Though we’re fewer than six months away from the Drug Supply Chain Security Act (DSCSA) enforcement date in November 2018, companies still fall into an array of buckets in terms of readiness. Some are prepared and even have aggregation capabilities, some are working out efficiency, connectivity or training issues in their packaging lines or level 4 systems. Others are perhaps a bit later to the party.
Unsurprisingly, last week’s序列化创新峰会由费城的商人托管在概念和新技术的准备和熟悉方面带来了一系列与会者的回复。
以下是基于他们所致的峰会的峰会的趋势细分：
Hopeful
Blockchain… it’s everywhere. The much-hyped technology will not solve any problems on its own but offers promise for the pharma supply chain in its ability to store and share one ledger of transactions with all partners.Tianna Umann, Cross Domain Solution Architect at Microsoft, explained that there are multiple types of blockchain (and trust levels), and that the kinds that benefit enterprise are private or consortium, as opposed to public.
智能合同本质上是实际合同条款的编程版本。它们提供将业务流程集成到区块链中的能力。
Umann提供了一个例子，该示例是为1000单位的药物治疗组创建了智能合同A.该装运通过供应链移动，每个载波扫描DataMatrix以确保所有1000个单位转移。每个步骤以及诸如温度和湿度的额外变量。当零售商店仅收到900个单位时，将被标记，并贸易伙伴被警告到1000个单位的智能合同已被侵犯，导致承运人立即上游招致罚款。
David Aguero, Manager Systems and Informatics, St. Jude Children’s Research Hospital pointed out that the DSCSA regulations don’t mandate a centralized ledger—it may ultimately be businesses needs that drive the adoption of the technology.
担心的
What is going to happen in Europe with the Falsified Medicines Directive (FMD) in February 2019???
只有大约2,200家公司中的45个左右，全面地向欧洲药品验证系统（EMV）达到了数百人。
Maarten Van Baelen, Market Access Director at Medicines for Europe, provided an update, explaining the good news that more partners are added each day. He feels that Europe can be ready by February with strong industry and governmental involvement, but that awareness among end users and manufacturers/market authorization holders (MAHs) still presents a challenge.
There are fees charged by the National Medicines Verification Organization (NMVO) to establish the system, and MAHs will have to pay operational fees in each of the countries they market products in.
There is also limited support of awareness in most hospitals regarding integration.Van Baelennotes that some hospitals only found out about the requirements six months ago and some are looking at ways to be exempted.
Intrigued
Sorin Haias,President and Founder ofLives International，讨论了冷链和序列化数据的集成。Haias，其公司为制药业提供数据记录器和热验证系统，解释说，客户可以使用Adent Prodigi来创建独特的序列号，然后将跟踪器放在最终包装中，以聚合的温度敏感产品。序列号与该包装中的唯一温度跟踪硬件相关联。
可以通过Prodigi及其Xpertrack平台的API显示关于温度，光，震动和更多的实时信息。在警报的情况下，将通知用户，并且从装运中的原始数据存储在Prodigi云中，并且当货物到达其最终目的地时，通过电子邮件发送状态报告。这似乎是组合多种形式的数据的有趣方式 -无论如何都要收集温度控制的产品 - 进入一个位置，因此公司可以跟踪风险切换和发货期间给定单元发生的情况。
不确定
药剂师讨论serializatio的必要性n at the unit of issue. At this point, meeting DSCSA requirements typically only tracks medicines to the hospital door. Often, pharmacists are splitting units of sale up into many doses, and what happens to doses within the hospital walls (from pharmacies to preparation to cabinets and more) isn’t tracked.
Dennis A. Tribble, Director of Healthcare Industry Operations at Becton Dickinson, noted that other tools will be needed to meet the spirit of the DSCSA regulations regarding location, sequestering and managing lots of suspected counterfeit drugs.
Excited
It may not beexactly与包装有关，但AI，混合现实和机器学习带来了一些真正有趣的医疗保健可能性。
Desmond Creary,Health Business Leader of the Americas at Microsoft, explained that in one Louisiana health system, HIPAA-compliant data analysis is being used to help predict which patients with heart disease are likely to code, allowing providers to make interventions before some serious complications arise. They are reducing the time for physicians to discuss, send tests and get opinions by reviewing data from similar patients—identifying what worked and what didn’t—to more quickly narrow down treatment options. This can reduce treatment plan decisions by days or weeks, when in the past, the patient would continue to become sicker while waiting.
在包装方面，Solutions Architect Luc Vo Van证明了使用HoloLens混合 - 现实耳机，他用于扫描盒子中的封装，检查委托状态和退役包。耳机旨在允许佩戴者执行任务最适合的工作职责，而无需移动到HMI或其他屏幕。
还提出了实验室使用示例，其中实验室程序出现在耳机上的员工视野中。他们能够继续使用手持工作而不与屏幕互动或需要去除手套。
amused.
Blame serialization! Supply Chain Wizard’s Evren Ozkaya brought up a fun fact: When a line stops, people are fairly quick to blame serialization for the downtime, even when the actual cause turns out to be completely unrelated (ahem, unplugged cord).
