Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database

Abstract

AimsTo explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug–adverse drug reaction (ADR) associations that led to drug safety signals.MethodsThis was a retrospective comparison of time to reporting selected drug–ADR associations which led to drug safety signals between patients and HCPs. ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug–ADR associations of actual drug safety signals. Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann–Whitney U test.ResultsIn total, 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs. 8.3 years (P < 0.001).ConclusionsPatients contributed a large proportion of reports on drug–ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.

Intensive monitoring of adverse drug events associated with the use of new glucose‐lowering drugs: results from an inception cohort study in Portugal

“…We identified a high proportion (36%) of ADEs not listed in the corresponding summary of product characteristics, which, given the only recent availability of the monitored drugs, are largely based on randomized clinical trial data. This finding appears consistent with the results of other studies which showed that consumer reports have the potential to identify new ADEs that were not previously included in the summary of product characteristics, and that the ADEs are sometimes reported earlier by consumers than by healthcare professionals [28][29][30]. Nevertheless, surprising differences among the monitored glucoselowering drugs were found in the present study, with the highest proportions of unlabelled ADEs being reported by new users of DPP-4 inhibitors alone.…”

Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century

“…For example, it has been found that patients often provide detailed clinical stories that describe their experiences and the impact of ADRs on their quality of life [40,42]. Recent studies using VigiBase data also show that patient reports can contribute to identifying possible safety issues [40,43]. From the reports in VigiBase it is notable that the proportion of female reports is slightly larger for patients compared to other groups of reporters.…”

Spontaneous adverse event notifications by patients subsequent to the marketing of a new formulation of Levothyrox® amidst a drug media crisis: atypical profile as compared with other drugs

“…Improving the access of spontaneous notifications to patients is an important goal for all regulatory agencies. By increasing the number of reports implementing pharmacovigilance databases, they theoretically allow to detect relevant signals of adverse‐reactions to drugs . We have previously shown that spontaneous notifications from patients could be reliably taken in consideration apart from their degree of severity .…”