Objectives:The aim of this study was to develop and to assess a specific Multi-Criteria Decision Analysis (MCDA) framework to evaluate new drugs in an hospital pharmacy and therapeutics committee (P&TC) setting.Methods:A pilot criteria framework was developed based on the EVIDEM (Evidence and Value: Impact on DEcisionMaking) framework, together with other relevant criteria, and assessed by a group of P&TC's members. The weighting of included criteria was done using a 5-point weighting technique. Two drugs were chosen by evaluation: an orphan-drug for Gaucher disease, and a nonorphan drug for the treatment of inflammatory bowel disease. Evidence matrices were developed, and value contribution of each drug was evaluated by P&TC's members. An agreed final framework was obtained through a discussion between the P&TC's members.Results:After criteria assessment, the pilot framework included eight quantitative criteria: “disease severity,” “unmet needs,” “comparative efficacy/effectiveness,” “comparative safety/tolerability,” “comparative patient-reported outcomes,” “comparative cost consequences-cost of treatment,” “comparative cost consequences-other medical costs,” and “quality of evidence”; and one contextual criterion: “opportunity costs and affordability.” The most valued criteria were: “comparative safety/tolerability,” “disease severity,” and “comparative efficacy/effectiveness.” When assessing the drugs most valued characteristics of the MCDA were the possibility that all team may contribute to drug assessment by means of scoring the matrices and the discussion to reach a consensus in drug positioning and value decision making.Conclusions:The reflective MCDA would integrate quantitative and qualitative criteria relevant for a P&TC setting, allowing reflective discussions based on the criteria weighting score.
Almost a quarter of the patients discontinued treatment with tenofovir during the study. The main cause for this was adverse effects. No association was found between any abnormal basal analytical parameter and a greater probability of discontinuing treatment.
BackgroundThe vasopressin receptor 2 antagonist tolvaptan is an aquaretic agent that promotes water elimination to resolve hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). There are ongoing studies researching its effectiveness in hyponatraemia secondary to heart failure, in which patients have body water excess that dilutes sodium.PurposeTo explore the efficacy of tolvaptan off-label use in hyponatraemia secondary to heart failure.Material and methodsObservational retrospective study carried out in a tertiary care hospital. We conducted a search to find all patients treated with tolvaptan. The next step was to identify off-label use in heart failure. Once patients were identified, we extracted their demographic data, laboratory tests and tolvaptan treatment duration and dosages. The data were inserted in an Excel chart to make a descriptive analysis.Results28 patients were found, but only 6 met off-label use criteria (2 women and 4 men). 1 patient passed away 72 h after his admission and was excluded. Median age was 70 years (range 54–80). Only 2 patients had a sodium charge with hypertonic saline fluid before tolvaptan treatment, but their sodium level did not increase. Neither had NaCl oral therapy. Mean tolvaptan dosage (calculated as total tolvaptan dosage in mg divided by treatment duration in days) was 15 ± 5 mg/day. Median treatment duration was 10 days (range 5–15). Mean natraemia levels were 120 ± 6 mEq/L at baseline, 124 ± 11 mEq/L after 24 h of treatment, 127 ± 5 mEq/L after 48 h of treatment and 130 ± 6 mEq/L after 72 h of treatment. The final mean natraemia level was 136 ± 3 mEq/L. The average sodium level increase was 16 ± 3 mEq/L. During tolvaptan treatment, 3 patients were receiving furosemide, 1 furosemide and hydrochlorothiazide, and 1 furosemide, chlorthalidone and spironolactone. These results are consistent with those found by Salterain-Gonzalez et al (2013) and Rodríguez-de Muñoz et al (2013).ConclusionBased on our data, it seems that tolvaptan is an effective option to increase natraemia in heart failure patients. However, due to our small population, we cannot conclude it categorically.No conflict of interest.
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