Review of economic data on closed system transfer drug for preparation and administration of hazardous drugs

Soubieux, Annaelle; Tanguay, Cynthia; Lachaine, J.; Bussières, J.-F.

doi:10.1136/ejhpharm-2018-001775

Cited by 5 publications

(11 citation statements)

References 19 publications

(26 reference statements)

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“…The CM-directive (Directive 2004/37/EC of the European Parliament and of the Council on the Protection of Workers from the Risks Related to Exposure to Carcinogens or Mutagens at Work) is up for revision in 2023 or 2024. In the run-up to that process, the producers of CSTDs are lobbying strongly to get their devices included in the guidelines,29 despite the lack of independent scientific evidence to support their added value compared with the method of using spikes,30 the higher costs for healthcare systems when implementing CSTDs,31 and the emerging evidence that, in some cases, CSTDs can compromise the quality of drug products through particle formation 32 33. Following persistent pressure from professional associations such as the European Oncology Nursing Society (EONS), European Cancer Organisation (ECO) and ESOP, the Directorate-General of Employment, Social Affairs and Inclusion of the EU launched an investigation to study the current situation in its member states.…”

Section: Discussionmentioning

confidence: 99%

Safe handling of cytostatic drugs: recommendations from independent science

Crul

Breukels

2022

Eur J Hosp Pharm

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ObjectivesDue to their mechanism of action, most classical cytostatic drugs have carcinogenic, mutagenic and/or reprotoxic properties. Therefore, occupational exposure of healthcare staff to these drugs should be prevented. Our objective was to lay out European legislation on this topic and reflect on the process of revising the European CM-directive. We summarise independent European and Dutch studies, and give a concise set of basic recommendations for safe working with cytotoxic drugs in healthcare facilities.MethodsWe were directly involved in the process of revising the CM-directive: first, through an EU commissioned workshop in the Netherlands, and after that by contributing to the pan-European stakeholder symposium. For this aim, we had to gather the relevant study data from the Netherlands and from Europe. We analysed all relevant industry-independent studies and collated a set of basic recommendations.ResultsIndependent studies show that the development of measures in recent years can lead to a safe work environment. Standardising the cleaning process leads to a significant improvement in environmental contamination in the majority of hospitals. In the Netherlands, exposure of workers was shown to be well beneath the limit value of 0.74 µg cyclophosphamide per week, therefore showing that the measures taken in recent years are adequate.ConclusionsThe safety of healthcare workers is of the utmost importance. Current practice in the Netherlands show that measures taken in recent years are adequate. European legislation should be based on independent scientific research and practice. The first goal should be to bring countries with less safe working levels to a higher level instead of introducing measures that only increase healthcare budgets but not healthcare safety.

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Section: Discussionmentioning

confidence: 99%

Safe handling of cytostatic drugs: recommendations from independent science

Crul

Breukels

2022

Eur J Hosp Pharm

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“…This single copy is for your personal, non-commercial use only. For permission to reprint multiple copies or to order presentation-ready copies for distribution, contact CJHP at publications@cshp.ca Une revue de la littérature publiée récemment recense seulement 12 articles présentant les coûts associés à un système intégrant un SCTM 21 . Ces publications étaient souvent incomplètes (moyenne de 9,2/24 critères CHEERS rapportés).…”

Section: Discussionunclassified

“…Il existe en outre très peu d'études économiques portant sur les coûts associés à la préparation et à l'administration des doses d'antinéoplasiques avec des systèmes intégrant des SCTM [21][22][23] . Compte tenu des différents types de SCTM disponibles, des coûts additionnels associés à l'utilisation de ces fournitures spécifiques et des ressources disponibles en santé, il nous semble utile de comparer le coût des fournitures utilisées pour la préparation et l'administration de doses d'antinéoplasiques en établissement de santé.…”

Section: Introductionunclassified

Analyse de minimisation de coût des fournitures utilisées pour la préparation et l’administration d’une dose d’antinéoplasique en établissement de santé

Soubieux

Plante

Ouellette-Frève

et al. 2020

CJHP

Self Cite

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RÉSUMÉContexte : Il existe de nombreuses stratégies visant à réduire les risques d’exposition professionnelle aux médicaments dangereux qui pèsent sur les travailleurs du domaine de la santé, dont les systèmes utilisés pour la préparation et l’administration des médicaments.Objectif : L’objectif principal était de comparer le coût des fournitures utilisées pour la préparation et l’administration d’une dose d’antinéoplasique par voie intraveineuse (IV) dans un établissement de santé canadien pour adultes entre un système classique et un autre intégrant un système clos de transfert de médicament (SCTM).Méthode : Il s’agit d’une analyse de minimisation de coûts. La perspective adoptée est celle d’un établissement de santé universitaire type. L’évaluation ne porte que sur le coût des fournitures utilisées pour la préparation et l’administration d’une dose d’antinéoplasique IV. Il n’est pas nécessaire de procéder à l’actualisation des coûts. Nous avons déterminé 12 scénarios comportant certaines des 11 étapes possibles de la préparation et de l’administration d’une dose IV d’antinéoplasique.Résultats : Le coût des fournitures utilisées pour la préparation et l’administration d’une dose d’antinéoplasique varie entre 9,89 $ et 22,37 $ la dose pour le système classique et entre 12,34 $ et 64,19 $ la dose pour les systèmes intégrant un SCTM. Le surcoût moyen annuel des systems intégrant un SCTM est de 1,63 à 3,15 fois supérieur par rapport au système classique et il représente une dépense annuelle additionnelle allant de 363 566 $ à 1 238 072 $ par année pour un établissement de santé type pour adultes.Conclusion : Cette analyse de minimisation de coûts présente des données originales entourant la préparation et l’administration IV d’antinéoplasiques. Compte tenu des coûts importants associés à la préparation et l’administration des antinéoplasiques, les décideurs devraient mener des analyses complètes des coûts et des conséquences afin d’assurer une prise de décision éclairée.ABSTRACTBackground: Many strategies aim to reduce the risk of work-related exposure to hazardous drugs for health care workers; these strategies include the use of specific systems to prepare and administer these drugs.Objective: To compare the cost of supplies used for preparing and administering one IV dose of antineoplastic in an adult health care facility in Canada between the traditional approach and one using a closed-system drug transfer device (CSTD).Method: This study was a cost reduction analysis conducted from the perspective of a typical university health care facility. The assessment focused only on the cost of supplies used to prepare and administer oneIV dose of antineoplastic. It was not necessary to account for discounting. We developed 12 scenarios involving some of the 11 possible steps in preparing and administering one IV dose of antineoplastic.Results:The cost of supplies used to prepare and administer one IV dose of antineoplastic ranged between $9.89 and $22.37 per dose with the classical system, and between $12.34 and $64.19 per dose for systemsinvolving a CSTD. The annual average extra cost of systems involving a CSTD was 1.63 to 3.15 higher than the cost with the classical system and represents extra spending of between $363 566 and $1 238 072 each year for a typical adult health care institution.Conclusion: This cost reduction analysis presents original data relating to the preparation and administration of IV antineoplastics. Given the significant costs associated with preparing and administering antineoplastic drugs, decision-makers should perform a thorough analysis of costs and consequences to allow informed decisions to be made.

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“…A major barrier to the use of CSTDs is their high cost. In a review prepared to review the economic data on the use of CSTDs for the preparation and administration of hazardous drugs and to evaluate them in the light of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) criteria, 12 there were seen to be very few studies which had examined the economic impact of these devices as of 2020. The authors emphasized that in order to make an informed decision about CSTDs, more studies should be conducted and health institutions should evaluate the benefit-economic burden balance in detail.…”

Section: Medical Devices Used For Safe Chemotherapy Applicationsmentioning

confidence: 99%

A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA^® IV GROUP products

Tekin

Karadoğan

Kısmet³

2022

J Oncol Pharm Pract

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Objective The healthcare workers and the workers in the manufacturing industry of chemotherapy drugs are exposed to the “hazardous” effects of these drugs during production, transportation, distribution, administration, and disposal. In order to be protected from these harmful effects, personal protective equipment and medical devices providing safe applications are used. The aim of the present article is to review of medical devices used for safe chemotherapy applications in line with the information obtained from the literature. Data sources The international and national reliable sources, were used in the literature review for data analysis by using the keywords including chemotherapy, chemotherapy drugs, antineoplastic drugs, cytotoxic drugs, hazardous drugs, exposure to chemotherapy drugs, side effects of chemotherapy drugs, closed-system drug transfer devices, healthcare staff, needle-free devices, needle-free connectors, surface contamination, and phthalates. Data summary In order to minimize cytotoxic drug exposure, international standards were developed in the mid-1980s stating that all cytotoxic drugs should be prepared preferably in a ventilated biological safety cabinet, nurses dealing with the use of these drugs should use appropriate personal protective equipment, and in case of cytotoxic drug spillage, predefined cleaning and decontamination protocols should be followed. Although the risk of acute and long-term toxic effects in healthcare workers has decreased in recent years with these applications in the preparation and administration of cancer drugs, measurable contamination occurs in the workplace. A large number of medical devices have been developed for minimizing this type of contamination with chemotherapy drugs. In this article, these medical devices have been reviewed in detail under subtitles of closed system transfer devices, needle-free devices, and valve technology. Conclusions Until the results of the evaluations to be made in new studies prove the opposite, the use of these devices with additional protection measures taken, especially during the application of dangerous drugs, is of great importance in terms of patient and employee safety.

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Review of economic data on closed system transfer drug for preparation and administration of hazardous drugs

Cited by 5 publications

References 19 publications

Safe handling of cytostatic drugs: recommendations from independent science

Safe handling of cytostatic drugs: recommendations from independent science

Analyse de minimisation de coût des fournitures utilisées pour la préparation et l’administration d’une dose d’antinéoplasique en établissement de santé

A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA^® IV GROUP products

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Review of economic data on closed system transfer drug for preparation and administration of hazardous drugs

Cited by 5 publications

References 19 publications

Safe handling of cytostatic drugs: recommendations from independent science

Safe handling of cytostatic drugs: recommendations from independent science

Analyse de minimisation de coût des fournitures utilisées pour la préparation et l’administration d’une dose d’antinéoplasique en établissement de santé

A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA® IV GROUP products

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A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA^® IV GROUP products