Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation

Research in Social and Administrative Pharmacy - Tập 16 - Trang 928-934 - 2020
Nikica Mirosevic Skvrce1, Iva Galic1, Carmen Pacadi2, Neva Kandzija3, Iva Mucalo4
1Agency for Medicinal Products and Medical Devices of Croatia, Ksaverska Cesta 4, 10 000, Zagreb, Croatia
2Mandis Pharm Community Pharmacies, Branimirova 65, Zagreb, 10 000, Zagreb, Croatia
3Nuffield Department of Obstetrics and Gynaecology, University of Oxford, John Radcliffe Hospital, OX3 9DU, Oxford, UK
4Centre for Applied Pharmacy, University of Zagreb Faculty of Pharmacy and Biochemistry, A. Kovacica 1, 10 000, Zagreb, Croatia

Tài liệu tham khảo

Classen, 1997, Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality, J Am Med Assoc, 277, 301, 10.1001/jama.1997.03540280039031 Pirmohamed, 2004, Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients, BMJ, 329, 15, 10.1136/bmj.329.7456.15 European Commission Kongkaew, 2008, Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies, Ann Pharmacother, 42, 1017, 10.1345/aph.1L037 Al Hamid, 2014, A systematic review of hospitalization resulting from medicine-related problems in adult patients, Br J Clin Pharmacol, 78, 202, 10.1111/bcp.12293 Khan, 2013, Comparative epidemiology of hospital-acquired adverse drug reactions in adult and children and their impact on cost and hospital stay-a systematic review, Eur J Clin Pharmacol, 69, 1985, 10.1007/s00228-013-1563-z Beijer, 2002, Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies, Pharm World Sci, 24, 46, 10.1023/A:1015570104121 Olivier, 2002, Assessing the feasibility of using an adverse drug reaction preventability scale in clinical practice: a study in a French emergency department, Drug Saf, 25, 1035, 10.2165/00002018-200225140-00005 Hakkarainen, 2012, Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions - a meta-analysis, PLoS One, 7, 10.1371/journal.pone.0033236 Union European Lane S, Lynn E , Shakir S. Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012. BMJ Open. 8:e019759. doi: 10.1136/bmjopen-2017-019759. World Health Organization, 2014 European Medicines Agency, 2014 Pharmacovigilance Risk Assessment Committee, 2015 Pharmacovigilance Risk Assessment Committee, 2015 Goedecke, 2016, Medication errors: new EU good practice guide on risk minimisation and error prevention, Drug Saf, 39, 491, 10.1007/s40264-016-0410-4 Pharmacovigilance Risk Assessment Committee, 2016 Newbould, 2017, Medication errors: a characterisation of spontaneously reported cases in EudraVigilance, Drug Saf, 40, 1241, 10.1007/s40264-017-0569-3 Karch, 1975, Adverse drug reactions. A critical review, J Am Med Assoc, 234, 1236, 10.1001/jama.1975.03260250028021 Ordinance on Pharmacovigilance, Official Gazette No. 125/2009, 76/2013, 83/2013. Act on Medicinal Products (Official Gazette No. 76/2013, 90/2014, 100/2018). 2001 International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2016 European Medicines Agency, 1995 European Medicines Agency 2000, Errors in Health care: a leading cause of death and injury, 26 von Laue, 2003, The epidemiology of preventable adverse drug events: a review of the literature, Wien Klin Wochenschr, 115, 407, 10.1007/BF03040432 Howard, 2007, Which drugs cause preventable admissions to hospital? A systematic review, Br J Clin Pharmacol, 63, 136, 10.1111/j.1365-2125.2006.02698.x SCOPE, 2016 Bates, 1993, Incidence and preventability of adverse drug events in hospitalized adults, J Gen Intern Med, 8, 289, 10.1007/BF02600138 Bates, 1995, Relationship between medication errors and adverse drug events, J Gen Intern Med, 10, 199, 10.1007/BF02600255 Bates, 1995, Incidence of adverse drug events and potential adverse drug events: implications for prevention, J Am Med Assoc, 274, 29, 10.1001/jama.1995.03530010043033 Alj, 2007, Detecting medication errors in pharmacovigilance database: capacities and limits, Int J Risk Saf Med, 19, 187 Jonville-Béra, 2009, Avoidability of adverse drug reactions spontaneously reported to a French regional drug monitoring centre, Drug Saf, 32, 429, 10.2165/00002018-200932050-00006 Bencheikh, 2009, Medication errors: pharmacovigilance centres in detection and prevention, Br J Clin Pharmacol, 67, 687, 10.1111/j.1365-2125.2009.03426.x Benkirane, 2009, Incidence of adverse drug events and medication errors in intensive care units: a prospective multicenter study, J Patient Saf, 5, 16, 10.1097/PTS.0b013e3181990d51 Kunac, 2011, Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis, Drug Saf, 34, 59, 10.2165/11539290-000000000-00000 Tanti, 2013, Medication errors through a national pharmacovigilance database approach: a study for Malta, Int J Risk Saf Med, 25, 17, 10.3233/JRS-120582 Thomas, 2000, Incidence and types of preventable adverse events in elderly patients: population: based review of medical records, BMJ, 320, 741, 10.1136/bmj.320.7237.741 Passarelli, 2005, Adverse drug reactions in an elderly hospitalised population: inappropriate prescription is a leading cause, Drugs Aging, 22, 767, 10.2165/00002512-200522090-00005 SCOPE, 2016 Banovac, 2017, Patient reporting in the EU: analysis of EudraVigilance data, Drug Saf, 40, 629, 10.1007/s40264-017-0534-1 Hazell, 2006, Under-reporting of adverse drug reactions: a systematic review, Drug Saf, 29, 385, 10.2165/00002018-200629050-00003