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Ann Pharm Fr ; 78(2): 158-166, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32037026

RESUMEN

OBJECTIVE: To date, few adapted pharmaceutical forms are available for infants leading to multiple steps of preparation and medicines dilution before administration. The main purpose of this study was to assess the risks on the steps of preparation and administration of medicines in a neonatal care unit and to propose corrective actions to ensure the medicines safety. METHODS: A global risk analysis was performed, conducted by a multidisciplinary working group of 9 experts, that is 9 meetings. RESULTS: We identified 57 scenarios: 59,6% of scenarios had an initial criticality C1, 31,6% C2 and 8,8% C3. The most risky phases were phases of needs identification including the step of doses calculation and phases of preparation. The strategic management together with the human factor were the most risky dangers. Nineteen corrective actions were proposed. After implementing those actions, 82,5% of scenarios had residual criticality C1, 17,5% C2 and no scenario had residual criticality C3. Follow-up actions have been implemented to control the residual risk as in service training. CONCLUSION: Neonatal unit care is a risky service and should be a priority in the risk management policy. This analysis joins the quality policy implemented in the hospital and similar risk analysis is on process.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Nutrición Enteral/efectos adversos , Alimentos Formulados/efectos adversos , Protocolos Clínicos , Composición de Medicamentos , Equipos y Suministros/efectos adversos , Implementación de Plan de Salud , Unidades Hospitalarias , Humanos , Lactante , Recién Nacido , Errores de Medicación , Seguridad del Paciente , Medición de Riesgo , Gestión de Riesgos
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