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Pharmacovigilance System in Sub-Saharan Africa


Pharmacovigilance System in Sub-Saharan Africa

A comprehensive system can address the need for passive and active identification approaches to medicines-related problems, communicate effectively safety information of medicine to the public, collaborate among various organizations and partners to incorporate pharmacovigilance activities at all health levels.

Pharmacovigilance System

The pharmacovigilance system efficiently identifies, collects, assesses and communicates medicine-related adverse events to the public in a timely manner. Pharmacovigilance system monitors and evaluates information received fromhealthcare professionals like pharmacists, nurses, doctors and dentists for better understanding of adverse drug reaction.A comprehensive system includes passive and active methods of surveillance, communicates effectively safety information of medicine to public through healthcare professionals, collaborates among wide range of partners and incorporates various health activities. Five components vital for smooth functioning of pharmacovigilance system include coordination among system, structure, and stakeholders; policy, law and regulation; risk assessment and evaluation; signal generation and data management; risk management and communication.
Adverse drug events profoundly impact the health system, morbidity and mortality rate. The cost of managing such events and other associated expenses results in economic loss to the pharmaceutical industry, loss of confidence in the health system due to non-adherence to treatment regime and development of drug resistance. The dynamic and scientific discipline of pharmacovigilance plays a crucial role in meeting different challenges of potent medicines. Strengthening the pharmacovigilance system to build capacity within developing countries and effectively manage various aspects of pharmaceutical services is essential. A well-structured and effective system establishes safety data in a precise manner for a stable and harmonised healthcare environment with perfect execution plans and tangible benefits.

Scope of Pharmacovigilance in Sub-Saharan Africa

Burden of adverse events or reactions, poor product quality and medication errors challenge the healthcare system in Sub-Saharan Africa. Shortages in basic infrastructure and equipment; lack of trained and skilled personnel; substandard and counterfeit medicines are problems faced in Sub-Saharan African countries. The pharmacovigilance system should include all challenging entities and resources impacted to protect the public from medicine-related harm. This system through timely identification and efficient assessment of adverse events aims to protect and communicate risks or benefits that support decision making process of the healthcare system. Safety monitoring is essential to ensure the availability of effective medicines and high-quality healthcare services.
International programs are designed to mitigate the effects of medication errors and spread of diseases like malaria and AIDs; pharmacovigilance indifference of pharmaceutical industry; disinterest of government officials and health professionals in regulations pertaining to safety reporting; and other activities in Sub-Saharan African countries. Greater efforts are being made to build pharmacovigilance system linked to existing activities and create a comprehensive system. Sub-Saharan African countries are required to develop strategic plans to incorporate active and passive approaches to coordinate among all stakeholders, strengthen risk management and communication to enhance the impact of pharmacovigilance in medicine safety systems. The implementation of these strategic plans should meet the specific needs of the country and ensure sustainability of pharmacovigilance systems. These successful implemented plans will improve health outcomes and patient safety.

Online Pharmacovigilance Course at JLI

James Lind Institute (JLI) provides an online program – Advanced PG Diploma in Clinical Research & Pharmacovigilance to better understand pharmacovigilance systems.
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