Research Article - (2013) Volume 4, Issue 3
At the inception of the UIP, the wastage and the WMF were built into the programme based on the guidelines of WHO/UNICEF. Indian Council of Medical Research (ICMR) conducted a study through its network of five Human Reproductive Research Centres (HRRCs) in 10 districts of four states of India to estimate the wastage and the wastage multiplier factor for the six vaccines currently being used under the UIP, GOI. Objectives: (i) To determine the amount of wastage of vaccines being used under UIP, (ii) To determine the reasons of wastage of vaccine, and (iii) To suggest methods for reducing the wastage of vaccine. Methods: The study was conducted through the network of five HRRCs in ten districts located in four states of India. Wastage at the point of administration of vaccine was estimated. Results and conclusion: WMF and % wastage were calculated separately for each of the six vaccines for each district. The estimated % wastage and its range, the estimated WMF and its range for DPT, DT, TT, OPV, BCG and Measles was respectively 38.9 (12.8-69.7), 1.64 (1.15-3.31); 39.1 (27.3-61.4), 1.64 (1.38-2.59); 48.0 (20.9-67.1), 1.92 (1.26-3.04); 52.7 (22.1-75.7), 2.12 (1.28-4.12); 49.3 (30.3-70.2), 1.97 (1.43-3.36); 38.7 (20.8-50.1), 1.39 (1.26- 2.00). The estimated % wastage of five of the six vaccines namely, DPT, DT, TT, OPV and Measles was found to be significantly higher than what is assumed in the UIP (p<0.0001). Among all the other reasons for wastage of vaccines, “Residual vaccine left in the vial” was the most frequently reported reason for wastage of vaccines. Therefore, vials of variable size with house to house campaign were recommended to minimize wastage of vaccines in UIP.
In India, under the Universal Immunization Programme (UIP) vaccines for six vaccine-preventable diseases (tuberculosis, diphtheria, pertussis (whooping cough), tetanus, poliomyelitis, and measles) are available for free of cost to all. UIP was launched in 1985 with much dynamism to attain the target to immunize all eligible children by 1990. In addition, expectant mothers should receive immunization against tetanus.
Lot of energy and money has been spent on the UIP but it did not reap the much hyped outcome. Given the tight budgetary allocations, various large scale surveys such as National Family Health Surveys (NFHS-3, 2007), District Linked Household Surveys (DLHS-3, 2007- 08), Coverage Evaluation Surveys 2009 (CES-2009) and some other Health Surveys had tried to assess effectiveness of the programme. Most of the survey-results showed the glaring gap between the target and achievement of 100% immunization even after several years.
The requirement of vaccine in the UIP is calculated on the basis of the number of infants/children/pregnant women in the target age group and the number of doses to be administered to each of the beneficiaries. In addition, a wastage factor is taken into account for the anticipated wastage of vaccine during administration as well as left over vaccine, which cannot be subsequently used. According to instructions under the programme, a fresh vial of the vaccine is to be opened even if there is only one child demanding vaccination. The opened vials are then to be discarded after the session and are not to be used after the session or on the subsequent day.
At present there are six vaccines in use in the programme, which are administered according to the national immunization schedule . The % wastage and the WMF for these vaccines are as follows:
|DPT (Diphtheria, Pertussis, Tetanus), DT (Diphtheria, Tetanus), TT (Tetanus) and OPV (Oral Polio Vaccine)||25%||1.33|
|BCG (for Tuberculosis)||50%||2.00|
At the inception of the programme, the wastage and the multiplier factor was built into the programme based on the guidelines of WHO/ UNICEF. However, no detailed studies have been done in India to determine whether these figures were applicable in India as well. Most recently, a study done in five selected states of India under the aegis of UNICEF reported % wastage of DPT and BCG as 27 and 61%. Another recently published paper from the neighboring country Bangladesh reported % wastage of BCG, Measles, TT and DPT as 84.9, 69.7, 35.5 and 44.4% [2,3]. Keeping this in view, ICMR conducted a study from April, 2009-September, 2010 through its network of five HRRCs to determine the % wastage and the WMF for the vaccines currently being used under the UIP and suggest measures for reducing wastage.
i. To determine the amount of wastage of vaccines being used under UIP.
ii. To determine the reasons of wastage of vaccine.
iii. To suggest methods for reducing the wastage of vaccine.
Determination of sample-size in terms of number of doses of vaccine to be studied is as described below:
Determination of sample-size
Wastage of a vaccine is defined as follows
Suppose n = no. of doses used, x = no. of children given vaccine, then
Or Wastage = 100p, where is the proportion of doses wasted.
The wastage multiplication factor (WMF) is given by
Wastage allowed for vaccines other than BCG was 25% (i.e., p=0.25) and for BCG it was 50% (i.e. p=0.50). With 95% level of confidence and a relative error of 5%, the formula for working out sample size for simple random sampling is as given below:
where q = 1-p.
Since information relating to wastage of vaccines will be collected from PHCs located within the district by following multistage sampling, a design effect of 2 is taken into account for arriving at the final sample size. Thus n′ is to be multiplied by 2 for obtaining the final sample size.
Therefore in view of the wastage allowance and taking into account the design effect, 10,000 doses were to be studied for estimation of wastage of vaccines except for Measles and BCG. For BCG a minimum of 3200 doses and for Measles (assuming an 8% relative error) a minimum of 4000 doses were to be studied for estimation of wastage. In the present study, % wastage was estimated at the point of service delivery. The study by UNICEF has also concluded that maximum wastage takes place at point of service delivery whereas less than one percent to 3.5% of the vaccine is wasted at supply chain levels .
Five HRRCs were selected from good and poor performing states in terms of immunization coverage as per the estimates available from NFHS-3:
Depending on the number of workers available at a PHC or at other health centre, the number of vials about which information was to be collected, was decided by taking into account the number of doses to be studied for a particular vaccine and the constitution of a vial for that vaccine as described above. Since a PHC covered approximately 30,000 population and one ANM was deputed per 5000 population, there were expected to be six ANMs in a PHC. Therefore a total of 30 ANMs in one district of the state were available for administering the vaccine and collecting the relevant information.
Single sample Z-test was used to compare the estimated % wastage of different vaccines with the corresponding % wastage as assumed in the UIP. A multiple linear regression analysis was carried out to assess the impact of site of immunization and immunization-provider on % wastage and WMF. The % wastage and WMF of each vaccine were treated as dependent variables and dummy independent variables were introduced for different categories of immunization-site and immunization-provider. A level of significance below 5 % (p<0.05) was considered statistically significant. The statistical package “IBM SPSS Statistics Version 19” was used for all statistical analyses.
Table 1 describes the number of doses of different vaccines covered by each HRRC in the two districts. From the table it is clear that in majority of the districts, the targeted number of doses could be covered.
|HRRC||District||No. of doses covered|
|RG Kar, Kolkata||24 Pgs (N)||41550||12340||29980||63320||18170||13410|
Table 1: Number of doses of different vaccines covered by each HRRC in each district.
The subcentre constituted about 37% of all the sites of immunization, followed by PHC and Urban Health centre with 9 and 8% respectively, school about 2% and other places or any combination of the previously mentioned sites formed 44% of all the sites reported.
At 94% of the sites the ANM administered vaccine followed by about 4% by Female Health Workers and two percent by others.
Table 2 describes the wastage multiplier factor (WMF) and % wastage of vaccines in each of the ten districts covered.
|District||Barabanki||Unnao||Ghaziabad||Bulandshahar||Bhojpur||Buxur||24 Prg (N)||Hoogly||North Goa||South Goa||Pooled|
|DPT||No. of doses used||5870||7350||13370||21290||12640||17820||41550||40390||12420||9790||182490|
|No. of children given vaccine||3822||4994||11133||18560||9258||13857||12569||19825||9575||8026||111569|
|DT||No. of doses used||70||230||3170||-||14090||19210||12340||6350||890||1090||58430|
|No. of children given vaccine||27||156||1692||-||8132||13964||6443||3617||570||673||35584|
|TT||No. of doses used||5590||6690||10010||11140||14320||19840||29980||30700||5090||4520||138830|
|No. of children/PW given vaccine||3666||4484||3292||3918||8248||14248||12423||14636||3214||3576||72241|
|OPV||No. of doses used||10180||11880||15460||23840||13140||19800||63320||55560||14180||11700||239060|
|No. of children given vaccine||4794||4946||11135||18560||6610||10890||15368||24196||9051||7440||112990|
|BCG||No. of doses used||4360||4700||5280||6540||2460||3160||18170||15120||2640||2300||68310|
|No. of children given vaccine||1621||1599||2986||4062||733||1582||7590||10542||1053||1105||34618|
|Measles||No. of doses used||1650||1985||4470||5810||4820||7195||13410||13100||3255||2655||58425|
|No. of children given vaccine||861||990||3210||4439||3634||5698||9175||9834||2300||1932||42132|
Table 2: Wastage multiplier factor (WMF) and % wastage of vaccines in the UIP.
The % wastage of DPT was found to be 38.9 with the corresponding WMF being 1.64. It varied from a minimum of 12.8% in Bulandshahar to a maximum of 69.7% in district 24 Parganas (North) with the corresponding range of WMF being 1.15 - 3.31.
The % wastage of DT was estimated to be 39.1 with the corresponding WMF being 1.64. It varied from a minimum of 27.3% in district Buxur to a maximum of 61.4% in district Barabanki with the corresponding range of WMF being 1.38 - 2.59.
The % wastage of TT was estimated to be 48.0 with the corresponding WMF being 1.92. It varied from a minimum of 20.9% in district South Goa to a maximum of 67.1% in district Ghaziabad with the corresponding range of WMF being 1.26 - 3.04.
The % wastage of OPV was estimated to be 52.7 with the corresponding WMF being 2.12. It varied from a minimum of 22.1% in district Bulandshahar to a maximum of 75.7% in district 24 Parganas (North) with the corresponding range of WMF being 1.28–4.12.
The % wastage of BCG was observed to be 49.3 with the corresponding WMF being 1.97. It varied from a minimum of 30.3% in district Hoogly to a maximum of 70.2% in district Bhojpur with the corresponding range of WMF being 1.43-3.36.
The % wastage of Measles was observed to be 38.7 with the corresponding WMF being 1.39. It varied from a minimum of 20.8% in district Buxur to a maximum of 50.1% in district Unnao with the corresponding range of WMF being 1.26-2.00.
The average and median number of vials discarded during use did not vary much from one vaccine to the other except for DT for which the average number of vials discarded was observed to be the least at 6.5 ± 2.6 (Figure 1). Further, the average and median number of doses of vaccine left in the current vial clearly indicated wastage of 50% or more doses for all the six vaccines so far as the current was concerned (Figure 2).
Forty-nine OPV vials were discarded unopened and 1053 OPV vials were discarded during use because of change of colour of vaccine vial monitor (VVM).
Other reasons for wastage of vaccines were also reported. Among all the other reasons for wastage of vaccines, “Residual vaccine left in the vial” was the most frequently reported reason as in 97-99% of immunization sessions it was reported for all the vaccines except for OPV for which, about 70% immunization sessions reported this reason. Since OPV is administered orally, more reasons of wastage could be noticed compared to other vaccines for example, in around 14% of the sessions “Excessive drops being given” is reported as against just about one percent for other vaccines. Similarly, in about eight percent of the sessions, wastage of OPV was reported because of “Movement of baby/lack of co-operation from child/spillage/wastage during administration”.
Wastage of vaccines was also analyzed by site of immunization (Table 3). No wastage of DPT was observed with household as site of immunization whereas a maximum of 52.3% of wastage of DPT was observed at sub-centre with the corresponding WMF being 1 and 2.1. For DT, minimum % wastage was found to be 3.3 at household and maximum % wastage of 43.6 was observed at sub-centre with the corresponding WMF being 1.03 and 1.77. Similarly, for TT and OPV also the minimum and maximum % wastage occurred at household and sub-centre respectively with the corresponding figures for minimum % wastage being 1.2 and 15.4 (WMF being 1.03 and 1.18) and corresponding maximum % wastage figures being 52.3 and 63.3 (WMF being 2.1 and 1.73). For BCG, minimum % wastage of 36.9 was observed at PHC and maximum % wastage of 66.0 was observed at other sites of immunization with the corresponding WMF being 1.58 and 2.94. In case of Measles, the minimum % wastage observed was 18.8 and the maximum % wastage observed was 35.6 with the corresponding WMF being 1.23 and 1.55.
|Vaccine||Site of immunization|
|Urban Health Centre||School||PHC||Sub-centre||Temple||House-hold||Others (combinations)|
|DPT||No. of doses used||9200||1010||12680||106360||380||220||22300|
|No. of children given vaccine||7433||805||10835||50704||366||220||15591|
|DT||No. of doses used||7600||60||1040||30980||70||60||15740|
|No. of children given vaccine||5611||53||832||17486||64||58||10314|
|TT||No. of doses used||8440||890||6750||78470||110||60||24650|
|No. of children/PW given vaccine||6525||728||5510||37468||97||58||15700|
|OPV||No. of doses used||10560||1100||14480||147280||440||260||30400|
|No. of children given vaccine||7942||575||11025||53991||366||220||13325|
|BCG||No. of doses used||3110||480||3790||40390||170||100||9910|
|No. of children given vaccine||1950||173||2396||20603||89||52||3368|
|Measles||No. of doses used||3235||225||3395||34400||140||85||8055|
|No. of children given vaccine||2627||145||2618||24437||92||55||5550|
Table 3: Wastage multiplier factor and percent wastage of vaccines by site of immunization.
It could be observed that the % wastage of vaccine for Measles was lower than that of other vaccines with the exception of DT. It could be due to the small size of the measles vaccine vial as it was a five-dose vial.
Wastage of vaccines was also analyzed by immunization-provider. However, no pattern was seen in % wastage of vaccines with the type of immunization-provider.
The % wastage and WMF was computed for each vaccine and for each session and a multiple regression analysis was carried out by treating % wastage and WMF as dependent variables and different categories of immunization site and immunization-provider as independent variables. The immunization sites such as school, PHC, sub centre, a combination of sites and HW(F) as immunization-provider significantly affected % wastage of DPT (p<0.05). Sub centre and a combination of sites of immunization both significantly affected % wastage of DT (p<0.01). Sub centre as immunization site (p<0.05) and ANM, HW(F) and Other Health Functionaries as immunization-providers (p<0.05) all significantly affected WMF and % wastage of TT. For % wastage of OPV, School, PHC, Sub centre and a combination of other sites of immunization and other health functionaries as immunization providers all significantly affected (p<0.05) % wastage.
The targeted number of doses could be covered in majority of the districts. However, in district Bulandshahar, not a single dose of DT could be covered the reason for which could not be ascertained.
The % wastage and WMF of each vaccine varied from state to state. The % wastage of OPV in the present study was found to be much higher than that of the estimate 14.5 obtained in the 1999 version of Pulse Polio Immunization (PPI) campaign . This is quite understandable as any immunization programme carried out in a campaign-mode may result in less wastage of vaccine.
The % wastage estimated in the present study for five of the six vaccines namely, DPT (38.9), DT (39.1), TT (48.0), OPV (52.7) and Measles (38.7) exceeded the assumed % wastage in the UIP (25.0) by a significantly large margin (p<0.0001). Whereas % wastage estimated for BCG (49.3) did not differ significantly from the assumed % wastage BCG in UIP (50.0). Pooling data of all the centres it was observed that % wastage of vaccine for Measles was lower than that of all the other vaccines. It could be due to the small size of the measles vaccine vial as it was a five-dose vial.
Further, no pattern in % wastage of vaccines was seen with regard to immunization coverage in any of the four states as reported earlier.
The average and median number of doses of vaccine left in the current vial, which could not be subsequently used, clearly indicated wastage of 50% or more doses for all the six vaccines.
Vaccine Vial Monitor (VVM) turned out to be a handy and effective tool to monitor the wastage of OPV as forty-nine OPV vials were discarded unopened and 1053 OPV vials were discarded during use because of change of colour of VVM.
Evaluating wastage by site of immunization, it was clear that in four out of the six vaccines in the UIP namely, DPT, DT, TT and OPV, household as the site of immunization resulted in least wastage of vaccines.
The % wastage and WMF estimated in the present study were respectively 38.9 and 1.64 for DPT; 39.1 and 1.64 for DT; 48.0 and 1.92 for TT; 52.7 and 2.12 for OPV; 49.3 and 1.97 for BCG; 38.7 and 1.39 for Measles. The estimated % wastage of five of the six vaccines namely, DPT, DT, TT, OPV and Measles was found to be significantly higher than what is assumed in the UIP.
In case of four out of the six vaccines in the UIP namely, DPT, DT, TT and OPV, immunization with house hold as the site of immunization resulted in least wastage of vaccines. However, subjecting data to multiple regression analysis and keeping house hold as a point of reference, other sites of immunization namely, school, PHC and sub centre were also found affecting % wastage of vaccines.
Among all the other reasons for wastage of vaccines, “Residual vaccine left in the vial” was the most frequently reported reason for wastage of vaccines, which has been reported by earlier authors also [5-7]. Therefore, based on the available evidence it is important to introduce vials of variable sizes viz., 5/10/20 - dose vials so that these vials could be used judiciously depending upon the number of target children available on the day of immunization.
A house to house campaign for immunization and keeping small size of the vaccine vials could be effective ways of reducing wastage of vaccines. However, economic burden in terms of manpower requirement  and storage capacity of vaccines could be major considerations.
The authors gratefully acknowledge all members of the staff of the participating HRRCs for helping in collection of data.