Abstract

PHARMACOVIGILANCE FRAMEWORK AND EXTENT OF MEDICATIONS ADVERSE REACTION SURVEILLANCE IN SOUTHERN NIGERIA

Oyeintonbara Miediegha and Samuel J. Bunu*

Abstract

An adverse drug reaction (ADR) monitoring and surveillance program is a helpful step toward increasing ADR detection, evaluation, and reporting, as well as in developing mechanisms to prevent ADRs and associated morbidity, mortality, and costs. Because time and insufficient staffing have been identified as barriers to ADR reporting, the design of an ADR surveillance program should focus on ways to overcome these barriers. A critical challenge to pharmacovigilance is the issue of ADRs under-reporting in different parts of the world. Previous studies point to widespread ADRs underreporting in Nigeria. But no known study in Bayelsa state. The aim of the study was to determine the existence of a pharmacovigilance framework and ascertain the extent, as well as, factors responsible for ADRs underreporting in Bayelsa State. The target study populations were Pharmacists, Doctors, Nurses, and Patients of government and private hospitals, community pharmacies. A questionnaire was administered and retrieved using a randomized sampling method among 400 participants. This study reveals that adverse drug reactions are largely under-reported due to several reasons such as lack of incentives, resources and equipment, lack of dedicated trained staff to participate in reporting ADRs, workload lack of insurance coverage and patients' non-compliance. There is appreciable knowledge of what constitutes adverse drug reaction and Pharmacovigilance but there is no effective Pharmacovigilance framework in Bayelsa State.

Keywords: Pharmacovigilance, Surveillance, Adverse Drug Reaction, Bayelsa.