Scope of Pharmacovigilance in Nigeria :- Pharmacovigilance can be defined as the science and procedures pertaining to the finding, estimation, understanding and prevention of adverse side effects or any other drug-related effect. It is a methodical way of persistent monitoring for unwanted side effects and other safety-related issues of drugs that are already available in the market.
Adverse Drug Reaction (ADR) is a response to a medicine which is harmful and unintended, and which occurs at doses usually used in man for the prevention, diagnosis or treatment of disease or the change of physiological functions.
A Serious Adverse Event (Experience) or Reaction is any untoward medical incidence that at any dose results in death, is life-threatening, requires patient hospitalization, or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, causes a congenital anomaly or birth defect, and requires an intervention to prevent permanent impairment or damage.
An Adverse Drug Reaction (ADR) Case Report is a notification relating to a patient with an adverse medical event or laboratory test abnormality suspected to be induced by a medicine.
Structure of National Pharmacovigilance Centre
The present structure of the National Pharmacovigilance Centre in Nigeria consists of the Pharmacovigilance unit of NAFDAC and the National Drug Safety Advisory Committee whose members also two times as Zonal Pharmacovigilance Coordinators. There are also present across the country, pockets of pharmacovigilance centers keenly operating in health care units.
Pharmacovigilance activities in Nigeria engross scrutinizing the following: Drugs; Herbal, complimentary and traditional medicines; Vaccines and Biological products; Blood products; Medical devices; Cosmetics and Chemicals.
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