ECA新闻20150527：从FDA的角度看美国药品供应链和患者安全（重要）

ECA新闻20150527：从FDA的角度看美国药品供应链和患者安全（重要）

2015-05-27 22:52:34

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ECA新闻

GMP News
27/05/2015

From an FDA Perspective: The US Drug Supply Chain and Patient Safety

从FDA的角度：美国药品供应链和患者安全

On the website of the U.S. Food and Drug Administration, Ilisa Bernstein, Deputy Director of FDA's Center for Drug Evaluation and Research's Office of Compliance, shares her thoughts on the important role drug supply chain integrity plays in patient safety and quality care. Ilisa Bernstein is focusing on three key areas:

在美国FDA网站上，Lisa Bernstein，FDA的CDER办公室副主任分享了她“关于药品供应链完整性在患者安全和质量保证上的重要角色”的想法。她主要关注的是三个关键领域：

1.) Protecting the drug supply chain 保护药品供应链

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan, new requirements were defined in the USA which aim at improving the traceability of prescription drugs within the supply chain.

为了提高供应链中处方药的可追踪性，在美国制订了新的要求，即“药品供应链安保法案(DSCSA)”及相关的实施计划。

The DSCSA is focussing on each step in the supply chain, tracking the different stages on the way to the pharmacist.

DSCSA聚集于供应链的每一个步骤，追踪药品到药师手中所经路线的不同阶段。

Under the DSCSA, doctors will be are required to purchase their prescription drugs only from authorized trading partners licensed by or registered with the state or federal government.

根据DSCSA，医生被要求仅从有授权的贸易商伙伴那里采购其处方药，这些贸易商应在联邦政府或州政府进行注册或获得许可。

When products occur from outside the legitimate supply chain, FDA will issue letters to doctors informing them that they may have obtained counterfeit or unapproved drugs.

如果药品来自合法供应链之外的途径，则FDA会向医生签发信函通知医生其可能拿到的是假药或未经批准的药品。

2.) Purchasing decisions and patient health 采购决策和患者健康

Ilisa Bernstein  says that she has "seen a growing trend of health care professionals and medical practice administrators who purchase prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain."

LISA说，她已“看到保健行业和医疗实践管理者从合法供应链以外的不良批发药品销售商处采购药品呈现增长趋势”。

Drugs sold by rogue distributors may be counterfeit, adulterated or may not have been evaluated by FDA for safety and effectiveness. Because FDA has not evaluated these products, there is no way of knowing if these drugs were made using quality manufacturing practices, contain harmful ingredients, or if they were stored under proper conditions.  For these reasons and more, it is important that health care professionals know the source of their drugs.

不良批发商销售的药品可能是假药、伪药或未经过FDA安全性和有效性评估的药品。如果FDA没有评估过这些药品，那就没有办法知道这些药品是否按GMP生产，是否含有有害成分，或者它们是否存贮在适当的条件下。由上述理由可知，保健行业知晓药品的来源很重要。

3.) Buyer beware 购买者要小心

In this context, she emphasizes "if an offer sounds too good to be true - it probably is. And that "deep discounts may indicate that the products are stolen, counterfeit, or unapproved".

在此情况下，她强调“如果一个报价听起来太优惠，不可能是真实的----当然可能是真的，很高的折扣可能表示产品是盗窃来的，是假药，或者是未经批准的”。

To be on the safe side, doctors should ensure they are receiving FDA-approved prescription drugs. After being received, checks of packaging, labels and safety information should be performed.

为了安全起见，医生应保证他们收到的是经FDA批准的处方药。在收到后，要检查包装、标签和安全信息。

She also recommends listening closely to patient feedback. "If several patients report that they are experiencing a new side effect or lack of therapeutic effect from the same product, consider that the drug may be substandard or counterfeit. Health care professionals and patients should report adverse events related to the use of a suspect product and drug quality issues to FDA's MedWatch Safety Information and Adverse Event Reporting Program."

她还建议密切关注患者反应，“如果几个患者报告他们在使用了相同的药品后，发生了新的不良反应，或没有疗效，则要考虑这些药品可能是不达标准的，或假药。健康专家和患者应报告与使用可疑药品有关的不良反应事件，以及药品质量问题给

FDA

的药品监测安全信息和不良反应事件报告中心”。

这个真的要好好学学

了解一下！！！！！！！