K Zribi1, C L Seydoux2, Y Coatantiec3, V Chenet4, F Karnycheff5, K Sejean6, A Vivet7, A Migeon8, K Aboulghit9, J-M Ayoubi10, B Bonan11. 1. Pharmacy Department, Hôpital Foch, Suresnes, France 40, rue Worth, 92150 Suresnes, France; Faculty of Pharmacy, Monastir University, Monastir, Tunisia. Electronic address: kaouthar_z@yahoo.fr. 2. Pharmacy Department, Hôpital Foch, Suresnes, France 40, rue Worth, 92150 Suresnes, France. Electronic address: c.lepage@hopital-foch.org. 3. Neonatal Care Unit, Hôpital Foch 92150 Suresnes, France. Electronic address: y.coatantiec@hopital-foch.org. 4. Quality and Risk direction, Hôpital Foch 92150 Suresnes, France. Electronic address: v.chenet@hopital-foch.org. 5. Clinical Biology Department, Hôpital Foch 92150 Suresnes, France. Electronic address: f.karnycheff@hopital-foch.org. 6. Pharmacy Department, Hôpital Foch, Suresnes, France 40, rue Worth, 92150 Suresnes, France. Electronic address: k.sejean@hopital-foch.org. 7. Neonatal Care Unit, Hôpital Foch 92150 Suresnes, France. Electronic address: annevivet@yahoo.fr. 8. Clinical Biology Department, Hôpital Foch 92150 Suresnes, France. Electronic address: a.migeon@hopital-foch.org. 9. Neonatal Care Unit, Hôpital Foch 92150 Suresnes, France. Electronic address: k.aboulghit@hopital-foch.org. 10. Mother Child Department, Hôpital Foch 92150 Suresnes, France. Electronic address: jm.ayoubi@hopital-foch.org. 11. Pharmacy Department, Hôpital Foch, Suresnes, France 40, rue Worth, 92150 Suresnes, France. Electronic address: b.bonan@hopital-foch.org.
Abstract
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.
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.
Keywords:
Analyse globale des risques; Gestion des risques; Global risk analysis; Medication safety; Paediatrics; Pédiatrie; Risk management; Sécurité des médicaments