PHARMACOVIGILANCE AND ADVERSE DRUG REACTION REPORTING PRACTICES AMONG GHANAIAN HEALTHCARE PROFESSIONALS

Background - Under-reporting of adverse drug reactions (ADRs) is a challenging medication safety problem globally. Even though ADRs are associated with significant morbidity and mortality, poor reporting among healthcare professionals (HCPs) persists, particularly in resource-limited settings. This study aimed to explore HCP experiences and factors influencing ADR reporting in the Ghanaian hospital setting. Methods - A concurrent mixed methods design was undertaken using face-to-face semi-structured qualitative interviews, focus groups and a survey. Nursing, pharmacy and medical staff were sampled using a stratified random sample from five hospitals in Tamale, Ghana coupled with purposive sampling for interviews. Survey data were analysed descriptively using SPSS and in-depth interviews and focus group discussions analysed using a six-stage thematic analysis using NVivo. Findings - 386 HCPs (86% response rate) participated in the survey. Pharmacovigilance (PV) knowledge was low (19%) with the majority being unaware of the national PV centre (68%) and basic information on reporting forms (65%). Pharmacy staff were however more knowledgeable compared to nursing and medical staff. Only 13% of HCPs reported to have observed an ADR at least once in a year and another 14% had completed a form. The majority (92%) of HCPs agreed that patient safety could improve if they reported ADRs and disagreed that litigation (82%) and lethargy (81%) were a hindrance. Pharmacists were perceived to have a key ADR reporting role. Use of verbal reporting was perceived to reduce ADR reporting formally along with complex interrelated system and human factors, such as lack of forms, inadequate infrastructure, stakeholder issues, uncertainty about reporting responsibilities, poor interpersonal relations, perceive patient attitudes, bureaucracies, fear of wrongdoing and blame. Conclusions – This study suggests that ADR reporting is low and often informal in the Ghanaian hospital setting but enhancing the role of pharmacists may be important in improving ADR reporting, as well as increasing HCP awareness through training – particularly for non-pharmacy staff - and logistical changes such as electronic ADR reporting