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      Cost-effectiveness of drug therapy prescribed in special situations at hospital Translated title: Coste-efectividad de los medicamentos en situaciones especiales en un hospital

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          Abstract

          Abstract Objective: The Pharmacy and Therapeutics Committee is an advisory body to the medical management of our hospital. Following Royal Decree 86/2015, which regulates the Pharmacy and Therapeutics Committee of the Balearic Islands, this committee prepared a technical report in which it assessed the possible internal use of off-label drugs, drugs for compassionate use, and drugs not included in the hospital's pharmacotherapeutic guide. The objective was to analyse the clinical response achieved with the use of these drugs and their associated costs. Method: Retrospective study of drugs whose use was requested from the hospital's Pharmacy and Therapeutics Committee hospital between January and December 2018. We analysed whether the requested treatment achieved the objective established by the physician. The cost was calculated based on the duration of the treatment until the objective was achieved or until treatment was discontinued. Results: In total, 70 requests were analysed: 59% achieved the expected therapeutic goal, 34% were considered to be therapeutic failures, and 7% were lost to follow-up. The overall cost of the 70 authorized treatments was €1,140,240. The average cost per request was €16,288. Oncology and Haematology services submitted more than 50% of the requests, and more than 75% of the budget was allocated to these medical services. Conclusions: More than half of the treatments analysed by the Pharmacy and Therapeutics Committee of the hospital achieved their therapeutic goal, although the economic cost of their use was high.

          Translated abstract

          Resumen Objetivo: La Comisión de Farmacia y Terapéutica, como órgano asesor de la Dirección Médica del hospital y bajo las condiciones del Real Decreto 86/2015, por el que se regula la Comisión de Farmacoterapéutica de las Islas Baleares, elabora un informe técnico donde evalúa la posibilidad de empleo interno de medicamentos off-label, uso compasivo y medicamentos no incluidos en la Guía Farmacoterapéutica del hospital. Asimismo, esta comisión realiza un seguimiento prospectivo de cada una de las solicitudes. El objetivo fue analizar la respuesta clínica alcanzada con el empleo de estos medicamentos, así como el coste asociado. Método: Estudio retrospectivo de los medicamentos solicitados a la Comisión de Farmacia y Terapéutica del hospital entre enero y diciembre de 2018. Se analizó si con cada tratamiento solicitado se alcanzó el objetivo propuesto por el clínico. Para el cálculo del coste se consideró la duración del tratamiento hasta alcanzar el objetivo propuesto o hasta su interrupción. Resultados: De un total de 70 solicitudes analizadas, un 59% alcanzaron el objetivo terapéutico esperado, un 34% fueron consideradas como fracaso terapéutico y hubo un 7% de pérdidas de seguimiento. El coste de las 70 peticiones fue de 1.140.240 €. La media de coste por solicitud fue de 16.288 €. Más del 50% de las solicitudes fueron realizadas por los servicios de oncología y hematología y más del 75% del presupuesto fue destinado a estos dos servicios. Conclusiones: Más de la mitad de los tratamientos considerados por la Comisión de Farmacia y Terapéutica del hospital alcanzan la finalidad terapéutica deseada, si bien el impacto económico de su empleo es elevado.

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          Off-label drug use in oncology: a systematic review of literature.

          The off-label use of medicines is widespread in several diseases. This type of prescribing practice is particularly more acute in oncology. However, the suitability of anticancer medications for off-label use remains an issue of controversy, due to uncertainty around the clinical benefits and potential toxicities, limited evidence to support clinical decision-making, increased out-of-pocket costs for patients and ethical concerns around the lack of informed consent. Currently, data pertaining to the global prevalence of off-label use in cancer therapy are lacking. The aim of this review was to provide an overview of off-label drug use prevalence in oncology.
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            Adverse drug reactions and off-label and unlicensed medicines in children: a nested case?control study of inpatients in a pediatric hospital

            Background Off-label and unlicensed (OLUL) prescribing has been prevalent in pediatric practice. Using data from a prospective cohort study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that OLUL status is a risk factor for ADRs. Methods A nested case?control study was conducted within a prospective cohort study. Details of all medicines administered were recorded, including information about OLUL status. The odds ratio for OLUL medicines being implicated in a probable or definite ADR was calculated. A multivariate Cox proportional hazards regression model was fitted to the data to assess the influence that OLUL medicine use had on the hazard of an ADR occurring. Results A total of 10,699 medicine courses were administered to 1,388 patients. The odds ratio (OR) of an OLUL medicine being implicated in an ADR compared with an authorized medicine was 2.25 (95% confidence interval (CI) 1.95 to 2.59). Medicines licensed in children but given to a child below the minimum age or weight had the greatest odds of being implicated in an ADR (19% of courses in this category were implicated, OR 3.54 (95% CI 2.82 to 4.44). Each additional OLUL medicine given significantly increased the hazard of an ADR (hazard ratio (HR) 1.3 95% CI 1.2 to 1.3, P <0.001). Each additional authorized medicine given also significantly increased the hazard (HR 1.2 95% CI 1.2 to 1.3, P <0.001). Conclusions OLUL medicines are more likely to be implicated in an ADR than authorized medicines. The number of medicines administered is a risk factor for ADRs highlighting the need to use the lowest number of medicines, at the lowest dose for the shortest period, with continual vigilance by prescribers, in order to reduce the risk of ADRs.
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              Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.

              Clinician prescribing of off-label medications is common due to a lack of pediatric-specific data regarding the dosing, efficacy and safety of medications regularly prescribed to children.
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                Author and article information

                Journal
                fh
                Farmacia Hospitalaria
                Farm Hosp.
                Grupo Aula Médica (Toledo, Toledo, Spain )
                1130-6343
                2171-8695
                December 2020
                : 44
                : 6
                : 272-278
                Affiliations
                [1] Palma de Mallorca orgnameHospital Universitario Son Llàtzer orgdiv1Servicio de Farmacia Spain
                Article
                S1130-63432020000600004 S1130-6343(20)04400600004
                10.7399/fh.11451
                33156745
                79aaa6ab-0d46-4d5b-b64a-234ca6139000

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 10 April 2020
                : 29 May 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 24, Pages: 7
                Product

                SciELO Spain

                Categories
                Originals

                Comisión de Farmacia y Terapéutica,Guía Farmacoterapéutica,Usos fuera de indicación,Informes de evaluación,Auditoria clínica,Resultados en salud,Ensayos de uso compasivo,Atención sanitaria,Pharmacy and Therapeutics Committee,Pharmacotherapeutic Guide,Off label use,Compassionate Use Trials,Assessment Studies,Clinical Audit,Outcome and Process Assessment,Health Care

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