Pharmacovigilance Electronic Reporting System (PvERS) in Kenya

Modern medicines and vaccines have had an indisputable contribution to improved global health which is portrayed by reduced childhood mortality from infectious diseases, eradication of deadly diseases like smallpox, and an increased lifespan across the world. Their benefits notwithstanding, vaccines and medicines have side effects that may be undesirable or unexpected and which led to the rise of pharmacovigilance in the 19th century. Through pharmacovigilance, the adverse effects of medicines and vaccines are detected, assessed, reported, and prevented during development, clinical trials, and after they are authorized for use. Clinical trials for drugs and vaccines are carried out in limited populations that do not accurately represent the entire population for whom the treatment is intended. Studies indicate that persons with different genetic makeup react differently to drugs which makes post-market surveillance a pivotal pillar in drug safety.

A regional study in sub-Saharan Africa revealed a 19% prevalence of substandard and fake medicines with a market size of up to USD 200 billion. These substandard drugs, often intended for unsuspecting marginalized communities with weak pharmaceutical regulation,  are associated with severe adverse drug reactions (ADRs). The rise in self-medication and online unregulated pharmacies has increased the number of patients getting treatment without medical guidance, heightening the incidence of ADRs. The detection, reporting, and followup of ADRs are critical in guiding medicine safety policies and instituting measures to reduce their incidence.

The pharmacovigilance reporting tools in Kenya, initially known as the Suspected Adverse Drug Reaction form and the Poor Quality Medicinal Products form, were originally available only as hard copies or downloadable PDF copies from the Pharmacy & Poisons Board (PPB) website. In 2012, an initiative to transform the Kenya paper-based pharmacovigilance data system IntelliSOFT Consulting Limited was contracted to develop the first version of the Pharmacovigilance Electronic Reporting System (PvERS). The system went live in the year 2013 and supported the reporting of suspected ADRs and Poor quality medical products. The digital health technology application was built to be easily accessible via mobile devices,  desktop computers, and the Web. This application was recognized by the World Health Organization (WHO) Uppsala Monitoring Center (UMC) as the first Vigiflow-compatible e-reporting system in Africa.

With new global technological developments, the stakeholders of the PvERS system kickstarted a new project in 2021 to implement significant structural and functional upgrades to the system necessitated by advancements in the business practices of pharmacovigilance and significant evolution in technology to improve the functionality and performance of the system. IntelliSOFT Consulting was again contracted to upgrade the PvERS system to:

1. Support reporting of Adverse events following immunization (AEFI).
2. Link PvERS system with the Clinical Trials Registry.
3. Improve data use and reporting by automating and updating the following forms: Adverse Transfusion Reaction Form, Medical Devices Incident Reporting Form, Medication Error Reporting Form, Suspected Poor-quality Medical Products And Health Technologies Form, Public Adverse Drug Reaction Reporting Form.
4. Integrate the PvERS application with Kenya Health Information System to support aggregate data reporting on safety reports.
5. Improve user management and system security through authentication.
6. Increase the system’s capacity to accommodate more user types like the general public.

The upgraded system was launched in 2021 and ICL continues to offer maintenance and support services to PPB to ensure consistent optimal performance and meaningful use of the system. The Pharmacovigilance Electronic Reporting Tool application is recognized as a Digital Public Good. The application was thoroughly vetted by a peer review committee that comprises digital health experts with representation in country governments, donors,  implementing partners, and technology vendors. The app is part of other global goods that have the potential to address global challenges and gain more visibility on a worldwide scale.

PvERs has advanced reporting and integration capabilities and was the first Vigiflow-compatible e-reporting system in Africa, and is now integrated with the Vigilance Hub. It is built upon the international ICH E2B standard—and uses the international Medical Dictionary for Regulatory Activities (MedDRA) terminology—for efficient data exchange between pharmaceutical companies and regulatory agencies using XML files. It supports the setup of a decentralized system for data collection and allows consumer reporting via an electronic form for the general public and healthcare professionals to report adverse events on medicines or vaccines (eReporting).