Gardisil

Jolie, BSN · Feb 19, 2009

pagan,

I would love to work with you. You are one of the most intellectually curious and conscientious professionals I've had the pleasure to "meet."

Thank you for raising this question, which I had never considered. I've had 2 discussions with my daughters' pediatrician (whom I think highly of), but who has expressed displeasure at my refusal of the vaccine for my girls, neither of whom is sexually active yet.

Keep the thoughts and questions coming!

soupermom · Feb 20, 2009

quadravalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

(hyoo-man pa-pil-lo- ma)

gardasil

classification

therapeutic: vaccines/immunizing agents

pharmacokinetics

absorption: well absorbed following im administration.

distribution: unk.

metabolism and excretion: unk.

half-life: unk.

time/action profile (antibody response)

route onset peak duration

im unknown 1 mo* unknown

*after third vaccination

contraindications/precautions

contraindicated in:

hypersensitivity

thrombocytopenia/bleeding disorder

ob: pregnancy.

adverse reactions/side effects *

*capitals indicate life threatening; underlines indicate most frequent.

local: injection site reactions. misc: anaphylaxis (rare).

interactions

drug-drug:

immunosuppressants or antineoplastics may ↓ antibody response.

route/dosage

im (adults and children--females 9-26 yr): three 0.5 ml doses at 0, 2 and 6 months.

nursing implications

assessment

assess vital signs prior to administration. do not administer to patient with a current or recent febrile illness; low grade fever (

patient/family teaching

provide information about vaccine and the importance of completing immunization series unless contraindicated to patient and guardian.

inform patient that vaccine does not replace routine cervical cancer screening or prevent other sexually transmitted diseases; such screening should be continued as usual.

advise patient to consult health care professional prior to taking rx, otc, or herbal products.

advise patient to notify health care professional if pregnancy is planned or suspected. women exposed to vaccine during pregnancy are encouraged to call manufacturer pregnancy registry at 800-986-8999.

instruct patient to report any adverse reactions to health care professional.

evaluation/desired outcomes

prevention of cervical cancer, genital warts, cervical adenocarcinoma in situ, cervical, vulvar, and lady partsl intraepithelial neoplasia caused by hpv.

view list beginning with this entry

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Elvish, BSN, DNP, RN, NP · Feb 20, 2009

Probably the reason they are listing it as contraindicated is that there has not been enough conclusive evidence to list it as safe. That's generally the case w/ vaccines. I'd imagine they want people to call the mfgr registry so they can track the effects.

pagandeva2000, LPN · Feb 20, 2009

Probably the reason they are listing it as contraindicated is that there has not been enough conclusive evidence to list it as safe. That's generally the case w/ vaccines. I'd imagine they want people to call the mfgr registry so they can track the effects.

That is what I suspected. What does annoy me, however, is that there is not much information about vaccines in any of my drug books, including my 2005 edition of Davis. I mean, I know Gardisil is probably not there, but many of the other ones are not listed in most drug books. But, I did gather that it is Pregnancy Catagory B, and as mentioned, it seems to not be recommended because there are not enough studies. Enough reason for me not to wish to be bothered, but I need clarity at work, because it seems that each nurse is doing what they want to do with no written policy.

pagandeva2000, LPN · Feb 20, 2009

pagan,
i would love to work with you. you are one of the most intellectually curious and conscientious professionals i've had the pleasure to "meet."
thank you for raising this question, which i had never considered. i've had 2 discussions with my daughters' pediatrician (whom i think highly of), but who has expressed displeasure at my refusal of the vaccine for my girls, neither of whom is sexually active yet.
keep the thoughts and questions coming!

thank you so much for the compliment. i am going to try and squeeze time today to review our policy and procedure manual to see what they have to say. i have no issues, either way, whether or not we are supposed to do pregnancy tests or not, but if there is no policy, i am not totally comfortable doing pregnancy tests indiscriminately because i have nothing to show the doctor as proof that we are following facility protocol (which can make problems worse). i highly suspect this is not a written policy, but nurses are basically doing their own thing.

quadravalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
(hyoo-man pa-pil-lo- ma)
gardasil
classification
therapeutic: vaccines/immunizing agents
pharmacokinetics
absorption: well absorbed following im administration.
distribution: unk.
metabolism and excretion: unk.
half-life: unk.
time/action profile (antibody response)
route onset peak duration
im unknown 1 mo* unknown
*after third vaccination
contraindications/precautions
contraindicated in:
hypersensitivity
thrombocytopenia/bleeding disorder
ob: pregnancy.
adverse reactions/side effects *
*capitals indicate life threatening; underlines indicate most frequent.
local: injection site reactions. misc: anaphylaxis (rare).
interactions
drug-drug:
immunosuppressants or antineoplastics may ↓ antibody response.
route/dosage
im (adults and children--females 9-26 yr): three 0.5 ml doses at 0, 2 and 6 months.
nursing implications
assessment
assess vital signs prior to administration. do not administer to patient with a current or recent febrile illness; low grade fever (
patient/family teaching
provide information about vaccine and the importance of completing immunization series unless contraindicated to patient and guardian.
inform patient that vaccine does not replace routine cervical cancer screening or prevent other sexually transmitted diseases; such screening should be continued as usual.
advise patient to consult health care professional prior to taking rx, otc, or herbal products.
advise patient to notify health care professional if pregnancy is planned or suspected. women exposed to vaccine during pregnancy are encouraged to call manufacturer pregnancy registry at 800-986-8999.
instruct patient to report any adverse reactions to health care professional.
evaluation/desired outcomes
prevention of cervical cancer, genital warts, cervical adenocarcinoma in situ, cervical, vulvar, and lady partsl intraepithelial neoplasia caused by hpv.
view list beginning with this entry
--------------------------------------------------------------------------------
copyright © 2009 f.a. davis company. all rights reserved.

thank you for sharing the 2009 davis explanation with us. i suspect that it is not being recommended because there are not enough studies. i am feeling that we need to order new drug books almost each year rather than the traditional q5 just to keep up with these people (like i am rich...:angryfire).

soupermom · Feb 20, 2009

I didn't post the entire thing for Gardasil from my Davis CD...I didn't want to get into some kind of copyright issue. But that should help answer the question you had...or at least confirm/deny something.

pagandeva2000, LPN · Feb 20, 2009

Pitiful update: When I got back from break, the first injection I had was Gardisil. The patient also had a script for oral contraceptives that were to be started on Sunday, so, I asked the nurse that originally told me that pregnancy tests had to be performed beforehand. She tells me that since the patient was prescribed the pill, that I should just ask her if she had been taking her bcps correctly and 'just give it'. I asked her outright "Where the hell is the written policy, so I can be sure??" She doesn't know. Sooo...I go ask another seasoned nurse and she tells me that the first time that Gardisil is administered, we do not have to do a pregnancy test, because the doctor already assessed it, therefore I can give, but it is when the patient returns when we have to do the urine HCG. I asked her "How did the doctor assess it when she didn't do or request a pregnancy test THEN??" No one knows. Went to an agency RN who says to me "Well, you should do one...I do...", but when I asked her where did she see this written, or who told her, she doesn't give a direct answer. Doctor says to do what I want...so, I did the urine pregnancy test, it came out negative, I documented it and then went to look up the policy, and guess what...there is none.

I was quite angry, but it was at the end of the day, so, I will ask the head nurse (she was not in for the past few days) and nursing supervisor if there is another policy book that I may have overlooked and will say that maybe we need a nursing meeting to discuss this and see if a policy can be written.

See, my issue is this...I happened to crosstrain in this clinic, and because they asked me to stay additional time (in fact, they may be keeping me there), I came across this. What about the floaters that come to this clinic, or agency nurses? It doesn't matter that we/they are not permanent nurses...only working there for the day...but, a license is a license. In addition, if something goes wrong, that patient is not going to care that the nurse that gave the shot was misinformed. To protect all of us, I believe that rather than everyone practicing indiscriminately, we should all be on the same page. I even called my girlfriend who crosstrained there last year (and works in another off site clinic of ours that has OB/GYN services) if she does pregnancy tests before giving Gardisil and she looked at me as if I suddenly grew three heads. She said "no", that she was never told to do this. Anyway, enough of my annoyances...I'll get down to the bottom of this. For now, to cover myself, I will do the pregnancy tests, inform the doctor if it is positive and let them make the decision (and document every word they say), and also I will call the pharmacy on Monday.

jackson145 · Feb 20, 2009

I watched a 20-yr old women bleed out & die in my E/D after a year of suffering with cervical cancer. I'll never forget that night.

I took my daughter to her Doc for the series as soon as it was available.

morte, LPN, LVN · Feb 21, 2009

why would we be vacinating ANY pregnant woman for anything that is not IMMEDIATELY life threatening?

Jolie, BSN · Feb 21, 2009

This seems to be yet another contradiction in the information provided by the manufacturer and those eager to vaccinate all young girls and women: hurry up and given them the series of shots before they become sexually active with multiple partners, yet provide little, if any "safety testing" to these very same girls and women whom we are to presume to be sexually active. It seems to me that every girl should have a pregnancy test and culture for HPV before the first shot is given, and a pregnancy test for each subsequent shot. Especially since we are being told that this vaccine is important because young girls and women may not be forthcoming with their parents or their health care providers about their sexual activity.

I hate to be cynical, but I believe this is another indication that HPV vaccination is more about profits than true protection.

chevyv, BSN, RN · Feb 21, 2009

I agree with the above poster regarding profits. There was another interesting thread here a few months ago. A woman's daughter died after getting the vaccine. My daughter is 8 and she won't be getting this vaccine, mandatory or not! I believe this is a vaccine protecting against a couple of strains of HPV, which please correct me, are sexaully transmitted diseases. I'm not sure my state should have the right to mandate me to vaccinate my daughter at this age or any age. Some are getting this as young as 8.

My best friend had her husband take her 12 yr old in for the usual shots and she had spoken with them over the phone so she knew what her daughter would be getting when her hubby brought their daughter in. They mentioned nothing about Gardisil over the phone. Wouldn't you know when the hubby came in they mentioned it was for female health to prevent cancer and he told them to go ahead thinking they had already talked to his wife over the phone. My friend was so upset after reading the controversial stuff, she sat down and cried to me. She called them and told them point blank they would not be coming back to that physician and cancelled the next appointment for the series.

CityKat, BSN, RN · Feb 21, 2009

I personally, am NOT a fan of this vaccine. Just another way to inoculate people and screw up the hemodynamics of our bodies. This is my opinion of course. Cervical cancer is one of those cancers that is SLOW growing and pre cancerous cells have a way of correcting themselves, even before the MD needs to do a colposcopy.

I don't understand why so many people are accepting this vaccine. I for one, do not trust the pharmaceutical companies with my health at all. Just my .02 though.