High Cost Is the Primary Barrier Reported by Physicians Who Prescribe Vaccines Not Included in India s Universal Immunization Program

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1 JOURNAL OF TROPICAL PEDIATRICS, VOL. 60, NO. 4, 2014 High Cost Is the Primary Barrier Reported by Physicians Who Prescribe Vaccines Not Included in India s Universal Immunization Program by Geoffrey D. Kahn, 1 Deep Thacker, 2 Somashekhar Nimbalkar, 3 and Mathuram Santosham 1 1 Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA 2 Department of Pediatrics, Child Health Foundation, Kutch, Gujarat , India 3 Pramukhswami Medical College, Karamsad, Gujarat , India Correspondence: Geoffrey D. Kahn, 855 N Wolfe St. Suite 600 Baltimore, MD 21205, USA. <gkahn@jhsph.edu>. Summary Haemophilus influenzae type B (Hib) vaccine, pneumococcal conjugate vaccine (PCV) and rotavirus (RV) vaccine are available in the private market in India, but, except for Hib in eight states, are not included in India s Universal Immunization Program (UIP). Pediatricians were surveyed about administering non-uip vaccines. Most give these vaccines to some of their patients (73 83%, depending on vaccine), but few give them to all patients (7 18%). High cost was the most frequently cited barrier (93 96%). Only 10 12% of respondents had concerns about the efficacy of PCV or RV vaccine, and concerns about Hib vaccine efficacy or any vaccine safety issues were rare (1 3%). Practice varied by type of healthcare facility, with pediatricians at government hospitals least likely to administer non-uip vaccines. Support for the inclusion of all three in the UIP was high (83 95%). Including Hib vaccine, PCV and RV vaccine in India s UIP would be supported by pediatricians and help eliminate the current barrier of high cost of these immunizations. Key words: India, Haemophilus vaccines, pneumococcal vaccines, rotavirus vaccines. Introduction A number of relatively new vaccines are available on the private market in India but are not yet included in the Universal Immunization Program (UIP), including Haemophilus influenzae type B (Hib; now available in eight states in India, although at the time of this survey, it was only available in two) vaccine, pneumococcal conjugate vaccine (PCV) and rotavirus (RV) vaccine. Hib vaccine became available in the private market in India in 1997, PCV in 2006 and RV vaccine in Data on nationwide coverage of Hib vaccine, PCV and RV vaccine through the private sector in India are lacking. However, data on open market sales suggest a steady increase in private market consumption of these vaccines since 2008 [1]. For Hib vaccine, which has been available for longer, several research studies have recorded variable private market coverage between states, with the highest Funding This work was supported by the Bill and Melinda Gates Foundation [OPP to M.S.]. recorded coverage of 41% in children presenting to a hospital in Vellore, Tamil Nadu [2 4]. Vaccine prices vary, but cost approximately Rs 400 (USD6.44) per dose for Hib, Rs 3600 (USD58.00) for PCV and Rs 1200 (USD19.33) for RV. All three vaccines are recommended by the Indian Academy of Pediatrics Committee on Immunization [5]. However, there continues to be a debate in the literature about the need for additional vaccines in India [6, 7]. We sought to assess the degree to which pediatricians are already administering these non-uip vaccines, what drives them to administer or not to their patients and the degree of support for including them in the UIP. Materials and Methods A survey was developed to measure attitudes and practices around administering non-uip vaccines and pilot tested among 10 pediatricians selected by convenience sampling. Revisions were made based on the testers feedback. The final survey consisted of 24 questions, took approximately 30 min to complete and was administered between August and October ß The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please journals.permissions@oup.com 287 doi: /tropej/fmu012 Advance Access published on 24 February 2014

2 Participants were current members of the Indian Academy of Pediatrics (IAP). Study participants were selected from a list of current IAP members by simple random sampling. Pediatricians who participated in the pilot testing of the survey instrument were excluded from consideration in the final survey. Participants received the survey in one of two ways: one group had the survey administered by telephone interview and the other group had the survey ed to them for them to fill out on their own. Assignment to each group was random. Telephone interviewers were trained and read from a standard script. All participants were called by phone to solicit their participation in the survey. Once verbal consent was obtained, participants assigned to the phone group were asked if they had time to complete the survey immediately or were asked to suggest a convenient time to call back. Participants assigned to the group were asked to confirm their address. Subjects who did not complete the survey within 1 week were sent up to two reminder s. Data were collected in Microsoft Excel and analyzed using SAS 9.2. Wilson confidence intervals were constructed around the response proportions, and responses were compared between groups with the Pearson chi-square test and Student t-test. Sample size was calculated to give confidence intervals of 5% around the pooled survey responses, with alpha of 0.05 and assuming a 50% response rate. We calculated that a total sample size of 382 was needed, so 764 surveys were distributed, 382 in each group. This study was approved by the Internal Review Board at the Johns Hopkins Bloomberg School of Public Health and the Human Research Ethics Committee at the Pramukhswami Medical College. Results In all, 382 surveys were sent to each arm of the study: telephone and . Fifty-nine responses (15.4%) and 275 phone responses (82.3%) were collected. The total response rate was 43.7%. Basic characteristics were similar between and telephone respondents, with the exception of type of practice (Table 1). Gender and state of practice were known for pediatricians who were contacted but did not complete the survey, and there were no significant differences between those who responded and those who did not (data not shown). Other characteristics, like type of practice, could not be assessed. The majority of pediatricians (73 83%, depending on the vaccine) administered all three non-uip vaccines to at least some of their patients (Table 2). However, only 7 18% of pediatricians administer the vaccines to all of their patients. Further, 80 90% of pediatricians stated that they gave non-uip vaccines only to those who could afford it. Roughly onefourth of pediatricians said they give non-uip vaccines only to patients who demand it (responses were not mutually exclusive). A small percentage (3%) of pediatricians recommend PCV only to high-risk children. When pediatricians who do not administer non- UIP vaccines to all their patients were asked their reasons for not prescribing, >90% responded that the vaccines were too expensive. There were very few pediatricians (3%) who had concerns about the safety of any of the vaccines. Few pediatricians had concerns about the efficacy of Hib vaccine or the burden of Hib disease. There was some question about the need for PCV and RV vaccine (5 7%), and relatively more concern about the efficacy of those two vaccines (10 12%). In this survey, 98% of pediatricians recommend Hib vaccine for their own children, grandchildren or children of close friends, and 88 89% recommend PCV and RV vaccine for their own or friends children. Pediatricians at government health service providers were the least likely to prescribe non-uip vaccines to any of their patients (Table 3). Almost all pediatricians at multispecialty private hospitals prescribed non-uip vaccines to at least some of their patients, and were more likely to prescribe non-uip vaccines to all of their patients. Pediatricians at individual private practices and medical colleges were similar, and fell between government health services and multispecialty private hospitals in terms of prescribing non-uip vaccines to any patients. Pediatricians at medical colleges were more likely to prescribe to all patients. Discussion The results of this survey suggest that there is strong support among IAP member pediatricians for the use of newer vaccines and that the consensus recommendations of the IAP are generally adhered to; a majority of pediatricians administer non-uip vaccines to at least some of their patients. Concerns about the safety, efficacy and need for Hib vaccine, which is currently being introduced in a state-by-state phased manner in India, are very low. It has also been available on the private market for a comparatively long time. Hib vaccine is the cheapest of the three and is available as a combination product with diphtheria, pertussis and tetanus and hepatitis B, which probably contributes to it being the vaccine most commonly administered to all patients. Concerns about the efficacy and relevant disease burden for PCV and RV vaccine are more common, but still low (12%). Professional education around disease burden and vaccine impact 288 Journal of Tropical Pediatrics Vol. 60, No. 4

3 TABLE 1 Characteristics of survey participants Telephone Total Test of difference (N ¼ 59) (N ¼ 275) (N ¼ 334) between groups Sex % p ¼ Male Female Age (years) p ¼ Mean Median Range Type of practice % p < Government health facility Medical college-based practice Individual private facility Multispecialty private hospital Time in pediatric practice % p ¼ <5 years years years >20 years Statistically significant results (p < 0.05) are shown in bold. TABLE 2 Pediatrician views and prescribing practices for new vaccines Hib PCV RV Which vaccines would you like to see included in the UIP? 95% (95% CI: 83% 84% 92 97%) (79 87%) (80 88%) Do you prescribe to any of your pediatric patients? 83% 73% 79% (79 87%) (68 78%) (74 83%) If yes, do you prescribe to a,b All patients 18% 7% 11% Only those who can afford it 80% 92% 88% Only those who demand it 23% 28% 26% Other (high-risk groups) 3% If no, what are your reasons for not prescribing to all your patients a,c Too expensive 96% 94% 93% Not sure risk of disease warrants it 2% 5% 7% Not sure of vaccine efficacy 1% 10% 12% Not sure of vaccine safety 1% 2% 3% Other (not government-recommended, not supplied 2% by the government) Other (not important in context of low UIP coverage) <1% Other (does not cover all strains) 1% Other (no Indian efficacy trials/local efficacy data) <1% <1% Other (treatment is cheaper) 1% Other (parents not interested) <1% Other (intussusception risk) <1% Do you recommend to your own children or grandchildren, or close friends? 98% 88% 89% (96 99%) (84 91%) (85 92%) a Multiple responses possible; all other responses were supplied by participants. b Denominator includes those who said they prescribe vaccine to any of their patients. c Denominator includes those who said they did not prescribe vaccine to any of their patients plus those who prescribe to some but not all of their patients. Journal of Tropical Pediatrics Vol. 60, No

4 TABLE 3 New vaccine prescribing practices stratified by type of practice for prescribing pediatrician Government health Individual private Medical Multispecialty service facility college private hospital (N ¼ 59) (N ¼ 177) (N ¼ 67) (N ¼ 28) Test of difference between groups Do you prescribe Hib vaccine to of your pediatric patients? Any 76% 82% 87% 96% p ¼ All 14% 9% 21% 43% p < Do you prescribe PCV to of your pediatric patients? Any 63% 71% 79% 93% p ¼ All 3% 3% 9% 14% p ¼ Do you prescribe RV to of your pediatric patients? Any 76% 77% 75% 100% p ¼ All 7% 6% 12% 25% p ¼ Statistically significant results (p < 0.05) are shown in bold. would likely be beneficial to maximize pediatrician buy-in, if and when these vaccines are introduced. However, there is apparent inequity in the children who receive non-uip vaccines on the private market. Pediatricians report that the most common reason for not prescribing these vaccines to all of their patients is because some patients cannot afford them. Among UIP vaccines, research has documented significant inequity in access, with household wealth being one of the strongest drivers of access to vaccination [8]. Research on patient demand for medical services has also shown that cost, along with a few other factors like physical distance to a facility, is one of the most important drivers in patient care-seeking behavior [9]. This inequity in access requires to be addressed by governments, advocacy organizations as well manufacturers and researchers alike to ensure that the vaccines produced eventually do reach those who require them the most. In the past decade, significant progress has been made in this direction [10], but the results of the survey indicate that more needs to be done. Children who attend private hospitals are more likely to receive non-uip vaccines than those who attend government facilities. This may be due to the fact that government facilities see a larger proportion of poor patients. Additionally, in some states, pediatricians at government facilities are discouraged from prescribing drugs that the hospital does not carry, like non-uip vaccines. Factors such as profit motive and aggressive marketing by pharmaceutical companies have also been alluded to by researchers in the public sector [11]. The IAP, responding to these issues, has striven to ensure that its guidelines are bereft of industry influence, to promulgate ethical practices and to counter antivaccine activists [12]. In our survey, the majority of pediatricians from both public and private hospitals support the use of vaccines that have been recommended by the IAP. This survey was intended to document pediatrician attitudes and practices, and does not reflect the number or proportion of children who are receiving non-uip vaccines in India. Significant differences in the type of practice were detected between the two surveyed groups (telephone and ). For this reason, results were analyzed both in aggregate and by practice type. A report by Indicus Analytics estimated that private hospital beds represented 78% of all hospital beds in India in 2009 [13]. Assuming a mix of private and public medical colleges in our sample, the aggregate results of this survey are similar to the overall public/private split given by Indicus, and we therefore conclude that our sample is likely to be nationally representative. In comparing gender and practice location between our sample and nonresponder pediatricians, we found no evidence of bias. However, we were unable to test other characteristics like type of practice or time in practice and so the possibility of bias cannot be ruled out, especially in view of the exceptionally low response rate from the arm of the survey. Conclusion Our study indicates that a majority of pediatricians prescribe Hib vaccine, PCV and RV vaccine to their patients. More than 85% of pediatricians indicated that they would prescribe these vaccines to their own children. However, very few prescribed these vaccines to all their patients. The most commonly cited barrier to administering non-uip vaccines was high cost. This finding corroborates other studies that have found an association between poverty and reduced access to a medical care. We hope that this inequity will soon be resolved so that all children in India have equal access to life-saving vaccines. 290 Journal of Tropical Pediatrics Vol. 60, No. 4

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