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Gardasil Question
  1. #1
    pagandeva2000 is offline New Member
    Join Date
    Feb 2009
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    1

    Exclamation Gardasil Question

    Hello!

    I am a new member here and hope for continued interaction with you all. I have a question/dilemma...

    Does Gardasil require a pregnancy test before administration? And if so, does this mean that before each shot that a pregnancy test have to be done? I see that this vaccine is Pregnancy Catagory B, but it is not recommended for pregnant women because there are not enough studies on it.

    The dilemma is that there is no policy at my hospital that I know of regarding this, and many nurses, myself included administered the vaccine without doing pregnancy tests. Now, another nurse, after having gone to an OB/GYN conference stated that she gained this information. I asked her where the policy was (in fact, asked several of the nurses where this policy is) and no one seems to know. One nurse told me that she doesn't do a pregnancy test the first time the order is in because it was already assessed by a physician. Another one stated that she does one all the time, a third said that she does it because everyone else does it. The drug books on the floor do not mention much about Gardasil at all, micromedex only says that it is catagory B, and it is advised that if the patient is pregnant, the remaining vaccinations of the series should be aborted until the pregnancy is resolved. I searched the manual and do not see it. The head nurse was absent for two days, so, I plan to inquire on Monday when she returns. I also plan to call the pharmacy, speak to a few providers and the Nurse Educator. In the meantime, I will do pregnancy tests in order to protect the patient as well as myself.

    Any answers and documents would be appreciated.

  2. #2
    painslayer is offline New Member
    Join Date
    Mar 2009
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    1

    Angry Board Complaint

    I just learned that somebody filed a Board complaint against my nursing license for administering Gardasil without a prior pregnancy test. Any help will be appreciated! I did call Merck and they sent me a letter saying the pregnancy is not required. But, at the same time, the vaccine is not indicated in pregnancy. A bit confusing, I guess.
    The Boards are getting crazy nowadays....

  3. #3
    Join Date
    Feb 2009
    Location
    MO
    Posts
    64

    Default

    Here is a detailed report of the studies done on this drug. I could read it and summarize but I am lazy, so I'm sorry. There is a pregnancy registry mentioned at the bottom that healthcare providers and patients to report fetal outcomes for women on the HPV. Like I said I didn't read it thoroughly, but I did skim and I think the bottom line is there isn't enough evidence to know for sure if it is teratogenic (damaging to the fetus) so it is better to be safe than sorry. This drug is believed to enhance the humoral immunity of the patient (enhancing B-cell activity which release antibodies that bind to the antigen of the virus and basically marking it to be eaten/destroyed) so it's also "possible" that the fetus could be mistaken as a foreign "object" with the currently hypersensitive immune system and initiate a bad response (>>>>>>>>). I am not aware of it actually being mandatory or not so I am not sure about that part. Hope this maybe helps some.... sorry don't know more about it exactly. :/

    Pregnancy:
    Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, use HPV vaccine during pregnancy only if clearly needed.

    An evaluation of the effect of the HPV vaccine on embryofetal, pre- and postweaning development was conducted using rats. One group of rats was administered the HPV vaccine twice prior to gestation, during the period of organogenesis (gestation day 6) and on lactation day 7. A second group of pregnant rats was administered the HPV vaccine during the period of organogenesis (gestation day 6) and on lactation day 7 only. The HPV vaccine was administered at 0.5 mL/rat/occasion (approximately 300-fold excess relative to the projected human dose on a mg/kg basis) by IM injection. No adverse reactions on mating, fertility, pregnancy, parturition, lactation, embryofetal, or pre- and postweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study. In addition, there were no treatment-related effects on developmental signs, behavior, reproductive performance, or fertility of the offspring. The effect of the HPV vaccine on male fertility has not been studied.

    In clinical studies, women underwent urine pregnancy testing prior to administration of each dose of the HPV vaccine. Women who were found to be pregnant before completion of a 3-dose regimen of the HPV vaccine were instructed to defer completion of their vaccination regimen until resolution of the pregnancy.

    HPV vaccine is not indicated for women 27 years of age or older. However, safety data in women 16 through 45 years of age was collected, and 3,620 women (HPV vaccine, n = 1,796 >> AAHS control or saline placebo, n = 1,824) reported at least 1 pregnancy each.

    The overall proportions of pregnancies that resulted in an adverse outcome, defined as the combined numbers of spontaneous >>>>>>>>, late fetal death, and congenital anomaly cases out of the total number of pregnancy outcomes for which an outcome was known (and excluding elective terminations), were 23.3% (423/1,812) in subjects who received HPV vaccine and 24.1% (438/1,820) in subjects who received AAHS control or saline placebo.

    Overall, 54 and 63 subjects in the group that received HPV vaccine or AAHS control or saline placebo, respectively (3% and 3.5% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse reaction during pregnancy. The most common events reported were conditions that can result in Caesarean section (eg, failure of labor, malpresentation, cephalopelvic disproportion), premature onset of labor (eg, threatened >>>>>>>>s, premature rupture of membranes), and pregnancy-related medical problems (eg, pre-eclampsia, hyperemesis). The proportions of pregnant subjects who experienced such events were comparable between the groups receiving HPV vaccine and AAHS control or saline placebo.

    There were 40 cases of congenital anomaly in pregnancies that occurred in subjects who received the HPV vaccine and 30 cases of congenital anomaly in pregnancies that occurred in subjects who received AAHS control or saline placebo.

    Subanalyses were conducted to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of the HPV vaccine or amorphous aluminum hydroxyphosphate sulfate (AAHS) control or saline placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received the HPV vaccine, compared with 1 case of congenital anomaly in the group that received AAHS control or saline placebo. The congenital anomalies seen in pregnancies with estimated onset within 30 days of vaccination included pyloric stenosis, congenital megacolon, congenital hydronephrosis, hip dysplasia, and club foot.

    Conversely, in pregnancies with onset more than 30 days following vaccination, 35 cases of congenital anomaly were observed in the group that received the HPV vaccine, compared with 29 cases of congenital anomaly in the group that received AAHS control or saline placebo.1

    Pregnancy registry: There is a pregnancy registry to monitor fetal outcomes of pregnant women exposed to the HPV vaccine. Patients and health care providers are encouraged to report any exposure to the HPV vaccine during pregnancy by calling 1-800-986-8999.1
    ---I answer questions to the best of my ability, but with always limited knowledge of the patient's situation and no ability to see your chart or full medical history my advice is limited and should also be confirmed with your own doctor/pharmacist/etc. Also, I do not promote following my advice without proper approval from your doctor either--

    Dr. B

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