[The Portuguese Pharmacovigilance System]

Area of Science:

• Pharmacovigilance and Drug Safety
• Public Health Policy
• Pharmacoepidemiology

Background:

• Established in 1992, Portugal's National Pharmacovigilance System (NPS) initially centralized operations.
• Recognized the need for geographic decentralization to improve accessibility for health professionals and university involvement.
• The NPS has operated for 20 years, adapting to European Union (EU) pharmacovigilance requirements.

Purpose of the Study:

• To reflect on the 20-year evolution of the National Pharmacovigilance System in Portugal.
• To highlight the system's increasing importance in safeguarding public health.
• To discuss the adaptation of the NPS to new European pharmacovigilance legislation.

Main Methods:

• Decentralization of the pharmacovigilance system into four regional centers.
• Conducting pharmacoepidemiological studies focused on drug safety.
• Collection, processing, and evaluation of spontaneous adverse drug reaction (ADR) reports.
• Ongoing dissemination of pharmacovigilance information and promotion of reporting.

Main Results:

• The NPS has become a mature and well-implemented system focused on evaluating drug safety profiles.
• Regional centers facilitate closer engagement with healthcare professionals and universities.
• The system effectively monitors and evaluates adverse drug reactions, contributing to risk reduction strategies.
• Adaptation to EU legislation enhances the system's capabilities, including potential for consumer ADR reporting.

Conclusions:

• The evolution and decentralization of the NPS have strengthened its role in drug safety and public health protection.
• The system's continuous adaptation to EU regulations ensures its effectiveness and relevance.
• Future adaptations, including direct consumer reporting, will further enhance pharmacovigilance in Portugal.