Knowledge, awareness, perception and reporting of experienced adverse drug reactions among outpatients in Nigeria.

Background Higher incidence of adverse drug reactions (ADRs) remain a major cause of morbidity and mortality. Most targeted ADR reporting activities are mainly professional-centered with less attention to patients' knowledge, perception and selfreporting of experienced ADRs. Objectives To comprehensively evaluate patients' knowledge, awareness, perception and reporting of experienced ADRs. Setting Three public healthcare facilities in Ibadan, southwestern Nigeria. Method A questionnaire-guided cross-sectional interview of 1190 consented ambulatory adult patients consecutively recruited from various clinics of the selected hospitals between February and June 2018. The 32-item pretested questionnaire comprised open- and closed-ended questions, as well as open-ended questions with relevant prompts. Data were summarised using descriptive statistics, while Chi square was used to investigate association between relevant categorical variables at p < 0.05. Main outcome measure Knowledge, awareness, perception and reporting of experienced ADRs among patients. Results Response rate was 99.1%. Mean age was 40.6 ± 14.9 years. Forty-nine (4.1%) patients were aware of pharmacovigilance. A total of 964 (81.0%) correctly understood what can be regarded as serious adverse drug reactions (ADRs), 444 (37.3%) had previously experienced ADRs, while 77 (6.5%) experienced reactions with current medication(s). Of this, 64 (83.1%) made a report largely to physician (52; 81.3%). Summarily, reported reactions were more with antimalarials (214; 49.1%), with itching (168; 78.5%) constituting the most frequently occurring reaction. Use of text message (276; 27.2%) and filling of ADR report form (248; 24.4%) were topmost on the list of suggested methods for ADR reporting. There was a significant association between patient's age and awareness of pharmacovigilance (p = 0.015), while educational qualification (p = 0.001) significantly influenced tendency to make a report of experienced ADRs. Conclusion Approximately four percent of patients were aware of pharmacovigilance, while more than three-quarters correctly understood the concept of serious adverse drug reactions. A little above one-quarter had previously experienced one form of reaction or the other, with majority reporting such reactions to physician. Continuous education of stakeholders in pharmacovigilance activities is advocated, while patient's active involvement in spontaneous reporting of ADRs should be carefully considered.