Underreporting in pharmacovigilance among the GPs from three Local Health Authority in Italy

Spontaneous reporting system of adverse drug reactions (ADR) represents the cornerstone of the post marketing surveillance of drug safety, and is crucial for rapid signal detection. Under-reporting is a serious drawback of the pharmacovigilance system that could occur due to several reasons such as conviction that ADRs are well documented, uncommunicative doctor-patient relationship, lack of failing to perceive the importance of the individual contribution to the overall knowledge of drug safety. Several interventions to increase ADRs reporting have been proposed; they include education, access to report forms in combination with verbal reminders and distribution of a drug-safety bulletin, and detailed drug-specific feedback to the reporting doctor. The present study aimed to assess knowledge, attitudes and behaviours regarding spontaneous reporting among general practitioners (GPs) and to evaluate whether a monthly e-mail-based newsletter on drug safety could affect the rate and the quality of the ADR reports coming from GPs. Three local health authorities (LHAs) of Emilia Romagna region were chosen on the basis of the rate of reports produced during the period preceding the study: Ferrara (high), Rimini (average), and Piacenza (low reporting rate). All GPs (n=737) were recruited. The remaining 7 regional LHAs were used as controls. The study covered a period of 3 years and was divided into: 1) identification of the reasons leading to underreporting through a questionnaire; 2) sending a newsletter for 10 months; 3) evaluation of the intervention outcomes during the following 10 months. Out of 737 GPs involved, 22.8% returned the questionnaire. Greater involvement was observed for physicians belonging to the LHA of Rimini (28%), followed by Ferrara (20.4%) and Piacenza (17.1%). Analysis of the questionnaires returned revealed that over 94% of respondents considered the spontaneous reporting as part of their profession, while 60% of them are not aware that the report should be carried out even without the certainty of a causal relationship between drug and adverse reaction. About 6.5% produced at least one report in the previous 6 months. As for the reasons for the failure to report an ADR, 47% of GPs indicated "the uncertainty that the event was caused by the drug", while 33% considered the adverse reaction “too banal to be reported”, and 22% of participants did not make reports for "lack of time". After the phase II in Rimini and Piacenza was observed an important increase in the number of reports (49.2%), rising from 63 reports in 2009 to 94 in 2010, while the remaining LHAs (controls) showed a more modest increase (8.78%). With regard to the reports of GPs, the increase was 200% for Rimini and Piacenza while in the controls there was a decrease of 25.5%. In 2011, without any intervention, there was a turnaround compared to the previous year: the number of ADRs recorded by our LHAs showed a decrease of 6.8%, which reaches 50.0% among the GPs. As for the controls, the data shows an overall decline of 4.3%, while the reports of GPs increased by 63.3%. The LHA of Ferrara was excluded by the final analysis for confounding factors (other concomitant interventions in pharmacovigilance). Although the extent of under-reporting is widely variable depending on the estimates, it is certain that the number of ADR reports is a minimum percentage of the total ADRs that actually do occur. Our study shows that the periodic and continuous update on the safety of drugs may represent an effective and inexpensive way to raise awareness of the health care professionals on the importance of the spontaneous reporting. Since the positive effect of the intervention on the number of reports seems to vanish when we stopped sending the newsletter, there is a clear need to raise awareness among regional and national health authorities to adopt constant educational strategies for doctors and other health professionals.