Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme

Abstract

Introduction Adverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free‐text comments which could be useful sources of information. Objectives To investigate patients' experiences of ADRs and their impact on patients as described in free‐text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency. Methods A qualitative review of narrative texts was conducted on free‐text data from 2255 patient YC reports from July to December 2015. Results Three key narrative themes emerged from analysis of the free‐text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms. Conclusion Free‐text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient’s Perspective

“…However, seasonal variation in spontaneously reporting ADRs has been described before [ 26 ]. Temporal associations have also been described in a qualitative analysis of patient reports to the UK yellow card scheme [ 27 ]. The descriptions of subthemes influencing the ADR may provide valuable insights in the actions patients take or what patients avoid in order to deal with an ADR.…”

“…Although the primary aim of post-marketing surveillance is signal detection [ 11 , 12 ], more information about ADRs can be acquired, especially from patients. Previous studies addressed that details such as the impact on daily life can be captured in patient reports [ 15 , 17 , 27 ] and we now also present a framework with themes on the time course of ADRs as identified from patient reports. The themes concerning the recurrence of ADR episodes and the moment of occurrence as described by patients in our study are not explicitly covered in the European guideline on the summary of product characteristics [ 7 ], the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist on reporting harms in systematic reviews [ 31 ] or the guideline for submitting adverse event reports for publication [ 32 ].…”

Anaphylactic events in mRNA vaccines: a reporting case-control study

“…Several highly successful PR schemes are in widespread use, and the availability of online reporting has only augmented the power of these systems. Some of the best known are the UK's Yellow Card Scheme [13] and the Vaccine Adverse Event Reporting System (VAERS) [16], maintained by the FDA.…”

“…In particular, much of the payload of such reporting lies in unstructured (plain text) fields, which makes structured analysis quite difficult. [13] Until recently, such analysis required manual coding of reports or reliance on the reporter's completion of a form that would often be complex or ambiguous for a layperson -for instance, a layperson may not know to differentiate between emergency room (ED) attendance versus hospital admission. Prior work in accessing the unstructured (plain text) element of VAERS reports has been limited both in its scope and in its success.…”