Starting and Strengthening a National Pharmacovigilance System

• Tác giả: Huihui Wang
• Ngôn ngữ: eng
• Ký hiệu phân loại: 615.11 Pharmacopoeias
• Thông tin xuất bản: World Bank, Washington, DC, 2023
• Bộ sưu tập: Tài liệu truy cập mở
• ID: 319146
• Chủ đề: 1. COVID-19 VACCINE; 2. EMERGING DISEASE CHALLENGE; 3. NATIONAL HEALTH SURVEILLANCE SYSTEM; 4. PHARMACOVIGILANCE CASE STUDY; 5. PUBLIC HEALTH RISK

Tóm tắt

The Spanish System of Pharmacovigilance (SSPV) started its activities almost 40 years ago, in 1985. Of particular interest to others considering various options for developing pharmacovigilance systems is the fact that this case study highlights an example that built from the ground up and actually started in academia: the SSPV began as a research project in a university institution in Catalonia that was later adopted by the Ministry of Health. From these origins, a regulatory framework gradually allowed this initiative to expand to the whole country. In 1990, after technical training for the professional staff involved, responsibility for coordinating the system was transferred to a specially created coordinating center for the SSPV located in the Spanish Medicines Agency. This report reviews the origins of the system and its key features, followed by two examples of the system in action and closing comments on aspects and lessons that may be of particular value to others developing pharmacovigilance systems elsewhere.