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Surgeon General Reports, SAMHSA TIPs, SAMHSA PEPs Put Prevention Into Practice (Static collection) Clinician's Handbook of Preventive Services, 2nd Edition. PPIP Adults and Older AdultsImmunization/Prophylaxis 46. Aspirin 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. Recommendations of Major Authorities
1. Indications 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. 2. DosageThe 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. 3. Contraindications/PrecautionsThe 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. 4. Adverse ReactionsSide 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. Provider Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Heart Association. . Heart and Stroke Facts: 1996 Statistical Supplement. Dallas, Tex: American Heart Association; 1995. American Heart Association. . Physicians' Health Study report on aspirin. Circulation. 1988. 77: -. Buring JE, Hennekens CH. . The Women's Health Study: summary of the study design. J Myocardial Ischemia. 1992. 4: 27-29. Canadian Task Force on the Periodic Health Examination. . Acetylsalicylic acid and the primary prevention of cardiovascular disease. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 56. Fuster V, Dyken ML, Vohonas PS, Hennekens C. . Aspirin as a therapeutic agent in cardiovascular disease. Circulation. 1993. 87: 659-675. (PubMed) Fuster V, Cohen M, Halperin J. . Aspirin in the prevention of coronary disease. N Engl J Med. 1989. 321: 183-186. (PubMed) Internal analgesic, antipyretic and antirheumatic drug products for over-the-counter human use; tentative final monograph. . Notice of proposed rulemaking (CFR 343. 10). Federal Register. November 16, 1988; 53:46204-46260. Manson JE, Stampfer MJ, Colditz GA, et al. . A prospective study of aspirin use and primary prevention of cardiovascular disease in women. JAMA. 1991. 266: 521-527. (PubMed) Physicians' Health Study Research Group, Steering Committee. . Final report from the aspirin component of the ongoing Physicians' Health Study. N Engl J Med. 1989. 321: 129-135. (PubMed) Peto R, Gray R, Collins R, et al. . A randomised trial of the effects of prophylactic daily aspirin among male British doctors. Br Med J. 1988. 296: 320-331. (PubMed) (Full Text in PMC) SALT Collaborative Group. . Swedish aspirin low-dose trial (SALT) of 75 mg aspirin as secondary prophylaxis after cerebrovascular ischaemic events. Lancet. 1991; 338:1345-1349. Juul-Moller S, Edvardsson N, Jahnmatz B, et. al. . Double-blind trial of aspirin in primary prevention of myocardial infarction in patients with stable chronic angina pectoris. Lancet. 1992; 340:1421-1425. Thun MJ, Namboodiri MM, Heath CW. . Aspirin use and reduced risk of fatal colon cancer. N Engl J Med. 1991. 325: 1593-1596. (PubMed) US Preventive Services Task Force. . Aspirin prophylaxis for the primary prevention of myocardial infarction. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 69. Willard JE, Lange RA, Hillis LD. . The use of aspirin in ischemic heart disease. N Engl J Med. 1992. 327: 175-181. (PubMed) 47. Estrogen and Progestin 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. Recommendations of Major Authorities
1. Considerations Table 47.1 presents the relative risk of selected conditions associated with long-term HRT. In addition, consider the following factors:
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. 3. ContraindicationsContraindications to estrogen replacement include:
Conditions that may be relative contraindications to estrogen replacement include:
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. 5. SurveillanceThe American College of Physicians (1992) has issued the following recommendations for surveillance of endometrial cancer in women taking estrogen: For Women Taking Unopposed EstrogenAt onset of treatment:
Evaluation of vaginal bleeding:
Frequency of screening while on treatment:
At onset of treatment:
Evaluation of vaginal bleeding:
Frequency of screening while on treatment:
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. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American College of Obstetricians and Gynecologists, Committee on Technical Bulletins. . Hormone Replacement Therapy. Washington, DC: American College of Obstetricians and Gynecologists; 1992. ACOG Technical Bulletin 166. American College of Obstetricians and Gynecologists. . Guidelines for Women's Health Care. Washington, DC: American College of Obstetricians and Gynecologists; 1996. American College of Physicians. . Guidelines for counseling postmenopausal women about preventive hormone therapy. Ann Intern Med. 1992. 117: 1038-1041. (PubMed) Barrett-Connor E, Bush TL. . Estrogen and coronary heart disease in women. JAMA. 1991; . 265: 1861-1867. (PubMed) Canadian Task Force on the Periodic Health Examination. . Prevention of osteoporotic fractures in women by estrogen replacement therapy. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 52. Grady D, Rubin SM, Petitti DB, et al. . Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med. 1992. 117: 1016-1037. (PubMed) Grodstein F, Stampfer MJ, Colditz GA, et al. . Postmenopausal hormone therapy and mortality. N Engl J Med. 1997. 336(25): 1769-1775. (PubMed) Henrich JB. . The postmenopausal estrogen/breast cancer controversy. JAMA. 1992. 268: 1900-1902. (PubMed) Mann KV, Wiese WH, Stachenko S. . Postmenopausal osteoporosis and fractures. In: Goldbloom RB, Lawrence RS. Preventing Disease: Beyond the Rhetoric. New York, NY: SpringerVerlag; 1990: chap 24. US Preventive Services Task Force. . Postmenopausal hormone prophylaxis. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 68. Tables 48. Hepatitis B 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. Recommendations of Major AuthoritiesImmunization
1. Vaccine Types 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. 2. ScheduleBoth 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. 3. Assessing ImmunityIn 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. 4. Dose and AdministrationFor 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. 5. Contraindications/PrecautionsThe 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. 6. Adverse ReactionsThe 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. 7. Patient EducationThe 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. 8. Vaccine Storage and HandlingStore 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. Basics of Hepatitis B Postexposure Prophylaxis1. Indications 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. 2. ScheduleAdminister 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. 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsUse HBIG with caution in patients with a history of hypersensitivity to human immune globulin (IG) preparations or thimerosal. 5. Adverse ReactionsThe 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. Patient Resources
American Academy of Family Physicians. . Recommendations for Hepatitis B Preexposure Vaccination and Postexposure Prophylaxis. Kansas City, Mo: American Academy of Family Physicians; 1992. American College of Obstetricians and Gynecologists. . Guidelines for Women's Health Care. Washington, DC: American College of Obstetricians and Gynecologists; 1996. American College of Physicians Task Force on Adult Immunization and Infectious Diseases Society of America. . Clinical issues regarding specific vaccines: hepatitis B. In: Guide for Adult Immunization. 3rd ed. Philadelphia, Pa: American College of Physicians; 1994:74-83. Canadian Task Force on the Periodic Health Examination. . The periodic health examination: 2. 1984 update. Can Med Assoc J. 1984. 130: 1278-1285. Centers for Disease Control. . Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1991. 40(No. RR-13): 1-25. Centers for Disease Control. . Protection against viral hepatitis: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1990. 39(No. RR-2): 1-26. Centers for Disease Control and Prevention. . Update: Recommendations to prevent Hepatitis B virus transmission United States. MMWR. 1995. 44: 574-575. US Preventive Services Task Force. . Adult immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 66. Tables
49. Influenza (Including Childhood Immunization) 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. Recommendations of Major AuthoritiesImmunization
1. Vaccine Types 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. 2. ScheduleAdminister 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. 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsDo 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. 5. Adverse ReactionsBecause 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. 6. Patient EducationEducational 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. 7. Vaccine Storage and HandlingDiscard 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. Basics of Influenza Prophylaxis1. Schedule 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. 2. Dosage and Administration3. Contraindications/Precautions 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. 4. Adverse ReactionsSide 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
American Academy of Pediatrics, Committee on Infectious Diseases. . Influenza. In: Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1994:275-283. American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American College of Physicians Task Force on Adult Immunization and Infectious Diseases Society of America. . Influenza. In: Guide for Adult Immunization. 3rd ed. Philadelphia, Pa: American College of Physicians; 1994:91-94. American Geriatrics Society, Clinical Practices Committee. . Prevention and Treatment of Influenza in the Elderly. New York, NY: American Geriatrics Society; 1988. Canadian Task Force on the Periodic Health Examination. . Prevention of influenza. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 61 and Appendix B. Centers for Disease Control and Prevention. . Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1996. 45(No. RR-5): 1-24. (PubMed) Centers for Disease Control and Prevention. . Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1997. 46(No. RR-9): 1-25. Murphy KR, Strunk RC. . Safe administration of influenza vaccine in asthmatic children hypersensitive to egg proteins. J Pediatr. 1985. 106: 931-933. (PubMed) US Preventive Services Task Force. . Adult immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 66. Tables
50. Pneumococcus (Including Childhood Immunization) 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. Recommendations of Major AuthoritiesImmunocompetent Persons
1. Vaccine Types 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. 2. ScheduleSome 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. 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsKnown 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. 5. Adverse ReactionsMild, 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. 6. Patient EducationEducational 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). 7. Vaccine Storage and HandlingStore vaccine at 2 ° to 8 ° C (36 ° to 46 ° F). Handle all vaccine preparations according to manufacturers' instructions. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Academy of Pediatrics, Committee on Infectious Diseases. . Pneumococcal infections. In: Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1994. American College of Obstetricians and Gynecologists. . Guidelines for Women's Health Care. Washington, DC: American College of Obstetricians and Gynecologists; 1996. American College of Physicians Task Force on Adult Immunization and Infectious Diseases Society of America. . Immunization for healthy adults. In: Guide for Adult Immunization. 3rd ed. Philadelphia, Pa: American College of Physicians; 1994: chap. 3. Atkinson W, Furphy L, Gantt J, et al, eds. . Epidemiology and Prevention of Vaccine-Preventable Diseases. Washington DC: Department of Health and Human Services-Public Health Service; 1996: chap 12. Broome CV, Breiman RF. . Pneumococcal vaccine past, present, and future. N Engl J Med. 1991. 325: 1506-1508. (PubMed) Butler JC, Breiman RF, Campbell JF, Lipman HB, Broome CV, Facklam RR. . Pneumococcal polysaccharide vaccine efficacy. JAMA. 1993. 270: 1826-1831. (PubMed) Butler JC, Hofmann J, Cetron MS, Elliott JA, Facklam RR, Breiman RF. . The continued emergence of drug-resistant Streptococcus pneumoniae in the United States: an update from the Centers for Disease Control and Prevention's Pneumococcal Sentinel Surveillance System. J Infect Dis. 1996. 174: 986-993. (PubMed) Canadian Task Force on the Periodic Health Examination. . Administration of pneumococcal vaccine. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 34. Centers for Disease Control and Prevention. . Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunizations Practices (ACIP). MMWR. 1997. 46(No. RR-8): 1-24. Centers for Disease Control. . Update on adult immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1991. 40(No. RR-12): 1-94. Centers for Disease Control and Prevention. . CDC Surveillance Summaries, August 1, 1997. MMWR. 1997;45(No. SS-3). Fedson DS, Harward MP, Reid RA, Kaiser DL. . Hospital-based pneumococcal immunization: epidemiologic rationale from the Shenandoah study. JAMA. 1990. 264: 1117-1122. (PubMed) Gable CB, Holzer SS, Engelhart L, et al. . Pneumococcal vaccine: efficacy and associated cost savings. JAMA. 1990. 264: 2910-2915. (PubMed) Hofmann J, Cetron MS, Farley MM, et al. . The prevalence of drug resistant Streptococcus pneumoniae in Atlanta. N Engl J Med. 1995. 333: 481-486. (PubMed) Plouffe JF, Breiman RF, Facklam RR; for The Franklin County Pneumonia Study Group. . Bacteremia with Streptococcus pneumoniae: implications for therapy and prevention. JAMA. 1996. 275: 194-198. (PubMed) Shapiro ED, Berg AT, Austrian R, et al. . The protective efficacy of polyvalent pneumococcal polysaccharide vaccine. N Engl J Med. 1991. 325: 1453-1460. (PubMed) US Preventive Services Task Force. . Adult immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 66. Tables 51. Rubella 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. Recommendations of Major Authorities
1. Vaccine Types 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. 2. Assessing ImmunityScreen 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). 3. Dose and AdministrationAdminister 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. 4. Contraindications/PrecautionsDo 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-Rho (D)IG (human) or any other blood product containing IG. Women who received anti-Rho (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. 5. Adverse ReactionsArthralgia 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. 6. Patient EducationThe 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. 7. Vaccine Storage and HandlingDiscard 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. Patient ResourceMeasles, 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 Selected ReferencesAdvisory Committee on Immunization Practices (ACIP). . General recommendations on immunization. MMWR. 1994. 43(No. RR-1): 1-38. Advisory Committee on Immunization Practices (ACIP). . Rubella prevention. MMWR. 1990. 39(No. RR-15): 1-18. American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American Academy of Pediatrics, Committee on Infectious Diseases. . Rubella. In: Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, Ill: American Academy of Pediatrics; 1994. American College of Obstetricians and Gynecologists. . Guidelines for Women's Health Care. Washington, DC: American College of Obstetricians and Gynecologists; 1996. American College of Physicians. . Guide for Adult Immunization. 3rd ed. Philadelphia, Pa: American College of Physicians; 1994:36. American College of Physicians Task Force on Adult Immunization and Infectious Diseases Society of America. . Rubella. In: Guide for Adult Immunization. 3rd ed. Philadelphia, Pa: American College of Physicians; 1994:125-129. Atkinson W, Furphy L, Gantt J, et al, eds. . Epidemiology and Prevention of Vaccine-Preventable Diseases. Washington DC: US Dept of Health and Human Services, Public Health Service; 1996: chap 8. Canadian Task Force on the Periodic Health Examination. . Screening and vaccinating adolescents and adults to prevent congenital rubella syndrome. In: The Canadian Guide to Clinical Preventive Health Care. Ottawa, Canada: Minister of Supply and Services; 1994: chap 12. Canadian Task Force on the Periodic Health Examination. . The periodic health examination 1979. Can Med Assoc J. 1979. 121: 1193-1254. (PubMed) (Full Text in PMC) Centers for Disease Control and Prevention. . General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994. 43(No. RR-1): 1-38. Centers for Disease Control. . Rubella prevention: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1990. 39(No. RR-15): 1-13. US Preventive Services Task Force. . Screening for vaccinating adolescents and adults to prevent congenital rubella syndrome. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 32. 52. Tetanus and Diphtheria 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. Recommendations of Major Authorities
1. Vaccine Types 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. 2. ScheduleThe 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. 3. Dose and AdministrationThe 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. 4. Contraindications/PrecautionsA 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. 5. Adverse ReactionsLocal 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. 6. Patient EducationThe 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. 7. Storage and HandlingStore 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. Basics of Tetanus Postexposure Prophylaxis1. Indications 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. 2. Dose and AdministrationThe 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. 3. Contraindications/PrecautionsAvoid intravenous injection, which can cause an anaphylactic reaction. 4. Adverse ReactionsThe 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. Patient Resources
American Academy of Family Physicians. . Summary of Policy Recommendations for Periodic Health Examination. Kansas City, Mo: American Academy of Family Physicians; 1997. American College of Obstetricians and Gynecologists. . Guidelines for Women's Health Care. Washington, DC: American College of Obstetricians and Gynecologists; 1996. American College of Physicians Task Force on Adult Immunization and Infectious Diseases Society of America. . Tetanus and diphtheria. In: Guide for Adult Immunization. 3rd ed. Philadelphia, Pa: American College of Physicians; 1994:130-133. Atkinson W, Furphy L, Gantt J, et al, eds. . Epidemiology and Prevention of Vaccine-Preventable Diseases. Washington DC: US Department of Health and Human Services, Public Health Service; 1996: chap 2-3. Canadian Task Force on the Periodic Health Examination. . The periodic health examination 1979. Can Med Assoc J. 1979. 121: 1193-1254. (PubMed) (Full Text in PMC) Centers for Disease Control. . Diphtheria, tetanus, and pertussis: guidelines for vaccine prophylaxis and other preventive measures. MMWR. 1985. 34: 405-426. Centers for Disease Control. . Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1991. 40(No. RR-10): 1-28. Centers for Disease Control and Prevention. . General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994. 43(No. RR-1): 1-38. Centers for Disease Control. . Update on adult immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1991. 40(No. RR-12): 1-94. Gergen PJ, McQuillan GM, Kiely M, Ezzati-Rice TM, Sutter RW, Virella G. . A population-based serologic survey of immunity to tetanus in the United States. N Engl J Med. 1995; 332: 761-6. US Preventive Services Task Force. . Adult immunizations. In: Guide to Clinical Preventive Services. 2nd ed. Washington, DC: US Department of Health and Human Services; 1996: chap 66. Tables
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