RESUMO
El procedimiento de registro de medicamentos centralizado implica una evaluación conjunta por todas las Agencias Reguladoras de los Estados miembros de la Unión Europea que es coordinada por la Agencia Europea de Medicamentos. Desde su implantación en 1995, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha contribuido de forma activa al Comité de medicamentos de uso humano. Las áreas terapéuticas en las que la AEMPS tiene más presencia son cardiovascular, órganos de los sentidos (fundamentalmente oftalmología) y genitourinario-hormonas sexuales. A esta labor contribuyen con sus conocimientos y su extensa experiencia los técnicos de la propia AEMPS así como profesionales del sistema sanitario español que actúan en calidad de expertos externos aportando su visión clínica y acercando la práctica diaria a la evaluación de medicamentos. Como sucede con otros espacios de decisión europeos, la participación del conjunto de Estados miembro no es homogénea siendo todavía una minoría de países los que lideran la mayoría de las evaluaciones del Comité de medicamentos de uso humano, aunque todos los países toman parte en la opinión final (AU)
The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision (AU)
Assuntos
Humanos , Aprovação de Drogas , Avaliação de Medicamentos , Controle de Medicamentos e Entorpecentes/organização & administração , Comercialização de MedicamentosRESUMO
The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEMPS) has actively contributed to the committee on medicinal products for human use. The therapeutic areas in which AEMPS has the greatest presence are cardiovascular, sensory organs (mainly ophthalmology) and genitourinary/sexual hormones. The technical staff of AEMPS contributes their expertise and extensive experience to this task, as do the practitioners of the Spanish healthcare system who act as external experts, providing their clinical vision and bringing the daily clinical practice to the evaluation of medicinal products. As with other European decision spaces, the joint participation of the member states is not homogeneous, with a minority of countries still heading the majority of assessments for the committee on medicinal products for human use, although all member countries take part in the final decision.
RESUMO
Las heparinas de bajo peso molecular han de mostrado ser tan eficaces y seguras en la profilaxis del tromboembolismo venoso como la heparina no fraccionada. Su baja unión a proteínas plasmáticas, macrófagos y endotelio contribuye a su excelente biodisponibilidad vía subcutánea, a una respuesta anticoagulante más predecible cuando se administra a dosis fijas y a una vida media mayor. Además su administración subcutánea es más cómoda para el paciente y no se precisan ajustes de dosis. En este trabajo se revisan los principales factores de riesgo del tromboembolismo venoso y los distintos métodos físicos y farmacológicos disponibles actualmente para prevenirlo. También se resumen las últimas recomendaciones publicadas para la profilaxis del TEV en pacientes no quirúrgicos (AU)
Assuntos
Feminino , Masculino , Humanos , Tromboembolia/prevenção & controle , Heparina de Baixo Peso Molecular/uso terapêutico , Fatores de Risco , Antibioticoprofilaxia , Infarto do Miocárdio/etiologiaRESUMO
BACKGROUND: Amphotericin B is the treatment of choice for systemic fungal infections. Among the different AB formulations available, the lipid forms appear to have a better profile of reliability, however, their cost is noticeably higher. In 1999 (pre-initiative period) an evaluation of the quality of the prescription of these preparations was made in our hospital, which revealed that they were not being used to best advantage and were responsible for generating a significant unnecessary expenditure. As a result of this, an information initiative was implemented with respect to the prescribing physicians for the purpose of reducing the inappropriate use of AB. METHOD: The quality of 100 prescriptions was evaluated prospectively, according to the standards of use of Amphotericin B established in the hospital. Following each evaluation, a pharmacologist personally handed over to each prescribing physician a set of rules governing the use of the Amphotericin B, discussing the indication and recommending the best alternative in each case. In order to measure the impact of this initiative, the appropriateness of the prescriptions during this period was compared with the pre-initiative period. RESULTS: The percentage of inappropriate prescriptions dropped from 58% to 21% following the implementation of the initiative. Likewise, a 33-million-peseta reduction in the total expenditure was achieved in 15 months as well as a savings of 24 million in inappropriate prescriptions. CONCLUSIONS: The information initiative improved the quality of the prescribing of preparations of Amphotericin B associated with lipids and considerably reduced the unnecessary expense associated with Amphotericin B misuse in our hospital.
Assuntos
Anfotericina B/uso terapêutico , Antifúngicos/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Hospitais Urbanos , Humanos , Estudos Prospectivos , EspanhaRESUMO
BACKGROUND: Amphotericin B is the treatment of choice for systemic fungal infections, however, its clinical usefulness is limited by its toxicity. The lipid formulations appear to be equally effective and safer, but are more costly. The increase in the consumption of, and expenditure on these formulas led us to undertake a study in order to identify their profile of use (quantitative and qualitative) and to assess the financial repercussions when used inappropriately. METHODS: A set of rules were developed for the use of amphotericin B, and the quality of the prescription of non-conventional amphotericin B (amphotericin B notC) was evaluated retrospectively together with the financial repercussions of its inappropriate use. RESULTS: In 54% of the treatments studied, a poor selection of amphotericin B was made; in 3.5%, the use of amphotericin B was not indicated. The excess expenditure derived from the inappropriate use amounted to 42 million pesetas, 35% of the total expenditure on medicines; the expenditure due to unnecessary prescription was 1,720,327 pesetas. CONCLUSIONS: The retrospective evaluation has shown that there is a high percentage of treatments that do not conform with the recommendations contained in the prescription rules. The holding of information sessions would assist in achieving a more efficient selection of the amphotericin B notC; this would improve prescription quality, which might also deliver significant financial savings.
