More harm than good: when drugs are removed from the market

许多批准的药物通常被销售,因为它们的损害比率是不可接受的。研究published todayBMC Medicinehas investigated why this happens, and Joel Lexchin tells us more in this blog.

毒品应该可以帮助我们,并且经常会帮助我们,但是有时候事实证明它们造成的危害超过了他们的福利,需要将其从市场上撤出。从加拿大的角度来看,这是我十多年来一直在研究的主题。

In Canada, about 4% of the drugs approved in any five-year period since 1990 eventually are退出出售因为它们对伤害比率的好处是不可接受的。

四个%的声音听起来不高,但是这个数字掩盖了暴露于这些产品的人数。其中一些药物,例如Rofecoxib(Vioxx)是该国开处方最多的药物之一。这种现实应该使任何有权开处方谨慎的人,尤其是在安全信息相对较少的新药方面。

何时进入加拿大市场和去除毒品之间的中位时间约为3。5年。我试图记住的信息,我试图将我工作的急诊科的医学生和居民传达给他们的急诊室,这是对开出新药的谨慎。除非您已经用完所有其他选项,否则除非新产品有效,否则不要使用它。

但是,这种谨慎的注意通常被渴望获得研究和开发新产品所花费的资金回报的药品公司所带来的促销信息所淹没。这些消息的工作非常好在fluencing the way that doctors prescribe

研究发现了什么?

The new study by Onakpoyaet al今天发表在BMC Medicine分析1953年至2013年之间全球462次提款,这为有关药物安全的故事增加了一些不安的皱纹。

Risk management plans and other methods to minimize risk that are common in developed countries have not been adapted to ensure patient safety in the developing world.

The first one is the finding that the withdrawal of drugs in Africa is significantly delayed compared to Europe or North America. This conclusion should not come as a surprise sincepharmacovigilance centres in most developing countriesare severely understaffed and under-resourced.

Risk management plans and other methods to minimize risk that are common in developed countries have not been adapted to ensure patient safety in the developing world.

What does this mean?

好消息是,非洲国家卫生组织计划计划的官方成员的数量已经增长大陆。但是,需要做更多的事情,以确保毒品安全,国际社会需要将其作为优先事项。

The other piece of bad news is that since 1960 there has not been any consistent decline in how long it takes between the first detection of an adverse reaction and when the drug is finally withdrawn from the market. And although the time to detect adverse reactions has shortened the decrease has not been substantial.

为什么很难改进?

One reason for the minimal improvement might be the uneven distribution of personnel, resources and authority between those who approve new drugs and those who monitor their safety.

In Canada, three to four times more people and money are allocated to the former compared to the latter. In the United States, the Food and Drug Administration’s Office of Surveillance and Epidemiology (OSE) is subordinate to the Office of New Drugs (OND).

One reason for the minimal improvement might be the uneven distribution of personnel, resources and authority between those who approve new drugs and those who monitor their safety.

这种分层关系提升了OND审稿人的意见,他们传统上接受了药理学和相关生物医学领域的培训,而不是OSE的流行病学家,药物安全专家和风险通信官员。

最后,虽然自发adve的依赖rse reaction reporting for the detection of safety problems has been declining in importance, it is still the major source of information. However, it is common knowledge that only between 1 and 10% of reactions are ever reported.

不愿举报

在一个最近的评论由不列颠哥伦比亚大学的科琳·霍尔(Corinne Hohl)博士领导,我们探讨了为什么临床医生不愿举报。临床医生需要支持立即和短期患者安全目标的系统。但是,报告系统适合临床实践,时间耗时,无法完成,并且不整合到临床过程中。

各方都需要分享减少不安全药物危害的危害的责任 - 制药行业,药物监管机构和临床医生,以确保他们服用的药物不会损害患者。

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