Safe Handling Of Cytotoxic Drugs Research Articles

Enhancement of paediatric oncology pharmacy practices in a low-middle-income country through teaching and training using the My Child Matters Grant.

The development of a successful oncology pharmacy system includes competency training, cost-efficient procurement, proper storage, preparation and administration of chemotherapy, and appropriate waste disposal. Low-middle-income countries such as Pakistan face several challenges within the realm of oncology pharmacy such as the unavailability of training programmes, resources and financial support, and inconsistencies in the safe handling of cytotoxic drugs. The Indus Hospital and Health Network (IHHN) is among the pioneers of oncology pharmacy practices in Pakistan, with a well-established Oncology Pharmacy Team and chemotherapy preparation in accordance with the United States Pharmacopeia 797 and 800 safety guidelines. The My Child Matters Grant was awarded by the Sanofi Espoir Foundation to the Department of Paediatric Hematology and Oncology at IHHN for holistic improvement in childhood cancer care through teaching, training and capacity building. Partnerships were formed with five public-sector paediatric oncology units nationwide. Initiatives were taken to improve oncology pharmacy practices including teaching and training courses, in-person assessment visits, and mentorship and liaison efforts. Despite prevailing challenges, promising improvements were noted at each centre. However, Pakistan needs to establish a national plan for childhood cancer with the creation of regional organisations for the training and monitoring of oncology pharmacists. Centralisation of pharmacy operations within hospitals is essential to maintain the availability, storage, preparation and administration standards of chemotherapy.

A simple and inexpensive method to monitor and minimize exposure from manipulation of cytotoxic drugs.

Pharmacy personnel that manipulate cytotoxic drugs are under continuous exposure risk. Therefore, training and strict adherence to recommended practices should always be promoted. The main objective of this study was to develop and apply a safe, effective and low-cost method for the training and assessment of the safe handling of cytotoxic drugs, using commercially available tonic water. To evaluate the potential of tonic water as a replacement marker for quinine hydrochloride, deliberate spills of 1 mL of four different tonic waters (one coloured and three non-coloured) were analysed under ultraviolet light (300-400 nm). The pigmented sample did not produce fluorescence under ultraviolet (UV) light. The three commercially available tonic waters that exhibited fluorescence were further analysed by UV/Vis spectrophotometry (300-500 nm). Afterwards, a protocol of simulated manipulation of cytotoxic drugs was developed and applied to 12 pharmacy technicians, that prepared 24 intravenous bags according to recommended routine procedures using tonic water. Participants responded to a brief questionnaire to evaluate the adequacy and applicability of the activity. Seven of the participants had spillages during manipulation, the majority of which recorded during manipulation with needles. All participants scored the tonic water manipulation simulation with 4 or 5 points for simplicity, efficiency and feasibility. The obtained results suggest that tonic water can be used to simulate the manipulation of cytotoxic drugs in training and assessment programs. By using this replacement marker for quinine hydrochloride, it is possible to perform a more cost-effective, yet equally effective, assessment.

Kicking the glove habit

British Journal of NursingVol. 32, No. 2 EditorialKicking the glove habitAndrew BartonAndrew Barton(E-mail Address: [email protected])Nurse Consultant, Vascular Access and IV Therapy, Frimley Health NHS Foundation Trust, and Chair, NIVASSearch for more papers by this authorAndrew BartonPublished Online:30 Jan 2023https://doi.org/10.12968/bjon.2023.32.2.S3AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References European Centre for Disease Prevention and Control. Use of gloves in healthcare and non-healthcare settings in the context of the COVID-19 pandemic. 2020. https://tinyurl.com/mwc4suc8 (accessed 16 January 2023) Google ScholarHealth and Safety Executive. The use of gloves. 2022a. https://tinyurl.com/ypwhc5rf (accessed 16 January 2023) Google ScholarHealth and Safety Executive. Safe handling of cytotoxic drugs in the workplace. 2022b. https://tinyurl.com/4s8f374j (accessed 16 January 2023) Google ScholarLoveday HP, Wilson JA, Pratt RJ et al. epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect. 2014;86(Suppl 1):S1-70. https://doi.org/10.1016/S0195-6701(13)60012-2 Crossref, Medline, Google ScholarWilson J, Bak A, Loveday HP. Applying human factors and ergonomics to the misuse of nonsterile clinical gloves in acute care. Am J Infect Control. 2017;45(7):779-786. https://doi.org/10.1016/j.ajic.2017.02.019 Crossref, Medline, Google Scholar FiguresReferencesRelatedDetails 26 January 2023Volume 32Issue 2ISSN (print): 0966-0461ISSN (online): 2052-2819 Metrics History Published online 30 January 2023 Published in print 26 January 2023 Information© MA Healthcare LimitedPDF download

Practices On Safe-Handling of Cytotoxic Drugs Among Oncology Nurses in Two Public Sector Hospitals

Administration of cytotoxic medicines (CDs) and occupational exposure to them are global issues. Inappropriate handling can lead to harmful residues getting into patient care areas, hospitals, and even the homes of patients. Objectives: To access the practices of nurses regarding safe handling of cytotoxic drugs and to evaluate the association among the level of practices and socio-demographic profile of the participants. Methods: Analytical cross-sectional study was carried out among 183 nurses of oncology department of public sector tertiary care hospitals, Lahore, Pakistan. The nurses working in oncology departments of age ranges 20 years to 50 years and having at least six months’ experience in oncology units were included in the study. Results: The majority (56%) of the nurses reported “Good Practices” regarding safe handling of cytotoxic drugs followed by Fair practices (38%) and poor practices (6%). No significant association was reported among the level of practices and socio-demographic profile of the participants. Conclusions: Safe handling of cytotoxic drugs is very important aspect and the nurses can prevent their selves as well as the patients from complications. Overall, good practices were reported by the nurses regarding safe handling of cytotoxic drugs but still a large proportion of the nurses have fair and poor practices. Effective measures are needed to enhance the practices of nurse’s working in oncology nurses regarding safe handling of cytotoxic drugs

CN32 Cancer nurses' experiences and perceptions of potential occupational exposure to cytotoxic drugs: Systematic review utilising framework analysis

In the UK control of substances Hazardous to Health Regulations (COSHH) define chemotherapy as a hazardous substance. Therefore, it is imperative that employers assess the risk and take suitable precautions for their employees. The ‘Safe Handling of Cytotoxic Drugs in the workplace’ recommends a hierarchy of protection; closed systems and personal protection equipment (PPE) to reduce the exposure to cytotoxic drugs. In the UK, closed systems are not mandatory, and the evidence base for use is inconclusive.

Safe handling of cytotoxic drugs practices for nurses working with patients in middle euphrates oncology teaching hospitals

Background: The expanding use of chemotherapy medications has resulted in an increase in chemotherapeutics exposures amongst nurses who work in oncology departments. Chemotherapy drugs agents may have toxicological consequences in humans, such as carcinogenic effects, teratogenic effects, and mutagenicity (Sarita Devi, 2019). Objectives of the study: to assess nurses practices for safe preparation and administration of cytotoxic drugs in the oncology teaching hospitals. Methodology: descriptive–observational study design carried out to assess the nurses practices regarding safe of the preparation and administration of cytotoxic drugs .purposeful sample from (125) nurses who provide direct care for patient receiving chemotherapy drugs were selected. Result: Represent that most of the sample shows fair practice regarding preparation of chemotherapy (cytotoxic) that considered as key element of handling of cytotoxic medications in a safe manner, also that the majority of the nurses who participate in the study related to practical level of the study sample related to chemotherapy administration fair. Conclusion: Regarding the nurses practices with respect to the safe handling of cytotoxic drugs during their daily caring in the oncology units the statistical results recorded moderate level of practices.

Development and Proof of Concept of an Audit Toolkit for the Safe Handling of Cytotoxic Drugs in Low- and Middle-Income Countries.

PURPOSEChemotherapies are considered high-risk drugs for patient and staff safety. Considering the rising burden of cancer and the increasing use of chemotherapy drugs in low- and middle-income countries (LMICs), promoting continuous improvements in the safety and quality of practices in these settings is essential. This paper describes the development and proof of concept of a toolkit to audit chemotherapy handling practices in the health care facilities of LMICs.METHODSA steering committee defined the audit method and the toolkit content. Several checklists were developed to facilitate the audit and data collection. Items included in checklists were derived from key reference works on safe handling. Different tools were validated using Delphi surveys and expert reviews. Audits of pilot sites were performed to test the toolkit's applicability and relevance.RESULTSThe toolkit contains a 134-item global assessment tool for the different processes at each step of the medication pathway and three step-specific observation checklists to assess different health workers' practices during the prescription, preparation, and administration of chemotherapies. The toolkit also proposes using a surface-wipe sampling method to measure any cytotoxic contamination of the immediate environment. The toolkit was tested in three teaching hospitals in Africa.CONCLUSIONThe toolkit developed was successfully implemented in a variety of LMIC settings, providing a comprehensive evaluation of the quality and safety of the chemotherapy drug handling practices in participating health care facilities. This toolkit can help facilities in LMICs to implement a new approach to continuously improving the quality and safety of their practices and ultimately ensure patient and staff safety.

'KNOWLEDGE REGARDING SAFE HANDLING OF CYTOTOXIC DRUGS AMONG STAFF NURSES WORKING IN SELECTED HOSPITALS, KAMRUP (METRO), ASSAM, WITH A VIEW TO DEVELOP AN INFORMATION BOOKLET: A DESCRIPTIVE STUDY'.

National Institute for Occupational Safety and Health (NIOSH), 2019 stated that about 8 million healthcare workers are potentially exposed to hazardous drugs in their workplace. Indian Council of Medical Research (ICMR), 2019 reported around 16.9% of nurses had their skin or eyes exposed to chemotherapy drugs. Widespread use of cytotoxic drugs in the treatment of cancer has led to higher health hazards among nurses who handle and administer such drugs, so nurses should know how to protect themselves from the effects of cytotoxic drugs by following safety measures during preparation, administration of cytotoxic drugs, cytotoxic waste disposal, cytotoxic spills and rationale use of PPE (Personal Protective Equipment) like mask, cap, two pairs of gloves, gown and shoe cover. Aim: The aim of the study was to assess the knowledge regarding safe handling of cytotoxic drugs among staff nurses working in selected hospitals, Kamrup(Metro), Assam. Methods And Materials: A quantitative descriptive study was conducted on safe handling of cytotoxic drugs among staff nurses.100 staff nurses who were working in selected hospitals, Kamrup (Metro), Assam and who fullled the inclusion criteria have been selected by using convenience sampling technique. The conceptual framework used in the study was based on modied Ludwig Von Bertalanffy (1968) general system theory. The tools used for the study were structured knowledge questionnaire to assess the knowledge regarding safe handling of cytotoxic drugs. Results: Data analysis was done by calculating mean, SD and chi-square test. It was found that majority i.e.56% of the staff nurses had moderate knowledge, 38% had adequate knowledge and 6% had inadequate knowledge. There was signicant association of knowledge with selected demographic variables like working area, physical contact towards cytotoxic drugs exposure and training attended on safe handling of cytotoxic drugs. However, there was no signicant association of knowledge with other demographic variables i.e. age, educational qualication, specialized oncology training, total years of working experience and total years of experience in specic working area. Conclusion: Through this study, the investigator concluded that staff nurses are moderately aware regarding safe handling of cytotoxic drugs. It was expected that all the staff nurses should have adequate knowledge on safe handling of cytotoxic drugs. An information booklet was provided to the staff nurses of selected hospitals and vigorous training should also be provided to the staff nurses inorder to update their body of knowledge.

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

BackgroundCytotoxic 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.MethodsThe 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.ResultsMean 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).ConclusionNurses’ 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.

Cyto-SAT: A self-assessment tool for the safe handling of cytotoxic drugs adapted for use in low- and middle-income countries.

The handling of cytotoxic medicines is a high-risk process for human and environmental health. Considering the rising burden of cancer in low- and middle-income countries (LMICs), we aimed to develop, validate, and pilot test a self-assessment tool to support the implementation of safe handling practices and promote continuous quality improvement for cytotoxic drug management in LMICs. First, the self-assessment tool Cyto-SAT was developed and validated. Key sources on the safe handling of cytotoxic medicines were reviewed to derive items addressing safety and quality aspects at every stage of the process. A two-round online Delphi survey was conducted to validate and prioritize the items. The validation rules in the first and second rounds were defined as ≥65% and ≥75% agreement, respectively. Then, intended users in healthcare facilities in LMICs evaluated the Cyto-SAT tool in a pilot test. They were asked to fill out an online evaluation questionnaire. Twenty-seven experts from 13 high-income countries and LMICs participated in the Delphi survey. Final expert consensus was achieved for 134/137 (97.8%) items. Consensus on priority was achieved for 52 of 134 (38.8%) items. The final Cyto-SAT tool comprises 134 items in 10 domains and 28 subdomains covering the whole cytotoxic drug handling process (https://pharmed.datapharma.ch/cyto-sat_en/). Staff from 34 institutions in 28 LMICs completed the Cyto-SAT evaluation. Almost all of them reported total agreement or agreement with its usefulness (96%), applicability (94%), usability (98%), and acceptability (97%). Cyto-SAT is the first self-assessment tool designed to assist professionals in LMICs in the safe handling of cytotoxic drugs. The pilot test revealed that Cyto-SAT is a useful and highly appreciated tool that supports practice improvement in LMICs. Cyto-SAT will be used in an international survey to obtain a global overview of handling practices in various LMIC settings.

KNOWLEDGE, ATTITUDES AND PRACTICES OF SAFE HANDLING OF CYTOTOXIC DRUGS AMONG ONCOLOGY NURSES IN TANTA UNIVERSITY HOSPITALS

Introduction: Occupational exposure to antineoplastic agents and safe handling of cytotoxic drugs (CDs) had gained a high concern among oncology nursing staff due to their potential health risks. Many organizations such as Occupational Safety and Health Administration (OSHA), Oncology Nursing Society and National Institute for Occupational Safety and Health (NIOSH) have recommended guidelines for safe handling of cytotoxic drugs. Aim of work: To assess the knowledge, attitudes, and practices (KAP) of oncology nursing staff working at Tanta University Hospitals towards the safe handling of CDs. Materials and methods: A cross-sectional study was conducted for 3 months (from February to April, 2018) at the Oncology department in Tanta University Hospitals, Egypt. A pre-designed questionnaire was used to assess nurses` KAP regarding safe handling of CDs. Results: A total of 55 oncology nurses participated in the study. The total KAP scores of nurses towards the safe handling of CDs were satisfactory among 63.6% of the studied group. The mean scores of responses for knowledge, attitudes, and practices were 19.05 ± 4.8 out of 26, 13.09 ± 3.07 out of 16, and 8.87 ± 1.35 out of 12, respectively. More than half of the nurses had previous training in the Oncology department. Defective use of personal protective equipments (PPE) during various steps of CDs handling was noticed. Conclusion: There was inadequate practice of safe handling of CDs and defective implementation of guidelines among the studied oncology nurses, necessitating more frequent in-service training and audit system to monitor and evaluate their performance after training.

ASHP Guidelines on Handling Hazardous Drugs.

ASHP published its first guidance on hazardous drugs (HDs) in 1983 as part of the 1983–84 ASHP Practice Spotlight: Safe Handling of Cytotoxic Drugs.[1][1],[2][2] This was followed by technical assistance bulletins in 1985 and 1990 and the ASHP Guidelines on Handling Hazardous Drugs in 2006.[3][3

Safe Handling of Cytotoxic Drugs and Use of Personal Protective Equipment among Nurses at a Regional Cancer Center

Safe Handling of Cytotoxic Drugs and Use of Personal Protective Equipment among Nurses at a Regional Cancer Center

Impact of educational intervention on knowledge regarding safe handling of cytotoxic drugs among the nursing personnel working in BPKIHS

Introduction: Cytotoxic drugs are toxic compounds and are known to have carcinogenic, mutagenic and/or teratogenic potential. It is also considered as hazardous drugs. With direct contact they may cause irritation to the skin, eyes, and mucous membranes, and ulceration and necrosis of tissue. Safe handling refers to the process in which health care workers adhere to evidence-based practices (EBP) set forth by national organizations that have been designed to eliminate or significantly reduce occupational exposure. The key to safe handling is to protect the health care worker throughout the three phases of contact with the hazardous drugs. These phases are drug preparation, administration and disposal.Objective: To assess the effectiveness of education in enhancing the knowledge regarding safe handling of cytotoxic drugs among nursing personnel working at BPKIHS.Methods: Fifty nurses were taken as sample from selected ward of BPKIHS. One group pretest post test design was used by using population enumeration methods.Results: The overall mean score of knowledge on safe handling cytotoxic drugs of the respondents were 35.3 in the pre-test which increased to 83.7 in the post-test after an educational intervention. The difference was significant (p&lt;0.001).Conclusion: Thus, the study's findings highlighted that there was a significant improvement in knowledge of the staffs after educational intervention. The educational intervention was very effective to improve the knowledge of the staffs. Health Renaissance 2015;13 (1):

Developing guidelines for the safe handling of cytotoxic drugs in academic research laboratories

Developing guidelines for the safe handling of cytotoxic drugs in academic research laboratories

Developing guidelines for the safe handling of cytotoxic drugs in academic research laboratories

Developing guidelines for the safe handling of cytotoxic drugs in academic research laboratories

Preventing the contamination of hospital personnel by cytotoxic agents: evaluation and training of the para-professional healthcare workers in oncology units.

This study was specifically focused on para-professional healthcare workers (PHCWs) who handle cytotoxic drugs and contaminated wastes at the Public Teaching Hospitals of Marseille (AP-HM), France. It first aimed at evaluating the knowledge and professional practice of the PHCWs who belong to a personnel category among the less informed and protected in hospitals. In a second time, this study also proposed to raise awareness, educate and train the staff on protective measures to minimise the exposure of the PHCWs to the potential toxicity of anticancer chemotherapy agents (or metabolites) when cleaning and handling both cytotoxic drugs and wastes. Among the 11 oncology units evaluated, 82% completed an assessment survey, 63% of which were PHCWs. Out of nine oncology units assessed, 89% reported limited knowledge of the general risk and of the safe handling of cytotoxic drugs, 89% reported using vinyl gloves which are the less protective ones. Forty-four per cent of the units used wet sweeping techniques for cleaning the floors, and 11% of the units did not have specific procedures for cleaning the equipments used for collecting contaminated excreta. Protective outer apparel was not always worn and chemotherapy wastes were not managed consistently between all units. Standardized procedures and guidelines to prevent occupational exposure were not used by PHCWs. More education and training are needed to improve safety.

Development and implementation of a regional program for the safe handling of hazardous drugs by hospital pharmacies.

Providing a safe work environment is an important goal for any hospital pharmacy department. Historically, great care has been exercised in the receipt, storage, preparation, distribution, administration, and disposal of cytotoxic drugs. Although other drugs have been acknowledged as potentially hazardous, most facilities do not have processes to identify and ensure their safe and consistent handling. Existing medication and chemical safety programs have limitations in their applicability to hospital pharmacy practice. For example, the Workplace Hazardous Material Information System excludes prescription drugs. The US National Institute for Occupational Safety and Health (NIOSH) recommends full handling precautions for all hazardous drugs. However, in a busy, diverse hospital pharmacy practice, application of such procedures may be impractical. The Canadian Society of Hospital Pharmacists (CSHP), in its “Hazardous Pharmaceuticals (Including Cytotoxic Drugs): Guidelines for Handling and Disposal”, provides information about general issues related to handling hazardous products, but greater detail (for example, a list of specific drugs considered hazardous) was required to develop procedures for use by front-line staff. The Winnipeg Regional Health Authority (WRHA) is a publicly funded organization that delivers acute, long-term, and community health services in Winnipeg, Manitoba (population catchment 800 000). The WRHA Pharmacy Program has a staff of approximately 150 full-time equivalent pharmacists and 150 full-time equivalent pharmacy technicians. Staff members of the WRHA Pharmacy Program deliver and manage pharmacy care at 8 facilities totalling about 2000 beds and provide selected pharmacy services for WRHA-affiliated clinics, personal care homes, and community health agencies. The WRHA has a single formulary for all acute care facilities. This article describes the development and implementation of the Safe Handling of Hazardous Drugs Program within the WRHA Pharmacy Program. The purpose of this project was to develop practical guidelines for the safe handling of all potentially hazardous drugs. In 2007, the WRHA introduced a new policy for handling parenteral cytotoxic drugs, which was applicable to all regional staff. However, information was lacking about the safe handling of cytotoxic drugs administered by other routes and handling of potentially hazardous non-cytotoxic drugs; therefore, the WRHA Pharmacy Program struck a Hazardous Drugs Task Force. The regional Nursing Leadership Council was invited to participate in this task force, to help in developing safe handling processes for hazardous drugs that would also be applicable to nursing staff, but the Council chose not to participate; instead, they focused on implementation and education related to the new policy for cytotoxic drugs. Therefore, the task force worked on processes for the safe handling of hazardous drugs within the pharmacy, with the understanding that other health care disciplines would be included later, at a time of their choosing.

Paclitaxel Exposure and its Effective Decontamination

ABSTRACTBackgroundApart from generic guidelines for the safe handling of cytotoxic drugs in pharmacy departments, there is no specific published literature pertaining to cleaning procedures and inadvertent exposure to paclitaxel.AimTo examine occupational exposure to paclitaxel; to identify an effective decontamination reagent; and to determine suitable glove type for skin protection.Method8 decontamination reagents were tested for paclitaxel degradation. Air sampling filters, Ghost Wipes and cotton wipes were tested under different storage conditions (room temperature, ≤ 4 °C) for 3 days. Disposable latex and nitrile gloves were tested for paclitaxel permeation using a one‐inch ASTM standard test cell. Environmental (airborne and surface) monitoring was carried out in the cytotoxic compounding and work areas. High performance liquid chromatography and photo‐ionisation detector were used for sample analysis and glove permeation tests, respectively.ResultsIsopropanol 50% and ethanol 60% demonstrated the least degradation (&lt; 2%) of paclitaxel in 80 minutes. Sodium hypochlorite 0.5% w/v showed the greatest degradation (&gt; 99%) of paclitaxel in 20 minutes. Sample wipes should be stored at ≤ 4 °C until analysis. Paclitaxel and sodium hypochlorite 0.5% w/v did not permeate through the latex and nitrile gloves after 4 hours of continuous exposure. No paclitaxel was detected in airborne and surface wipe samples.ConclusionNo detectable paclitaxel was measured within the cytotoxic compounding area. Sodium hypochlorite 0.5% w/v is a suitable decontamination reagent for paclitaxel surface contamination. Wearing either latex or nitrile gloves can prevent contamination when handling paclitaxel.

A centralized Pharmacy Unit for cytotoxic drugs in accordance with Italian legislation

In May 2002, a centralized Unit for cytotoxic drug preparations [Unità Farmaci Antiblastici (UFA)] was established at the Centro di Riferimento Oncologico, Aviano, Italy. The Unit was created following provisions under Law 626/94 (Legislative Decree - Ministry of Health), governing the safe handling of cytotoxic drugs. New guidelines governing drug preparation ('NBP' standards of preparation) published in Italian Pharmacopoeia (2002, XI Edition) have been mandatory since 2004 and set out rules for proper pharmacy practice applicable also to antineoplastic drug preparations. Aims and objectives To review legislation on cytotoxic drug preparation and compliance within our Unit, to assess current quality levels and identify those areas requiring improvement. The study reviewed: (1) the organization and equipment of the Unit UFA and its working methodology; (2) written documentation concerning work procedures; (3) the stability and sterility of injectable drug formulations; (4) staff training, occupational exposure and risk management; (5) accidents and mistakes occurring in the UFA service. The study showed up the strengths of our Unit and identified those areas which need improvement to guarantee product quality excellence. A critical evaluation of the whole cytotoxic preparation process is a useful method for quality improvements to be initiated. Knowledge regarding risks, techniques, and procedures for handling antineoplastic drugs is growing. Ongoing analysis will ensure greater patient and health care worker safety.