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  • Caroline Pagotto (a1), Fabiana Varallo (a1) and Patrícia Mastroianni (a1)


Introduction: Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV).

Objectives: To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact.

Methods: A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers.

Results: 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality.

Conclusion: Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.



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1.Leendertse, AJ, Visser, D, Egberts, AC, van den Bemt, PM. The relationship between study characteristics and the prevalence of medication-related hospitalizations: A literature review and novel analysis. Drug Saf. 2010;33:233244.
2.Dequiro, AB, Mol, PG, van Doormaal, JE, et al.Preventable and non-preventable adverse drug events in hospitalized patients: A prospective chart review in the Netherland. Drug Saf. 2011;34:10891100.
3.Hazell, L, Shaki, SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2006;29:385386.
4.Ribeiro-Vaz, I, Herdeiro, MT, Polónia, J, Figueiras, A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saude Publica. 2011;45:129135.
5.Meyboom, RH, Egberts, AC, Gribnau, FW, Hekster, YA. Pharmacovigilance in Perspective. Drug Saf. 1999;21:429447.
6.Conforti, A, Opri, S, D'Incau, P, et al.Adverse drug reaction reporting by nurses: Analysis of Italian pharmacovigilance database. Pharmacoepidemiol Drug Saf. 2012;21:597602.
7.Gedde-Dahl, A, Harg, P, Stenberg-Nilsen, H, et al.Characteristics and quality of adverse drug reaction reports by pharmacists in Norway. Pharmacoepidemiol Drug Saf. 2007;16:9991005.
8.OPS. Buenas Prácticas de Farmacovigilancia para las Américas. Washington, DC: OPS, © 2010. (Red PARF Documento Técnico No. 5). 78 pág.
9.Forsetlund, L, Bjorndal, A, Rashidian, A, et al.Continuing Education meeting and workshops: Effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2009;15:CD00303.
10.López-Gonzalez, E, Herdeiro, MT, Figueiras, A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2009;32:1931.
11.Molokhia, M, Tanna, S, Bell, D. Improving reporting of adverse drug reactions: Systematic review. Clin Epidemiol. 2009;1:7592.
12.Moher, D, Liberati, A, Tetzlaff, J, Altman, DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. J Clin Epidemiol. 2009;62:10061012.
13.Herdeiro, MT, Ribeiro-Vaz, I, Ferreira, M, et al.Workshop- and telephone-based interventions to improve adverse drug reaction reporting: A cluster-randomized trial in Portugal. Drug Saf. 2012;35:655665.
14.Cereza, G, Agustí, A, Pedrós, C, et al.Effect of an intervention on the features of adverse drug reactions spontaneously reported in a hospital. Eur J Clin Pharmacol. 2010;66:937945.
15.Gony, M, Badie, K, Sommet, A, et al.Improving adverse drug reaction reporting in hospitals results of the French pharmacovigilance in Midi-Pyrénées Region (PharmacoMIP) Network 2-Year Pilot Study. Drug Saf. 2010;33:409416.
16.Pedrós, C, Vallano, A, Cereza, G, et al.An intervention to improve spontaneous adverse drug reaction reporting by hospital physicians: A time series analysis in Spain. Drug Saf. 2009;32:7783.
17.Herdeiro, MT, Polónia, J, Gestal-Otero, JJ, Figueiras, A. Improving the reporting of adverse drug reactions. A cluster-randomized trial among pharmacists in Portugal. Drug Saf. 2008;31:335344.
18.Figueiras, A, Herdeiro, MT, Polónia, J, Gestal-Otero, JJ. An educational intervention to improve physician reporting of adverse drug reactions. A cluster-randomized controlled trial. JAMA. 2006;296:10861093.
19.Bracchi, RC, Houghton, J, Woods, FJ, et al.A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme. Br J Clin Pharmacol. 2005;60:221223.
20.Backström, M, Mjorndal, T, Dahlqvist, R. Spontaneous reporting of adverse drug reactions by nurses. Pharmacoepidemiol Drug Saf. 2002;11:647650.
21.Clarkson, A, Ingleby, E, Choonara, I, Bryan, P, Arlett, P. A novel scheme for the reporting of adverse drug reactions. Arch Dis Child. 2001;84:337339.
22.McGettigan, P, Golden, J, Conroy, RM, Arthur, N, Feely, J. Reporting of adverse drug reaction by hospital doctors and the response to intervention. Br J Clin Pharmacol. 1997;44:98100.
23.Scott, HD, Thacher-Renshaw, A, Rosenbaum, SE, et al.Physician reporting of adverse drug reaction. Results of the Rhode Island adverse drug reaction reporting project. JAMA. 1990;263:17851788.
24.Biagi, C, Montanaro, N, Buccellato, E, et al.Underreporting in pharmacovigilance: An intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013;69:237244.
25.Primo, LP, Capucho, HC. Intervenções educativas para estímulo a notificações voluntárias em um hospital de ensino da rede sentinela. Rev Bras Farm Hosp Serv. 2011;2:2630.
26.Johansson, ML, Hägg, S, Wallerstedt, SM. Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: A randomized controlled study. BMC Clin Pharmacol. 2011;11:1419.
27.Johansson, ML, Brunlöf, G, Edward, C, Wallerstedt, SM. Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports. Eur J Clin Pharmacol. 2009;65:511514.
28.Gerritsen, R, Faddegon, H, Dijkers, F, van Grootheest, K, van Puijenbroek, E. Effectiveness of pharmacovigilance training of general practitioners: A retrospective cohort study in the Netherlands comparing two methods. Drug Saf. 2011;34:755762.
29.Baniasadi, S, Fahimi, F, Shalviri, G. Developing an adverse drug reaction reporting system at a teaching hospital. Basic Clin Pharmacol Toxicol. 2008;102:408411.
30.Bäckström, M, Ekman, E, Mjörndal, T. Adverse drug reaction reporting by nurses in Sweden. Eur J Clin Pharmacol. 2007;63:613618.
31.Durrieu, G, Hurault, C, Bongard, V, Damase-Michel, C, Montastruc, JL. Perception of risk of adverse drug reactions by medical students: Influence of 1 year pharmacological course. Br J Clin Pharmacol. 2007;64:233236.
32.Granas, AG, Buajordet, M, Stenberg-Nilsen, H, Harg, P, Horn, AM. Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf. 2007;16:429434.
33.Bäckström, M, Mjörndal, T. A small economic inducement to stimulate increased reporting of adverse drug reactions – A way of dealing with an old problem? Eur J Clin Pharmacol. 2006;62:381385.
34.Cox, AR, Marriott, JF, Wilson, KA, Ferner, RE. Adverse drug reaction teaching in UK undergraduate medical and programmes. J Clin Pharm Ther. 2004;29:3135.
35.Rosebraugh, CJ, Tsong, Y, Zhou, F, et al.Improving the quality of adverse drug reaction reporting by 4th-year medical students. Pharmacoepidemiol Drug Saf. 2003;12:97101.
36.Morrison-Griffiths, S, Walley, TJ, Park, BK, Breckenridge, AM, Pirmohamed, M. Reporting of adverse drug reactions by nurses. Lancet. 2003;361:13471348.
37.Goldman, SA. Use of a mail-out continuing education article to teach health professionals about drug-induced disease. J Clin Pharmacol. 1999;39:11261135.
38.Zolezzi, M, Parsotam, N. Adverse drug reaction reporting in New Zealand: Implications for pharmacists. Ther Clin Risk Manag. 2005;1:181188.
39.Grootheest, K, Olsson, S, Couper, M, de Jong-van den Berg, L. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf. 2004;13:457464.



  • Caroline Pagotto (a1), Fabiana Varallo (a1) and Patrícia Mastroianni (a1)


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