ESTABLISHING IMMUNIZATION SAFETY SURVEILLANCE SYSTEM IN ALBANIA
Abstract
INTRODUCTION: While vaccine use increases, adverse events following immunization are becoming a public concern with the rate of adverse events following immunization (AEFI) increasing with the number of administered doses of vaccines. The safety of vaccines is ensured during clinical studies before the licensure of the vaccine. However, clinical trials have limitations, such as, rare events that cannot be detected and events occurring in specific groups of people. The consequences of AEFI influence public health policies and the incidence of vaccine-preventable diseases, although these might not be related directly to vaccines themselves.
OBJECTIVES: The objective of this article is to examine the evolution of vaccine safety issues in Albania by mapping stakeholders involved in vaccine safety control and analyzing the different periods when changes in the vaccine safety system has taken place
METHODS: A grey literature review, by searching the archive of IPH, provided a list of different stakeholders involved in vaccine safety in Albania. By reviewing all documents of the various organizations included in vaccine safety, we differentiated and characterized the roles of each in this area.
RESULTS: The main stakeholders involved in AEFI and vaccine safety in Albania are; the Institute of Public Health (IPH), which manages the National Immunization Program (NIP), the Directorate of Public Health (DPH) at the Ministry of Health (MoH), the 36 District Public Health Directories each with a microbiological laboratory for the assessment of AEFI, the pharmacovigilance center and National Regulatory Authority in the National Agency for Medicines and Medical Devices (NAMMD),National Immunization Safety Expert Committee in MoH and the Secretariat that supports the national AEFI committee
CONCLUSIONS: Despite huge progress over the last decade in Albania regarding vaccine safety, much remains to be achieved. The changes in the vaccine safety system have enforced and increased public trust on vaccination, leading to a strengthened National Immunization Program.References
Bino, S. & Ahmetaj, A. (2015). Vaccine Procurement and Regulations in Albania. Country Presentation. Retrieved January 12, 2016, from UNICEF website: http://www.unicef.org/supply/files/ALB_Country_Presentation_27_10_2015_rev1.pdf
Bino, S. (2003). Measles‐Rubella Mass Immunization Campaign in Albania, November 2000. The Journal of Infectious Diseases J INFECT DIS,187 (S1).
Duclos, P. (2004). A global perspective on vaccine safety. Vaccine, 22(15-16), 2059-2063.
Food, Medicine and Healthcare Administration and Control Authority of Ethiopia. (2011). Guide for AEFI Surveillance in Ethiopia. Retrieved October, 2015, from www.fmhaca.gov.et
Johns Hopkins Bloomberg School of Public Health & International Vaccine Access Center (IVAC). (2015). Case Studies of IPV Introductions: Albania, Nigeria, and Tunisia. Baltimore.
Kakarriqi E. (2002). Epidemiological background of infectious diseases in Albania (1960-2001) and their prevention and control in the context of natural disasters and infectious diseases. Albania, Tirana: Department of Epidemiology Institute of Public Health. Retrieved January 23, 2016, from http://www.gideononline.com/features/resources/
Kartoglu, U., & Milstien, J. (2014). Tools and approaches to ensure quality of vaccines throughout the cold chain. Expert Review of Vaccines, 13(7), 843-854
Kucuku, M. (2012). Role of Pharmacovigilance on Vaccines Control. Journal of Rural Medicine J Rural Med,7(1), 42-45
Maure, C. G., Dodoo, A. N., Bonhoeffer, J., & Zuber, P. L. (2014). The Global Vaccine Safety Initiative: Enhancing vaccine pharmacovigilance capacity at country level. Bulletin of the World Health Organization 92(9), 695-696.
Nelaj E., Mesi A., N., Preza I., & Xhabija A. (2014). On the Electronic Vaccination System and its Advantages. Health Bulletin, 1(2), 11-16. Retrieved December 12, 2015, from http://www.ishp.gov.al/wp-content/uploads/2014/04/Bulletin-20141-2.pdf
PATH. (2011). Assessment of a Remote Alarm System for Vaccine Storage in Albania. Retrieved September, 2015, from PATH website: http://www.path.org/publications/detail.php?i=2058
Safe Injection Global Network. (2001). Albania seizes an opportunity to improve injection safety. Retrieved fromhttp://www.injectionsafety.org/html/april_2001.html
UNICEF. (2005). Building trust and responding to adverse events following immunization in south Asia: using strategic communication. Retrieved February 10, 2016, from UNICEF website: http://www.unicef.org/rosa/Immunisation_report_17May_05(final_editing_text).pdf
UNICEF. (2002). Guidelines for the use of the Vaccine Arrival Report in UNICEF shipments Retrieved February 1, 2016, from http://www.unicef.org/supply/index_vaccine_safety.html
World Health Organization & PATH. (2015). Optimize: Albania Report. Seattle: PATH. Retrieved February, 2016, from PATH website: https://www.path.org/publications/files/TS_opt_albania_rpt.pdf
World Health Organization & UNICEF. (2015). Albania: WHO and UNICEF estimates of immunization coverage. Retrieved October 10, 2015, from: http://www.who.int/immunization/monitoring_surveillance/data/alb.pdf
World Health Organization, Albania Country Office. (2012). [Draft report of the planning group meeting to chart out an action plan for Post Marketing Surveillance of AEFI]. Unpublished raw data.
World Health Organization. (2011). Global Vaccine Safety Blueprint. Retrieved January 10, 2016, from: http://www.who.int/immunization/sage/Blueprint_draft_14Oct2011_nov11.pdf
World Health Organization & CIOMS. (2012). Definition and application of terms for vaccine pharmacovigilance. Report of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Retrieved December, 2015, from World Health Organization website: http://whqlibdoc.who.int/publications/2012/9789290360834_eng.pdf
World Health Organization. (2013). Causality assessment of an adverse events following immunization. User manual for the revised WHO classification. Retrieved February 1, 2016, from http://www.who.int/vaccine_safety/publications/aevi_manual.pdf
World Health Organization. (2014). Global manual on surveillance of adverse events following immunization. Retrieved October, 2015 from World Health Organization website: http://www.who.int/vaccine_safety/publications/Global_Manual_on_Surveillance_of_AEFI.pdf
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