Access to orphan drugs despite poor quality of clinical evidence

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Mechanism of coordinated access to orphan drugs

Context Although the EU Council stated[1] that “All health systems in the EU aim to make provision, which is patient-centered and responsive to individual need”, numerous sources show important and unacceptable differences in access to orphan drugs in the Member States of the European Union (EU COM [2], EURORDIS [3,4], BE EU Presidency [5,8], EU Council [6]). With this regard, in the context of...

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Access to essential drugs in poor countries.

THE EFFECTIVENESS OF DRUGS DEpends on a long chain of factors: research and development (R&D) of an appropriate pharmaceutical agent, production, quality control, distribution, inventory control, reliable information for health care professionals and the general public, diagnosis, prescription, financial accessibility, drug dispensing, observance, and pharmacovigilance. At each level, those inv...

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Access To Orphan Drugs In Greece During Economic Crisis.

Background & Objectives Orphan Drugs (ODs) are medicinal products intended for diagnosis, prevention or treatment of rare diseases. Access to ODs is crucial for patients' health and quality of life. However, patients claim that access to orphan drugs is sometimes restricted, a phenomenon that has grown during the economic crisis. The aim of this study was to identify current problems and future...

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Does price reveal poor-quality drugs? Evidence from 17 countries.

Focusing on 8 drug types on the WHO-approved medicine list, we constructed an original dataset of 899 drug samples from 17 low- and median-income countries and tested them for visual appearance, disintegration, and analyzed their ingredients by chromatography and spectrometry. Fifteen percent of the samples fail at least one test and can be considered substandard. After controlling for local fa...

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Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

OBJECTIVE To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. METHODS A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. RESULTS Fifty seven articles and 35 countries were...

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ژورنال

عنوان ژورنال: British Journal of Clinical Pharmacology

سال: 2011

ISSN: 0306-5251

DOI: 10.1111/j.1365-2125.2010.03877.x