The assessment of risks, benefits and availability of non-narcotic analgesics. A commonsense approach.

Medical toxicology Pub Date : 1986-01-01
I Darmansjah
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Abstract

In Indonesia, about 50% of all available non-narcotic analgesics are marketed as single drugs and the other half comprise fixed combination products. Each country should decide through a national drug policy which drugs are to be available, but it is important such policies be flexible and cognisant of the needs of the public and of the pharmaceutical industry. A drug should not be withdrawn from the market without an objective scientific assessment of its benefit-risk ratio. However, reevaluation of some drugs marketed previously should be undertaken, including combinations of non-narcotic analgesics. Although it is often said that evaluation of drugs should be left to experts in the established drug control agencies and that the third world countries should follow their decisions, there is a good argument for the developing countries to formulate and implement their own drug policies. In evaluating a non-narcotic analgesic, efficacy and safety must be carefully considered and a drug with marginal efficacy should not be approved for use. However, a non-narcotic analgesic with superior efficacy should probably be approved for use even if there is some risk associated with usual therapeutic dosages. Commonsense reasoning demands that drugs should be for the layperson to treat common ailments, although such drugs must fulfil exacting criteria of efficacy, safety and simplicity of use.

非麻醉性镇痛药的风险、获益和可得性评估。一个常识性的方法。
在印度尼西亚,所有可用的非麻醉性镇痛药中约有50%作为单一药物销售,另一半包括固定组合产品。每个国家应通过一项国家药物政策来决定提供哪些药物,但重要的是这种政策要灵活,并认识到公众和制药业的需要。未经对获益风险比进行客观科学评估的药品不得退出市场。但是,应该对以前销售的一些药物进行重新评价,包括非麻醉性镇痛药的组合。虽然人们经常说,对药物的评价应该留给已建立的药物管制机构的专家,第三世界国家应该遵循他们的决定,但是发展中国家有充分的理由制定和执行它们自己的药物政策。在评价一种非麻醉性镇痛药时,必须仔细考虑其疗效和安全性,不应批准使用疗效有限的药物。然而,一种疗效优越的非麻醉性镇痛药可能应该被批准使用,即使与通常的治疗剂量有一些风险。常识性的推理要求,药物应该是给外行人治疗常见病的,尽管这些药物必须符合疗效、安全性和使用简单性的严格标准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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