rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.14412/1995-4484-2018-123-126rsp-2510Research ArticleДИСКУССИИDISCUSSIONДискуссионные проблемы фармакологического надзораDEBATABLE PROBLEMS OF PHARMACOVIGILANCEМуравьевЮ. В.MuravyevYu. V.

Москва.

Moscow.

murawyu@mail.ruМуравьеваЛ. А.MuravyevаL. A.

Химки.

Khimki.

ФГБНУ «Научноисследовательский институт ревматологии им. В.А.Насоновой».РоссияV.A. Nasonova Research Institute of Rheumatology.Russian FederationЦентральное поликлиническое отделение МБУЗ «Химкинская центральная клиническая больница».РоссияCentral Polyclinic Department, Khimki Central Clinical Hospital.Russian Federation201804032018561123126Copyright © Муравьев Ю.В., Муравьева Л.А., 20182018Муравьев Ю.В., Муравьева Л.А.Muravyev Y.V., Muravyevа L.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://rsp.mediar-press.net/rsp/article/view/2510

В статье обсуждаются возможные причины возникновения проблем, связанных с фармакологическим надзором.

The paper discusses the possible causes of the problems related to pharmacovigilance.

фармакологическая бдительностьфармакологический надзорнеблагоприятные реакциимониторингметод спонтанных сообщенийpharmacological alertnesspharmacovigilanceadverse reactionsmonitoringspontaneous message methodReferencesEdwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-9. doi: 10.1016/S0140-6736(00)02799-9Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-9. doi: 10.1016/S0140-6736(00)02799-9Viewpoint Part 2 The Uppsala monitoring centre. WHO Collaborating Centre for International drug monitoring; 2004. 2. Viewpoint Part 1 The Uppsala monitoring centre. WHO Collaborating Centre for International drug monitoring; 2002.Viewpoint Part 2 The Uppsala monitoring centre. WHO Collaborating Centre for International drug monitoring; 2004. 2. Viewpoint Part 1 The Uppsala monitoring centre. WHO Collaborating Centre for International drug monitoring; 2002.Xiang Y, Xie Y, Yi D. Pharmacovigilance of major pharmaceutical innovation. Zhonggo Zhong Yao Za Zhi. 2011;36(20):2831-5.Xiang Y, Xie Y, Yi D. Pharmacovigilance of major pharmaceutical innovation. Zhonggo Zhong Yao Za Zhi. 2011;36(20):2831-5.Prakash B, Singh G. Pharmacovigilance: scope for a dermatologist. Ind J Dermatol. 2011;56(5):490-3. doi: 10.4103/0019-5154.87121Prakash B, Singh G. Pharmacovigilance: scope for a dermatologist. Ind J Dermatol. 2011;56(5):490-3. doi: 10.4103/0019-5154.87121Barker CI, Talbot JC, Aronson JK. Selected national pharmacovigilance websites: an analysis of contents. Drug Saf. 2012;35(2):141-8. doi: 10.2165/11596270-000000000-00000Barker CI, Talbot JC, Aronson JK. Selected national pharmacovigilance websites: an analysis of contents. Drug Saf. 2012;35(2):141-8. doi: 10.2165/11596270-000000000-00000Routledge PA. 150 years of pharmaco-vigilance. Lancet. 1998;351:1200-1. doi: 10.1016/S0140-6736(98)03148-1Routledge PA. 150 years of pharmaco-vigilance. Lancet. 1998;351:1200-1. doi: 10.1016/S0140-6736(98)03148-1Rich ML. Fatal case of aplastic anaemia following chloramphenicol therapy. Ann Intern Med. 1950;33:1459. doi: 10.7326/00034819-33-6-1459Rich ML. Fatal case of aplastic anaemia following chloramphenicol therapy. Ann Intern Med. 1950;33:1459. doi: 10.7326/00034819-33-6-1459Wallerstein RO, Condit PK, Kasper CK, et al. Statewide study of chloramphenicol therapy and fatal aplastic anemia. JAMA. 1969;208:2045-50. doi: 10.1001/jama.1969.03160110017004Wallerstein RO, Condit PK, Kasper CK, et al. Statewide study of chloramphenicol therapy and fatal aplastic anemia. JAMA. 1969;208:2045-50. doi: 10.1001/jama.1969.03160110017004McCredie J. The thalidomide story. Sydney Publishing (University of Sydney, 17 January 2016).McCredie J. The thalidomide story. Sydney Publishing (University of Sydney, 17 January 2016).Randall T. Thalidomide's back in the news, but in more favorable circumstances. JAMA. 1990;263:1467-8. doi: 10.1001/jama.1990.03440110019002Randall T. Thalidomide's back in the news, but in more favorable circumstances. JAMA. 1990;263:1467-8. doi: 10.1001/jama.1990.03440110019002Кузнецов СА, составитель, главный редактор. Большой толковый словарь русского языка: А-Я / РАН. Ин-т лингв. исслед. Санкт-Петербург: Норинт; 1998. 1534 с. [Kuznetsov SA, composer, editor in chief. Bol'shoi tolkovyi slovar' russkogo yazyka: A-Ya [A large explanatory dictionary of the Russian language: AYa]. St. Petersburg: Norint; 1998. 1534 p.].Кузнецов СА, составитель, главный редактор. Большой толковый словарь русского языка: А-Я / РАН. Ин-т лингв. исслед. Санкт-Петербург: Норинт; 1998. 1534 с. [Kuznetsov SA, composer, editor in chief. Bol'shoi tolkovyi slovar' russkogo yazyka: A-Ya [A large explanatory dictionary of the Russian language: AYa]. St. Petersburg: Norint; 1998. 1534 p.].Van Grootheest K. The dawn of pharmacovigilance. Intern J Pharm Med. 2003;17:195-200. doi: 10.2165/00124363-20031705000006Van Grootheest K. The dawn of pharmacovigilance. Intern J Pharm Med. 2003;17:195-200. doi: 10.2165/00124363-20031705000006Guidelines for Preparing Core Clinical Safety Information on Drugs – Report of CIOMS Working Group III. Geneva: WHO; 1995.Guidelines for Preparing Core Clinical Safety Information on Drugs – Report of CIOMS Working Group III. Geneva: WHO; 1995.International Drug Monitoring: The Role of National Ceentres. Geneva, World Health Organization, 1972 (WHO Technical Report, No 498).International Drug Monitoring: The Role of National Ceentres. Geneva, World Health Organization, 1972 (WHO Technical Report, No 498).Ожегов СИ; под ред. Шведовой НЮ. Словарь русского языка: Около 57000 слов. 17-е изд. Москва: Русский язык; 1985. 797 с. [Ozhegov SI; Shvedova NYu, editor. Slovar' russkogo yazyka: Okolo 57 000 slov [Dictionary of the Russian language: About 57 000 words]. 17th ed. Moscow: Russkii yazyk; 1985. 797 p.].Ожегов СИ; под ред. Шведовой НЮ. Словарь русского языка: Около 57000 слов. 17-е изд. Москва: Русский язык; 1985. 797 с. [Ozhegov SI; Shvedova NYu, editor. Slovar' russkogo yazyka: Okolo 57 000 slov [Dictionary of the Russian language: About 57 000 words]. 17th ed. Moscow: Russkii yazyk; 1985. 797 p.].Abbing HDCR. Legal aspects of medical devices: Study on regulatory mechanisms for safety control. Health Services Research. IOS Press; 1993. P. 358-61.Abbing HDCR. Legal aspects of medical devices: Study on regulatory mechanisms for safety control. Health Services Research. IOS Press; 1993. P. 358-61.Fracchia GN, Theofilatou M (eds); Mehta U, Milstien JB, Duclos P, Folb PI. Developing a national system for dealing with adverse events following immunization. Bull WHO. 2000;78(2):170-7.Fracchia GN, Theofilatou M (eds); Mehta U, Milstien JB, Duclos P, Folb PI. Developing a national system for dealing with adverse events following immunization. Bull WHO. 2000;78(2):170-7.Craven BM, Stewart GT, Khan M, Chan TYK. Monitoring the safety of herbal medicines. Drug Safety. 1997;7(4):209-15.Craven BM, Stewart GT, Khan M, Chan TYK. Monitoring the safety of herbal medicines. Drug Safety. 1997;7(4):209-15.Инструкция по сбору информации о неблагоприятных побочных реакциях лекарственных средств, средств традиционной медицины и биологически активных добавок (Утверждено 19.01.2001 г. Министерством здравоохранения и социального развития Российской Федерации). Режим доступа: http://rudoctor.net/medicine2009/bz-yw/medcmtys.htm, свободный (дата обращения: 06.01.2017) [Instruktsiya po sboru informatsii o neblagopriyatnykh pobochnykh reaktsiyakh lekarstvennykh sredstv, sredstv traditsionnoi meditsiny i biologicheski aktivnykh dobavok [Instructions for collecting information on adverse reactions of medications, traditional medicine and biologically active additives] (Approved on January 19, 2001 by the Ministry of Health and Social Development of the Russian Federation). Access mode: http://rudoctor.net/medicine2009/bzyw/med-cmtys.htm, free (date of circulation: 06/01/2017)].Инструкция по сбору информации о неблагоприятных побочных реакциях лекарственных средств, средств традиционной медицины и биологически активных добавок (Утверждено 19.01.2001 г. Министерством здравоохранения и социального развития Российской Федерации). Режим доступа: http://rudoctor.net/medicine2009/bz-yw/medcmtys.htm, свободный (дата обращения: 06.01.2017) [Instruktsiya po sboru informatsii o neblagopriyatnykh pobochnykh reaktsiyakh lekarstvennykh sredstv, sredstv traditsionnoi meditsiny i biologicheski aktivnykh dobavok [Instructions for collecting information on adverse reactions of medications, traditional medicine and biologically active additives] (Approved on January 19, 2001 by the Ministry of Health and Social Development of the Russian Federation). Access mode: http://rudoctor.net/medicine2009/bzyw/med-cmtys.htm, free (date of circulation: 06/01/2017)].Лепахин ВК, Стуров НВ, Астахова АВ. Методы выявления и регистрации неблагоприятных побочных реакций на лекарственные средства в период их широкого применения. Трудный пациент. 2008;(8):42-6 [Lepakhin VK, Sturov NV, Astakhova AV. Methods for detecting and recording adverse adverse reactions to medicines in the period of their widespread use. Trudnyi Patsient. 2008;(8):42-6 (In Russ.)].Лепахин ВК, Стуров НВ, Астахова АВ. Методы выявления и регистрации неблагоприятных побочных реакций на лекарственные средства в период их широкого применения. Трудный пациент. 2008;(8):42-6 [Lepakhin VK, Sturov NV, Astakhova AV. Methods for detecting and recording adverse adverse reactions to medicines in the period of their widespread use. Trudnyi Patsient. 2008;(8):42-6 (In Russ.)].Мурашко МА, Косенко ВВ, Глаголев СВ, Шипков ВГ. Мониторинг безопасности лекарственных препаратов в вопросах и ответах. Брошюра для специалистов здравоохранения. Москва; 2014 [Murashko MA, Kosenko VV, Glagolev SV, Shipkov VG. Monitoring bezopasnosti lekarstvennykh preparatov v voprosakh i otvetakh. Broshyura dlya spetsialistov zdravookhraneniya [Monitoring of drug safety in questions and answers. Brochure for health professionals]. Moscow; 2014].Мурашко МА, Косенко ВВ, Глаголев СВ, Шипков ВГ. Мониторинг безопасности лекарственных препаратов в вопросах и ответах. Брошюра для специалистов здравоохранения. Москва; 2014 [Murashko MA, Kosenko VV, Glagolev SV, Shipkov VG. Monitoring bezopasnosti lekarstvennykh preparatov v voprosakh i otvetakh. Broshyura dlya spetsialistov zdravookhraneniya [Monitoring of drug safety in questions and answers. Brochure for health professionals]. Moscow; 2014].Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety. 1999;21(6):429-47. doi: 10.2165/00002018-199921060-00001Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety. 1999;21(6):429-47. doi: 10.2165/00002018-199921060-00001

The authors declare that there are no conflicts of interest present.