mso hpv by KzOLGr

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									                              Massachusetts Department of Public Health
                                      Immunization Program


                                           Model Standing Orders

                          Human Papillomavirus (HPV) Vaccine
These model standing orders are current as of January 2012. They should be reviewed carefully against
the most current recommendations and may be revised by the clinician signing them.

            Manufacturer      HPV Types                Target Groups                 Protects Against
Gardasil   Merck             6, 11, 16, 18     Females and males 9 – 26 y/o    Cervical, vulvar and vaginal
HPV4                                                                           cancer; genital warts
Cervarix GSK                 16, 18            Females 10 – 25 y/o             Cervical cancer
HPV2

Recommendations for Females
   Routine vaccination of females aged 11 or 12 years with 3 doses of HPV vaccine; can be started
    beginning at age 9 years.
   Vaccinate females aged 13 through 26 years who have not been previously vaccinated or who have
    not completed the 3-dose vaccination series.

Recommendations for Males
   Routine vaccination of males aged 11 – 12 years with 3 doses of HPV4; can be started beginning at
    age 9 years.
   Vaccinate males 13 trough 21 years who have not been vaccinated previously or who have not
    completed the 3-dose series.
   Vaccinate males aged 22 through 26 years who have sex with men
   Other males aged 22 through 26 years may be vaccinated.
   Use only HPV4 (Guardasil) to vaccinate males; HPV2 (Cervarix) is not licensed for use with males.

Recommendations for Females and Males
   If a person reaches age 26 years before the vaccination series is complete, remaining doses can be
    administered after age 26 years.
   Ideally, vaccine should be administered before potential exposure to HPV through sexual contact.

Order:
1. Provide patient, parent or legal representative with a copy of the Vaccine Information Statement
   (VIS) and answer any questions. The vaccine information statement (VIS) for quadrivalent HPV can
   be found at www.immunize.org/vis.
2. Screen for contraindications according to Table 2

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              Clinician’s Signature                                                  Date
97767634-4967-4015-b83d-04f5ff6a3fae.rtf                                                Page 1 of 4
3. Have adolescents and adults seated during vaccination to prevent injury should syncope occur.
4. Administer 0.5mL of HPV vaccine intramuscularly (IM) in the deltoid muscle according to the
   schedule (See Table 3). Always check package insert prior to administration of any vaccine.

Table 1. Needle Length and Injection Site for IM Injection

                      Age group                          Needle length              Injection site

     Children, 3 – 18 years old                      5/8†--1 inch           Deltoid muscle of arm§
                                                     1 - 1¼ inch            Anterolateral thigh
     Adults (≥19 yrs)
      Men and women, <30 lbs (60 kg)                 1 inch¶                Deltoid muscle of arm

      Men and women, 130--152 lbs (60--70 kg)        1 inch

      Men, 152--260 lbs (70--118 kg)
                                                     1 – 1½ inches
      Women, 152--200 lbs (70--90 kg)
      Men, >260 lbs (118 kg)
                                                     1½ inches
      Women, >200 lbs (90 kg)
    † If skin is stretched tightly and subcutaneous tissues are not bunched.
    § Preferred site.
    ¶ Some experts recommend a 5/8-inch needle for men and women who weigh <60 kg.

5. Administer HPV vaccine simultaneously with all age appropriate vaccines that are recommended,
   such as Tdap, Td and MCV4, but at a different anatomical site.
6. If possible, observe patient for an allergic reaction for 15 - 20 minutes after administering vaccine.
7. Personnel should be aware of presyncopal manifestations and take appropriate measures to prevent
   injuries if weakness or dizziness occurs. Having vaccine recipients sit or lie down for 15 minutes
   after vaccination to prevent many syncopal episodes and secondary injuries. If syncope develops,
   patients should be observed until symptoms resolve
8. Have personnel trained in CPR, signed emergency standing orders, epinephrine, and equipment for
   maintaining an airway available to treat anaphylactic reactions. See p. 12-13 of the General
   Recommendations on Immunization at www.cdc.gov/mmwr/pdf/rr/rr6002.pdf. Model standing
   orders for emergency treatment of vaccine reactions are available at
   www.mass.gov/eohhs/docs/dph/cdc/immunization/mso-emergency-treatment.pdf
9. Report administration errors to the Institute for Safe Medical Practices (ISMP) via the Medication
   Error Reporting Program (MERP)website: www.ismp.org
10. Report clinically significant adverse events to the Vaccine Adverse Event Reporting System
    (VAERS) at 1-800-822-7967 or www.vaers.hhs.gov/.
11. See General Protocols for Vaccine Storage, Administration, Standing Orders and Mass Immunization
    Clinics www.mass.gov/eohhs/docs/dph/cdc/immunization/mso-protocols-general.pdf


___________________________________                                               ____/___/____
              Clinician’s Signature                                                    Date
97767634-4967-4015-b83d-04f5ff6a3fae.rtf                                                 Page 2 of 4
Table 2. Contraindications and Precautions for Administration of HPV Vaccine

                                                                  Invalid Contraindications to HPV Vaccine
         Valid Contraindications to HPV Vaccine
                                                                     (HPV vaccine should be administered)
Severe allergic reaction (e.g. anaphylaxis) to a previous        Minor acute illness, with or without fever
dose of HPV vaccine or any other component of the
vaccine. See package inserts for specific compnents.1            Equivocal or abnormal Pap test 3

             Valid Precautions to HPV Vaccine                    History of genital warts3
Vaccination of people with moderate to severe illness            Breastfeeding
should be deferred until after illness improves.
                                                                                       4
(temporary precaution)                                           Immunosuppression
Pregnancy 2                                                      Anticoagulation or bleeding disorder 5
1
    Guardasil contains yeast. The tip cap and rubber plunger of the Cervarix prefilled syringes contain latex;
    the vial stopper of the Cervarix vial does not contain latex.
2
    HPV vaccines are not recommended for use in pregnant women. If a woman is found to be pregnant
    after initiating the vaccination series, the remainder of the 3-dose series should be delayed until
    completion of pregnancy. Pregnancy testing is not needed before vaccination. If a vaccine dose has
    been administered during pregnancy, no intervention is needed. Patients and health-care providers
    should report any exposure to HPV4 during pregnancy to Merck at telephone, 800-986-8999, and any
    exposure to HPV2 during pregnancy to GlaxoSmithKline at telephone, 888-452-9622.
3
    HPV vaccine can be given to females who have an equivocal or abnormal Pap test, a positive Hybrid
    Capture II® high risk test, or genital warts. Advise vaccine recipients that there are no data to indicate that
    the vaccine has any therapeutic effect on existing Pap test abnormalities, HPV infection or genital warts.
    Vaccination would provide protection against infection with vaccine HPV types not already acquired.
4
    People who are immunocompromised either from disease or medication can receive quadrivalent HPV
     vaccine. However the immune response to vaccination and vaccine effectiveness might be less than in
     people who are immunocompetent.
5
    Minimize the risk of bleeding after an IM injection by administering the vaccine immediately after the
    patient has received antihemophilia or other appropriate coagulation replacement therapy. Use a 23-
    gauge (or smaller) needle with immediate application of direct pressure to the vaccination site for > 2
    minutes.


Cervical Cancer Screening
     Vaccination is not a substitute for routine cervical cancer screening. Women who receive HPV vaccine
      should continue to undergo cervical cancer screening per standard of care.
     Prevaccination testing (Pap test or screening for HPV-DNA, type-specific HPV tests, or HPV antibody)
      is not recommended.




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                Clinician’s Signature                                                        Date
97767634-4967-4015-b83d-04f5ff6a3fae.rtf                                                       Page 3 of 4
Table 3. HPV Vaccine Schedule1,2,3,4

                   Dose                   Schedule                  Minimum Age/Interval5
                  1st Dose                  0 mos                            9 years
                  2nd Dose        1 - 2 mos after 1st dose            4 weeks after 1st dose
                  3rd Dose              6 mos after 1st          12 weeks after 2nd dose and 24
                                                                    weeks after the 1st dose
        1
            There are no maximum intervals.
        2
            If the schedule is interrupted, the vaccine series does not need to be repeated.
        3
            Whenever possible, the same HPV product should be used for all doses in the series.
        4
            HPV doses received after a shorter-than-recommended dosing interval should be re-administered.
        5
            An accelerated schedule using minimum intervals is not recommended.


References:
CDC. Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males —ACIP,
2011. MMWR 2011;60(50):1705-1708. www.cdc.gov/mmwr/pdf/wk/mm6050.pdf
CDC. FDA Licensure of Bivalent Human Papillomavirus Vaccine (HPV2, Cervarix) for Use in Females
and Updated HPV Vaccination Recommendations from the ACIP. MMWR 2010;59(20):626-629.
www.cdc.gov/mmwr/PDF/wk/mm5920.pdf
CDC. FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in
Males and Guidance from ACIP. MMWR 2010;59(20):630-632.
www.cdc.gov/mmwr/PDF/wk/mm5920.pdf
CDC. Quadrivalent Human Papillomavirus Vaccine: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR. 2007;56: 1-24. Available at:
http://www.cdc.gov/mmwr/PDF/rr/rr56e312.pdf
CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR. (2011, Jan 28) 60(RR02); 1-60.
www.cdc.gov/mmwr/pdf/rr/rr6002.pdf
Human Papillomavirus: HPV Information for Clinicians—CDC Brochure. Available from: U.S.
Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA.
www.cdc.gov/std/hpv/hpv-clinicians-brochure.htm. [Accessed January 25, 2010]
Immunization Action Coalition (IAC). Guide to Contraindications and Precautions to Commonly Used
Vaccines. (2/11). www.immunize.org/catg.d/p3072a.pdf
Package inserts for all vaccines licensed in the U.S.
www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM093833




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                Clinician’s Signature                                                     Date
97767634-4967-4015-b83d-04f5ff6a3fae.rtf                                                       Page 4 of 4

								
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