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Meeting the needs


Analysing the interaction between cytotoxic chemotherapy drugs and medical devices used for preparation and administration


Sterility and operator safety are key features of the CareFusion closed system device


Elena Dreassi, Gianfranco Corbini and Assunta Zanfini Dipartimento Farmaco Chimico Tecnologico , Università degli Studi di Siena Siena, Italy


Silvano Giorgi, Maria Grazia Rossetti and Eleonora Cesqui Farmacia Ospedaliera Azienda ospedaliera Universitaria Senese, Siena, Italy


Oncological galenic preparations are derived from dilutions of antiblastic drugs, and are therefore defined as magistral preparations in accordance with the Good Manufacturing Practices outlined in the Official Italian Pharmacopoeia XII Glossary - defined as ‘medicinal products prepared in a pharmacy based upon an individual patient’s medical prescription. All mixtures, dilutions and drug concentrations prepared for individual patients based upon medical Indications … are also technically similar to magistral preparations’.


To date, oncological galenic


preparations belong to the group that are prepared in hospital pharmacies due to the complex preparation procedures and also to the requirement to adhere to specific work safety provisions. The majority of antiblastics, also known as antiblastic chemotherapeutics (ACs), are used in therapies that require dosage personalisation, based upon the differences between the various diseases


A Figure 1: SmartSite® (A) and Texium® (B) devices


(for example, stage of the cancer, site and presence of metastasis), the individual variations between patients and the large number of medicines used in this field of medicine, each of which possess different pharmacokinetic and pharmacodynamic properties.


In almost all cases, these medicines are administered intravenously, thus the injectable antiblastic chemotherapic drugs used for cancer therapy must possess the characteristics of the injectable forms stated in the Official Italian Pharmacopeia XII, that is to say, they must be sterile, non-pyrogenic, particle-free, controlled, stable and traceable.


These preparations must be prepared in accordance with a validated protocol that regulates the environment, operator, methods and devices used. This protocol must be validated at regular intervals or each time any of the above points is changed; the


pharmacist in charge of the hospital pharmacy’s galenic laboratory will be responsible for performing the validation. The healthcare professionals assigned to the preparation and administration of anti-tumour drugs are at risk every day of coming into contact with carcinogenic compounds, with the dangers of accumulation and possible onset of damage to their health. To ensure increased protection for employees, the Azienda Ospedaliera Senese (Siena’s Public Hospital) has chosen sampling devices available on the market that can prevent possible leaking problems connected with antiblastic chemotherapic drug preparation work (the opening of vials, reconstitution and transfers from vial to bag for infusion purposes), as well as guaranteeing the sterile state of the sampling and the possibility of reusing any preparation residuals on subsequent


www.hospitalpharmacyeurope.com B


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