Improving the Monitoring of Adverse Events Following Immunization (in Order of Discussion)
https://doi.org/10.31631/2073-3046-2016-15-6-95-101
Abstract
Detection of post-vaccination complications with the subsequent investigation of causes and measures to prevent their occurrence increases the perception of the immunization society and improves health care. This is primarily increases the immunization coverage, which leads to lower morbidity. The purpose of this article is to offer for discussion a new algorithm for the registration of diseases postvaccination period, based on a synthesis of the existing national system and modern international approaches.
About the Authors
N. I. Briko
State Educational Institution of Higher Professional Training «I.M. Sechenov First Moscow State Medical University» of the Ministry of Healthcare of the Russian FederationMinistry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
L. S. Namazova-Baranova
Federal State Autonomous Institution «Scientific Center of Children's Health» of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
Y. V. Lobzin
Federal State Budget Institution «Scientifics and Research Institute of Children’s infections», Federal Biomedical Agency
Russian Federation
Russian Federation
S. M. Kharit
Federal State Budget Institution «Scientifics and Research Institute of Children’s infections», Federal Biomedical Agency
Russian Federation
Russian Federation
E. P. Nacharova
Federal State Budget Institution «Scientifics and Research Institute of Children’s infections», Federal Biomedical Agency
Russian Federation
Russian Federation
I. V. Feldblium
State Educational Institution of Higher Professional Training «Perm state medical University named after academician E. A. Wagner»
Russian Federation
Russian Federation
References
1. Lopalco P.L., Johansen K., Ciancio B. Monitoring and assessing vaccine safety: a European perspective. Expert Rev Vaccines. 2010, 9 (4): 371 – 80.
2. Plotkin S.A., Orenstein W., Offit P. Vaccines. 5th ed. Philadelphia: Saunders; 2008: 1748.
3. The Federal law About immunoprevention of infectious diseases of September 17, 1998 N 157-FZ. Available athttp: //docs .cntd.ru/document/901717430 (in Russian).
4. Chen R.T., Rastogy S.C., Mullen J.R., Hayes S.W., Cochi S.L., Donlon J.A.et al. The Vaccine Adverse Event Reporting system (VAERS). Vaccine. 1994 6 (12): 542 – 550.
5. Methodical instructions MR 3.3.1.1123-02 3.3.1. Vaccinal prevention. Monitoring postvaktsinalnykh of complications and their prevention. (approved as the chief state health officer of the Russian Federation 26.05.2002). Available at: http: //www.consultant.ru/document/cons_doc_LAW_100503/ (in Russian).
6. Methodical instructions MR 3.3.1879-04. Investigation postvaktsinatslnykh of complications. (approved as the chief state sanitary doctor of the Russian Federation 04.03.2004). Available at: http://www.hrsa.gov/vaccinecompensation/data/statisticsreport.pdf (in Russian).
7. Letter of Federal service on surveillance in healthcare and social development of april 2, 2012 of № 04I-232/12 On Providing Data on Undesirable Reactions to Medicines. Available at: http://docs.cntd.ru/document/902342119 (in Russian).
8. Sanitary and epidemiologic rules of the joint venture 3.3.2367-08. Organization of immunoprevention of infectious diseases. Available at: http://docs.cntd.ru/document/902107048 (in Russian).
9. Resolution of the government of the Russian Federation of 02.08.99 N 885. The list the postvaccinale complications caused by the preventive inoculations included in a national calendar of the preventive inoculations, and preventive inoculations according to epidemic indications granting the right to citizens on receiving the State lump sum benefits. Available at: http://docs.cntd.ru/document/901740048 (in Russian).
10. The order of the Russian Ministry of Health of 29.07.1998 N. 230. About increase of readiness of bodies and establishments of Gossanepidsluzhby of Russia to work in emergency situations. Available at: http://docs.cntd.ru/document/58816164 (in Russian).
11. Gayderova L.A., Yunasova T.N., Popov of V. F. Safety of vaccines against measles, epidemic parotitis and a rubella according to domestic and foreign systems of registration of the undesirable phenomena of the postvacinal period. Epidemiologia i Vaccinoprofilaktika. [Epidemiology and Vaccinal Prevention]. 2007; 2 (33): 44 – 47 (in Russian).
12. Crawford N.W., Clothier H., Hodgson K., Selvaraj G., Easton M.L., Buttery J.P. Active surveillance for adverse events fol-lowing immunization. Expert Rev. Vaccines. 2014; 13 (2): 265 – 76.
13. Iskander J.K., Miller E.R., Chen R.T. The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. Pediatr. Ann. 2004; 33 (9): 599 – 606.
14. WHO, UNICEF, World Bank. State of the world’s vaccines and immunization, 3rd ed. Geneva: World Health Organization. 2009: 169.
15. The resolution of the Chief state health officer of the Russian Federation of February 24, 2009 No. 11. About submission of extraordinary reports on emergency situations in the field of public health care of sanitary and epidemiologic character. Available at: http://docs.cntd.ru/document/902152543 (in Russian).
16. The order of the Russian Ministry of Health No. 757n of August 26, 2010. About the statement of a procedure of monitoring of safety of medicines for medical application, registration of side effects, serious undesirable reactions, unforeseen undesirable reactions at use of medicines for medical application. Available at; http://docs.cntd.ru/document/902233184 (in Russian).
17. The resolution of the government of the Russian Federation of 27.12.2000 N 1013 (in edition of August 4, 2015 N 790) An order of payments of the welfare lump sums and monthly monetary compensations to citizens at emergence at them the postvaccinal complications is approved. Available at: http://docs.cntd.ru/document/901777996 (in Russian).
18. The order of May 5, 2012 N 502n About the statement of an order of creation and activity of the medical commission of the medical organization (in an edition of 02.12.2013 N 886n). Available at: http://docs .cntd.ru/document/902348296 (in Russian).
19. The federal law About the address of medicines of April 12, 2010 N 61-FZ (with changes for July 3, 2016). Available at: http://docs .cntd.ru/document/917039904 (in Russian).
Review
For citations:
Briko N.I., Namazova-Baranova L.S., Lobzin Y.V., Kharit S.M., Nacharova E.P., Feldblium I.V. Improving the Monitoring of Adverse Events Following Immunization (in Order of Discussion). Epidemiology and Vaccinal Prevention. 2016;15(6):95-101. (In Russ.) https://doi.org/10.31631/2073-3046-2016-15-6-95-101
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