Counterfeiting pharmaceuticals is unforgivable and causes untold damage. To pharmaceutical manufacturers, to healthcare professionals and organisations, to consumer trust, to the ability of governments to encourage uptake of vaccines and, of course, to patients. 这是非法的，可能危及生命，我们都必须发挥自己的作用来阻止它.
然而，世界卫生组织(WHO)表示，在一些地区，估计有10%的医疗全球十大赌钱软件app是不合格或伪造的[i]. 例如，2021年2月在墨西哥发现了假COVID-19疫苗[ii] and counterfeit leukaemia drugs have been found globally[iii]. 新冠肺炎疫情发生以来，抗击疫情的挑战更加严峻.
这是因为大流行造成了一些人认为的完美风暴，导致全球供应链中断, 监管混乱和公众对医疗全球十大赌钱软件app的迫切需求为犯罪分子试图分销其非法商品提供了温床[iv].
Reassuringly, 制药公司采取了一系列措施，以尽量减少假药到达患者手中的可能性. 此外，假冒问题在受监管的供应链之外最为明显[v]. 但总有改进、创新和审查程序的空间.
What can be done?
There is no single solution. No silver bullet that will stop counterfeiters in their tracks. The whole industry needs to consider a multi-layered approach. While not an exhaustive list, there are some key steps that can be taken.
第一步是确保有专人负责从生产现场监控供应链的安全, through to storage, forwarding, shipping, receipt of goods and even their use in a healthcare setting. 从生产的那一刻到病人接受的那一刻，都需要有保证. 这应该包括与供应商的定期联系和对每一步的持续审查.
Once in place, that person needs to be closely aligned to regulatory bodies, and agencies in their own country and globally. For example, the US Food and Drug Administration (FDA), WHO and Interpol. 他们制定了应对假药的战略，这些战略需要得到遵守，或者将在将犯罪者绳之以法方面发挥作用.
But it’s important not to make prevention someone else’s job. 组织还需要确保包装的设计使复制比以往任何时候都更加困难-小到单个包装或剂量. This can include bar codes, RFID tracking, 全息图和唯一标识符——自2019年以来，欧盟法律要求使用最后一项[vi].
甚至有解决方案，允许制造商嵌入传统的全息效果直接到包装注塑过程中[vii]. DNA标记也已经进入市场，被认为是不可能伪造的[viii]. 这些必须在整个供应链中进行检查，以确保在任何一点上都没有篡改.
Active and passive cold chain
考虑到这一点，还有另一个因素需要考虑:运输中的散装货物的完整性. They need to be protected from tampering as best they can. This can be achieved with what’s known as an active container.
进一步解释一下，许多现代药品需要冷链运输. 这就需要专门的包装，以便在货物运输过程中保持恒温. 实现这一目标有两种主要选择:被动包装或主动容器.
前者之所以如此称呼，是因为它没有活动部件或任何主动保持货物温度的东西. It’s like a giant beer cooler or carboard box with insulation and cool packs.
Active containers are different. They’re reusable, 电池供电和绝缘的金属单元，可以容纳药品托盘. 重要的是，活动容器通常有可以关闭、闩锁和密封的门.
Once this has taken place, the contents remain safe from tampering – as well as temperature deviations. What’s more, there are built-in monitoring tools in many containers. 这些记录一切，从位置，温度，电池电量和湿度，到开门.
This provides assurances about safety. If someone opens the unit, it will be recorded, 从而更快地调查和评估与假冒相关的风险, security concerns or shipment processes. 被动包装，其纸板，可移动的绝缘和包装，没有这些.
考虑这些运输方式之间的区别是很重要的, because since 2013, the EU’s Good Distribution Practice of Medicinal Products for Human Use says, “药品应当使用对药品质量无不良影响的容器运输, and that offer adequate protection from external influences, including contamination.”[ix]
Why take the risk?
这并不是说我们不应该信任货运代理在运输过程中保护药品, whether in active containers or not. We should, and the US Drug Supply Chain Security Act of 2013 aimed to assure this, 具有批发分销商和第三方物流供应商的国家许可标准[x]. 但货运代理自己表示，全球制药供应链也无法幸免, “Bad actors seeking to pass off counterfeit pharmaceuticals.”[xi]
因此，如果有一种措施可以进一步降低风险，为什么不采取呢? Furthermore, when Total Landed Cost (TLC) is accounted for, active containers cost less to use overall. Given they’re safer and cheaper, 至关重要的是，更多的制药公司将活性容器视为分层方法的一部分，以减少假冒的可能性.
This industry, therefore, 必须一直寻找新的创新来保护自己免受日益增长的假药威胁吗. 当与其他措施结合使用时，主动容器可以经济有效地发挥作用, cutting out a potentially weak link in the supply chain.
[i] WHO, Substandard and falsified medical products, January 2018
[ii] 世卫组织，医疗全球十大赌钱软件app警报第2/2021号:伪造的COVID-19疫苗BNT162b2, 2021年3月
[iii] 世卫组织，医疗全球十大赌钱软件app警报N°3/2019:伪造的ICLUSIG(亚洲和全球)，2019年2月
[iv] 《全球十大赌钱软件app》，《可以赌足球的app》，2021年4月
[v] UPS, The fight against counterfeit drugs, June 2021
[vi] 欧洲委员会，人用医药全球十大赌钱软件app的安全特性，2021年4月
[viii] L&NW, Schreiner-MediPharm为药品标签提供防伪功能，2019年8月
[ix] Official Journal of the European Union, Guidelines on Good Distribution Practice of Medicinal Products for Human Use, March 2013