Bibliographic Details
| Title: |
CARACTERIZACIÓN DE LAS NOTAS DE SEGURIDAD DE PRODUCTOS FARMACÉUTICOS EMITIDAS POR DOS AUTORIDADES REGULADORAS DE AMÉRICA LATINA. |
| Alternate Title: |
CHARACTERIZATION OF THE SAFETY NOTES OF PHARMACEUTICAL PRODUCTS ISSUED BY TWO REGULATORY AUTHORITIES FROM LATIN AMERICA. |
| Authors: |
Pérez-Salazar, Katheryn1, Yataco-Camarena, Marilena1, Rodríguez-Tanta, L. Yesenia1,2 yesi.psb26@gmail.com |
| Source: |
Revista Peruana de Medicina Experimental y Salud Pública. 2026, Vol. 43 Issue 2, p231-237. 7p. |
| Abstract (English): |
Pharmaceutical product safety notes (PPSNs) are regulatory communications that disseminate updated information on the risks of pharmaceutical products (PPs). This study characterized the PPSNs issued by the Direccion General de Medicamentos, Insumos y Drogas (Peru) and the Instituto de Salud Publica de Chile (ISP) between 2014 and 2023. A retrospective analysis of PPSNs published on their websites was conducted. Those describing adverse drug reactions (ADRs) were included. Data were extracted on the type of ADRs, regulatory actions, sources of evidence, and reasons for issuance. Of 746 PPSNs identified, 153 met the criteria (100 Peru, 53 Chile), with a monthly average of 0.83 and 0.44, respectively. Differences in content and PPs were observed. Both agencies based their PPSNs mainly on alerts from the U.S. Food and Drug Administration. The most frequent action was the modification of the technical data sheet; the ISP additionally implemented monitoring and restrictions. In conclusion, PPSNs depend on external alerts, which evidences the need to strengthen local pharmacovigilance and evaluate their impact on the safety of PPs. [ABSTRACT FROM AUTHOR] |
| Abstract (Spanish): |
Las notas de seguridad de productos farmacéuticos (NSPF) son comunicaciones regulatorias que difunden información actualizada sobre riesgos de productos farmacéuticos (PF). Este estudio caracterizó las NSPF emitidas por la Dirección General de Medicamentos, Insumos y Drogas (Perú) y el Instituto de Salud Pública de Chile (ISP) entre 2014 y 2023. Se realizó un análisis retrospectivo de NSPF publicadas en sus sitios web. Se incluyeron aquellas que describían reacciones adversas a medicamentos (RAMs). Se extrajeron datos sobre tipo de RAMs, acciones regulatorias, fuentes de evidencia y razones de emisión. De 746 NSPF identificadas, 153 cumplieron criterios (100 Perú, 53 Chile), con un promedio mensual de 0,83 y 0,44, respectivamente. Se observaron diferencias en contenido y PF. Ambas agencias basaron sus NSPF principalmente en alertas de la U.S. Food and Drug Administration. La acción más frecuente fue la modificación de la ficha técnica; el ISP además, implementó monitoreo y restricciones. En conclusión, las NSPF dependen de alertas externas, lo que evidencia la necesidad de fortalecer la farmacovigilancia local y evaluar su impacto en la seguridad de los PF. [ABSTRACT FROM AUTHOR] |
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| Database: |
MedicLatina |
