Background: Spontaneous reporting of adverse drug reactions (ADRs) is the method most widely used by pharmacovigilance systems, with the principal limitation being the physician’s underreporting.
Objective: This study sought to evaluate the results of workshop and telephone-interview interventions designed to improve the quantity and relevance of ADR reporting by physicians.
Methods: A cluster-randomized controlled trial was conducted on 6579 physicians in northern Portugal in 2008. Following randomization, we allocated 1034 physicians to a telephone-interview intervention, 438 to a workshop intervention and the remaining 5107 to the control group. At the workshop, a real clinical case was presented and participants were then asked to report on it by completing the relevant form. In the telephone intervention, participants were asked (i) whether they had ever had any suspicion of ADRs; (ii) whether they had experienced any difficulties in reporting; (iii) whether they remembered the different methods that could be used for reporting purposes; and (iv) whether they attached importance to the individual physician’s role in reporting. We followed up physicians to assess ADR reporting rates to the Northern Pharmacovigilance Centre. In terms of relevance, adverse reactions were classified as serious or unexpected. Statistical analysis was performed on an intention-to-treat basis, and generalized linear mixed models were applied using the penalized quasi-likelihood method. The physicians studied were followed up over a period of 20 months.
Results: Two hundred physicians underwent the educational intervention. Comparison with the control group showed that the workshop intervention increased the spontaneous ADR reporting rate by an average of 4-fold (relative risk [RR] 3.97; 95% CI 3.86, 4.08; p < 0.001) across the 20 months post-intervention. Telephone interviews, in contrast, proved less efficient since they led to no significant difference (p = 0.052) vis-à-vis the control group in ADR reporting (RR 1.02; 95% CI 1.00, 1.04). The effects of the interventions on the reporting rate of serious and high-causality ADRs indicated that the RRs associated with workshops were 6.84 (95% CI 6.69, 6.98; p<0.001) for serious ADRs and 3.58 (95% CI 3.51, 3.66; p<0.001) for high-causality ADRs.
Conclusions: Whereas telephone interventions only increased spontaneous reporting in the first 4 months of follow-up, workshops significantly increased both the quantity and relevance of spontaneous ADR reporting for more than 1 year.
Educational Intervention Reporting Rate Outreach Visit Outpatient Centre Telephone Intervention
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
This is a preview of subscription content, log in to check access.
The authors wish to express their sincere thanks to the following: Professor Altamiro da Costa Pereira for his invaluable help in developing this study; Professor Adolfo Figueiras, whose work on this project was funded by the Consortium for Biomedical Research in Epidemiology and Public Health (CIBER en Epidemiología y Salud Pública [CIBERESP]).[AC08_008]; María Piñeiro (CIBERESP), who contributed greatly to the statistical analysis; and Professor Maria Teresa Herdeiro, whose work on this project was funded, in part, by Science and Technology Fund (Fundação para a Ciência e Tecnologia) grant SFRH/BPD/35746/2007 from the Portuguese Ministry of Science, Technology and Higher Education.
The authors declare that they have no conflicts of interest directly relevant to the contents of this study.
Einarson TR. Drug-related hospital admissions. Ann Pharmacother 1993; 27(7–8): 832–40PubMedGoogle Scholar
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279(15): 1200–5PubMedCrossRefGoogle Scholar
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 329(7456): 15–9PubMedCrossRefGoogle Scholar
Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287(17): 2215–20PubMedCrossRefGoogle Scholar
Pedros 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(1): 77–83PubMedCrossRefGoogle Scholar
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29(5): 385–96PubMedCrossRefGoogle Scholar
Herdeiro MT, Figueiras A, Polonia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28(9): 825–33PubMedCrossRefGoogle Scholar
Inman WHW. Assessment drug safety problems. In: Gent M, Shigmatsu I, editors. Epidemiological issues in reported drug-induced illnesses. Honolulu, Ontario: McMaster University Library Press, 1976: 17–24Google Scholar
Smith CC, Bennett PM, Pearce HM, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 1996; 42(4): 423–9PubMedCrossRefGoogle Scholar
Herdeiro MT, Figueiras A, Polonia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2006; 29(4): 331–40PubMedCrossRefGoogle Scholar
Herdeiro MT, Polonia J, Gestal-Otero JJ, et al. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. J Eval Clin Pract 2004; 10(4): 483–9PubMedCrossRefGoogle Scholar
Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf 2009; 32(1): 19–31PubMedCrossRefGoogle Scholar
Figueiras A, Herdeiro MT, Polonia J, et al. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 2006; 296(9): 1086–93PubMedCrossRefGoogle Scholar
Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999; 319(7211): 670–4PubMedCrossRefGoogle Scholar
Pinheiro JC, Bates DM. Mixed-effects models in S and S-PLUS. 3rd ed. New York: Springer, 2006Google Scholar
Vorcewest TE, Barstow L, Butcher B. System for voluntary reporting of adverse drug-reactions in a university hospital. Am J Hosp Pharm 1989; 46(11): 2300–3Google Scholar
Sivaram C, Johnson S, Tirmizi SN, et al. Morning report: a forum for reporting adverse drug reactions. Jt Comm J Qual Improv 1996; 22(4): 259–63PubMedGoogle Scholar
Castel JM, Figueras A, Pedros C, et al. Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads. Drug Saf 2003; 26(14): 1049–55PubMedCrossRefGoogle Scholar
McGettigan P, Golden J, Conroy RM, et al. Reporting of adverse drug reactions by hospital doctors and the response to intervention. Br J Clin Pharmacol 1997; 44: 98–100PubMedCrossRefGoogle Scholar
Backstrom M, Mjorndal 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: 381–5PubMedCrossRefGoogle Scholar
Gilroy GW, Scollins MJ, Gay CA, et al. Pharmacy-coordinated program that encourages physician reporting of adverse drug reactions. Am J Hosp Pharm 1990; 47: 1327–33PubMedGoogle Scholar
Gony M, Badie K, Sommet A, et al. Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrenees region (Pharmaco-MIP) network 2-year pilot study. Drug Saf 2010; 33(5): 409–16PubMedCrossRefGoogle Scholar
Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions: results of the Rhode Island adverse drug reaction reporting project. JAMA 1990; 263(13): 1785–8PubMedCrossRefGoogle Scholar
Thomson O’Brien MA, Freemantle N, Oxman AD, et al. Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2001: (2): CD003030Google Scholar
Davis D, O’Brien MA, Freemantle N, et al. Impact of formal continuing medical education: do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes?. JAMA 1999; 282(9): 867–74PubMedCrossRefGoogle Scholar
Davis D, Thomson M, Oxman A, et al. Changing physicians performance: a systematic review of the effect of continuing medical education strategies. JAMA 1995; 274(9): 700–5PubMedCrossRefGoogle Scholar
Thomson O’Brien MA, Oxman AD, Davis DA, et al. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2000; (2): CD000409Google Scholar
Figueiras A, Sastre I, Tato F, et al. One-to-one versus group sessions to improve prescription in primary care: a pragmatic randomized controlled trial. Med Care 2001; 39(2): 158–67PubMedCrossRefGoogle Scholar
Ribeiro-Vaz I, Herdeiro MT, Polonia J, et al. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saude Publica 2010; 45(1): 129–35PubMedCrossRefGoogle Scholar