RESUMO
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.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Nutrição Enteral/efeitos adversos , Alimentos Formulados/efeitos adversos , Protocolos Clínicos , Composição de Medicamentos , Equipamentos e Provisões/efeitos adversos , Implementação de Plano de Saúde , Unidades Hospitalares , Humanos , Lactente , Recém-Nascido , Erros de Medicação , Segurança do Paciente , Medição de Risco , Gestão de RiscosRESUMO
INTRODUCTION: Urinary catheterization and acute urinary retention increase the risk of urinary tract infection (UTI). Our study aimed to investigate the incidence of UTI following acute stroke at our stroke center (SC) and to assess urinary catheter-care practices among French SCs. METHODS: Stroke patients hospitalized within 24h of stroke onset were prospectively enrolled between May and September 2013. Neurological deficit level was assessed on admission using the US National Institutes of Health Stroke Scale (NIHSS). Patients were followed-up until discharge. Indwelling urinary catheterization (IUC) was the only technique authorized during the study. An electronic survey was also conducted among French SCs to assess their practices regarding urinary catheterization in acute stroke patients. RESULTS: A total of 212 patients were included, with 45 (21.2%) receiving indwelling urinary catheters. The overall estimated incidence of UTI was 14.2%, and 18% among patients receiving IUC. On univariate analysis, IUC was significantly associated with older age, longer hospital stays and higher NIHSS scores. Of the 30 SCs that responded to our survey, 19 (63.3%) declared using IUC when urinary catheterization was needed. The main argument given to justify its use was that it was departmental policy to adopt this technique. Also, 27 participants (90%) stated that conducting a study to assess the impact of urinary catheterization techniques on UTI rates in acute stroke patients would be relevant. DISCUSSION: Our results are in accord with previously reported data and confirm the high burden of UTI among acute stroke subjects. However, no association was found between IUC and UTI on univariate analysis due to a lack of statistical power. Also, our survey showed high heterogeneity in catheter-use practices among French SCs, but offered no data to help determine the best urinary catheterization technique. CONCLUSION: Urinary catheterization is common after acute stroke and a well-known risk factor of UTI. However, as high heterogeneity in catheter-use practices is found among French SCs, randomized studies comparing the efficacy of urinary catheterization techniques in terms of UTI prevention in acute stroke patients are now warranted.