Legislación sobre autorización de genéricos / Regulation about generics approval

Objetivo: Analizar la legislación vigente referida a medicamentosgenéricos y actualizar su conocimiento.Método: En este trabajo se ha revisado la normativa europeay nacional respecto a los procesos de autorización y los procedimientosque garantizan la calidad, seguridad, y eficacia de losmedicamentos genéricos.Resultados: Los países pertenecientes a la Unión Europeahan desarrollado, a través de la Agencia Europea de Medicamentos(EMEA), una homogeneización en materia de autorización demedicamentos y exclusividad de los datos, ordenado en la Directiva2004/27 y el Reglamento 726/2004, normativas que se recogela Ley 29/2006 de Garantías y Uso Racional de los Medicamentosy Productos Sanitarios.Conclusiones: Aunque los mecanismos de regulación delprecio y la política de financiación son diferentes en los estadosmiembros, en casi todos los países se han desarrollado medidaspara contener el crecimiento del gasto farmacéutico, siendo unamedida importante para ello el uso de medicamentos genéricos,de menor coste que los medicamentos innovadores

Objective: To analyze current legislation referring to genericdrugs and to update knowledge concerning these drugs.Method: In this paper Spanish and European regulations havebeen reviewed in relation to the authorisation and procedures thatguarantee the quality, safety and efficacy of generics.Results: The countries belonging to the European Union haveestablished, through the European Medicine Agency (EMEA), uniformcriteria for authorisation and data exclusivity, regulated byDirective 2004/27 and Regulation 726/2004, which are beingimplemented in our country through Law 29/2006 of Guarantyand Rational Use of Medicines and Medical Devices.Conclusions: Although mechanisms of price regulation andfinancing policy are different throughout the member States, mostcountries have introduced measures to reduce the increase inexpenditure on medicines, with generic products being an importantaspect since they are less expensive than innovating medicines

A propósito de los antiepilépticos genéricos / Regarding generic antiepileptic drugs

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[Regulation about generics approval]. / Legislación sobre autorización de genéricos.

OBJECTIVE: To analyze current legislation referring to generic drugs and to update knowledge concerning these drugs. METHOD: In this paper Spanish and European regulations have been reviewed in relation to the authorisation and procedures that guarantee the quality, safety and efficacy of generics. RESULTS: The countries belonging to the European Union have established, through the European Medicine Agency (EMEA), uniform criteria for authorisation and data exclusivity, regulated by Directive 2004/27 and Regulation 726/2004, which are being implemented in our country through Law 29/2006 of Guaranty and Rational Use of Medicines and Medical Devices. CONCLUSIONS: Although mechanisms of price regulation and financing policy are different throughout the member States, most countries have introduced measures to reduce the increase in expenditure on medicines, with generic products being an important aspect since they are less expensive than innovating medicines.

Síndrome de secreción inadecuada de hormona antidiurética asociado al uso de inhibidores selectivos de recaptación de serotonina

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[The use of antitubercular drugs in primary care]. / Utilización de antituberculosos en atención primaria.

OBJECTIVES: To quantify the consumption of tuberculosis medication prescribed through the National Health Service in Spain during 1996. To calculate the prevalence of tuberculosis from this consumption. To analyse possible inequalities between autonomous communities. To analyse the cost of these drugs. DESIGN: A crossover, retrospective and observational study. SETTING: Primary care. MEASUREMENTS AND RESULTS: 5533233 DDDs were taken in 1996. 2215890 of these DDDs belonged to the rifinah association (rifampicin + isoniazid), followed by the active principle rifampicin with 973510 DDDs. Amikacin at 8,078 DDDs represented the lowest dose. DID (dose per inhabitant per day) in Spain was 0.37. Dosage was greater in Galicia (0.66) and Ceuta (0.52). The Canaries (0.19) and Balearics (0.27) were below the national average. Use was 40.05% for rifinah, followed by 17.59% for rifampicin. The least common active principles were amikacin (0.14%) and streptomycin (0.74%). The number of cases of tubercular disease in Spain calculated was 11,211; its prevalence was 27.7 cases per 100,000 inhabitants. Total medication cost was 863275147 pesetas (0.1% of total pharmaceutical expenditure). The attributable cost was rifinah, 40.26%, the rifater association, 21.68%, and rifampicin, 18.34%. CONCLUSIONS: The most often prescribed drug is the rifampicin + ilsoniazid association. Use varies between autonomous communities. We think that the prevalence calculated is high for a developed country.

Use of antituberculosis drugs in Spain 1996.

PURPOSE: To determine and analyse the consumption of antituberculosis agents in Spain. METHODS: Pharmacoepidemiological study on the use of antituberculosis agents during 1996 using data from prescriptions redeemed by the National Health Service. RESULTS: During 1996, 5 533 233 defined daily doses (DDD) were consumed. Of these, 2 215 890 DDDs belonged to a combination commercialized as Rifinah (Rifampicin+Isoniazid). The use of daily doses per inhabitant in Spain was 0.37. Regarding the percentage of use, this reflects a use of 40.05% of the Rifinah combination, followed by Rifampicin, 17.59%. Regarding estimation of tuberculosis, the findings of the study revealed 11,202 cases, implying a prevalence of 27.7 cases per 100,000 inhabitants. The total cost of this group of drugs was 863 275 147 Pts (0.1% of the total amount met by the NHS). Expenditure in Pts per 1000 inhabitants was 21 326. Of total costs, 40.26% was from Rifinah. Isoniazid was the drug with the lowest cost, 0.17%. CONCLUSIONS: The most prescribed drug in Spain was the Rifampicin+Isoniazid combination. However, differences exist in the different regions of the country and these should receive further study. The estimated prevalence of tuberculosis is higher than that expected for a developed country such as Spain.