BackgroundIn exercising their hospital activity, the pharmacist is faced with multiple tasks that can compromise, for security reasons, a positive trend in the health status of patients.There are areas that are traditionally regarded as critical (preparation of non-sterile formulations, handling cytotoxic or other sterile mixtures).The Cytotoxic Preparation Manual, by the Portuguese Council in Hospital Pharmacy Specialty, states: “double checking should be implemented in the critical steps of the preparation process. Double checking should be carried out independently by a second person or by a computerised system”. Compliance with this recommendation is not uniform in the various hospitals due to a shortage of human resources.PurposeTo create conditions for the fulfilment of the double validation process by eliminating the actual and permanent physical presence of a second element in the preparation of sterile room mixtures, keeping the final quality of the process.Material and methodsMultiple image capture methods in handling the environment in the laminar air flow chamber were tested, after consultation with the national Data Protection Authority, which enabled such viewing. The final solution was a system composed of special glasses with a high definition camera which enables real time recording with up to 30 images per second and marking of critical points that can be downloaded to a computer for a verification process.ResultsThe test phase was successfully passed, after correct viewing images in the real work environment. The ocular device allows the use of a visor and does not interfere with the manipulation. It allows identification of the drug, solvent validation and identification of a reconstituted final volume for the patient and medical prescription. The validation can be done elsewhere from the pharmaceutical services, outside the clean room, and consists of the display of marked critical points and, in doubtful cases, the full view of the event. This validation reduces by at least 75% the time allocated to the second element.ConclusionThe possibility of implementation/maintenance of the double validation process, reducing by more than 75% of the associated workload and elimination of sterile equipment required for entry into the clean room, enables compliance with the rules of the Cytotoxic Preparation Manual, with rationalisation of associated resources.References and/or AcknowledgementsManual de Preparação de CitotóxicosNo conflict of interest.

BackgroundThe biosimilar medicines are identical to authorised biological medicines. The biosimilar infliximab, a TNF-α inhibitor, was approved by the EMA for use in rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. Studies have shown that the biosimilar of infliximab demonstrates pharmacokinetics and therapeutic equivalence relative to its reference, with lower costs, making it a useful alternative in terms of cost-efficacy. Portugal was the first EU country that authorised the the use of biosimilar monoclonal antibodies.PurposeTo analyse the efficacy and cost of treatment with the biosimilar infliximab in comparison with its reference.Material and methodsAll new patients treated with infliximab between January 2014 and July 2015 were considered for our study. The criteria used to evaluate treatment efficacy were: for psoriatic and rheumatoid arthritis, the number of tender joints and the number of swollen joints; for ankylosing spondylitis, the BASDAI and BASFI scales; for patients with Crohn’s disease and ulcerative colitis, biochemical and clinical development before and after treatment with infliximab.ResultsOur sample comprised 46 patients, 23 treated with the biological reference and 23 with the biosimilar. According to the medical records, there was similar efficacy between the reference and the biosimilar infliximab. 73.9% (17/23 in both arms) of treated patients were responders. 21.3% (5/23) of patients treated with the reference infliximab and 13.0% (3/23) in the biosimilar group stopped treatment because of inefficacy. One patient in the biosimilar treatment group stopped because of toxicity. The economic impact of switching all patients to a biosimilar could result in a 30% saving in annual spending on infliximab, corresponding to 200 000€ (for actual prices).ConclusionThe use and monitoring of biosimilars in hospitals, and their proven efficiency and safety compared with the reference, has opened the discussion on the therapeutic change (switch) between biopharmaceuticals and their biosimilars. The savings associated with the use of biosimilars contributes to the sustainability of the health system, relieving resources so that patients continue to take advantage of therapeutic innovation in Portugal.References and/or AcknowledgementsMcKeage K. Biodrugs 2014;28:313-21What you need to know about biosimilar medical products, European CommissionNo conflict of interest.