, this includes "re-importation", and importation of drugs produced outside the US that are exported to both the US and Canada. There are also non-FDA approved drugs that have specific permission to be imported.

As a nurse, we should do what's best for the patient. I don't necessarily agree with the FDA's position that the safety and efficacy of Canadian drugs cannot be proven, Canada has their own FDA that seems to work quite well, so there shouldn't be any problem giving the drug.

That being said, if it is truly a drug and not a homeopathic or dietary supplement, it's technically illegal for that to be given in the US unless your patient is involved in a trial or has an exemption. Although I'd probably take my chances.

In my state, there is a difference between a patient self-administering a drug and an RN administering a patient's own medication to them. When a patient self-administers their own medication, they are responsible for properly identifying and administering the medication. When we give a patient a medication obtained from the patient, we need to confirm what it is because we now become responsible for the drug just as if we were giving out of our own stock. So, unless the patient as received specific FDA approval, as the above post did, it would seem that you'd be in a dicey legal position. The best scenario would be if your facility allows patients to take their own meds from their own supply, since this would remove your staff from direct liability.

Up Vote Up Vote ×

I think this whole issue could be resolved if the OP would clarify the medication in question.

Up Vote Up Vote ×
Specializes in L&D RN.

Yes very cloudy area, the med is Clobazam, used for seizure disorder in a pediatric patient. Up til now, the family has been giving it but this limits them to their daily activities and they would like the RN/LPN on duty to give it if possible. It comes from Canada, I have a local MD order to give it. Family pays out of pocket as the insurance will not cover it.

Up Vote Up Vote ×

Clobazam is a benzodiazepine derivative, TONS of info on it if you want the drug facts.

The drug has not been removed from the market, it just has not received official approval yet. It has just completed phase III clinical trials. The FD&C makes it legal for phase I clinical trial drugs to be given so it should be no problem.

Again, as I have scoured the FD&C and can find nothing that states that it is illegal to administer non FDA approved drugs. It is illegal to sell them however, not a problem since the family is providing the medication. The drug has never been deemed unsafe, just has not jumped through all the hoops so far.

Has no one ever given fish oil for cholesterol or ginseng for arthritis???

Can anyone cite exactly where it states it is illegal for a healthcare provider under the guidance of a physician to administer a non FDA approved medication?

Can anyone cite case study where a healthcare worker under a physicians guidance was cited for administering a non FDA approved medication?

So far there has been a lot of arm chair lawyering but not a lot of actual law cited.

Up Vote Up Vote ×
Specializes in L&D RN.

Exactly! Cited legal info is what I need. Thanks to all of you for your input thus far. I have a call out to our local Department of Health and they are also researching this. I will let you know when I (hopefully) get the "legal" info :)

Up Vote Up Vote ×
Yes. I work in an ALF, and quite a few residents get supplements and homeopathic "medications", none of which are FDA-approved. They're listed in the MAR with the other medications.

I once had a home health patient for whom the majority of "meds" on his MAR and ordered by the MD on the 485, were supplements and homeopathic meds.

Up Vote Up Vote ×

As far as legality, I know it was a concern on one case that I worked. A home health patient was receiving a non-FDA approved med by IV route. An IV nurse came to the home to give the med. I was told to leave the room and put nothing about the situation in my nurses notes. I asked about assessing the site and what to do if there appeared to be a problem with the site. Again, I was told that I was not to address this in my charting. I was new to nursing at the time, but very happy to leave that particular case soon. I did not agree with my employer's method of handling the situation. I might have been new to nursing but I was aware that my license was being put in jeopardy should something go wrong. Nowadays, I have enough fortitude to refuse to work in such a similar situation.

Up Vote Up Vote ×
Specializes in Psych/CD/Medical/Emp Hlth/Staff ED.
Clobazam is a benzodiazepine derivative, TONS of info on it if you want the drug facts.

The drug has not been removed from the market, it just has not received official approval yet. It has just completed phase III clinical trials. The FD&C makes it legal for phase I clinical trial drugs to be given so it should be no problem.

Again, as I have scoured the FD&C and can find nothing that states that it is illegal to administer non FDA approved drugs. It is illegal to sell them however, not a problem since the family is providing the medication. The drug has never been deemed unsafe, just has not jumped through all the hoops so far.

Has no one ever given fish oil for cholesterol or ginseng for arthritis???

Can anyone cite exactly where it states it is illegal for a healthcare provider under the guidance of a physician to administer a non FDA approved medication?

Can anyone cite case study where a healthcare worker under a physicians guidance was cited for administering a non FDA approved medication?

So far there has been a lot of arm chair lawyering but not a lot of actual law cited.

Fish oil and Ginseng are viewed differently than benzodiazepines by the FDA (for good reason). Fish oil and Ginseng are considered dietary supplements, Clobazam is a schedule IV drug. Being a controlled substance, the pharmacy your patient obtained it from must obtain a State of Hawaii Controlled Substance Registration (Hawaii Revised Statutes 329-101(f)) even though they are foreign. At least at my hospital, when administer a medication to a patient that is "patient's own" we are still considered to be dispensing/administering the medication, and dispensing a medication that was obtained illegally is a bit dicey.

The main issue here is more that the drug is considered an investigational drug by the FDA since it is currently in trials. The FDA does allow patient who are not part of the trial to be prescribed these medications, but only for patients "with serious or life threatening conditions who lack other therapeutic options". The FDA's explanation of the law can be found here:

Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs

The actual law can be found here: http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf

Up Vote Up Vote ×
+ Join the Discussion