I IMMUNIZATIONS ^446 ^485 ^633
In the United States, vaccination programs that focus on infants and children have decreased the occurrence of many vaccine-preventable diseases. However, many adolescents and adults continue to be affected adversely by vaccine-preventable diseases, such as influenza, pertussis, varicella, hepatitis A, hepatitis B, human papillomavirus (HPV), measles, mumps, rubella, and pneumococcal pneumonia.
In part, this is because vaccine programs have not focused on improving vaccination coverage. The following four factors have contributed to the low level of immunization in adults: 1) a disinterest by the general public and physicians in adult immunization because of the attitude that immunization is for children, 2) misconceptions about the safety and efficacy of vaccines compared with the consequences of the diseases, 3) concerns about liability, and 4) a poorly developed immunization system. The approval of vaccines against HPV has made the topic of immunization particularly relevant to obstetriciangynecologists, and vaccines against HPV are discussed in some detail later in this section. For information on immunization of health care providers, see the “Human Resources” section in Part 1.The American College of Obstetricians and Gynecologists (the College) has developed the dedicated immunization web site Immunization for Women (available at www.immunizationforwomen.org) to provide up- to-date information and resources to help obstetrician-gynecologists become routine vaccinators. The College’s guide Immunization Coding for Obstetrician-Gynecologists addresses reimbursement and coding for vaccinations and includes coding examples and other coding resources. For additional sources of College information on immunization, see Resources at the end of this section.
Integrating Immunizations Into Practice
Given demonstrated vaccine efficacy, safety, and the large potential for prevention of many infectious diseases, obstetrician-gynecologists and other women’s health care providers should embrace immunizations as an integral part of their practice.
Physician recommendation has been shown to be a very effective way to ensure patients accept vaccinations. Physicians also can provide vaccinations or referrals to vaccination clinics or services, when indicated. The combination of recommending immunization and offering the vaccine at the same time has proved to be the most effective strategy for patient acceptance.Obstetrician-gynecologists and other clinicians who provide wellwoman examinations and preconception care have opportunities in which to counsel women on the need for immunizations. It is helpful to ask new patients who are scheduling well-woman examinations or preconception counseling to bring previous vaccination records. Clinicians should attempt to gather a complete immunization history from each woman, including risk factors indicating the need for immunization; they also should attempt to obtain previous records. If there are doubts about past immunizations, it is safest to assume that a woman has not been immunized and to initiate the appropriate vaccination or vaccination series.
The vaccination of adolescents poses unique challenges for obstetriciangynecologists related to privacy, confidentiality, and informed consent. College Fellows should respect the importance of protecting adolescents’ access to reproductive health care services, including HPV vaccination, while complying with local and national professional norms and applicable legal requirements.
The following are recommended key strategies for integrating immunizations into practice:
• Talk with patients directly and recommend indicated immunizations (see “Recommended Immunizations and Schedules” later in this section).
• Designate a vaccine coordinator in the office and identify a backup coordinator who is trained in the event that the designated coordinator is absent. Among other duties, the vaccine coordinator orders the vaccines, receives vaccine deliveries, and ensures that vaccines are stored properly.
• Document that recommended vaccines have been offered, that patients have been educated on indicated immunizations, and that patients accepted, refused, or obtained their vaccines at an outside facility.
• Always give a vaccine information statement (VIS) for all vaccines recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) before vaccine administration (see “Vaccine Information Statements” later in this section).
• When a vaccine has been administered, record the following information in the patient’s permanent medical record (or a permanent office log):
— The name, address, and title of the person who administered the vaccine
— The date of administration
— The vaccine manufacturer
— The lot number of the vaccine used
• Use prompts, paper or electronic, to help remind staff and health care providers which patients are due for immunizations (see also the “Information Management” section in Part 2).
If financial or business concerns limit a physician’s ability to provide vaccinations in his or her practice, the physician should provide information about alternative sources for vaccination and, when possible, refer patients to alternative community sources, such as state or local health department clinics.
Rarely, vaccine availability can be limited because of increased demand, decreased supply, or both. In cases of limited availability, allocation strategies may be developed by health care or regulatory authorities to prioritize vaccine administration to specific subsets of the population. It is critical that health care providers understand and comply with these guidelines and recommendations regarding vaccination and allocation. Health care providers should be prepared to explain to patients the importance of, and the rationale for, allocation mechanisms while continuing to address their patients’ health care needs through alternative strategies other than vaccination.
Recommended Immunizations and Schedules
The current CDC immunization schedules, which are approved by the College, can be found online at www.cdc.gov/vaccines/schedules/hcp/ adult.html. A listing of the College’s recommended routine immunizations for women without risk factors by age group is available at the College’s Immunization for Women web site at www.immunizationforwomen.org.
Additional or earlier immunizations are recommended for women with certain high-risk factors (see also “Special Populations” at www.immu nizationforwomen.org/Immunization_Facts/Special_Populations). This information also is available at the College’s well-woman web site at www. acog.org/wellwoman.Immunization recommendations can change quickly, as was seen in 2009 during the H1N1 influenza outbreak. Obstetrician-gynecologists can refer to the CDC web site (www.cdc.gov/vaccines) as well as the College’s Immunization for Women web site for the most current recommendations.
Vaccine Administration, Storage, and Handling
The clinician should read vaccine package inserts thoroughly. The storage temperature, body site for injection (usually the deltoid), route of injection (eg, intramuscular, subcutaneous, or intradermal), and length of needle are critical items in maximizing efficacy.
Contraindications to Vaccination
Contraindications to vaccination are conditions under which vaccination should not be administered because of an increased likelihood of a severe reaction. The CDC notes that the only contraindication that is applicable to all vaccines is a history of a severe allergic reaction to a previous dose of a vaccine or a vaccine component. Severe hypersensitivity reactions following immunizations, including anaphylaxis, are rare. The reactions are almost always caused by hypersensitivity to one or more of the vaccine components (residual animal proteins, antibiotics, preservatives, or stabilizers). On rare occasions, an anaphylactic reaction will be caused by trace amounts of an antibiotic, such as neomycin or streptomycin (eg, neomycin in measles-mumps-rubella vaccine). Vaccination is contraindicated in women with a previous anaphylactic reaction to a vaccine or one of its components. It is important to note that none of the current licensed vaccines contain penicillin; therefore, a history of penicillin hypersensitivity is not a contraindication to vaccination.
Syncope or presyncope following immunization is a potential adverse effect, especially in adolescents, and a 15-minute observation period following injection is recommended for all vaccines.According to the CDC, the following conditions are not contraindications to vaccination:
• Mild acute illness with or without fever
• Mild-to-moderate local reaction (ie, swelling, redness, soreness); low-grade or moderate fever after previous dose
• Lack of previous physical examination in a well-appearing person
• Current antimicrobial therapy (Antibacterial drugs might interfere with Ty21a oral typhoid vaccine, and certain antiviral drugs might interfere with varicella vaccines and live, attenuated influenza vaccine.)
• Convalescent phase of illness
• Recent exposure to an infectious disease
• History of penicillin allergy, other nonvaccine allergies, relatives with allergies, or receiving allergen extract immunotherapy
For a complete list of contraindications for specific vaccines, see the CDC’s guide to contraindications and precautions, available at www.cdc.gov/ vaccines/schedules/hcp/imz/adult-contraindications.html.
Vaccine Information Statements ^235
Federal law requires that a VIS developed by the CDC be given to all patients, regardless of age, before the administration of every dose of certain vaccines. State health departments or the CDC should be consulted to determine which vaccines are currently covered by this federal law. Vaccine information statements are available on the Internet at www.cdc.gov/ vaccines/hcp/vis/index.html. The federal requirement to provide a relevant VIS is in addition to any applicable state laws, and no state law can negate that requirement. In addition, some states may have informed consent laws regarding immunization.
Reporting of Adverse Events
Health care providers are encouraged to report all vaccine-related adverse events to the Vaccine Adverse Event Reporting System, a national vaccine safety surveillance program cosponsored by the CDC and the U.S.
Food and Drug Administration (FDA). It collects and analyzes information from reports of adverse events following immunization. By monitoring such events, the Vaccine Adverse Event Reporting System helps to identify any important new safety concerns and thereby assists in ensuring that the benefits of vaccines continue to be far greater than the risks. Information on the Vaccine Adverse Event Reporting System program, including reporting forms and frequently asked questions, can be found at www.vaers.hhs. gov/.Immunization Against Human Papillomavirus
The first vaccine shown to be effective at preventing infection with some genotypes of HPV was licensed by the FDA in 2006. This quadrivalent HPV vaccine is indicated to prevent cancers and intraepithelial neoplasias of the cervix, anus, vulva, and vagina and genital warts associated with HPV genotypes 6, 11, 16, and 18. Approximately 70% of all cases of cervical cancer are caused by HPV genotypes 16 and 18, and 90% of cases of genital warts are caused by HPV genotypes 6 and 11. Indications, dosage, and storage are addressed in Box 3-4. Originally approved for nonpregnant females aged 9-26 years, the administration of this vaccine was subsequently approved for males aged 9-26 years for the prevention of genital warts.
A second, bivalent formulation of an HPV vaccine was approved by the FDA in 2009 for administration to females aged 9-25 years (see Box 3-4) for the prevention of cervical cancer, cervical intraepithelial neoplasia 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia 1 caused by oncogenic HPV genotypes 16 and 18. Results of
Box 3-4. Key Information Regarding the Bivalent and Quadrivalent Human Papillomavirus Vaccines* ^
Dosage
Administered intramuscularly as three separate 0.5-mL doses based on the following schedule:
1. First dose: at elected date
2. Second dose: 1-2 months after the first dose
3. Third dose: 6 months after the first dose
Minimum interval between first and second dose is 4 weeks, between second and third dose is 12 weeks, and between first and third dose is 24 weeks. If the vaccine schedule is interrupted, the series does not need to be restarted, regardless of the length of time between doses. Whenever possible, the same vaccine product should be used for all doses in the series.
Recommended Age
• Target population: females and males1 aged 11 years or 12 years (can be started as early as age 9 years)
• Females and males1 who did not receive the vaccination at the target age can be vaccinated from age 13 years through 26 years
Contraindications
Individuals who develop symptoms indicative of hypersensitivity to the active substances or to any of the components of either vaccine after receiving a dose of vaccine should not receive further doses of the product. Safety and effectiveness of the two formulations have not been established in pregnant women. Any exposure to it during pregnancy should be reported to the manufacturer by calling 1-877-888-4231 for the quadrivalent vaccine and 1-888-4529622 for the bivalent vaccine.
Precautions
As with any vaccine, vaccination may not protect all vaccine recipients. Neither vaccine is intended to be used for treatment of active disease (ie, genital warts, cervical cancer, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia). Human papillomavirus (HPV) vaccines can be administered simultaneously or at any time before or after a different inactivated or live vaccine administration. Because vaccinated individuals may develop syncope, sometimes resulting in falling with injury, health care providers should consider observing patients for 15 minutes after vaccine administration.
(continued)
Box 3-4. Key Information Regarding the Bivalent and Quadrivalent Human Papillomavirus Vaccines[‡] (continued)
Storage
Both formulations should be refrigerated at 2-8°C (36-46°F), should not be frozen, and should be protected from light.
Vaccine Adverse Event Reporting
To report an adverse event associated with administration, go to http://vaers. hhs.gov.
Advisory Committee on Immunization Practices Recommendations
For current recommendations by the Advisory Committee on Immunization Practices, go to http://www.cdc.gov/vaccines/recs/acip/default.htm.
Current Procedural Terminology Codet
The American Medical Association has established a Current Procedural Terminology code of 90649 for quadrivalent HPV vaccination and 90650 for bivalent HPV vaccine.
monitored in various long-term studies, and there is currently no indication for a booster vaccine.
Although obstetrician-gynecologists are not likely to care for many patients in the initial vaccination target group, they play a critical role during the catch-up vaccination period (Box 3-4). They also play an essential role in engaging mothers to vaccinate their children. During a health care visit with a patient in the age range for vaccination, an assessment of the patient’s HPV vaccine status should be conducted and documented in the patient record. Testing for HPV is not required or recommended as a prerequisite for administration of the vaccine. Vaccination with either HPV vaccine is not recommended for pregnant women. The presence of immunosuppression, such as that experienced in patients with human immunodeficiency virus (HIV) infection, is not a contraindication to administration of either the quadrivalent or bivalent HPV vaccine. However, the immune response may be smaller in the immunocompromised patient than in immunocompetent patients.
The HPV vaccine is most effective if given before any exposure to HPV infection, but sexually active women can receive and benefit from vaccination. Women with previous abnormal cervical cytologic findings or genital warts also can receive the HPV vaccine. Patients should be counseled that the vaccine may be less effective in women who have been exposed to HPV before vaccination than in women who were HPV naive at the time of vaccination.
The vaccine can be given to patients with previous cervical intraepithelial neoplasia, but practitioners need to emphasize that the benefits may be limited, and cervical cancer screening and corresponding management based on College recommendations must continue. The HPV vaccines are a preventive tool and not a substitute for cancer screening. Current cervical cancer screening recommendations should be followed regardless of vaccination status (see also the “Cancer Screening and Prevention” section later in Part 3 and the “Abnormal Cervical Cytology” section in Part 4). Similarly, HPV vaccines are not intended to treat patients with cervical cytologic abnormalities or genital warts. Patients with these conditions should undergo the appropriate evaluation and treatment.
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