RESUMO
BACKGROUND: Pharmacovigilance systems increase access to safe medicines and healthcare, but their integration in public healthcare remains a challenge in many countries. The main barriers to pharmacovigilance integration are attributed to high patient load and limited capacities. OBJECTIVE: To explore the challenges associated with the effective integration of pharmacovigilance systems in public healthcare in a developing country such as Namibia. METHODS: A nationwide qualitative assessment of integration of pharmacovigilance systems particularly spontaneous adverse drug reaction (ADR) reporting at public health facility level was conducted. Key informant interviews were conducted among pivotal healthcare professionals involved in pharmacovigilance. The main outcomes were themes on challenges and strategies for effective integration of PV services at the facility level. Qualitative data were collected over a one-month period (i.e., March 2019), and thematically analysed. RESULTS: Eight (8) key informants were recruited; the majority were pharmacists (n = 7) and male (n = 5). The main challenges affecting the effective integration of pharmacovigilance systems reporting at public health facilities were "weak pharmacovigilance policies and structures", "negative attitude of healthcare workers towards pharmacovigilance", and "limited capacity and support for implementation of pharmacovigilance activities". The main strategies for effective integration of PV systems at facilities included local capacity-building through continuing profession education and support, advocacy, stakeholder engagement, facility/region based pharmacovigilance champions, and facility-based policies for universal and inclusive reporting, (i.e. patients and health workers at all levels) as well as development of workable standard operational procedures. CONCLUSIONS: The pharmacovigilance systems at healthcare facilities in Namibia were observed to have sub-optimal policies, structures and support systems, and lack health care worker buy-in. There is a need for a policy framework to ensure effective and sustainable integration of pharmacovigilance activities at public healthcare facilities.
