Purpose The purpose of this study was to assess the cost saved and the amount of drug wasted when compounding anticancer drugs in the centralized unit for chemotherapy preparation. A secondary objective was to estimate the centralization impact of activities related to the preparation of chemotherapies. Methods This was a two-month, single-centre, prospective study conducted at the National Oncology Institute in Rabat. The cost saved and the amount of drug wasted were calculated using a standardized data collection sheet (the prescribed dose, the amount of drug deployed, the amount remaining after compounding, the amount of drug saved and the drug wastage). The centralization impact was calculated using the amount of drug wasted in the centralized unit for chemotherapy preparation and a theoretical amount of drug wasted without centralization of preparation. Results During the study period, the total amount of drug saved was 249,959.5 mg (7.2% of drug used), which represented 96,657 USD. The amount of drug wasted was 89,290.5 mg or 42275.5 USD. The drug waste per dilution and per drug was 6.4 mg [1.6-16.1]. While the potential savings over one year (580,000 USD) reached 13.9% of the cytostatic drugs budget for 2018, the potential drug waste cost reached 6.1%. The centralization impact is estimated at an average of 79.5% ± 13.7% waste reduction. Conclusion The outcome of our study showed that the grouping of prescriptions in centralized unit for chemotherapy preparation could result in significant savings on the amount of drugs deployed. The centralization of cytostatic preparations is of economic interest.
Objective The purpose of our study was to evaluate the contribution of an automated drug dispensing system in securing cancer chemotherapy production process at the pharmacy of the National Institute of Oncology in Rabat. Methods The failure modes and effects analysis method was applied to the chemotherapy production process in two phases: Phase 1, using an open shelf for storage then phase 2, using an automated drug dispensing system. The failure modes were defined and their criticality indexes was calculated on the basis of the likelihood of occurrence, the potential severity for the patients and/or the impact on the process and the detection probability. The criticality indexes of the two phases were prioritized and compared. Results We identified 35 failure modes for phase 1 and 37 for phase 2. The sum of criticality indexes was 5957 and 4586, respectively, for phase 1 and phase 2, corresponding to a criticality reduction of −23%. The greatest improvements concerned that the needed drug is missing during the picking, storage of potential expired drugs, and double compounding. Conclusion Our study highlighted the contribution of automated drug dispensing system in risk minimization. The use of automated drug dispensing system is a part of security improvement in chemotherapy production unit.
Objective: To determine the incidence and frequency of adverse drug reactions (ADRs) induced by cancer chemotherapy in pediatric inpatients. Patients and methods: This was a six-month prospective observational study in the pediatric hematology-oncology department of the children's hospital of Rabat. This study took into account ADRs manifested by in inpatient children and undergoing cancer chemotherapy. A modified version of the Moroccan Poison Control and Pharmacovigilance Centre's notification form was used to collect demographic, clinical, cancer treatment and ADR-related data. The causality, severity and preventability were assessed for each adverse event. Results: 106 patients out of 118 followed have developed a total of 266 ADRs. The most frequent ADRs were anemia (14.3%), infections (9.4%), leukopenia (8.6%) and fever (8.3%). Vincristine (16.3%), etoposide (14%) and cytarabine (13%) were the most frequently administered products. Cytarabine followed by etoposide were the drugs most involved in ADRs. The majority of ADRs (55.6%) were probable according to the WHO method of causality assessment. Conclusion: Cancer chemotherapy is associated with a high risk of developing ADRs, particularly hematological ADRs in children. Pediatric patients receiving cytarabine and daunorubicin combinations and regimens including anthracyclines should receive more attention. Risk management plans need to be implemented by health care teams in this area.
In clinical treatment, the analytical quality assessment of the delivery of chemotherapeutic preparations is required to guarantee the patient’s safety regarding the dose and most importantly the appropriate anticancer drug. On its own, the development of rapid analytical methods allowing both qualitative and quantitative control of the formulation of prepared solutions could significantly enhance the hospital’s workflow, reducing costs, and potentially providing optimal patient care. UV-visible spectroscopy is a nondestructive, fast, and economical technique for molecular characterization of samples. A discrimination and quantification study of three chemotherapeutic drugs doxorubicin, daunorubicin, and epirubicin was conducted, using clinically relevant concentration ranges prepared in 0.9% NaCl solutions. The application of the partial least square discriminant analysis PLS-DA method on the UV-visible spectral data shows a perfect discrimination of the three drugs with a sensitivity and specificity of 100%. The use of partial least square regression PLS shows high quantification performance of these molecules in solution represented by the low value of root mean square error of calibration (RMSEC) and root mean square error of cross validation (RMSCECV) on the one hand and the high value of R -square on the other hand. This study demonstrated the viability of UV-visible fingerprinting (routine approach) coupled with chemometric tools for the classification and quantification of chemotherapeutic drugs during clinical preparation.
Introduction There is a need for an economic evaluation of the use of closed system (CSTD) in chemotherapy compounding, especially in resource-constrained settings. Objective The objective of this study was to assess the cost saving of the management of cancer drug leftovers before and after introduction of CSTD associated with an extension of the beyond-use date (BUD) of cancer vials. A secondary objective was to estimate the level of minimization of drug wastage. Materials and methods This was a prospective, single-center study with two periods of two months each. The cost of drugs saved by using conventional systems (syringe and needle) without a closed system in the first period was compared to the cost of drugs saved by using the CSTD Chemoclave® system in the second period. The drug waste minimization rate compared actual drug waste to potential waste in Period 2. Results In Period 1, the amount of drug saved accounted for an average of 10.3% of the amount used in milligrams and the amount of drug wasted accounted for an average of 18.7%. In period 2, these proportions were 15.2% and 6.4% respectively. The CSTD generated an extra cost of 11,962.5 USD compared to the conventional system. The drug saved cost related only to the CSTD and the acquisition cost of the CSTD was a deficit of -7,444.95 USD and the cost saved from the compounding (CSTD and syringes) was a gain of 1,722.01 USD. The waste minimization represented an average of 72.5% ± 24.4% of potential waste. Conclusion The use of CSTD to extend the BUD allowed to reduce waste due to microbiological instability without adding an economic profit.
The hierarchical Bayesian modeling approach was used to select the appropriate empirical kinetics model of sustained release and to optimize the in vitro dissolution rate of the sustained-release suppository by controlling the composition of Eudragit L-100 and Eudragit S-100 in the experimental mixture. Thirteen formulations of suppositories were prepared with 2 g (10%) mixture of Eudragit ® R-100 and S-100 according to a personalized mixture experimental design. The cumulative release of active ingredient was measured at five times (20, 50, 80, 160, and 235 minutes). The best model was selected using Rsq (Adjust) and akaike information criterion for standard method and by using the weight of widely applicable information criterion (WAIC) and leave-one-out (LOO) cross-validation for the Bayesian approach. Frequentist approach gave three best model depending on the formulation. Compared to this, the Bayesian method was able to define a single model, which is the first-order model. The relative probability of this model is 0.97, 0.99 based on the WAIC, and LOO, respectively. The relationship between K 1 (Release rate constant) and the quantities of the two Eudragits is quadratic, for Eudragit_L, Q release (%) = 0.0031X 2 -0.0026 X + 0.0069 and X is the Eudragit L100 and K 1 (Rate release) = 0.41 minutes −1. The Bayesian method allowed finding the most adequate model among several models that can be generated by the standard frequentist approach.
parallel testing was performed using Chemfort VA from which the filter system had been removed. Results No drug was found in any of the test samples with the intact air filter system in Chemfort VAs, either fresh, following aging for 3 years or after 7 days of exposure to drug vapours. Recovered vapour was consistently found in the positive control samples which had Chemfor VAs without a filter system. Mean±SD (n=5) levels were 69±34 and 35±20 ng for cyclophosphamide and 5-FU, respectively. Conclusion and relevance The results confirm the efficacy of the Chemfort air filtration system, even after 7 days of exposure to drug vapour or a shelf life of 3 years.
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