Anyone mixing antigens for allergy drops?
- 0Jun 5, '11 by allergyrnI have been working as an allergy nurse for 3 months and have been asked to train in mixing serums myself for allergy drop therapy. Right now, I mainly do pt education for the drops, order, deliver, etc. along with PFT's. I will soon be doing the skin testing and will prepare the antigen serum myself. If this were just for injections, I would not be apprehensive, but since the drops are "off label" I'm wondering if it's within my scope of practice to compound and deliver? I've tried finding info online on specific regulations and can't really find anything that states that RNs are allowed to mix for drops. Anyone doing this already??
- 0Jun 5, '11 by MunoRNYou would need to confirm that this OK with your BON before doing this since it seems unlikely to me that you can do this. My impression is that only pharmacists can do custom compounding of allergen extracts, whether it's a shot or sublingual.
I'm not sure these extracts are really 'off-label' since they are FDA regulated as category 3B drugs, for both SQ and SL use, although each type of extract is approved separately so maybe you are using unapproved extracts?. Using them for another purpose than allergen tolerance would be an off label use.
- 0Jun 6, '11 by allergyrnThanks everyone...I do know that RN's can mix the allergens if they are for injections. They are not FDA approved d/t the route of administration. They are in the 3rd stage of FDA approval. I will try to contact someone from Pharmacy, the BON in FL takes absolutely forever to return any calls.
- 0Jun 6, '11 by MunoRNIf it's in phase 3 of clinical trials then you can't even give it unless the prescribing MD and the patient are included in one of the phase 3 trials. Being in a phase 3 trial hardly makes use of a drug a free-for-all, in fact there are usually much more stringent and specific rules about preparation and use of the drug.
The only difference off-label vs on-label use makes is in terms of marketing the drug, there are plenty of off-label uses for many drugs, although that doesn't mean that the same rules don't apply in terms of it's handling and use regardless of the route, it's still the same drug.Last edit by MunoRN on Jun 6, '11
- 0Jun 6, '11 by allergyrnI'm not exactly sure what the phases entail, but we do prescribe for pts who are not in clinical trials. One of our pts is actually a pharmacist and said that it didn't really matter. Right now, the pt signs a consent acknowledging that it's 'off-label' and then the physician signs the script. It is sent into a pharmacy and they ship it to us. The pharmacy will actually provide training to me on mixing (as long as we order supplies from them). The regulations on mixing for injectable form states that even an MA can do it, as long as they are properly trained. One of the physicians attended an aaoa course last year on SLIT therapy and they recommend employing an RN to oversee (hence, my position). There are no exact guidelines on mixing for SLIT since it is not widely used in the U.S. That's where the difficulty in finding info comes in.
- 0Jun 6, '11 by MunoRNMaybe it's different with allergy extracts, but access to investigational drugs is pretty limited.
"To authorize these expanded access treatment uses, FDA generally must be satisfied that the patient’s serious or immediately life-threatening disease or condition has no satisfactory approved therapy; that the potential benefit for the patient justifies the potential risks".
I'm not sure that allergy drops would fit this requirement in most cases, unless the allergy poses an immediate life threatening risk, although in that case there is an "alternative therapy" available which is monitored de-sensitization, which is a better option in that case anyway since allergy drops can take weeks, months or years to have significant effect.
Compounding and giving allergy antigens might be OK, but I'd make sure you confirm that completely before doing so given the circumstances.Last edit by MunoRN on Jun 6, '11