Weird Situation with Gardasil and Completing Series After 26

[Lnsean]

Just wanted to get your input on what you guys would do in this situation. I had a patient come in today for Gardasil...she's currently 26...and her birthday is in August. I know it's a 3-dose schedule at 0, 2, and 6 months. I gave her the first dose today and told her to come back for the 2nd dose and 3rd dose without realizing that she will turn 27 for the 3rd dose. I know that you can start the series at 26 or younger and complete it after your 27. Now, as a pharmacist, when I go to do the 3rd dose...the computer will probably flag this as being outside of indication because it doesn't know its the final dose in a series of 3. My question is...as a pharmacist...am I allowed (legally) to administer the 3rd dose...OR should I refer her to a clinic or doctor for the final dose. I feel like if it's part of a series and she was indicated at 26 then the whole series would fall under that indication and this would allow me to complete her 3rd dose. I hope i am not overthinking this...lol..

Any insight would be appreciated.

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[bacillus1]

You are not prohibited from administering Gardasil, it's just a question of whether it'll be paid for. I believe many insurances will cover it as long as the first dose was given at 26 or less.

 

[Unchained]

You shouldn't be recommending your patients receive Gardasil at all. Do some research as to what other countries are experiencing with it and the side effects that patients are experiencing.

 

[bacillus1]

You shouldn't be recommending your patients receive Gardasil at all. Do some research as to what other countries are experiencing with it and the side effects that patients are experiencing.

WRONG! I hate the amount of misinformation about this vaccine, and to tell you the truth I bought into it as well until I did my own research. Unfortunately this research was done after 26, so it's too late for me to get it. It prevents 90% of cancer and genital wart causing strains. Do not talk about not getting gardasil unless either you or someone you know has been affected by the disease. It's the same as with all other vaccines (e.g."Oh, what's the big deal with one person out of thousands catching measles?").

 

[Lnsean]

You shouldn't be recommending your patients receive Gardasil at all. Do some research as to what other countries are experiencing with it and the side effects that patients are experiencing.

Nah this wasn't my recommendation. The patient's PCP told her to go to a pharmacy and get it done. Personally, I feel the side effects fail in comparison to the long term benefits. I would've recommended it anyway if she had asked for my opinion. A few shots to protect yourself against the most common strains of HPV/cancers....I'm a male and I would get it too if I wasn't already too old. Anyway, I'm not here to debate that...the evidence is there hence the FDA indication. I'm asking if a pharmacist is able to give the 3rd dose of the 3-dose series if the patient becomes older than 26 when completing it.

 

[beautifulrobot]

I'm asking if a pharmacist is able to give the 3rd dose of the 3-dose series if the patient becomes older than 26 when completing it.

I cant think of a reason why not. What is your concern/in what way do you think it might not be ok?

 

[Dred Pirate]

You shouldn't be recommending your patients receive Gardasil at all. Do some research as to what other countries are experiencing with it and the side effects that patients are experiencing.

here we go with this bs again

 

[Sine Cura]

This is a good illustration that you cannot always rely on your pharmacy management software to alert you. In my experience, CVS and Walmart's systems did not provide alerts in the past

Unfortunately state regulations generally do not address this type of scenario. They typically refer to ACIP recommendations, which themselves do not address the possibility of follow-up doses in a multi-dose series falling outside of the recommended age range, as these are just recommendations that don't consider what pharmacists can or can't administer.

This problem can be bypassed just by having the provider write a prescription, if a prescription is permitted and the state does not place restrictions on what prescriptions can be written for pharmacist-administered immunizations.

Sometimes insurance claims won't be rejected due to being outside of age range but you expose yourself to the possibility of a claw-back later.

 

[Lnsean]

I cant think of a reason why not. What is your concern/in what way do you think it might not be ok?

Because the FDA indication is for 26...she would be 27 when getting her 3rd and final dose...just curious if this would present any regulatory issue...from a pharmacist perspective.

 

[Lnsean]

This is a good illustration that you cannot always rely on your pharmacy management software to alert you. In my experience, CVS and Walmart's systems did not provide alerts in the past

Unfortunately state regulations generally do not address this type of scenario. They typically refer to ACIP recommendations, which themselves do not address the possibility of follow-up doses in a multi-dose series falling outside of the recommended age range, as these are just recommendations that don't consider what pharmacists can or can't administer.

This problem can be bypassed just by having the provider write a prescription, if a prescription is permitted and the state does not place restrictions on what prescriptions can be written for pharmacist-administered immunizations.

Sometimes insurance claims won't be rejected due to being outside of age range but you expose yourself to the possibility of a claw-back later.

Nah..there's no way any software would alert this. She's 26 now and she's indicated for the vaccine. I just forgot that she would be 27 when getting her 3rd dose. I mean it doesn't change anything really...she wanted it and the first dose I gave her is within indication...I am just unsure what to do with her 3rd dose that's all (if I should tell her to go to her doctor---which would be an inconvenience---or if I could finish the series for her being that she started the series within indicated age)

 

[Momus]

I got mine completed at 30 yr old. My insurance didn't cover it at retail pharmacy since I wasn't on the right age but PCP can bill it. I'm looking to add the 4th one gardisil 9 soon on my next visit. I'm 33 now... Shoot me up. I got the first dose when I was 28, and I waited a year in between doses. Don't want any warts growing on me, playing the field to too much lol.

I'm also the first one to get flu shot every August. I gave the injection myself. I'm pretty much up to date on everything. Did 2x pneumonia shot even tho I have no indication for it. All of these paid by insurance. Can't harm you

 

[beautifulrobot]

Because the FDA indication is for 26...she would be 27 when getting her 3rd and final dose...just curious if this would present any regulatory issue...from a pharmacist perspective.

The only way it might pose a regulatory/legal issue is if this was considered off-label use and you didn't do your due diligence to counsel that it is off-label, or if the laws in your state have particular restrictions on providing vaccinations outside of a pre-specified schedule/protocol. I don't think this would be considered off-label use since you started the series when she was still 26, but even if it was considered off-label, as long as you counseled the patient that it may be considered off-label you've pretty much covered yourself. But again, I don't even think this particular circumstance is considered off-label. I can't find any guidance in the package insert or from the CDC that specifically says the entire series needs to be completed BEFORE the 27th birthday, most of the information I found just states that the vaccine is recommend through 26 years of age. There are definitely folks who get the vaccine at a later age - it's not contraindicated, it's just not recommended / the costs usually outweigh the benefits as you get older (i.e. most sexually active folks have been exposed to HPV by the time they reach their late 20s, so it kind of defeats the purpose of getting vaccinated), as well as the vaccine's effects just haven't been as well studied in older populations.

 

[wagrxm2000]

Your with walgreens right? I could be wrong but doesn't our protocol prevent us from giving it after 26?

 

[waiter]

Your with walgreens right? I could be wrong but doesn't our protocol prevent us from giving it after 26?

I believe you're right & the immunization selection tool would recommend to not vaccinate per protocol

 

[confettiflyer]

You shouldn't be recommending your patients receive Gardasil at all. Do some research as to what other countries are experiencing with it and the side effects that patients are experiencing.

This is some dumb **** advice right here.


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[Apples2Oranges]

got my gardasil shots at 13. haven't died yet nor gotten cancer in the past 10 years so i guess it works. not gonna jinx it though.

 

[bp2313]

I got one last year and it was free. I turned 27 and it's $45 but I'll get my second and third regardless. But I'll wait till the health fair day at my store to help out the quota . Btw I got my first one during my shift and I didn't pass out nor give anyone wrong drugs.

 

[Lnsean]

Your with walgreens right? I could be wrong but doesn't our protocol prevent us from giving it after 26?

She's 26 now and will be 26 for the first 2 doses...she will be 27 for the 3rd dose....the protocol doesn't know that it's a 3rd dose in the series..it thinks that you're trying to start in someone who is 27. So, professionally, I feel that I should complete the series for her without her having to go to an MD/NP for the 3rd dose.

 

[Lnsean]

The only way it might pose a regulatory/legal issue is if this was considered off-label use and you didn't do your due diligence to counsel that it is off-label, or if the laws in your state have particular restrictions on providing vaccinations outside of a pre-specified schedule/protocol. I don't think this would be considered off-label use since you started the series when she was still 26, but even if it was considered off-label, as long as you counseled the patient that it may be considered off-label you've pretty much covered yourself. But again, I don't even think this particular circumstance is considered off-label. I can't find any guidance in the package insert or from the CDC that specifically says the entire series needs to be completed BEFORE the 27th birthday, most of the information I found just states that the vaccine is recommend through 26 years of age. There are definitely folks who get the vaccine at a later age - it's not contraindicated, it's just not recommended / the costs usually outweigh the benefits as you get older (i.e. most sexually active folks have been exposed to HPV by the time they reach their late 20s, so it kind of defeats the purpose of getting vaccinated), as well as the vaccine's effects just haven't been as well studied in older populations.

I am in agreement with this. She was within the indicated age when the series began...so I feel that I should be able to complete the series for her without her having to go to a doctor/NP for the 3rd dose.

 

[Charcoales]

Just give it if it's covered, let them complete their series srs.

 

[BidingMyTime]

Can't harm you

Oh no. I can't believe you said that. Those magic words ring an alarm on unchained's cell phone, so s/he can immediately get on-line to let you know why you are wrong.

To the OP, I can't imagine clinically any reason why you couldn't give the 3rd dose. The series was started when indicated, of course the expectation is that you would finish it at the recommended dosing intervals. Even if the FDA/CDC guidelines don't specifically state this, this is surely what was intended---otherwise it looks like the FDA/CDC is saying that 26 year olds can get 1 or 2 shots, but not the whole series, and that would make no sense.

Now whether or not ins will pay for it, that's a different matter.

 

[drugdealer2b]

This happened to me as a patient. I started the series at 26 and second and third dose were after turning 27. I couldn't find a pharmacist that was willing to give me the last two doses because I was no longer in the recommended age range. I believe my insurance rejected as well. I ended up having to go to the doctor to get them done and billed to insurance.