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BackgroundIn the University Medical Center Mainz standard concentrations are defined for medicinal products to be administered by continuous injection with syringe pumps in adult intensive care patients. Patient-individual doses are provided by adjusting the injection rate. Various medicines are aseptically prepared in the pharmacy department as ready-to-use products. Batch preparation of the products and keeping them in stock is only possible if stability of the products is tested using a validated method. Purpose The purpose of this study was to test the stability of ready-to-administer epinephrine solutions for injection 20 µg/ml in 50 ml plastic syringes. Materials and Methods Epinephrine bulk solution 20 µg/ml was prepared aseptically by diluting Suprarenin 25 mg/25 ml SanofiAventis with 5% glucose infusion solution in empty infusion bags (PP/PE). The solution was filled with the NeoCare Compounder into 50 ml BD Perfusion Syringes, Luer Lock Tip, protected from light. The syringes were stored at 2-8°C in the refrigerator. Epinephrine concentration was determined by using a validated HPLC method with UV detection at 280 nm and an innovative HPLC column Nucleodur which contains sulfonyl groups. Results The concentration of epinephrine in the 50 ml syringes remained unchanged over a period of 2 months. After 28 days and 2 months of refrigerated storage the concentration amounted to 100.5% and 100.8% of the nominal concentration, respectively. Neither adrenochrome (detection wavelength 480 nm) nor any other degradation products were detected during the study period. With regard to these results batch production is feasible. Stability over 2 months is assured. Conclusions Epinephrine solution for injection 20 µg/ml, aseptically prepared by diluting the marketed injection concentrate with 5% glucose infusion solution in 50 ml light-protected plastic syringes, is stable under refrigerated storage conditions for at least 2 months.No conflict of interest.

BackgroundMercaptopurine is indicated for the treatment of acute lymphoblastic leukaemia (ALL). In our country, there is no commercial presentation that allows proper dosage in paediatric patients. However, in March 2012, an expensive 20 mg/mL mercaptopurine suspension (100 mL) that may be purchased as a foreign drug was commercialised. In order to meet the needs of these patients using a more cost effective alternative, the pharmacy department developed a mercaptopurine compounded drug.PurposeTo assess the economic impact of the development of a 50 mg/mL mercaptopurine suspension (12 mL) compared with the use of a commercial syrup.Material and methodsMercaptopurine suspension is compounded by adding simple syrup, cherry syrup and sterile water for irrigation to 50 mg of mercaptopurine triturated tablets. It is prepared in a biological safety cabinet, packed in amber glass bottles and its shelf life is 28 days.This was a retrospective study from March 2012 to September 2015. Collected data, from Farmatools and Farmis software, were: number of ALL patients treated with the suspension, number of suspensions dispensed, number of mercaptopurine tablets used and its cost, and treatment phase of the ALL-SEHOP-PETHEMA protocol when the dispensation was done. Mercaptopurine suspension appraisal was done according to the valuation rules of the Regional Health Management. The Ministry of Health website was consulted for the commercial suspension price. Total savings by the development of a compounded medicine instead of buying the commercial presentation was established by comparing the direct costs between both alternatives.ResultsDuring the study period, 40 mercaptopurine suspensions were prepared to treat 3 patients (according to the ALL-SEHOP-PETHEMA protocol, 2 suspensions were dispensed for the consolidation phase of the treatment and 38 for the maintenance phase). Each one cost 28.1€ (16.6€ mercaptopurine suspension, 0.3€ storage, 11.2€ professional fees); total expenditure was 1124€. Each commercial suspension costs 269.36€ and its shelf life is 56 days; total expenditure would have been 5387.2€. Cost savings achieved by developing the mercaptopurine suspension instead of buying the commercial presentation was 4263.2€.ConclusionThe compounded 50 mg/mL mercaptopurine suspension can meet the therapeutic needs of ALL paediatric patients and save costs. It would be useful to assess the addition of a preservative to the compounded suspension to increase its shelf life and save on costs.No conflict of interest.

BackgroundThe implementing Law 1015/2009 normalises the compassionate use of investigational drugs, access to off-label and unauthorised drugs in Spain.Rituximab is an anti-CD20 monoclonal antibody widely used in off-label conditions to treat autoimmune diseases.1,2,3,4 PurposeThe creation of an Autoimmune Diseases Unit (ADU) in our hospital caused an increase in the use of rituximab in off-label conditions. This study aims to identify rituximab off-label use and to describe the dosage prescribed in each indication.Material and methodsObservational, retrospective study (June 2009 to March 2017). Patients who received off-label rituximab (at least one dose) prescribed by the ADU were included.Collected data, obtained from Farmatools® software and medical records, were: sex, age, rituximab off-label indication, dosage, number of cycles received.ResultsForty-four patients (55±15 years’ old, 31/44 females) received off-label rituximab.Off-label indications identified (all of them of autoimmune aetiology) were: systemic lupus erythematosus (16/44), vasculitis (13/44), inflammatory myopathy (6/44), scleroderma (4/44), mixed cryoglobulinemia (3/44), others (2/44).The rituximab prescribed regimen was a cycle consisting of four doses of 375 mg/m2 administered weekly, which is the dosage aprobed for the treatment of lymphoma. 23/44 patients received a single cycle of treatment with rituximab, 11/44 received two cycles, 2/44 received three cycles and 2/44 more than four cycles, which is partially consistent with the literature previously published1,2,3,4 (most patients received one cycle). 6/44 patients did nott start rituximab treatment.ConclusionSystemic lupus erythematosus and vasculitis were the most frequently rituximab off-label prescribed indications and 375 mg/m2 weekly for 4 weeks was the prescribed dosage. These results agree with the data published in the literature.1,2,3,4 Considering the variety of off-label indications for which rituximab is prescribed in the ADU, it would be useful to develop protocols for the use of rituximab in these situations.References and/or Acknowledgements1. Murray E, Perry M. Off-label use of rituximab in systemic lupus erythematosus: a systematic review. Clin Reumathol2010;29(7):707–716.2. Hiemstra T, Jayne D. Newer therapies for vasculitis. Best Pract Res Clin Rheumatol2009;23(3):379–389.3. Daoussis D, et al. Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study. Rheumatology2010;49:271–280.4. Saunders P, et al. Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated intersticial luna disease (RECITAL): Study protocol for a randomised controlled trial. Trials2017;18(1):27.No conflict of interest