Effectiveness of Closed System Drug Transfer Devices in Reducing Leakage during Antineoplastic Drugs Compounding

Piccardo, Maria Teresa; Forlani, Alessandra; Izzotti, Alberto

doi:10.3390/ijerph18157957

Cited by 3 publications

(3 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Different brands of CSTDs may also offer different performances (Piccardo 2021). 23 The NIOSH CSTD containment protocol that was proposed in 2015 is still unpublished. 24 Diverging conclusions as to which CSTD would be approved per this draft procedure were published.…”

Section: Discussionmentioning

confidence: 99%

Canadian monitoring program of the surface contamination with 11 antineoplastic drugs in 122 centers

Delafoy

Roussy

Hudon

et al. 2022

J Oncol Pharm Pract

View full text Add to dashboard Cite

Introduction Occupational exposure to antineoplastic drugs can lead to long-term adverse effects on workers’ health. Environmental monitoring is conducted once a year, as part of a Canadian monitoring program. The objective was to describe contamination with 11 antineoplastic drugs measured on surfaces. Methods Six standardized sites in oncology pharmacy and six in outpatient clinic were sampled in each hospital. Samples were analyzed by ultra-performance liquid chromatography coupled with tandem mass spectrometry (non-platinum drugs) and by inductively coupled plasma mass spectrometry (platinum-based drugs). The limits of detection (in ng/cm2) were: 0.0006 for cyclophosphamide; 0.001 for docetaxel; 0.04 for 5-fluorouracil; 0.0004 for gemcitabine; 0.0007 for irinotecan; 0.0009 for methotrexate; 0.004 for paclitaxel, 0.009 for vinorelbine, 0.02 for doxorubicine, 0.0037 for etoposide and 0.004 for the platinum. Sub-analyses were done with a Kolmogorov-Smirnov test Results 122 Canadian hospitals participated. Cyclophosphamide (451/1412, 32% of positive samples, 90th percentile of concentration 0.0160 ng/cm2) and gemcitabine (320/1412, 23%, 0.0036 ng/cm2) were most frequently measured on surfaces. The surfaces most frequently contaminated with at least one drug were the front grille inside the biological safety cabinet (97/121, 80%) and the armrest of patient treatment chair (92/118, 78%).The distribution of cyclophosphamide concentration was higher for centers that prepared ≥ 5000 antineoplastic drug preparations/year (p < 0.0001). Conclusions This monitoring program allowed centers to benchmark their contamination with pragmatic contamination thresholds derived from the Canadian 90th percentiles. Problematic areas need corrective measures such as decontamination. The program helps to increase the workers’ awareness.

show abstract

Section: Discussionmentioning

confidence: 99%

Canadian monitoring program of the surface contamination with 11 antineoplastic drugs in 122 centers

Delafoy

Roussy

Hudon

et al. 2022

J Oncol Pharm Pract

View full text Add to dashboard Cite

show abstract

“…Closed system drug-transfer devices are not a substitute for class II type B BSC. There is evidence from studies 24 – 48 that closed-system drug-transfer devices can reduce contamination during preparation and increase or extend the beyond-use date of a drug. Further emerging evidence suggests that when these devices are not used as specified, they could become open to the environment.…”

Section: Recommendationsmentioning

confidence: 99%

Safe handling of hazardous drugs

Kennedy

Coakley

et al. 2022

J Oncol Pharm Pract

View full text Add to dashboard Cite

Background: This evidence-based practice guideline was developed to update and address new issues in the handling of hazardous drugs including being compliant with NAPRA (National Association of Pharmacy Regulatory Authorities) and USP 800 (United States Pharmacopeia) standards, the use of personal protective equipment and treatment in diverse settings including in the home setting. Methods: This guideline was developed from an adaptation and endorsement of existing guidelines and from three systematic reviews. Prior to publication, this guideline underwent a series of peer, patient, methodological and external reviews to gather feedback. All comments were addressed and the guideline was amended when required. This guideline applies to and is intended for all health care workers who may come into contact with hazardous drugs at any point in the medication circuit. Results: The recommendations represent a reasonable and practical set of procedures that the intended users of this guideline should implement to minimize the opportunity for accidental exposure. These recommendations are not limited to just the point of care, but cover the entire chain of handling of cytotoxics from the time they enter the institution until they leave in the patient or as waste. Conclusions: Decreasing the likelihood of accidental exposure to cytotoxic agents within the medication circuit is the main objective of this evidenced-based guideline. The recommendations differ slightly from previous guidelines due to new evidence.

show abstract

“…Overall, the chemotherapeutic process is complex, and errors can occur at all stages, ranging from prescription and compounding to administration. All these stages must be carefully monitored in order to contain and reduce the risk of errors that can impact the health of patients and healthcare personnel involved [1][2][3]. To contain the risk, the compounding activity takes place in Pharmaceutics 2023, 15, 1429 2 of 17 dedicated centralized production units (CPU) in hospitals, named UFA (Unità Farmaci Antiblastici, unit for cytotoxic drug preparations) in Italy [4], under the responsibility of the pharmacists whose competences include organization, management and chemotherapy validations, while technicians are responsible for the final preparation [5,6].…”

Section: Introductionmentioning

confidence: 99%

A Method for Risk Assessment Evaluating the Safety, Stability and Efficacy in Clinical Practice of Anticancer Drug Preparations in the Centralized Compounding Unit of the Veneto Institute of Oncology-IRCCS

Rigamonti,

Sebellin,

Pipitone

et al. 2023

Pharmaceutics

View full text Add to dashboard Cite

Background. Preparation of injectable anticancer drugs in hospital pharmacies is a high-risk activity that requires a proper risk assessment (RA) and quality assurance system (QAS) to ensure both a decrease in risk associated with chemotherapy compounding and high quality of the final product, especially in terms of its microbiological stability. Methods. At the centralized compounding unit (UFA) of the Italian Hospital IOV-IRCCS, a quick and deductive method was applied to evaluate the “added value” provided by each prescribed preparation, and its RA was calculated applying a formula that integrates different pharmacological, technological and organizational aspects. According to specific RA range values, the preparations were divided into different risk levels, in order to determine the QAS to be adopted, according to the Italian Ministry of Health guidelines, whose adherence was meticulously evaluated through a specific self-assessment procedure. A review of the scientific literature was carried out to integrate the risk-based predictive extended stability (RBPES) of drugs with data concerning their physiochemical and biological stability. Results. Based on the self-assessment comprising all microbiological validations of the working area, personnel and products, the microbiological risk level within the IOV-IRCCS’ UFA was defined through the creation of a transcoding matrix, conferring a microbiological stability to preparations and vial leftovers of a maximum of 7 days. The calculated RBPES were successfully integrated with stability data from the literature, leading to the drafting of a stability table of drugs and preparations in use in our UFA. Conclusions. Our methods allowed us to perform an in-depth analysis of the highly specific and technical process of anticancer drug compounding in our UFA, ensuring a certain grade of quality and safety to preparations, especially in terms of microbiological stability. The resulting RBPES table represents an invaluable tool with positive repercussions at organizational and economic levels.

show abstract

Effectiveness of Closed System Drug Transfer Devices in Reducing Leakage during Antineoplastic Drugs Compounding

Cited by 3 publications

References 25 publications

Canadian monitoring program of the surface contamination with 11 antineoplastic drugs in 122 centers

Canadian monitoring program of the surface contamination with 11 antineoplastic drugs in 122 centers

Safe handling of hazardous drugs

A Method for Risk Assessment Evaluating the Safety, Stability and Efficacy in Clinical Practice of Anticancer Drug Preparations in the Centralized Compounding Unit of the Veneto Institute of Oncology-IRCCS

Contact Info

Product

Resources

About