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3 Operatioal Guidelies for Hepatitis B Vaccie itroductio i the Uiversal Immuizatio Program Miistry of Health & Family Welfare Govermet of Idia New Delhi 2011

4 Published by: Copyright: Address: Web: Miistry of Health ad Family Welfare, Govermet of Idia (Re-prited i 2011) Miistry of Health ad Family Welfare, Govermet of Idia, Nirma Bhawa, Maulaa Azad Road, New Delhi , Idia riidia2008@gmail com www mohfw ic i Suggestios for improvig or ehacig the Operatioal Guidelies for Hepatitis B vaccie i the Uiversal Immuizatio Programme are always welcome ad ecouraged ii

5 Table of Cotets Abbreviatios Target Audiece HEPATITIS B DISEASE AND VACCINE Backgroud 3 Hepatitis B Virus 5 Modes of Trasmissio 7 Cliical Features 8 Hepatitis B Vaccie 11 Vacciatio Schedule 12 Storage Temperature 15 Safety of Hepatitis B Vaccie 16 Ijectio Techique ad Safety 18 Adverse Evets Followig Immuizatio 22 HEPATITIS B VACCINATION IN INDIA Itroductio ad Progress 27 Objectives ad Strategies 29 STEPS FOR THE INCLUSION OF HEPATITIS B VACCINE IN THE UIP Plaig at the state & district level 33 1 Estimate Beeficiaries ad Sessios 35 2 Estimate Vaccie & Syrige Needs 37 3 Estimate Storage Needs 40 4 Maage Cold Chai 42 5 Update Recordig ad Reportig Systems 50 6 Prepare ad Trai Staff 52 7 Pla Advocacy & Social Mobilizatio 58 8 Supervise, Moitor ad Evaluate 65 ANNEXURES i v v iii

6 Abbreviatios ADS AEFI ASHA AWW CHC DNA DPT EPI GAVI Alliace GoI HBcAg HBeAg HBsAg HBV Hib Vaccie HIV ILR IPC MOI/c NGO OPV Petavalet PHC TT UIP UNICEF VVM WHO Auto Disable Syrige Adverse Evets Followig Immuizatio Accredited Social Health Activist Agawadi Worker Commuity Health Cetre Deoxyriboucleic acid Diphtheria, Pertussis, Tetaus Vaccie Expaded Program o Immuizatio Global Alliace for Vaccies ad Immuizatio Govermet of Idia Hepatitis B Core Atige Hepatitis B e Atige Hepatitis B Surface Atige Hepatitis B Virus Haemophilus Ifluezae type b Vaccie Huma Immuodeficiecy Virus Ice Lied Refrigerator Iterpersoal Commuicatio Medical Officer I charge No Govermetal Orgaizatio Oral Polio Vaccie Petavalet (DPT+HepB+ Hib) vaccie Primary Health Cetre Tetaus Toxoid Uiversal Immuizatio Programme Uited Natios' Childre's Fud Vaccie Vial Moitor World Health Orgaizatio iv

7 Target Audiece These guidelies are meat to assist immuizatio programme maagers at state, district ad sub-district levels i itroducig hepatitis B vaccie ito immuizatio programmes The itetio is to provide iformatio that is practical as well as techically ad operatioally soud v

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9 HEPATITIS B DISEASE AND VACCINE

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11 Backgroud Hepatitis B is a major public health problem worldwide Approximately 30% of the world's populatio, or about 200 Crore (2 billio) persos, are estimated to be ifected with Hepatitis B Virus (HBV) Of these, a estimated 36 crore (360 millio) have chroic HBV ifectio ad are at the risk of serious illess ad death from liver cirrhosis ad Hepato Cellular Carcioma (liver cacer); diseases that are estimated to cause about 5,00,000-7,00,000 deaths each year worldwide Safe ad effective vaccie is available agaist hepatitis B sice 1982 The World Health Orgaizatio (WHO) recommeds that routie vacciatio of all ifats agaist HBV ifectio should become a itegral part of atioal immuizatio schedules worldwide High coverage with the primary vaccie series amog ifats has the greatest impact o the prevalece of chroic HBV ifectio i childre I the fourteeth meetig of Global Advisory Group (GAG) o Expaded Program o Immuizatio (EPI) 1991, it was recommeded that hepatitis B vaccie should be a itegral part of atioal immuizatio programmes worldwide by 1997 ad this decisio was reaffirmed i the 45th World Health Assembly (1992) As of ed of 2008, 177 coutries have fully icluded ad 2 coutries have partially icluded this vaccie i their atioal immuizatio programmes I coutries that have implemeted uiversal childhood hepatitis B vacciatio, chroic HBV ifectio ad icidece rates of log-term complicatios like liver cacer have declied markedly 3

12 Hepatitis B Surface Atige Prevalece High > 8% Itermedate 2% - 7% Low <2% Prevalece of chroic ifectio with hepatitis B virus, by coutry, 2006 (CDC) I Idia, the available data idicate that the coutry has itermediate edemicity of hepatitis B, with prevalece of Hepatitis B Surface Atige (HBsAg) betwee 2% ad 10% amog several populatios studied The umber of HBsAg carriers i Idia has bee estimated to be over 4 crore (40 millio) About 15-25% of HBsAg carriers are likely to suffer from cirrhosis ad liver cacer ad may die prematurely Ifectios occurrig durig ifacy ad childhood have the greatest risk of becomig chroic Of the 2 6 crore (26 millio) ifats bor every year i Idia, approximately 10 lakh (1 millio) ru the life-time risk of developig chroic HBV ifectio The hepatitis B vaccie, as part of the Uiversal Immuizatio Programme (UIP), would prevet these chroic ifectios, ad hece Govermet of Idia is icludig the vaccie i the UIP 4

13 Hepatitis B Virus HBsAg Hepatitis B Virus HBcAg HBeAg Diagram showig empty o ifectious surface atige particles ad ifectious HBV particle with core HBV is a 42m partially double straded DNA virus, belogig to family Hepadaviridae, ad is composed of a ucleocapsid core (core atige or HBcAg), surrouded by a outer lipoprotei coat (surface atige or HBsAg) Surface atige (HBsAg) is produced i vast excess ad is foud i the blood of the ifected perso as filametous or spherical particles (without core) havig a mea diameter of 22m Durig rapid replicatio a core related protei(e atige or HBeAg) is produced ot icorporated ito the virio but secreted out ito the serum HBV is foud i all body fluids HBV-related acute ad chroic liver disease is oe of the major causes of ifectious disease-related mortality worldwide Humas are the oly kow atural host for HBV, although some o-huma primates have bee ifected i laboratory coditios HBV is relatively resiliet ad, i some istaces, has bee show to remai ifectious o evirometal surfaces for about a week at room temperature 5

14 HBV cotais umerous atigeic compoets, icludig surface atige o the lipoprotei coat (HBsAg), Hepatitis B core atige (HBcAg), ad Hepatitis B e atige (HBeAg) Several well-defied atige-atibody systems are associated with HBV ifectio as show i the table below Atige or Presece i serum Iferece Atibody HBsAg Yes, days after Ifectio ad ifectivity (Australia exposure atige, Surface atige o the outer lipoprotei coat ) HBcAg Difficult to detect Ifectio (Core atige) Detected i the liver tissue with acute or chroic ifectio HBeAg Yes, with high virus titres High ifectivity (Core related protei that is secreted out ito serum) ad durig rapid replicatio of virus Ati-HBs Yes, durig covalescece Immuity to HBV after Acute ifectio or followig HepB vacciatio IgM ati- HBc Yes Recet ifectio Total Ati-HBc Yes Ifectio i udefied past Ati-HBe Yes Low ifectivity 6

15 Modes of Trasmissio HBV is trasmitted through cotact with ifected blood or body fluids across breakages i ski/mucous membraes ad uprotected sexual itercourse HBV is 100 times more ifectious tha Huma Immuodeficiecy Virus (HIV) Ulike HIV, HBV is able to remai active o surfaces (e g table tops, razor blades, blood stais etc) for about a week without losig ifectivity The primary routes of trasmissio are: Child to child (also adult to child): Ifected childre ad most chroically ifected adults look healthy Trasmissio occurs durig play through cuts, bites, scrapes, scratches or cotact with wouds (Most commo mode of trasmissio i Idia ) Peri-atal trasmissio: from mother to baby, usually at the time of birth through usafe blood trasfusios ad orga trasplat through drug users sharig eedles, or through usafe ijectios or other usafe medical procedures through uprotected sexual cotact 7

16 Cliical Features Outcomes of HBV Ifectio Hepatitis B disease is the iflammatio of the liver cells caused by HBV The outcomes of HBV ifectio are age depedet ad iclude acute (short term ad cliically apparet) hepatitis B ad chroic (log- term ad mostly uapparet) disease The ifectig dose of virus ad the age of the perso ifected are importat factors that correlate with the severity of acute or chroic hepatitis B Oly a small proportio of acute HBV are actually recogized cliically Spectrum of liver diseases followig HBV ifectio Hepatitis B virus Ifectio Acute Chroic Fulmiat Recovery Mild Severe Death Recovery Cirrhosis Liver Cacer Acute hepatitis B ifectio Acute hepatitis B occurs i approximately 1% of periatal, 10% of early childhood (1-5 years old) ad about 30% late (> 5 years old) HBV ifectios The course of acute hepatitis B is extremely variable ad the icubatio period rages from 2 to 5 moths (average 3 moths) Commo symptoms iclude: Fever (mild or abset) 8

17 Loss of appetite Tiredess Pai i muscles, joits Nausea, diarrhoea ad vomitig Pai abdome Headache Dark urie Pale stools Jaudice Most acute hepatitis cases result i recovery except about 1% of them, progressig to fulmiat hepatitis Fulmiat hepatitis has a very high mortality at about 70% Chroic hepatitis B ifectio Chroic HBV ifectio is oe of the most commo ad persistet viral ifectios i humas If ifectio occurs i ifacy, 99% remai asymptomatic 90% of these become chroic carriers I cotrast, 30% of those ifected durig childhood (1-5 yrs) ad 6% of those ifected durig adulthood become chroic carriers Persos with chroic HBV ifectio have a 15-25% risk of dyig prematurely due to HBV related liver cirrhosis ad cacer The example i the table below demostrates, out of 100 persos ifected at differet ages, the umber of persos at the risk of developig chroic HBV ifectio ad complicatios 9

18 Type IF Ifected THEN chroic AND Cirrhosis/ HBV ifectio Carcioma* Ifat % = 90 15% of 90 = 14 Child(1-5yrs) % = 30 15% of 30 = 5 Adult 100 6% = 6 15% of 6 = 1 *assumig the lower rate of 15% complicatios I Africa ad Asia, liver cacer is secod oly to tobacco as the most frequet cause of cacer deaths amog adult males, most of which are attributed to HBV ifectio Diagosis It is ot possible, o cliical grouds, to differetiate hepatitis B from hepatitis caused by other viral agets Diagosis of hepatitis B is cofirmed by demostratio of specific atiges ad/or atibodies i the patiet's serum Acute HBV ifectio: Presece of HBsAg (surface atige) ad IgM atibody agaist core atige (IgM ati-hbc) Presece of HBeAg (hepatitis B e atige) durig the iitial, highly replicative phase of ifectio HBeAg idicates high ifectivity Appearace of Atibody (after several weeks of ifectio) to HBsAg (Ati-HBs) ad disappearace of HBsAg sigals recovery Chroic HBV Ifectio: Persistece of HBsAg for more tha 6 moths is characteristic with or without HBeAg (Presece of HBeAg ifers high ifectivity) Marker of HBV ifectio: Total Ati-HBc i serum idicates HBV ifectio curret, or past 10

19 Hepatitis B Vaccie The hepatitis B vaccie is the first vaccie agaist a cacer (primary liver cacer) Safe ad effective, the vaccie has bee available commercially sice 1982 Hepatitis B vaccies are available as: Moovalet, or stad aloe ad Combiatio (DPT-HepB, DPT-HepB+ Hib, ad HepB-Hib etc ) The curretly used hepatitis B vaccies i UIP are prepared by usig the HBsAg grow i yeast cells by DNA recombiat techology The vaccie cotais oly the 22m o ifectious surface atige (HBsAg) particles ad ot the etire virus It does ot cotai ay live compoets, reducig chaces of vaccie-iduced complicatios It however cotais alum as adjuvat ad may cotai thiomersal used as a preservative i multi-dose preparatios The completed vacciatio series iduces protective atibody levels i about 95% of vacciee, i a variety of vacciatio schedules Whe coutries iclude hepatitis B vaccie as part of routie childhood immuizatio programmes, followig sustaied high coverage, HBV ifectio i childre is essetially elimiated i 10 to 15 years resultig i sigificat reductio i log term complicatios of HBV ifectio such as cirrhosis ad liver cacer later 11

20 Vacciatio Schedule Hepatitis B vaccie schedule The hepatitis B vacciatio schedule i UIP icludes Birth dose withi 24 hour of delivery, followed by 3 more doses of HepB vaccie alog with DPT Birth dose should be provided for all istitutioal deliveries, withi 24 hrs of birth Subsequetly, 3 doses should be provided at 6, 10 ad 14 weeks age alog with three doses of DPT ad OPV Prospective of birth dose Vacciatio Schedule: Age Vaccies Birth HepB BCG OPV0 birth dose zero dose 6 weeks HepB1 DPT1 OPV1 10 weeks HepB2DPT2OPV2 14 weeks HepB3 DPT3 OPV3 Target Age Group & Phasig I Ifats ru the highest risk of developig chroic hepatitis B (90%) disease followig ifectio by HBV This risk decreases sigificatly with icreasig age Therefore, ifats should be immuized before they are exposed to HBV ifectio startig at birth Accordigly, the Govermet of Idia (GoI) has decided to adopt the strategy to admiister a dose of 12

21 hepatitis B vaccie immediately after birth ad three doses alog with DPT i the prospective birth cohort 1 of childre below the age of oe year I the iitial stage of the itroductio of hepatitis B vaccie, the vaccie will be admiistered to ew cohort ad oly those childre, who are comig for the first dose of DPT will be started with the hepatitis B vacciatio (Phasig i) Dosage The stadard paediatric dose of the hepatitis B vaccies (Moovalet hepatitis B vaccie ad combiatios) is 0 5ml It is a cloudy liquid that is available i a 10 dose vial ad does ot require recostitutio If the vaccie is allowed to stad for a log time, it separates from the liquid ad looks like fie sad at the bottom of the vial The vaccie must be mixed by rollig the vial getly betwee the hads Log-Term Protectio ad Booster Doses Based upo the curret scietific evideces, the protectio afforded by hepatitis B vaccie lasts for lifelog Eve if the atibodies wae i the serum, log-term protectio relies o immuological memory, allowig a protective memory respose of the body to produce atibodies with the help of memory B cells ad memory T4 cells, after exposure to HBV or vaccie Booster doses are, therefore, ot recommeded 1 The ew birth cohort who presets for first dose of DPT 13

22 Remember OPV (oral) Vit A (oral) Measles (subcutaeous) BCG (itradermal) Hep-B (itramuscular) DPT (itramuscular) All due vaccies ca be give at same time but i differet sites e g it is safe ad effective to give BCG, OPV, DPT, HepB, Measles & VitA at same time to a 9 moth completed child who has ever bee immuized 14

23 Storage Temperatrue The storage temperature for hepatitis B vaccie is the same as for DPT vaccie, i e betwee +2 C ad +8 C The vaccie is geerally heat-stable but is highly freeze-sesitive ad MUST NEVER BE FROZEN The freezig poit of hepatitis B vaccie is about -0 5 C The freezig of the vaccie causes the HBsAg protei to dissociate from alum adjuvat ad thus to lose its immuogeicity/potecy 15

24 Safety of Hepatitis B Vaccie Hepatitis B vaccie is a very safe vaccie with prove efficacy Sice 1982, over 120 crore (1 2 billio) doses of hepatitis B vaccie have bee used worldwide The rates of mild fever ad/ or irritability followig simultaeous vacciatio of childre by hepatitis B ad DPT vaccies is similar as whe DPT vaccie is admiistered aloe Mild trasiet side effects: Most commo side effect is pai at the ijectio site Mild systemic complaits like fatigue, headache, irritability ad fever higher tha 37 7 C which may usually start withi a day after the vacciatio ad may last for oe to two days Serious allergic (aaphylactic) reactios: Serious allergic reactios to the vaccie are rare at about 1-2 per 10 lakh (1 millio) doses ad may iclude: geeralized urticaria, difficulty i breathig, swellig of the mouth ad throat, hypotesio, shock Cotraidicatios The oly two cotraidicatios to withhold or postpoe the admiistratio of hepatitis B vaccie are: A severe allergic reactio to a vaccie compoet or followig a prior dose of hepatitis B vaccie Such allergic reactios are rare Further doses are 16

25 cotraidicated if there is a history of aaphylaxis to a previous dose Persos with moderate or severe acute illess should ot be vacciated util their coditio improves However, a mior illess, such as a upper respiratory ifectio, is ot a cotraidicatio to vacciatio The followig are NOT cotraidicatios Mior illess, such as respiratory tract ifectio or diarrhoea with temperature be low 38 5 C Asthma Prematurity or low birth weight History of jaudice at birth Treatmet with atibiotics Ifectio with HIV History of seizures (covulsios, fits) Diseases of the heart, lug, kidey or liver Cogeital aomalies Neurological coditios such as cerebral palsy ad Dow's sydrome 17

26 Ijectio Techique ad Safety Hepatitis B vaccie, like DPT vaccie, is give itramuscularly o atero-lateral aspect of mid-thigh (vastus lateralis muscle) Both vaccies ca be admiistered simultaeously, though o differet thighs i e if DPT is ijected i left thigh of a ifat, the hepatitis B vaccie ca be give o right side, at the same time Stretch ski flat betwee figer ad thumb o both sides at outer Mid-thigh (Atero-lateral aspect) keepig eedle at 90 0 to surface Admiisterig vaccie: DOs Divide the thigh ito three equal parts from kee to hip Clea the ski, if dirty, with a clea water swab ad let it dry Place your thumb ad idex figer o each side of the place where you ited to iject ad stretch ski slightly Push the eedle at a 90 0 agle deep ito the muscle Press the top of the pluger with your thumb to iject the vaccie ad withdraw the eedle 18

27 Admiisterig vaccie: DON'Ts DO NOT give hepatitis B vaccie i buttock as this route of admiistratio has bee associated with decreased protective atibody levels, because of ijectio ito subcutaeous fat I additio there may be a risk of ijury to the sciatic erve DO NOT admiister hepatitis B vaccie itra-dermally because this route of admiistratio does ot produce a adequate atibody respose i childre DO NOT mix hepatitis B vaccie i the same syrige with other vaccies Follow safe ijectio ad Waste Disposal practices Ijectio safety should be followed meticulously for each ijectio give ad waste should be disposed carefully to prevet damage to self ad others Auto Disable Syrige l Use Auto Disable Syriges (ADS) supplied by Govermet of Idia ad ot ay other Disposable syriges/ eedles or Glass syriges 19

28 l l Follow GOI guidelies (Cetral Pollutio Cotrol Board or CPCB) guidelies for safe disposal of immuizatio waste disposal Keep hads clea before givig ijectios o o Wash or disifect hads prior to preparig ijectio material Cover ay small cuts o the service provider's ski Wear sterile gloves to cover if pos sible l l l Use sterile ijectio equipmet, every time Prevet the cotamiatio of vaccie ad ijec tio equipmet o Prepare each ijectio i a desigated clea area where cotamiatio from blood or body fluid is ulikely o If ijectio site is dirty, wash with clea water swab o Always pierce the rubber cap of a vial with a sterile eedle o Do ot leave eedle i the stopper of a vial o Follow product-specific recommedatios for use, storage, ad hadlig of a vaccie o Discard ay eedle that has touched ay o-sterile surface Assume all used equipmet is cotamiated o Always cut a used syrige at hub immediately after use usig the hub cutter provided for the purpose 20

29 o o Do ot keep used syriges lyig o the table or do t throw carelessly ito a dust bi Never try to recap or bed eedle of a syrige l l Practice safe disposal of all medical sharps waste o Used sharps (eedles) are cut ad deposited i a hub cutter ad the carried to the PHC for safe disposal o At PHC disifect sharps by boilig i water for at least 10 miutes or by chemical method (1% hypochlorite solutio for 30 mi) o Treated sharps are to be disposed i safety pit o Disifect plastic portio of a syrige ad sed the collected material for recyclig o Alterately sed all collected material for safe disposal at a Commo Biomedical Waste Treatmet Facility (CBWTF), if such facility is available Prevet eedle-stick ijuries o Do ot recap o Collect sharps i a pucture proof cotaier (Hub cutter) o Aticipate sudde movemet of the child Safe immuizatio practices Do ot racap the eedle Do ot leave the eedle iside the vial Do ot touch the eedle 21

30 Adverse Evets Followig Immuizatio (AEFI) Surveillace A AEFI is a medical icidet that takes place after a immuizatio, causes cocer ad is believed to be caused by the immuizatio Hepatitis B vaccie is a very safe vaccie ad AEFIs are extremely rare Noetheless, ay suspected AEFIs must be reported as per GoI s atioal AEFI surveillace guidelies, 2010 The stadard reportig formats eed to be filled for serious AEFIs Maagemet of AEFI Although extremely rare, the health system has to be prepared for maagig these serious AEFI AEFI maagemet for hepatitis B vaccie is similar to that of other vaccies i the immuizatio schedule 22

31 Whe parets brig a child with complaits after the immuizatio, Please liste patietly Do ot igore them Do ot paic ad please atted to the patiet immediately Keep the child uder observatio Iitiate actio as per suggested guidelies stated below: A Redess ad swellig at the site of ijectio cold compress B Fever ad pai at the site of ijectio Give Paracetamol, 10-15mg/Kg body weight (The Paracetamol syrup cotais 125mg per 5ml ad ca also be prescribed for ifats) C Aaphylactic Reactio Refer to aexure 8 of this hadbook for recogitio ad maagemet of aaphylaxis The risk of serious adverse evets associated with Hepatitis B vaccie is very low (1-2 / 1,000,000) This must be balaced with a expected 4,000 to 5,000 HBV-related serious liver diseases such as cirrhosis ad cacer that would occur i the same populatio without immuizatio, assumig a 5% lifetime risk of HBV ifectio ad a 15% log term serious liver diseases amog the chroically ifected 23

32 Limitatios Hepatitis B vaccie is highly efficacious with more tha 95% ifats developig atibodies with complete course of vacciatio However, i order to maitai public trust i the vaccie, it eeds to be clarified that a small percetage of vacciee, who may ot develop atibodies ad still remai vulerable to hepatitis B Furthermore, it is importat to clarify that hepatitis B vaccie protects agaist hepatitis B virus oly It does ot protect agaist other types of hepatitis or jaudice Hece, Jaudice may still occur due to ifectio from other hepatitis viruses or other causes such as haemolysis ad obstructio to the bile flow 24

33 HEPATITIS B VACCINATION IN INDIA

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35 Itroductio ad Progress Several aalyses idicate that the iclusio of hepatitis B vaccie i the uiversal immuizatio programme is highly cost-effective itervetio Idia has itermediate edemicity of hepatitis B with prevalece of HBsAg betwee 2% ad 10% amog several populatios studied The vaccie has bee available i the private sector i Idia for last few years The GoI itroduced hepatitis B vaccie i , as a pilot i 33 districts ad 14 cities across the coutry The success of this pilot programme led to the further expasio of vacciatio to 10 selected states of Idia i (i e Jammu & Kashmir, Himachal Pradesh, Pujab, Madhya Pradesh, Maharashtra, West Begal, Adhra Pradesh, Karataka, Kerala ad Tamiladu) These states were selected o the basis of better UIP performace as i CES 2002 These states have bee show i shade i the figure o ext page The states, which are ot shaded will be itroducig hepatitis B vacciatio i

36 Hep B Vacciatio i Idia JAMMU & KASHMIR HIMACHAL PRADESH PUNJAB UTARANCHAL HARYANA ARUNACHAL PR SIKKIM RAJASTHAN UTTAR PRADESH ASSAM NAGALAND BIHAR MEGHALAYA MANIPUR TRIPURA GUJARAT JHARKHAND MIZORAM MADHYA PRADESH WEST BENGAL CHHATTISGARH D&N HAVELI ORISSA MAHARASHTRA GOA KARNATAKA ANDHRA PRADESH LAKSHWADEEP PONDICHERY TAMILNADU ANDAMAN & NICOBAR States which itroduced HepB Vaccie i Itroducig i

37 Objectives ad Strategies The log term goal of icludig hepatitis B vacciatio i UIP i Idia is to reduce morbidity ad mortality associated with chroic HBV ifectio, icludig cirrhosis ad liver cacer The short-term goals ad objectives are as follows: Delivery of hepatitis B vaccie alog with all other UIP vaccies accordig to safe ijectio practices Traiig of health care workers, ad sesitisatio of policy makers ad the commuity about HBV ifectio ad hepatitis B vaccie Utilisig itroductio of hepatitis B vaccie as a opportuity to icrease attetio ad actio o improvig the moitorig of cold chai, ijectio safety ad proper disposal of medical waste icludig AD syriges 29

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39 STEPS FOR THE INCLUSION OF HEPATITIS B VACCINE IN THE UIP

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41 Steps for the Iclusio of Hepatitis B Vaccie i the UIP The iclusio of hepatitis B vaccie ito the routie immuizatio schedule requires careful plaig at all levels This iitially ivolves top-dow macro-plaig at the state level Later o, with micro-plaig, precise logistics ad fiacial eeds for each district ad sub-district levels are calculated bottom-up, i e, startig from the more peripheral levels ad movig towards the higher levels These activities eed to be started at least 3-6 moths prior to the vaccie itroductio The ew vaccie itroductio plaig should be see as a opportuity to stregthe RI service delivery Plaig at State / Regioal Level This icludes the followig elemets: seek commitmet ad support for itroductio of hepatitis B from various departmets ad stakeholders develop advocacy ad social mobilizatio activities pla prepare a traiig pla develop ad dissemiate immuizatio guidelies (e g ijectio safety, cold chai, AEFI surveillace etc ) develop plas for supervisio, moitorig ad evaluatio, icludig pla for providig feedback Plaig at District / Sub-district levels This icludes the followig elemets: Revise micro-plas: use prescribed formats for UIP at each level 33

42 Estimate: Calculate vaccie ad logistics requiremet at each level Cold chai: evaluate the availability ad adequacy at all levels Idetig ad delivery: esure availability of required vaccie ad other logistics eeded to itroduce the vaccie Modify ad dissemiate revised formats: reportig, recordig ad immuizatio card etc Traiigs: health workers ad staff at all levels Advocacy ad social mobilizatio activities aroud the itroductio of the ew vaccie More geerally, programme maagers at all levels eed to udertake the followig activities, which will be described i some detail i the followig sectios estimate beeficiaries ad sessios estimate vaccie ad syrige eeds estimate storage eeds maage cold chai update recordig ad reportig systems prepare ad trai staff pla advocacy ad social mobilizatio supervise, moitor, evaluate ad provide feedback 34

43 1 Estimate Beeficiaries ad Sessios The iclusio of hepatitis B vaccie ito UIP will result i icrease i the umber of ijectios ad the workload at a immuizatio sessios I this sectio, we lear to calculate the additioal umber of ijectios, with the itroductio of this ew vaccie i UIP schedule There will ot be ay chage i the process of estimated umber of beeficiaries To estimate the beeficiaries (actual surveyed as per Commuity Need Assessmet-CNA or if that is ot available, estimatio based o populatio ad idicators such as birth rate ad Ifat Mortality Rate-IMR) usig the same figures as used i the UIP Calculate the total umber of ijectios required to be give uder UIP, icludig hepatitis B vaccie for the estimated umber of beeficiaries The itroductio of hep B vaccie i UIP will lead to additioal 4 ijectios per beeficiaries i the immuizatio program ( 1 ijectio for birth dose ad 3 for primary schedule of 6, 10 ad 14 weeks) It may be oted that i those areas, where istitutioal deliveries are low, the actual requiremet of birth dose would be less i e if oly 50% deliveries are takig place i istitutioal set up the 3 doses ad 0 5 for birth dose should be used for estimatig the umber of beeficiaries While the beeficiaries remai the same, the actual ijectio load will icrease This will have effect o the sessios plaed You ca ow calculate the umber of sessios required based o the ijectio load, accordig to the guidelies (as give below) The make the resultat chages 35

44 i the existig micro-plas, cosiderig the additioal ijectio load of hepatitis B vaccie Make a workable micro-pla suitable to local coditios ad staff availability Outreach sites If less tha 25 ijectios are expected, the pla a ses sio for every alterate moth or oce i three moths For every ijectios, pla oe sessio a moth If more tha 50 ijectios are expected, the pla two ses sios a moth However, esure that a miimum of 4 sessios are held i a year Fixed sites (PHC/CHC/Referral Hospitals) Number of sessios at fixed sites (PHC/CHC/Referral Hospitals) should be plaed based o workload to suit local coditios Avoid overcrowdig ad pla daily sessios at busy sites if eeded 36

45 2 Estimate vaccie ad syrige Need Why forecast? Accurate forecastig is essetial to esure that a right amout of vaccies, ijectio ad cold chai equipmet are available to vacciate all eligible ifats at a give time i a give area Efficiet forecastig allows for efficiet maagemet of logistics, proper schedule of delivery i maageable quatities, ad efficiet immuizatio services Furthermore, it esures a adequate buffer stock to meet uexpected eeds Wastage rate ad wastage factor Wastage rate (%) is the proportio of vaccie (ad other ijectio items) that is wasted due to a variety of reasos to that which was appropriately used (i e umber of ifats vac ciated) Wastage factor is a mathematical derivative used to ac cout for the correct amout eeded for a immuizatio sessio, takig ito accout the existig wastage rate e g if the wastage rate is 25%, the wastage multiplicatio factor is 100/(100-25) = 1 33 Therefore, if 50 ifats are to be vacciated with 4 doses of Hepatitis B, the the vaccie requiremet is 50 x 4 x 1 33 = 266 doses Buffer stock Buffer stock esures that there is sufficiet stock to tide over sudde ad uexpected shortages This is geerally 25% of requiremet 37

46 The umber of hepatitis B vaccie doses required is estimated usig the umber of target ifats, the umber of doses i immuizatio schedule (i e 4), the wastage factor ad buffer stock required Calculate vaccie requiremet Use followig steps to calculate the total umber of doses eeded to itroduce hepatitis B vaccie Step 1: Calculate the doses admiistered per year Doses admiistered per year = Target ifats x umber of doses per ifat Step 2: Calculate the yearly vaccie requiremet with wastage Total vaccie doses used per year = Doses admiistered per year x wastage multiplicatio factor (1 33) Step 3: Calculate the yearly vaccie requiremet with buffer stock Total vaccie doses eeded to itroduce vaccie i first year = Total vaccie doses used per year x buffer stock factor (1 25) To combie these 3 steps i oe formula: Total vaccie doses eeded to itroduce vaccie i first year = Target Ifats x 4 x 1 33 x 1 25 Case Study 1 Dr Airuddh Kumar is District Immuizatio Officer of Hariyali District i Va Pradesh where Hepatitis B vaccie is to be itroduced for the first time The target ifats i his district are 50,000 He calculates vaccie requiremets thus: Total vaccie doses eeded to itroduce vaccie i first year = 50,000 X 4 X 1 33 X 1 25 = 332,500 doses 38

47 Calculate syrige requiremet Use the followig steps to estimate the umber of syriges eeded for itroductio of the hepatitis B vaccie Step 1: Calculate the umber of ijectios admiistered per year Ijectios admiistered per year = Target ifats x Number of doses per ifat Step 2: Calculate the yearly syrige requiremet with wastage Aual umber of syriges eeded = umber of ijectios admiistered per year x Wastage factor (1 11) Step 3: Calculate the yearly syrige requiremet with buffer stock Total syriges eeded per year = Aual umber of syriges eeded x buffer stock factor (1 25) To combie these 3 steps i oe formula for hepatitis B vaccie: There are 4 additioal doses (ad therefore syriges) eeded for hep B vaccie Therefore, the additioal requiremet will be as follows: Total syriges eeded per year = Target Ifats x 4 x 1 11 x 1 25 Case Study 2 With the itroductio of Hepatitis B ito the immuizatio programme, Dr Airuddh Kumar is ow calculatig his additioal syrige requiremets for the target ifats of 50,000 He calculates syrige requiremets thus: Total additioal syriges eeded i the first year = 50,000 X 4 X 1 11 X 1 25 = 277,500 syriges 39

48 3 Estimate Storage Needs Addig hepatitis B vaccie to the UIP requires a re-evaluatio of storage capacity at all levels Sice both exposure to heat ad freezig destroys the potecy of hepatitis B vaccie, it should be stored at temperatures betwee +2 C ad +8 C oly Hece, assess cold chai requiremets at all levels ad implemet plas, to accordigly revise cold chai storage capacity Assessig cold chai storage capacity Iclusio of hepatitis B Vaccie (as a 10 dose vial) ito UIP requires additioal storage space Hece, oe eeds to estimate the total requiremet of cold chai space based o the additioal hepatitis B vaccie requiremet at each level of storage The table below outlies the storage capacity of various cold chai equipmets Equipmet ILR 300 ltrs ILR 140 ltrs Cold Box 20 ltrs Cold Box 5 ltrs Vaccie Carrier Storage Capacity (mixed atige) 60,000 doses 25,000 doses 6000 doses ad 52 Ice Packs 1500 doses ad 20 Ice Packs vials ad 4 Ice Packs 40

49 State ad district cold stores idet vaccies o a quarterly basis Thus, at the begiig of each quarter, the state/district should have: vaccie stock for 3 moths (1/4 th of the estimated aual requiremet) additioal 25% of quarterly requiremet as buffer stock PHC cold stores, however, idet vaccies every moth Thus, at the begiig of each moth, the PHC should have: vaccie stock of 1 moth (1/12th of the estimated aual requiremet) additioal 25% of mothly requiremet as buffer stock Case Study 3 We take a example of a Primary Health Cetre (PHC), which caters to a total populatio of 100,000 Assume aual birth rate of 25/1000, there will be 2500 target beeficiaries (Sice, this is a hypothetical example ad for the simplicity of calculatios, we are ot takig ifat mortality rate i cosideratio) Therefore, a total umber of childre to be immuised every moth i e 2500/12=210 Let s calculate vaccie storage space requiremet at that PHC: It has bee estimated that for every child to be fully immuised ( icludig Hep B) cold chai space eed is 69 cubic cm( ml)* Thus, total cold chai space eeded= 75 7*210/1000*1 25=18 12 litres (less tha 1/2 of the small ILR, ie 45 litres) 41

50 4 Maage Cold Chai Effects of heatig ad freezig o vaccie potecy Hepatitis B vaccie loses its potecy upo freezig, so protectio from temperatures colder tha +2 C is crucial at all levels of cold chai Vaccie freezig does occur at all levels ad there is very limited awareess of this problem amog programme maagers Adjuvats (such as alumiium salts) are icluded i some vaccies (All TT series vaccies icludig, DPT, TT ad Hepatitis B ) to ehace immuogeicity of vaccie atiges These adjuvat cotaiig vaccies are sesitive to freezig I hepatitis B vaccie, freezig breaks the bod betwee hepatitis B surface atige (HBsAg) ad the alum adjuvat This process is irreversible ad Hepatitis B vaccie thus loses its immuological potecy, oce froze Whe does the vaccies get Froze? Vaccie freezig is commoly foud to occur at two levels, durig storage i ILRs, ad durig vaccie trasport to the sessio sites Prevetig vaccie freezig durig storage There are various ways to prevet ad reduce freezig durig storage: I cold rooms store freeze-sesitive vaccies away from evaporator 42

51 I ice-lied refrigerators (ILRs) keep all vaccies, particularly freeze-sesitive vaccies such as hepatitis B ad 'T' series vaccies i the baskets i the ILRs, set the thermostat to esure a temperature of +2 C to +8 C do ot adjust the thermostat after power cuts or if the temperature occasioally rises above +8 C ALWAYS esure sufficiet gaps for air circulatio while storig the vaccie cotaiig boxes 43

52 Job-aid 1: Sticker for Ice Lied Refrigerators 44

53 Prevet vaccie freezig durig trasport Studies show that the maximum istaces of vaccie freezig occur durig trasport of vaccie to the sessio sites To prevet this, follow the steps give below for preparig ad coditioig ice packs (This job-aid ca be used as a sticker for vaccie carriers) Job-aid 2: Sticker for Vaccie Carriers 45

54 Check for heat damage Vaccie Vial Moitor (VVM): A VVM is a label that chages colour whe the vial has bee exposed to heat over a period of time Before opeig a vial, check the status of the VVM, prited o the vial label or cap The VVM is a square iside a circle As the vial is exposed to heat, the square becomes darker Use oly vials with ier squares that are lighter tha the outside circle Ier square is lighter tha outer circle If the expriy date has ot bee passed, USE the vaccie At a later time, ier square is lighter tha outer circle If the expiry date has ot bee passed, USE the vaccie Discard poit: Ier square matches colour of outer circle DO NOT use the vaccie Iform your supervisor Beyod the discard poit: Ier square darker tha outer circle DO NOT use the vaccie Iform your supervisor Not usable Usable VVM merely idicates the exposure of Hepatitis B vaccie to heat Remember that the vaccie is vulerable to freezig too 46

55 Check for cold damage (freezig) Shake test: Shake test determies whether adsorbed vaccies (DPT, DT, TT or HepB) have bee froze at some poit i the cold chai After freezig, the vaccie is o loger a uiform cloudy liquid, but teds to form flakes which gradually settle to the bottom after the vial has bee shake Sedimetatio occurs faster i a vaccie vial which has bee froze tha i a vaccie vial from the same batch which has ever bee froze Coduct the test at the storage poit whe you suspect that a large umber of vials have bee froze If there is obvious flocculatio or freezig, the discard the vials Coductig Shake Test Step 1 - prepare a froze cotrol sample: Take a vial of vaccie of the same type, batch ad maufacturer as the vial you wat to test Freeze the vial util the cotets are solid (at least 10 hours at -10 C) ad the let it thaw This vial is the cotrol sample Mark the vial clearly so that it is easily idetifiable ad will ot be used by mistake 47

56 Step 2 - choose a test sample: Take a vial(s) of vaccie from the batch(es) that you suspect has bee froze This is the test sample Step 3 - Shake the cotrol ad test samples: Hold the cotrol sample ad the test sample together i oe had ad shake vigorously for secods Step 4 - Allow to rest: Leave both vials to rest by placig the vials o a table ad ot movig them further Step 5 - Compare the vials: View both vials agaist the light to compare the sedimetatio rate If the test sample shows a much slower sedimetatio rate tha the cotrol sample, the test sample has most probably ot bee froze ad ca be used If the sedimetatio rate is similar or more tha the cotrol, the test vial has probably bee damaged by freezig It should ot be used 48

57 Miimize Vaccie Wastage It is importat to miimize wastage of hepatitis B vaccie just as it is importat to miimize the wastage of other vaccies too It must be remembered that all vaccies cost a cosiderable amout of moey Strategies to decrease vaccie wastage iclude: Predictig accurate vaccie requiremet based o micro-plaig ad procurig oly required quatities Esure stock positio is itimated to higher authorities o a regular basis Maiteace of the cold chai at all levels icludig trasport Prevetio from freezig Meticulous plaig ad coduct of sessios Raisig demad for immuizatio services by commuicatio with the commuity Use of vaccie vial moitors (VVM) Quarterly moitorig of wastage 49

58 5 Update Recordig ad Reportig Systems Addig ay ew vaccie i immuizatio program requires updatig the forms ad IEC materials that list the vaccies i the immuizatio programme Update Forms Idetify ad update all recordig ad reportig formats to reflect the additio of the ew vaccie Vaccie stock forms ad Immuizatio cards or Mother ad Child Protectio (MCP) cards, Mothly Progress Report at all levels (See Aexure 6) MCH/Immuizatio Register Moitorig Chart Supervisory checklists (See Aexure 7) Computer databases Immuizatio coverage surveys ad evaluatios; It is preferred to revise these formats to iclude hepatitis B vaccie ad distribute them before itroductio Alteratively, i the iitial stage of itroductio, the existig forms ca be adapted locally (e g health workers may add hepatitis B vaccie data by had to existig forms ad use these as log as they last) However, errors ad omissios are more likely to occur if the latter course is chose This process may be doe either at the state level or district level, depedig upo the prevailig practices i the state However, if the 50

59 modificatio is doe at the state level ad templates are shared further dow, it will expedite the etire process Update Iformatioal Materials The iformatioal materials for commuity ad caregivers eed to be revised/updated ad distributed before the vaccie is itroduced Materials that must be revised iclude: posted immuizatio schedules, (ti-plates, posters, wall paitigs ad billboards) immuizatio cards ad couterfoils materials for parets traiig material for health workers 51

60 6 Prepare ad Trai Staff Traiig for health care staff is essetial to successfully itroduce hepatitis B vaccie ito the UIP The health care providers are resposible for hadlig ad admiisterig the vaccie ad they are a major source of iformatio for parets ad other members of public Additioal traiigs ca be miimized if delivery of iformatio o hepatitis B disease ad vaccie is itegrated ito existig traiig programmes Health care persoel, who eed traiig iclude District Immuizatio Officers (DIO), Medical Officers (MO), cold chai hadlers, supervisors, data maagers ad frotlie Health Workers (HW) Traiig Approach Traiig activities would commece at the atioal-level, with a orietatio of state officers o hepatitis B vaccie itroductio This would be followed by traiig of district-level traiers at the State level I tur, this should be followed by the traiig of all Medical Officers at district level The supervisory staff, cold chai hadlers, ad Auxiliary Nurse Midwifes (ANMs) also eed to be traied i various aspects of Hepatitis B vacciatio This group of staff ca be traied by MOs i their respected PHC/CHC areas Additioally, sesitizatio of the frotlie Health Workers ad commuity level workers icludig ASHAs may also be coducted 52

61 These orietatio traiig should ideally be coducted before Hep B vaccie is itroduced i the program ad before public iformatio campaigs are udertake It also eed to be esured to update all traiig materials related to immuizatio to iclude iformatio about hepatitis B disease ad vaccie Also, advocate for iclusio of iformatio about hepatitis B disease ad vaccie i the curricula for health care staff traiig programmes ad medical/ursig courses Traiig Tips As the traiigs of Medical Officers ad Health Workers i Immuizatio program i Idia are already ogoig ad the cotet o Hepatitis B vacciatio has already bee icorporated i those traiigs, choosig what to teach is importat Some poits to cosider whe plaig traiig are: Use skill-based traiig, iteractive discussios ad hads o approach to teach tasks ad procedures Teach i settigs that are as close as possible to real work coditios (staff meetigs, i-service traiig workshops ad ewsletters ) Teams that work together should be traied together Esure follow-up ad supervisio after traiig Use every opportuity to reach health care staff, eve if this meas that some idividuals may receive the same iformatio more tha oce 53

62 Traiig Cotet - Broad areas Traiig must cover iformatio o hepatitis B vaccie ad HBV-related diseases as well as programmatic issues The mai hepatitis B specific topics that should be covered i the traiig are: Types of Hepatitis Hepatitis B virus, trasmissio ad disease, Importace of ifat vacciatio Hepatitis B vaccie ad schedule Vaccie ad logistics maagemet Vaccie admiistratio Ijectio safety, ad waste disposal, AEFI surveillace Reports ad records Advocacy ad commuicatio The attetio eed to be paid that how ad whe the vaccie will be admiistered ad which childre should receive the vaccie The cotet The cotet should focus o practical aspects, which traiee will be able to put to use immediately after retur rather tha teach mere theory For the traiig of Medical officers i Hepatitis B vaccie ad disease, this operatioal guidelies ca be utilised There are stadardised ageda ad power poit presetatios, based upo these modules, which ca be utilised for traiig purpose Besides, this stadard 54

63 iformatio o Hepatitis B from various sources icludig FAQ ca be utilised for this purpose For the traiig of health workers, the Frequetly Asked Questios (FAQs) give i Immuizatio Hadbook for Medical officers ad health workers should be utilised as traiig cotet Besides this the two key resources to develop traiig cotet are: Immuizatio Hadbook for Health Workers Immuizatio Hadbook for Medical Officers 55

64 Suggested Ageda ad topics to be covered I the traiig Of Medical Officers Review objectives/expectatios (10 mi) Routie Immuizatio recap ad Itroductio to New Vaccies (30 mi) Hepatitis B Disease ad Vaccie, schedule, route of admiistratio, storage ad care of vaccie (60 mi) Iclusio of Hepatitis B Vaccie uder UIP Steps i itroductio - plaig vaccie requiremets, assessig cold chai space, sessio plaig (60 mi) Coduct of Immuizatio sessio with Hepatitis B vaccie packig the VC, ijectio techique ad safety, recordig reportig, (30 mi) Tips for HW traiig ad developmet of traiig pla (10 mi) Frequetly Asked Questios (20 Mi) Ope discussio 56

65 Suggested ageda ad topics for half- day traiig of Health Workers Registratio (10 mi) Pre-test (see Aex 5A ) (10 mi) Review objectives/expectatios (5 mi) Routie immuizatio recap ad discussio o schedules (10 mi) Hepatitis B disease ad importace of ifat immuizatio (20 mi) Hepatitis B vaccie ad its schedule ( 10 mi) Cold chai maiteace, coditioig of icepacks ad packig of vaccie carrier (20 mi) Ijectio techique ad waste maagemet (20 mi) (demostratio) AEFI surveillace (10 mi) Some of the materials that could be used ad dissemiated durig traiig sessio are: Job aids o vaccie freezig (stickers for ILRs ad vaccie carriers) CDs with presetatio for traiig (Supplied separately State ad District Traiers to use it) Flipbooks for traiig by MOs (Supplied separately District ad Block traiers to use it) 57

66 7 Advocacy ad Social Mobilizatio The itroductio of hepatitis B vaccie i the UIP, advocacy ad social mobilizatio are importat i order: to geerate support ad commitmet for the ew vaccie; ad to dispel miscoceptios about the disease ad the vaccie that could udermie public cofidece Advocacy with stakeholders/key decisio makers/opiio leaders is essetial to esure that the vaccie is offered to all eligible ifats i every district Social mobilizatio is eeded to esure that the geeral public, icludig caregivers accept the vaccie These activities are ecessary because hepatitis B disease has: o exteral maifestatio for most ifectios; a isidious oset ad a very log iterval before oset of complicatios; a impressio of NOT beig resposible for these complicatios; ad o directly recogizable deaths i most cases Advocacy Advocacy is a process for raisig awareess, especially amog decisio-makers ad service providers, to esure that (hepatitis B immuizatio) is available for all childre Icreasig awareess i the commuity of the importace of HBV as a cause of disease ad death is a key activity ad requires soud scietific data o the curret ad future 58

67 disease burde Aother critical aspect is to show the impact of immuizatio i prevetig that disease burde As early all disease prevetio will occur several decades after delivery of immuizatio i that cohort, special advocacy efforts are eeded The decisio-makers ad opiio leaders who should be cosidered for advocacy efforts iclude: health departmet officials other govermet officials (ICDS, Dept of Educatio) elected represetatives at state, district ad pachayat evels cliicias i the private sector ogovermetal orgaizatios commuity leaders ad decisio-makers media religious leaders, ad teachers The key messages for these groups could iclude: Disease burde associated with HBV-related cirrhosis ad liver cacer i Idia or i the state; modes of HBV trasmissio; importace of ifat immuizatio i prevetig chroic hepatitis B; efficacy ad cost-effectiveess of hepatitis B immuizatio; safety of hepatitis B vaccie; 59

68 importace of the additio of hepatitis B vaccie to stregthe immuizatio services; importace of their role as advocates for the successful itroductio of hepatitis B vaccie Possible key messages for policy-makers Ifat immuizatio for hepatitis B will prevet large umber of chroic liver diseases decades later Of the 2 6 crore ifats bor every year i the coutry, aroud 10 lakh ru the life-time risk of developig chroic HBV ifectio of whom 1-2 lakh may suffer serious liver disease icludig liver cirrhosis ad cacer Ifat Immuizatio is highly cost effective i prevetig liver cirrhosis ad cacer There is o cure for hepatitis B Prevetio is better! Sustaied high coverage with hepatitis B vaccie ca virtually elimiate hepatitis B ifectios i years Lauchig of Hepatitis B vacciatio Itroduce the vaccie ito the programme with a well publicised lauch at various level This lauch should be atteded by all the stakeholders ad geeral public The opportuity should be utilised to educate public ad policy makers alike about the disease, its prevetio ad how the immuizatio beefits the idividual ad the atio For a successful lauch apart from the mass media evet 60

69 oe to oe cotact with people (Iterpersoal Commuicatio- IPC) is equally importat I this, take help of other govermet departmets, local media ad NGOs that ca spread the message ad motivate the commuity to utilize immuizatio Social Mobilizatio Social mobilizatio is targeted towards the commuity ad caregivers ad is focused o gettig childre to the immuizatio sessio A rage of media should be used to deliver the messages, icludig health workers, Agawadi workers (AWWs), Accredited Social Health Activists (ASHA), commuity voluteers ad mass media Health workers, i particular, ca be motivated to geerate iterest i the hep B vaccie as this ca improve coverage of other vaccies too They are the mai source of iformatio to the geeral public All these opportuities should be utilised for spread messages about routie immuizatio ad traditioal atiges i RI Possible key messages for the parets ad geeral public are: Hepatitis B ad its cosequeces modes of HBV trasmissio importace of ifat immuizatio target group for immuizatio, ad a explaatio of why older childre are ot beig immuized with hepatitis B vaccie how may times ad whe ifats should be 61

70 immuized make sure that the baby is immuized at birth t the hospital ad later three times with DPT ad OPV at 6, 10 ad 14 weeks age Importace of all other vaccies of UIP i additio to hepatitis B vaccie limitatios of hepatitis B vaccie Social Mobilizatio Chaels Surveys show that the best chaels for icreasig demad for immuizatio are health workers, AWWs, local leaders ad local groups Geerally, parets perceive health workers as a credible source of iformatio about health Iter-persoal commuicatio is the best way to give parets iformatio about the hepatitis B vaccie ad whe ad where to brig their child for the vacciatio Mass commuicatio media, ivolvig radio, TV ad prit materials, ca complemet the basic chael of IPC, but it is ot a substitute for it ad is iadequate by itself I summary, for social mobilizatio: Used hadouts ad pamphlets for awareess geeratio Use FAQ o HepB for HWs Use traiig material for all category of health staffs Prepare to respod i a timely maer to miscoceptios about hepatitis B disease ad vaccie that could udermie public cofidece i the programme Miscoceptios about the safety of hepatitis B vaccie may also occur because of case reports of AEFIs 62

71 Activities/ Materials for Itroducig Hepatitis B Vaccie Materials Iteded Use Mai Messages Iter Persoal Commuicatio To iitiate discussios with Basic facts about hepatitis B disease ad vaccie (IPC) (ANM, small groups of Whe ad where to brig AWW, ASHA, etc ) parets as part of RI sessios ad o other occasios childre for immuizatio Brig RI card for every visit Treatig side effects Ifo-kit for health workers (Aexure 1 ad 2) Pamphlet for parets (Aexure 3 ) A referece for health workers helpig them respod to parets' questios ad listig their duties A referece for parets to clarify doubts regardig the vaccie ad the schedule Basic facts about hepatitis B disease ad vaccie What health workers have to do to while addig hepatitis B vaccie Basic facts about hepatitis B disease ad vaccie Ages at which childre should get vaccies Importace of immuizatio Pamphlet for commuity leaders (Aexure 4 ) Posters, hoardigs, baers, wall paitig Prit, Radio ad televisio spots A referece for commuity leaders to help pla support activities ad respod to public s questios To raise public awareess ad provide iformatio about the immuizatio schedule To raise awareess amog the public, commuity leaders, ad health workers Basic facts about hepatitis B disease ad vaccie What leaders ca do to provide support Vaccies i the UIP, icludig hepatitis B Ages at which childre should get vaccies Importace of immuizatio Icreased protectio to the public through hepatitis B vaccie No additioal visits eeded for gettig the vaccie Caregivers should brig childre for all vaccies 63

72 Dissemiatio Strategy Esure timely dissemiatio of guidelies, tools, ad other commuicatio materials to the appropriate audieces Failures i commuicatio commoly occur because the dissemiated materials sometimes do ot reach ad or the formats are ot appropriate for the iteded audiece The materials ofte ed up at warehouses at some itermediate poit A few geeral guidelies for more effective dissemiatio are the followig: Desig a dissemiatio pla that specifies: who is supposed to use ad therefore receive the materials i what quatity ed-users eed them by what meas they will be set to the iteded users who is resposible for sedig them the budget eeded Additioally, Use those chaels that are most coveiet for the audiece, ot those most easy for the programme maagers (e g mass media) Ask audiece members what chaels ad formats are easiest for them to use Moitor dissemiatio - that the material is reachig the iteded people ad that they feel it is appropriate ad useful for them 64

73 8 Supervise, Moitor ad Evaluate Supervise plaig ad implemetatio Supervisio i the plaig phase is focused o checkig the ifrastructure ad huma resource capacity, fidig challeges ad to solve them After iclusio of hepatitis B vaccie i the schedule, it is focused o checkig the adequacy of implemetatio ad o prevetig deviatios from guidelies Supervisio must focus o the critical aspects of quality, effectiveess ad safety ad o aticipated weakesses Supervisors have a importat role to prevet bad plas ad to alter poor implemetatio To achieve this, Supervisors must themselves be familiar with what is expected i the programme ad what role they are expected to play A key compoet of supervisio is to ecourage ad motivate frotlie health workers (ANMs, AWWs, ASHAs) ad guide them through o the job traiig, wherever ecessary Tools for supervisio Supervisors should use a checklist (Aexure 7) as a tool to documet the level of implemetatio of plas, ad coverage with the vaccie Alteratively, the check lists give i Immuizatio hadbook for Medical Officers may also be utilised for supervisory visits,the checklists to be used by a state should be developed locally if local specific additioal 65

74 iformatio is required ad if the form is required i local laguage Schedule supervisory visits Supervisig officers should visit a few immuizatio sessios i actio to observe the actual implemetatio of the programme i field Durig the visit, they should try to assess the proper maiteace of cold chai, safe disposal of AD syriges, ad actual coverage of beeficiaries with all doses of vaccies uder UIP by sample checks i the field ad fid out ay weakesses or costraits Supervisio should be coducted as per a pre-determied pla at various levels as below: At state level: Supervisors from the state level should make supervisory visits to all districts before itroductio of the vaccie If that is ot possible, visit select districts ad blocks, with particular difficulties or questioable preparatios At district level: Supervisors from district should make plaed supervisory visits to all blocks/phcs, particularly with difficulties or questioable prepara tios for logistics or social mobilizatio At block/phc level: Supervisors from the block/phc should make supervisory visits to selected immuizatio sessio sites At all levels: I additio to the above, supervisory visits may be eeded at all levels, depedig o the outcome of the scheduled visits 66

75 Moitor implemetatio Moitorig of ogoig activities is crucial for effective implemetatio of Hep B vacciatio program This opportuity should be utilised for stregtheig RI moitorig i these states The moitorig of hep B vacciatio should be doe to esure a early uptake ad improvig coverage with this ew atige i RI program Icorporate moitorig of hepatitis B vaccie itroductio ito routie moitorig systems as soo as the vaccie is icluded i UIP Staff at all levels should closely moitor progress i vaccie itroductio, particularly durig the first year With the additio of hepatitis B vaccie to the UIP, a fully immuized (FI) child is defied as the oe completig HepB3, i additio to other traditioal vaccies (BCG, 3 doses of OPV, 3 doses of DPT ad Measles vaccie) i the UIP schedule by oe year of age Develop a moitorig pla which could iclude moitorig of: Vaccie ad Logistic Supply Vaccie utilizatio (coverage) ad wastage Cold Chai Ijectio safety ad waste disposal Vacciatio practice at immuizatio sites Coverage moitorig, icludig birth dose Implemetatio of traiig, IEC ad social mobilizatio 67

76 Moitor vaccies ad logistics supply Examie available records for supply, utilizatio ad balace of vaccies ad AD syriges ad physically verify whether there is a logical associatio betwee vaccies ad AD syriges supplied ad used Explore ad address reasos if the followig are foud: utilizatio of vaccie ad AD syriges shows a patter of rapid icrease or decrease week after week; or doses cosumed for vaccies to be provided at the same time (DPT, HepB ad OPV) differ widely from each other for the same period If there is ay mismatch betwee the reported umber of doses ad AD syriges used, cosult the cocered vacciators, doctors, store i charge ad supervisig authorities to fid out the reaso for the variace/mismatch If their reply is foud covicig ad realistic appreciate ad thak them If the reply poits towards problems or irregularity i work/ maagemet, discuss solutios with the cocered persos ad also iform the seior authorities Moitor vaccie utilizatio (coverage) Hepatitis B vaccie coverage ca be moitored usig both reported ad evaluated coverage data Use reported coverage data I geeral, coverage data of UIP, is reported by all levels Aalyze HepB3 ad DPT3 immuizatio coverage data at every level o at least a quarterly basis This will help i plaig, to correct problems ad to moitor programme 68

77 impact Usig reported data to estimate coverage has its advatages The iformatio is timely, the method makes use of umbers that are already routiely gathered ad data ca poit out problems i service delivery However, coverage estimates based o such data may be biased whe the size of the target populatio is wrog or, more commoly, whe reports o the umber of doses admiistered are icomplete This ca lead to overestimatio or uderestimatio of coverage To esure completeess ad accuracy, state ad district immuizatio maagers should audit reported data from districts ad blocks periodically, preferably o a quarterly basis, particularly, i the first year after iclusio of hepatitis B vaccie The followig are examples of reported data that ca be used to moitor hepatitis B immuizatio HepB3 Coverage: This measures the proportio of ifats who complete the hepatitis B immuizatio series Childre immuized with HepB3 by 1 yr of age Target populatio (childre uder 1 yr of age) x 100 HepB1 vs HepB3: This moitors the drop-out rate (the proportio of childre that are icompletely vacciated) for HepB (HepB1 - HepB3) HepB1 x 100 The dropout rates for hepatitis B vaccie should ot be higher 69

78 tha drop-out rates for DPT ad OPV Use the WHO vaccie coverage moitorig chart to moitor these idicators graphically ad provide feedback to lower admiistrative levels HepB3 vs DPT3: This moitors completio of hepatitis B vaccie series i compariso with that of the DPT series By the time the child has completed DPT series it should have received the last (third or fourth) dose of hepatitis B vaccie (DPT3 - HepB3) HepB3 x 100 If DPT3 coverage exceeds HepB3 coverage by more tha 5%, assess missed opportuities for admiisterig hepatitis B vaccie, which may iclude: Cocer about wastig expesive vaccie leadig to: Reluctace to ope a vial for oe child 70

79 HepB vaccie offered less ofte tha DPT vaccie HepB vaccie ot available at all sessio sites Other reasos for missed immuizatio: Hepatitis B vaccie shortages or supply problems False belief that hepatitis B vaccie has excessive cotraidicatios Iadequate staff traiig to admiister ew vaccie I the case of moovalet vaccie, reluctace of mothers to accept multiple ijectios i sigle visit HepB-birth dose coverage: Hepatitis B vaccie birth dose is give at a set up differet tha routie immuizatio program Special efforts should be made to improve coverage with birth dose, ad recordig ad reportig also Measurig the percetage of childre receivig hepatitis B vaccie withi 24 hrs after birth provides a idicator of the success of the programme i prevetig peri-atal HBV ifectios It is also a good idicator of program efficiecy There are a few additioal activities, which ca be doe to icrease coverage with birth dose of hepatitis B vaccie: Labor room ad ursery staff have a greater role ad they should also be traied Obstetricias ad to the staff urses may be give orietatio traiig The hepatitis B vaccie may be made available roud the clock close to the labor room 71

80 Experiece has show the issues related to the recordig ad reportig of birth dose The states ad districts have to pay specific attetio to this issue ad may streamlie it The stadardized IEC material for use at these istitutios may be utilized ad promietly displayed Use evaluated coverage data for moitorig Immuizatio coverage surveys are useful for obtaiig additioal iformatio relatig to ay improvemet i immuizatio coverage They ofte provide more accurate iformatio tha reported data Stadard questioaires used for EPI surveys have to be modified to iclude hepatitis B vaccie doses The importat surveys of UIP coverage are: UNICEF Coverage Evaluatio Survey Natioal Family Health Survey (NFHS); ad District Level Household Surveys (DLHS) Serological surveys ca also be used to provide serologic evidece of receipt of vacciatio Moitor cold chai The cosequeces of failures i cold chai are well kow hepatitis B vaccie gets damaged by higher temperatures as well as by freezig The system will ed up deliverig vaccies that are o loger potet ad effective if proper cold chai is ot maitaied Therefore, strict attetio to maiteace of cold chai is essetial The basic iformatio that should be kow to a supervisor/programme maager o the cold chai ad the capacity ad maiteace of various equip- 72

81 mets is summarized earlier The efforts should be directed towards improvig cold chai maiteace ad temperature moitorig at various level The posters o freeze sesitivity of RI vaccies ad correct placemet of vaccies i ILR should be displayed at strategically correct places at differet levels Moitor immuizatio safety Hepatitis B vaccie is very safe However, ay AEFIs suspected by health workers or public to temporally be associated with hepatitis B vacciatio should be reported i the prescribed GoI formats, icludig death, disability, hospitalizatios, ad ay other severe or uusual medical evet or evet clusters The mior AEFIs should be reported through mothly reportig formats The immuizatio waste should be disposed off as per stadard waste disposal guidelies Check compliace with safety strategies from existig supervisor checklists (Aexure 9) ad seek explaatios for deviatios from safety orms, such as recappig, o-use of hub-cutters ad other icorrect practices Evaluate impact The ultimate outcomes of hepatitis B immuizatio (prevetig chroic HBV ifectio ad its log-term 73

82 cosequeces -cirrhosis ad liver cacer) are difficult to measure However, serological surveys ca provide data o reductio i rates of HBV ifectio, compared to baselie HBsAg positivity data already available Thus, a serological survey of 3-5 year old childre coducted approximately 5 years after the full implemetatio of hepatitis B immuizatio programme ad compariso with results from childre of similar age i previous surveys ca also provide data o programme s effectiveess, as part of a log-term evaluatio process Post itroductio evaluatio (PIE) The atioal govt or state may pla to coduct the Post Itroductio Evaluatio (PIE) of Hepatitis B vaccie itroductio i the state/s These PIE are usually doe withi 6-12 moths of vaccie itroductio i a state ad aims to fid out the status of vaccie itroductio, its impact o the health system ad to derive corrective lessos The states should be ecouraged to coduct such evaluatios 74

83 ANNEXURES 75

84

85 Aexure-1 Iformatio for Health Workers: 20 Frequetly Asked Questios about Hepatitis B Disease ad Vaccie 1 What is hepatitis B? Hepatitis B is a disease due to ifectio ad iflammatio (swellig) of liver caused by HBV Ifectio with HBV ca cause short term (acute) or log- term (chroic) disease 2 What are the cliical features of acute ad chroic hepatitis B? About 10% of ifats ad up-to 30% adults ifected by HBV develop a shortterm (acute) illess with the followig cliical features: Fever Loss of appetite Tiredess Pai i muscles ad joits Nausea, diarrhoea ad vomitig Pai abdome Headache Dark urie Pale stools Jaudice The icubatio period is usually 2 to 5 moths Although most acute ifectios resolve ormally, a few (about 1% of acute ifectios) ca lead to fulmiat hepatitis ad ca result i death I cotrast, 90% of ifats, 30% of childre of 1-5 yr ad about 6% adults ifected with HBV develop chroic ifectios Chroic ifectios remai sub-cliical for a log time without symptoms Persos with chroic ifectio have a 15-25% risk of dyig prematurely due to HBV related liver cirrhosis ad cacer Most of the chroic carriers of HBV look healthy but are capable of spreadig the disease to others 77

86 3 Why is hepatitis B a public health problem? HBV ifectio is a major cause of acute ad chroic liver disease About oethird of the world s populatio i e about 200 crore (two billio) persos, are estimated to be ifected with HBV Of these 35 crore (350 millio) suffer from chroic ifectio The majority of the serious cosequeces of i fectio with hepatitis B virus occur i people who develop the chroic ifectio Worldwide about 5,00,000-7,00,000 die aually from hepatitis B related complicatios 4 Who is at risk of gettig hepatitis B? Ayoe who has ot bee vacciated ca get HBV Ifats ad childre are particularly vulerable for chroic ifectios Childre cotract the disease from their mother at birth, or simply from aother child while playig Chroic ifectios from ifacy are dagerous because of the liver damage ad cacer 5 How is hepatitis B spread? HBV is trasmitted through cotact with ifected blood or body fluids across ski/mucous membrae ad uprotected sexual itercourse HBV is 100 times more ifectious tha Huma Immuodeficiecy Virus (HIV) Ulike HIV, HBV is able to remai active o surfaces (e g table tops, razor blades, blood stais etc) for about a week The primary ways HBV ca be spread are described below Child-to-child trasmissio: This (icludig adult to child) is oe of the commo modes of trasmissio Ifats ad childre frequetly have o symptoms followig hepatitis B ifectio The ifected child may look perfectly healthy Child-to-child trasmissio usually happes durig play, mock fights, scratchig, bitig etc as a result of cotact through ski sores, small breaks i the ski, or mucous membraes with blood, sores or saliva Spread from iaimate objects, such as sharig of toys, towels or toothbrushes may also occur because HBV ca survive for at least 7 days outside the body 78