Table 4 Comparison of pharmacovigilance priorities between state and exogenous actors
From: Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
PPB | County | Generic pharma | Multinational corporation | INGO (non-state) | IGO (external actors) |
|---|---|---|---|---|---|
• Drug safety in addition to availability • Increase ADR reporting (public & health workers) • Poor quality medicines reporting • Active surveillance • Ensure quality of products in the market • Harmonization of PV system • Pharmaco-surveillance of commonly used drugs and drugs used in public programs (e.g., TB, and malaria). • Increase awareness of PV • Capacity building • PV Legislation (No explicit PV laws) • Kenya as a leader in patient safety-a Centre of Excellence • Facilitate ease of reporting • Take action on ADR reports • Introduce industry reporting | • Drug safety in addition to access • Detect and report ADRs • Detect and report poor quality medicines • Monitoring quality of medicines • Strengthen PV systems • Pharmaco-surveillance of drugs targeted by public programs (TB, family planning, and malaria; high morbidity, commonly used) • Quality testing of drugs entering through ports • Health facilities know proper storage conditions for medicines | • Substandard, fake, and counterfeit drugs | • Harmonization of reporting requirements • Training for all employees to increase awareness of PV • PV as a clearly defined role • Maintain compliance with national PV requirements • Spontaneous reporting only- no mandatory reporting | • Drug safety in addition to access • PV Systems strengthening • Capacity building to improve the quantity and quality of ADR reports • PV Legislation (e.g., qualified PV personnel in each drug company) • Synchronize priority areas with PPB and other IGO/INGOs • Systems surveillance approach to PV • Establish PV systems • Adoption of a National Pharmacovigilance Policy | • Increase policy makers and donors awareness of the connection between access and PV Health systems strengthening • Active surveillance • Ensure quality of products procured • Harmonization of PV systems and reporting tools, nationally • Capacity building to improve the quantity and quality of information that supports decision making. • Negotiate with government to achieve an appropriate legal framework for PV • Support for pharmaceutical policies and laws • All countries have PV systems. • Global populations are covered by PV activities. • Participation in UMC is expanded to increase the chance of finding rare adverse reactions • Redefine the focus of PV to include old issues with older drugs (Evergreening) |