The contribution of Ghanaian patients to the reporting of adverse drug reactions: A quantitative and qualitative study

Tom G. Jacobs, H. Hilda Ampadu, Jarno Hoekman, Alexander N.O. Dodoo, Aukje K. Mantel-Teeuwisse

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

Abstract

Background: Under-reporting of adverse drug reactions (ADRs) is a major challenge for pharmacovigilance in Africa. This study sets out to assess the level of awareness of Ghanaian patients about ADRs and ADR-reporting and explores how different patients in Ghana recognize an ADR and the steps they take when they experience an ADR. Methods: This was a two-part study consisting of a survey to quantify the awareness of Ghanaian patients on ADRs and ADR-reporting, and in-depth interviews to explore how patients recognize an ADR and the steps they take thereafter. Participants were selected from 28 health care facilities (HCF) in rural and urban areas in 4 out of the 10 administrative regions of Ghana. Chi-square tests were used to examine associations between demographic variables and i) awareness of ADRs and ADR-reporting, ii) ADR experience and iii) awareness of the Ghana Food and Drug Authority (Ghana-FDA) and its patient reporting system (PRS). Only participants that indicated they experienced an ADR were included for the in-depth interviews. Data was investigated for participants' awareness of ADRs, ADR reporting and steps taken when they experience ADRs. Results: Of the total 572 participants enrolled in the study, 14% indicated they were unaware of ADRs and were excluded. Of the remaining 491 participants, 38% had experienced an ADR, of which 67% reported the ADR, 68% of them reported it to a doctor. Only 3% of the 491 participants were aware of the Ghana-FDA's PRS. The interview phase consisted of 33 patients who had experienced an ADR. Three key findings from the interview phase were; most participants recognized an ADR themselves, the symptoms of the ADR were the most mentioned reason for reporting and participants experienced a wide variety of obstacles in ADR-reporting. Conclusions: Most Ghanaian patients appear unaware of or unable/unwilling to use formal national channels for ADR reporting like the Ghana-FDA PRS. Motivation for ADR reporting appeared mainly personal and not communal. These findings warrant further attention in order to increase patient reporting of ADRs.

Original languageEnglish
Article number1384
JournalBMC Public Health
Volume18
Issue number1
DOIs
Publication statusPublished - 18 Dec 2018
Externally publishedYes

Keywords

  • Adverse drug reactions
  • Communication
  • Patient interviews
  • Patient reporting
  • Pharmacovigilance
  • Questionnaire

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