Manual versus automated chemotherapy preparation: A retrospective pharmaco-economic analysis.

INTRODUCTION: The National Oncology Institute of Morocco's (NIO) shift to an automated cytotoxic drug preparation system (PHARMODUCT®) has prompted an evaluation of its economic and clinical impacts compared to traditional manual methods. METHODS: A retrospective cost-benefit analysis over six months, extrapolated to annual projections, assessed initial investments, labour, equipment, drugs and consumables. Four commonly used chemotherapy drugs were analyzed, with a focus on the cost implications of drug waste in manual preparation versus the efficiency of vial-sharing in automated methods. RESULTS: The automated system incurred a higher initial cost $2,934,098.74, but reduced annual drug consumption costs by 19.74% and drug-related expenses by $41,228.27. It also decreased personnel costs by $48,073.35. Despite the upfront investment, the system is projected to break even within two years, with no medication waste due to its vial-sharing capability. CONCLUSION: The initial higher investment in pharmaceutical automation promises considerable long-term savings and efficiency gains. Despite the study's limited scope and duration, the findings endorse the adoption of automated systems in oncology pharmacy settings for sustainable financial management and improved clinical outcomes.

Optimizing chemotherapy medication leftover management circuit in a centralized chemotherapy preparation unit: A comprehensive FMECA risk analysis and continuous improvement approach.

OBJECTIVE: Chemotherapy medications are usually having high costs, and new targeted drugs can be especially expensive, representing a challenge on healthcare, particularly in low- and middle-income countries. As cytotoxic leftover management is crucial for reducing medication wastage, the aim of this study is to evaluate and optimize leftover management circuit in NIO'S Pharmacy Centralized Chemotherapy Preparation Unit (CCPU) through a Failure Mode, Effects and Criticality Analysis (FMECA), and propose continuous improvement element to enhance the security of the process. METHOD: The FMECA were conducted in NIO's CCPU from March to May 2023, then continuous improvement plan was established to enhance the security of the process. The failure modes, their causes, impact, and criticality were assessed through criticality index calculation (CI = severity × frequency × detectability), and the risk concerned safety and effectiveness disruptions in chemotherapy preparation circuit using cytotoxic leftover. RESULTS: Leftover management circuits were described in flowchart form, where 18 failure modes were detected in four different steps of the process from chemotherapy preparation to disposal. Failure with highest critical index were detected in the case of equipment malfunction, improper storage temperature, and humidity. Continuous improvement recommendations were proposed in a table form. CONCLUSION: FMECA analysis applied to NIO's chemotherapy leftover management process allowed us to evaluate, secure, and optimize the circuit, and to propose several actions to implement in a perspective of continuous improvement.

Retrospective and FMECA analysis of failures in closed-system devices.

INTRODUCTION: Cytotoxic drugs can be hazardous to healthcare workers involved in their preparation and/or administration. Exposure occurs during routine handling of drug vials and ampoules, preparation, administration and disposal of cytotoxic waste. The use of closed-system devices provides protection against exposure to cytotoxics, but these devices are the subject of numerous incidents. Given the nature of the drugs they contain, these incidents can be dangerous for the personnel handling them. OBJECTIVE: The aim of our study is to analyze material vigilance data relating to problems frequently encountered with the various consumables of the closed system and to assess the risk of exposure of personnel to cytotoxic drugs when using these using the Failure Mode and Criticality Analysis (FMECA) method. MATERIALS AND METHODS: Our study was conducted at the pharmacy of the National Institute of Oncology, the closed system drug transfer device (CSDT) used is a ChemoClave-ICU®, This device is mechanical and needleless For the materiovigilance study we carried out a retrospective study over the period from 2019 to 2022, analyzing materiovigilance data collected by National Institute of Oncology's materiovigilance and pharmacovigilance cell. Our team, trained in the FMECA method, conducted the study over a three-month period, between September and November 2022. The method was used to assess the risks incurred by staff when using the CSDT device to prepare cytotoxic drugs. CONCLUSION: Our study revealed that the most frequent incident was linked to a manufacturing defect in the device in question. According to the FMECA analysis, this incident represents a major risk, as its occurrence hampers the cytotoxic preparation process. CSDT have the advantage of being easy to use and acceptable to staff, but standards need to be developed and validated to assess the performance of these devices.

Evaluating cost savings in cytotoxic leftover management: A prospective study of vial sharing and dose rounding techniques in the Moroccan National Institute of Oncology.

OBJECTIVE: Most intravenous anticancer drugs are administered in a dose per unit area or body weight, if not promptly administered to another patient cytotoxic leftover would be destroyed. To contain wastage, low-cost measures are highly desirable to contain and reduce expenditures without impairing the quality of care. The objective of the study is to evaluate the cost saved through the use of the two cytotoxic waste management techniques implemented in National Institute of Oncology's centralized chemotherapy preparation unit, vial sharing and dose rounding. METHOD: A 6-month prospective single centre study from 1 February to 1 August 2023 at the National Institute of Oncology of Rabat in Morocco. The number of prepared preparations and amount of drug saved by both vial sharing and dose rounding was collected using the centralized chemotherapy preparation unit's 'leftover tracking file', the corresponding cost saved were calculated and then compared for each technique and with 2018 results. RESULTS: In total, 18,218 preparations were considered in the 6-month study. With the vial sharing technique 636,524.5 mg were saved corresponding to 246,031.4 (USD) saved cost, against 212,838.4 mg by dose rounding corresponding to 75,598.5 (USD) saved cost. This saving corresponded to a total of 321,629.4 (USD). Compared to the 2018 results leftovers costs saved by vial sharing corresponded to 289,972.05 (USD) by vial sharing technique for 1-year extrapolated period, and this study shows a saved cost of 321,629.9 (USD) by both vial sharing and dose rounding techniques. CONCLUSION: Dose rounding technique combined with vial sharing allowed National Institute of Oncology's centralized chemotherapy preparation unit to limit expensive cytotoxic cost wastage, highlighting these technique benefits.

Assessment of patients' knowledge of their treatment with capecitabine at the National Institute of Oncology in Rabat.

INTRODUCTION: Capecitabine is a molecule of choice in the therapeutic arsenal of anticancer drugs used in Morocco for the treatment of breast cancer and colorectal cancer. Its frequent use imposes a follow-up and a post-prescription monitoring of the treatment modalities as well as the adverse events that may occur following its administration. OBJECTIVE: The objective of this study is to evaluate the level of knowledge of patients in the day hospital of an oncology facility about their treatment with capecitabine. MATERIALS AND METHODS: This is a prospective study conducted over a period of 2 months (January-February 2022) at the day hospital in the National Institute of Oncology in Rabat, and it was conducted using a questionnaire in order to evaluate patients' knowledge about their treatment with capecitabine. RESULTS: This study involved 95 patients, 76% claimed to have ever received pharmaceutical advice on capecitabine treatment. The main indications were colorectal and breast cancer. Ninety seven percent knew the indication for capecitabine and the action of the molecule on the relevant tumor. Eighty three percent receiving capecitabine therapy reported the occurrence of side effects and hand-foot syndrome was the most reported in 31.2% of the total listed side effects. DISCUSSION: Capecitabine is an oral treatment of choice for colorectal and breast cancer in Morocco. Therapeutic education happens to be an effective tool in order to guarantee the best effectiveness and manage the possible side effects that can occur during the treatment.

Risk assessment of personnel exposure in a central cytotoxic preparation unit using the FMECA method.

INTRODUCTION: Personnel involved in the preparation of cytotoxics are exposed to them and the resulting risks. To protect themselves, many means of protection are currently implemented. Nevertheless, the exposure of these manipulators remains a possibility to be considered. MATERIALS AND METHODS: The study was conducted during the period (October-November 2022) in the pharmacy of the National Institute of Oncology (INO), a hospital structure specializing in cancer care. The Failure Mode, Effects and Criticality Analysis method was used to assess the risks of exposure of personnel in a central cytotoxic preparation unit and then calculate the criticality index (CI = severity × frequency × detectability). The risks were classified into toxic, traumatic, chemical, and environmental risks. We have cited 12 failure modes of which nine are minor and three are major. The three major modes cited are essentially related to the particulate environment, direct contact and daily passive inhalation of handling. CONCLUSION: Our study shows that in our institution, the analysis of the risk of exposure of personnel to cytotoxics remains important, hence the interest of automaton in charge of preparations and which will gradually take charge of all the preparations. The existing procedures and the pharmacotechnical equipment used also contribute to protection and risk reduction.

Retrospective analysis of failures of ambulatory elastomeric pumps containing 5-FU in a hospital pharmacy unit.

INTRODUCTION: Ambulatory chemotherapy is an important and major advance in clinical oncology practice since it allows the administration of chemotherapy in the comfort of the patient's home without the assistance of a health professional by means of an elastomeric pump. However, these pumps are not without risks and can be the cause of incidents due to technical failures. Our objective is to study the technical failures of elastomeric pumps in the Cytotoxic Preparation Unit and in the patient's home, to evaluate the possible impact of these failures on the patient and on the staff and to propose measures to reduce them. MATERIALS AND METHODS: This is a retrospective study conducted at the pharmacy of the National Institute of Oncology in Rabat. It gathered all the specific reports on elastomeric pumps issued during the period (January 2017-May 2021) by the cytotoxic preparation unit to the materiovigilance cell via a notification form. RESULTS: 205 cases of elastomeric pump materialovigilance were identified during the study period. The main technical failures were: chemotherapy product leakage (44%), flow rate anomalies (30%) and injection difficulties (20%). Following these incidents, certain actions were undertaken such as alerts sent to the supplier and letters sent to the competent health authorities. CONCLUSION: Despite the failures that may have occurred, elastomeric pumps have revolutionized home chemotherapy delivery. They are considered reliable, consistent, easy to use and handle, and are well accepted in the population.

Tamoxifen induced hands deformities.

INTRODUCTION: Tamoxifen is widely used for the treatment of hormone-responsive breast cancer. In this article, we report a case of a patient who developed hand deformities following long-term administration of tamoxifen. CASE REPORT: A 57-year-old woman, followed for invasive ductal carcinoma of the left breast under tamoxifen for 7 years, presenting joint pain with deformities in her fingers. MANAGEMENT & OUTCOME: Following the appearance of the adverse effect, tamoxifen was stopped. A series of biologic and radiologic analysis were performed in order to explain the appearance of this event. A substitution treatment was discussed and a rheumatologist's opinion was requested. DISCUSSION: Tamoxifen appears to be associated with the development of inflammatory osteoarthritis resembling rheumatoid arthritis. Possible mechanisms of such an effect are discussed.

Contribution of an anticancer drug compounding robot in reducing the risks of manual preparation in a hospital pharmacy unit specialized in oncology.

INTRODUCTION: In the last few years, pharmaceutical technology has evolved. In the field of oncology pharmacy, robots for the preparation of anti-cancer drugs have appeared to progressively replace manual preparation. The objective of this study is to evaluate the contribution of the robot in reducing the risk of manual preparation. METHODS: The study was conducted at the pharmacy of the National Institute of Oncology in Rabat (May-August 2021). The method used to compare the two types of preparation is the method of analysis of failure modes, their effects and their criticality (FMECA). It will calculate the criticality index (CI = severity × frequency × detectability). The risks have been categorized into human, technical, and environmental risks. RESULTS: The anticancer drugs reconstitution step was the most critical in manual preparation (CI = 126.7) and robotic preparation (CI = 40.7). The robot has made it possible to reduce several CIs of manual preparation including: musculoskeletal disorders of pharmacy operators -93 (89%), error in cancer drug and diluent selection -72 (60%), as well as lack of traceability -145 (97%). CONCLUSION: The preparation robot has made it possible to reduce many of the risks of manual preparation, and constitutes an important advance in the field of oncology pharmacy.

Economic impact of implementation of an automated drug supplying and management system in a Central Chemotherapy Preparation Unit in a Moroccan hospital.

OBJECTIVE: Automated Drug Supplying and management System (ADS) are effective devices that secure drug's circuit and reduce hospital's expenses. The purposes of this study are to estimate the earnings made from ADS through a cost-benefit medical economic study, to highlight its impact on Central Chemotherapy Preparation Unit's (CCPU) global organization, its ergonomy and staff's satisfaction. METHOD: Measurement of cytotoxic drug's consumption, expiration losses, pharmacy staff's working time, drugs stock-out before and after the implementation of ADS on the one hand, and assess its ergonomy and acceptability by users on the other hand. RESULTS: After the implementation of ADS, cytotoxic drug's consumption decreased by 9 (%), expiration losses by 98.3 (%), and we could see a gain in working time among CCPU'S technicians of 1.32 (h/day) and pharmacist of 0.67 (h/day), in contrast to the stock manager who increased his working time by 0.95 (h/day). Stock-out have decreased by 41.1 (%). The cost-benefit analysis has shown a net benefit of 67,437 between the two six-month phases, which corresponds to an economy of 134,874 (USD) over one year. The ADS was generally appreciated by the CCPU and pharmaceutical staff and 93(%) don't want to return to the old system. CONCLUSION: ADS implementation within CCPU led to financial savings in the hospital, an optimization of expenses and better pharmaceutical management.

Risk reduction in a cancer chemotherapy production unit: Contribution of an automated drug dispensing system.

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.