Pharmacy Department, Hôpital Foch, Suresnes, France 40, rue Worth, 92150 Suresnes, France; Faculty of Pharmacy, Monastir University, Monastir, Tunisia.
Pharmacy Department, Hôpital Foch, Suresnes, France 40, rue Worth, 92150 Suresnes, France.
Ann Pharm Fr. 2020 Mar;78(2):158-166. doi: 10.1016/j.pharma.2019.12.005. Epub 2019 Dec 13.
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.
A global risk analysis was performed, conducted by a multidisciplinary working group of 9 experts, that is 9 meetings.
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.
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.
迄今为止，可供婴儿使用的已调整剂型药物很少，这导致在给药前需要进行多次准备步骤和药物稀释。本研究的主要目的是评估新生儿护理单元中药物准备和给药步骤的风险，并提出纠正措施以确保药物安全。
由 9 名专家组成的多学科工作组进行了全面的风险分析，共进行了 9 次会议。
我们确定了 57 个场景：59.6%的场景初始关键度为 C1，31.6%为 C2，8.8%为 C3。风险最高的阶段是需求识别阶段，包括剂量计算步骤和准备阶段。战略管理和人为因素是最危险的危险。提出了 19 项纠正措施。实施这些措施后，82.5%的场景残余关键度为 C1，17.5%为 C2，没有场景残余关键度为 C3。已实施后续行动以控制服务培训中的剩余风险。
新生儿单元护理是一项高风险服务，应成为风险管理政策的重点。该分析符合医院实施的质量政策，类似的风险分析正在进行中。
