Background: Adverse drug reactions (ADRs) are one of major health concern affecting population of all ages causing significant morbidity mortality and hospitalization of the patients increasing the economic burden on the society. Monitoring of ADRs is of paramount importance for the continued effective and safe use of medicines. Though they are unavoidable accompaniments of pharmacotherapy, the reporting of ADR is poor and inadequate. Substantial under-reporting and selective reporting of ADRs are the major drawbacks of the commonly followed method of spontaneous reporting by healthcare professionals (HCP). Patient direct reporting of ADR has been incorporated into the pharmacivigilance (PV) system in several countries like USA, Canada, Australia, New Zealand, Denmark, Sweden and the Netherlands. Patient direct reporting of ADR was qualitatively similar to HCP ADR report. Patient reports often had richer narratives than those of HCPs. Patient reports often contained detailed information about the impact of the suspected ADR on the patient’s quality of life. The quality of ADR reported by the patients was similar to the reports by HCP in terms of description of ADRs and its severity. So, present study was taken to evaluate the process of spontaneous reporting of suspected ADR by the patient and compare the quality of ADR reported by Health care professional and Patients.Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine Comparison between spontaneous reporting by healthcare professionals and patient direct reporting of adverse drug reactions was assessed in terms of response rate, pattern of ADR reported, causality by Naranjo s scale, severity by modified Hartwig scale and preventability by using Schumock and Thornton scale. Social, emotional, occupational impact due to ADR and narrative elaboration scores were also compared.Results: Majority of the ADRs were from HCP as compared to patient reporting, indicating that better awareness among HCP about pharmacovigilance Majority of the reactions reported by patient were mild in severity, in contrast majority of ADR reported by HCP were moderate. Comparisons between HCP reporting and patient direct reporting also revealed that majority of ADR in both groups were probably preventable. Qualitative analysis reported ADR showed that majority of ADR reported by HCP had no narration or had scant narration, in contrast to patient direct reporting had very elaborate narration of ADR. Patient who did direct reporting of ADR highlighted more about emotional impact, occupational impact and social impact of ADR occurred to them, when compared to ADRs reported by HCP.Conclusions: Patients were clearly willing to report any adverse drug reactions occurring to them. The evidence indicates that patient reporting of suspected ADRs has more Potential benefits than drawbacks. The results indicate that patient perceptions of potential ADRs are relevant and should be an integral part of ADR reporting system.
Factors affecting patient reporting of adverse drug reactions: a systematic review