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Field Evaluation of Freeze- Preventive Vaccine Carriers in Nepal

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Field Evaluation of Freeze- Preventive Vaccine Carriers in Nepal Field Evaluation of Freeze- Preventive Vaccine Carriers in Nepal This report was written by PATH and supported in whole or part by a grant from the Bill & Melinda Gates Foundation. The views expressed herein are solely those of the authors and do not necessarily reflect the views of the foundation. Contact information Pat Lennon Portfolio Leader of Supply Systems and Equipment Medical Devices and Health Technologies [email protected] Mailing Address PO Box 900922 Seattle, WA 98109 USA Street Address 2201 Westlake Avenue Suite 200 Seattle, WA 98121 USA www.path.org © 2020 PATH. All rights reserved. Photos in report are credited to PATH. June 2020 Contents ABBREVIATIONS ........................................................................................................................................ V EXECUTIVE SUMMARY ............................................................................................................................. VI 1 INTRODUCTION .................................................................................................................................... 1 2 FREEZE-PREVENTIVE VACCINE CARRIERS .................................................................................... 1 2.1 Equipment description .................................................................................................................... 2 3 FIELD EVALUATION IN NEPAL ........................................................................................................... 3 3.1 Objectives ....................................................................................................................................... 4 3.2 Implementation partner .................................................................................................................. 4 3.3 Approvals ........................................................................................................................................ 4 4 METHODOLOGY ................................................................................................................................... 4 4.1 Pilot design ..................................................................................................................................... 4 4.1.1 Sampling methodology ....................................................................................................... 4 4.1.2 Trainings ............................................................................................................................. 6 4.1.3 Field implementation ........................................................................................................... 6 4.2 Vaccine transport system in Nepal ................................................................................................. 7 4.3 Data collection ................................................................................................................................ 7 4.3.1 Evaluation of performance .................................................................................................. 7 4.3.2 Evaluation of acceptability .................................................................................................. 8 4.3.3 Evaluation of health system impact .................................................................................... 8 5 RESULTS ............................................................................................................................................... 8 5.1 Performance of three freeze-preventive vaccine carriers .............................................................. 8 5.1.1 Mean kinetic temperature ................................................................................................. 12 5.1.2 Excursions ......................................................................................................................... 14 5.1.3 Ambient temperature analysis .......................................................................................... 15 5.1.4 Vaccine vial monitor life loss ............................................................................................. 17 5.1.5 Cool-down rates and times ............................................................................................... 18 5.1.6 Freezer performance......................................................................................................... 20 5.2 Acceptability ................................................................................................................................. 22 5.2.1 Feedback on the freeze-preventive vaccine carrier .......................................................... 22 5.3 Systems fit and costing analysis .................................................................................................. 22 5.3.1 Systems fit ......................................................................................................................... 22 iii 5.3.2 Costing data ...................................................................................................................... 23 5.4 Electronic temperature monitors .................................................................................................. 26 5.4.1 LogTag .............................................................................................................................. 26 5.4.2 Parsyl ................................................................................................................................ 26 6 DISCUSSION ....................................................................................................................................... 26 6.1 Context of use .............................................................................................................................. 26 6.2 Carrier performance ..................................................................................................................... 27 6.2.1 Mean kinetic temperature ................................................................................................. 27 6.2.2 Excursions ......................................................................................................................... 27 6.2.3 Vaccine vial monitor life loss ............................................................................................. 27 6.2.4 Ambient temperature analysis .......................................................................................... 27 6.2.5 Cool-down rates and times ............................................................................................... 27 6.2.6 Freezer performance......................................................................................................... 28 6.3 Limitations and data gaps ............................................................................................................ 28 7 CONCLUSION AND RECOMMENDATIONS ...................................................................................... 28 8 REFERENCES ..................................................................................................................................... 30 iv Abbreviations AHW auxiliary health worker ANM auxiliary nurse midwife BCG bacillus Calmette–Guérin BPKIHS B.P. Koirala Institute of Health Sciences CCH cold chain handler CCP cold chain point DTP diphtheria-tetanus-pertussis DVS district vaccine store EPI Expanded Programme on Immunization FPVC freeze-preventive vaccine carrier HepB hepatitis B HP health post JE Japanese encephalitis MKT mean kinetic temperature MOH Ministry of Health MR measles-rubella NA not applicable OPV oral poliovirus vaccine PHC primary health care PCV pneumococcal conjugate vaccine PQS Performance, Quality and Safety (World Health Organization) PUF polyurethane foam SVC standard vaccine carrier TD tetanus-diphtheria UNICEF United Nations Children’s Fund VVM vaccine vial monitor WHO World Health Organization v Executive summary Preventing vaccine freezing is one of the biggest barriers in vaccine management. Toward addressing this challenge, B.P. Koirala Institute of Health Sciences in Dharan, Nepal, in collaboration with PATH, conducted a field evaluation of freeze-preventive vaccine carriers (FPVCs) in 24 health facilities located across one hilly district and one plains district of eastern Nepal. The primary study objectives were to evaluate the performance, acceptability, and fit of the FPVCs within the existing immunization system. The study was carried out in three phases. The AOV International FPVC was evaluated in phase 1 (May to August 2018) under simulated use. Phase 1a was conducted from May to July 2019, during which two additional carriers (Leff Trade and Blowkings) were evaluated, also under simulated use. During phase 2 (November to December 2019), all three carriers were studied under actual-use conditions. This report details the results of phase 2. The evaluation design had half the FPVCs contain conditioned ice packs and the other half unconditioned ice packs. The FPVCs were prepared by cold chain handlers and transported by health workers to outreach vaccination sessions carrying the vaccines. Quantitative and qualitative data were collected from health workers from all 24 health facilities, logbooks, and electronic temperature monitors in all three types of vaccine carriers and in some deep freezers/refrigerators. Study results indicate these long-range FPVCs successfully prevented freezing in outreach vaccination settings and
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