Attitudes and opinions of Portuguese community pharmacy professionals towards patient reporting of adverse drug reactions and the pharmacovigilance system
Tóm tắt
Từ khóa
Tài liệu tham khảo
World Health Organization. WHO. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organization; 2002. p. 1–48.
Härmark L, Van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64(8):743–52.
EC. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance. Directive 2001/83/EC on the Community code relating to medicinal products for human us [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.douri=OJ:L:2010:348:0074:0099:EN:PDF . Accessed 30 May 2011; 2010.
Matos C, van Hunsel F, Joaquim J. Are consumers ready to take part in the pharmacovigilance system? A Portuguese preliminary study concerning ADR reporting. Eur J Clin Pharmacol. 2015;71(7):883–90.
Marques J, Ribeiro-Vaz I, Pereira AC, et al. A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal. Int J Pharm Pract. 2014;22(4):275–82.
Figueiras A, Tato F, Fontaiñas J, et al. Physicians’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract. 2001;7(4):347–54.
Gavaza P, Brown CM, Lawson KA, et al. Influence of attitudes on pharmacists’ intention to report serious adverse drug events to the Food and Drug Administration. Br J Clin Pharmacol. 2011;72(1):143–52.
Leone R, Moretti U, D’Incau P, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013;36(4):267–76.
Van Grootheest AC, Van Puijenbroek EP, de Jong-van den Berg LTW. Contribution of pharmacists to the reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11(3):205–10.
Borg J-J, Aislaitner G, Pirozynski M, et al. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? Drug Saf. 2011;34(3):187–97.
Steurbaut S, Hanssens Y. Pharmacovigilance: empowering healthcare professionals and patients. Int J Clin Pharm. 2014;36(5):859–62.
Waller PC. Making the most of spontaneous adverse drug reaction reporting. Basic Clin Pharmacol Toxicol. 2006;98(3):320–3.
Blenkinsopp A, Wilkie P, Wang M, et al. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148–56.
Anderson C, Krska J, Murphy E, et al. The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective. Br J Clin Pharmacol. 2011;72(5):806–22.
Herdeiro MT, Figueiras A, Polónia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting. Drug Saf. 2006;29(4):331–40.
Parretta E, Rafaniello C, Magro L, et al. Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy. Expert Opin Drug Saf. 2014;13(Supp 1):21–9.
Pellegrino ML, Desiderio V, Mores N, et al. The role of the pharmacist in patient reporting of adverse drug reactions: the Italian interregional project [in Italian]. G Ital di Farm e Farm. 2015;7(1):63–74.
Matos C, Joaquim J, Pires T. Attitudes and knowledge of community pharmacy professionals regarding the spontaneous reporting of adverse drug reactions: a preliminary study in Coimbra, Portugal. Drugs Ther Perspect. 2017;33(2):86–92.
Infarmed. Estatística do Medicamento e Produtos de Saúde 2014; 2014.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Lawrance Eribaum Association; 1988.
Herdeiro MT, Ferreira M, Ribeiro-Vaz I, et al. The Portuguese pharmacovigilance system. Acta Médica Port. 2012;25(4):241–9.
Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions. Drug Saf. 2009;32(1):19–31.
Marques JI, Polónia J, Figueiras AG, et al. Nurses’ attitudes and spontaneous adverse drug reaction reporting: a case–control study in Portugal. J Nurs Manag. 2016;24(3):409–16.
Duarte M, Ferreira P, Soares M, et al. Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study. Drugs Ther Perspect. 2015;31(9):316–22.
Toklu HZ, Soyalan M, Gültekin O, et al. The knowledge and attitude of the healthcare professionals towards pharmacovigilance and adverse drug reaction reporting in northern Cyprus. J Pharmacovigil. 2016;4:193. doi: 10.4172/2329-6887.1000193 .
Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur J Clin Pharmacol. 1997;52(6):423–7.
Krska J. Views of British community pharmacists on direct patient reporting of adverse drug reactions (ADRs). Pharmacoepidemiol Drug Saf. 2013;22(10):1130–3.
INFARMED. Sistema Nacional de Farmacovigilância (SNF): Notificações e Casos de RAM - Ano/2015; 2016.