Inconsistent Country-Wide Reporting of Adverse Drug Reactions to Antimicrobials in Sierra Leone (2017–2021): A Wake-Up Call to Improve Reporting

International Journal of Environmental Research and Public Health

Pruthu Thekkur¹  Abdulai Jawo Bah²  Joseph Sam Kanu²  Fawzi Thomas³  Onome T. Abiri³  Thomas A. Conteh³  James P. Komeh³  Arpine Abrahamyan⁴  Robert Terry⁵  Rony Zachariah⁵ 

[1] Centre for Operational Research, International Union against Tuberculosis and Lung Disease, 75001 Paris, France;College of Medicine & Allied Health Sciences, University of Sierra Leone, Freetown 02717, Sierra Leone;National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Freetown 02717, Sierra Leone;Tuberculosis Research and Prevention NGO (TB-RPC), Yerevan 0014, Armenia;UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in Tropical Diseases (TDR), 1211 Geneva, Switzerland;

关键词: SORT IT;    operational research;    VigiBase;    health system strengthening;    universal health coverage;   

DOI  :  10.3390/ijerph19063264

来源: DOAJ

【 摘 要 】

Background: Monitoring of adverse drug reactions (ADRs) to antimicrobials is important, as they can cause life-threatening illness, permanent disabilities, and death. We assessed country-wide ADR reporting on antimicrobials and their outcomes. Methods: A cross-sectional study was conducted using individual case safety reports (ICSRs) entered into the national pharmacovigilance database (VigiFlow) during 2017–2021. Results: Of 566 ICSRs, inconsistent reporting was seen, with the highest reporting in 2017 and 2019 (mass drug campaigns for deworming), zero reporting in 2018 (reasons unknown), and only a handful in 2020 and 2021 (since COVID-19). Of 566 ICSRs, 90% were for antiparasitics (actively reported during mass campaigns), while the rest (passive reporting from health facilities) included 8% antibiotics, 7% antivirals, and 0.2% antifungals. In total, 90% of the reports took >30 days to be entered (median = 165; range 2–420 days), while 44% had <75% of all variables filled in (desired target = 100%). There were 10 serious ADRs, 18 drug withdrawals, and 60% of ADRs affected the gastrointestinal system. The patient outcomes (N-566) were: recovered (59.5%), recovering (35.5%), not recovered (1.4%), death (0.2%), and unknown (3.4%). There was no final ascertainment of ‘recovering’ outcomes. Conclusions: ADR reporting is inconsistent, with delays and incomplete data. This is a wake-up call for introducing active reporting and setting performance targets.

【 授权许可】

Unknown