Definition of Pharmacovigilance and Its Historical Development in the World and Türkiye
Özet
The unofficial history of pharmacovigilance begins with the proposition expressed in the Hippocratic oath, "Thou shalt do no harm." Since ancient times, human beings have somehow followed every material they used to obtain health, and thousands of years of knowledge have emerged. This journey, which extends from the Sumerians to 19th-century England and from there to humanity's efforts to create a joint memory, has survived to the present day as a highly effective supra-state organization. The concept of pharmacovigilance, which is a shared asset of humankind, has continued to grow and expand its scope with the participation and contribution of our country. Many painful events, which irreversibly changed thousands of lives, occurred during the journey. Our experience, shaped like this, has carried us to this day.
This section deals with the definition of pharmacovigilance and its historical development in Türkiye and around the globe. It mentions milestones and events that changed the course in chronological order, and finally, what was needed to prevent tragedies such as the "Thalidomide Disaster" from happening again was expressed.
Referanslar
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Lima, H.M.M., Humanity and the Use of Substances: A Historical Overview. Drugs and Human Behavior: Biopsychosocial Aspects of Psychotropic Substances Use, 2021: p. 3-26.
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Simpson, D., Simpson and ‘the discovery of chloroform’. Scottish Medical Journal, 1990. 35(5): p. 149-153.
Knight, P.R. and D.R. Bacon, An unexplained death: Hannah Greener and chloroform. The Journal of the American Society of Anesthesiologists, 2002. 96(5): p. 1250-1253.
Lile, D.J., FDA overview, in Translational Surgery. 2023, Elsevier. p. 501-507.
Muchmore, A.I., Food and Drug Regulation: Statutory and Regulatory Supplement. 2021.
Connolly, C.A., Children and drug safety : balancing risk and protection in twentieth-century America. Critical issues in health and medicine. 2018, New Brunswick: Rutgers University Press. vii, 246 pages.
Wax, P.M., Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Annals of internal medicine, 1995. 122(6): p. 456-461.
McGuire, T.F., Food, Drug, or Both: Dual Classification under the Federal Food, Drug, and Cosmetic Act. U. Ill. L. Rev., 1984: p. 987.
Schumacher, H., D.A. Blake, J.M. Gurian, et al., A comparison of the teratogenic activity of thalidomide in rabbits and rats. Journal of Pharmacology and Experimental Therapeutics, 1968. 160(1): p. 189-200.
Smithells, R. and C. Newman, Recognition of thalidomide defects. Journal of medical genetics, 1992. 29(10): p. 716.
Kim, J.H. and A.R. Scialli, Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicological sciences, 2011. 122(1): p. 1-6.
Vargesson, N. and T. Stephens, Thalidomide: history, withdrawal, renaissance, and safety concerns. Expert Opinion on Drug Safety, 2021. 20(12): p. 1455-1457.
McBride, W.G., Thalidomide and congenital abnormalities. Lancet, 1961. 2(1358): p. 90927-8.
Kinch, M. and L. Weiman, The Price of Health: The Modern Pharmaceutical Enterprise and the Betrayal of a History of Care. 2021: Simon and Schuster.
Ali, I., W. A Wani, K. Saleem, et al., Thalidomide: A banned drug resurged into future anticancer drug. Current drug therapy, 2012. 7(1): p. 13-23.
Çınar, E.N. and E. Vatanoğlu-Lutz, ORD. PROF. DR. SÜREYYA TAHSİN AYGÜ (1895-1981). Nobel Medicus Journal, 2018. 14(1).
The importance of pharmacovigilance. 2002, World Health Organization.
Fortnum, H., A. Lee, B. Rupnik, et al., Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain. Journal of clinical pharmacy and therapeutics, 2012. 37(2): p. 161-165.
McLernon, D.J., C.M. Bond, P.C. Hannaford, et al., Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug safety, 2010. 33: p. 775-788.
Safety of medicines: a guide to detecting and reporting adverse drug reactions: why health professionals need to take action. 2002, World Health Organization.
Edwards, I.R., Considerations on causality in pharmacovigilance. International Journal of Risk & Safety in Medicine, 2012. 24(1): p. 41-54.
Temiz Nemutlu, N., Ankara ilinde reçetelenen ilaçlara bağlı istenmeyen etkilerin izlenmesi ve farmakovijilans konusunda farkındalığın artırılması. 2017, Sağlık Bilimleri Enstitüsü.
Organization, W.H., International drug monitoring: the role of national centres, report of a WHO meeting [held in Geneva from 20 to 25 September 1971]. 1972: World Health Organization.
Organization, W.H., The importance of pharmacovigilance. 2002.
Soyalan, M., R. Demirdamar, H. Toklu, et al., Kuzey Kıbrıs Türk Cumhuriyeti’nde ulusal farmakovijilans sistemi ve mevcut uygulamalar. Marmara Pharmaceutical Journal, 2012. 16(3): p. 159-163.
Kayaalp, O., Klinik farmakolojinin esasları ve temel düzenlemeler. 2008: Pelikan Yayıncılık.
Santoro, A., G. Genov, A. Spooner, et al., Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug safety, 2017. 40: p. 855-869.
Ozcan, G., E. Aykac, Y. Kasap, et al., Adverse drug reaction reporting pattern in Turkey: analysis of the national database in the context of the first pharmacovigilance legislation. Drugs-real world outcomes, 2016. 3: p. 33-43.
İkinci Çokay, E., Advers etki sebebiyle pazardan toplatılan ilaçlar. 2020, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü.
Gülmez, S.E., Pharmacovigilance in Turkey. Mann's Pharmacovigilance, 2014: p. 225-227.
Aydinkarahaliloglu, N., E. Aykac, Y. Kasap, et al., Pharmaceutical risk management in Turkey: the first national overview. Regulatory Toxicology and Pharmacology, 2013. 67(3): p. 344-350.
Lima, H.M.M., Humanity and the Use of Substances: A Historical Overview. Drugs and Human Behavior: Biopsychosocial Aspects of Psychotropic Substances Use, 2021: p. 3-26.
Derya, K., N. Sürmelioğlu, and Y. KARATAŞ, Past, present and future of pharmacovigilance. Arşiv Kaynak Tarama Dergisi, 2016. 25(2): p. 129-139.
Simpson, D., Simpson and ‘the discovery of chloroform’. Scottish Medical Journal, 1990. 35(5): p. 149-153.
Knight, P.R. and D.R. Bacon, An unexplained death: Hannah Greener and chloroform. The Journal of the American Society of Anesthesiologists, 2002. 96(5): p. 1250-1253.
Lile, D.J., FDA overview, in Translational Surgery. 2023, Elsevier. p. 501-507.
Muchmore, A.I., Food and Drug Regulation: Statutory and Regulatory Supplement. 2021.
Connolly, C.A., Children and drug safety : balancing risk and protection in twentieth-century America. Critical issues in health and medicine. 2018, New Brunswick: Rutgers University Press. vii, 246 pages.
Wax, P.M., Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Annals of internal medicine, 1995. 122(6): p. 456-461.
McGuire, T.F., Food, Drug, or Both: Dual Classification under the Federal Food, Drug, and Cosmetic Act. U. Ill. L. Rev., 1984: p. 987.
Schumacher, H., D.A. Blake, J.M. Gurian, et al., A comparison of the teratogenic activity of thalidomide in rabbits and rats. Journal of Pharmacology and Experimental Therapeutics, 1968. 160(1): p. 189-200.
Smithells, R. and C. Newman, Recognition of thalidomide defects. Journal of medical genetics, 1992. 29(10): p. 716.
Kim, J.H. and A.R. Scialli, Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicological sciences, 2011. 122(1): p. 1-6.
Vargesson, N. and T. Stephens, Thalidomide: history, withdrawal, renaissance, and safety concerns. Expert Opinion on Drug Safety, 2021. 20(12): p. 1455-1457.
McBride, W.G., Thalidomide and congenital abnormalities. Lancet, 1961. 2(1358): p. 90927-8.
Kinch, M. and L. Weiman, The Price of Health: The Modern Pharmaceutical Enterprise and the Betrayal of a History of Care. 2021: Simon and Schuster.
Ali, I., W. A Wani, K. Saleem, et al., Thalidomide: A banned drug resurged into future anticancer drug. Current drug therapy, 2012. 7(1): p. 13-23.
Çınar, E.N. and E. Vatanoğlu-Lutz, ORD. PROF. DR. SÜREYYA TAHSİN AYGÜ (1895-1981). Nobel Medicus Journal, 2018. 14(1).
The importance of pharmacovigilance. 2002, World Health Organization.
Fortnum, H., A. Lee, B. Rupnik, et al., Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain. Journal of clinical pharmacy and therapeutics, 2012. 37(2): p. 161-165.
McLernon, D.J., C.M. Bond, P.C. Hannaford, et al., Adverse drug reaction reporting in the UK: a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug safety, 2010. 33: p. 775-788.
Safety of medicines: a guide to detecting and reporting adverse drug reactions: why health professionals need to take action. 2002, World Health Organization.
Edwards, I.R., Considerations on causality in pharmacovigilance. International Journal of Risk & Safety in Medicine, 2012. 24(1): p. 41-54.
Temiz Nemutlu, N., Ankara ilinde reçetelenen ilaçlara bağlı istenmeyen etkilerin izlenmesi ve farmakovijilans konusunda farkındalığın artırılması. 2017, Sağlık Bilimleri Enstitüsü.
Organization, W.H., International drug monitoring: the role of national centres, report of a WHO meeting [held in Geneva from 20 to 25 September 1971]. 1972: World Health Organization.
Organization, W.H., The importance of pharmacovigilance. 2002.
Soyalan, M., R. Demirdamar, H. Toklu, et al., Kuzey Kıbrıs Türk Cumhuriyeti’nde ulusal farmakovijilans sistemi ve mevcut uygulamalar. Marmara Pharmaceutical Journal, 2012. 16(3): p. 159-163.
Kayaalp, O., Klinik farmakolojinin esasları ve temel düzenlemeler. 2008: Pelikan Yayıncılık.
Santoro, A., G. Genov, A. Spooner, et al., Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug safety, 2017. 40: p. 855-869.
Ozcan, G., E. Aykac, Y. Kasap, et al., Adverse drug reaction reporting pattern in Turkey: analysis of the national database in the context of the first pharmacovigilance legislation. Drugs-real world outcomes, 2016. 3: p. 33-43.
İkinci Çokay, E., Advers etki sebebiyle pazardan toplatılan ilaçlar. 2020, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü.
Gülmez, S.E., Pharmacovigilance in Turkey. Mann's Pharmacovigilance, 2014: p. 225-227.
Aydinkarahaliloglu, N., E. Aykac, Y. Kasap, et al., Pharmaceutical risk management in Turkey: the first national overview. Regulatory Toxicology and Pharmacology, 2013. 67(3): p. 344-350.
Sayfalar
125-131
Gelecek
16 Nisan 2024
Telif Hakkı (c) 2024 Akademisyen Yayınevi Kitap Portalı
Lisans
LisansNasıl Atıf Yapılır
1.
Öztürk Karagöz B. Definition of Pharmacovigilance and Its Historical Development in the World and Türkiye. Içinde: Yamalı C, editör. Current Research in Pharmacy and Pharmaceutical Sciences II-2024 [Internet]. Türkiye: Akademisyen Yayınevi Kitap DOI Portalı; 2024 [a.yer 13 Temmuz 2026]. ss. 125-31. Erişim adresi: https://www.omp35.books.akademisyen.net/index.php/akya/catalog/book/3054/chapter/13724
