Estimates on State-Specific Pneumococcal Conjugate Vaccines (PCV) Coverage in the Private Sector in the Year 2012: Evidence from PCV Utilization Data

Size: px

Start display at page:

Download "Estimates on State-Specific Pneumococcal Conjugate Vaccines (PCV) Coverage in the Private Sector in the Year 2012: Evidence from PCV Utilization Data"

Jeffrey Hood
6 years ago
Views:

Brief Research Article Estimates on State-Specific Pneumococcal Conjugate Vaccines (PCV) Coverage in the Private Sector in the Year 2012: Evidence from PCV Utilization Data Habib Hasan Farooqui 1,

1 Brief Research Article Estimates on State-Specific Pneumococcal Conjugate Vaccines (PCV) Coverage in the Private Sector in the Year 2012: Evidence from PCV Utilization Data Habib Hasan Farooqui 1, Sanjay Zodpey 2, Maulik Chokshi 3, Naveen Thacker 4 1 Assistant Professor, 2 Director, 3 Associate Professor, Indian Institute of Public Health, Delhi, 4 Past President, Indian Academy of Pediatrics (IAP), India Summary The pneumococcal conjugate vaccine (PCV) is not available through universal immunization programs but is available through private healthcare providers. Because the PCV rates are unknown, we developed a Microsoft Excel-based assessment model to estimate state-specifi c PCV for the year Our fi ndings suggest that in the private sector, the overall PCV was around 0.33% that ranged between a minimum of 0.07% for Assam, India and a maximum of 2.38% for Delhi, India. Further, in major metropolitan areas, overall PCV rates were: 2.28% for Delhi, India, 13.31% for Mumbai (Maharashtra), India 0.76% for Lucknow (Uttar Pradesh), India, 1.93% for Kolkata (West Bengal), India, and 4.92% for Chennai (Tamil Nadu), India highlighting that urban centers are major drivers for PCV utilization driver in the states with high PCV consumption. Hence, to improve PCV, both demand side (increasing consumer awareness about pneumonia prevention) and supply side (controlling vaccine prices and indigenous vaccine production) interventions are required. Keywords: Coverage, immunization, pneumococcal conjugate vaccine (PCV) Pneumonia is one of the most common causes of morbidity and mortality in children younger than 5 years in India. For India, Child Health Epidemiology Reference Group (CHERG) established by the World Health Organization (WHO) predicted around 43 million pneumonia cases (23% of the world s total) in The latest India-specific analysis suggest that in 2010, 3.6 million ( million) episodes of severe pneumonia and 0.35 million ( million) all deaths caused by pneumonia occurred in children younger than 5 years in India. Further, it was reported that 0.56 million Corresponding Author: Dr. Habib Hasan Farooqui, Indian Institute of Public Health-Delhi, Plot No. 47, Sector 44, Institutional Area, Gurgaon , Haryana, India. drhabibhasan@gmail.com Website: DOI: / X PMID: *** Access this article online Quick Response Code: ( million) severe episodes of pneumococcal pneumonia and 105 thousand ( thousand) pneumococcal deaths occurred in India. 2 However, it is expected that with the availability of a new generation of vaccines that prevent pneumonia, the situation would improve. New generations of pneumonia-preventing vaccines include Hemophilus influenzae B vaccine (Hib Vaccine), pneumococcal conjugate vaccine (PCV), influenza vaccine, and others. The PCV are a significant improvement over the previous generation of polysaccharide vaccines, as they are immunogenic This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. For reprints contact: reprints@medknow.com Cite this article as: Farooqui HH, Zodpey S, Chokshi M, Thacker N. Estimates on state-specifi c Pneumococcal Conjugate Vaccines (PCV) in the private sector in the year 2012: Evidence from PCV utilization data. Indian J Public Health 2016;60: Indian Journal of Public Health Published by Wolters Kluwer - Medknow

2 146 Farooqui, et al.: Estimates on state-specific pneumococcal conjugate vaccines (PCV) in private sector in the year 2012 in infants, elicit longer lasting immune memory, and additionally prevent nasopharyngeal carriage. This new generation of PCVs have serotype for around 52% to 64% invasive pneumococcal disease prevalent in India. Hence, it can potentially prevent significant fraction of invasive pneumococcal disease. 3 Given the fact that PCV is not available through the universal immunization program of the Government of India and can only be accessed through private sector pediatricians, the PCV assessment was felt necessary. Further, anecdotal evidences suggest that even in the private sector, uptake of PCVs is significantly limited to an affluent class of urban metropolitan areas. 4 The objective of this research was to generate evidence on state-specific PCV in the private sector. We developed and parameterized a Microsoft Excelbased assessment model to estimate PCV across major Indian states for the year The input parameters for the assessment model were: The number of eligible children for PCV immunization in selected states, the number of PCV doses consumed across those states, and the number of doses required for complete PCV immunization. The numbers of eligible children for PCV immunization across selected Indian states were estimated from the 2011 census of India. 5 The number of doses of PCVs consumed was estimated from the PCV sales figures (value and volume across brands) from IMS Health sales data for the year For the present study, IMS vaccine sales audit data on PCV for selected Indian states was used as proxy indicator for vaccine utilization in the private sector. The selection of 14 Indian states was driven by IMS vaccine sales data availability. However, these states comprise around 90% of Indian birth. 5 The number of doses and schedule for PCV immunization was based on Indian Academy of Pediatrics Committee on Immunization (IAPCOI) recommendations (i.e., three doses at 6, 10, 14 weeks, and a booster at 15 months). 7 We assumed that any child receiving one dose of the selected vaccine has received all the subsequent doses and completed the schedule. number of PCV doses (all brands) sold in each state in the private market in 2012 by recommended dosing schedule of IAPCOI. Step 2: The PCV figures for across states were estimated for two scenarios, i.e., overall and urban. The overall model assumes that sold PCV doses in private market were consumed by any child (urban and rural) in the birth in the respective state whereas in the urban model assumes that only the urban birth consumed the PCV doses sold in the respective states. Overall or Urban PCV (%) = Children fully immunized by PCV in private sector/birth (urban + rural) or (urban) of the respective states 100%. In addition, correlation coefficient analysis was conducted to observe relationship between state-level PCV in the private sector and state-specific sociodemographic variables viz the level of urbanization (defined as the proportion of population living in urban areas), female literacy level, state specific per capita income, and state-specific gross domestic product (GSDP). The study has received appropriate ethical approval from the institutional ethics committee. Our findings suggest that at an all India level, overall PCV in private sector was around 0.33% that ranged between a minimum of 0.07% for Assam, India and a maximum of 2.38% for Delhi, India [Table 1, Figure 1]. However, the urban PCV in the private sector was 2.10%, with a range of minimum of 0.41% and 2.45% for Kerala, India and Delhi, India respectively [Table 1]. Further, we repeated similar analysis for the major metropolitan cities from the selected states where the urban population was significantly high (capital city) to understand the impact of differential utilization of PCV Calculations for Pcv Coverage Assessment Step 1: The model estimated the number of eligible children immunized with PCV by dividing the total Figure 1: Private sector PCV for selected Indian states in year 2012

3 Farooqui, et al.: Estimates on state-specific pneumococcal conjugate vaccines (PCV) in private sector in the year in urban areas on overall PCV rates. The overall PCV rates for were 2.28% for Delhi, India, 13.31% for Mumbai (Maharashtra), India, 0.76% for Lucknow (Uttar Pradesh), India, 1.93% for Kolkata (West Bengal), India, and 4.92% for Chennai (Tamil Nadu), India [Table 2]. This led to the realization that estimated annual urban PCV rates for capital cities in the private sector was times higher for Chennai, Tamil Nadu, India, time higher for Mumbai, Maharashtra, India, 3.89 times for Kolkata, West Bengal, India, and 1.61 times for Lucknow, Uttar Pradesh, India as compared to respective states annual urban PCV rates. This highlights the fact that urban centers are major drivers for PCV utilization driver in the states with high PCV consumption. It is recognized that in India, immunization rates are influenced by sociodemographic factors and other household factors. In correlation analysis, we observed a strong correlation between state-specific private sector PCV sales and statespecific female literacy rates (r = 0.70), state-specific Table 1: Estimated state-specific PCV (overall and urban) for the year 2012 in the private sector Indian states Overall birth Urban birth (rural + (2011)* urban) (2011)* PCV doses (2011) # PCV doses (2012) # Immunized based on number of PCV doses sold (2011)^ Immunized based on number of PCV doses sold (2012)^** Overall (%)^^ Urban (%)^^ North Delhi 2,22,993 2,07,783 25,708 23,851 8,569 5, Punjab+Haryana 8,86,684 2,93,285 6,941 18,302 2,314 5, West Gujarat 9,60,867 3,66,677 3,187 6,129 1,062 1, Maharashtra 17,75,560 7,47,266 14,723 46,765 4,908 13, Central Rajasthan 13,57,306 2,77, , , Madhya Pradesh 14,10,287 3,18,987 2,937 9, , Uttar Pradesh 35,00,559 6,25,316 6,693 17,051 2,231 4, East West Bengal 12,82,793 3,26, , , Bihar 20,14,957 1,76,882 6,275 13,220 2,092 3, North East Assam 5,48,850 54, , South Andhra Pardesh 12,14,847 3,99,588 8,153 20,828 2,718 6, Karnataka 9,33,645 3,48,115 11,940 20,986 3,980 5, Kerala 4,82,341 2,29,950 2,009 3, Tamil Nadu 10,04,971 4,85,604 11,694 14,588 3,898 3, Overall 1,75,96,660 48,56,939 1,01,300 2,09,872 33,766 58, *Census of India 2011, # IMS Health vaccine sales audit 2012, ^From Step 1, ^^From Step 2, **Immunized (2012) is calculated from PCV doses sold in 2012 as function of 3 doses of PCV consumed at 6,10,14 weeks by minus booster dose for 2011 birth Table 2: Estimated PCV (overall and urban) in the private sector for the year 2012 across selected cities Indian states Overall birth (rural + urban) (2011)* Urban birth (2011)* PCV doses (2011) # PCV doses (2012) # Immunized based on number of PCV doses sold (2012)^** Overall PCV in (%) of the capital city^^ Urban PCV in (%) of the capital city^^ Urban PCV in (%) in state excluding the capital Coverage % (capital city) divided by % (state excluding the capital) Delhi 2,22,993 2,07,783 25,708 23,851 5, Mumbai (Maharashtra) 56,413 56,413 8,335 25,306 7, Lucknow (Uttar Pradesh) 95,208 60, , Kolkata (West Bengal) 72,709 72, ,320 1, Chennai (Tamil Nadu) 63,417 63,417 11,347 13,138 3, *Census of India 2011, as per Census of India there is no rural population in Mumbai, Kolkata, and Chennai, # IMS Health vaccine sales audit, ^From Step 1, ^^From Step 2, **Immunized (2012) is calculated from PCV doses sold in 2012 as function of 3 doses of PCV consumed at 6,10,14 weeks by minus booster dose for 2011 birth

4 148 Farooqui, et al.: Estimates on state-specific pneumococcal conjugate vaccines (PCV) in private sector in the year 2012 per capita income (r = 0.61), and state-specific level of urbanization (r = 0.71). However, the correlation was weak with the state-specific Gross Domestic Product (r = 0.35). To our knowledge, this study is a first of its kind on PCV assessment in India. Our estimates for overall PCV in the private sector in India for year 2012 were 0.33% (minimum 0.07% and maximum of 2.38%). Further, we observed that annual urban PCV rates for capital cities was times higher for Chennai, India, times higher for Mumbai, India, 3.89 times for Kolkata, India, and 1.61 times for Lucknow, India as compared to respective states annual urban PCV rates, highlighting the fact that PCV is predominantly an urban vaccine and its uptake and are largely concentrated in private sector clients. A national survey conducted among the private sector pediatricians registered with the IAP has additionally reported that majority (85.6%) of pediatricians administer PCV vaccine selectively or routinely. 8 District level health surveys have reported as well that for acute respiratory infections (ARI) mothers prefer to visit private health care provider. 9 In another study conducted in Chandigarh, India regarding newer vaccines (Hepatitis B, Hib, measles mumps rubella (MMR), and others), it was observed that more than 50% children got immunization from the private sector. 10 Hence, improved access of PCV in the private sector should contribute significantly to pneumonia prevention in children. In our benchmarking exercise, we observed that PCV rates in selected states and capital cities are still much lower than Hib rates in the private sector. 11 Similar findings were reported for other newer vaccines earlier. In Chandigarh, India, the rates for other newer vaccines was (44.7%) for Hepatitis B, followed by Hib (27.8%), and MMR vaccine (27.6%) in In addition, it has been reported that in the private sector, access to PCV is significantly higher in clients belonging to a highincome group as compared to a low-income group. 4 The limited access of PCV to a high-risk population is further constrained by the lack of awareness, geographic location, and affordability. In addition, it has been reported that the perceptions of disease susceptibility and severity or of vaccine safety and efficacy were not associated with routine PCV vaccine administration by pediatricians. 12 This may lead to a situation where populations who are at the highest risk of pneumococcal pneumonia may not have an access to the PCV. One of the limitations of our analysis is a lack of primary data on PCV utilization. Because vaccines are perishable commodities and require robust cold chain, so IMS vaccine audit sales data is reliable proxy for PCV utilization. Further, given the limited access to vaccine and very low anticipated, the WHO s 30-cluster sample survey design was technically, practically, and financially not feasible. 13 In conclusion, we observed that the private sector although complements the public sector in enhancing access to care and delivery of immunization services but potentially increases inequity in care as well. Hence, public sector intervention is required to ensure equitable access to vaccines. In this regard, Government of India s Mission Indradhanush initiative is worth mentioning and commendable. 11 With reference to inequity in PCV access (i.e., population with a high risk of pneumococcal disease have poor PCV access as compared to those with low disease risk) it is highly pertinent to improve PCV among population by both the demand side (increasing consumer awareness about pneumonia and pneumonia prevention) and the supply side (controlling vaccine prices and indigenous vaccine production) interventions. Acknowledgement We would like to acknowledge the technical advice provided by Dr. Niteen Wairagkar and support of all the pediatricians and their clients interviewed for this research. Financial support and sponsorship This work was supported by the Bill and Melinda Gates Foundation. (Contract number-22693). Confl icts of interest There are no conflicts of interest. References 1. Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ 2008;86: Farooqui H, Jit M, Heymann DL, Zodpey S. Burden of severe pneumonia, pneumococcal pneumonia and pneumonia deaths in Indian states: Modelling based estimates. PloS One 2015;10:e

5 Farooqui, et al.: Estimates on state-specific pneumococcal conjugate vaccines (PCV) in private sector in the year Prospective multicentre hospital surveillance of Streptococcus pneumoniae disease in India. Invasive Bacterial Infection Surveillance (IBIS) Group, International Clinical Epidemiology Network (INCLEN). Lancet 1999;353: Zodpey S, Hasan H, Chokshi M, Kumar BR, Thacker N. Pediatricians perspective on pneumococcal conjugate vaccines: An exploratory study in private sector. Indian J Public Health 2015;59: Census of India The Registrar General and Census Commissioner, Available from: in/. [Last accessed on 2014 Jan 15]. 6. IMS Health. IMS Health, Available from: imshealth.com. [Last accessed on 2015 Apr 04]. 7. Vashishtha VM, Kalra A, Bose A, Choudhury P, Yewale VN, Bansal CP, et al. Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years India, 2013 and Updates on Immunization. Indian Pediatr 2013;50: Gargano LM, Thacker N, Choudhury P, Weiss PS, Pazol K, Bahl S, et al. Predictors of administration and attitudes about pneumococcal, Haemophilus influenzae type b and rotavirus vaccines among pediatricians in India: A national survey. Vaccine 2012;30: IIPS. District Level Household and Facility Survey (DLHS-3), : India. Mumbai: International Institute for Population Sciences (IIPS) p Puri S, Bhatia V, Singh A, Swami HM, Kaur A. Uptake of newer vaccines in Chandigarh. Indian J Pediatr 2007;74: Sharma A, Kaplan WA, Chokshi M, Hasan Farooqui H, Zodpey SP. Implications of private sector Hib vaccine for the introduction of public sector Hib-containing pentavalent vaccine in India: Evidence from retrospective time series data. BMJ Open 2015;5:e Gargano LM, Thacker N, Choudhury P, Weiss PS, Russ RM, Pazol K, et al. Pediatricians perceptions of vaccine effectiveness and safety are significant predictors of vaccine administration in India. Int Health 2013;5: WHO. Immunization Coverage Cluster Survey - Reference Manual. Geneva: World Health Organization; p

Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

Original Article Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India Mansi Chaturvedi, Nithya J. Gogtay, Urmila M. Thatte Department of Clinical