Occupational risks evaluation in a centralized antineoplastic agent preparation unit.

OBJECTIVE: The global professional risk assessment applied to the central unit of antineoplastic agent preparations is part of a mandatory approach required by the European legislation for workers. This study identified the hazardous situations related to the staff activity and then enabled the preparation of a formal plan of occupational prevention. METHODS: The nature of study approved by a working group constituted by experts was the global risk analysis. After identifying the hazardous situations, the global risk analysis estimated the risk level of each hazardous situation based on a criticality score, including severity and frequency. The global risk analysis highlighted the initial and residual risks after establishing a plan to reduce the high criticality risks. RESULTS: Hence, 33 unacceptable hazardous situations were identified. The critical categories of professional risks were "Product, emissions, and waste risks" with 17 (55%) hazardous situations; "Psychosocial risk factors" with 8 (24%) hazardous situations; and "Risks related to work equipment" with 6 (18%) hazardous situations. Once the risk reduction plan was in place, all hazardous situations were considered under control. The corrective actions led to a reorganization of human resources, the update of protection protocols, and optimization of ergonomic work tools. Staff-specific medical monitoring and regular surface contamination tests have been scheduled annually. In addition, initial and continuous training, specific to product and waste risks, has been updated. CONCLUSION: The global professional risk assessment related to centralized antineoplastic agent preparation unit generated failure in our system and enabled corrective actions for staff safety.

A virtual centralized cytotoxic preparation unit simulation to evaluate the pharmacy staff knowledge.

BACKGROUND: The risk of medication errors related to drug preparation unit cannot be totally avoided because of human interference. The aim of this study is to investigate the background and knowledge of the pharmacy staff by replicating the cytotoxic preparation unit with potential errors. METHODS: A 10-m2 room was provided to duplicate the centralized chemotherapy unit with three areas reproducing virtually the equipment preparation bench, the isolator, and the dispensing bench. The 14 situations selected by experts were integrated to each corresponded area. For each participant, a form was given and answers were analyzed by two independent experts. Statistical processing data were performed using GraphPad Prism® software. RESULTS: A total of 19 professionals participated in error simulation workshop over a one-month period. The overall rate of correct responses was 58 ± 19%. In five situations, correct responses rate was lower than 50%: wrong drug batch related to the preparation sheet (40%), inappropriate sterilizing conditions (15%), the time on the preparation sheet provides an expired expiry date for melphalan preparation (45%), a maximum drug dose exceeded (25%), the dispensing form not corresponds to the preparation sheet and final product label (30%). The rate of correct responses was 45 ± 25% for professionals not specifically dedicated to chemotherapy preparation. The overall satisfaction workshop rate was 8.7 ± 1.0 out of 10. CONCLUSION: This study showed the importance of training programs to sensitize personal staff to the risks of chemotherapy preparation and prevent errors.

Physicochemical and microbiological stabilities of hydrocortisone in InOrpha suspending agent studied under various conditions.

Hydrocortisone is principally used as replacement therapy in adrenocortical deficiency states. In pediatric practice, posology ranges from 10 to 20 mg/m2 per day, divided in three doses, for the purpose of mimicking the nycthemeral cycle. Hydrocortisone is marketed in France in tablet form that contains 10 mg of the active ingredient. This galenic formulation is not suitable for pediatric use, and often requires a grinding operation or a dose fractionation to facilitate administration. To overcome this difficulty, the objective of this study was to develop and evaluate the physicochemical and microbiological stabilities of hydrocortisone in a sugar-free, alcohol-free, and paraben-free InOrpha suspending agent. The studied samples were formulated into a 2-mg/mL suspension and stored in glass bottles at two temperature conditions, between 2 degrees C to 8 degrees C and at room temperature). Two series of twelve samples were tested for physicochemical stability using high-performance liquid chromatography as well as for a microbiological status for 28 days (daily opening of the bottles from day 0 of compounding) and for 56 days (first opening at day 28 from compounding and daily opening for 28 consecutive days). The high-performance liquid chromatography method developed is linear, accurate, precise, and robust. On the other hand, a forced degradation study has demonstrated the selectivity and specificity of the method validated as stability indicating. In both storage conditions, high-performance liquid chromatography analysis showed that tested samples had concentrations ranging within 90% to 110% of the initial concentration for 28 consecutive days upon daily bottle opening and, for a maximum of 42 days with a first opening at day 28 from the compounding time. Microbiological status remained stable throughout the course of the study. Based on the data collected, the study led to the development of a new galenic formulation of hydrocortisone suitable for pediatric use which can be safely stored under refrigerated conditions or at room temperature for a maximum of 42 consecutive days.