1. The impact of changing vaccine vial size presentation on
coverage, wastage rate, supply chain, and costs: a study from Zambia
Wendy Prosser
20th November, 2019

2. Thanks to our generous sponsors

3. 5-Dose Measles-Rubella Implementation Research in Zambia
Presenter: Wendy Prosser
Authors:
Kirstin Krudwig*, Natasha Kanagat*, Dr. Francis Mwansa^, Guissimon Phiri^, Wendy Prosser*
*JSI; ^Ministry of Health/Zambia

4. Table of Contents
Background
Methods
Findings

5. Background

6. Framing the Issue
Countries need access to affordable and appropriate vaccine products and programmatic tools to achieve immunization coverage targets.
A continued reliance on multi-dose presentations to maintain low costs
Healthcare worker (HCW) fear of wastage and stockouts leads to missed opportunities to immunize
More evidence needed to assess dose per container (DPC) trade-offs between costs and system impacts, including supply chain design
DPC decisions impact program performance

7. Project findings available at www.jsi.com/dpcp
Project Background
Dose Per Container Partnership (DPCP) conducted research in 11 countries to understand the decision-making process and the programmatic implications when considering DPC to optimize equitable, timely, safe, and cost effective coverage
DPCP has gathered evidence on these systems components:
Coverage (equity, timeliness, session size and frequency)
Cost per dose and cost effectiveness
Supply, distribution, and cold chain storage
Wastage rate (open and closed vial)
Safety (risks of multi dose containers and adherence to multi-dose vial policy)
HCW behavior and needs (missed opportunities, willingness to open a vial)
Provide short background on overall DPCP work before introducing the Zambia study
Project findings available at 7

8. Zambia Background
Implementation research, on switching from 10 dose vials to 5 dose vials of MR vaccine
Looking at effects on:
coverage and timeliness of coverage
open vial wastage,
dropouts and missed opportunities
session size and frequency,
storage and distribution capacity, and logistics,
service delivery,
total systems costs for routine immunization
MOH selected 14 districts in Central and Luapula Provinces

9. MCV in Zambia
10-dose vials of measles containing vaccine (MCV) Measles 2nd dose introduced in July 2013
Measles to MR switch in study districts in May and country-wide in June 2017
MR is given at 9 & 18 months through fixed and outreach sessions
Coverage*
MCV1 by 12 months of age has fluctuated from 89% in 2008 to 80% in 2013 to 96% in 2017
MCV2 coverage in 2017 was 64%
Disparities between regions and districts with MCV1 coverage in districts ranging from 64% to 256% 9
*Coverage as reported by JRF, 2017

10. Methods

11. Pre- and Post-Intervention Mixed Methods Design
Household cluster Coverage Survey
Health Facility (HF), District, and National Key Informant Interviews
Routine Immunization Session Observation (baseline only)
HF & District Costing Survey
Administrative Data Review (12 months retrospective)
HF data collected during implementation on DPCP form (MR vials opened, session size & frequency, quantity of stock) 11

12. Sample
5 dose
10 dose
Total
# of districts 7 14
# of HFs
135
105
240
Target Population
38,041
30,574
68,615
Cluster randomized block design used to allocate districts into control (10 dose vials) and intervention (5 dose vials)
Districts matched according to average population size per HF and number of HFs within each district.
Intervention HFs received 5 dose vials through regular distribution system. 12

13. Household Survey
Two-stage cluster design was conducted at baseline and endline
Questionnaire adapted from WHO’s Coverage Cluster Survey
Two cohorts: months to measure MCV1, months to measure MCV2
Each sample cohort had ~3,700 children per survey
Data collected in SurveyCTO
Data analyzed in Stata 14 to examine MCV1 and MCV 2 coverage and timely coverage
Intervention effect was estimated using difference-in- difference (DinD) analysis 13

14. Implementation Monitoring
DPCP designed form to collect data on:
Wastage, average session size, frequency of RI sessions, frequency of MR given during a session, stockouts, and resupply data
HCWs filled out form every day & submitted to district at end of month with other HMIS forms
District staff entered data into Macro-enabled Excel then sent to DPCP
Data was reviewed and cleaned in-country on rolling basis
Data analyzed in Stata controlling for study group, urban or rural status, total health facility catchment area population, facility distance to district, province, and district reporting rate 14

15. Findings

16. COVERAGE MCV1 (12-23 months) MCV2 (24-35 months)
Data Source: Card + Recall
MCV1 (12-23 months)
MCV2 (24-35 months)
Intervention Effect: 3.0% (p=.023)
Intervention Effect: 10.2% (p<.001)
MCV1 Card Coverage: BL – 72-73%, EL – 85% MCV2 Card Coverage: BL – 63%, EL – 75-76%

17. TIMELY COVERAGE MCV1 Coverage by 9 months + 4 weeks
Data Source: Cards only
MCV1 Coverage by 9 months + 4 weeks
MCV2 Coverage by 18 months + 4 weeks
Intervention Effect: 1.0% (p=.692)
Intervention Effect: 7.2% (p=.097)

18. OTHER PROGRAMMATIC RESULTS
Drop-out rates between MCV1 and MCV2 improved for the months age group
No difference noted in timely coverage between intervention and control
No significant change noted in session frequency or size, although qualitative findings suggest that there was a change in session frequency
For internal review only

19. Difference between intervention and control
WASTAGE
Intervention
Control
Difference between intervention and control
Fixed
16.7%
30.5%
-13.8%***
Outreach
17.5%
31.2%
-13.7%***
Total
16.2%
-14.4%***
“The wastage is not much with MR 5 dose vial compared to the time we were using 10 dose vial. The wastage was high and this made us have high missed opportunities.” – HCW
*** p<0.001
All respondents using 10-dose and 5-dose vials at district and HF levels noted the importance of limiting wastage. 19

20. COLD CHAIN, SUPPLY CHAIN AND DISTRIBUTION CAPACITY
88.46 cm3
Total net storage requirement per FIC for MR 10-dose vials of MR
93.66 cm3
Total net storage requirement per FIC for MR 5-dose vials
4.9% increase in cold chain requirements when switching from 10- to 5-dose vials (when considering wastage rates found during implementation).
Cold chain equipment capacity varied from liters depending on HF size and all had sufficient cold chain space for the increase in volume required for introducing 5-dose MR vials.
# of HFs with each size CCE
13 HFs: 48 liters
86 HFs: 24 liters
3 HFs: 42 liters
2 HFs: 36.5 liters
5 HFs: 18 liters
Total 109 HFs with CCE 20

21. HCW and district views on cold chain regarding the 5 dose vial and stock outs
All HCWs using 5-dose vials reported carrying the MR vial to outreach. They reported sufficient space in cold boxes and vaccine carriers.
None of the facilities expressed concerns with refrigerator space with regards to the 5-dose vial.
These perspectives were corroborated by district respondents.
More than half of the HCWs mentioned having had stock outs of vaccines in the past 12 months.
Vaccines included: OPV, BCG, PCV and in one case, the MR 5-dose vial. The duration of the stock outs ranged from 4 days to 31 days.
In the event of a stock out, HCWs stated that they requested more from districts or picked up vaccines from HFs that were close to them.
HCWs said that they explained to community that there was a stock out and requested them to come to the next session for that vaccine. 21

22. COST
No change in cold chain, transport, outreach and sharps waste disposal costs.
Increase in average facility HR costs at some HFs because of the switch to using 5-dose MR vials including increase in frequency or time spent providing fixed immunization sessions, conducting stock management activities, and reporting
Some districts reported increase in time spent on vaccine stock management
5-dose vials increased program costs by $0.11 per dose of MR used compared to 10-dose MR vials (excluding cost of vaccine)
Wastage-adjusted vaccine price per dose is $0.98 with 5-dose vials and $0.94 with 10-dose vials
In small HFs, vaccine purchase costs are lower using 5-dose vials because the reduction in wastage outweighs the increase in vaccine price
Of the categories that were looked at (cold chain, transport, outreach, sharps disposal, and HR), only HR had any increase in cost due to switch to 5 dose vials. On average, this increased program costs by $0.11 per dose. 22

23. VACCINE PROCUREMENT COST
Purchase price per dose (UNICEF, 2018):
5-dose MR: $0.82
10-dose MR: $0.62
Modeling results: with 5-dose vials across the country with the updated wastage rate and factoring in HCW behavior, procurement costs increase 2.5% ($32k USD) but total cost per dose administered decreased (from $2.88 USD for 10- dose vials to $2.83 USD for 5-dose vials)
This is balanced out with fewer missed opportunities to vaccinate and higher coverage rate 23

24. HCW BEHAVIOR AND NEEDS
Vaccines offered at every fixed and outreach session
HCWs using 10-dose vials indicated that they waited for a minimum of 5 children before offering BCG or measles vaccines.
All except one respondent using 5- dose vial reported opening vials regardless of the number of children at a session.
“We have no restrictions when to open the five [5] dose vial compared when we had the ten [10] dose vial we were required to have a specific number of the children to allow us open the vial.” – HCW
HCWs using 5 dose vials said they are…
Less concerned about MR wastage
More comfortable opening vials to vaccinate children. 24

25. KEY FINDINGS A few key findings from Zambia:
MCV1 coverage improved by 3% and MCV2 by 10%
Opportunity for reduction in missed opportunities to vaccinate when using 5 dose vials as HCWs more willing to open a vial for only 1 child
Wastage is significantly reduced from 31% with 10-dose to 16% with 5-dose
Cold chain equipment could easily accommodate 4.9% increase 25

26. FINAL THOUGHTS
Most prominent concern from EPI managers when discussing vial size is cold chain space and vaccine cost. Findings show:
Changing to smaller vial size had minimum impact on capacity of cold chain at service delivery point and there were no additional constraints.
Cost of vaccine increases with smaller vial size, but with lower wastage and considering higher coverage, the cost can balance out
There are many trade-offs to consider when switching DPC and must be considered within the context of the country
A system design analysis can help provide evidence for DPC decisions
Visit:

27. Thanks to our generous sponsors
2019 Global Health Supply Chain Summit, Johannesburg, S. Africa

28. 2019 Global Health Supply Chain Summit, Johannesburg, S. Africa
Additional slides
2019 Global Health Supply Chain Summit, Johannesburg, S. Africa

29. DROP-OUT RATES Penta 1 – MCV1 for Children 12-23 months
Data Source: Cards + Recall
Penta 1 – MCV1 for Children months
MCV1 - MCV2 for Children months
Intervention Effect: .2% (p=.838)
Intervention Effect: % (p<.001)

30. SESSION FREQUENCY AND SIZE
Although most HCWs interviewed who used 5-dose vials reported being able to conduct more fixed and outreach sessions,
frequency of offering MR did not change based on vial size.
There also was no significant difference in session size between arms.
Intervention
Control
Intervention
Control
This data was collected on a daily basis by HCWs and submitted to districts monthly throughout the year of implementation. HFs in both arms had more outreach sessions than fixed. There was no significant difference in the number of sessions when MR was provided. Penta and/or MR (which is our proxy for any session held) was provided slightly more in control facilities than in intervention. These findings were surprising as HCWs said that they were able to open an MR vial more frequently when they were not worried about wastage.
Average # of times per month MR administered per HF
Average # of times per month Penta and/or MR administered*
* p<0.05

31. MEASLES-RUBELLA DISTRIBUTION
HFs using 5 dose MR were restocked an average of 4.47 times during the 11 month period compared to HFs using 10 dose MR which were restocked an average of 3.43 times.
The quantity of doses restocked at a time varied between arms. 5 dose HFs were restocked with an average of doses while 10 dose HFs received an average of doses.
HFs in both arms reported stock-outs of MR throughout implementation. There was no significant difference in average length of stock outs (11.99 days in intervention compared to days in control).
HFs received 5-dose MR vials more frequently and in smaller quantities than10-dose vials 31