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