Retinoblastoma is a relatively uncommon childhood tumor. If untreated, RB grows to fill the eye and destroys the ocular globe's internal architecture. Metastatic spread usually begins after the first 6 months, and death occurs within a matter of years. When treated, overall survival rounds 97%, the alkylating drug melphalan being the most extensively used chemotherapeutic agent in localized treatment. In our hospital, pediatric oncologists asked the Pharmacy Department for assessment in order to implement a new chemotherapy protocol for the treatment of advanced intraocular elegible retinoblastoma cases using melphalan administered directly through the ophthalmic artery. In this paper, we describe the protocol implementation carried out by our collaborative interdisciplinary team as well as the clinical outcomes of five cases treated with ophthalmic intra-arterial melphalan therapy. Oncology pharmacists can contribute with their knowledge to the implementation process of new collaborative practice protocols recommending doses, predicting possible adverse effects and assessing about drug stability and elaboration, packaging and administration methods.

The presence of contamination in the healthcare work environment by one of the types of hazardous drugs, cytostatics, has been found in multiple international studies. Recent studies and guidelines recommend surface monitoring for risk assessment of healthcare professionals’ exposure. The availability of detection techniques is critical to successfully carry out this type of monitoring. The use of new semi-quantitative techniques allows quicker results. The main objective of this study was to determine the existence of hazardous drugs on the working surfaces in different locations of a tertiary hospital using the BD HD Check® semi-quantitative device. The presence of methotrexate, doxorubicin and cyclophosphamide was analysed at 80, 89 and 82 locations in 10, 13 and 11 clinical units, respectively. A total of 251 samples were analysed. The monitoring results were positive for 13.1% of the analysed samples, with 36.3% of the methotrexate samples, 0% of the doxorubicin samples and 4.9% of the cyclophosphamide samples. Mapping the presence of HD in our hospital has allowed us to evaluate the effectiveness of controls established in the hospital to minimise the exposure of healthcare professionals to hazardous drugs. The speed in obtaining results has enabled immediate corrective actions in cases where contaminated surfaces were detected.

Background Pharmaceutical industry does not always provide suitable preparations for paediatric population. In these situations formulations should be developed for small scale compounding in hospital pharmacies, especially when cytotoxic drugs are involved. Purpose Some guidelines for non-sterile pharmaceutical compounding preparations (eg, USP797) recommends in absence of stability information, an expiry date of 14 days under refrigeration for liquid preparations. The aim of the study is to develop a methotrexate oral formulation that yields stable for at least 25 days, an adequate period for three weekly administrations of one chemotherapy cycle. Materials and methods Two formulations of 2.5 mg/ml were prepared by dissolving respectively tablets or injectable solution of methotrexate with Ora-Plus and Ora Sweet SF mixed in a 1:1 ratio. Preparations packed in amber coloured bottles were kept at 2-8° C. Samples were taken at 1, 7, 15, 25 days, and were analysed for appearance, pH, microbiological growth and methotrexate concentrations by Fluorescense Polarisation Immunoassay (FPIA) and ultraviolet-visible spectroscopy (UV-S) at 370 nm only with the solution (no supported for suspensions). Assays were specific for methotrexate (without cross-reactivity with metabolites) and calibrated with a known concentration. A stability study has been performed on these two formulations. Samples were diluted 1/100 with Xsystems Dilution Buffer. In FPIA was also performed the 1:100 dilution protocol of TDx/TDxFLx analyser. Results Both formulations show stability for at least 25 days, with remaining content of methotrexate of 98.76% in suspension and 97.06% (FPIA) or 96.20% (UV-S) in solution. Appearance assay (no odour or colour changes), pH (5.0) and microbiological growth (negative) in all samples were appropriate and similar for both formulations. Conclusions Methotrexate can be extemporaneously prepared in suspension or solution and stored at least 25 days under refrigeration without significant degradation. For paediatric patients who cannot swallow tablets, these formulations provide an accurate and suitable option for administering oral methotrexate.

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