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General Principles for Immunizations. Federal Requirements for Vaccinators. Vaccine Information Statement (VIS) Give a current, take-home copy of the relevant VIS to the parent, legal representative, or adult recipient before each dose of each vaccine Use the VIS published by the CDC
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Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Federal Requirements for Vaccinators • Vaccine Information Statement (VIS) • Give a current, take-home copy of the relevant VIS to the parent, legal representative, or adult recipient before each dose of each vaccine • Use the VIS published by the CDC • Mandatory for vaccines covered under the VICP • Mandatory for vaccines purchased under federal contract • Encouraged for all other vaccines
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Federal Requirements for Vaccinators • Vaccine Information Statement (VIS) • Provide VIS for each component of combination vaccines if there is no VIS for the combination • Use visual or oral supplements for illiterate or blind patients • Translations are available
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Federal Requirements for Vaccinators • Permanent Medical Record or Office Log • Name of the VIS, publication date, and date it was given to the recipient • Patient signature is not required • VIS should not be construed as informed consent, which may be required in some states • Name and title of individual who administered the vaccine • Date of administration • Manufacturer • Lot number • Address where the permanent record is kept
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Federal Requirements for Vaccinators • Report to VAERS • Any event listed by the manufacturer as a contraindication to subsequent doses of the vaccine • Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination • Adhere to the Occupational Safety and Health Administration Bloodborne Pathogens Standard
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #1 • Any vaccines can be given at the same time (using separate sites) • Exception: VAR and smallpox vaccine • VAR PI warns against concomitant administration with PPSV23 (impaired response to VAR) VAR: varicella
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #2 • Live vaccines not given at the same time should be separated by at least 4 weeks • Exceptions • YFV may be given at any time after single-antigen measles vaccine • Live oral vaccines (RV and Ty21a) may be given at any time in relation to any other live vaccines • LAIV is not an exception YFV: yellow fever vaccine; RV: rotavirus; Ty21a: typhoid 21a; LAIV: live-attenuated influenza vaccine
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #3 • Different inactivated vaccines may be given at any time with respect to each other • Exception: The AAP recommends a minimum interval of 1 month between Tdap and MCV4-D (formulation with diphtheria toxoid conjugate, Menactra) if not given on the same day • Concern that too many doses of diphtheria toxoid in sequence can cause increased reactogenicity
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #4 • There are minimum acceptable intervals between doses of the same vaccine • Exceptions • The 4-day grace period (not applicable to RAB) • Early, accelerated, or compressed schedules in certain situations • Caveat • A minimum interval is a minimum interval except when it’s not • DTaP doses 3 and 4: 6 mo, but 4 is OK • VAR doses 1 and 2: 3 mo, but 28 days is OK RAB: rabies vaccine
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #5 • There are minimum ages for administration of all vaccines • Exceptions • HepB • BCG • Rabies vaccine
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #6 • Partial or fractional doses of a vaccine should never be used • Exception: None
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #7 • A multidose vaccine series should not be restarted if the recommended dosing interval is exceeded • Exception: Oral typhoid Ty21a
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #8 • Similar vaccines made by different manufacturers are interchangeable • Exception • Preference for using the same brand of DTaP, HPV, and RV for the entire series • Vaccination should not be deferred if same brand is not available
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #9 • There is no harm in vaccinating a person who has already had the disease or the vaccine • In fact, there is reason to vaccinate when disease can be caused by multiple serotypes • Exceptions • Too many doses of PPSV23 or tetanus or diphtheria toxoid-containing vaccines can cause increased reactogenicity • Increased reactogenicity if anthrax vaccine given to person who has had anthrax
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Rules by Which to Vaccinate: #10 • Live vaccines should be deferred after receipt of antibody-containing blood products • Exceptions • LAIV, Ty21a, RV, YFV, ZOS • MMR and VAR should not be deferred in postpartum women who received antibody-containing blood products during pregnancy, including anti-Rho(D) globulin
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Administration Errors
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Administration Errors
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Other Vaccination Pearls • Indications for serology • Prevaccination • Adults without personal history of chickenpox • Internationally adopted children (consider) • Postvaccination • HepB: high-risk health care workers and dialysis patients • RAB: pre-exposure prophylaxis for laboratory workers • Some cases of invalid dosing
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Other Vaccination Pearls • Physical examination not required for vaccination • Gloves not routinely needed • Not necessary to change needles after withdrawing vaccine from vial • Rubber stopper should be swiped with alcohol • Aspirating back on the syringe not necessary • Injections in the same area should be separated by ≥ 1 inch • Syringes should not be prefilled by the end user (exception: mass influenza immunization campaigns where only 1 vaccine type is being used)
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Contraindications • Contraindications increase likelihood of a serious adverse event • When present, vaccine should not be given • Permanent contraindications for all vaccines: severe allergy to vaccine or component
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Precautions • Might increase risk of a serious adverse event • Could compromise immunogenicity • Could be mistaken for a vaccine reaction • Default position: defer vaccination • Risk of deferral: susceptibility to disease • Risk of vaccination: largely theoretical • Considerations: epidemiology of disease, patient’s circumstances, missed opportunities
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Notable Contraindications • DTaP • Encephalopathy within 7 days of pertussis-containing vaccine • Progressive neurological disorder (until stabilized) • Allergic to components • Baker’s yeast: HepB, HPV • Rodent or neural proteins: JEV (JE-VAX) • Eggs: LAIV, IIV, YFV • Gelatin or neomycin: MMR, VAR
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Notable Contraindications • Pregnancy: LAIV, MMR, smallpox, VAR, ZOS • Immune impairment • Any: smallpox, Ty21a, YFV • Severe: LAIV, MMR, VAR, ZOS • Aspirin or salicylate therapy: LAIV • Untreated active TB: MMR, VAR, ZOS
IAC. http://www.immunize.org/catg.d/p4060.pdf. Accessed Nov 2010. Vaccine Screening Questions • Is the child sick today? • Does the patient have allergies to medicines, food, a vaccine component, or latex? • Has the patient had serious reactions to previous vaccinations? • Has the child had a health problem with lung, heart, kidney or metabolic disease (eg, diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy? • If the child is between 2 and 4 years, has a health care provider told you that the child had wheezing or asthma in the past 12 months?
Vaccine Screening Questions • Has the child, a sibling, or parent had a seizure; has the child had brain or other nervous system problems? • Does the child have cancer, leukemia, AIDS, or another immune system problem? • Has the child taken cortisone, prednisone, other steroids, anticancer drugs, or had radiation treatments in the past 3 months? • Has the child received a blood or blood product transfusion, been given immune globulin or an antiviral drug in the last year? • Is the child/teen pregnant or is there a chance of becoming pregnant in the next month? • Has the child received vaccinations in the past 4 weeks? IAC. http://www.immunize.org/catg.d/p4060.pdf. Accessed Nov 2010.
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Erroneous Contraindications • Mild acute illness with or without fever • Mild respiratory illness (including otitis media) • Mild gastroenteritis • Antibiotic or antiviral therapy • Low-grade fever, redness, pain, swelling after pervious dose • Prematurity (delay HepB in infants < 2000 gm whose mothers are HBsAg-negative) • Pregnant, unimmunized, or immunosuppressed household contact (except pre-event smallpox)
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Erroneous Contraindications • Breastfeeding (except pre-event smallpox) • Convalescent phase of illness • Exposure to an infectious disease • Positive tuberculin skin test without active disease • Simultaneous tuberculin skin test • Allergy to penicillin, duck meat or feathers, or environmental allergens • Fainting after previous dose • Seizures, SIDS, allergies, vaccine reactions in family members
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Erroneous Contraindications • Malnutrition • Lack of a previous physical exam in a well-appearing individual • Stable neurological condition (eg, CP, seizures, developmental delay) • Allergy shots • Extensive limb swelling after DTP, DTaP, or Td that is not an Arthus-type reaction • Brachial neuritis after previous dose of tetanus toxoid-containing vaccine • Autoimmune disease • History of the vaccine-preventable disease
Marshall G. The Vaccine Handbook. PCI Books, Inc: 2010. Use of Live Vaccines in Households of Immunosuppressed Individuals