Chemotherapy safe handling practices in Ethiopia: A comprehensive multi-center evaluation.

INTRODUCTION: The increasing incidence of cancer and capacity for cancer care in Ethiopia has led to an upsurge in chemotherapy use in the country; however, studies indicate that there is a gap in the safe handling of chemotherapy by healthcare workers. There exists a need to understand if such unsafe practices occur in Ethiopia and, if so, which areas along the chemotherapy life cycle need the most improvement. METHODS: This study utilized a multi-method design through an online survey administered to health care professionals and evaluative site visits of eight cancer units in Addis Ababa, Ethiopia to understand the current conditions of chemotherapy handling. In addition, a survey was conducted among Ethiopian health care professionals from across the country. RESULTS: Fifty-five percent of survey participants disagreed or strongly disagreed that there are systems in place to identify, prevent, and address chemotherapy hazards in their workplace, and 71% of respondents denied having an active and effective health and safety committee and/or worker health and safety representative where they work. At evaluative site visits, only 30% of health care workers met the minimum guidelines for proper hand hygiene, and 20% of health care workers used adequate Personal Protective Equipment according to guidelines across the chemotherapy lifecycle. CONCLUSIONS: Results of this study indicate an urgent need for implementation of evidence-based interventions to improve chemotherapy handling in Ethiopia so that all patients and health care workers are protected from the hazardous toxicities of these drugs.

Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting.

OBJECTIVE: Available guidelines are ambiguous about safe handling monoclonal antibodies (MABs) and whether or not to use a Closed System Drug-Transfer Device (CSTD). In this article we want to describe a standardized working method on handling MABs in a clinical trial setting. DATA SOURCES: The current workflow at the clinical trial unit of the Ghent University Hospital was critically analyzed, after which an extensive literature review was performed using the National Institute for Occupational Safety and Health Working Group guidelines and the database PubMed (Keywords: monoclonal antibodies, closed system transfer devices, safety guidelines, safe handling, management, administration, (bio)compatibility, volume loss, contamination, clinical trial unit. Period: 2020-2022). DATA SUMMARY: Literature data are ambiguous. CSTDs can reduce cross-contamination and minimize exposure to potential hazardous drugs for healthcare professionals. However, in recent years more questions have been raised about their in-use compatibility and their impact on final product quality. This makes the debate on implementing CSTDs a hot topic in daily pharmacy practice and demands a holistic and standardized approach when deciding whether or not to use a CSTD when handling MABs. In a clinical trial setting, where safety data are frequently not available and the compatibility of CSTDs and investigational product is often unknown, this poses additional challenges that need to be taken into account. CONCLUSION: We developed a flowchart which standardizes the use of a CSTD when handling MABs. It allows other healthcare professionals and clinical trial sponsors to define and evaluate the necessary criteria when standardizing the position of a CSTD in their safe handling procedures.

Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings.

AIM: The aims were to (a) review the scientific literature on occupational risk, including exposure mechanisms and risk assessment, with regards to handling monoclonal antibodies (mABs) in healthcare settings; and (b) update the recommendations in the Clinical Oncology Society of Australia (COSA) safe handling of monoclonal antibodies in healthcare settings position statement, published in 2013. METHODS: A literature search was conducted between April 24, 2022, and July 3, 2022, to identify evidence relating to occupational exposure and handling of mABs in healthcare settings. Evidence in the literature was compared to the Position Statement published in 2013, and any potential additions, deletions, or revisions were discussed by the authors, and then agreed changes were made. RESULTS: Thirty-nine references were included in this update, comprising of the 2013 Position Statement itself and 10 of its references, as well as 28 new references. The risks to healthcare workers in the preparation and administration of mABs arise from four distinct exposure mechanisms: dermal, mucosal, inhalation, and oral. Updates included recommendations on using protective eyewear during the preparation and administration of mABs, developing a local institutional risk assessment tool and handling recommendations, considerations for using closed system transfer devices, and to have awareness of the nomenclature change from 2021 for new mABs. CONCLUSION: Practitioners should follow the 14 recommendations to lower occupational risk when handling mABs. Another Position Statement update should occur in 5-10 years to ensure the currency of recommendations.

Chemotherapy supply chain management, safe-handling and disposal in Ethiopia: the case of Tikur Anbessa specialized hospital.

Optimal chemotherapy management is substandard in low and middle-income countries. We aimed to identify major gaps to design interventional strategies for improved chemotherapy management at Tikur Anbessa Specialized Hospital (TASH), Ethiopia. This study was conducted using an observational checklist, open-ended questions, record review, and key informant interviews of department heads and focal persons at TASH. Findings were categorized into specific themes that developed. Chemotherapy represented 60.2% of the hospital medication budget. Drug utilization was quantified via monthly consumption documentation and forecasting. However, unreliable data resulted in frequent stockouts (unavailability of the item when it is needed) of chemotherapy with only 67.8% availability. Thirteen healthcare personnel (9 nurses, 2 pharmacists and 2 hospital cleaners) were interviewed: all clinical staff but neither of hospital cleaners believed that they were at risk of hazardous agents. Challenges identified included inadequate and frequent stockouts (unavailability of the item when it is needed) of personal protective equipment, lack of standardized guidelines for chemotherapy handling, admixture, and disposal, lack of designated preparation rooms, and lack of training. All nine nurses handled chemotherapy admixtures despite only two nurses previously receiving in-service training. Most of the participants had never witnessed the disposal of anticancer drugs. Prompted by the results of this study, a dialogue was initiated among members of TASH, the American Cancer Society and the University of North Carolina to implement action-oriented projects to address the gaps identified at TASH. These gaps directly and indirectly affect care and treatment outcomes of patients at a large cancer center. Collaborations with well-resourced centers are potential models for improving chemotherapy management.

Development and Evaluation of an e-Learning Module for Low- and Middle-Income Countries on the Safe Handling of Chemotherapy Drugs.

Despite the growing use of chemotherapy drugs in resource-constrained settings, training opportunities on safe handling practices are lacking. This study's objectives were to develop and evaluate an e-learning training module on the safe handling of chemotherapy drugs to strengthen knowledge and practices in low- and middle-income countries (LMICs). The module's curriculum was developed using the Six-Step Approach for Curriculum Development for Medical Education. Asynchronous, self-paced, e-learning lessons within the module were created and uploaded onto a free online platform, Pharm-Ed. The study ran online from January to April 2021. Participant recruitment was done using convenience sampling through various channels (social media, communities of practice). Training module effectiveness was evaluated using knowledge assessments (a pre-test and post-test study design) and participant satisfaction. We developed a comprehensive e-learning module on the safe handling of chemotherapy drugs comprising 11 asynchronous, self-paced, e-learning lessons. Eighty-two participants (68% pharmacists and 17% pharmacy students) from 17 countries completed at least one lesson, with a total of 259 lessons completed. Evaluation of the different lessons showed significant improvements in theoretical knowledge (p < 0.01) in all except one lesson and a high degree of participant satisfaction. As the use of anti-cancer drugs in LMICs will continue to increase, this e-learning module is an effective means to address the lack of training opportunities on the safe handling of chemotherapies for healthcare workers in these countries. The module could be integrated into a multi-modal approach aimed at reducing occupational exposure and increasing patient safety in cancer care centers.

Onco-pharmacist led evaluation of knowledge, attitude & practice (KAP) of safe handling cytotoxic drugs among health care professional's (HCP's) in tertiary care hospital: A hospital based interventional Study.

BACKGROUND: Cytotoxic drugs (CDs) are hazardous in nature. But it is necessary for the treatment in cancer patients. The healthcare professionals (HCPs) act as a facilitator through which the manufactured CDs reach the patient. However, safe handling of CDs becomes a primary concern not only for the recipients but also for the HCPs. METHODS: On Ethics committee approval, a prospective- interventional study was conducted among HCPs who are involved in handling of CDs in Oncology department of tertiary care hospital. The participants were screened for their eligibility criteria & 73 HCPs were recruited. The initial data was collected from the HCPs through interview & questionnaires. Later the participants were trained by oncology-pharmacist (7-8 months) for safe handling of CDs. After the training the participants were tested again through interview & questionnaires. RESULTS: 73 participants, (75%) nurses & (25%) physicians were included in the study. Among these participants, only 32.87% underwent training on reconstitution whereas 67.12% of the participants didn't undergo any training. The increase in mean score of KAP after the training was observed to be 3.44 ± 4.32, 1.23 ± 1.51 and 1.3 ± 1.01 respectively. CONCLUSION: The study concludes that mandatory requirement of training for HCPs using SOP's by qualified oncology-pharmacist to minimize the hazardous effects of CDs. It also highlights the improvisation techniques for handling of CDs will enhance the safety profile of HCPs & the patients, which helps in refining the quality of pharmaceutical and health care services provided in the cancer care settings.

Knowledge of safe handling, administration, and waste management of chemotherapeutic drugs among oncology nurses working at Khartoum Oncology Hospital, Sudan.

Introduction: Knowledge of chemotherapeutic drug (CD) handling, administration, and waste disposal are important among nurses involved in cancer therapy. Inadequate knowledge of the management of CD could cause environmental contamination and potential harm to patients and nurses. To assess the knowledge of safe handling, administration, and waste management of CD among oncology nurses working at Khartoum Oncology Hospital, Sudan. Methods: A questionnaire was developed by a team of experts to assess the knowledge in three domains of oncology nursing practice (handling, administration, and disposal). The study involved 78 oncology nurses working in Khartoum Oncology Hospital in Sudan from April 2020. Results: The mean CD knowledge score of nurses was 12.7 ± 3.9 out of 26 items in the questionnaire. For each domain, their knowledge showed poor scores related to safe handling (mean = 2.0 ± 1.5 out of eight knowledge items) and good scores for administration (mean = 6.2 ± 1.7 out of 10) and poor scores for waste disposal (mean = 4.4 ± 1.5 out of eight). Simple linear regression indicated that education level (ß = 3.715, p = .008) and training (ß = 0.969, p = .004) significantly predicted knowledge among nurses. Conclusion: There is a significant need to enhance the knowledge and safe handling skills of CD among oncology nurses in Sudan. Implementation of strict guidelines to manage cytotoxic waste to reduce health risks and hospital contamination.

The relationship between safety climate and nurses' safe handling of chemotherapy: A partial least squares structural equation modeling analysis.

PURPOSE: Safety climate plays a critical role in nurses' safety behaviors. However, few are aware of the safety climate sub-dimensions associated with safety behavior. This study aimed to investigate the relationship between nurses' perception of the workplace safety climate and their safety behavior regarding the handling of chemotherapy upon intravenous administration. METHODS: This study included a cross-sectional survey of nurses recruited by purposive sampling at three hospitals in Taiwan. A total of 484 self-administered questionnaires were returned. Each participant had to complete the questionnaire that was developed by the authors, including the Taiwanese Safety Climate Instrument and Chemotherapy Safety Precautions Questionnaire. Exploratory factor analysis and Confirmatory factor analysis was conducted to verify the psychometric properties. We used the samples (N = 247) for confirmatory factor analysis to verify the model using partial least squares structural equation modeling. RESULTS: We found that nurses' perceptions of workplace safety climate can explain and predict their safety behavior regarding administration chemotherapy, particularly the dimension of "perception of interaction with colleagues," "experience of clinical jobs hindering the use of personal protective equipment," "perception of comfort using personal protective equipment," and "easy usage of personal protective equipment." The study further revealed that the dimensions of the Taiwanese Safety Climate Instrument were moderate predictors of the Chemotherapy Safety Precautions. CONCLUSIONS: Nurses have a positive perception of the workplace safety climate and frequently implement behaviors regarding the safe handling of chemotherapy. Organizational managers should enable nurses to share their perceptions of workplace safety with their colleagues and purchase easy-to-use and comfortable personal protective equipment.

Closed safety system for administration (CSSA): proposal for a new cytotoxic chemotherapy acronym.

Exposure to cytotoxic chemotherapy can result in acute and chronic conditions including nausea, headaches, rashes, miscarriages, infertility and genetic aberrations. Surface contamination can occur during drug administration, and can subsequently spread throughout the healthcare environment. Dermal contact with contaminated surfaces can lead to drug absorption. Closed system drug-transfer devices (CSTDs) were initially developed to protect pharmacists during compounding. Components include a vial adapter to prevent pressurisation leakage and a syringe connector for transferring the drug to the intravenous infusion bag. Membrane-based CSTDs require a Luer adapter for drug administration whereas Luer system-based products do not. Most European nurses are familiar with needleless connectors. Unfortunately, these devices do not provide protection from chemotherapy exposure. To decrease confusion, CytoPrevent, a multi-national, primarily European organisation has proposed the term 'closed safety system for administration' (CSSA) for Luer based CSTDs. Along with education, the new term can help promote safety for nurses administering cytotoxic chemotherapy.

Pharmacy practitioners' adherence to safe-handling practices of chemotherapeutic drugs: A cross-sectional study in Saudi Arabia.

BACKGROUND: Chemotherapy drug handling and occupational exposure are topics of concern for a variety of oncology health care professionals. Inappropriate handling can pose health risks to practitioners particularly, those who handle them on a daily basis. Therefore, this study aimed to assess chemotherapy handling practices among oncology pharmacists and pharmacy technicians in Saudi Arabia. METHODS: A cross-sectional study was conducted using an online survey with a structured pre-validated questionnaire. Data was collected from pharmacists and pharmacy technicians who handle chemotherapeutic agents in Saudi Arabia, and analyzed using descriptive and inferential statistics. RESULTS: A total of 79 oncology pharmacy practitioners responded to the survey. The majority (92.4%) had written chemotherapy guidelines at their workplaces. Almost all participants (98.7%) reported the availability of protective gloves and gowns, however, the availability of eye protection was only 57%. Most used chemotherapy-designated gloves (83.6%), and gowns (86.1%). However, 54.4% have reused disposable gowns. The extent of utilization of most protective equipment ranged from 70% (always using closed system transfer device) to 98% (always using shoe cover); while the practice of always using eye protection and face shield was only 30.4% and 38%, respectively. With regard to cleaning practice, the work area was cleaned at least once a day by 35%; monthly decontamination (77%); certification by the biomedical department every 6 months (67%) and at least yearly (95%). Accidental exposure was reported by 28%, and the most common adverse effect was skin irritation (82%). There was no workplace medical surveillance available for 50%. The majority (88.6%) received relevant training, but not periodic updates on their training (38%). The main barriers against the use of personal protective equipment were: that some personal protective equipments were not always available (38%), and personal protective equipments were too uncomfortable to use (30.4%). The demographic variables did not have a statistically significant effect (p > 0.05) on the responses except for type of institution (workplace) on some of the cleaning practices that showed significant differences namely, the monthly decontamination and certification by the biomedical department. CONCLUSIONS: Most protective equipment and chemotherapy guidelines were available, and the majority of pharmacy practitioners adhered to many aspects of chemotherapy safe-handling practices. Nevertheless, some areas such as medical surveillance programs, use of eye protection and face shields, the practice of re-using disposable gowns, some of the barriers against personal protective equipment use, and the provision of periodic training need improvement for better protection of the health care professionals.

The safe handling of chemotherapy drugs in low- and middle-income countries: An overview of practices.

INTRODUCTION: The rising burden of cancer in low- and middle-income countries (LMICs) has led to substantial efforts to improve access to chemotherapy. The present study's objectives were to obtain an overview of the safe handling practices implemented in LMICs' healthcare facilities when dealing with chemotherapy drugs and to prioritize opportunities for improving them. METHODS: We conducted an online survey, from June 2018 to April 2019, among LMIC healthcare facilities dealing with chemotherapy drugs. Facilities were asked to self-assess their chemotherapy handling processes using Cyto-SAT, a self-assessment tool incorporating 134 items organized into 10 domains (management, personnel, logistics, prescription, preparation, administration, incident management, waste management, cleaning, and patient counselling). Data were recorded on an online platform (www.datapharma.ch/cyto-SAT). RESULTS: The survey enrolled 53 healthcare facilities (15 from low-income, 26 from lower-middle-income, and 12 from upper-middle-income countries). The median level of implementation of safe practices was 63% (Q1:39%-Q3:77%). Facilities in low-income countries (LICs) reported lower median levels of safe practices than middle-income countries (MICs) [LICs: 32% (Q1:24%-Q3:62%), Lower-MICs: 63% (Q1:49%-Q3:70%), Upper-MICs: 85% (Q1:77%-Q3:93%)]. The biggest differences between country categories were observed in the domains related to personnel, preparation processes, and incident management. CONCLUSION: This overview of practices highlighted a large variability and major gaps in the safe handling of chemotherapy drugs in LMICs. Improvement strategies are needed to increase patient and staff safety and limit environmental contamination, especially in LICs. Safe handling programs should be part of continuing efforts to improve access to quality cancer drugs and should be integrated into national cancer control programs.

Framing Cancer Survivors' Access to and Use and Disposal of Prescribed Opioids Within the Opioid Epidemic.

PURPOSE: To explore cancer survivors' access to and use and disposal of opioids in the context of the opioid epidemic. PARTICIPANTS & SETTING: Community-based recruitment strategies were employed for individuals aged 18 years or older who were previously diagnosed with cancer, completed cancer treatment within the past five years, or were cancer free, and who were prescribed opioids for cancer-related pain. METHODOLOGIC APPROACH: This qualitative study used semistructured interviews. Data were analyzed using applied thematic analysis techniques. FINDINGS: Themes included the following: (a) restrictive policies affecting opioid access and supply, (b) decreased opioid use because of concerns of addiction and other opioid-related side effects, and (c) lack of clarity on safeguarding and disposal of opioids. IMPLICATIONS FOR NURSING: Cancer survivors may encounter barriers to opioid access, alter medication-taking behavior over fear of addiction and side effects, and face inadequate education regarding proper disposal of opioids. Nurses can advocate for appropriate access to prescribed opioids, assess opioid-taking behavior, provide education regarding storage and disposal, and implement educational interventions accordingly.

NanoSafe III: A User Friendly Safety Management System for Nanomaterials in Laboratories and Small Facilities.

Research in nanoscience continues to bring forward a steady stream of new nanomaterials and processes that are being developed and marketed. While scientific committees and expert groups deal with the harmonization of terminology and legal challenges, risk assessors in research labs continue to have to deal with the gap between regulations and rapidly developing information. The risk assessment of nanomaterial processes is currently slow and tedious because it is performed on a material-by-material basis. Safety data sheets are rarely available for (new) nanomaterials, and even when they are, they often lack nano-specific information. Exposure estimations or measurements are difficult to perform and require sophisticated and expensive equipment and personal expertise. The use of banding-based risk assessment tools for laboratory environments is an efficient way to evaluate the occupational risks associated with nanomaterials. Herein, we present an updated version of our risk assessment tool for working with nanomaterials based on a three-step control banding approach and the precautionary principle. The first step is to determine the hazard band of the nanomaterial. A decision tree allows the assignment of the material to one of three bands based on known or expected effects on human health. In the second step, the work exposure is evaluated and the processes are classified into three "nano" levels for each specific hazard band. The work exposure is estimated using a laboratory exposure model. The result of this calculation in combination with recommended occupational exposure limits (rOEL) for nanomaterials and an additional safety factor gives the final "nano" level. Finally, we update the technical, organizational, and personal protective measures to allow nanomaterial processes to be established in research environments.

Reconciliation and Disposal of Oral Medication: Creating a Safe Process for Clinical Research Personnel.

Clinical research nurses and non-licensed study coordinators observed variation in procedures for reconciliation and disposal of oral investigational medications across the institution. An academic medical center implemented a quality improvement project to standardize the process of reconciliation and disposal of oral investigational medications. An interprofessional collaborative workgroup was formed, which led to multiple interventions to standardize practice, including revision of three policies and procedures, redesign of specific work areas to establish drug-counting rooms, review of personal protective equipment requirements, revision of educational training, and regular cleaning of potentially contaminated workstations.

Defining cytotoxic drugs - you know it when you see it?

Safe handling precautions are an important measure used to prevent occupational exposure to hazardous antineoplastic drugs. Historically, the terms 'antineoplastic', 'chemotherapy' and 'cytotoxic' are frequently conflated. However, many current antineoplastic drugs do not have cytotoxic mechanisms of actions, leading to confusion when developing safe handling policies. Based on the mechanistic criteria outlined in this review, we have compiled a list of the most commonly used antineoplastic drugs with their cytotoxic or non-cytotoxic designations. We propose that this list can be used when discussing drug-specific safe handling precaution measures.

Assessment of workplace environmental contamination and occupational exposure to cisplatin and doxorubicin aerosols during electrostatic pressurized intraperitoneal aerosol chemotherapy.

BACKGROUND: Electrostatic precipitation pressurized intraperitoneal aerosol chemotherapy (ePIPAC) is a novel approach for intraperitoneal drug delivery. As ePIPAC using cisplatin and doxorubicin is performed in an operating room, the challenge is to safely deliver the chemotherapeutic aerosol intraperitoneally while preventing exposure to healthcare workers. The objective of this study was to describe cisplatin and doxorubicin workplace environmental contamination and healthcare worker exposure during ePIPAC. METHODS: Antineoplastic drugs concentrations of cisplatin and doxorubicin were measured in wipe samples from the operating room, and urine samples were collected from healthcare workers. The air samples were collected in order to detect Cisplatin contamination. Cisplatin was analysed by inductively coupled plasma-mass spectrometry and doxorubicin by ultra-high-performance liquid chromatography coupled with tandem mass spectrometry. RESULTS: No trace of cisplatin was found in the air. Cisplatin and doxorubicin were detected on the operating room floor, surfaces, devices and personal protective equipment even after a cleaning protocol. No traces of cisplatin or doxorubicin were found in the urine samples. CONCLUSION: In this study, no internal contamination was found in the ePIPAC surgical team even after implementing two successive ePIPAC procedures. These results showed the effectiveness of the individual and collective protective measures applied. However, the cleaning procedure during ePIPAC should be respected to limit environmental exposure to chemotherapy to cisplatin and doxorubicin during ePIPAC.

Oral Chemotherapy: An Evidence-Based Practice Change for Safe Handling of Patient Waste.

BACKGROUND: Safe handling practices for patient waste have focused on patients receiving IV chemotherapy, but these practices do not address safe handling for patients receiving oral chemotherapy. OBJECTIVES: The aim of this article is to evaluate evidence and formulate best practice recommendations for handling and disposing waste from patients receiving oral chemotherapy. METHODS: A literature search established a framework for the project. For healthcare providers and staff, procedures were established to access biohazard supplies and to follow safe handling of patient waste post-oral chemotherapy administration. Supply cost utilization was evaluated pre- and postimplementation. Staff perceptions were assessed six months after project implementation. FINDINGS: The cost of supplies per patient day increased minimally. Staff self-reported use of biohazard precautions when handling patients' waste increased. The majority of staff reported that they had access to supplies and were knowledgeable regarding safe handling procedures six months after this practice change.

Knowledge and Practices on the Safe Handling of Cytotoxic Drugs Among Oncology Nurses Working at Tertiary Teaching Hospitals in Addis Ababa, Ethiopia.

BACKGROUND: Cytotoxic drugs (CDs) administration and occupational exposure is a worldwide concern. Inappropriate handling may cause toxic residues to infiltrate hospital environments and patient care areas, and can even be traced to patients' homes. Hence, the study sought to assess knowledge and practices on the safe handling of cytotoxic drugs Among Oncology Nurses at Tertiary Teaching Hospitals in Addis Ababa, Ethiopia. METHODS: The researchers conducted a hospital-based cross-sectional study among 77 nurses from April 1-30, 2019. Purposive sampling was used in recruiting the respondents. Structured questionnaires were filled through self-administered interviewing. Data were analyzed using SPSS version 23 software. Multiple linear regression was performed to see the association between dependent variables and independent variables at a p-value of less than 0.05. RESULTS: Mean score of knowledge and practice of nurses was 7.82±2.22 out of 15 and 22.1±5.50 out of 40 respectively. Nearly 69% of nurses reported the lack of training program on the handling of CDs at their workplaces and the use of Personal Protective Equipment (PPE) remains suboptimal as none used all of PPE. Nurses who had not heard about CDs had an average knowledge score of 0.33 points lower than nurses who had heard about CDs (p ≤ 0.01). Nurses who have scored higher knowledge points had 0.33 points more practice score of safe CD handling than those who had lower knowledge score (p < 0.05) and also married nurses had average safe CDs handling practice score 0.27 points lower than their counterparts (p < 0.05). CONCLUSION: Nurses' knowledge and practice of safe handling of cytotoxic drugs are inadequate. Nurses who have scored higher knowledge points and are married were more likely to practice safe CD handling. Provision of proper PPE and training regarding the handling of CDs for Oncology Nurses are recommended and chemotherapy safety protocol and guidelines should be established.

Hazardous Drug Contamination: Presence of Bathroom Contamination in an Ambulatory Cancer Center.

BACKGROUND: Many hazardous drugs (HDs) are excreted in urine and feces, and evidence has shown that bathrooms of patients receiving chemotherapy at home are contaminated with HDs. However, little information exists on bathroom contamination in ambulatory clinics where HDs are administered. OBJECTIVES: This project aimed to determine the presence of HD residue in the patient and staff bathrooms of an ambulatory cancer center. METHODS: A quality improvement project was initiated to examine potential contamination by the HDs 5-fluorouracil and oxaliplatin in a patient bathroom and a secured badge-access staff bathroom in the infusion department of an ambulatory comprehensive cancer center. Twice-daily wipe testing was conducted on the floor in front of the toilet and the flush handle for five consecutive days. FINDINGS: Sixty-five percent of the samples from the floor of the patient bathroom were positive for at least one of the HDs. In the staff bathroom, 35% of the floor samples were positive for at least one HD. None of the flush handle samples were above the level of detection.

Disease area and mode of action as criteria to assign a default occupational exposure limit.

In the early stages of drug research and development, there are only a few or no toxicological data available for newly synthesized small molecule drug candidates (DC). Calculation of the DC's occupational exposure limit (OEL) without toxicological data is not possible. Nevertheless, an OEL is needed to indicate the level of protection required to minimize risks for laboratory researchers and technicians. For this reason, simplified guidance is required to predict possible health hazards of DCs and their corresponding safe inhalation exposure levels. Here, we evaluated 860 drug substances (DS) with OELs calculated by Novartis and grouped the DSs by disease area (DA) and then their mode of action (MoA). 28% of the evaluated DSs (n = 242) had an OEL <10 µg/m3 and 72% (n = 618) had an OEL ≥10 µg/m3. Our evaluation confirms that in the absence of any compound-specific data, the default OEL of 10 µg/m3 is a reasonably safe exposure limit for small molecule DCs. Furthermore, our analysis suggests certain DAs and MoAs as valid criteria that may be integrated into a company's specific strategy for the assessment of data-poor compounds in order to identify DCs in an early stage of their development which require a default OEL <10 µg/m3.