Immunization Handbook

Transcription

1 Immunization Handbook Federated States of Micronesia Immunization February 2009 The FSM Department of Health, Education and Social Affairs wishes to acknowledge the contributions of the World Health Organization, UNICEF, and the U.S. Centers for Disease Control and Prevention in the production of this handbook. 1

2 TABLE OF CONTENTS PROGRAM GOAL,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, 3 PROGRAM OBJECTIVES... 3 IMMUNIZATION SCHEDULES... 4 Infant and Children Catch up schedule for children 4 months to 6 years Catch up schedule for children 7 years to 18 years NEW INFANT VACCINES Rotavirus vaccine Pneumococcal (PCV 7) ADULT AND ADOLESCENT VACCINES Influenza Pneumococcal disease Hepatitis b Rubella Adult tetanus, diphtheria, pertussis Human papillomavirus vaccine VACCINE ADMINISTRATION... 6 CONTRAINDICATIONS... 7 ADVERSE EVENTS REPORTING SYSTEM 8 VACCINE PROCUREMENT AND MANAGEMENT MONITORING AND PERFORMANCE INDICATORS WHATAVACCINATORNEEDSTODO HOW TO GIVE VACCINES SAFELY BEFORE IMMUNIZING PREPARE THE VACCINES KEEP VACCINES AT THE RIGHT TEMPERATURE MULTI DOSE VIAL POLICY RECORD IMMUNIZATIONS GIVEN THE IMMUNIZATION REGISTRY REFRIGERATOR TEMPERATURE MONITORING PARENTS/PATIENT ADVISE DTP MMR

3 Td OPV Hib Hepatitis B BCG What to do ADVERSE EVENTS FROM IMMUNIZATIONS VACCINE-PREVENTABLE DISEASES VITAMIN A SUPPLEMENTATION INFANTS BORN TO HBV CARRIER MOTHERS WHAT WE CAN EXPECT IN THE NEAR FUTURE

4 PROGRAM GOAL To improve child survival and health by controlling or eliminating targeted vaccine preventable diseases in the Federated States of Micronesia PROGRAM OBJECTIVES To immunize all infants and children against the following diseases: tuberculosis, hepatitis B, Haemophilus influenzae type b, poliomyelitis, diphtheria, tetanus, pertussis, rotavirus, influenza, pneumococcal disease, measles, mumps and rubella. To protect all pregnant women against tetanus and rubella. To provide vaccines free of charge for the target populations. To provide safe immunization using vaccines that have been stored and transported at the recommended temperature and are correctly prepared and administered. To introduce new vaccines, as appropriate based on assessment of disease burden, cost effectiveness, and affordability. 4

5 IMMUNIZATION SCHEDULES Infants and children Age Vaccine Birth BCG, Hep B1* 2 months OPV1, DTaP1, HepB2, Hib1,PCV7, Rotavirus 4 months OPV2, DTaP2, Hib2, PCV7, Rotavirus 6 months OPV3, DTaP3, Hep B3, PCV7, Rotavirus 12 months OPV4, DTaP4, Hib3, MMR1, PCV7 13 months MMR2** School entry (5 6 yrs) Adolescent (15 19 yrs) DTaP5*** Tdap or Td, HPV for girls *First dose of Hepatitis B vaccine is to be administered within 12 hours of birth and the second dose within 2 months of birth. ** Second dose MMR may be given anytime after 30 days of first dose. ***Fifth dose of DTaP recommended if fourth dose given before age 4 years. 5

6 Minimum Age for Dose 1 Catch up Schedule for Children Age 4 months through 6 years Minimum Interval Between Doses Dose 1 to Dose2 Dose 2 todose3 Dose 3 to Dose 4 Dose 4 to Dose DtaP 6 wks 4 wk 4wk 6 mo 6 mo IPV/OPV 6 wks 4 wk 4 wk 4 wk HepB Birth 4 wk 8wk MMR 12 months 4 wk Hib 6wk 4 weeks: if first dose given at age <12 months. 8 weeks: (as final dose) if first dose at age months. Pneumo PCV7 (Prevnar) 6wks No further dose needed if first dose given 15 months. 4 weeks: if first dose given at age <12 months and current age<24 months 8 weeks (as final dose) if first dose given at age 12 months or current age months. No further doses needed for healthy children if first dose given at age 24 months. 4 wk: if current age <12mo 8 wk (as final dose) if current age >12 mo and second dose given at age<15 mo. No further doses needed: if previous dose given at >15mo. 4 weeks: if current age<12 months 8 weeks(as final dose) if current age 12 months. No further doses needed for healthy children if first dose given at age 24 months. Rotavirus 6 wks 4 wks 4 wks 4wks 8wk (as final dose) This dose only necessary for children age 12 mo 5yr who received 3 doses before age 12 mo. 8 weeks: This dose only necessary for children aged 12 months 5 years who received 3 doses before age of 12 months. 6

7 Catch up Schedule for Children Age 7 through 18 years in the FSM Vaccine Dose 1 to Dose 2 Minimum Interval Between Doses Dose 2 to Dose 3 to Booster Dose Dose 3 Td: 4 weeks 6months 6 mo: if first dose given at age < 12 mo and current age < 11 y. 5 yrs: if first dose given at age >12 mo and third dose given at age <7 yrs and current age >11 yrs. 10 yrs: if third dose given >7 yr. OPV: 4 weeks 4weeks HepB: 4 weeks 8weeks MMR: 4 weeks Note: Hib and Pneumococcal vaccines are not recommended for children over 5 years. First dose of rotavirus vaccine must be given before 12 weeks and all three doses must be completed before 32 weeks. 7

8 NEW INFANT VACCINE Rotavirus Vaccine A new vaccine for rotavirus was approved by the ACIP in February 2006 is now available in the FSM. Rotavirus infections can result in severe non bloody diarrhea, usually preceded or accompanied by vomiting and fever. Transmission is presumed to be by the fecal oral route and no specific antiviral therapy is available. Rotavirus gastroenteritis most commonly occurs in infants and children between 4 and 24 months. Virtually all children are infected by 3 years of age. The licensed pentavalent rotavirus vaccine is an oral vaccine that contains 5 live reassortant rotaviruses. This oral vaccine is normally given at 2, 4, and 6 months of age. The timing of this vaccine is very tight. The first dose must be given before 12 weeks of age and all three doses must be completed before 32 weeks. Pentavalent rotavirus vaccine is provided in a squeezable plastic dosing tube with a twist off cap designed to allow for the vaccine to be administered directly to infants by mouth. Each tube contains a single 2 ml dose of the vaccine as a liquid buffered stabilized solution that is pale yellow in color but may have a pink tint. This formulation protects the vaccine virus from gastric acid and stabilizes the vaccine, allowing for storage at refrigerator temperatures (2 C 8 C) for 24 months. Pentavalent rotavirus vaccine should be administered as soon as possible after being removed from refrigeration. Pneumococcal Conjugate Vaccine (PCV7) Prevnar is the brand name for this vaccine marketed by Wyeth Pharmaceuticals. This vaccine protects against pneumococcal disease; clinical syndromes include pneumonia, bacteremia, and meningitis. While this organism attacks all age groups the highest rates of invasive pneumococcal disease occurs among young children, especially those younger than 2 years of age. Schedule: PCV7 is given at the same time as all other 8

9 routine childhood immunizations. Newborns: A three dose primary series at 2, 4, 6, followed by a booster dose at 12 to 15 months. (same schedule as HiB). Unvaccinated children 7 11 months; should receive 2 doses at least 4 weeks apart, followed by a booster dose at months. Unvaccinated children months; should be vaccinated with two doses separated by 8 weeks. (no booster) Unvaccinated healthy children months: should receive a single dose of PCV7. PCV7 (Prevnar) is never given after the fifth birthday. Adult & Adolescent Vaccines Immunization programs throughout the world have dramatically reduced many childhood infections. However, the disparity between the impacts of vaccine preventable diseases of adults compared with those of children is striking. Vaccinations are not only for children. Each year in the United States alone over 50,000 to 70,000 adults die of influenza, pneumococcal infections and hepatitis. These are all vaccine preventable diseases. Influenza Influenza (Flu) is a highly infectious viral disease. Classical influenza has an incubation period of 2 3 days and is characterized by abrupt onset of fever, myalgia (mainly back muscles), sore throat, nonproductive cough and headache. These systemic symptoms and fever usually last 3 or 4 days, rarely more than 5 days. The most common complication of flu is secondary bacterial pneumonia. Primary viral pneumonia is an uncommon complication with a high fatality rate. Other complications include myocarditis (inflammation of heart) and worsening of chronic bronchitis and other chronic pulmonary diseases. In the USA death rate is 0.5 to 1 per 1,000 cases. The elderly are at greatest risk of death. Persons over 65 years of age account for over 90% of deaths attributed to influenza and pneumonia. While the 9

10 death rate is high in older adults, the hospitalization rates for children under 12 months of age are also high. (Therefore, flu shots are recommended for children 6 months to 23 months of age.) Unlike areas with temperate climates such as the US mainland, Japan and Australia, the tropical FSM has no Flu Season. The risk of influenza transmission is the same throughout the year. Two types of influenza vaccine are available in the USA; Trivalent Inactivated Influenza vaccine, (TIV, injection) and the Live Attenuated Influenza Vaccine (aerosol mist). There is no evidence that one form is more effective than the other, however, only TIV is available from the FSM Department of Health. TIV is recommended for all persons 50 years of age and older, all children 6 23 months of age and pregnant women. Persons 6 month of age and older with a chronic medical condition should also receive TIV annually. These chronic conditions include: Pulmonary illnesses, such as emphysema, chronic bronchitis, or asthma. Cardiovascular illnesses, such as congestive heart failure Metabolic diseases, including diabetes mellitus Renal dysfunction Hemoglobinopathy, such as sickle cell disease Immunosuppression, including HIV infection Any condition that compromises respiratory function or handling of respiratory secretions. Annual FLU SHOTS may be administered to anyone (over age 6 months) wishing to avoid influenza. Since there is no Flu Season in the FSM the vaccine can be administered year around but always respecting the vaccine s expiration date. Pneumococcal Disease Streptococcus pneumoniae causes an acute bacterial infection which occurs throughout the world. S. pneumoniae is a human pathogen with the reservoir believed to be in the nasopharynx of asymptomatic human carriers. Transmission is by direct person to person contact via the respiratory 10

11 droplets and by autoinoculation in persons carrying the bacteria in their upper respiratory tract. The major clinical symptoms of pneumococcal disease are pneumonia (infection of lungs), bacteremia (infection in blood), and meningitis (infection of brain coverings). Pneumococcal pneumonia is the most common clinical presentation of pneumococcal disease in adults. Symptoms generally include an abrupt onset of fever and chills or rigors. Other symptoms include chest pains; cough productive of mucopurulent, rusty sputum, shortness of breath, rapid breathing, rapid heart rate, malaise and weakness. The case fatality rate is 5% 7% and may be much higher among elderly persons Pneumococcal bacteremia occurs in about 25% 30% of all patients with pneumococcal pneumonia. The overall case fatality rate is about 20% but may be as high as 60% among elderly patients. Pneumococcal meningitis causes 13% 19% of all cases of bacterial meningitis in the USA. Symptoms include headache, lethargy, vomiting, irritability, fever, seizures and coma. Case fatality is about 30% but may be as high as 80% among the elderly. Long term neurological damage is common among survivors. Pneumococcal Polysaccharide Vaccine (PPV23) should be administered routinely to all adults 65 years of age and older. The vaccine is also indicated for persons 2 years of age and older with normal immune systems that have a chronic disease, including cardiovascular disease, pulmonary disease, diabetes, alcoholism, cirrhosis, or spinal fluid leak. Most recipients need only a single lifetime dose of PPV23. Hepatitis B Adult Hepatitis B vaccine candidates include: Men who have sex with men Heterosexual with multiple partners Persons diagnosed with an Sexually Transmitted Disease Prostitutes 11

12 Injection drug users Inmates of long term correctional facilities Person receiving hemodialysis Healthcare workers Household members of chronically infected persons(carrier) The usual schedule for adults is two doses separated by no less than 4 weeks, and a third dose 4 6 months after the second dose. The first and third dose must be separated by no less than 16 weeks. Adults 20 years of age or older should receive 1 ml (10 mcg) of pediatric or adult formulation Recombivax HB (Merck) or 1 ml (20 mcg) of adult formulation Engerix B (GlaxoSmithKline). Rubella Prevention of Congenital Rubella Syndrome (CRS) is the main objective of the rubella vaccination program in the FSM. Rubella can be a disastrous illness in early pregnancy, leading to fetal death, premature delivery, and an array of congenital defects. Spontaneous abortion and stillbirths are common. Screening for MMR can be part of prenatal care but administer the vaccine only after delivery. After delivery but before discharge, all women should be vaccinated with MMR if they do not have proof of two doses of this rubella containing vaccine (rubella as a single antigen is not available in the FSM). This will protect the fetus during the next pregnancy. Adult Tetanus, Diphtheria, Pertussis Vaccines (Tdap: Boostrix and Adacel ) Following a complete childhood DTP series of five doses, a booster of Td is recommended at age years and every ten years thereafter. Two new Tdap products were approved for adolescents and adults in Currently Tdap is a one time only dose. This vaccine is now recommended as a routine substitute for a single Td dose in adults. All subsequent boosters should be Td vaccine. In order to reduce the pertussis risk to their new baby, immediate postpartum vaccination with Tdap vaccine is also recommended for new mothers, fathers and other adult 12

13 household members. A tetanus shot has been given as standard wound management in emergency rooms and clinics for decades. For adults who require tetanuscontaining vaccine as part of wound management, a single dose of Tdap is preferred to Td if they have not previously received Tdap. Human Papilloma Vaccine This new vaccine protects against infection from four strains of human papilloma virus (HPV), which are known to cause about 70 per cent of cases of cervical cancer as well as cancers of the vulva and vagina, and genital warts. This new, very expensive vaccine is now available in the FSM. ACIP Recommendations for the Use of Quadrivalent HPV Vaccine: Routine vaccination with three doses of quadrivalent HPV vaccine is recommended for females years of age. The vaccination series can be started in females as young as 9 years of age. Catch up vaccination is recommended for females years of age who have not been vaccinated previously or who have not completed the full vaccine series. Ideally, vaccine should be administered before potential exposure to HPV through sexual contact. The FSM is conducting a HPV catch up campaign in Each dose of quadrivalent HPV vaccine is 0.5 ml, administered intramuscularly. Quadrivalent HPV vaccine is administered in a three dose schedule. The second and third doses should be administered 2 and 6 months after the first dose. Once the series has started it is never necessary to repeat a dose. The body s immune system will remember the previous dose(s). Quadrivalent HPV vaccine can be administered at the same visit when other age appropriate vaccines are provided, such as Tdap, Td and MCV4. At present, cervical cancer screening recommendations have not changed for females who receive quadrivalent HPV vaccine. 13

14 Special situations: Quadrivalent HPV vaccine can be given to females who have an equivocal or abnormal Pap test, a positive Hybrid Capture II high risk test, or genital warts. Vaccine recipients should be advised that data from clinical trials do not indicate the vaccine will have any therapeutic effect on existing Pap test abnormalities, HPV infection or genital warts. Vaccination of these females would provide protection against infection with vaccine HPV types not already acquired. Lactating women can receive quadrivalent HPV vaccine. Females who are immunocompromised either from disease or medication can receive quadrivalent HPV vaccine. However the immune response to vaccination and vaccine effectiveness might be less than in females who are immunocompetent. Pregnancy: Quadrivalent HPV vaccine is not recommended for use in pregnancy. The vaccine has not been associated causally with adverse outcomes of pregnancy or adverse events to the developing fetus. However, data on vaccination during pregnancy are limited. Any exposure to vaccine during pregnancy should be reported to the CDC vaccine pregnancy registry at ( ). Contraindications to use of HPV vaccine: Quadrivalent HPV vaccine is contraindicated for people with a history of immediate hypersensitivity to yeast or to any vaccine component. Pregnant women Pregnant women who have been vaccinated with 3 or more doses of tetanus containing vaccines (DTP, DTaP, DT or TT) should receive an additional dose of TT during the pregnancy if the last dose was more than 10 years ago, up to a total of 5 doses. Pregnant women who have no 14

15 history of receiving tetanus vaccine as a child or adult, or have received only 1 or 2 doses of tetanus containing vaccine should follow the schedule below based on the number of doses received. Schedule for Women with no previous doses of Tetanus Vaccine. 1 st dose: at first contact (even early pregnancy 2 nd dose; at least 4 weeks after 1 st dose 3 rd dose: at least 6 months after second dose or during next pregnancy. 4th dose: at least 1 year after 3 r d dose or during subsequent pregnancy 5 th dose: at least 1 year after 4 th dose or subsequent pregnancy 15

16 VACCINE ADIMINSTRATION Use a sterile syringe and needle, for every injection. The needle should not be recapped, nor the syringe and needles ever separated. Used injection equipment is to be placed in a safety box and destroyed by incineration. Reconstituted vaccines (BCG, MMR) must be kept cool and protected from light and discarded at the end of 6 hours. The vaccine and the diluent must be from the same manufacturer. Multi dose vials of OPV, DTP, TT and Hep B vaccines can be used for up to 4 weeks, provided that all the following is fulfilled: 1. The expiry date has not passed 2. Vaccines are stored at an appropriate temperature. 3. The VVM, if attached, has not changed color enough to be discarded 4. Aseptic technique has been used to withdraw all doses 5. The punctured vial septum has not been submerged in non sterile water (ice water etc). 6. Date of first opening must be specified on the Label. All EPI vaccines may be given at the same time without affecting safety or efficacy. The vaccines should not be mixed in the same syringe and must each be given in a separate site. When a child is overdue for several vaccines, they should be given at the same visit. All staff routinely administering vaccines should be trained and have a copy of the FSM Immunization Handbook for ready reference. CONTRAINDICATIONS There are very few true contraindication (reasons for not giving a vaccine) and precaution conditions. Only two are 16

17 generally considered to be permanent: severe allergy to a vaccine component or severe allergic reaction following a prior dose of a vaccine, and encephalopathy (infection of the brain) within 7 days of pertussis vaccine. 10 Mild illness or fever is not a contraindication to immunization. However, a child who is very unwell, or who has a high fever (>38.5 C) should not be immunized. A child with previous anaphylactic reactions to a vaccine should not receive that vaccine. 17

18 ADVERSE EVENTS REPORTING SYSTEM The National Childhood Vaccine Injury Act (USA) of 1986 applies to the Federated States of Micronesia. All vaccine providers are required to report adverse events following immunization. The vaccine adverse event reporting system (VAERS) seeks to capture all clinically significant medical events occurring post-vaccination. The immunization coordinators in the four FSM states have the VAERS reporting forms to be filed out and sent to the FSM immunization program manager. VACCINE PROCUREMENT & MANAGEMENT Vaccine procurement is the responsibility of the State Immunization Coordinator and the National Immunization Program Manager. Vaccine requirements are to be estimated annually, and submitted to the National manager. Most vaccines are procured through the CDC contract system, while BCG and OPV are procured from UNICEF. A vaccine arrival report is to be completed for all international vaccine arrivals, and a decision made by the Immunization Program Manager as to the quality of the vaccine before use in the FSM. A computerized vaccine inventory with lot numbers, and expiration dates is to be maintained at the national and state level. Vaccines are to be protected from thermal damage during storage and transportation (conditioning of ice packs, monitoring and adjustment of cold chain equipment temperatures). Vaccine storage temperatures are to be monitored two times a day (morning and afternoon) and records kept for 12 month. Vaccines are to be transported by airfreight from the national vaccine store in Pohnpei to the states. Shipment by sea should be used only when air transportation is not an option, such as to the outer islands. 18

19 Cold chain equipment is procured according to WHO/UNICEF standards. A national cold chain equipment inventory is kept that specifies: location, model and power source, working condition, age and expected future life. This information is reviewed and update annually, and used to plan for equipment placement, maintenance and long-term replacement. Remember that freezing as well as heat will destroy some MONITORING & PERFORMANCE INDICATIORS All immunizations are to be recorded on the child s immunization card, in the clinic register and entered into the Web IZ computerized database. Data on immunizations administered in each state is to be conveyed to the national level using the Web IZ monthly report. At all sites where vaccines are administered, target populations should be calculated based on birth registrations and censuses by the public health nurses. Immunization coverage should be reviewed monthly for all antigens, and children that have missed vaccinations should be identified for immediate follow up. The National Immunization Program manager sets the denominator used at the national level based on birth registrations and the census. Performance indicators and targets Coverage: Hospital based Birth dose of Hepatitis B within 12 hours (99 %). Second dose of Hepatitis B within 2 months (95 %). Fully immunized children by the age of 2 year (95 %) Two doses of MMR by the age of 2 years (MMR1 100% and MMR2 95%) Number of State Immunization Programs submitting completed monthly reports on time (100%) Vaccine management: Vaccine outages at the national level (zero% for all antigens) Number of doses of vaccine used (administered plus wastage) is within +/- 5% of the estimated vaccine requirements (100% for each vaccine) Vaccine wastage for all single dose antigens (5% or less) 19

20 Vaccine arrival reports for international shipments completed (100%) Number of times monthly reports indicate that cold chain equipment is working at each site for the full month (12 months per year for each site). Number of days per year cold chain equipment temperature outside recommended range. (less than 12 days per year) Immunization Safety Number of reported VAERS reports that are investigated and classified (100 %) 20

21 SCHOOL IMMUNIZATION LAWS The school immunization law of the Federated States of Micronesia (Title 41 FSMC Chapter 4) as amended in 1997 requires that all children attending school have a valid School Immunization Certificate. The State Departments of Health issues this certificate after the student has received: 5 doses of diphtheria-tetanus-pertussis vaccine, 4 doses of polio vaccine, 3 doses of hepatitis B vaccine and 2 doses of measles-mumps-rubella vaccine. Exemptions: 3.1 A child may be exempted from obtaining the required immunizations upon submission of a written statement from a licensed physician that the present condition of the child is such that the required immunizations would endanger the life or health of the child. The statement shall contain following information: a. The name of the child, a list of the antigens for which the exemption is requested, specification of the condition that would be exacerbated by the immunization(s) and a determination when, or if, the child s condition will allow immunization at a future date. 3.2 Any child granted an exemption shall be excluded from school during those periods when there exists an outbreak of the disease(s) for which they have been exempted from immunization. The child shall be allowed to return to school when the danger of infection has passed. 3.3 No child shall be exempted from immunizations on grounds of religious or personal beliefs, which either oppose immunizations or the concept of immunization against communicable diseases. Part 5. Provisional Certificates 5.1 The immunizations listed in section 2.1 require multiple dosages with specific minimum time intervals between each dosage. All children, whether currently enrolled or newly registering in school, and who have not completed the regiment of immunizations required by these regulations, shall receive a provisional School Immunization Certificate. The certificate shall be clearly marked with the word provisional, until such time as the full regiment of immunizations has been completed. 5.2 A provisional School Immunization Certificate shall remain valid only as long the child adheres to the minimum time intervals required by the immunization schedule. No child with a valid provisional certificate shall be denied admittance to school for failure to comply with these regulations. 21

22 WHAT A VACCINATOR NEEDS TO DO CHECK LIST OF ACTIVITIES 1. Before vaccinating Plan for the immunization session Calculate vaccine supplies needed, especially for outreach session Keep vaccines at right temperature (+2 C to +8 C) Check the child s name, date of birth and address Check what vaccines the child needs according to the vaccination card or the vaccination register 22

23 Check the vaccine (and diluent if it is to be reconstituted) Tell the mother about the vaccine, likely reactions, and treatment Prepare the vaccines 2. Vaccinating > Give the right vaccines safely > Make sure that you give the vaccine in the right site of injection according to the vaccine ordered 3. After vaccinating > Discard used injection equipment safely > Record the immunizations given on vaccination card and register. Submit data to CASA clerk for computer entry. > Tell the mother when to come back for the next immunization 4. After the session > Report the immunizations every month > Review coverage progress and identify problems > Plan strategies to immunize children who have missed out > Make referrals for children that have transferred out of the district or state

24 Make enquires about children with suspected EPI diseases. Document and report promptly by phone to the EPI Manager Vaccines given to children Age given BCG HepB* OPV Hib DTaP MMR Birth V V 2 months V V V V 4 months V V V 6 months V V V 12 months V V V V 13 months V School entry (5 6 yrs) V Adolescent (15 19 yrs) Where given How Dose Type Appearance BCG Left upper arm Intradermal 0.5 ml Live virus powder + diluent White, cloudy liquid HepB* Right upper arm IM 0.5 ml Inactivated White, cloudy 17 24

25 Ready to use OPV Oral Oral 2 drops Live Virus Vial with dropper Hib Left upper thigh IM 0.5 ml Inactivated ready to use DTaP Left upper thigh IM 0.5 ml Inactived ready to use MMR Left upper arm SC 0.5 ml Live virus powder + diluent Td Left upper arm IM 0.5 ml Inactivated ready to use liquid Clear, pink, or orange liquid Clear, slightly cloudy liquid White, cloudy liquid Clear, slightly yellow liquid White, cloudy liquid Hep B should be given within 12 hours of birth. If not given at the time of birth, it should be given as soon as possible in the first week of life. ** DTaP should be given in the left upper arm to children over one year of age Tetanus Toxoid for Pregnant Women Adults need 5 doses of tetanus containing vaccine (DTP, TT, DT or Td) for long term protection. Note that 3 doses of DTP (DTaP) before the age of one year count only as 2 adult doses. Schedule for giving TT/Td vaccines to pregnant women: Pregnant women who have received no doses of tetanus containing vaccines should be vaccinated immediately (Td 1) and follow the schedule above. Pregnant women who have only received one dose of TT/Td more than one month ago, should receive 1 dose of Td immediately (Td 2) and then follow the schedule above. Pregnant women who have only received two doses of TT/Td (or 3 DTP under the age of one year), should receive 1 dose of Td immediately (Td 3) if the last dose was more than 6 months ago and then follow the schedule above 25

26 Pregnant women that have only received three doses of TT/Td (or 3 DTP under the age of one year plus one TT/DT or Td) and the last dose was more than a year ago, should receive 1 dose of Td immediately (Td 4) then follow the schedule above Pregnant women that have received four doses of TT/Td (or 3 DTP under the age of one year plus two TT/DT or Td) and the last dose was more than one year ago, should receive 1 dose of Td immediately (Td 5). All women should be encouraged to complete the tetanus schedule for women whether they are pregnant or not. A woman who has received 5 doses of tetanus toxoid containing vaccine is protected during her childbearing years regardless of if she was immunized when pregnant or not. Vaccines in the delivery room The nursing staffs in the hospital delivery room play an important role in the immunization programs of the FSM. The newborn infant should receive its first dose of Hepatitis B vaccine as soon as possible after birth (within 12 hours or less). This will protect those infants exposed to hepatitis during the birth process. In addition, BCG is administered at the same time. MMR vaccine should be administered, after delivery, to any women without proof of prior vaccination. This will protect her fetus from rubella during future pregnancies. HOW TO GIVE VACCINES SAFELY HOW TO GIVE AN INJECTION 1. Wash skin that looks dirty with soap and water. It is not 26

27 necessary to swab clean skin with alcohol or disinfectant. 2. Hold syringe barrel between thumb, index, and middle fingers. Do not touch the needle. 3. Insert needle with a smooth action. 4. Use thumb to push the plunger without moving the syringe around. 5. Pull needle out quickly and smoothly (less painful than doing it slowly) 6. Ask the parent to press the site gently with a clean swab for a few seconds to stop bleeding and relieve pain. 7. Do not rub the area where the injection was given. DTAP, HIB, PCV 7, OR HEP B VACCINE: INTRAMUSCULAR (IM) INJECTION IN THIGH 27

28 Position the child sideways on the parent s lap with his or her whole leg bare. The child s left arm should be tucked around the parent s body. One of the parent s arms should be tucked around the child supporting his or her head and holding the right arm. The parent s other hand should hold the child s legs Gently stretch the skin flat between your thumb and forefinger of the middle third of the thigh.quickly push the entire needle straight down through the skin and into the muscle. MMR vaccine: subcutaneous (SC) injection IN LEFT UPPER ARM The injection is given into the layer below the skin (subcutaneous fat) on the left upper arm. 1. Position child sideways on parent s lap with the whole arm bare. 2. The left arm should be tucked around the parent s body. 3. One of the parent s arms should be tucked around the child supporting his or her head and holding the left arm that is to receive the injection. 4. The parent s other hand should hold the child s legs. 5. Hold the top of the child s arm from underneath. Reach your fingers around and pinch up the skin. 6. Quickly push the needle into the pinched up skin- the needle should point towards the shoulder. 7. To control the needle, support the end of the syringe with your thumb and forefinger but do not touch the needle. BCG VACCINE: INTRADERMAL (ID) INJECTION IN LEFT ARM 28

29 The injection is given into the skin in the left upper arm. 1. Position child mother s lap clothing from shoulder. sideways on and remove the arm 2. The mother should hold the child close to her body, supporting his or her head and holding the arms close to the body. 3. Hold the syringe in your right hand with the bevel of the needle facing upwards

30 4. Stretch the skin out flat with your left thumb and forefinger. 5. Lay the syringe and needle almost flat along the child s skin with the eye of the needle facing upwards. 6. Insert the tip of the needle just under the skin -just past the bevel (the eye of the needle). 7. Keep the needle FLAT along the skin, so that it goes into the top layer of the skin only. Keep the bevel of the needle facing up. 8. Do not push too far and do not point down or the needle will go under the skin and an abscess or enlarged glands may result. 9. To hold the needle in position, put your left thumb on the lower end of the syringe near the needle, but do not touch the needle. 10. Hold the plunger end of the syringe between the index and middle fingers of your right hand. Press the plunger in slowly with your right thumb. If done correctly, a small pale lump should form in the skin. 11. Remove the needle

31 OPV ADMINISTRATION 1. Ask the parent to hold the child with the head supported and tilted slightly back. 2. The chin and cheeks should be dry: OPV is less likely to spill out. 3. Open the child s mouth gently, either with your thumb on the chin (for small infants) or by squeezing the child s cheeks gently between your fingers 4. Let 2 drops of vaccine fall from the dropper onto the tongue. Do not let the dropper touch the child. More than one injection at the same visit All the different EPI vaccines are safe and effective when given at the same time. For example, a child aged 1 year who has never been immunized can receive during one visit to a clinic: 1. BCG in left arm 2. Measles/ Mumps/ Rubella in the right arm 3. DTaP (left thigh) and HepB (right thigh) Hib (left arm) 4. OPV1 (orally) 5. Prepare all injections (so they can all be given one after other). Do not mix different vaccines in one syringe 6. Give injections, as needed, in this order: BCG Measles/Rubella DTP Hepatitis B Hib 3. Give OPV last (when child is crying) 23 31

32 Use auto-disable syringes (ADs) There are several types of disposable syringes. The standard syringe and the auto disable (ADs). The AD syringes can only be used one time because the plunger cannot be retracted once it has been pushed in. All syringes should be discarded in a safety box together with needles and sharps immediately after use. You do need to: Throw the needle cap and piston cap in the safety box - do not recap the needle Do not touch the tip of the needle or let it touch any surface. Dispose of syringe and needle into the safety box immediately after use You do not need to: Inject air before vaccine into a vial withdrawing Draw back the piston to check for blood. TD VACCINE (Adolescent and Pregnant Women) Tetanus vaccine (Td) is given into the left arm to children when they leave school (15-19 years) and pregnant women with no or an incomplete history of tetanus immunization 1. Ask the child or woman to sit down

33 2. Tell them to drop their shoulder and place their left hand behind their back or resting on the hip. This relaxes the muscle in the arm and makes the injection nearly painless. 3. Put your finger and thumb on the OUTER part of the upper arm. 4. Use your left hand to squeeze up the muscle of the arm. 5. Quickly push the needle straight down through the skin between your fingers. Go deep into the muscle. 6. Press the plunger with your thumb to inject the vaccine. 7. Pull out the needle quickly and smoothly and ask the child/woman to press the site gently with a cotton pad in case of bleeding and also because gentle pressure relieves pain. BEFORE IMMUNIZING CHECK WHAT VACCINES THE CHILD NEEDS 1. Look at the child s immunization card and clinic register 2. Identify which vaccine series have not been completed. 3. If they have no card, give them one. Mark the vaccines, only if you are certain they have been given. 4. Give all vaccines due. If more than one type of vaccine is needed, they may all be given at the same time. 5. Doses of the same vaccine must be at least four weeks apart. Check the vaccine 1. Is this the correct vaccine for the child? 2. Is the vial/ampoule in good condition? Discard damaged vials/ampoules and those with no label 3. Check the label to see that 25 33

34 a. the expiry date has not passed b. VVM, if present (see below) Discard vaccine if past expiry date or if VVM past discard point 4. Look at vaccine - check for colour and particles Discard vaccine with any change in appearance or presence of particles and lumps that will not dissolve. Explain to mother about the vaccine, likely reactions and treatment 1. Explain to the mother what disease(s) the vaccine(s) protects from. 2. Reassure the mother that reactions are common and show that the child is responding well to the vaccine. 3. Advise treatment for fever, pain/swelling at injection site. a. Give extra fluids e.g. more breastfeeds or water b. Paracetamol may be given. c. Extra hugs and attention - but keep pressure off the area(s) d. Cold cloth on the injection site is soothing for local reaction 4. Tell mother to bring child to health centre if reaction continues for more than a day or two, or if it is more serious. PREPARE THE VACCINES Always start by washing your hands with water and soap and dry them well with a clean cloth. TO DRAW UP VACCINE FROM A VIAL 34

35 1. Shake the vial to mix the contents. Do not touch the rubber top. 2. Insert the needle and turn the vial upside down. Do not touch the needle. 3. Gently pull the plunger to fill the syringe just over the 0.5 ml mark (to be able to remove the air). 4. With the needle still in the vial pointing upwards, tap the syringe to bring any air bubbles to the top of the vaccine. Gently push the piston to remove air and excess vaccine from the syringe. 5. Stop exactly at the 0.5 ml mark TO RECONSTITUTE BCG AND MEASLES/MUMPS/RUBELLA VACCINES The diluent for reconstituting BCG and MMR vaccines comes in ampoules, bot0tles, or plastic tubes. Cool the diluent to the same temperature as the vaccine before mixing or keep the diluent with vaccine in the vaccine carrier. 1. Check that the diluent matches the vaccine: from the same manufacturer. 2. Draw up amount of diluent required into mixing syringe. 3. Inject all the diluent into the vial. 4. Roll the vial between your fingers to mix the vaccine and diluent. 5. Place used mixing syringe and needle into the safety box. Do not leave mixing needle in vial. Keep reconstituted vaccine cool between+ 2 to +8 degrees and away from sunlight. Discard reconstituted vaccines 27 within six hours or at the end of the session, whichever comes sooner. Note: When using multi dose vials reconstitute vaccine also when you only have one or few children to immunize. Do not delay immunization in order to save vaccines. Do not reconstitute vaccine until the child is ready for immunization. Plan outreach immunization session 1. Inform municipal and island officers of the date and time of the immunization visit 2. Arrange how to get to the outreach site. 3. Check from the register book, the list of children for immunization and the number of target children; and the number of pregnant women for TT/Td immunization. 4. Work with the village health volunteers to make sure that all the children turn up. 5. Check materials, equipment and vaccines. Vaccine carrier and vaccine. Syringes- 0.5 ml and 0.05 ml (and needles, if not attached to syringes) Reconstitution syringes with needles- 5 ml and 2 ml Safety boxes Immunization register book for children 35

36 Handout leaflets on reactions to the vaccines to mothers Arrange the immunization site and waiting area, ensuring that site is suitable and with everything needed within reach. 7. After the session: Pack any unopened vaccines, together with any opened vials of TT, DTP, OPV with good VVM 36

37 and that has not been contaminated (dirty syringe or submerged in water), back in the cold box. Collect used materials to return to health centre. Thank the local people who have helped organize the session and remind them when you will return. 8. At the Health Centre: If the ice packs are still frozen, put unopened vials in the returned box in the refrigerator so they will be used first during the next session. If the ice in the ice packs has melted, discard all vaccines EXCEPT for any in vials carrying VVMs that are not past discard point. Return these vaccines to the refrigerator for use during the next session. Put ice packs from carrier into the freezer and check and record the temperature of the refrigerator. KEEP VACCINES AT THE RIGHT TEMP. Vaccines must be stored at the right temperature (+ 2 C to + 8 C). To keep vaccines cold during outreach sessions, special boxes are used called Skis. The temperature inside the box is kept cold by ice packs. A foam pad fits on top of the ice packs in a vaccine carrier. When the carrier lid is open, the foam pad keeps the vaccines inside cold. 37

38 HOW TO LOAD A VACCINE CARRIER Place ice into carrier. Close the lid. 1. Remove ice packs from freezer and let them sit at room temperature for about 30 minutes before drying them and placing them in the vaccine carrier. 2. Place the ice packs along each side of the vaccine carrier. 3. Place OPV, measles/mumps/rubella vaccine and BCG at the bottom of the vaccine carrier. 4. Place DTaP and TT/Td at the top of the vaccine carrier. Do not let vials touch the ice packs. Wrap newspaper or cardboard around them to protect them from freezing. 5. Place a foam pad on top of the ice packs. 6. Make sure that the vaccine carrier is tightly shut. MULTI DOSE VIAL POLICY Whenever feasible the FSM Immunization Program uses single dose vials. However, when multi dose vials are provided the program has the following policy: 1. Opened vials of OPV and opened vials of DPT, Td, TT, Hepatitis B, and Hib vaccines packaged according to 38

39 manufactures standards, should be used in subsequent immunization sessions, provided that: a. The expiry date has not passed and, b. The vaccines are stored under the appropriate cold chain conditions (2-8 degree centigrade) and, c. The vaccines are not taken out of the Public Health clinics for immunization activities (e.g. outreach). d. However, no vial should be used after one month of opening 2. Opened vials of measles (M), Measles Mumps and Rubella (MMR), and BCG vaccines must be discarded six hours after reconstituted. 3. If sterile procedures have not been fully observed or if there is a suspicion that an opened vial of vaccine has been contaminated, it must be discarded immediately. HOW TO USE THE VACCINE VIAL MONITOR Innei square is lighter than outer ring. USE the vaccine, if expiry date nol reached. As lime passes: Inner square is stilt lighter than ouiernng. USE the vaccine if expiry date nol Discard point: Inner square matches the CQIQUI of outer ring. DO MOT use the vaccine. Beyond Hie discard point: Inner square is darfcei Itianouler ring DO NQT use the vaccine. The vaccine vial monitor (VVM) allows health workers to check whether the vaccine has been damaged by heat. The VVM 39

40 gradually changes color with heat and gives an indication when the vaccine should not be used. Discard used injection equipment safely 1. Prepare the safety box and place it within reach in the area where you are immunizing. 2. Place needle cap in the safety box. Needles should never be recapped. 3. Place the syringe and needle directly into the safety box after immunizing. 4. Fill the safety box to about % full - a safety box can hold about 150 used syringes 5. When the safety box is filled, close the lid and seal the box. 6. Return the safety box to the health centre for destruction. RECORD IMMUNIZATION GIVEN The immunization should not be recorded until after it has been given. 1. Complete the child s yellow immunization card by recording the date for each vaccine 2. Remind the mother to keep the yellow card in a safe place and always to bring it when going to the health centre or hospital. 3. Record the date that each vaccine is given in the register Ensure child returns to complete the immunizations 40

41 1. Tell mother how many more visits needed to protect the child 2. Advise when fully immunized 3. Tell mother the place, date, and time of next session 4. Answer mother s concerns and advise on possible reactions and treatment and give the mother a handout leaflet Report the immunizations At the end of each month, every State Immunization Program should complete and submit an immunization coverage report, which is programmed in WebIZ to the National Program Manager. THE IMMUNIZATION REGISTRY The National Immunization Program introduced its first computerized immunization registry in 1999 called CASA. In 2007, it was replaced by a Web based registry call WebIZ. With the new registry it is possible to keep records of individual children in a national database. The purpose of the registry is to improve coverage further by identifying children that have not been immunized in time. Children will be entered in the Web IZ registry in two ways, through information in the child s birth certificate and by reports from the public health nurses providing immunization. The registry has the ability to generate monthly reports of vaccines administered by age, list of children late for immunization, provide individual immunization records, and even print Immunization Certificate for students. By using the internet it is expected that the immunization programs in all four FSM states will have access to the records in other states. It is also foreseen that Guam and Hawaii will someday share immunization records. Review coverage progress & problems 1. Identify problems by talking with community leaders, village health committees, parents and other health workers. 41

42 2. Plot coverage to check the percentage of people immunized and how the number of immunizations given compares with targets. 3. Check the register of names to see who is missing out on their immunizations. Plan strategies for those missing out 1. Identify the target population = the number of infants born the previous year. 2. Estimate number missing by using WebIZ to generate not-upto-date children list. 3. Develop strategies and plan activities to ensure these children are reached. Consider: Increasing people s knowledge about immunization Changing hours of immunization sessions so more convenient Involving community health workers in solving transport problems Remind parents or asking community leaders to remind parents that have not brought their children for immunization 4. Monitor progress in reaching these children Search for children with EPI diseases Ask in the village if there have been any cases of: Acute flaccid paralysis Fever and Rash (measles or rubella) Néonatal/maternel tetanus Pertussis (Whooping cough) 42

43 REFRIGERATOR TEMPERATURE MONITORING If you suspect a case of EPI diseases you should : 1. Ask to see the child and document the history. The history should include the date of onset, symptoms and signs of illness and immunization history 2. Enquire about other cases in the family and in the community 3. Find out if the child has traveled to other state(s) in FSM or abroad in the last few weeks 4. Report the case to the EPI Manager immediately by phone. It is important that you report the case even if the mother tells you that she has already taken the child to the hospital or to see a doctor. The refrigerators temperature should be checked two times a day (morning and afternoon) to ensure that it is in the safe range of +2 to + 8 deg. Celsius. If the temperature is too high (above 8 deg. C): 1. Make sure that the refrigerator is working 2. If the refrigerator is working, turn the thermostat knob so that the arrow points to a HIGHER number. This will increase the amount of cooling and make the refrigerator colder 3. Check the VVMs on the vaccines to see if they have been damaged 4. If the refrigerator is not working, store vaccines in an other place until the refrigerator is repaired If the temperature is too low (below 2 deg. C): 1. Turn the thermostat knob so that the arrow points to a LOWER number. This will decrease the 43

44 amount of cooling and make the refrigerator warmer. 2. Check DPT, Hep B, DPT and TT/Td for freezing using the shake test. If adjusting the thermostat still does not make the refrigerator stay between + 2 to + 8 C, you should contact your supervisor. Cleaning the refrigerator Clean the refrigerator at least once every three months. Soak a cloth in soap and warm water and use it to clean the interior of the refrigerator and its fittings. Never use detergents, scouring powder, strongly scented products to clean the interior of the refrigerator as they may damage the surfaces. The exterior of the refrigerator should be wiped clean regularly, using a damp cloth and a small quantity of detergent. The door seals should be cleaned only with soap and water and then thoroughly dried. The cooling unit behind the refrigerator should be cleaned with a brush to remove any dust. Defrosting Check the formation of ice in the refrigerator every week and, defrost the refrigerator if 3 mm thick or more. To defrost the refrigerator, turn it off and remove all items. Do not use any sharp objects to scrape off the ice as this may damage the refrigerator walls. As the ice melts, water from the refrigerator will collect in a container at the back of the refrigerator. When all ice has melted, wipe the refrigerator dry and restart it. If you have to defrost more than once a month, the door seal may be faulty or the door may be being opened too frequently. 44