Important information regarding reporting of adverse drug reactions: a qualitative study.

OBJECTIVE

To give an overview of the views of different types of reporters (patients and healthcare professionals (HCPs)) and assessors of adverse drug reactions (ADRs) on what they consider important information regarding an ADR report.

METHODS

A semi-structured interview was conducted among reporters and assessors of ADRs in the Netherlands. All interviews were audiotaped and transcribed verbatim. Content analysis was used on the data. All transcripts were coded individually by two researchers. A list was drafted of all elements of information mentioned during the interviews.

KEY FINDINGS

In total 16 interviews were conducted. Elements of information that were explicitly brought up during the interviews were the impact of the ADR on the patient's daily life and information regarding causality. Furthermore, the correctness of reported information was found important by assessors of ADRs. Generally, patient reporting was seen as a very positive development for pharmacovigilance.

CONCLUSION

Patients reported that the severity of ADRs and their impact on daily life were important subjects. In the interviews with HCPs, either reporters or assessors, the focus was mainly on causality. The correctness of the given information is considered by ADR assessors to be very important. Regarding patient reporting the overall view was positive. Because HCPs and patients have different views regarding ADR reporting, in daily practice it is important to receive reports from both groups to assess the true nature of the ADR.