假冒药品是不可原谅的，会造成难以估量的损害. 给制药商, 给医疗保健专业人员和组织, 对消费者的信任, 政府鼓励接种疫苗的能力, 当然, 给病人. It’s illegal, potentially life-threatening and we must all play our part in stopping it.
Yet the World Health Organisation (WHO) says an estimated 10 per cent of medical products in some regions are substandard or falsified[i]. For example, fake COVID-19 vaccines were identified in Mexico in February 2021[ii] 而且全球都发现了假冒的白血病药物[3]. Since the outbreak of COVID-19, the challenge of cracking down has become even more important.
This is because the pandemic has created what some see as a perfect storm where worldwide supply chain disruptions, regulatory confusion and an urgent public need for medical products provide a breeding ground for criminals to attempt distribution of their illegal goods[iv].
令人放心的是, there are a wide range of measures taken by pharmaceutical companies to minimise the likelihood of fake drugs reaching patients. 此外, the problem of counterfeits is most pronounced outside of the regulated supply chain[v]. But there is always room for improvement, innovation and the review of procedures.
我们能做些什么??
没有单一的解决办法. 没有能阻止造假者的灵丹妙药. 整个行业都需要考虑多层次的方法. 虽然不是一个详尽的清单，但有一些关键步骤可以采取.
The first step is ensuring an individual is dedicated to monitoring the security of the supply chain from manufacturing sites, 直通到仓库, 转发, 航运, 接收货物，甚至在医疗保健环境中使用. There need to be assurances from the moment of production to the second a patient receives it. This should involve regular contact with suppliers and an ongoing review of every step.
一旦就位, 此人需要与监管机构保持密切联系, 在他们自己的国家和全球的机构. 例如，美国食品和药物管理局(FDA)、世卫组织和国际刑警组织. They have developed strategies to tackle counterfeit drugs that need to be followed or will have a role in bringing perpetrators to justice.
但重要的是不要把预防变成别人的工作. Organisations also need to ensure packaging is designed to make copying it harder than ever – down to the individual pack or dose. 这可以包括条形码, 射频识别跟踪, holograms and unique identifiers – the last of which have been required by law in the EU since 2019[vi].
There are even solutions that allow manufacturers to embed traditional holographic effects directly into packaging during the injection moulding process(七). DNA markers have also come onto the market, which are deemed to be impossible to counterfeit(八). These must be checked throughout the supply chain to ensure no tampering at any point.
主动冷链和被动冷链
With this in mind, there’s another factor to consider: the integrity of bulk shipments in transit. 需要尽可能地保护它们不被篡改. 这可以通过所谓的活动容器来实现.
To explain a little further, many modern pharmaceuticals require a cold-chain for transportation. This calls for specialist packing to maintain a constant temperature as the shipment is transported. There are two main choices for achieving this: passive packaging or active containers.
The former is called so because it doesn’t have moving parts or anything that proactively works to maintain the temperature in the shipment. 它就像一个巨大的啤酒冷却器，或者有隔热层和冷袋的纸箱.
活动容器是不同的. 它们是可重用的, battery powered and insulated metal units that can accommodate pallets of pharmaceuticals. Importantly, active containers often have doors that can be closed, latched and sealed.
一旦这发生了, 里面的东西是安全的，不会被篡改，也不会受到温度偏差的影响. 更重要的是，许多容器中都有内置的监控工具. These record everything from position, temperature, battery level and humidity, to door openings.
这为安全提供了保证. 如果有人打开房间, 它将被记录下来, leading to quicker investigations and risk assessments related to counterfeit, 安全问题或装运过程. Passive packaging, with its cardboard, removable insulation and wrapping, has none of this.
The difference between these methods of transportation is important to consider, 因为从2013年开始, 欧盟人用医药m88官方良好销售规范规定, “Medicinal products should be transported in containers that have no adverse effect on the quality of the products, 这就提供了足够的保护免受外部影响, 包括污染.”[ix]
为什么要冒这个险?
This isn’t to say that we shouldn’t trust forwarders to protect drugs when in transit, 无论是否在活动容器中. 我们应该, 2013年美国《m88官方》旨在确保这一点, with national licensure standards for wholesale distributors and third-party logistics providers[x]. But forwarders themselves suggest global pharma supply chains are not immune from, “不法分子试图假冒假冒药品.”[xi]
As a result, if there’s a measure that can be taken to cut risk even further, why not take it? 此外, 当考虑总到岸成本(TLC)时, 总的来说，主动容器的使用成本更低. 因为它们更安全，更便宜, it’s vital that more pharmaceutical companies consider active containers as part of a layered approach to reduce the likelihood of counterfeiting.
这个行业, 因此, must always look for new innovations to secure itself from the growing threat of counterfeit pharmaceuticals. Active containers can cost-effectively play a role when used in conjunction with other measures, 切断供应链中潜在的薄弱环节.
[i] 世卫组织，不合格和伪造的医疗m88官方，2018年1月
[ii] WHO, Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2, March 2021
[3] WHO, Medical Product Alert N° 3/2019: Falsified ICLUSIG (Asia and globally), February 2019
[iv] Pharma Times, COVID and the growing threat of counterfeit medicines, April 2021
[vi] European Commission, SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE, April 2021
(八) L&NW, Schreiner-MediPharm offering counterfeit-proof feature for pharma labels, August 2019