Chimezie Anyakora and Ofure Odibeli
Despite the enormous benefits of medicines and vaccines in transforming the prevention and treatment of diseases, medicinal products may also have side effects, some of which may be undesirable and/or unexpected.
Adverse Drug Reactions (ADRs) are common and often preventable causes of illness, disability, and even death. In some countries, ADRs rank among the top 10 leading causes of mortality. This is of particular importance in low-and-middle-income countries (LMICs), like those in Africa where rigorous monitoring of medicines is often lacking, leading to a growing burden of poor quality medicines.
Hence, to prevent or reduce harm to patients, and thus improve public health, there is a critical need to strengthen mechanisms for evaluating and monitoring the safety of medicines in clinical use. Drug safety and pharmacovigilance (PV) therefore remain an inseparable, dynamic clinical and scientific discipline, as PV plays an essential role in ensuring that doctors, together with the patients, have enough information to make crucial decisions in choosing a drug for treatment.
Harmonization of regulatory systems will ensure that weak or non-existent pharmacovigilance systems draw from the more established ones
What is pharmacovigilance and why is it important?
According to the World Health Organisation, Pharmacovigilance (PV) is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” PV ensures safe use of medicines throughout the life cycle of the products by detecting problems related to the use of medicines and communicating the findings in a timely manner.
The clinical trial process, although rigorous, involves studying medicines in a relatively small number of selected individuals for a short period of time. However, certain side effects may only emerge once these products have been used by a heterogeneous population, including people with other concurrent diseases such as the elderly, and over a long period of time.
The true picture of a product’s safety actually evolves over the months and even years that make up a product’s lifetime in the marketplace. Therefore, post market surveillance (which is a crucial part of pharmacovigilance) is the only way to get an accurate picture of a drug’s safety and ensure adverse events are properly reported for review.
The COVID-19 pandemic highlighted how relevant pharmacovigilance is during public health emergencies. The pandemic was characterised by a frantic need to access medical treatment and products, leading to accelerated approval of drugs and vaccines, unverified and unqualified claims of some remedies, and a surge in the influx of poor quality medicines, particularly in Africa.
Challenges and strategies to strengthen pharmacovigilance systems in Africa
One critical challenge limiting the development of pharmacovigilance in Africa is the poor availability of trained personnel with adequate knowledge and skills to actively participate in pharmacovigilance programmes. The overall knowledge of pharmacists and other healthcare professional on pharmacovigilance is still below average in Africa.
To address this challenge, Bloom Public Health strongly proposes to establish a pharmaceutical training academy that will deliver training to new graduates in Sub-Saharan Africa. Amongst other relevant training areas, the Academy will provide in-depth training on Good Pharmacovigilance Practice (GPvP), covering topics such as, drug safety, global regulatory requirements, audit, risk assessment, ADR reporting, device safety and vigilance, amongst others.
The Academy will provide a sustainable supply of highly skilled pharmacovigilance personnel for Africa’s public health sector. Bloom Public Health is actively working to engage relevant stakeholders and deploy strategic partnerships to achieve the establishment of this academy.
Another major challenge is poor record keeping and documentation of medicine related events, especially ADRs. Some reasons for under-reporting include fear of litigation, poor understanding of the subject matter, feeling that the “known” ADRs do not need not be reported, time constraints and cumbersome reporting processes, and lack of appropriate structures and processes at the institutional level.
It is therefore imperative to inculcate a more articulate approach to routine data gathering and documentation into the healthcare system. African governments should decentralise the activities of National Pharmacovigilance Centres (NPCs) by creating zonal centres as an effective way of enhancing pharmacovigilance activities. This will aid distribution of ADR forms and collection of the Individual Case Safety Reports (ICSRs) from reporters, transmission of acknowledgements and feedback information to the reporters, and dissemination of information from national centres to patients and healthcare workers.
Also, targeted pharmacovigilance awareness campaigns should leverage public health programmes (e.g. HIV, malaria, tuberculosis) to promote the reporting of medicine-related harm.
Poor budgeting and funding for pharmacovigilance also limits the progress on pharmacovigilance in sub-Saharan Africa. Most national governments provide little or no budgetary support for pharmacovigilance activities, relying heavily on donor funding. However, political will is necessary to enable establishment of sustainable budgets to recruit full-time pharmacovigilance staff, conduct routine pharmacovigilance trainings, and develop national pharmacovigilance policies.
In addition, Africa should accelerate regional regulatory harmonization to foster collaboration and reliance. Harmonization of regulatory systems will ensure that weak or non-existent pharmacovigilance systems draw from the more established ones.
Although Africa has made considerable progress in pharmacovigilance over the last two decades, more still needs to be done. Governments and relevant stakeholders at national and regional levels must therefore collaborate to strengthen pharmacovigilance in Africa, and, so ultimately, improve the health of the population.
Anyakora is the CEO of Bloom Public Health and a public health expert &
Odibeli is a pharmacist and the regional communications manager at Bloom Public Health