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

Abstract

BackgroundUnder-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.MethodsThis 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.ResultsOf 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.ConclusionsMost 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.

A cross-sectional survey of knowledge, attitude, and willingness to engage in spontaneous reporting of adverse drug reactions by Korean consumers

“…As studies showed that consumers needed more steps to identify their symptoms as ADRs than HCPs [ 19 ], we incorporated the knowledge or ability to recognise ADRs into our conceptual framework reflecting consumers’ perspectives. Based on the framework, five questions were formulated, addressing the objective knowledge of ADRs [ 19 , 26 ]. For the case of knowledge about SR, the questions about their awareness of the SR system and the relief scheme supported by the Korean government were included and the questions that measure self-efficacy, indicating perceived ability to spontaneously report, were considered.…”

“…As studies showed that consumers needed more steps to identify their symptoms as ADRs than HCPs [19], we incorporated the knowledge or ability to recognise ADRs into our conceptual framework reflecting consumers' perspectives. Based on the framework, five questions were formulated, addressing the objective knowledge of ADRs [19,26].…”

“…Some recent studies that have analysed consumers’ reporting behaviour [ 16 – 18 ] have identified distinctive barriers and motives for ADR reporting, such as poor awareness of the SR system and altruism. The majority of the published studies on PV activities by consumers have largely been limited to descriptive analyses based on a small number of participants, and have seldom been driven by a conceptual framework that allows for the comprehensive evaluation of factors contributing to the reporting behaviour [ 16 , 19 ]. Therefore, we conducted this study to assess the knowledge, attitude, and intent in relation to the voluntary reporting of ADRs, and explore the factors that contribute to the consumers’ reporting intention in South Korea based on a conceptual model.…”

Factors that influence the intention to use mobile phone caller tunes for patient reporting of adverse drug reactions: a qualitative study

“…Similar findings have been reported in previous studies in Ghana. 23,24 Lack of patient reporting of ADRs may result from failure by health professionals to provide adequate information on drug safety to patients. 21 For the same reason, patients believe that it is a waste of time to complete the form on their own.…”

Ethical Tenets of PRN Medicines Management in Healthcare Settings: A Clinical Perspective

“…The patient is partner in PRN medicines management and can be involved in recognising and reporting symptom improvements, medications’ side effects and adverse reactions. Additionally, he/she should be motivated, informed and educated on how to report them, and how their reports lead to the improvement of the medication process [ 70 , 71 ], wellbeing and healthcare outcomes [ 72 , 73 ].…”