Adults and Older AdultsImmunization/Prophylaxis

More than 13 million Americans have coronary heart disease, according to the Third National Health and Nutrition Examination Survey (NHANES III). Heart disease continues to be the leading cause of death in both men and women, and in 1993, nearly 490,000 Americans died of ischemic heart disease. Studies suggest that aspirin in low doses is beneficial in patients with ischemic cardiovascular disease. The Swedish Aspirin Low-Dose Trial (SALT) supports the indication that aspirin reduces the risk of death or stroke in subjects with transient ischemic attack (TIA) or ischemic stroke. The use of aspirin in the primary prevention of myocardial infarction (MI) in patients with stable angina is supported by the Swedish Angina Pectoris Trial (SAPAT). The use of aspirin is also supported in patients who have had a previous MI.

Evidence from the US Physicians' Health Study (a randomized controlled trial) and the Nurses' Health Study (a prospective cohort study) suggests that use of low-dose aspirin significantly decreases the incidence of first MI in middle-aged men and women. However, these studies did not document a decrease in total cardiovascular mortality with aspirin prophylaxis, and the risk of hemorrhagic stroke and sudden death may be increased with its use. A smaller British study of aspirin prophylaxis in physicians found no significant reduction in the incidence of MI. The Women's Health Study, a large randomized, controlled trial that includes aspirin prophylaxis, is in progress.

Aspirin use for the primary prevention of colon cancer is also being investigated. Observational studies have shown an association between aspirin use and a reduction in the incidence of colon cancer. Although this association is of interest, prospective confirmation (eg, in a randomized, controlled trial) is lacking.

American Academy of Family Physicians --

Men aged 40 to 84 years with risk factors for coronary artery disease should be counseled about the risks and benefits of aspirin prophylaxis.

American Heart Association --

Care should be exercised before beginning a lifelong program of aspirin therapy. The decision to begin taking aspirin should be made only after consultation by each individual with his or her physician. The individual who begins a regular aspirin regimen should be aware of the side effects of the drug and should report symptoms to his or her physician. All risk factors for coronary heart disease and stroke should be determined and a concerted program to reduce those risk factors begun.

Canadian Task Force on the Periodic Health Examination --

The evidence is not strong enough to support a recommendation that routine aspirin therapy be used or not be used for the primary prevention of cardiovascular disease in asymptomatic men and women. The decision on whether to prescribe aspirin should be made on an individual basis after the benefits of decreased risk of ischemic cardiovascular events have been balanced against the potential risks associated with prolonged aspirin use.

US Preventive Services Task Force --

There is insufficient evidence to recommend for or against routine aspirin prophylaxis for the primary prevention of myocardial infarction in asymptomatic persons. Although aspirin reduces the risk of myocardial infarction in men 40 to 84 years of age, its use is associated with important adverse effects, and the balance of benefits and harms is uncertain. If aspirin prophylaxis is considered, clinicians and patients should discuss potential benefits and risks for the individual before beginning its use.

Individuals should not take aspirin daily for cardiovascular uses without first consulting a physician. No major authority recommends routine universal aspirin prophylaxis. People who have had coronary heart disease, TIA, or ischemic stroke are most likely to benefit.

The optimal dosage of aspirin for the primary, secondary, and tertiary prevention of heart disease is not clearly established. The dose regimens from clinical trials range from 50 mg to 325 mg taken by mouth daily. Doses greater than 325 mg daily confer no added protection but increase the incidence of side effects. It remains to be established whether doses of less than 325 mg every other day confer protection.

The only contraindication to regular aspirin use is allergy to aspirin. Because of an increased risk of adverse events, individuals with liver or kidney disease, peptic ulcer disease, history of gastrointestinal bleeding, or bleeding disorder should specifically address this issue with their clinicians before starting aspirin prophylaxis. Because of the potential increased risk of hemorrhagic stroke, it is not advisable to use aspirin for prophylaxis in patients with poorly controlled hypertension. Patients using aspirin prophylaxis should inform their surgeon or dentist before undergoing even minor surgical or dental procedures. Prolonged bleeding can persist for up to 10 days after terminating use of aspirin.

Side effects of aspirin prophylaxis are dose-related and include gastrointestinal upset and bleeding disorders (eg, easy bruising, epistaxis, hematemesis, melena), gout, and kidney stones. These events require medical attention, and clinicians must consider discontinuation of aspirin prophylaxis if any of these events occur.

Aspirin: A New Look at an Old Drug. FDA Office of Consumer Affairs. HFE 88 Room 1675, 5600 Fishers Ln, Rockville, MD 20857; (800)532-4440.

Summary Minutes of the January 23, 1997, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Cardiovascular and Renal Drugs Advisory Committee. A copy of the summary minutes can be obtained through a written request to the Freedom of Information Office (HFI-35), Food and Drug Administration, Rm 12A-16, 5600 Fishers Lane, Rockville, MD 20857.

In postmenopausal women, use of supplemental estrogen can reduce the risk of osteoporosis. Osteoporosis contributes to approximately 1.2 million fractures in the United States annually; about two thirds of these fractures occur in women. Women who are older, Caucasian, slender, and those who have had a bilateral oophorectomy or early menopause are at increased risk for developing osteoporosis-related fractures. Approximately 15% of Caucasian women older than age 50 years suffer hip fractures, and approximately 1.5% of women in this population die as a result. According to a recent meta-analysis, use of estrogen was associated with a 25% decrease in the relative risk of hip fracture in women over age 50 years. Numerous observational and nonrandomized experimental studies suggest that the benefits of hormone replacement therapy (HRT) on bone mass and fracture risk wane after stopping estrogen. As a result, preventing fractures in older, postmenopausal women may require indefinite HRT. (See chapter 62 for information on osteoporosis.)

The use of estrogen to prevent coronary heart disease is currently being investigated in a multi-center prospective trial. Coronary heart disease causes approximately 30% of deaths of women over 50 years of age. A large case-control study was recently published that showed a reduced risk of mortality from all causes of 37% for women using post-menopausal HRT. According to Grodstein et al, the largest reduction in the risk of mortality was for coronary heart disease (53%); however, this protective effect was only statistically significant for women with one or more risk factors for cardiovascular disease. Other observational studies have shown that estrogen supplementation is associated with a 35% reduction in the relative risk of death from coronary heart disease. Estrogen supplementation also provides several benefits that improve climacteric symptoms, such as decreasing vasomotor symptoms (hot flushes or flashes) and alleviating genitourinary symptoms (dryness, urgency, incontinence, frequency).

Use of estrogen supplementation may, however, lead to significant adverse health outcomes. In women with an intact uterus who use estrogen for 10 to 20 years, the incidence of endometrial cancer increases eight-fold. Concomitant use of progestin decreases the risk of endometrial cancer to a level comparable to that of women not taking estrogen. Whether use of progestin will blunt any potential cardiovascular benefits of estrogen is unclear. Whether estrogen supplementation increases a woman's risk for breast cancer also remains controversial. This potential risk appears not to be associated with short-term estrogen use (fewer than 5 years), but may increase by approximately 25% with more than 10 years of estrogen use. Adding progestin to estrogen supplementation does not appear to protect against the risk of breast cancer. Estrogen increases the risk of venous thromboembolism.

American Academy of Family Physicians --

All perimenopausal women should be counseled about the benefits and risks of postmenopausal HRT.

American College of Obstetricians and Gynecologists, American College of Physicians (ACP), Canadian Task Force on the Periodic Health Examination, and US Preventive Services Task Force (USPSTF) --

All perimenopausal and postmenopausal women should be counseled regarding the probable risks and benefits of HRT, so that they can participate fully with their health care provider in deciding whether to take preventive hormone therapy. According to the USPSTF, there is insufficient evidence to recommend for or against HRT in all postmenopausal women. According to the ACP, all women, regardless of race, should consider preventive hormone therapy. Women who have had a hysterectomy are likely to benefit from estrogen therapy. There is no reason to add progestin to the hormone regimen in such women. Women who have coronary heart disease or who are at increased risk for coronary heart disease are more likely to benefit from HRT. If such women have a uterus, progestin should be added to the estrogen therapy unless careful endometrial monitoring is performed. The risks of HRT may outweigh its benefits in women who are at increased risk for breast cancer.

Table 47.1 presents the relative risk of selected conditions associated with long-term HRT. In addition, consider the following factors:

• Coronary heart disease risk factors, such as family history, blood pressure, weight, smoking status, cholesterol
• Osteoporosis risk factors, such as race, body build, physical activity level, bone mineral density
• Breast cancer risk factors, such as personal and family history, late parity (after age 30 years), early menarche (before age 12 years), and late menopause (after age 50 years)
• Patient desire to decrease climacteric symptoms, such as decreased vasomotor and genitourinary tract symptoms
• Patient tolerance for side effects, such as endometrial bleeding and breast tenderness
• Patient willingness to participate in follow-up, such as endometrial sampling and mammography

To prevent irreversible bone loss, begin estrogen replacement soon after the onset of menopause. An absolute upper age limit for estrogen replacement has not been established. Use of progestin or careful endometrial monitoring is recommended for women with intact uteri.

Several different regimens for hormone replacement have been developed. Oral preparations have been better evaluated for primary prevention than has transdermal or other routes of administration. The most common initial oral dosage in the United States is 0.625 mg of conjugated estrogen taken every day. For women who cannot tolerate this dosage, 0.3 mg of conjugated estrogen daily with 1500 mg of calcium daily may provide protection against bone loss. Cyclic regimens of estrogen have been widely used, but they provide no physiologic advantages and cause patient confusion. Progestin may be given cyclically or continuously. The usual dosage for cyclic administration is 5 mg to 10 mg of progesterone acetate (or equivalent) daily for the first 10 to 14 days of the month. The usual dosage for continuous administration of progesterone acetate is 2.5 mg daily.

Contraindications to estrogen replacement include:

• Unexplained vaginal bleeding
• Active liver disease
• Chronic impaired liver function
• Recent venous thrombosis (with or without emboli)
• Carcinoma of the breast
• Endometrial carcinoma, except in certain circumstances

Conditions that may be relative contraindications to estrogen replacement include:

• Seizure disorders
• Hypertension
• Uterine leiomyomas
• Familial hyperlipidemia
• Migraine headaches
• Thrombophlebitis
• Endometriosis
• Gallbladder disease

The most common side effects of estrogen therapy include endometrial bleeding, breast tenderness, nausea, bloating, and headaches. Other risks include an increased risk of endometrial cancer and the potential risk of breast cancer and thromboembolic events. When a progestin is added to estrogen therapy, the most common side effects are bloating, weight gain, nausea, irritability, breast tenderness, and depression. These symptoms generally can be alleviated by decreasing the dose of progestin. If progestin is used in a continuous regimen, it causes unpredictable endometrial bleeding in 30% to 50% of women. Such bleeding abates after 6 to 8 months of use because of uterine atrophy.

The American College of Physicians (1992) has issued the following recommendations for surveillance of endometrial cancer in women taking estrogen:

At onset of treatment:

• Pelvic examination
• Endometrial evaluation (endometrial biopsy, transvaginal ultrasound, or dilatation and curettage) to rule out hyperplasia or cancer

Evaluation of vaginal bleeding:

• Any episode of vaginal bleeding should prompt evaluation by endometrial biopsy, transvaginal ultrasound, or dilatation and curettage unless the woman has had a normal evaluation in the previous 6 months

Frequency of screening while on treatment:

• Probably yearly

At onset of treatment:

• Pelvic examination
• No endometrial evaluation required

Evaluation of vaginal bleeding:

• For women on cyclic estrogen-plus-progestin therapy: If bleeding occurs other than at the time of expected withdrawal bleeding (days 10 through 15 if the progestin is given on days 1 through 10), an endometrial biopsy, transvaginal ultrasound, or dilatation and curettage should be performed.
• For women on continuous estrogen-plus-progestin therapy: If bleeding is heavy (heavier than a normal menstrual period), prolonged (more than 10 days), or frequent (more often than monthly), and if bleeding persists longer than 10 months after beginning therapy, an endometrial biopsy, transvaginal ultrasound, or dilatation and curettage should be performed.

Frequency of screening while on treatment:

• No routine screening required

Both the American College of Obstetricians and Gynecologists and the American College of Physicians recommend screening for breast cancer at the same frequency and with the same methods as those used for women who are not taking estrogen/progestin replac ement.

Hormone Replacement Therapy: Facts To Help You Decide; Action for a Healthier Life: A Guide for Mid-Life and Older Women. American Association of Retired Persons, Fulfillment Services, 601 E St, NW, Washington, DC 20049; (202)434-2277.

Osteoporosis in Women: Keeping Your Bones Healthy and Strong. American Academy of Family Physicians, 8880 Ward Parkway, Kansas City, MO 64114-2797; (800)944-0000. Internet address: http://www.aafp.org

Age Page Osteoporosis: The Bone Thinner; Age Page -- Should You Take Estrogen? National Institute on Aging, Bldg 31, Room 5C27, 31 Center Dr MSC 2922, Bethesda, MD 20892-2922; (301)496-1752. Internet address: http://www.nih.gov/nia/health/pubpub/pubpub.htm

Hormone Replacement Therapy; Preventing Osteoporosis. American College of Obstetricians and Gynecologists, 409 12th St SW, Washington, DC 20024; (800)762-2264. Internet address: http://www.acog.org

Table 47.1. Relative Risk of Selected Conditions for a 50-Year-Old White Woman Treated with Long-Term Hormone Replacement

At least 200,000 new hepatitis B virus (HBV) infections occur yearly in the United States. Most of these infections occur in young adults, primarily as a result of blood or sexual contact. ( See Table 48.1 for a list of groups at high risk for infection.) HBV infection causes significant morbidity and mortality. Approximately 30% to 40% of infected persons become ill with jaundice, and each year approximately 15,000 hospitalizations and 350 to 450 deaths are attributable to acute HBV infection. Between 1% and 10% of adults with acute HBV infection become chronically infected. Chronic active HBV infection develops in an estimated 25% of individuals with chronic infection. Cirrhosis and liver failure ultimately develop in 3000 to 4000 of these persons annually. The risk of liver cancer is significantly increased in individuals with chronic HBV infection. HBV-related liver cancer leads to 1000 to 1500 deaths annually in the United States.

Hepatitis B vaccine is 95% effective in preventing HBV infection. Among vaccine recipients in whom adequate antibody levels develop, the effectiveness is virtually 100%. The antibody response to hepatitis B vaccination is decreased in patients with human immunodeficiency virus (HIV) infection, those undergoing hemodialysis, and persons aged 40 years and older. Furthermore, antibody levels decrease with time. After 7 years, antibody levels are low or undetectable in as many as 50% of vaccine recipients. However, patients with normal immune systems continue to be protected against infection.

For persons experiencing percutaneous or sexual contact with HBV, administration of hepatitis B immune globulin (HBIG) is approximately 75% effective for preventing infection.

Hepatitis B is currently designated as an infectious disease notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

See chapter 14 for information on hepatitis B immunization and prophylaxis for children and adolescents.

All major authorities, including Advisory Committee on Immunization Practices, American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists, American College of Physicians, and US Preventive Services Task Force (USPSTF) --

Individuals in groups at increased risk for HBV infection ( see Table 48.1) should be vaccinated with the hepatitis B vaccine. The USPSTF has also recommended routine immunization of all young adults not previously immunized. The AAFP recommends offering immunization to young adults to age 24 years who have no reliable history of HBV infection or previous immunization.

All major authorities, including Advisory Committee on Immunization Practices, American College of Physicians (ACP), Canadian Task Force on the Periodic Health Examination, and US Preventive Services Task Force --

HBIG should be used for prophylaxis of unimmunized or inadequately immunized adults exposed to percutaneous or mucosal contact with hepatitis B surface antigen (HBsAg)-positive blood or sexual contact with a person with acute HBV infection. ACP has also recommended HBIG use after sexual contact with an asymptomatic person who is HBsAg-positive.

Two types of recombinant-derived hepatitis B vaccines are currently licensed for use in the United States -- Recombivax HB and Engerix-B. These vaccines may be used interchangeably at any point in the vaccination schedule. Plasma-derived vaccine is no longer distributed in the United States.

Both vaccines are given as a three-dose series, with the second and third doses administered 1 and 6 months after the first dose. If a three-dose series is interrupted after the first dose, administer the second dose as soon as possible. Separate administration of the second and third doses by at least 2 months. A four-dose series (at 0, 1, 2, and 12 months), which may induce immunity faster than a three-dose series, has been approved for Engerix-B vaccine but has not been shown to be advantageous in clinical trials. Upon completion, both the three- and four-dose regimens confer essentially the same level of immunity. For hemodialysis patients, the fourth dose of Engerix-B vaccine should be given 6 months (rather than 12 months) after the first dose. Patients in whom postvaccination testing shows inadequate antibody response after the initial vaccination series may receive one or more additional doses of vaccine.

In adult populations at high risk for HBV infection, prevaccination antibody testing with hepatitis B core antibody (anti-HBc) and hepatitis B surface antibody (anti-HBs) may be cost-effective. The decision to undertake prevaccination testing should take into account the cost of vaccination, the cost of testing for susceptibility, and the expected number of immune individuals. Also consider the likelihood of patient follow-up and vaccine delivery after prevaccination testing.

Postvaccination testing is indicated for immunocompromised persons who are at continued risk of HBV infection (eg, dialysis patients), because their future medical management may depend on knowledge of their immune status. Persons at occupational risk with continued percutaneous/mucosal exposures (eg, sharp injuries, blood splashes) should be tested after vaccination, because knowledge of their antibody status is needed to determine proper postexposure prophylaxis. All health care workers who have contact with patients or blood (eg, physicians, nurses, operating room technicians, dentists, dental hygienists, emergency medical technicians, phlebotomists, laboratory technologists/technicians, physician assistants, nurse practitioners) should be tested. Health care personnel who were vaccinated as students should also undergo postvaccination testing. Postvaccination testing is not indicated for persons at low risk of continued mucosal or percutaneous exposures to blood (eg, public safety workers, health care workers without direct patient contact). Consider postvaccination testing of sexual partners of persons with chronic HBV infection. If such contacts are aware of their immune status, those who are vaccine nonresponders can use methods to prevent sexual transmission of HBV infection.

Perform postvaccination antibody testing between 1 and 2 months after completion of the vaccine series. Maximum antibody response occurs at approximately 6 weeks following the third dose of vaccine. Antibody has been shown to disappear within 6 months of vaccination in adults.

For adults older than 19 years of age, the recommended dose of both types of vaccine is 1 mL given intramuscularly. ( See Table 14.2 for recommended doses of hepatitis B vaccine for individuals 19 years of age and younger.) The proper injection site is the deltoid muscle; injection into the buttock results in decreased antibody response because of deposition of vaccine into fat. Hepatitis B vaccine may be given concurrently with HBIG and other vaccines but at different sites. Increase the dose for hemodialysis patients and those who are immunocompromised. The Advisory Committee on Immunization Practices recommends using either 1 mL of a special formulation of Recombivax HB containing 40 m g or two 1-mL doses of Engerix-B given at the same site.

The only contraindication to hepatitis B vaccination is prior anaphylaxis or severe hypersensitivity to the vaccine or its components. Pregnancy and lactation are not contraindications to vaccination.

The side effects of hepatitis B vaccination are relatively minor and include pain at the injection site (3% to 29% of patients) and temperature higher than 37.7 ° C (100 ° F) (1% to 6% of patients). The reported rate of occurrence of Guillain-Barré syndrome is very low (0.5 cases per 100,000 population) among adults receiving plasma-derived HBV vaccine. No such association has been found with the use of recombinant hepatitis vaccines, although insufficient data are available from which to draw firm conclusions on this issue. The estimated incidence of anaphylaxis is low (one case per 600,000 doses distributed). Very rarely hepatitis B vaccine may cause a life-threatening hypersensitivity reaction in certain individuals.

Any adverse side effects should be reported to the Vaccine Adverse Events Reporting System (VAERS). See Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

The US Department of Health and Human Services has developed vaccine information statements about hepatitis B vaccination (see Patient Resources). These statements must be available to patients in facilities where federally purchased vaccines are used, and their availability in other settings is encouraged.

Store vaccine at 2 ° to 8 ° C (36 ° to 46 ° F); freezing the vaccine will destroy its potency. Do not use vaccine that has been frozen. Handle all vaccine preparations according to manufacturers' instructions.

According to the Advisory Committee on Immunization Practices (ACIP), all susceptible sexual partners of persons with acute HBV infection should receive a dose of HBIG if prophylaxis can begin within 14 days of the last sexual exposure; the HBV vaccine series should also be started. HBIG is not recommended for sexual contacts of persons with chronic HBV infection. For postexposure prophylaxis of persons not previously vaccinated, ACIP recommends use of hepatitis B vaccine in addition to HBIG. An alternative treatment for exposed individuals who would not routinely be considered at high risk and in need of vaccination is to administer one dose of HBIG (without vaccine) and retest the sex partner's HBsAg status 3 months later. If the sex partner has become HBsAg-negative, no further treatment is needed. If the sex partner is still HBsAg-positive, a second dose of HBIG should be given and a vaccination series begun. Adult household contacts of individuals with acute HBV infection do not need prophylaxis with HBIG unless they have had identifiable blood exposure, such as that which occurs by sharing a toothbrush or razor with the infected individual. Patients with such exposures should be treated in the same manner as patients with sexual exposure. If the index patient becomes a HBV carrier, all household contacts should receive hepatitis B vaccine. The recommendations of ACIP for HBV prophylaxis following percutaneous or mucosal exposure to blood and for sexual contacts of persons with acute HBV infection are given in Table 48.2.

Administer HBIG as soon as possible after exposure to infection. HBIG may be given as late as 14 days after exposure, but the effectiveness of HBIG is uncertain if it is given 7 days or more after exposure. If the patient is known to have been nonresponsive to a primary HBV vaccination series (by anti-HBsAg level), give a second injection of HBIG 1 month later in lieu of a vaccine booster dose.

The recommended dose of HBIG is 0.06 mL/kg given intramuscularly. The preferred site for administration in adults is the deltoid muscle. If the gluteal region is used, administer the vaccine only to the upper, outer quadrant. Before injection, draw back the plunger to verify that injection into a vein or artery will not occur. HBIG and hepatitis B vaccine may be given concurrently but at different sites.

Use HBIG with caution in patients with a history of hypersensitivity to human immune globulin (IG) preparations or thimerosal.

The main side effects of HBIG injection are pain and swelling at the injection site. Urticaria, angioedema, and very rarely, anaphylaxis can occur. HIV is not known to be transmitted by HBIG injection.

Hepatitis B: What Patients Need To Know. US Department of Health and Human Services. Available from state and local health departments.

Resource Guide for Adult Immunization, 2nd ed. Provides a comprehensive listing of materials relevant to adolescent and adult immunization. To receive a free, single copy write to National Center for Adult Immunization Resource Guide, 4733 Bethesda Ave, Suite 750, Bethesda, MD 20814-5228; fax: (301)907-0878. E-mail address: adultimm@aol.com

Hepatitis B Fact Sheets (set of three: adolescents, high risk adults, and health care providers). To receive a free sample set, write to National Center for Adult Immunization Resource Guide, 4733 Bethesda Ave, Suite 750, Bethesda, MD 20814-5228; fax: (301)907-0878. E-mail address: adultimm@aol.com

Table 48.1. Groups at High Risk for Hepatitis B Virus Infection

Table 48.2. Recommendations for Hepatitis B Prophylaxis Following Percutaneous Exposure

Influenza is a significant cause of mortality and morbidity in the United States. Between 1972 and 1992, at least 10,000 deaths occurred in each of nine separate influenza epidemics in the United States. In four of these epidemics, more than 40,000 deaths occurred. Approximately 90% of influenza-related deaths occur in persons aged 65 years and older. Older adults with underlying health problems, such as pulmonary or cardiovascular disorders, are at particularly high risk of death and serious illness from influenza. Nonelderly adults and children with certain chronic medical problems are also at increased risk for influenza-related complications (Table 49.1).

Influenza vaccine is approximately 50% to 60% effective in preventing hospitalizations and pneumonia and 80% effective in preventing death in older adults. Approximately 55% of noninstitutionalized older adults receive immunization annually. The antiviral agents amantadine and rimantadine are 70% to 90% effective for preventing influenza type A illness in adults, but these medications do not prevent influenza type B.

Advisory Committee on Immunization Practices, American Academy of Family Physicians, American College of Physicians, American Geriatrics Society, Canadian Task Force on the Periodic Health Examination, and US Preventive Services Task Force --

Influenza immunization should be provided annually to all individuals 65 years of age or older. Immunization should also be provided to adults and children at least 6 months of age who are at increased risk for influenza-related complications due to certain medical conditions, such as chronic pulmonary and cardiovascular disorders (Table 49.1), or who may transmit influenza to individuals at increased risk, such as health care workers and household members (Table 49.2).

American College of Obstetricians and Gynecologists --

All women 60 years of age and older should receive immunization against influenza yearly.

Advisory Committee on Immunization Practices (ACIP), American College of Physicians, and US Preventive Services Task Force --

Amantadine and rimantidine may be used prophylactically in the following situations: (1) for high-risk persons who have not yet received the vaccine or are vaccinated after influenza type A activity in the community has already begun, (2) for unimmunized persons who provide care for high-risk persons, (3) for immunocompromised patients and others expected to have a suboptimal response to immunization or (4) for high-risk persons in whom the vaccine is contraindicated (eg, those with anaphylactic hypersensitivity to egg protein). ACIP stipulates that use is only appropriate in persons older than 1 year of age.

Canadian Task Force on the Periodic Health Examination --

There is good evidence that early daily administration of amantadine to high-risk persons and to unvaccinated persons exposed to influenza type A during an outbreak of influenza reduces the spread of the infection.

Two basic types of influenza vaccine are available; one is prepared from whole-virus particles, and the other is prepared from split-virus particles. Either type of vaccine is equally appropriate for use in adults and children older than age 12 years. Use only the split-virus preparation in children aged 12 years or younger. The vaccines are trivalent containing viruses or virus particles from three strains: two type A and one type B. The mixture of viruses used is updated annually according to antigenic change in the viruses causing infection.

Administer influenza vaccine annually, preferably shortly before the onset of the influenza season. Because antibody levels decline with time, do not give immunizations too early in the season. Because the influenza season in the United States usually begins in December, the period between October and mid November is usually the optimal time for immunization campaigns. Take advantage, however, of the opportunity to begin immunizing all high-risk patients, including older adults, who are seen for health care beginning in September. Immunization programs may begin as soon as the current vaccine is available if regional influenza activity is expected to begin earlier than December. Offer immunization up to and even after the time that influenza virus activity is documented in a community. In some years, this activity may occur as late as April.

The recommended dose in adults and children aged 3 years and older is 0.5 mL, administered intramuscularly. The recommended dose for children aged 6 to 35 months is 0.25 mL. Use only split-virus vaccine for children aged 12 years and younger. Administer two doses of vaccine, at least 1 month apart, to children younger than age 9 years who have not previously been vaccinated; this approach maximizes the chance of a satisfactory antibody response. Administer the second dose before December, if possible. The vaccine may be given concurrently with pneumococcal vaccine and all routine childhood vaccines, including diphtheria-tetanus-pertussis vaccines (DTaP/DTP). Because the influenza vaccine can cause fever when administered to young children, DTaP (which is less frequently associated with fever and other adverse reactions) is preferable to DTP.

Do not routinely administer inactivated influenza vaccine to persons known to have anaphylactic hypersensitivity to eggs or other components of the influenza vaccine. Use of an antiviral agent (eg, amantadine or rimantadine) is an option for preventing influenza type A in such persons. Persons who have a history of anaphylactic hypersensitivity to vaccine components but who are also at high risk for complications of influenza may benefit from vaccination after appropriate allergy evaluation and desensitization. Specific information about vaccine components can be found in package inserts for each manufacturer. Do not vaccinate adults with acute febrile illness until their symptoms have abated. The presence of minor illness, with or without fever, is not a contraindication to use of influenza vaccine, particularly in children with mild upper respiratory tract infection or allergic rhinitis.

Because influenza vaccine contains only noninfectious viruses, it cannot cause influenza. Respiratory disease that occurs after vaccination represents coincidental illness unrelated to influenza vaccination. Adverse reactions to vaccination generally are mild. Soreness at the site of injection persisting up to 2 days is the most common side effect. Fever, malaise, myalgia, and other systemic symptoms occur infrequently; these symptoms may occur as early as 6 hours after immunization and can persist for as long as 48 hours. Rarely, an immediate allergic reaction can occur. Guillain-Barré syndrome was associated with swine flu immunization in 1976, but has not subsequently been clearly associated with influenza immunization.

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). See Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

Educational efforts and outreach to older adults are necessary to attain better rates of influenza immunization. Distribution of informational brochures, use of posters in office waiting rooms, and mailing of reminder postcards are useful interventions to improve immunization rates.

The US Department of Health and Human Services has developed vaccine information statements about influenza vaccination (Patient Resources). These statements must be available to patients in facilities where federally purchased vaccines are used, and their availability in other settings is encouraged.

Discard all unused vaccine from the previous year. Store vaccine at 2 ° to 8 ° C (36 ° to 46 ° F), and do not freeze. Handle all vaccine preparations according to manufacturers' instructions.

Amantadine or rimantadine may be administered daily for 2 weeks following immunization during a community outbreak of influenza type A. For immunodeficient patients and patients for whom influenza vaccine is contraindicated, amantadine or rimantadine may be administered daily for the duration of a community outbreak. When used for control of institutional outbreaks, amantadine and rimantadine should be administered for at least 1 week after the outbreak is terminated.

See Table 49.3.

Use amantadine or rimantadine with caution in patients who have reduced renal function or a history of seizures or neuropsychiatric disorders. Use amantadine with caution in patients who take psychotropic medication.

Side effects occur in 5% to 10% of patients receiving amantadine. These reactions mainly affect the central nervous system (nervousness, anxiety, insomnia, difficulty concentrating, lightheadedness) and gastrointestinal tract (anorexia or nausea). More serious but less common central nervous system side effects (seizures, confusion) associated with amantadine use have affected older people, those with renal failure, and those with seizure, mental, or behavioral disorders. Rimantadine may also cause central nervous system side effects but less frequently than amantadine. Side effects tend to diminish or resolve after 1 week of continuous use of either drug and cease after discontinuation.

Because rimantadine has only recently been approved for marketing, its safety in certain patient populations (eg, chronically ill and elderly persons) has not been thoroughly evaluated. Be aware that more than 90% of amantadine is excreted unchanged, whereas approximately 75% of rimantadine is metabolized by the liver. Both drugs and their metabolites are excreted by the
kidney.

Age Page What to Do About Flu; Age Page -- "Shots" for Safety; Age Page -- Pneumonia Prevention: Its Worth a Shot. National Institute on Aging, Bldg 31, Room 5C27, 31 Center Dr MSC 2922, Bethesda, MD 20892-2922; (301)496-1752; Internet address: http://www.nih.gov/nia/health/pubpub/pubpub.htm

Flu. National Institute of Allergy and Infectious Diseases, 31 Center Dr, Bldg 31, Room 7A50, Bethesda, MD 20892; (301)496-5717.

Vaccine Information Statement -- Influenza Vaccine: What you need to know before you or your child gets the vaccine, No. I1904. National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828. Other sources of this information are state and local health departments and the American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 69990-0927; (800)433-9016. Internet address: http://www.aap.org

Prevention and control of influenza, No. I1829; Six common misconceptions about vaccination and how to respond to them, No. 00-6561. National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, Atlanta, GA 30333; (404)639-8225. Fax (404)639-8828.

Table 49.1. Groups at Increased Risk for Influenza-Related Complications

Table 49.2. Groups That Can Transmit Influenza to Persons at High Risk

Table 49.3. Recommended Dosage for Amantadine and Rimantadine Prophylaxis

Streptococcus pneumoniae infections are a major cause of morbidity and mortality in the United States, causing up to 36% of cases of community-acquired pneumonia in adults and approximately 40,000 deaths annually. Bacteremia develops in up to 30% of patients with pneumococcal pneumonia. The risk of mortality from pneumococcal infection is particularly high in older adults; mortality from pneumococcal bacteremia may be as high as 40% among persons aged 84 years and older. Other groups at increased risk include the very young and persons with chronic cardiovascular and pulmonary conditions, organ transplants, diabetes mellitus, alcoholism, cirrhosis, functional or anatomic asplenia (eg, sickle cell disease or splenectomy), Hodgkin's and non-Hodgkin's lymphomas, multiple myeloma, renal failure, nephrotic syndrome, and human immunodeficiency virus (HIV) infection (Table 50.1).

The currently available 23-valent pneumococcal vaccine, which replaced a 14-valent vaccine in 1983, contains antigens for at least 85% to 90% of the serotypes of S. pneumoniae causing bacteremia in the United States. The 23-valent vaccine has a protective efficacy of approximately 60% (for included serotypes) for all patients. Efficacy of the vaccine may decrease with increasing age and as the period of time since vaccination increases. In immunocompromised patients and those with certain chronic illnesses, the initial antibody response to pneumococcal vaccine is lower and declines more rapidly.

Compliance with recommendations for immunization with pneumococcal vaccine has been poor. According to data from the 1994 Behavioral Risk Factor Survillance System, only 37% of persons aged 65 years and older report being vaccinated. Many opportunities for vaccination, such as during hospitalization or at discharge, are missed. Data suggest that two thirds of patients with serious pneumonia were hospitalized at least once during the preceding 3 to 5 years. Recent research indicates that predischarge vaccination of patients hospitalized for pneumonia of any etiology decreases the rate of subsequent hospitalization for pneumococcal disease in this group. The emergence of drug-resistant strains of S. pneumoniae emphasizes the need for preventing pneumococcal infections by improving vaccine coverage.

S. pneumoniae infection (drug-resistant invasive disease only) is currently designated as an infectious disease notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

Advisory Committee on Immunization Practices (ACIP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Physicians (ACP), and US Preventive Services Task Force (USPSTF) --

All immunocompetent persons 65 years of age or older should be immunized once with pneumococcal vaccine. Immunization is also indicated for persons younger than age 65 years with medical or living conditions that put them at risk for invasive pneumococcal disease.

ACP, USPSTF, and ACIP --

Routine revaccination is not recommended. ACP recommends that persons older than 65 years of age receive a second dose of vaccine if they received the vaccine more than 6 years previously and were less than 65 years of age at the time of primary vaccination. ACIP recommends a second dose of vaccine only in persons 65 years of age or older who received the vaccine more than 5 years previously and were less than 65 years of age at the time of primary vaccination. According to USPSTF, revaccination may be appropriate in immunocompetent persons at highest risk for morbidity and mortality from pneumococcal disease (eg, persons older than 75 years of age or with severe chronic disease) who were vaccinated more than 5 years previously.

American College of Obstetricians and Gynecologists --

All immunocompetent women 65 years of age or older should be offered immunization against pneumococcal disease. In addition, immunizations should be offered to immunocompetent women aged 19 to 64 years who have chronic conditions (eg, cardiopulmonary disorders, diabetes mellitus, renal dysfunction, alcoholism, cirrhosis) or who live in a chronic care facility.

Canadian Task Force on the Periodic Health Examination --

There is insufficient evidence to include vaccination or exclude it from the periodic health examination of immunocompetent persons 55 years of age or older living independently. There is good evidence to include vaccination in the periodic health examination of immunocompetent persons 55 years of age or older living in institutions and patients with sickle cell disease or a history of splenectomy.

Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) --

Immunocompromised persons older than age 2 years should receive immunization. ACIP recommends a one-time revaccination for persons over 2 years of age who are at highest risk for serious pneumococcal infection and those who are likely to have a rapid decline in pneumococcal antibody levels, provided that at least 5 years have passed since receipt of a previous dose of pneumococcal vaccine. According to the American College of Physicians, revaccination is recommended for immunocompromised adults who were vaccinated 6 or more years previously. AAP recommends considering revaccination in 3 to 5 years for immunocompromised children who will be 10 years of age or younger at the time of revaccination.

American Academy of Family Physicians --

Children over age 2 years and adolescents and adults with chronic cardiac or pulmonary disease, diabetes mellitus, or anatomic asplenia, as well as any person over age 2 years who lives in a special environment or social setting with an increased risk of pneumococcal disease should be vaccinated.

American College of Obstetricians and Gynecologists --

Women 19 years of age and older who are immunocompromised should be offered immunization against pneumococcal disease.

Canadian Task Force on the Periodic Health Examination --

There is fair evidence to exclude pneumococcal vaccination from the periodic health examination of immunosuppressed patients.

US Preventive Services Task Force --

There is insufficient evidence to recommend for or against pneumococcal vaccine as an efficacious vaccine for immunocompromised individuals, but recommendations for vaccinating these persons may be made on other grounds, including the high incidence and case-fatality rates of pneumococcal disease and minimal adverse effects from the vaccine. It may be appropriate to consider periodic revaccination in these high-risk immunocompromised patients, who are likely to have poor initial antibody response and rapid decline of antibodies after vaccination.

Only 23-valent vaccine is currently available in the United States. A protein-polysaccharide conjugate vaccine, which is immunogenic in infants, is currently under development; however, these vaccines are likely to contain fewer than 23 pneumococcal serotypes.

Some disagreement among authorities exists regarding the indications for vaccination and revaccination (see Recommendations of Major Authorities). Consider health-care contacts of all types, including hospitalizations, as opportunities to provide immunization to appropriate patients. If possible, vaccinate patients who are undergoing splenectomy at least 2 weeks before surgery.

The recommended dose for adults and children is 0.5 mL given intramuscularly or subcutaneously. Pneumococcal vaccine and influenza vaccine may be given concurrently but at different sites.

Known hypersensitivity to any of the vaccine components is a contraindication to vaccination. Revaccination may lead to an increased incidence of adverse reactions, particularly if revaccination is performed at intervals of 3 years or less.

Mild, local side effects, such as erythema and pain at the injection site, develop in approximately 50% of patients. Fever, myalgia, and severe local reactions are reported in fewer than 1% of persons vaccinated. Anaphylactic reactions are rare (approximately five reactions per 1 million doses of vaccine).

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). See Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

Educational efforts and outreach to older adults are necessary to attain better rates of pneumococcal immunization. The National Institute on Aging has developed patient education materials on pneumococcal vaccination (see Patient Resources).

Store vaccine at 2 ° to 8 ° C (36 ° to 46 ° F). Handle all vaccine preparations according to manufacturers' instructions.

Age Page "Shots" for Safety; Age Page -- Pneumonia Prevention: It's Worth a Shot. National Institute on Aging, Bldg 31, Rm 5C27, 31 Center Dr MSC 2922, Bethesda, MD 20892-2922; (301)496-1752. Internet address: http://www.nih.gov/nia/health/pubpub/pubpub.htm

Pneumococcal Polysaccharide Vaccine (MMWR 1997 Reprint); Immunization Is a Family Affair: Adults Need Them Too (Poster); Immunization of Adults: a Call to Action; Today's Health: Immunization 1995 (Videotape Segment on Vaccine Misconceptions); Six Common Misconceptions about Vaccination and How to Respond to Them. To order these and other materials, contact the National Immunization Program, M/S E-34, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, Atlanta, GA 30333; (404)639-8225; fax (404)639-8828.

Table 50.1. Groups at Increased Risk for Pneumococcal Disease

The incidence of rubella has decreased markedly since the rubella vaccine was introduced in 1969. However, in the adult population, rubella continues to be a concern for nonimmunized women of child-bearing age. When rubella is contracted during pregnancy, especially during the first trimester, it can result in miscarriage, stillbirth, or the development of congenital rubella syndrome (CRS). CRS develops in an estimated 85% of infants born to women who acquire rubella during the first trimester of pregnancy. The most frequently occurring clinical manifestations of CRS are deafness, low birth weight, hepatomegaly, splenomegaly, ocular defects, psychomotor retardation, congenital heart disease, and petechiae. In 1995, approximately 128 cases of rubella and 6 cases of CRS were reported.

Rubella vaccine is approximately 95% effective at conferring immunity, which is probably lifelong. Screening and subsequent immunization of susceptible women of childbearing age have been shown to decrease the incidence of CRS.

Rubella is currently designated as an infectious disease notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

See chapter 15 for information on immunization of children and adolescents against measles, mumps, and rubella.

Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), American College of Obstetricians and Gynecologists, American College of Physicians (ACP), Canadian Task Force on the Periodic Health Examination (CTFPHE), and US Preventive Services Task Force (USPSTF) --

Women of childbearing age who lack documented evidence of immunity or prior immunization should be immunized. The CTFPHE and USPSTF state that an acceptable alternative is to offer immunization to all women of childbearing age without consideration of immunity or prior immunization. Some authorities (ACIP, AAP, and ACP) recommend immunization of susceptible males as well. The CTFPHE and USPSTF state that there is insufficient evidence to recommend for or against vaccination of young men in settings where large numbers of susceptible adults of both sexes congregate, such as military bases or colleges, and that men in other settings should not be routinely vaccinated.

American College of Physicians --

All health care workers should have documented serologic immunity or be vaccinated.

American Academy of Family Physicians --

Clinicians should assure the immunity of women of childbearing potential by history, serology, or vaccination. All persons needing immunization should be given a single-dose vaccination. Adolescents and young adults in settings where such individuals congregate (eg, high schools, technical schools, and colleges) should be given a second dose at least 1 month after the first dose if they have not previously received a second dose.

Rubella vaccine is made from a live virus. The currently available vaccine is designated RA 27/3 and is available in either a monovalent form (rubella only) or in combinations: measles-rubella (MR), rubella-mumps, and measles-mumps-rubella (MMR). Any of these vaccines may be used in adults, but authorities recommend using MMR, unless it is contraindicated.

Screen all women of childbearing age for immunity to rubella. Immunize those who have neither documentation of prior immunization after 12 months of age nor documented immunity by antibody testing. Do not accept a reported history of infection as evidence of immunity. Antibody testing may be offered to persons suspected of lacking immunity, but authorities agree that immunization may be provided without such testing. Screening and vaccination may be considered for other adults, especially those living in high-risk settings (eg, colleges, military bases).

Administer a 0.5-mL dose of reconstituted vaccine (any type) subcutaneously, using a 5/8 in to 3/4 in, 23- to 25-gauge needle.

Do not administer rubella vaccine to pregnant women, and advise all women receiving the vaccine not to become pregnant for 3 months after vaccination. Counsel women who do become pregnant within 3 months of vaccination that concerns for the fetus exist but that generally interruption of the pregnancy is not necessary. Do not immunize patients who are immunocompromised (except those who are HIV-positive).

Immune globulin-containing preparations, such as immune globulin (IG), hepatitis B immune globulin (HBIG), varicella zoster immune globulin (VZIG), packed red blood cells, whole blood, or plasma, may interfere with the immune response to MMR vaccination. Therefore, do not administer MMR 2 weeks before or 3 to 11 months after such preparations are given (depending on the immune globulin content of the preparation). Repeat vaccination after the window of immune globulin interference has expired, or perform antibody testing to determine the patient's immunity status. The Advisory Committee on Immunization Practices provides detailed information regarding this issue in their general recommendations on immunization (see Selected References).

Do not delay administration of rubella or MMR vaccine to rubella-susceptible postpartum women even if they are receiving treatment for D (formerly Rh) sensitization with anti-Rh_o (D)IG (human) or any other blood product containing IG. Women who received anti-Rh_o (D)IG (human) during the last trimester of pregnancy or at the time of delivery and received postpartum rubella immunization should have their immunity confirmed by antibody level testing 3 months after immunization.

Delay immunizing adults who have a febrile illnesses. Use caution when administering rubella vaccine in the form of MMR to adults with a history of allergy to eggs. Do not administer rubella vaccine to adults who have experienced anaphylactic reactions to topically or systemically administered neomycin.

Arthralgia develops in approximately 25% of adults immunized with rubella vaccine, and 13% to 15% of immunized adults report arthritis-like symptoms. Such symptoms generally develop 1 to 3 weeks after vaccination, persist for 1 day to 3 weeks, and seldom recur. Rarely, recurrent arthralgia and sometimes arthritis persist for an extended length of time. Paresthesias and pain in the arms and legs may also rarely develop and follow the same course as arthralgias. These adverse reactions seem to occur more often in patients who are nonimmune after vaccination. Other adverse reactions include low-grade fever, rash, and lymphadenopathy.

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

The National Childhood Vaccine Injury Act requires health care providers to provide the following information to patients prior to administering MMR: (1) a concise description of the benefits of the vaccine, (2) a concise description of the risks associated with the vaccine, (3) notice of the availability of the National Vaccine Injury Compensation Program. See Appendix B for details. For additional information about this requirement, contact the Training Coordinator, National Immunization Program, Centers for Disease Control and Prevention: (404)639-8226.

Discard reconstituted vaccine that is not used within 8 hours. Store unreconstituted vaccine at 2 ° to 8 ° C (36 ° to 46 ° F) or colder; protect it from light. Handle all vaccine preparations according to manufacturers' instructions.

Measles, Mumps, and Rubella: What You Need to Know. US Department of Health and Human Services. This material is available from State and local health departments and from the American Academy of Pediatrics, Division of Publications, PO Box 927, Elk Grove Village, IL 60009-0927, (800)433-9016. Internet address: http://www.aap.org

Tetanus occurs almost exclusively in unvaccinated or inadequately vaccinated persons. Approximately 50 cases are reported each year in the United States. Sixty-seven percent of cases occur in adults over age 50 years. The overall case fatality rate is approximately 25%, but mortality is considerably higher among older adults than among groups of other ages. Serologic studies have demonstrated that approximately 30% of adults over 70 years of age lack protective levels of antitoxin antibodies. Immunization with tetanus toxoid is almost 100% effective for preventing illness. Tetanus immune globulin (TIG) is highly protective when given prophylactically for wound management.

Diphtheria immunization of children has reduced the incidence of this disease in the United States to fewer than 10 cases yearly; these cases occur primarily in adults. As with tetanus, most cases of diphtheria occur in unimmunized or incompletely immunized persons. The overall case fatality rate is 5% to 10%; death rates are higher (up to 20%) among children younger than age 5 years and adults older than age 40 years. Diphtheria immunization has resulted in serologic evidence of immunity in most children, but up to 60% of adults lack protective levels of antitoxin antibodies. Administration of a complete vaccination series substantially reduces the risk of developing diphtheria, and vaccinated individuals in whom disease develops have milder illness. Vaccination does not prevent carriage of the causative agent (Clostridium diphtheriae).

Tetanus and diphtheria are currently designated as infectious diseases notifiable at the national level. Refer to Appendix C for further information on nationally notifiable diseases.

See chapter 12 for information on the general clinical presentations of diphtheria, tetanus, and pertussis and for immunization and prophylaxis information for children and adolescents.

Advisory Committee on Immunization Practices, American College of Obstetricians and Gynecologists, and American College of Physicians (ACP) --

Adults should receive a tetanus-diphtheria (Td) booster vaccination every 10 years. ACP also recommends an alternative strategy of a single booster at 50 years of age for persons who have completed the full primary series, including the teenage and young-adult boosters.

American Academy of Family Physicians --

A tetanus-diphtheria (Td) vaccine series should be completed for adults who have not received the primary series. Booster vaccination should be given every 10 years or at least at age 50 years.

Canadian Task Force on the Periodic Health Examination --

Adults in good health should receive a tetanus booster vaccination every 10 years. Concomitant booster vaccination against diphtheria is optional.

US Preventive Services Task Force --

The series of combined tetanus-diphtheria (Td) toxoids should be completed for patients who have not received the primary series, and all adults should receive periodic Td boosters. The optimal interval for booster doses is not established. The standard regimen is to provide Td at least once every 10 years, but in the US, intervals of 15 to 30 years between boosters are likely to be adequate in persons who received a complete five-dose series in childhood.

There are three basic types of toxoid available for immunization of adults: tetanus and diphtheria toxoids adsorbed for adult use (Td), tetanus toxoid (TT), and tetanus toxoid fluid. Use Td unless immunization against diphtheria is not desired. US authorities recommend giving combined tetanus-diphtheria booster immunizations to adults because of the prevalence of low levels of diphtheria antitoxin antibodies in adults. Of the two single-antigen preparations available for tetanus immunization, TT is preferable because it is more immunogenic than the fluid preparation. Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTP) and diphtheria and tetanus toxoids adsorbed (DT) are for use in children under 7 years of age. Do not use these preparations in adults.

The standard regimen is to provide booster vaccinations every 10 years, although some authorities have recently stated that boosters may be given less frequently (see Recommendations of Major Authorities). If childhood immunizations have been received according to the usual schedule, with a booster dose at 14 to 16 years of age, the first adult vaccination will be needed at about 25 years of age. Administer three vaccinations to adults who have not received a primary series; give the second vaccination 4 to 8 weeks after the first, and give the third vaccination 6 to 12 months after the second. After administering this series, give booster vaccinations every 10 years.

A primary series may be completed without restarting with the first vaccination, regardless of how much time has elapsed between vaccinations. Because immunosuppressive therapies may reduce the immune response, defer vaccination for 1 month after discontinuation of immunosuppressive therapy.

For management of certain wounds, administration of a tetanus booster may be indicated if the patient has completed a primary series and 5 years have elapsed since the last vaccination (Table 52.1). Td booster should always be given as part of wound management when vaccination history is unknown or fewer than 3 doses have been received.

The recommended dose for all adult tetanus and diphtheria vaccines is 0.5 mL given intramuscularly, preferably in the deltoid muscle using a 1- to 1 1/2-inch, 20- to 25-gauge needle. Tetanus toxoid fluid may be given subcutaneously. Td, TT, or tetanus toxoid (fluid) may be administered concurrently with TIGs but different sites of delivery and separate syringes must be used.

A history of a neurologic or a severe hypersensitivity reaction (eg, anaphylaxis) following a previous dose is a contraindication to receiving diphtheria and tetanus toxoids.

If an anaphylactic reaction to a previous dose is suspected, perform intradermal skin testing to document immediate hypersensitivity before discontinuing tetanus toxoid vaccinations. Mild, nonspecific skin-test reactivity is common. Avoid administering vaccinations more frequently than every 10 years (except for management of certain wounds), because induction of high serum tetanus antitoxin antibody levels may lead to Arthus hypersensitivity reactions (severe local reactions starting 2 to 8 hours after a vaccination and often associated with fever and malaise). Patients who have experienced an Arthus reaction should not receive booster vaccinations more frequently than every 10 years, even for wound treatment. Do not vaccinate women during the first trimester of pregnancy.

Local reactions (usually erythema and induration, with or without tenderness) can occur after vaccination with Td or other preparations. Fever and other systemic reactions can occur but are less common. Arthus reactions can occur (as discussed above), particularly among patients who have received multiple tetanus boosters using the adsorbed preparations. Severe reactions (eg, anaphylaxis and neurologic complications) have been reported rarely.

Any adverse side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS). Refer to Table B.4 for a detailed listing of adverse events. VAERS forms and instructions are available in the FDA Drug Bulletin (Food and Drug Administration) and the Physician's Desk Reference or by calling the 24-hour VAERS information recording at (800)822-7967. Refer to Appendix B for details.

The National Childhood Vaccine Injury Act requires health care providers to provide the following information to patients prior to administering MMR: (1) a concise description of the benefits of the vaccine, (2) a concise description of the risks associated with the vaccine, (3) notice of the availability of the National Vaccine Injury Compensation Program. See Appendix B for details. For additional information about this requirement, contact the Training Coordinator, National Immunization Program, Centers for Disease Control and Prevention: (404)639-8226.

Store toxoids at 2 ° to 8 ° C (36 ° to 46 ° F); do not freeze. Do not use vaccine that has been frozen. Handle all vaccine preparations according to manufacturers' instructions.

Patients who may have been exposed to tetanus because of wounds may need prophylaxis via immediate passive immunization with tetanus immune globulin (TIG), active immunization with tetanus toxoid (preferably Td), or both. See Table 52.1 for guidelines on passive and active immunization according to the nature of the wound and the patient's immunization status.

The recommended adult dose of TIG is 250 units injected intramuscularly, preferably in the deltoid muscle. It can be given concurrently with tetanus toxoid, but it should be given at a different site and with a different syringe.

Avoid intravenous injection, which can cause an anaphylactic reaction.

The side effects of TIG are relatively minor (site soreness and mild temperature elevation), but a few cases of more serious side effects (anaphylaxis, angioneurotic edema, nephrotic syndrome) have been reported.

Age Page "Shots" for Safety. National Institute on Aging, Bldg 31, Room 5C27, 31 Center Dr MSC 2922, Bethesda, MD 20892-2922; (301)496-1752. Internet address: http://www.nih.gov/nia/health/pubpub/pubpub.htm

Table 52.1. Summary Guide to Tetanus Prophylaxis in Routine Wound Management