Impact of Patient Safety Centres In Pharmacovigilance

Introduction: The Food and Drugs Authority (FDA, Ghana) introduced direct patient reporting through community pharmacies designated as Patient Safety Centres (PSC) in June 2016 to address under reporting with spontaneous reporting. Designation of PSC: A PSC is a community pharmacy where a patient can obtain medicine safety information and report adverse reactions to health products to Ghana, FDA. A pharmacy has to meet 3 criteria to be designated as a PSC: presence of a pharmacist at the facility, pharmacist must receive training on pharmacovigilance and pharmacy must be willing to display FDA's social and behavior change communication (SBCC) materials on patient safety. Sustaining PSC: Three strategies were employed. * Recognition and featuring PSC in Ghana's pharmacovigilance newsletter, DrugEens. * Telephone follow-up and routine visitation to PSC as constant reminders to report adverse reactions. * Award of continuing professional education points to pharmacists who submit safety reports. Aim: To describe the implementation of PSC and its contribution to patient safety. Methods: ADRs received from PSCs between June 2016 to March 2023 were extracted from national database and descriptive analysis done. Comments received during follow-up on PSCs were used to ascertain impact. Results: A total of 420 spontaneous reports were received from PSCs during the period ( in table 1) with antibacterial for systemic use as the highest (20.3%) therapeutic group. Highest (25.9%) adverse reaction was gastrointestinal disorders. PSCs reports contributed 3.3% of spontaneous reports received from 2016. PSCs reported unique safety issues not received from other healthcare facilities including eye redness to weight loss powder, genital irritation to condoms, burns to a cosmetic cream and nodule to retin A. Comments from PSC Visits: Comments by pharmacists included, "PSC initiative has contributed to client's knowledge about side effects and how to report them." and "Patients still come for us to complete the form for them. Few clients complete it themselves." Conclusion: PSCs contributed over 3% of safety reports since 2016. Aim of PSC was for patient to report directly using available reporting tools, however most reports received were completed by pharmacists for patients. Reports from PSCs in early periods increased over time with active awareness creation and availability of SBCC materials. Rates dwindled when SBCC materials got old. From 2019 after introduction of Med