Original Title: Sistemas cerrados versus abiertos para la preparación y administración de fármacos citostáticos y biopeligrosos (Grupo 1 NIOSH): análisis de la evidencia científica, costes y requisitos organizativos

Authors' objectives: General objective To analyse the usefulness of CSTDs in the preparation, transport, administration and disposal of cytostatic and other NIOSH Group 1 HDs for intravenous administration compared to open systems. Specific objectives • To compare the effectiveness of CSTDs with open systems in terms of preparation, transport, administration and disposal of cytostatic and other NIOSH Group 1 HDs. • To estimate the increase in costs associated with the widespread use of these CSTDs in the preparation, transport, administration and disposal of this type of medication within the Basque Health Service (Osakidetza). • To explore the organisational changes required for the widespread use of these devices in healthcare organisations.

Authors' results and conclusions: Systematic review From the search for studies in biomedical databases, we found a systematic review (Gurusamy et al.) published by the Cochrane Collaboration in 2018. This Cochrane systematic review included 23 studies, and of these, 14 were included in a meta-analysis. Based on their analysis of data from these 23 studies, the authors concluded that there was insufficient evidence of benefits of the use of closed over open systems for the management of HDs in terms of exposure, meaning that it was not possible to recommend in favour or against the use of these devices. Seeking to obtain new evidence on the effectiveness of closed devices for handing HDs, we updated the search for publications on this topic based on the evidence provided by the systematic review of Gurusamy et al., yielding two new studies. Although both studies conclude that there is a reduction in surface contamination in the pharmacy department associated with the use of CSTDs, they cannot be considered to provide significant new evidence given their methodological limitations. It follows that the available evidence is inconclusive about the effectiveness of the CSTDs in the management of HDs. The authors of the evaluation have agreed by a thorough analysis of the use of the three types of devices that the closed tree type system is the most effective method to reduce the risks arising from exposure to HDs. From the literature search on costs, four studies were included in our review of costs. Based on these published cost analyses, we are able to conclude that CSTDs are more expensive than open systems, although, on the other hand, they might allow savings in terms of the amount of drug used. Organisational considerations The questionnaire on the use of CSTDs sent to all Osakidetza hospitals (n=14) identified that five of them have specific cancer-related activity. Considering the results of the questionnaire, it can be deduced that, at the time of the analysis (April 2018), basically three types of procedures for the intravenous infusion of cytostatics were in use in Osakidetza hospitals with cancer-related activity: 1. A procedure using a tree-type CSTD 2. A procedure using a valve-type CSTD. 3. A procedure in which CSTDs are only used for the preparation and transport stages, while an open system is used for drug administration. Cost analysis Based on the results obtained, it can be stated that open systems are less expensive, being €4.87 and €6.37 cheaper than closed tree- and valve-type systems, respectively. The valve-type is 6.45 % more expensive than the tree-type system. If Osakidetza were to decide to deploy a tree-type closed system, there would be cost savings of €1.50 and €4.87 at Cruces and Donostia University hospitals, respectively, for each procedure like those studied. The use of tree and valve CSTDs increases the total cost of the HDs dministration procedure with open systems (€ 358) by 1.36 % and 1.77 % respectively. Regulatory considerations The choice of the most appropriate systems for the infusion of hazardous drugs also has legal and health and safety health implications. We must take measures to ensure that occupational exposure does not represent a danger for the personnel handling these drugs given their potential toxicity. As established in article 15 of Spanish law 31/95 on occupational risk prevention concerning the principles of preventive action, the dangerous must be replaced by the non- or less dangerous. Safety measures with a general impact, in both technical and organisational terms, must be adopted before individual measures; and advances in techniques and materials must be taken advantage of to minimise and, if possible, eliminate risks for workers. CONCLUSIONS • Regarding the effectiveness: although there is no solid evidence on the benefits of using closed devices compared to open systems for the management of HD, there is consensus that the closed tree type system presents fewer chances of exposure risk and therefore consider more secure. • In terms of costs: open systems are the cheapest , followed by closed tree-type and valve-type systems that are the most expensive. The use of closed tree and valve systems increases the total cost of the HD administration procedure with current open systems (€ 358) by 1.36 % and 1.77 % respectively. • Regarding normative aspects: article 15 of Spanish law 31/95 on occupational risk prevention indicates that, as far as possible, we must change dangerous procedures to minimise risk workers.

Authors' recommendations: The progressive replacement of open systems and valve -type closed systems by tree-type closed systems in the five hospital centers of Osakidetza where cancer care is provided.

Authors' methods: The methodology used for systematic reviews was based on a structured search in existing databases of scientific publications and critical reading of articles retrieved, followed by synthesis of the results and assessment of thereof in the context of the Basque Country. The organisational considerations related to the implementation of closed systems for the preparation, transport, administration and disposal of NIOSH Group 1 HDs were analysed by Osakidetza staff specialised in the areas of pharmacy, nursing and occupational health and patient safety. Based on a questionnaire on the use of CSTDs sent to the 14 hospitals of the Osakidetza network, a cost analysis was undertaken for the three systems identified: an open system, which is valve based in the preparation stage and open in the administration stage; a tree-type closed system; and a valvetype closed system. In addition, for this analysis, we standardised the procedures to be analysed, considering the administration of two drugs and one chemotherapy cycle, as these are among the procedures most representative of routine practice. The analysis was carried out from the perspective of the funding body (Osakidetza), and for this reason, we only considered the direct healthcare costs associated with the deployment of CSTDs for the preparation and administration of cytostatic and other NIOSH group 1 hazardous drugs that would fall to this organisation should such devices be deployed. Costs were taken into account if they differed between the procedures and stages. On this basis, the cost analysis included variables with differences in the preparation or administration stages, but not those with differences in the transport or disposal stages, as the estimated economic differences were not considered significant

Project Status: Completed

Year Published: 2019

URL for published report: https://www.euskadi.eus/web01-a2aznscp/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=052485&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>