Cold Chain: A Lynchpin of National Immunization Program
Keywords:Vaccine, National Immunization Program (NIP), Freeze Sensitivity, Heat Sensitivity, Primary healthcare centers (PHCs), eVIN (Electronic Vaccine Intelligent Network)
Cold chain management (CCM), a lynchpin of National Immunization Program (NIP) is to deliver the vaccines or other immunological products/ vaccines to right people, at right place, and in right time ineffective manner under the controlled conditions to ensure its potency. To comply it, CCM is required with standardized equipment’s and standard procedures to transport the immunological products to ensure the availability of high-quality vaccines and immunization-related materials to all levels of the program. It is vital to ensure accurate implementation of pertinent strategies focusing on vaccine storage; transportation, immunization, safety, management & monitoring. If the CCM is managed properly, the program costs can be reduced markedly without sacrificing the potency of product. Apart from that, high and unwanted vaccine wastage rates are due to poorly managed planning resulting into significant variation in operation program cost, improper management of waste with the negative impact on public health. The review enlightens on how vaccines are stored, transported and monitored to sustain immunological products/vaccines integrity throughout the way of their transportation emphasizing on the various equipment’s and logistic needs to cover the entire cold chain management rigorously till the reach of target population child/mother at the primary healthcare centers(PHCs).
A critical leap to polio eradication in India (2006). UNICEF Pub 2003. Available from:URL: http://w3.whosea.org/n/Section1226/immeeting/aefi/documents/CommunicationforImmunization/AcriticalleaptoPolioEradication.pdf
Afsar A, Kartoglu U. (2006) Vaccine stock management: guidelines for immunization and vaccine store managers. Geneva, 2006. WHO/IVB/06.12 Available from: www.whqlibdoc.who.int/hq/2006/WHO_IVB_ 06.12_eng.pdf
Aggarwal, A, Singh A. J. (1995) Evaluation of cold chain system in rural areas of Haryana, Indian Pediatr, 32(1), 31–34.
Aggarwal, K., Kannan, A.T., Kumar P. (2002) Study of operational aspects of pulse polio booths during Intensified Pulse Polio Immunization Campaign in assembly segments of East Delhi, J Commun Dis, 34, 215–220.
Agrawal, D. K. (2005) Textbook of Logistics and Supply Chain Management, MacMillanIndia Ltd., New Delhi.
Bachani, D., Bansal, R. D. (1990) Logistics management in Universal Immunization Programme, Indian J Public Health, 34, 179–84.
Baldiwala, Q. (2001) Developing a global supply chain, Logistics Spectrum 35, 25–29.
Bell, K. N. (2001) Risk factors for improper vaccine storage and handling in private provider offices, Pediatrics, 107(6), 100–105. https://doi.org/10.1542/peds.107.6.e100
Bishara R. Global perspectives in regulatory oversight. (video). Extensio et Progressio, Authentic e-Learning and Global Learning Opportunities. Available from: www.vimeo. com/51441317
Burgess, M.A., McIntyre P.B. (1999) Vaccines and the cold chain: is it too hot...or too cold, Med J Aust, 171–182.
Burton A, Monasch R, Lautenbach B, et al. (2009) WHO and UNICEF estimates of national infant immunization coverage: methods and processes, Bull World Health Organ, 87, 535–541. https://doi.org/10.2471/BLT.08.053819
Chen, D., Kristensen, D. (2009) Opportunities and challenges of developing thermo-stable vaccines, Expert Rev Vaccines, 8, 547–557. https://doi.org/10.1586/erv.09.20
Chudasama, R. K., et al. (2009) Evaluation of Intensive Pulse Polio Immunization in the South Gujarat Region of India, The Internet Journal of Pediatrics and Neonatology, 9(2), 213–217.
Dellepiane, N., Griffiths, E., Milstien, J.B. (2000) New challenges in assuring vaccine quality, Bull World Health Organ, 78(2), 155–162.
Dietz, V., Galazka, A., et al. (1997) Factors affecting the immunogenicity and potency of tetanus toxoid: implications for the elimination of neonatal and non-neonatal tetanus as public health problems, Bull World Health Organ 75(1), 81–93.
Dietz, V., Milstien, J.B., Van Loon F., et al. (1996) Performance and potency of tetanus toxoid: implications for eliminating neonatal tetanus, Bull World Health Organ, 74(6), 619–628.
Dr. Bob (2014) Los Angeles Times, “Vaccination controversy swirls around O.C.’s ‘Dr. Bob’,” Sept. 6, 2014.
Erica W. et. al. (2004) Synopsis Preventing cold chain failure: vaccine storage and handling. CMAJ, 171(9), 1050–1055. https://doi.org/10.1503/cmaj.1041565
First study validating the shake test with 100% positive predictive value. World Health Organization. Shake and tell– video article. Available from: www.vimeo.com/8381355.
Gazmararian, J.A., Oster, N.V., Green, D.C., et al. (2002) Vaccine storage practices in primary health care physician offices, Am J Prev Med 23(4), 246–253. https://doi.org/10.1016/S0749-3797(02)00512-3
Geneva, World Health Organization, 1989 (unpublished document BS/89.1614, available on request from the Global Programme for Vaccines and Immunization, World Health Organization, 1211 Geneva 27, Switzerland).
Goel, N. K, et al. (2004) Evaluation of cold chain system in Chandigarh during PPI campaign 2001–2002, Indian J Public Health, 48, 200–204.
Goel, N.K., Swami H.M., Bhatia S.P. (2004) Evaluation of cold chain system in Chandigarh during PPI campaign 2001–2002, Indian J Public Health, 48, 200–204.
Hanjeet, K. et al. (1996) Evaluation of cold chain monitoring in Kelantan, Malaysia, Bull World Health Organ, 74, 391–397.
Health Canada. Guidelines for temperature control of drug products during storage and transportation (GUI-0069). Available from: www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/GUI-0069- eng.pdf.
Hinman A. (1999) Eradication of vaccine preventable diseases, Annu Rev Public Health; 20, 241–249. https://doi.org/10.1146/annurev.publhealth.20.1.211
Hinman, A. (1999) Eradication of vaccine preventable diseases, Annu Rev Public Health, 20, 211–229. http://timesofindia.indiatimes.com/life-style/health-fitness/health-news/25-ofvaccines-go-waste-due-to-lack-of-cold-chain/articleshow/53001625.cms. https://doi.org/10.1146/annurev.publhealth.20.1.211 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=203,retrieved 5/22/2012
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=205.50, retrieved 5/22/2012
http://www.pharmaceuticaloutsourcing.com/pdf/POD001_054E_Bristol-Myers.pdf, retrieved 5/22/2012 (“Preserving the Cool Chain,” Mary Simpson, Edith Penxten, Elie Dechesne,)
Jain, R., et al. (2003) Cold chain monitoring of OPV at transit levels in India: correlation of VVM and potency status, Biologicals 31, 237–44. https://doi.org/10.1016/S1045-1056(03)00061-7
Jezek J, Chen D, Watson L, et al. (2009) A heat-stable hepatitis B vaccine formulation, Hum Vaccine, 5(8), 529–535. https://doi.org/10.4161/hv.5.8.8600
Kaplan, S., Garrick, B.J. (1981) On the quantitative definition of risk. Risk Anal 1, 11–27. https://doi.org/10.1111/j.1539-6924.1981.tb01350.x
Kartoglu, U., et al. (2012) ensuring the optimal potency of vaccines: effective vaccine management practices). In: Badur S, Bakir M, editors. AsiKitabi (book of vaccines). Akademi Publishing, Turkey, 169–189.
Kartoglu, U., et al. (2010) Validation of the shake test for detecting freeze damage to adsorbed vaccines, Bull World Health Organ, 88, 624–631. https://doi.org/10.2471/BLT.08.056879
Kartoglu, U., Nelaj, E., Maire, D. (2010) Improving temperature monitoring in the vaccine cold chain at the periphery: an intervention study using a 30-day electronic refrigerator temperature logger (Fridge-tag), Vaccine, 28, 4065–4072. https://doi.org/10.1016/j.vaccine.2010.03.076
Kurzatkowski W, Kartoglu U, Staniszewska M, et al. (2013) Structural damages in adsorbed vaccines affected by freezing, Biologicals, 41(2), 71–76. https://doi.org/10.1016/j.biologicals.2011.10.011
L. Yuan, S. et al. (1995) Vaccine storage and handling: Knowledge and practice in primary care physicians’ offices, Can Fam Physician, 41, 1169–1176.
Le Tailec, D., (2009) et al. CervarixTM, the GSK HPV-16/HPV- 18 AS04-adjuvanted cervical cancer vaccine, demonstrates stability upon long-term storage and under simulated cold chain break conditions, Hum Vaccin, 5, 67–74.
Levine, O.S., et al. (2011) The future of immunisation policy, implementation, and financing. Lancet, 378(9789), 439–448. https://doi.org/10.1016/S0140-6736(11)60406-6
Levinson DR. Vaccines for children program: vulnerabilities in vaccine management. Department of Health and Human Services, Office of Inspector General. 2012. OEI-04-10-00430 Available from: www.oig.hhs.gov/oei/reports/oei-04-10-00430.pdf. Documenting how poorly cold chain is maintained in an industrialized country.
Lewis, P.R., Reimer R.F., Dixon A.J. (2001) Evaluating the efficacy of vaccine storage in the general practice setting, Aust N Z J Public Health Dec, 25(6), 547–550.
Lugosi, L., Battersby, A. (1990) Transport and storage of vaccines in Hungary: the first cold chain monitor study in Europe, Bull World Health Organ, 68, 431–43.
Mallik S., et al. (2011) Assessing cold chain status in a metro city of India: an intervention study, African Health Sciences, 11(1), 128–133.
Matthias DM, Robertson J, Garrison MM, et al. Freezing temperatures in the vaccine cold chain: a systematic review. Vaccine 2007;25:3980-6 • Best systematic review documenting the freezing events in the vaccine cold chain. https://doi.org/10.1016/j.vaccine.2007.02.052
McColloster P.J. (2011) US vaccine refrigeration guidelines: loose links in the cold chain, Hum Vaccine, 7, 574–575. https://doi.org/10.4161/hv.7.5.14489
Milstien J, Kartoglu U, Zaffran M. Temperature sensitivity of vaccines. Geneva: World Health Organization; 2006. Available from: www.whqlibdoc.who.int/hq/2006/WHO_IVB_06.10_eng.pdf.
Ministry of Health & Family Welfare, Government of India. (2003) Cold Chain Management for Vaccine Handler. New Delhi: Dept. Health & Family Welfare, Govt. of India.
Mishra, N., Kumar, S. (2016) Determinants of Immunization: A Study from Uttar Pradesh using Multinomial logistic Regression Approach, Sch. J. App. Med. Sci. 4(3), 990–993.
Murhekar, M.V., Dutta, S., Kapoor, A.N., et al. (2013) Frequent exposure to suboptimal temperatures in vaccine cold-chain system in India: results of temperature monitoring in 10 states, Bull World Health Organ, 91, 906–913. https://doi.org/10.2471/BLT.13.119974
Nagdeve D, Bharti D. (2006) Urban-rural differentials in maternal and child health in Andhra Pradesh, India Rural and Remote Health 2003. Available from: URL: http://e-jrh.deakin.edu.au/articles/subviewnew.asp?ArticleID=146.
National Health and Medical Research Council (2008). The Australian Immunisation Handbook 9th Ed. Commonwealth of Australia. View this reference at http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook-home.
Ortega, M. P., et al. (2002) Vaccine storage cold chain at primary care centers in one area of Madrid: keeping the chain intact and degree of knowledge, Rev EspSaludPublica, 76(4), 333–346.
Pande, R. P. (2003) Selective gender differences in childhood nutrition and immunization in rural India: the role of siblings, Demography 40, 395–418. https://doi.org/10.1353/dem.2003.0029
Parenteral Drug Association (2007) Guidance for temperature-controlled medicinal products: maintaining the quality of temperature-sensitive medicinal products through the transportation environment. Bethesda (MD) Parenteral Drug Association (PDA) PDA J Pharm Sci Technol, Report No. 39.
Patil A.V. et al. (2002) Current health scenario in rural India, Aust J Rural Health 10, 129–131. https://doi.org/10.1111/j.1440-1584.2002.tb00022.x
Sachdeva, S., Datta U. (2010) Status of vaccine cold chain maintenance in Delhi, India, India J Med Microbiol 28, 184–185. https://doi.org/10.4103/0255-0857.62507
Samant, Y. (2007) Evaluation of the Cold-Chain for Oral Polio Vaccine in a Rural District of India, Public Health Rep, 122(1), 112–121.
Samant, Y., et. al. (2007) Relationship between vaccine vial monitors and cold chain infrastructure in a rural district of India. Rural and Remote Health 7 (online), 2007: 617. Available from: http://www.rrh.org.au.
Schondorf, I., et al. (2007) Overcoming the need for a cold chain with conjugated meningococcal Group C vaccine: a controlled, randomized, double-blind study in toddlers on the safety and immunogenicity of Menjugate, stored at room temperature for 6 months, Vaccine 25, 1175–1182. https://doi.org/10.1016/j.vaccine.2006.10.022
Srinivasan R. (2005) Healthcare in India—2005; issues and prospects: http://planningcommission.nic.in/reports/sereport/ser/vision2025/health.pdf.
Stamatis D.H. (2003) Failure mode and effect analysis. FMEA from theory to execution. American Society for Quality; 2003.
Sudarshan, M.K., Sundar, M., Girish, N., Patel, N.G. (1994) An evaluation of cold chain system for vaccines in Bangalore, Indian J Pediatr 61, 173–178. https://doi.org/10.1007/BF02843611
Tembleque M.D.S., et.al. (2013) Vaccines and recommendations for their use in inflammatory bowel disease World J Gastroenterol. 19(9), 1354–1358. https://doi.org/10.3748/wjg.v19.i9.1354
Thakker, Y., Woods, S. (1992) Storage of vaccines in the community: weak link in the cold chain? BMJ 304(6829), 756–758. https://doi.org/10.1136/bmj.304.6829.756
Umit, K., Milstien, J. (2014) Tools and approaches to ensure quality of vaccines throughout the cold chain, Expert Rev. Vaccines 13(7), 843–854. https://doi.org/10.1586/14760584.2014.923761
United Nations/AGECC. Energy for a sustainable future: summary report and recommendations, 2010. New York. Available from: www.un.org/wcm/webdav/site/climatechange/shared/Documents/AGECC%20summary%20report%5B1%5D.pdf.
Wirkas, T., et al. (2007) A vaccine cold chain freezing study in PNG highlights technology needs for hot climate countries, Vaccine, 25, 691–697. https://doi.org/10.1016/j.vaccine.2006.08.028.
World Health Organization (2006). Temperature sensitivity of vaccines. View this reference at http://www.who.int/vaccines-documents/DocsPDF06/847.pdf.
World Health Organization. Children: reducing mortality (2012) WHO Fact sheet no. 178. Available from: www.who.int/mediacentre/factsheets/fs178/en/.
World Health Organization. Establishing and improving primary and intermediate vaccine stores. Geneva: 2002; WHO/V&B/ 02.34.
World Health Organization. Guidelines on stability evaluation of vaccines. Expert committee on biological standardization, technical report series 57th report. Geneva 2006;962:annex3.
World Health Organization. Model guidance for the storage and transport of time- and temperature sensitive pharmaceutical products. WHO Expert committee on specifications for
pharmaceutical preparations 45th report. WHO Technical Report Series. No.961;2011. Annex9.
World Health Organization. Requirements for yellow fever vaccine. Expert committee on biological standardization, technical report series 46th Report. Geneva 1998. 840:Annex2. Available from: www.whqlibdoc.who.int/trs/WHO_TRS_872.
World Health Organization. Vaccines, Immunization and Biologicals. The cold chain (Cited 2006 Oct 18), November 26, 2002. www.logisticsweek.com July 2015 www.who.int/biologicals/areas/vaccines/controlled temperaturechain/en/-Temperaturecontrolledchain (CTC).
Yuan, L. et al. (1995) Vaccine storage and handling. Knowledge and practice in primary care physicians’ offices. Can Fam Physician. 41, 1169–1176.
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Based on a work at https://jptrm.chitkara.edu.in