- 17 Downloads
Fatal outcomes related to the use of drugs in the past, for example, most prominently, the thalidomide tragedy, has caused the development of systematic, structured and regulated pharmacovigilance system in the 1960s. Pharmacovigilance includes processes for monitoring and evaluating adverse drug effects with the aim to improve the safety of a drug therapy. Core functions of pharmacovigilance are case management, signal management, and benefit-risk management. They cover the early stages in a drug’s life cycle, but also, as it is impossible to identify all safety concerns during clinical trials, post-marketing observational analyses. In later stages of a drug’s life cycle safety monitoring is based on spontaneous reporting of ADEs. In the EU and the USA, good pharmacovigilance systems are established; however, in some middle- and low-income countries, pharmacovigilance is still at its beginning or not available.
This chapter focusses on pharmacovigilance, describing how it works, what methods are used, describing more or less advanced pharmacovigilance systems in different countries, what an adverse drug effect and an adverse drug event is, and how to prevent and to manage adverse drug effects, especially in the field of neuropsychopharmacology.
- Cantudo Cuenca M, Munoz Cejudo B, Mora Mora M, Fernandez Martinez G, Cantal Sanchez M. Applying different scales for calculating the anticholinergic burden in older patients. European Association of Hospital Pharmacists. https://www.eahp.eu/sites/default/files/4cps-180.pdf Accessed 16 Dec 2019.
- Dean L. Clozapine therapy and CYP2D6, CYP1A2, and CYP3A4 genotypes. In: Pratt V, McLeod H, Rubinstein W, Dean L, Kattman B, Malheiro A, editors. Medical genetics summaries. Bethesda: National Center for Biotechnology Information (US); 2012.Google Scholar
- Dodd S, Mitchell PB, Bauer M, Yatham L, Young AH, Kennedy SH, Williams L, Suppes T, Lopez Jaramillo C, Trivedi MH, Fava M, Rush AJ, McIntyre RS, Thase ME, Lam RW, Severus E, Kasper S, Berk M. Monitoring for antidepressant-associated adverse events in the treatment of patients with major depressive disorder: an international consensus statement. World J Biol Psychiatry. 2018;19:330–48.PubMedCrossRefGoogle Scholar
- FDA. Guidance for industry – good pharmacovigilance practices and pharmacoepidemiologic assessment. Food and Drug Administration. 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents Accessed 21 Nov 2019.
- Hadi MA, Neoh CF, Zin RM, Elrggal ME, Cheema E. Pharmacovigilance: pharmacists' perspective on spontaneous adverse drug reaction reporting. Int Pharm Res Pract. 2017;6:91–8.Google Scholar
- Hiemke C, Bergemann N, Clement HW, Conca A, Deckert J, Domschke K, Eckermann G, Egberts K, Gerlach M, Greiner C, Grunder G, Haen E, Havemann-Reinecke U, Hefner G, Helmer R, Janssen G, Jaquenoud E, Laux G, Messer T, Mossner R, Muller MJ, Paulzen M, Pfuhlmann B, Riederer P, Saria A, Schoppek B, Schoretsanitis G, Schwarz M, Gracia MS, Stegmann B, Steimer W, Stingl JC, Uhr M, Ulrich S, Unterecker S, Waschgler R, Zernig G, Zurek G, Baumann P. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017. Pharmacopsychiatry. 2018;51:9–62.PubMedCrossRefGoogle Scholar
- Huhn M, Nikolakopoulou A, Schneider-Thoma J, Krause M, Samara M, Peter N, Arndt T, Backers L, Rothe P, Cipriani A, Davis J, Salanti G, Leucht S. Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. Lancet. 2019;394:939–51.PubMedPubMedCentralCrossRefGoogle Scholar
- WHO-UMC. The use of the WHO-UMC system for standardised case causality assessment. World Health Organisation – the Uppsala Monitoring Centre. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf Accessed 13 Dec 2019.
- WHO. Pharmacovigilance: ensuring the safe use of medicines. Geneva: World Health Organization; 2004. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ Accessed 22 Nov 2019Google Scholar