Table 2 Pharmacovigilance policy implementation situation in Jordan, Oman, and Kuwait. Adapted from Alshammari et al. [21]
Jordan | Oman | Kuwait | |
|---|---|---|---|
Organization overseeing pharmacovigilance | Jordan Food and Drug Administration (JFDA) | Oman Ministry of Health’s Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) | Kuwait Ministry of Health’s Drug and Food Control Administration (KDFCA) |
Pharmacovigilance system structure | National & Regional Centres | National Centre with Regional Centre Network | National Centre (Unofficial) |
Pharmacovigilance centre, department, or unit name | Department of Rational Drug Use and Pharmacovigilance | Department of Pharmacovigilance and Drug Information | Drug Registration Department’s Quality Assurance Unit (Unofficial) |
National pharmacovigilance system establishment year | 2001 | 1992 | 2008 |
Year joined WHO Program for International Drug Monitoring as full member | 2001 | 1995 | 2021 |
Pharmacovigilance guidance or legislation | Law titled “The Pharmacovigilance Directives” | Guidelines titled “Guideline on Good Pharmacovigilance Practices in Oman” | A memo issued by KDFCA to companies |
Dedicated budget | No | No | No |
Number of staff members | 5 full-time employees | 5 full-time employees | 5 full-time employees, plus one part-time employee |
National adverse drug reaction (ADR) or pharmacovigilance advisory committee | Health Hazard Evaluation Committee | No | No |
Standard adverse drug reaction reporting form present | Yes | Yes | Yes |
Product types covered | Pharmaceuticals, herbal medicines, cosmetics, biologicals, medical devices | Pharmaceuticals, herbal medicines, biologicals | Pharmaceuticals, herbal medicines, biologicals, medical devices |
Type of drug-related problems covered | Suspected ADRs, lack of efficacy, quality defects, drug abuse/misuse, medication errors | Suspected ADRs, lack of efficacy, quality defects, medication errors, counterfeit | Suspected ADRs, lack of efficacy, quality defects, medication errors, drug abuse/misuse, counterfeit |
Computerized case-report management system | Yes | Yes | No |
Qualified Person for Pharmacovigilance (QPPV) Requirement | Yes | Yes | No |
Submission of regular Periodic Safety Update Reports (PSUR)/Periodic Benefit-Risk Evaluation Reports (PBRER) | Originator and generic products | Originator products only | Originator and generic products |
Submission of Risk Management Plans (RMPs) | Yes | Yes | Yes |