Industry guidance on container closure integrity strategies for difficult-to-test parenteral products (DTPs).

BackgroundOccupational exposure to hazardous drugs is a recognised occupational risk in hospital pharmacy practice. Although international guidelines are available, the implementation is heterogeneous, and there are currently no formally endorsed national recommendations regarding the safety of pharmacy technicians in Portugal.ObjectiveTo develop consensus-based national recommendations for the safe handling of hazardous drugs by pharmacy technicians in Portugal.MethodsA modified Delphi study was conducted involving 43 invited experts from Portuguese hospital pharmacies. Fifty-eight statements were evaluated using a 0-10 agreement scale through one formal quantitative round, followed by a structured online consensus validation meeting and documentary confirmation. Consensus was predefined as a median score >7.ResultsThirty-six experts completed Round 1 (response rate 83.7%). All 58 statements voted on in Round 1 achieved consensus, with median scores of 10 for all recommendations and 98% of ratings ≥7. Following consolidation and merging procedures, the final set comprised 55 recommendations. The final recommendations were organised into five domains: occupational health surveillance, engineering controls and PPE, preparation technique and quality assurance, administrative safeguards, and environmental contamination and waste management.ConclusionsThis study establishes the first structured national consensus on hazardous drug handling safety for pharmacy technicians in Portugal. The resulting framework supports harmonisation of institutional practices, strengthens occupational risk governance, and provides a foundation for future implementation and evaluation studies.

Background: In the paediatric intensive care unit (PICU), certain drugs should be avoided or administered with strict precautions and close monitoring. This is due to their potential for toxicity or adverse effects or a lack of safety data, especially for critically ill children with organ failure. Additionally, practitioners must assess the unique pharmacokinetic and pharmacodynamic properties of drugs when treating critically ill children. In this narrative review, we highlight the risks, advantages, and disadvantages of three exemplary cases of drugs for paediatric patients hospitalised in the PICU: chloramphenicol, acetylsalicylic acid, and propofol. Methods: Apart from key papers on these drugs, a retrospective analysis of the English literature on chloramphenicol, acetylsalicylic acid (ASA), and propofol was performed on PubMed for papers from January 2014 to December 2025. Results: Chloramphenicol should be avoided in neonates due to the risk of grey baby syndrome. Acetylsalicylic acid (ASA) is contraindicated in children ≤18 years with suspected viral illness because of the risk of Reye's syndrome, but remains essential for Kawasaki disease and post-cardiac surgery antiplatelet therapy. Propofol should be avoided when used for a longer period at high doses. With proper dosing and monitoring, propofol-related infusion syndrome (PRIS) is preventable, but high-risk patients should receive alternative treatment. Conclusions: This narrative review highlights the significant risks associated with the use of chloramphenicol, ASA, and propofol in paediatric intensive care settings. Their potential for life-threatening and severe adverse reactions emphasises the need for cautious and informed use. Clinicians must carefully consider the risks and benefits of these drugs. To minimise adverse events, strict monitoring, dose adjustments, and the use of safer alternatives are essential. However, it appears that their use in well-defined circumstances in acute illness in children is still warranted. The findings of this narrative review underscore the need for further research to focus on identifying high-risk biomarkers, genetic predispositions, and safer alternatives to improve evidence-based guidelines and reduce morbidity and mortality in paediatric intensive care.

IntroductionThe purpose of this series of three studies was to identify the limitations of the 2015 NIOSH Vapor Containment Performance Protocol for Assessing Closed System Transfer Devices (CSTDs) as well as the variables that may impact results when testing CSTDs.MethodsTwo different lots of Equashield® CSTDs were tested in accordance with Task 2 of the protocol, using 70% isopropyl alcohol (IPA) as a challenge agent and either a Gasmet™ DX5000 Terra multigas FTIR analyzer or MIRAN® SapphIRe XL Infrared analyzer to measure IPA vapor concentrations. All studies were conducted in NIOSH-designed, custom-built testing chambers. Variables assessed to determine impact on results included: user technique, brand of IV bag, brand of IV administration line, where (inside or outside the chamber) IV bags, IV lines, and y-site adapter CSTDs were assembled, CSTD manufacturing dates, and analyzer type.ResultsThe variables that impacted testing results included user technique and experience, use or non-use of bulky gloves during y-site adapter-to-IV-line assembly, and analyzer. Variations in the brands of IV bags and IV administration lines and manufacturing dates of CSTDs did not impact the results.ConclusionBased on the known limitations of the 2015 NIOSH protocol, an improved testing protocol - with a better hazardous drug (HD) surrogate than IPA - is needed for assessing the true effectiveness of CSTDs in containing HDs. In the meantime, this protocol can be used to help CSTD manufacturers and/or end users isolate and mitigate potential weaknesses in their CSTD products and/or the compounding techniques used.

The reliable identification of narcotic and hazardous drugs in blood is of critical importance in forensic, clinical, and public health investigations. In this work, gas chromatography (GC) combined with quantitative structure–retention relationship (QSRR) modeling was employed to predict the retention times (RTs) of narcotic and hazardous drugs in blood samples. Experimental RTs of 75 drugs were determined using GC equipped with a non-polar HP-5 column, and a wide range of molecular descriptors was calculated from optimized molecular structures. Genetic algorithms were applied for descriptor selection, and linear and nonlinear predictive models, including GA-PLS, GA-KPLS, and artificial neural networks (ANN), were developed and evaluated using leave-group-out cross-validation and an external test set. The results demonstrated that nonlinear approaches provided superior predictive performance compared to linear models, with the ANN model showing the highest accuracy (R2 = 0.969 for the training set and 0.932 for the test set) and the lowest prediction errors. Analysis of selected descriptors revealed that molecular hydrophobicity, structural complexity, hydrogen bonding capability, and three-dimensional molecular features play a significant role in chromatographic retention behavior. Overall, the proposed QSRR and machine learning framework enables accurate prediction of GC retention times, reduces the need for extensive experimental measurements, and offers an efficient tool for the screening and analysis of novel narcotic and hazardous drug derivatives.

BackgroundCytotoxic drugs play a crucial role in cancer care but are highly hazardous to the health of healthcare workers if not handled safely. However, despite global guidelines for safe handling, knowledge and practice gaps persist, particularly in low- and middle-income countries (LMICs). There is no documented evidence in Ghana regarding this problem. The objective of this study was to evaluate the knowledge and practice of oncology personnel regarding safe handling of cytotoxic and hazardous drugs at Komfo Anokye Teaching Hospital, Ghana.MethodsA cross-sectional survey was conducted among 75 healthcare workers, comprising pharmacists, nurses, medical officers, and pharmacy technicians, who were involved in handling cytotoxic drugs. Data were gathered using a structured, pretested questionnaire and analysed using SPSS v20. Descriptive statistics and linear regression analyses were used to evaluate knowledge, practices, and predictors.ResultsMost respondents (mean age, 30.9 years) demonstrated good knowledge of safe handling practices, with a mean knowledge score of 7.67/10. All identified hand hygiene and worker protection as important safety practices. Significant gaps were identified; only 19% were aware of glove variability, and 15% knew that gowns could not be reused. Reported practices were good overall (mean practice score = 7.24/10), although 15% reported touching cytotoxic tablets with bare hands, and 19% reused personal protective equipment (PPE). The availability of PPE was high for gloves and aprons, but less so for head and shoe covers, which were also underutilised. Professional cadre was a significant predictor of knowledge (p = 0.022), but no factor significantly predicted practice.ConclusionWhile oncology personnel had high knowledge and compliance rates with safe handling procedures, there are crucial gaps, especially in the use of PPE and awareness of equipment standards. Regular training and institutional policy reinforcement are recommended to enhance safety and minimise occupational hazards in cytotoxic drug handling.

Intimate partner violence (IPV) victimization is associated with suicidal behaviour. Suicidal behaviour may also be raised among those who perpetrate IPV compared to those who do not; general population-based evidence is, however, lacking. We aimed to investigate the associations between using violence against an intimate partner with suicidal thoughts, suicide attempt and non-suicidal self-harm in the past year. We analysed data from the 2014 Adult Psychiatric Morbidity Survey. Logistic regressions estimated associations between IPV perpetration and suicide attempt, suicidal ideation, and self-harm. Associations were estimated for men and women separately, and we explored interaction in estimates by IPV victimization. After adjustment for demographic and socioeconomic covariates, lifetime IPV perpetration was strongly associated with past-year suicide attempt (men: odds ratio [OR] 3.6, 95% confidence interval 1.0-13.2, women: OR 4.2, 1.9-9.4), suicidal ideation (men: OR 2.7, 1.5-4.9, women: OR 2.6, 1.7-4.1) and self-harm (men: OR 4.9, 1.5-15.2, women: OR 3.3, 1.8-6.0). Estimates were substantially attenuated with adjustment for non-IPV life adversities, hazardous alcohol use, drug use and IPV victimization. Only the association with lifetime suicide attempt in women remained significant (OR 1.6, 1.1-2.3). Estimates were generally higher among those who had not experienced IPV victimization, although we found no evidence for interaction by IPV victimization on the association between IPV perpetration and suicidal behaviour. There were greater odds of suicidality and self-harm among self-reported perpetrators of IPV compared to the general population. Many of these associations were accounted for by non-IPV life adversities, IPV victimization and substance use. Improving the identification and management of IPV perpetration, and developing targeted safety planning and interventions for this group could reduce suicide for perpetrators and victims of IPV.

We examined prevalence and factors associated with STIs among MSM in Kenya. A cross-sectional analysis was conducted using baseline data from the Mbili Pamoja cohort study, which enrolled 501 MSM (250 in Kisumu and 251 in Nairobi) aged 18-39 years between June and November 2024. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) were detected in urine and clinician-collected rectal swabs. Multivariable logistic regression was used to identify factors associated with urethral and rectal CT/NG. The prevalence of urethral CT and/or NG infections was 9.2% in Kisumu and 3.7% in Nairobi; rectal CT and/or NG prevalence was 10.4% in Kisumu and 18.7% in Nairobi. In multivariable analysis, urethral CT/NG was more common among MSM aged 25-29 years vs. 18-24 years, last sex partner being a cisgender woman, and identifying as transgender or non-binary. Hazardous drug use was inversely associated with urethral STIs. Rectal STIs were increased for participants reporting receptive or versatile sexual role, group sex, being transgender/non-binary, and elevated depressive symptoms. Hazardous alcohol use, food insecurity, and recent antibiotic use were inversely associated with rectal infections. Self-reported dysuria and penile discharge showed low sensitivity (38.6% and 30.6%, respectively) and high specificity (>80%) for urethral infections. Rectal symptoms were infrequently reported but showed moderate sensitivity and high specificity. MSM in Kisumu and Nairobi have substantial burden of frequently asymptomatic urethral and rectal CT and NG infections. While some modifiable sexual exposures were identified, results also highlight the need for integrated mental health and substance use services.

PurposeExternal contamination of hazardous drug vials poses significant risks of environmental contamination and occupational exposure. This study evaluated the effectiveness of Vial Protect Pack shrink-tack labels (VPP I and II) in preventing surface contamination on vials containing doxorubicin, paclitaxel, and gemcitabine.MethodsA total of 150 vials from 14 production lots were tested: 60 doxorubicin vials (10 mg, 6 lots) with VPP I, 60 paclitaxel vials (30 mg/5 mL, 5 lots) with VPP II, and 30 gemcitabine vials (200 mg/5 mL, 3 lots) with VPP II. External vial surfaces were sampled using standardized wipe protocols and analyzed by liquid chromatography tandem mass spectrometry.ResultsAll 150 vials showed contamination levels below the analytical detection limits, indicating no measurable drug residues on external vial surfaces across all drugs and production lots tested. No lot-to-lot variation was observed.ConclusionVPP shrink-tack labels maintained external contamination below analytical detection limits on all tested vials, demonstrating their effectiveness as an engineering control to reduce occupational exposure. Incorporating vials with validated contamination-control technology into hospital procurement policies may enhance healthcare worker protection and support safer compounding practices.

ObjectiveTo review the pharmaceutical challenges associated with pediatric anticancer formulations and discuss current limitations, hospital practice difficulties, and emerging technological strategies to improve safety, accuracy, and acceptability of pediatric oncology treatments.Data SourcesRelevant literature on pediatric oncology formulations, compounding practices, and innovative drug-delivery technologies was analyzed using a narrative review approach.Data SummaryPediatric oncology presents unique pharmaceutical challenges due to the limited availability of age-appropriate anticancer formulations. Because most anticancer drugs are developed for adults, pediatric treatment frequently relies on off-label use and extemporaneous manipulation of dosage forms, raising concerns regarding dose accuracy, stability, excipient-related toxicity, and occupational safety in hospital settings. Extemporaneous compounding may lead to dosing variability, reduced stability, and healthcare professional exposure to hazardous drugs. Emerging approaches, including 3D-printed individualized mini-tablets, orodispersible films, nanocarrier-based delivery systems, physiologically based pharmacokinetic modeling, and therapeutic drug monitoring, show potential to improve dosing precision, safety, and treatment acceptability.ConclusionsThe lack of suitable pediatric anticancer formulations remains a major barrier to safe and effective therapy. Hospital pharmacists play a central role in mitigating formulation-related risks through controlled preparation and innovative practices. Integration of emerging pharmaceutical technologies into clinical practice may enable safer, more standardized, and individualized pediatric oncology treatments.

To describe the development and implementation of a standardized, pharmacy-led assessment of risk (AOR) process for investigational products (IPs) in compliance with United States Pharmacopeia (USP) chapter <800> across a large academic health network. USP <800> mandates institutions to maintain a hazardous drug list but offers limited guidance for investigational agents. The US National Institute for Occupational Safety and Health (NIOSH) has a published list of hazardous drugs that institutions should reference. However, the list only includes agents approved through December 2015, leaving a large gap in hazardous drug standardization for marketed products, providing less precedent for those working with investigational agents. In response, a multidisciplinary workgroup led by pharmacy services developed a system-wide IP AOR process. Two distinct tools incorporating toxicological and biosafety criteria were created to assess small-molecule and biopharmaceutical agents. A centralized database and oversight committee were established to ensure consistency, transparency, and regulatory compliance. As of July 2025, 255 IPs were assessed: 8 high-risk hazardous, 126 low-risk hazardous, and 121 nonhazardous agents. The process has enabled appropriate labeling, safe handling, and efficient review workflows across research pharmacies. The IP AOR process demonstrates the essential role of pharmacists in operationalizing USP <800> requirements for investigational drugs. This model supports occupational safety, regulatory compliance, and scalable implementation across health systems engaged in clinical research. The process outlined in this manuscript is applicable to both investigational agents and any newly marketed drugs being brought into an institution that haven't been reviewed by NIOSH for inclusion on their list.

Background: Surgical instrumentation nurses working in oncological operating rooms are occupationally exposed to cytostatic drugs through skin contact, inhalation, and ingestion. Procedures such as Hyperthermic Intraperitoneal Chemotherapy (HIPEC) represent a high-risk scenario with limited specific institutional protocols for this professional group. Objective: To describe and analyze the evidence-based protective measures for surgical instrumentation staff exposed to cytostatic drugs in the oncological operating room, based on a systematic review of the scientific literature published between 2020 and 2025. Methods: A systematic narrative review was conducted using the PubMed, Scielo, LILACS, and CINAHL databases. Studies published between January 2020 and December 2024 were included, using the MeSH terms: "cytostatics," "occupational exposure," "operating room nursing," "HIPEC," "hazardous drugs," "personal protective equipment." A total of 32 articles met the inclusion criteria. Results: Evidence shows that cutaneous and inhalatory routes are the main exposure pathways in the operating room. The use of double nitrile gloves, impermeable gowns, FFP2/FFP3 masks, and eye protection significantly reduces the risk of contamination. Engineering controls (closed transfer systems) and administrative protocols are the most effective measures. The correct sequence for donning and doffing personal protective equipment (PPE) is a critical step frequently neglected in clinical practice. Conclusion: Implementing a hierarchical risk-control strategy, specific institutional protocols, continuous training, and periodic health surveillance are essential to protect surgical instrumentation nurses from cytostatic-related occupational hazards.

Introduction/Rationale for Study: This retrospective, observational analysis evaluated real-world hazardous drug (HD) surface wipe test data collected from U.S. healthcare facilities following implementation of a closed-system transfer device (CSTD). Methods: Wipe test submissions collected between 2018 and 2022 were analyzed to characterize the frequency, magnitude, and distribution of HD contamination across hospital systems, care locations, and drug analytes under routine clinical practice conditions. Although pre-implementation (baseline) wipe data were not available, this analysis reflects real-world effectiveness of CSTD use in minimizing detectable HD surface contamination within participating facilities. Results: Among 5531 wipe samples analyzed, 4.45% demonstrated measurable contamination, with the majority originating from two hospital systems. Higher contamination frequencies were observed in patient administration rooms and infusion areas compared with other locations, with 5-fluorouracil demonstrating higher contamination frequency relative to other analytes. Conclusion: An independent statistical analysis corroborated the initial Sponsor findings, confirming that using the CSTD significantly minimizes contamination and the potential for HD exposure risks. Variability in contamination across facilities and locations highlights the need for standardized cleaning protocols and clear standards for acceptable limits in hazardous drug handling. Overall, these data provide insight into HD contamination patterns observed during routine clinical use of a CSTD and support continued optimization of handling practices, along with prospective studies employing standardized wipe protocols and pre/post implementation designs.

Protocol for the development and validation of a questionnaire to evaluate user-robot interaction in the compounding of hazardous drugs in a hospital setting.

IntroductionOccupational exposure to antineoplastic drugs remains a significant concern for healthcare workers. Surface contamination is a key indicator of exposure risks and reflects the effectiveness of practices. This study aimed to describe contamination with 11 antineoplastic drugs on 12 surfaces in Canadian healthcare centres participating in the 2025 monitoring program and to examine practices implemented by these centres, including the potential influence of hazardous drug committees.MethodsEach centre sampled six standardized sites in oncology pharmacies and six in outpatient clinics. Ultra-performance liquid chromatography-tandem mass spectrometry quantified cyclophosphamide, docetaxel, doxorubicin, etoposide, 5-fluorouracil, gemcitabine, irinotecan, methotrexate, paclitaxel and vinorelbine. Inductively coupled plasma mass spectrometry quantified platinum-based drugs. The Kolmogorov-Smirnov test assessed differences in contamination, and chi-square tests compared practice implementation.ResultsA total of 127 centres participated. Overall, 35% (504/1 453) of surfaces were contaminated, most frequently cyclophosphamide (22%, 90th percentile 0.0052 ng/cm2) and gemcitabine (14%, 0.0017 ng/cm2). The most contaminated sites were the front grille inside the biological safety cabinet (70%) and the armrest of the treatment chair (67%). More than half of centres (67/122, 55%) reported having a hazardous drugs committee. Cyclophosphamide surface contamination differed by committee presence and meeting frequency (p = 0.034). Centres with a committee were more likely to implement certain handling practices, including cleaning vials before storage (p = 0.004).ConclusionsSurface contamination remains frequent but at low concentrations, with evidence of improvement over time. Multidisciplinary committees, continuous monitoring and broader staff engagement are essential to strengthen safety culture and reduce occupational exposure.

Occupational exposure of healthcare workers to antineoplastic drugs can be prevented through the consistent use of protective measures. Despite clear scientific evidence of exposure risks, adherence to safety standards and use of personal protective equipment remain insufficient. The most frequently cited barriers include lack of training, weak safety culture, and inconsistent institutional policies. Training interventions have been shown to improve knowledge, attitudes, and performance related to safe handling. This study evaluated the effectiveness of an educational intervention on factors influencing the use of personal protective equipment among nurses who administer antineoplastic drugs, guided by the "Factors Predicting Use of Hazardous Drug Safe Handling Precautions" model. A single-group, before-and-after comparative design was applied. The study included 67 nurses from internal medicine, adult oncology, and pediatric oncology departments of a university hospital in western Turkey. Data were collected using the Hazardous Drug Handling Questionnaire before and three months after the intervention. The program was structured according to national and international guidelines and based on Pender's Health Promotion Model. Statistical analyses were conducted using paired sample t-tests and McNemar's test. The intervention led to significant improvements in knowledge of hazardous drug risks, self-efficacy, perceived risk, interpersonal modeling, and frequency of personal protective equipment use (p < 0.05). No significant changes were observed in perceived barriers, interpersonal norms, or perceived conflict of interest. Nurses' perceptions of workplace safety climate declined slightly after training (p = 0.047). Reports of the presence of written procedures and spill kits in units increased significantly. Moreover, the proportion of nurses associating health problems with occupational exposure nearly doubled after the intervention. The educational intervention effectively enhanced individual-level determinants of safe handling behaviors. However, the limited impact on organizational-level factors indicates that training alone cannot ensure sustained behavior change. These findings highlight the need for institutional strategies that include leadership engagement and supportive policies. Strengthening nurses' competencies and self-efficacy in personal protective equipment contributes to building a safety-oriented workplace culture and supports the delivery of safe, high-quality nursing care.

BackgroundCrushing oral hazardous medications (HMs) is often necessary for patients with swallowing difficulties; however, this practice poses significant health risks to caregivers and patients due to exposure to toxic particles and potential alteration of drug properties. Despite existing guidelines, practical implementation in home settings remains limited, especially in the absence of clear, accessible instructions.MethodsThis interventional study was conducted at a tertiary care hospital in Saudi Arabia. A formulary review identified 26 oral hazardous medications suitable for safe crushing, based on evidence from regulatory sources, leaflet products, and published literature. An educational intervention was developed, including bilingual infographics and standardized medication instructions disseminated via the hospital's electronic medical record (EMR) and mobile application. Fifty participants who were prescribed hazardous oral drugs and required manipulation at home completed a pre- and post-intervention survey assessing knowledge and practices related to preparation, storage, disposal, and spill management.ResultsSurvey findings revealed significant gaps in baseline knowledge: only 17 (34%) participants recognized hazardous medications, 13 (26%) understood associated risks, and 4 (8%) demonstrated appropriate spill management. Following the pharmacist-led intervention, all knowledge domains improved significantly (p < 0.001), with all 50 (100%) participants correctly identifying medication risks, preparation steps, safe disposal practices, and appropriate spill response. A validated list of 26 oral hazardous medications with evidence-based crushing instructions was also compiled to guide safe manipulation at home.ConclusionThis study highlights the effectiveness of pharmacist-led counseling and bilingual educational tools in improving caregiver awareness and safety practices when handling hazardous oral medications. Integration of standardized instructions into electronic systems, along with targeted education, can significantly reduce exposure risks in home settings. These findings support broader adoption of structured interventions to ensure safe medication handling and improve patient outcomes.

Translated article] Development of the mobile application Guide to medication reconciliation in the critically ill patient.

ObjectivesThe charging policy of pharmacy intravenous admixture service (PIVAS) is not merely a minor “billing issue” confined to individual hospitals, but rather a critical component that impacts the safety, efficiency, equity, and long-term sustainability of the national healthcare system. Its implications extend across patients, medical institutions, the pharmaceutical industry, and even the broader public health landscape. To establish a foundation for the national charging standard of intravenous admixture service, this study comprehensively investigated and analyzed the operational costs and current charging policies of PIVAS across 30 provinces in China.MethodsQuestionnaires were distributed through the “Wenjuan Xing” platform from May 6th to 1 July 2022. After data generation and export by the platform, statistical and descriptive analyses of the questionnaire results were conducted using statistical software, including EXCEL, SPSS.ResultsA total of 761 PIVAS surveyed, 91.59% were affiliated with the pharmacy department, while 6.70% belonged to the hospital independent department. Most PIVAS strongly agreed with imposing fees, while most tertiary hospitals agreed that dispensing fees should be categorized based on hospital levels; however, most secondary hospitals disagreed. Approximately 60.58% of PIVAS have implemented a charging system which allows charges after inspection and evaluation. Regarding changes for different drugs nationwide, common drugs had an average charge standard of 4.39 yuan per bag while antibacterial drugs averaged 5.01 yuan per bag. Hazardous drugs had an average charge of 23.17 yuan per bag, whereas parenteral nutrition solutions averaged 38.75 yuan per bag. The annual operating cost of PIVAS in China was approximately RMB 2,098,100, with the integrated operating cost comprising 89.36% of the total, while dispensing cost accounted for only 10.64%. Human costs emerged as the highest annual consumption (74.20%), followed by facility maintenance (4.77%) and equipment acquisition costs (3.44%).ConclusionThe lack of a unified inspection and evaluation standard as well as charging standard in China is currently an urgent issue that needs to be addressed. The existing charging standard falls below the recommended level, thus it is necessary to develop a more reasonable and equitable charging standard that takes into account operational costs. This study can serve as an empirical reference for national medical insurance and health administration authorities in establishing unified regulatory standards and dynamic pricing adjustment mechanisms for PIVAS. It contributes to the transition of PIVAS from “regionally fragmented management” to “nationally standardized operations,” thereby supporting the dual objectives of enhancing healthcare service quality and optimizing the utilization efficiency of medical insurance funds.

ABSTRACTThe treatment of non‐muscle invasive bladder cancer patients with intravesical mitomycin‐C reduces the chances of tumor recurrence. Mitomycin‐C is a hazardous drug and should be handled and administered safely by healthcare workers. Recently, a new ready‐to‐use administration system for mitomycin‐C has been developed. However, no research compares the healthcare workers' occupational exposure to mitomycin‐C during its administration using the conventional administration system versus the new administration system. The aim of this study was to compare the occupational exposure of healthcare workers to mitomycin‐C between two mitomycin‐C administration systems. This quasi‐experimental pilot study compared environmental contamination of mitomycin‐C between the conventional (n = 6) and the new (n = 6) administration system in a nursing ward and outpatient clinic. Surface wipe samples were taken from four locations where spillage could have occurred (n = 48). The data were analyzed using a two‐sample t‐test. Mitomycin‐C traces were found in two samples that exceeded the lower limit of quantification (0.09 and 0.14 ng/cm2). Both samples were from healthcare workers' gloves using the conventional administration system. No statistically significant difference was found when comparing the two systems (p = 0.18). The results indicate that both systems are safe to use in inpatient and outpatient clinical settings. Given that the new system is safe, this point‐of‐care preparation product may offer advantages for both the urology and hospital pharmacy departments.