Table 3.
Analysis of core Pharmacovigilance structural indicators at the national regulatory authority of Ethiopia, Addis Ababa, Ethiopia, 2020.
| S.N | Core structural indicators | Yes | No | Remark |
|---|---|---|---|---|
| 1 | Availability of statutory provision for PV | √ | Incorporated within the Proclamation | |
| 2 | Presence of PV center or unit | √ | Organized as a separate directorate | |
| 3 | Availability of regular financial provision for the PVC | √ | Considered with other budget plans of the authority | |
| 4 | Presence of human resources to carry out PV functions | √ | A mix of professionals in medicine, medical device, food, and laboratory | |
| 5 | Presence of SOP for PV | √ | SOP for receiving and processing ICSRs | |
| 6 | Presence of national ADRs database | √ | Directly adapted from WHO | |
| 7 | Digitalization of ADR database | √ | Shared with WHO | |
| 8 | ADR reports sent to the WHO database | √ | For reports with completed data | |
| 9 | Presence of publication of ADR bulletin (newsletter) by PV center | √ | Newsletter published every 4 months (quarterly) | |
| 10 | Availability of clear communication tools | √ | Fax, E-mail, website, Toll-free line (8482) | |
| 11 | Presence of standard ADR reporting tool | √ | Manual and electronic yellow form, mobile application (Med-safety) | |
| 11a: Presence of relevant fields in the standard ADR form to report suspected medication errors | √ | |||
| 11b: Presence of relevant fields in the standard ADR form to report suspected counterfeit/ substandard medicines | √ | |||
| 11c: Presence of relevant fields in the standard ADR form to report therapeutic ineffectiveness | √ | |||
| 11d: Presence of relevant fields in the standard ADR form to report suspected misuse, abuse and/or dependence on medicines | √ | |||
| 11e: Availability of standard ADR reporting form for the general public | √ | |||
| 12 | Presence of mechanism in place for collection, recording, and analysis of ADR reports | √ | ||
| 13 | Presence of tools for PV information dissemination | √ | PV Newsletter, website, email, phone | |
| 14 | Availability of PV advisory committee or an expert committee in the setting | √ | Transformed the Adverse Event Following Immunizations committee to a general safety advisory committee |