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[Something more about adverse reactions to medications]
A Sáenz Calvo1, M Ausejo Segura, I Bórdas Rodríguez
1Centro de Salud Gómes, Acebo, INSALUD, Area/Sector xi di Madrid.
Atencion Primaria
|May 15, 1995
Summary
Adverse drug effects (ADE) were studied in primary care patients, revealing specific frequencies and patient demographics. Primary care settings are valuable for pharmacosurveillance research.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Primary Care Medicine
Context:
- A descriptive, longitudinal study conducted in 1990 at an urban health center in Madrid, Spain.
- Involved 15,483 patients, nine general practitioners, and one pharmacist.
- Physicians documented adverse drug effects (ADE) observed in patients, reporting details on medications, clinical manifestations, and outcomes.
Purpose:
- To characterize the incidence and nature of adverse drug effects (ADE) within a primary care population.
- To identify patient demographics and drug classes most frequently associated with ADE.
- To assess the utility of primary care settings for pharmacosurveillance.
Summary:
- A total of 326 adverse drug effects (ADE) were reported, translating to 30.9 ADE per 1,000 patients.
- 117 active pharmaceutical ingredients were implicated, with 415 clinical manifestations recorded.
- Women and specific age groups (infants under one year, elderly) exhibited higher relative frequencies of ADE.
Impact:
- Highlights discrepancies between absolute and relative frequencies of ADE when considering prescription units.
- Identifies novel ADE not previously documented in existing literature.
- Underscores the significant role of primary care in ongoing pharmacosurveillance and drug safety research.
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