| アブストラクト | Background: The quality of pharmacovigilance data is important for guiding medicine safety and clinical practice. In baseline and follow-up studies after introducing interventions to improve the quality of reporting of Individual Case Safety Reports (ICSRs) in Sierra Leone, we compared (a) timeliness and completeness of reporting and (b) patient outcomes classified as 'recovering'. Methods: Baseline (January 2017-December 2021) and follow-up (June 2022-April 2023) studies of ICSRs in the national pharmacovigilance database. Interventions introduced following recommendations from the baseline study included: updating standard operating procedures and guidelines, setting performance targets follow-up of patient outcomes, and training. Results: There were 566 ICSRs in the baseline study and 59 in the follow-up study. Timelines (reporting < 30 days) improved by five-fold (10% at baseline to 47% in follow-up). For the completeness of variables in ICSRs (desired threshold >/= 90%),this was 44% at baseline and increased to 80% in the follow-up study. 'Recovering' outcomes reduced from 36% (baseline study) to 3% (follow-up study, p < 0.001). Conclusions: Significant improvements in timeliness, completeness, and validation of ICSRs were observed following operational research in Sierra Leone. While enhancing pharmacovigilance and patient safety, this study highlights the important synergistic role operational research can play in improving monitoring and evaluation systems. |
|---|
| ジャーナル名 | Tropical medicine and infectious disease |
|---|
| Pubmed追加日 | 2023/10/27 |
|---|
| 投稿者 | Conteh, Thomas A; Thomas, Fawzi; Abiri, Onome T; Komeh, James P; Kanu, Abdulai; Kanu, Joseph Sam; Fofanah, Bobson Derrick; Thekkur, Pruthu; Zachariah, Rony |
|---|
| 組織名 | National Pharmacovigilance Center, Pharmacy Board of Sierra Leone, Ministry of;Health, Freetown 047235, Sierra Leone.;College of Medicine & Allied Health Sciences, University of Sierra Leone,;Freetown 047235, Sierra Leone.;National Disease Surveillance Program, Directorate of Health Security and;Emergencies, Ministry of Health and Sanitation, Freetown 047235, Sierra Leone.;World Health Organization, Country Office, Freetown 047235, Sierra Leone.;Centre for Operational Research, International Union against Tuberculosis and;Lung Disease, 75001 Paris, France.;UNICEF, UNDP, World Bank, WHO Special Programme for Research and Training in;Tropical Diseases (TDR), 1211 Geneva, Switzerland. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37888598/ |
|---|
