当无法获得授权药品时的替代方案

F. Selmin, U. Musazzi, F. Cilurzo, P. Minghetti
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引用次数: 3

摘要

医药产品的工业化使我们在药品的质量、疗效、安全性和可获得性方面取得了重要成果;然而,并不是所有患者的合理期望都得到了满足。当批准的药品在市场上买不到时,医生可以在以下情况下开其他药物治疗:超说明书处方、临时制剂、同情用药以及在国外获得批准的药品。应根据良好的科学证据、专家的医学判断和已发表的文献逐一评估这些替代方案中的最佳解决方案,同时还要关注可获得性、成本和国家一级的监管要求。
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Alternatives When an Authorized Medicinal Product is Not Available
The industrialization of medicinal products has permitted us to reach important results in terms of quality, efficacy, safety, and availability of drugs; however, not all the legitimate expectations of patients are met. When an authorized medicinal product is not available on the market, the physician can prescribe other pharmacological treatments in the following scenario: off-label prescriptions, extemporaneous preparations, compassionate use of medicinal products, and medicinal products authorized in foreign countries. The best solution among these alternatives should be evaluated case-by-case on the basis of good scientific evidence, expert medical judgement, and published literature, also keeping an eye on the availability, the cost, and the regulatory requirements at a national level.
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