Themes in the course of Adverse Drug Reactions from a patient perspective


Pharmacovigilance centre Lareb has published a study structuring themes in the course of adverse drug reactions (ADRs) from a patient perspective. We developed a framework with six themes and multiple subthemes identified from patient descriptions.

Open-ended text fields in patient-reported ADR data contain extensive details on the course and timeframe of ADRs as experienced by patients. We did a qualitative analysis on these descriptions in patient-reported ADRs of biologics, direct oral anticoagulants and drugs for lower urinary tract symptoms. Four themes were identified describing the course of ADRs: frequency, duration, intensity and moment of ADR occurrence. Also two themes were identified from factors influencing the course of ADRs: triggering factors and improving factors.

The identified themes will be used in improving data collection in cohort event monitoring. Details about the course of ADRs will be systematically collected in the ADR Monitor according to the presented themes. This enables enhanced data analysis, which may ultimately provide valuable insights on patterns in the course of ADRs.

Read the full article here.

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