Vaccine Vial Monitors Impact Study during 1997 National Immunization Days in Turkey O.Z. Asfar, B. Altay

Transcription

1 WHO/EPI/TECHNET.98/WP.23 English only Distribution: Limited Vaccine Vial Monitors Impact Study during 1997 National Immunization Days in Turkey O.Z. Asfar, B. Altay Technet Consultation March 1998 Copenhagen, Denmark EXPANDED PROGRAMME ON IMMUNIZATION GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION World Health Organization, Geneva,

2 VVM IMPACT STUDY DURING 1997 NIDS IN TURKEY Oya Zeren Afsar, Birhan Altay Ministry of Health, General Directorate of Primary Health Care, Ankara, Turkey. Executive summary The purpose of this study is to test the utilization of VVMs by the health personnel in the field and to monitor the change in vaccine wastage rates with the introduction of VVMs and open vial policy, as recommended by WHO. The study was conducted in selected health centers of 12 provinces during the 2 nd round of National Immunization Days (NIDs) in Contrary to the common practice in Turkey; OPV vials carrying VVMs were not discarded at the end of the day, but continued to be used in subsequent sessions. In addition, selected empty vials kept in the cold chain were monitored for a period to detect the time of reaching the end point. Wastage rates were compared with the rates in 1st round of NIDs, when the open vial policy had not been implemented and all opened and unopened vials taken to outreach sessions had been discarded at the end of the day. The total number of discarded unopened vials in 12 provinces was 3860 in the 1st round while it dropped to 900 in the 2nd round. The differences according to the provinces were statistically significant (t=4.17,p<0.05) and wastage due to heat exposure was found to decline 77%. The mean wastage rate, resulting from the unused portion of opened vials, was 15.0%±2.3% in the 1st round and decreased to 8.3%±1.5% in the 2nd round. This difference was also significant (t=2.59,p<0.05), indicating a 45% reduction in the wastage rate. 14.1% of the opened vials were used in the next day. No significant difference was found between the stationary teams and house-to-house vaccinating mobile teams in terms of the percentage of opened vials remaining for the next day. None of the vials reached to the end point before they were finished. This may be due to the fact that all vials were finished in one or two days, considering the implementation strategy of NIDs. Among the empty vials monitored within the cold chain, the number of vials reaching the end point made a peak in 3rd and 4th day after the opening. These vials were used in the southern provinces, where the temperature varied between 25 o C-30 o C at that time of the year. Although no objective data was compiled regarding the acceptibility of VVM by the health personnel, the impression was that it had been easily recognized and interpreted by the staff in the field. The VVM is a valuable logistics management tool particularly for the grassroot level, leading considerable savings in the national budget while preserving the safety and efficiency of the vaccines. 2

3 Rationale Introduction OPV with VVMs was introduced in Turkey in , with the donation of Rotary International through UNICEF to be used in the NIDs. Based on the... adopted in the 5th TECHNET meeting in Manila, Philippines; the MoH decided to conduct a field study to assess the use of VVMs in the field, their impact on wastage rates and to evaluate the knowledge, attitude and practices of health workers. Considering that the implementation strategies differ in NIDs and routine immunization, and that the 1997 NIDs might be the last one conducted in Turkey, we have decided to carry on an impact study in the second round of 1997 NIDs as a first step. The purpose of this study is to test the utilization of VVMs by the health personnel in the field and to monitor the change in vaccine wastage rates with the introduction of VVMs and open vial policy, as recommended by WHO. Country Total population of Turkey is according to the 1997 census. The country has a surface area of km 2. The climate is characterized by variations of temperature and rainfall. In summer, temperatures rise considerably in southern region whereas in winter weather conditions can hamper transport and access in eastern region. Turkey is administratively divided to 80 provinces and Health Directorates are responsible for delivering health services in provincial level. NIDs Within the polio eradication programme, Turkey took part in Operation MECACAR and conducted three NIDs in 1995, 1996 and NIDs were held in the last weeks of April and May. OPV was the only vaccine administered during the NIDs and the duration of the rounds was 5 days. The vaccination was conducted mainly on a house-to-house basis, whereas stations were also established in large cities. According to the current immunization policy in Turkey, opened vials of OPV are discarded within 8 hours. If the vaccine is brought to an outreach activity, unopened vials of OPV are also discarded at the end of the day. Planning After the 1 st round of 1997 NIDs, 19 provinces out of 80 were selected from every region of the country. Mid-level managers of each province were contacted by phone, informed briefly and asked if they wanted to take part in this study. 16 provinces decided to participate. Since the time was too short for proper training, provincial EPI managers who were motivated and well known by the investigators were included. However, complete data could be received from 12 provinces after the study (Annex 1). 3

4 A text containing information on the use and interpretation of VVMs was prepared from VVM Training Guidelines-WHO/EPI/LHTM/94.2 and VVM and Opened Vial Policy, Q&A-WHO/EPI/LHIS/ In addition, a brief guide containing the preparation, training, implementation and evaluation stages of the study were prepared. Both documents were sent to the provincial managers and they were recontacted by the phone for further clarifications. Every provincial manager selected at least two health centres for the study. They were recommended to include both densely and scarcely populated areas. However; the availability of correct, complete and timely data was the primary criterion for selecting the health centres rather than being representative for the province. Training Provincial EPI managers gave a theoretical and practical training about VVMs to the personnel working in those selected health centres. They also informed the personnel on opened vial policy, follow-up of empty vials and data collection during the study. Study The study started with the 2 nd round of NIDs and finished at the end of the round. Opened empty vials were monitored for an additional one month to detect the end point of VVMs. Opened vial policy was implemented during the study by the mobile and/or stationary teams of participating health centres. Moreover, unopened vials were not discarded after returning to the health centre and used in the next day. As the teams vaccinated a great number of children in a short time in NIDs, all OPV vials were finished in maximum two days after opening. Teams used the VVM follow-up form shown in Annex 2 for data recording. A separate form was used for each day of the study, containing a row for each vial opened in that day. Vials were monitored, finishing or end-point dates were recorded according to the three alternatives shown on the form. Weather temperature at midday were measured and recorded. Data about the vaccine manufacturers were also collected with the purpose of revealing the difference, if any, between the VVMs used by different manufacturers. The first vial of each day was not discarded after finishing and monitored under cold chain for a longer period of time. These empty vials were taken to the outreach session in cold boxes with the other vaccines in the morning, and returned to the refrigerator in the evening until the end of the round. They were further kept in the refrigerator for approximately one month after NIDs. All forms filled by the teams were sent to the Provincial Halth Directorate after the end of the study. They were evaluated by the provincial EPI managers and data were transferred into the two tables in Annex 3, to be sent to the MoH. Additional information were requested to calculate the wastage rates of the participating health centres in both rounds. Wastage rates obtained during the study were compared with the rates in 1st round, when the open vial policy had not been implemented and all opened and unopened vials taken to outreach sessions had been discarded at the end of the day. 4

5 Results and evaluation A total of 34 health centres in 12 provinces participated in the study. 181 mobile teams and 57 stationary teams worked in the areas covered by those health centres. TABLE 1: Total number of unopened vials discarded in both rounds, according to the provinces. 1 st round 2 nd round Adana Bal kesir Denizli Eskisehir 80 0 Elazig 0 0 Icel Kastamonu Konya Malatya Mardin Mugla 0 0 Ayd n TOTAL Total number of discarded unopened vials in 12 provinces was 3860 in the 1 st round while it dropped to 900 in the 2 nd round. The differences according to the provinces were statistically significant (t=4.17,p<0.05) and wastage due to heat exposure was found to decline 77%. TABLE 2: Wastage rates (%) in both rounds, according to the provinces.* 1 st round 2 nd round Bal kesir 16 7 Denizli Eskisehir 8 0 Elazig Icel 10 8 Kastamonu 28 4 Mardin 6 11 Mugla Ayd n 14 8 Mean * Complete data was received from 9 provinces. The mean wastage rate, resulting from the unused portion of opened vials, was 15.0%±2.3% in the 1 st round and decreased to 8.3%±1.5% in the 2 nd round. This difference was also significant (t=2.59,p<0.05), indicating a 45% reduction in the wastage rate. 14.1% of the opened vials were used in the next day. 5

6 TABLE 3: Monitoring of opened vials in mobile and stationary teams. MOBILE STATIONARY TOTAL # of vials finished within 8 hours after opening # of vials finished in the next day of opening # of vials that VVM reached the end point before the vial is finished TOTAL # OF OPENED V ALS Totally, 14.1% (495/3013) of the opened vials remained and used in the next day. No significant difference was found between the stationary teams and house-tohouse vaccinating mobile teams in terms of the percentage of opened vials remaining for the next day. None of the vials reached to the end point before they were finished. This may be due to the fact that all vials were finished in one or two days, considering the implementation strategy of NIDs. F gure 1: Number of vials that VVM reached the end point, according to the period after opening DAYS Among the empty vials monitored in the cold chain, the number of vials reaching the end point made a peak in 3rd and 4th day after the opening. These vials were used in the southern provinces, where the temperature varied between 25 o C-30 o C at that time of the year. Since most of the OPV implemented in this study belonged to one manufacturer (SB), we had no opportunity to compare the VVMs on vials of different manufacturers. 6

7 Although no objective data was compiled regarding the acceptibility of VVM by the health personnel, the impression of the provincial EPI managers was that it had been easily recognized and interpreted by most of the staff in the field. Conclusions The VVM seems to be a valuable logistics management tool particularly for the grassroot level, providing considerable savings in the national budget while preserving the safety and efficiency of the vaccines. Further studies are needed to assess the attitude and practice of the personnel. Proper training should be made prior to the introduction of VVM and opened vial policy throughout the country. However, there are some points avoiding the MoH to endorse the use of VVM and opened vial policy: After all those years of training on the vulnerability of OPV, it seems very difficult to convince the staff, mid-level managers and even the senior level managers to the policy of using opened OPV vials until VVM reaches the end point. Current trend among the staff is to consider VVM as defective because it does not darken as fast as it should. WHO, together with the Ministries of Health, should clarify the opened vial policy and its messages to the field, providing definite answers to these questions which are raised/likely to be raised by the managers and health staff: * What has changed in OPV to allow it to be used longer? * Are there any recent studies regarding the stability and efficacy of OPV after opening? * If the stability of OPV has not changed, why have we thrown away the vaccine in 8 hours since years? * Are VVMs produced by different manufacturers standardized and confident enough today? (Vials of SB was double-labelled due to a previous error in VVMs. Since the VVM on the inner label was darkened, this situation created a lot of doubt and distrust among the personnel in the field.) 7

8 ANNEX 2 VVM FOLLOW-UP FORM Vial no. PROVINCE: TEAM MOBILE STATIONARY HEALTH CENTRE: DATE:.../.../... If vial is finished before VVM reached the end point If the empty vial is monitored If VVM reaches the end point before the vial is finished Manufacturer (Vaccine) Mid-day temperature Date of finishing Date of reaching the end point Date of reaching the end point # of doses left in the vial Name of the person who filled the form:... Signature:... 8

9 ANNEX 3 TABLE A: (For all vials opened and finished) Manufacturer:... MOBILE STATIONARY TOTAL # of vials finished within 8 hours after opening # of vials finished in the next day of opening # of vials that VVM reached the end point before the vial is finished TOTAL # OF OPENED V ALS TABLE B: (For the first vial of each day, followed empty within the cold chain) # of vials that VVM reached the end point according to the period after opening. Manufacturer:... MOBILE STATIONARY 1. day 2. day 3. day 4. day 5. day 6. day 7. day 8. day 9. day 10. day... day... day TOTAL 9

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