An Assessment of Hepatitis B Vaccine Introduction in India: Lessons

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Original Article

An Assessment of Hepatitis B Vaccine Introduction in India: Lessons for Roll out and Scale up of New Vaccines in Immunization Programs *Chandrakant Lahariya, B. P. Subramanya, Stephen Sosler World Health Organization- India/National Polio Surveillance Project, New Delhi, India

Abstract Background: Hepatitis B vaccine was introduced in the Universal Immunization Program (UIP) of 10 states of India in the year 2007-08. This assessment was planned and conducted to ascertain the reasons for low reported coverage of Hepatitis B (Hep B) vaccine in comparison of similarly timed diphtheria, pertussis, and tetanus (DPT) vaccine; to identify operational and programmatic challenges in new vaccine introductions, and to derive lessons for further scale up of Hep B vaccination (or for introduction of any new vaccine) in UIP of India. Materials and Methods: Purposive sampling with both quantitative and qualitative data collection. Two districts each were purposively selected from 5 of the 10 states, which introduced Hep B vaccine, in the year 2007-08. A protocol was devised and data was collected through desk review, in-depth interviews and on-site observation at state, districts and facility levels. The assessment was completed in December 2009. Results: Coverage with three doses of Hep B vaccine was lower than similarly timed three doses of DPT vaccine. Poor stock management (“stock outs or nil stocks” at various levels), incomplete recording and reporting, perceived high cost & related fear of wastage of vaccine in 10 dose vial, and incomplete knowledge amongst health functionaries about vaccination schedule were the main reasons cited for reported lower coverage. Hep B vaccine birth dose was introduced in only 3 of 5 states evaluated. The additional reasons for low Hep B birth dose coverage were lack of knowledge amongst Health Workers about birth dose administration, no mechanism for recording birth dose, and insufficient trainings, official communications, and coordination at various levels. Conclusions: This assessment documents challenges faced in the introduction of hepatitis B vaccine in UIP in India and summarizes the lessons learnt. It is concluded that for successful introduction and scale up of any new vaccine in national or state immunization program; clear and timely central level instructions and oversight and improved stock management is required. At state and district levels; quality trainings, effective supervision and monitoring, improving data recording and reporting are key factor for success. The additional focus on Hep B birth dose administration may help in improving coverage. The lessons from this assessment can possibly be utilized for future introduction and scale up of any new vaccine (or other similar interventions) in India or in any other developing country setting.

Key words: Birth dose, Hepatitis B vaccine, India, New vaccines introduction, Vaccination

*Corresponding Author: Dr. Chandrakant Lahariya, Routine Immunization and New Vaccines Focal Person, World Health Organization- India/National Polio Surveillance Project, New Delhi - 110 029, India. E-mail: [email protected]

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Website: www.ijph.in DOI: 10.4103/0019-557X.111357 PMID: ***

Introduction Hepatitis B virus (HBV) infection has been identified as a major public health problem worldwide and in India.1,2 A safe and effective vaccine to prevent from Hepatitis B (Hep B) diseases is available for nearly 3 decades and has been included in the national immunization programs of nearly 175 World Health Organization (WHO) member countries by the end of 2009.3,4 The introduction of Hep B vaccination has reduced disease burden in these countries.5-8 India has “intermediate to high endemicity” for Hepatitis B surface antigen and an estimated 40 million chronic HBV carriers, constituting approximately 11% of the estimated

Indian Journal of Public Health, Volume 57, Issue 1, January-March, 2013

[Downloaded free from http://www.ijph.in on Monday, June 11, 2018, IP: 190.105.157.20] Lahariya, et al.: Assessment of Hepatitis B Vaccine Introduction in India

global burden.9-11 With an annual birth cohort of 2.6 Crore (26 million), an estimated 10 lakh (1 million) people annually become chronic HBV carriers and amounts to approx. 100,000-200,000 premature deaths from cirrhosis or hepato-cellular carcinoma in India.12-14 Hep B vaccination program was initially launched in 14 metropolitan cities of India in June 2002 and then additional 33 rural districts were included for vaccination in October 2003.15 The use of Hep B vaccine was further expanded to cover all districts in 10 states of the country in 2007-08 [Map 1].16 The national policy in India recommends that children receive 3 doses of HepB vaccine, administered concurrently with diphtheria, pertussis and tetanus (DPT) and trivalent oral polio vaccine at 6, 10 and 14 weeks. In addition, a birth dose is recommended for all new-borns (within 24 h of delivery) for all institutional deliveries.17 Following the vaccine introduction, the coverage reports received by the Government of India from these states reflected that the coverage with three doses of Hep B was lower than similarly timed DPT vaccine (while the immunization schedule for both vaccines was similar).18 Therefore, in the mid of 2009, Immunization Division, Ministry of Health and Family Welfare, Government of India requested World Health Organization (WHO)-India’s National Polio Surveillance Project (NPSP), to conduct an assessment of Hep B vaccine introduction and usage in India. The objectives of this assessment were to ascertain the reasons for low reported coverage of Hep B vaccine in comparison to similarly timed DPT vaccine, to recognize

Deep blue: states where assessment was done Light blue: states where Hepatitis b vaccination was ongoing on but not included in the assessment Yellow: Districts within states visited for the assessment Map 1: Hepatitis B introduction states, and states and districts where this assessment was conducted

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the corresponding operational and programmatic issues, and to derive lessons for further scale up of Hep B vaccination (or introduction and scale up of any other new vaccine) in the UIP of India.

Materials and Methods An assessment with quantitative and qualitative methods (observations and field visits) was conducted from August to December 2009. The assessment methodology and protocol was developed in consultation with the Government of India and other subject matter experts, to cover the specific identified objectives, in August/ September 2009. The vaccination was introduced in 10 states in 2007-08; however, 5 states namely Punjab, Madhya Pradesh (MP), West Bengal (WB), Karnataka (KA) and Tamil Nadu (TN) were selected for this assessment. In each of the selected states, 2 districts were selected [Map 1]. The states for assessment were purposively selected, based upon regional representation and a mix of well performing and poor performing states as per the state coverage reports for 2008.18 The DPT3-Hep B3 coverage difference of the calendar year 2008 were used for selecting the states for evaluation. The districts within the states were selected to provide geographical representation, with one district close to state headquarter and the other farther away.18 The desk review of immunization data (reported coverage data of period of April to September 2009) was performed in October/November 2009 followed by field visits in December 2009. The in-depth interviews of State Immunization Officers, District Immunization Officers, cold chain officers and handlers, pediatricians, both in public and private sector, and of vaccinators/Auxiliary Nurse Midwives, were conducted besides session site and cold chain point observations. The data was collected through pre-tested and standardized assessment tools. Ten assessment teams, each consisting of two subject matter experts and who had experience in immunization program implementation, visited selected districts. These teams had representatives from WHO India’s National Polio Surveillance Project; WHO Headquarter, Geneva; Centre for Disease Control and Prevention, Atlanta, USA; United States Agency for International Development/ Maternal and Child Health Integrated Project (USAID/ MCHIP)- India, Indian Institute of Public Health (IIPH), Gandhi Nagar and Institute of Liver and Biliary Sciences



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(ILBS), Delhi. Prior to the field visits, all members of assessment teams attended a national level briefing, held in New Delhi, to standardize data collection process. The teams collected data by completing standardized pretested questionnaires during interviews and observations at states, districts, Primary Health Centers (PHC), and session site level. At the district level, team members interviewed 2 pediatricians (one in the government hospital and second in the private sector). The data was analyzed using MS-Excel based tool specially designed for data entry from the assessment tools. The quantitative data was expressed in terms of means, frequencies and percentages. The qualitative data was analyzed manually by adopting free listing of responses, domain identification and coding of responses. The informed consent of the each participant in this assessment was sought, before starting the interviews.

Results The comprehensive desk review of the Hep B vaccine introduction related issues and reported coverage data was done prior to the field visit. During the field visits at various level, a total of 143 respondents were interviewed [Table 1], the field based observations of cold chain storage points (vaccine storage and stock management) and from session site observations included a total of 36 site observations. The data on Hep B vaccine coverage and drop out was reviewed for April to September 2009 [Table 2]. The reported coverage of three doses of Hepatitis B vaccine (Hep B3) was lower than three doses of DPT vaccine (DPT3) in 8 of the 10 assessment districts. One district had reported higher coverage for Hep B3 than DPT3

[Table 2]. However, this coverage gap had significantly less than reported coverage in calendar year 2008. The Hep B1 to Hep B3 dropout rate was higher than DPT1DPT3 drop out during the same period. The reasons for lower coverage and high drop outs were explored with the officials during in depth interviews and the summary reasons cited by them were: shortage or stock-outs of vaccine, improper or incomplete data recording and reporting for Hep B vaccination at various levels, lack of awareness amongst health workers about Hep B vaccine schedule and benefits, and health workers not opening Hep B vaccine vial, if beneficiaries were a few, to keep vaccine wastage rate low etc. The Government of India had issued guidelines for the administration of Hep B vaccine birth dose within 24 h of delivery. However, only 3 (KA, TN and WB) of the 5 states visited had started the birth dose of Hep B vaccine in the program. Moreover, in these three states, the timing of birth dose was variable from 24 h to up to 2 weeks, and only a small proportion of children who had received Table 1: Total data collected for this assessment Persons interviewed

State level District PHC level level and session site

Total

Program managers (Immunization ofﬁcers/ MOs) Pediatricians

5

10

20

35

–

–

20

Data manager/assistant Vaccine stock and cold chain in charge staff ANMs/HWs Total respondents

5 5

20 (10 Govt.+10 Private) 9 10

20 20

34 35

15

49

19 79

19 143

PHC - Primary Health Centers, ANM - Auxiliary Nurse Midwives, MO – Medical Ofﬁcers, HW – Health Workers

Table 2: DPT and Hep B coverage and drop-out rates for the assessment districts18 State

District

Karnataka

Ramanagara Raichur Vidisha Betul Mohali Amritsar Kanchipuram Salem South 24 Pargana Birbhum

Madhya Pradesh Punjab Tamil Nadu West Bengal

DPT3 Hep B3 DPT1-DPT3 Hep B1-Hep B3 DPT3-Hep B3 DPT3– Hep B3 coverage coverage (%)* coverage (%)* dropout rate (%) dropout rate (%) coverage gap rate (%) gap 2008 (%)* 94.6 120.9 66.2 85.2 93.0 92.0 97.7 95.9 84.7 96.4

94.6 66.1 60.1 81.6 92.9 87.0 98.8 95.2 40.5 64.6

−10.3 2.1 12.4 7.5 4.9 0.7 4.4 2.5 −9.9 −6.9

−10.4 33.5 17.8 8.9 4.1 −0.4 1.8 4.4 −0.4 3.8

0.0 45.4 6.1 3.6 0.1 5.0 −1.1 0.7 44.2 31.8

40.2 100.0 83.9 38.0 44.9 12.6 15.1 61.7 91.5 94.8

DPT - Diphtheria, pertussis and tetanus, Hep B - Hepatitis B, *Data in the last column is from Joint Reporting Form (JRF) 2008 and for entire year, the data in the rest of the columns is for April to Sept 2009 (6 months period only)



birth dose, received it within first 24 h of life. The other 2 states (Punjab and TN), did not start birth dose due to concerns about vaccine wastage and the fear of Adverse Events Following Immunization. The recording and reporting of the birth dose was also incomplete. The separate box for recording the birth dose was found in RI card in 3 of 6 districts which had introduced Hep B birth dose (both districts in KA and 1 district in MP, data from second district of MP was missing). Moreover, since Hep B birth dose was being given through facility level only (unlike routine immunization, which is given at session sites also), there was no streamlined mechanism to record and report Hep B birth dose. Majority of the health functionaries at facilities interviewed said that apprehensions about the wastage of vaccine doses prevented them from opening a new vial. There was limited knowledge and information amongst program managers and health workers about till what age Hep B birth dose should be given. The assessment teams noted that the Routine Immunization (RI) cards for recording Hep B data were updated to incorporate Hep B vaccine dose in 17 (of 20) session sites visited. At a few places, though the formats at lower level facilities were not modified to create separate column for entering Hep B coverage; the monthly reporting formats for DPT and Hep B vaccine related columns were completed at next level of facility (This is not possible if lower level information is not available). It was revealed that in such cases, Hep B vaccine coverage was assumed as equal to that of respective DPT doses coverage and it was reflected in the monthly reports. Similarly, at one site, Hep B birth dose coverage was assumed as equal to that of BCG Vaccine coverage. The assessment teams also conducted visits to private practitioners providing immunization and noted that the efforts to collect coverage report from the private sector were fragmented and sporadic. KA and TN have a coordinated mechanism where data from the private sector was systematically collected besides collecting information from the community on the vaccination status of children irrespective of the place of vaccination. In WB and MP states, the reports were being collected from only 1 to 2 large hospitals/clinics at the district headquarters only. In general, the higher level stores were not receiving regular indents for the vaccines, and were sending vaccines by “push mechanism.” The assessment teams verified the stocks for the period April-December 2009

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(until the time of study). Nine of 16 (56%) state or district level and 12 of 20 (60%) Primary Health Centre level stores had experienced at least one “nil stock or stock-out” situation for Hep B vaccine, during this period. The majority of these stock-outs lasted for a few weeks. During this period, while there was no “nil stock or stock out” in TN, all stores visited in WB had faced at least one stock-out. In one district each of KA and Punjab, while the district stores appeared to have sufficient stocks, there were stock-outs at PHC stores. In one districts of MP, stock-out was found at the time of visit, both at the district as well as the PHC stores. It was observed that the quantity of Hep B vaccine available at the state stores was about 1/3 of the DPT vaccine stock. At the district level, Hep B stocks were lower compared to the DPT stock, except in TN and Punjab. Amongst 36 vaccine stores visited, the stock registers were maintained (details on quantity received, dates of receipt and distribution, batch numbers, expiry dates, quantity received and distributed, etc.,) at majority of the stores. However, at a few district and PHC stores, critical information such as batch numbers and expiry dates of the vaccines were missing. Additionally, 3 of the 5 states (KA, MP and WB) reported cold chain space constraint for storing Hep B vaccine. There were anecdotal reports of incidents of vaccines being found frozen at various levels, however, no frozen Hep B vaccine was found at any of the site visited in the assessment. Twenty eight of 35 (80%) and 17 of 19 (89%) program managers and health workers, respectively, reported to have attended sensitization/training workshops on Hep B vaccine. However, the knowledge about various aspects, i.e., disease prevented, doses required and why birth dose etc., was suboptimal and indicated the need for refresher and the improvement in the quality of trainings. A total 10 private pediatricians were visited in this assessment. All of them were using Hep B vaccine in their clinics. Hep B vaccine was being shared with private sector in 3 districts visited. In WB, the vaccine was shared with the immunization clinics run by NonGovernment Organizations. Three pediatricians reported to provide birth dose also. Five of 10 pediatricians in private sector reported that they provided immunization coverage reports to the government. The Government officials said that it was the non-receipt of coverage report from private sector as a reason for them not to share vaccines.


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Lahariya, et al.: Assessment of Hepatitis B Vaccine Introduction in India

Discussion

Box 1: Summary of previous assessments of Hepatitis B vaccination in India

This is the third field based review cum uptake assessment of Hep B vaccine implementation in India. However, this assessment is the biggest and most comprehensive amongst all three assessments. The first 2 review cum assessments were done in 2004 and 2007, respectively [Box 1].15,19 The present assessment found variable gaps in the reported coverage of DPT3-Hep B3. These gaps, though had been reduced over the period of time in the majority of the districts. The reasons for coverage gaps have been corroborated from the findings of the previous two reviews cum assessments also and indicate the need for better central level instruction and oversight prior to the introduction of any new vaccine [Box 1]. The assessment findings suggest that central level oversight and instructions and regular and timely vaccine supply from national level may help in smooth implementation. At state and district level proper vaccine stock management, quality and timely training, regular monitoring and supervision of the program implementation is required for effective and successful introduction. One major reason for low coverage with the birth dose of Hep B was that the decision to include birth dose for all institutional deliveries was communicated in mid2008 (almost a year after vaccine introduction) through an official government letter.20 However, it was noted during the field visit that this information did not trickle down to the field staff, sufficiently. The fear of high vaccine wastage was another reason for low uptake of Hep B birth dose. In India, at peripheral health facilities, only 1-2 deliveries take place, in a day, and health staff was often apprehensive of opening a new 10 dose Hep B vaccine vial, where remaining doses would be go wasted, it may be noted that at the time when this assessment was conducted, India did not have policy to re-use an opened multi-dose vial for subsequent immunization sessions. The observations in this assessment are corroborated from studies in the other parts of the word. A study from rural Indonesia identified weakness in policy development and implementation, poor communication, lack of effective training as reasons for poor coverage with Hep B birth dose.21 Another study from Philippines found that only 22% of children were vaccinated within 24 h of delivery

The first rapid review cum assessment of Hep B vaccine introduction in India was done in August 2004 in 4 cities (Bangalore, Hyderabad, Ahmadabad, Mumbai) and 4 districts (Mysore, Chittoor, Ratnagiri, Surat). 15 This assessment had noted “Lower than expected coverage and higher than anticipated drop-out of hepatitis B immunization in many of the first phase introduction sites.” It was also found that the distribution of vaccines from districts/cities to hospitals and primary health centers and further down the delivery system in many locations were based on previous indents. Placing need based indents after visual assessment of balance stock was being practiced at relatively few locations. Almost all the health care providers (Medical Officers, Supervisors and Health Workers) stated that Hepatitis B vaccination had not added extra work and they reported the use of Auto Disabled (AD) syringes more time efficient and convenient. The findings from this assessment were used to give recommendation to distribute of Hep B vaccination to the private practitioners; conducting review of Hep B vaccination coverage during national immunization review meetings; to start routine orientation and trainings of Health Workers (HW) when a new vaccine is introduced, and for strengthening of monitoring and supervision activities by District Immunization Officer. It was also recommended that incentives (e.g., official recognition) be provided to general practitioners and institutions to report numbers of fully immunized children on a monthly basis.15 The second assessment of Hep B vaccination in India was done in April-May 2007.19 The initial desk review was followed by field visits to 2 cities (Bangalore and Hyderabad) and 2 districts (Indore and Roopnagar). It was noted that amongst target population and program managers, the Hep B vaccine was perceived as vaccine against Jaundice. The concerns on the multiple injections in single visit were raised by a few health workers and by a few parents, during this review. This review had noted that birth dose was being given till the 2 weeks of age. There was no separate column for Hep B vaccination entry in the Immunization card, in any of the sites visited.19 There were a few common observations in this and previous review. The findings from these two reviews had been utilized for the drafting of operational guidelines for hepatitis B vaccine introduction, prior to the roll-out in 10 states of India.

and noted that availability of a copy of Hep B vaccination policy and providing trainings to health workers was associated with increased coverage with birth dose.22 One group of researchers in Vietnam noted that community based pregnancy tracking practices, relation



of immunization program with private maternity services and large urban hospitals, perceived contraindications, and family perceptions were favorably associated with increased chances of receiving Hep B birth dose.23 The lessons from this assessment were used for further scale up of Hep B vaccination in Universal Immunization Program (UIP) in India in 2011. Specifically the Govt. of India adopted Open Vial Policy for birth dose of Hep B vaccine.24 The efforts were made to involve nursery room staff and Obstetrician by sensitizing them about Hep B birth dose administration. It has been recommended that “Janani Suraksha Yojana” platform be used for increasing coverage with Hep B birth dose. The birth dose focus be targeted and closely monitored in the high risk populations, such as tribal communities with traditionally high endemicity.9-11 There was a limited involvement of private practitioners in Hep B vaccination program in the assessment districts. In a few districts, the vaccine was not being shared with the private practitioners for various reasons, which was probably a missed opportunity for vaccination. In 2009, Govt. of India issued guidelines on sharing vaccines with private practitioners,26 however, there was limited awareness about these guidelines at the field level. It is recommended that these guidelines for sharing vaccine with private sector should be widely distributed. It is suggested that at the time of introduction of new vaccines, private practitioners may also be sensitized and trained about new vaccines and their professional associations may be involved in the introduction, advocacy and social mobilization related efforts. The data recording and reporting has traditionally been weak in UIP in India.27,28 This assessment notes that the formats were not revised and the complete information was not available from data to take steps for programmatic corrections. There were limited monitoring and supervision at the field level. It appears that though, there were 2 previous review cum assessments of Hep B vaccine introduction, the findings and recommendations from those 2 reviews15,19 were not fully utilized for taking corrective actions. It is suggested that the findings of this and other previous assessments are optimally utilized for any new vaccine introduction and scale up in India. This assessment has limitation of small sample size, purposive selection of the states and districts and therefore, the results may not be generalizable. The assessment did not cover

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all operational (cold chain, injection safety and waste disposal) aspects of program implementation. In conclusion, there appears a need for better central and state level oversight and follow-up, distribution of detailed and specific policy guidelines and communication in timely manner, streamlined vaccine supply to the field prior and during the introduction of a new vaccine. At the state and district level, quality and timely trainings, effective supervision and monitoring, improving data reporting and use of data for action, focus on birth dose administration, and the involvement of private physicians may help in improving and streamlining new vaccines in UIP in India. This assessment provides important lessons for scale up of Hepatitis B vaccine to other states of India and also for the introduction of any new vaccine in the national or state immunization program of India. The lessons from this assessment can possibly be utilized for future introduction and scale up of any other similar health intervention, in the developing country setting.

Acknowledgments The authors acknowledged the contribution of the following subject matter experts who participated in the data collection from the field. WHO India/NPSP: Renu Paruthi, Balwinder Singh, Vibhor Jain, Harish Verma, Dipankar Mukherjee, Sahir Pall, Arvinder Narula, Vishesh Kumar, JVVRK Prasad, Asha Raghavan; WHO HQ: Steven T. Wiersma; CDC Atlanta, USA: Alice Pope, Carla Lee; IIPH, Gandhi Nagar: Deepak Saxena, Parthasarathy Ganguly; USAID/MCHIP, New Delhi: Neeraj Agarwal; ILBS, New Delhi: Vibhuti Sharma.

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Cite this article as: Lahariya C, Subramanya BP, Sosler S. An assessment of hepatitis b vaccine introduction in India: Lessons for roll out and scale up of new vaccines in immunization programs. Indian J Public Health 2013;57:8-14. Source of Support: This study was conducted on the request of Ministry of Health and Family Welfare, The Government of India and was funded by the World Health Organization. Disclaimer: The views stated are solely attributable to the individual authors and do not necessarily reflect of the views of the organizations they have been associated at present or in the past. The views expressed do not necessarily represent the decisions or the states policies of the World Health Organization. Conflict of Interest: No.
