Failure mode and effect analysis applied to improve the medication management process in a pharmacy of a teaching hospital and a proposal for a simplified rating system.

BACKGROUND: Healthcare is not as safe as it should be and medication error remains a significant source of preventable morbidity and mortality among patients. OBJECTIVES: To present a failure mode and effect analysis (FMEA) of the medication management process in the pharmacy of the largest teaching hospital in Tunisia. Secondly, to examine the validity of a proposed simplified risk rating method by comparing the degree of concordance with the FMEA rating system in classifying failure modes related to the studied process. METHODS: The FMEA method was applied to the medication management process in the pharmacy for 5 months from January 2020. For the traditional FMEA rating system, failure modes were prioritised according to the risk priority number, which considers severity, occurrence and non-detectability. Failure modes were classified for the traditional method considering three categories: accepted, requiring control and critical. The proposed rating system was based on two indices: the number of parts, which reflected severity, and the number of causes according to the 5M method (manpower, machines, material, methods and medium), which reflected occurrence. Failure modes were classified for the proposed method considering three categories: low, medium and high. Failure modes were independently analysed to determine the degree of agreement in ranking of risk between the two studied methods. Prioritised failure modes were targeted by decisions and solutions aiming to reduce risk and enhance safety. RESULTS: Twenty-four failure modes were identified for the six-step process of medication management in a pharmacy (overall criticality=2607). The most critical failure modes were: data error in drugs reception (risk priority number (RPN)=432), break in the cold chain (RPN=320) and non-optimal pharmaceutical analysis (RPN=280). A good agreement was found between the classic FMEA and the proposed rating methods (κ=0.795). A high correlation was shown between the two scorings (r=0.785). Three failure modes were underestimated by the proposed rating method. CONCLUSIONS: An FMEA study on the medication management process in a teaching pharmacy showed that FMEA is an effective, proactive risk assessment that enables a better understanding of the studied process. The proposed risk scoring permits a good concordance with the classic method, with the advantage of being fast. Targeting the identified risks will allow integration into a continuous process of improvement and increase patient safety.

Evaluation of anticoagulant therapy management in a teaching hospital in Tunisia: information and education for vitamin k antagonist newly treated patients need to be improved.

OBJECTIVE: The objective of this study was to assess the level of Vitamin K antagonist (VKA) therapy knowledge among VKA newly treated patients. METHODS: Questionnaire-based interviews were administered in a university hospital to VKA newly treated patients covering both cognitive (i.e. indication, route of administration, treatment monitoring and side effects) and know-how (i.e. safety precautions, what affects anticoagulant therapy and the management of overdose signs) aspects of therapy knowledge. KEY FINDINGS: A total of 55 patients were included. The mean overall score of patients' knowledge was 5.78 (SD = 3.425) out of 20. The mean scores of cognitive and practical knowledge were 3.8 (2.26) and 1.98 (1.78) out of 10, respectively. Factors associated with an insufficient level of VKA therapy knowledge included low level of education, lack of access to therapy information and continuous access to this information. CONCLUSIONS: Knowledge about VKA therapy among newly treated patients is insufficient. Patient's medication knowledge should be improved to ensure better adherence.

Prevalence and risk factors of pressure ulcers in a Tunisian hospital.

BACKGROUND: the aim of thisstudywas to investigate the prevalence of pressure ulcers in hospitalized patients at the Charles Nicolle Hospital in Tunis, measure the risk of their occurrence, analyzepreventive and curative measuresundertaken and evaluatefactorspredisposing to pressure ulcers. METHODS: A one-day survey was performed in all hospitalized patients. Emergency services, neonatology and pediatrics were excluded. The Braden scale was used to measure the patient's risk for the development of pressure ulcers. Analysis of risk factors was performed using SPSS version 19 software. RESULTS: A total of 473 patients was included. The mean age was 52.26 years. Nearly 10% of patients had a moderate or a high risk of developing pressure ulcers with a Braden score less than 18. The prevalence of patients with pressure ulcers was 5.3% with a prevalence of 4.7% of nosocomial pressure ulcer. There was no significant difference in prevalence between medical and surgical services. The prevalence was relatively more important in intensive care and general surgery. The most frequent sites were sacrum and heels. Stages 3 (46.4%) and 2 (37.5%) were the mainly stages descriped. Evaluation of management of bedsores formed revealed that half was treated with modern wound dressings. Statistical analysis revealed that a Braden score <18 is correlated with pressure ulcers ( 96% of patients with bedsores. Patients transferred from other services, patients recently operated or those with probably inadequate diet seem to be more at risk of developing pressure ulcers. In contrast, age and sex were not identified as significant risk factors. CONCLUSION: pressure ulcer remains a significant problem in hospital.  This problem is preventable when applying adequate prevention but its management requires a multidisciplinary approach.

Errors in preparation and administration of parenteral drugs in neonatology: evaluation and corrective actions.

BACKGROUND: The medication iatrogenic risk is quite unevaluated in neonatology Objective: Assessment of errors that occurred during the preparation and administration of injectable medicines in a neonatal unit in order to implement corrective actions to reduce the occurrence of these errors. METHODS: A prospective, observational study was performed in a neonatal unit over a period of one month. The practice of preparing and administering injectable medications were identified through a standardized data collection form. These practices were compared with summaries of the characteristics of each product (RCP) and the bibliography. RESULTS: One hundred preparations were observed of 13 different drugs. 85 errors during preparations and administration steps were detected. These errors were divided into preparation errors in 59% of cases such as changing the dilution protocol (32%), the use of bad solvent (11%) and administration errors in 41% of cases as errors timing of administration (18%) or omission of administration (9%). CONCLUSION: This study showed a high rate of errors during stages of preparation and administration of injectable drugs. In order to optimize the care of newborns and reduce the risk of medication errors, corrective actions have been implemented through the establishment of a quality assurance system which consisted of the development of injectable drugs preparation procedures, the introduction of a labeling system and staff training.