Dispensing Immunizing Agents - NYS

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pharmalt82

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I'm looking for laws that state whether a pharmacy in NYS, persuant to an Rx, is allowed to, for example, dispense M-M-R II to patients in order for them to take it to their doctors for administration.

I'm seeing this being done for many different immunizing agents for which RPhs do not have the authority to administer but can dispense. Ex. Gardasil, Hep-B vaccines, etc. We get calls from doctors saying that they just don't stock a lot of basic vaccines. Patients are paying cash or using their insurance to get the vaccines.

The package inserts of these vaccines state storage temperature ranges that, at many times, encompass the temperature outside (ex. between 36°F to 46°F). Also, some vaccines give you a 30 to 60 minute post-reconstitution use-by time-limit. Other vaccines allow for significant time periods of high temperature excursions. This leeway is used to justify dispensing to a patient who is claiming to, as per the Rx, immediately go to the doctor after getting the vial. We're also seeing patients purchasing the appropriately sized needles and syringes. This system can easily be used to, for example, have a patient self-administer Gardasil as per the doctor's instructions.

What level of liability are we taking on here? Is this allowed? I'm trying to look for regulations that support or disallow this practice.
 
I don't think there are any regulations concerning this practice. I don't think we'd be liable given appropriate counseling takes place (as is legally required in NY, and you ALWAYS do, right?).
 
Okay, so let's assume that this practice is legal. Then, the only thing we have to worry about is appropriate counseling and restrictions regarding storage?
Do we simply have to look at each package insert or an appropriate table for each vaccine for storage restrictions?
Is self-administration of something like Gardasil by a patient legal? What if a sig written by a doctor clearly states self-administration? Do we still type this on the label and just look the other way?
 
Why wouldn't this be ok? It is very standard practice.

Really? Dispensing temperature controlled vaccines to patients for office use is standard?

No sir. What would you even dispense the vaccine in that would maintain the correct temperature? Anyways, a patient cannot be trusted with the transport of temperature controlled vaccines. If a doctor wants to administer a certain vaccine at their office they need to order it from their vendor. Jesus Christ people. Get your **** together.
 
Really? Dispensing temperature controlled vaccines to patients for office use is standard?

No sir. What would you even dispense the vaccine in that would maintain the correct temperature? Anyways, a patient cannot be trusted with the transport of temperature controlled vaccines. If a doctor wants to administer a certain vaccine at their office they need to order it from their vendor. Jesus Christ people. Get your **** together.

Do you trust patients to take a package of Vivotif Berna home and put it in the fridge?
 
Do you trust patients to take a package of Vivotif Berna home and put it in the fridge?
Yes, b/c it's oral and much more stable. (i.e. has a 12 hour temp excursion window). What would you cost-effectively dispense a tightly temp controlled injectable in that would guarantee safe transport under whatever circumstance a numb-nut patient may subject it to?
 
Yes, b/c it's oral and much more stable. (i.e. has a 12 hour temp excursion window). What would you cost-effectively dispense a tightly temp controlled injectable in that would guarantee safe transport under whatever circumstance a numb-nut patient may subject it to?
The best solution I've seen is MD's who write the sig to include administration date/time. Then you can dispense such that it will last outside the fridge until that time (i.e. can only be picked up 30 minutes before it will be used).
However, I don't worry about it at all. Just like the Vivotif example, there is some level of responsibility on the part of the patient. Unless they give me some reason to distrust their capacity to meet the storage needs of the product, I let them handle it.
 
I suppose I'm nitpicking about whether federal or state law specifically mentions that we can, in a retail environment, dispense vaccines. We are specifically authorized to dispense drugs and devices by federal law. I forgot the exact part of the CFR where I read that. Do vaccines like Gardasil count as drugs? Good job bringing up Vivotif. It's classified as a vaccine but practically every pharmacy gives this out. You would think that wholesalers/distributors would clearly tell us what we can and cannot buy from them. Then again, why would they care? As long as they're making money...
 
Really? Dispensing temperature controlled vaccines to patients for office use is standard?

No sir.

Yes sir. You are wrong. It really is an industry standard. At least every pharmacy I worked at or interned at did it. :shrug:
 
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