Building Medicine Safety Monitoring Systems that Safeguard People’s Health

A critical aspect of introducing a new medicine or vaccine in a country is monitoring for potential adverse events. Besides negatively affecting a patient’s health and quality of life, unreported and unaddressed adverse events can strain and undermine trust in the health system.

The practice, known as pharmacovigilance, requires robust systems and expertise that many low- and middle-income countries lack.

These countries are also more likely to have substandard and falsified products on their markets and to experience challenges with their supply chain infrastructure, which may contribute to even more adverse events for products that require a cold chain.

Luckily, an effective pharmacovigilance system is not medicine- or vaccine-specific. The same processes, infrastructure, skills, and tools can be used to measure the safety of new medicines for drug-resistant tuberculosis, new combination treatments for HIV, and vaccines for diseases such as dengue, Ebola, and COVID-19.

Targeted Technical Assistance in Cameroon, Mozambique, and Senegal

Last year, in partnership with the Global Fund, MSH launched a project in Cameroon, Mozambique, and Senegal to improve those countries’ pharmacovigilance systems, with the overall objective of facilitating the introduction of innovative health products for better HIV, TB, malaria, and other health services.

The project involves the countries joining a WHO network called the Coalition of Interested Parties (CIP), which seeks to establish and promote a unified, strategic, and coordinated approach to national and regional regulatory systems strengthening efforts.

Through participation in the CIP and with support from MSH, countries have formulated plans to strengthen their pharmacovigilance systems based on the findings of a benchmarking assessment. MSH is working with national regulatory authorities in the selected countries to address the identified gaps and achieve their plans’ defined objectives, which include improving human resources capacity, regulatory processes, and information and quality management systems. The last step in the project includes monitoring progress toward defined milestones, with the goal of ensuring these countries’ pharmacovigilance systems achieve “maturity level 3,” which WHO defines as a stable and functioning regulatory system.

Building on Past Successes

MSH has a long history of helping countries improve pharmacovigilance systems. With funding from USAID through the MTaPS program, MSH provided technical assistance to establish or strengthen pharmacovigilance systems in seven countries (Bangladesh, Burkina Faso, Mozambique, Nepal, Rwanda, Tanzania, and the Philippines) and three regional economic communities (EAC, ECOWAS, and IGAD). The work involved, for example, helping national regulatory authorities develop protocols for monitoring cohorts of patients exposed to medicines or vaccines, providing supportive supervision, and training health care providers and regulators to collect and analyze data to inform local clinical and regulatory decisions.

MSH also helped Mozambique, Rwanda, and the Philippines introduce an electronic tool to capture and analyze data on adverse events. Rwanda is using the tool to monitor outcomes from the administration of the new Ebola vaccine, including watching for miscarriages and stillbirths among women who become pregnant following vaccination.

MSH is also supporting the distribution of COVID-19 vaccines in Ukraine and Jordan while building their monitoring infrastructures. New technologies, including mobile phone applications for real-time reporting of adverse events—such as that deployed in Kenya with support from MSH—helped community health workers in low- and middle-income countries report suspected COVID-19 cases early in the pandemic.

Efforts like these require a great deal of time, coordination, funding, and political will to start and sustain. Competing priorities might make such investments seem dispensable, but an accurate, comprehensive pharmacovigilance system should be front and center in any new medicine or vaccine rollout plan. Combining expertise from other programs and building on our past efforts and lessons is the best way to build sustainable and strong pharmacovigilance systems that safeguard people from harm.