BackgroundAbiraterone and enzalutamide are expensive drugs used in hospitals for metastatic prostate cancer and it is necessary to evaluate health outcomes from its use to establish whether it is cost effectivePurposeTo analyse the effectiveness and cost of abitarerone and enzalutamide in asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer patients (mCRPC) to whom chemotherapy is not clinically indicated and in those whose disease has progressed after docetaxel chemotherapy regimen-based.Material and methodsA retrospective descriptive study covering the period from January 2013 to June 2017 of mCRPC patients starting treatment with abiraterone or enzalutamide between January 2013 and June 2016 was performed. Parameters collected were: age, sex, drug, previous chemotherapy, progression-free survival (PFS) and economic spending. Data were collected from the Electronic Prescription Software Prisma® and the program of electronic patient records Diraya® and afterwards, organised in an Excel® base design for this study.ResultsA total of 74 patients with a median age of 76 years, 53 chemotherapy-naive and 21 chemotherapy-treated, were included. Fifty-nine patients were treated with abiraterone and 15 with enzalutamide. The mean PFS was 12.3 months with 49.2% of 1 year PFS. However, in the group of chemotherapy-naive patients it was 15 months, with 56% of 1 year PFS and 9.6 months (28% of 1 year PFS) in chemotherapy-treated patients. No difference was found between abiraterone group (12.4 PFS) and the enzalutamide group (12 PFS) nor in the age of the groups where PFS was 13 months in patients younger than 75 years and 12 months in those older than 75. The cost of treatment/patient was €35 559 and the total expenditure was €2,631,366 (2% of the total pharmacy service budget).ConclusionThe results of the effectiveness regarding PFS are lower than the ones obtained in the pivotal studies ‘301 and 302’ (abiraterone) and ‘PREVAIL and AFFIRM (enzalutamide). Chemoterapy-naïve patients have better PFS than chemotherapy-treated and there is no difference between the abiraterone group and the enzalutamide group. The cost of abiraterone and enzalutamida per life-year gained were less than €30 000.References and/or AcknowledgementsPivotal study 301 & 302 Pivotal study PREVAIl & AFFIRMNo conflict of interest
BackgroundBiological drugs represent a great economic impact for the pharmacy service, where dermatology is one of the services with greatest use of this type of drugs.PurposeTo describe and analyse the evolution of expenditure on biological drugs of subcutaneous administration for the treatment of psoriasis in the dermatology service.Material and methodsRetrospective study which includes all patients who have been given biological drugs with subcutaneous administration for the treatment of psoriasis from January 2011 to December 2016. Parameters collected were: number of patients per drug, economic expenditure (€) and percentage of total expenditure.Data were obtained through the Prisma® prescription and validation program, and collected in an Excel® database designed for this purpose.ResultsFour drugs were identified: adalimumab, etanercept, ustekinumab and secukinumab.The total number of patients was 114 in 2012 (29 adalimumab, 51 etanercept, 34 ustekinumab), 126 in 2013 (35 adalimumab, 50 etanercept, 41 ustekinumab), 128 in 2014 (35 adalimumab, 46 etanercept, 47 ustekinumab), 136 in 2015 (36 adalimumab, 48 etanercept, 52 ustekinumab) and 149 in 2016 (49 adalimumab, 41 etanercept, 58 ustekinumab, 1 secukinumab).The cost progression was €8 50 236 in 2012, €1,245,813 in 2013, €1,228,421 in 2014, €1,205,766 in 2015 and €1,211,130 in 2016.Regarding the average cost per patient, it is €8858 for adlimumab, €7509 for etanercept, €9967 for ustekinumab and €24 056 for secukinumab.Spending on biological medication for psoriasis equals approximately 4% of the total hospital pharmacy budget.ConclusionDuring the past 5 years there has been an increase of 30.7% of patients undergoing biological treatment. The greatest increase in the number of patients is observed in treatment with adalimumab and ustekinumab.The cost has been increased to €360,894, which represents an increase of 42% from 2012 to 2016.The drug with a lower cost per patient year is etanercept, followed by adalimumab, while secukinumab is the most costly.With only four drugs, psoriasis represents an important part of the total pharmacy budget.No conflict of interest
In 1992, 19 ADRs were notified, a value that progressively increased over the years, reaching its highest in 2003 (84 ADRs). In 2004 it decreased to 46, remained constant (mean 35.7±9.7) and then declined to 31 in the last year. Conclusion and relevance More than one-third of ADRs were serious, but most patients recovered without sequelae. Most notifications to the RPC come from the MDS-H, but a significant number were detected by health staff and HP. In recent years, reported ADRs has decreased, so the HP could be an essential element to develop the pharmacovigilance programme, which is key to improving the safety of medicines by promoting relevant modifications in the technical data sheets and issuing alerts from the Spanish Agency for Medicines and Health Products.
BackgroundHigh alert medications are drugs that bear a heightened risk of causing significant patient harm when used in error. The Institute for Safe Medication Practices (ISMP) and other organisations, worried about safe medication practices, insist on specific procedures to reduce the risk of adverse events when these drugs are handled.PurposeTo assess the degree of compliance with the standards of high alert medications in different nursing units in a secondary hospital.Material and methodsThis was an observational, descriptive, transversal study carried out in a secondary hospital. The items studied were:Knowledge of the list of high alert medications.Standardisation storage, preparation and administration.Number of limited presentations and concentrations of heparin, morphine and insulin, among others.Double checking practices in preparations and administrations.No storage of concentrated solutions.Protocols to prescribe and simplify processes.Standardisation infusion dosage, especially morphine, insulin, heparin and inotropic solutions.Results12 hospitalisation units were reviewed. Regarding the ISMP standards: all units had knowledge of the high alert medications list and they were prescribed using protocols; 7 had standardised storage, preparation and administration; 8 had established electronically maximum doses and automated alerts; 4 had limited the number of presentations and concentrations of heparin, 10 of morphine and 2 of insulin. Preparation and administration double-checking practices was not used. Every unit stored solutions of potassium chloride, 1 stored potassium phosphate and 7 sodium chloride. 8 used established protocols to simplify processes and so reduce dependence on memory. Finally, all had standardised infusion dosage, especially morphine solutions, insulin, heparin and inotropics used for adults, in a single concentration in at least 90% of cases.ConclusionIn general, hospitalisation units achieved most of the ISMP objectives about safe medication practices. However, further standards should be implemented in order to accomplish ISMP requirements, especially insisting on double checking in high alert medication preparation and administration by nurses, and avoiding the storage of concentrated solutions.No conflict of interest
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