Documentation of vaccine wastage in two different geographic contexts under the universal immunization program in India

Before national introduction of RVV in India in April 2016, a pilot introduction linked to surveillance of intussusception was planned. This pilot introduction was led by Department of Biotechnology in partnership with Ministry of Health and Family Welfare (MoHFW), monitored through an Interministerial-Interagency Coordination Group and funded by Bill and Melinda Gates Foundation. The RVV pilot introduction was launched in two districts Kangra (Himachal Pradesh) and Pune (Maharashtra) in December 2015, which preceded the national introduction (April 2016). The district Kangra continued to receive the RVV supply from the project for 2 years (till December 2017), although the RVV was launched in the state through national rollout in April 2016. The RVV was launched in Maharashtra state (and Pune district) through national rollout in July 2019. District Kangra with population 1.5 million had one district hospital (DH), one sub-district hospital (SDH), 13 community health centres (CHCs), 84 primary health centres (PHCs) and 440 sub-centers. In the Kangra district about 262 fixed sessions and 903 outreach sessions were organised every month. In Pune district, a selected part of the district covering 1 million population with a network of 29 PHCs and six rural hospitals (RH) was included. The immunization and vaccine logistics related health functionaries in these two districts and community mobilisers were trained for implementation through a cascade training system. The RVV was launched in December 2015 and routinely administered to the infants from January 2016. The birth cohorts targeted in these two districts were 41,400 (Kangra 23,400 and Pune 18,000). Three doses of ROTAVAC® (Bharat Biotech) were given at 6, 10 and 14 weeks to the infants. Five doses vials of RVV were used till September 2016 and then 10 doses vials were used, similar to the national RVV supply guideline. The PCV was launched in Himachal Pradesh in May 2017 as part of the national phased introduction with two primary and one booster schedule. The PCV was administered to infants routinely under UIP from July 2017. IPV introduced under UIP underwent transition from 0.5 ml intramuscular to 0.1 ml intradermal (fractional IPV- fIPV) since January 2017. Availability of all these combinations in vaccine vial size, administration route across two different geographies (Kangra- hilly and Pune- plain regions) provided an opportunity to document the vaccine wastages. The state governments also requested to estimate the wastage of the other vaccines under UIP in the districts to inform the program.

The vaccine is supplied from district store to the sub-district stores, cold chain points (CCPs) at CHCs and PHCs on monthly basis. From these CHCs/PHCs, for the sessions at sub-centres and outreach sites, vaccines are supplied using vaccine carriers on the day of session. The unopened and partially used vaccine vials under open vial policy are returned to the store after the session, which are reissued for the next sessions. These vaccine transactions are recorded in the vaccine stock and issue/return register and the children vaccinated numbers are written in the session registers. But the number of remaining doses in the partially used open vial is not written in any register.

This cross-sectional study was undertaken in two districts, Kangra (Himachal Pradesh) and Pune (Maharashtra). In each district, the facilities (all levels) providing vaccination and session sites (including outreach sessions) in both urban and rural areas were included to obtain a comprehensive picture of vaccine utilisation and wastage. In Kangra, the DH, 14 CHCS, 14 PHCs, 14 sub-centres were included. In Pune, the DH, five RHs, 4 CHCs, 10 PHCs and 20 sub-centres were included.

These selected 49 facilities (vaccine stores and also service delivery point), 34 sub-centres (service delivery point) and 34 outreach session sites (one per sub-centre) were visited by the trained research staff for data collection. The vaccine supply, logistics and administration data for all UIP vaccines were collected for the period January 2016 to December 2017. Month and vaccine wise data were collected from the multiple registers (at vaccine stores: vaccine stock register- issue and return, vaccine distribution register for sessions and monthly report; at session sites: vaccinator’s logistics diary and RCH register, session and monthly vaccination report) including sessions held, vaccines supplied and returned, vaccine utilisation, children vaccinated, and vaccines discarded or wasted using structured tools (Supplementary files 1 and 2). The interviews with cold chain handlers (CCHs) (n = 43), vaccinators (n = 31), store-in-charges (n = 23), medical officers (MOs) (n = 35) and district immunization officers (DIOs) (n = 2) were done to gain additional understanding the perceptions, practices and experience related to vaccine usage and wastage handling using semi-structured guide after obtaining informed consent (Supplementary file 3). Double data entry of the data collected was done using a MySQL and PHP based online data entry program followed by matching and corrections. The data was extracted into Microsoft excel format.

The descriptive analysis performed using Microsoft Excel 2013 and Stata 15.0. The wastage rate at store level and session site levels were estimated using the formula; Wastage rate = Doses wasted × 100 /Doses issued, expressed as percentage. For the stores the doses wasted for specific periods were estimated using the opening stock balance, new doses received, closing stock, and the children vaccinated. For the stores, all doses administrated at the sessions held at facility and outreach sites under the respective store were considered. For the outreach sessions, all doses administrated at the outreach session were considered. Wastage for each vaccine for every month for each facility, session site and store and for each different dose type (IPV and fIPV), vial size (5, 10, 20 and 50 doses), vaccine type (lyophilized and liquid), and applicability of open vial policy (open vial or single use) were calculated. The vaccines under open vial policy in India include OPV, IPV, DPT, HBV, LPV, TT, and PCV, which once opened can be used at more than one session within 28 days, if stored appropriately, handled aseptically and expiry date and VVM are valid [5]. As there was no entry of the returned doses in the partially used open vials from the session sites, we could not estimate the wastage for the open vials at outreach sessions. The reference periods for vaccine wastage rates estimation for Kangra district were January 2016–December 2017 for BCG, OPV, DPT, HBV, LPV, TT, TT, Measles and RVV; April 2016 to December 2016 for IPV; January 2017 to December 2017 for fIPV; July 2017 to December 2017 for PCV and August 2017 to December 2017 for MR vaccine. All the reference periods for the vaccine wastage rates for Pune district were same except the MR and PCV vaccines, as these were not introduced during the observation period. The beneficiary turnout rate (%) was estimated by vaccine doses administered/ number of beneficiaries due on the scheduled day.

According to the records, the number of doses administered per vaccination session varied widely by vaccine, which ranged between 0 to 45 doses per day. The distribution and dispersion of doses administered for different vaccines for two districts are shown in Fig. 1a and b).

The doses administered per session for most of the vaccine doses were higher in Kangra district than Pune. The dosage administered per session for LPV, RVV, OPV and IPV were similar in both districts. There were fewer doses of BCG and HBV administered at these sessions, as most of these birth doses were given at the hospitals immediately after delivery. About 75–80% of the vaccination sessions had beneficiary turnout number less than the doses in one vaccine vial. In Kangra the overall turnout rate for vaccination sessions was 86% with BCG (81%), DPT (83%), HBV (80%), IPV (88%), measles (87%), measles-rubella (MR) (86%), OPV (86%), PCV (86%), LPV (87%), RVV (85%), and TT (85%). In Pune the overall turnout rate for vaccination sessions was 67% with BCG (64%), DPT (53%), HBV (70%), IPV (98%), Measles (68%), OPV (64%), LPV (72%), RVV (75%), and TT (64%). While 3–4 vaccination sessions monthly were conducted under each sub-centre in Pune, usually 1–2 sessions monthly in Kangra district.

Vaccine wastage at the outreach session level: The doses issued to the session sites and administered and vaccine usage and wastage rates for each vaccine not following open vial policy were calculated for the two districts (Table 1).

The overall wastage rates for BCG and pooled RVV was higher in Kangra district than Pune. The vaccine wastage rates for the outreach sessions for various vaccines (RVV, Measles, MR and BCG) and pooled for the districts are summarised in Table 2. It was observed that while 45% of the outreach sessions in Kangra had < 25% wastage rates for vaccines, 80% of the Pune sessions had similar wastage level.

The vaccine usage and wastage rates for each vaccine for the CCPs were calculated using the doses issued for the sessions and administered on monthly basis. The summarised wastage rates for the vaccines and their ranges across various CCPs (pooled for the district including district, CHC and PHC stores) are reflected in Table 3. The wastage rates varied widely for different vaccines and between the districts. The vaccine wastage rates were > 25% for all vaccines in Kangra district. The wastage rates were 26–50% for most of the vaccines except OPV and fIPV which had wastage rates > 50%. The wastage rates were < 25% for HBV, Measles, OPV, LPV, TT, IPV and RVV-pooled in Pune. The wastage rates were 26–50% for BCG, DPT, fIPV and RVV-10 dose vials. No wastage of unopened vials was documented at the CCPs. The ranges of wastage for different vaccines at CCPs varied widely. The wastage for vaccines at facility and outreach levels are compared in Supplementary file 4.

At the cold chain point level, with transition from 5- to 10-doses of RVV vials, the wastage rate increased both in Kangra (29 to 33.2%) and Pune (17.8 to 25.7%) (Table 3). The wastage rate for RVV at outreach session level increased with transition from 5- to 10-doses vial in Kangra (22.9 to 36.6%), while it declined in Pune (25.1 to 18%) (Table 1).

With transition of IPV dosage from 0.5 ml to fractional 0.1 ml (fIPV), the wastage rates at CCP level increased sizably in Kangra (36.1 to 54.8%) and marginally in Pune (18.4 to 26.9%) (Table 3).

The wastage rates for vaccines according to the type (liquid or lyophilised), reuse type (open vial policy), and vial sizes (number of doses) for oral and injectable routes for two districts for cold chain stores and outreach levels are summarised in Table 4.

Generally the wastage rates for majority of the vaccines in Kangra district were higher than Pune, except for five dose (both oral and injectable) and 10 dose (only injectable) vials. The higher wastage rates in Pune district for five dose vials were due to measles and RVV. The lower wastage rate in Kangra district for 10 dose injectable vials was due to lesser wastage of MR vaccine at outreach sessions (Table 1). While the pooled wastage rates for liquid vaccines were higher than the lyophilized vaccines in Kangra, the reverse pattern was observed in Pune (Supplementary files 5 and 6). The wastage rated for single use vials and pooled oral vaccines were comparable for the two districts. For the five dose vials, the wastage was lesser in Kangra than Pune.

Almost all health functionaries indicated that the vaccine wastage increased with transition of 5 to 10 doses vials of RVV and IM IPV to f-IPV in both districts. To minimise the wastage, the store-in-charges had been issuing the vials according to the anticipated beneficiary numbers. Majority of the vaccinators and CCHs from Kangra reported that the outreach sessions were rescheduled/reorganised to minimise the wastages. The MOs and DIO were aware about the session rescheduling/reorganisations made by the vaccinators. Few vaccinators from sites with high beneficiary load, didn’t find much difference in the wastage with the change in vial. The statements from various stakeholders are presented in the Supplementary document (Supplementary file 7).