Pharmacovigilance Concept Overview

Definition and Importance of Pharmacovigilance

• Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems.
• PV is crucial to prevent drug-related adverse effects in humans, ensure patient safety, and promote the rational use of drugs.

Current Status of Pharmacovigilance

• PV is well established in most industrialized countries, but its practice in low and middle-income countries is variable.
• Some countries have no PV systems, while a few have systems comparable to those in industrialized countries.

WHO's Initiative for Pharmacovigilance

• The World Health Organisation (WHO) has embarked on a consultative process to produce a Pharmacovigilance Strategy for all countries.
• The strategy aims to advance PV systems through the Global Fund and similar health initiatives.

Minimum Requirements for Pharmacovigilance

• The minimum requirements for a national PV system include guaranteed funding and a focus on patient safety.
• The requirements were developed through a consultative process involving experts and stakeholders.

Functions of a National Pharmacovigilance System

• The functions of a national PV system include: • Promoting PV and collecting/managing ADR reports, medication errors, and suspected counterfeit/substandard drugs. • Identifying signals of medicine safety and unknown or poorly characterized adverse events. • Assessing risk and options for risk management. • Identifying quality problems in medicines resulting in ADRs. • Providing effective communication on medicine safety. • Applying pharmacovigilance information for public health programmes, patients, and national medicines policies. • Developing and maintaining drug utilization information. • Identifying issues associated with unregulated prescribing and dispensing of medicines.