医疗保健包装（HCP）：目前药物供应链安全法案（DSCSA）的重点是什么？
Peter Sturtevant：今年,重点转向批发商/说tributors; beginning November 27, 2019, DSCSA will require them to verify the unique identifier of returned products before these can be placed into inventory for resale. A manufacturer that receives a verification request from a wholesaler/distributor or dispenser will be required to verify all serialized packages.
GS1刚刚推出了与GS1 US合作的新的消息传递标准，用于验证序列化处方产品，以满足可销售返回的要求。由由制造商，分销商和解决方案提供商组成的全球GS1工作组开发和审查，此新标准指定了用于产品验证请求和响应的轻量通信框架。它将使供应链合作伙伴能够验证其占有的产品适用于前向分配，帮助他们确定是否接受，拒绝或检疫。
HCP：Pharma制造商如何将序列化相关的数据放在他们公司内有意义的用途，以帮助展示投资回报（ROI）？
Peter Sturtevant：该行业使这些投资能够满足法律要求，目的是提高患者安全。根据患者安全网络，不良药物事件是所有护理环境中最常见的可预防不良事件之一，占近700,000次急诊部门访问和100,000名住院治疗[1]。世界卫生组织（世卫组织）指出，不安全的药物措施和药物错误是全球医疗保健系统避免危害的主要原因，全球成本估计为42亿美元[2]。知道这一点，我们如何为储蓄生活拨款？
除了检查监管盒并提高患者安全外，可以通过制药供应链中产生效率，包括可追溯性，库存管理，安全供应链和合同管理，实现序列化的经济益处。由于必须以相当大的累积费用销毁无法验证的产品，改善了可销售返回的验证可以进一步降低供应链成本。
HCP：Is the ultimate goal(s) of serialization to improve patient safety and reduce the nation’s healthcare costs?
Peter Sturtevant：大多数医疗监管控制像DSCSA年代erialization of pharmaceuticals is aimed at improving patient safety while also driving operational efficiencies. The ability to track and verify complete, correct product identification throughout the supply chain and at point of use will help ensure delivery of what the Institute for Healthcare Improvement (IHI) calls the “five rights” of medication administration: the right drug reaches the right patient in the right dose, at the right time, via the right route. It also facilitates safe, timely and accurate removal of expired or recalled products from inventory.
HCP：Some have expressed a belief that serialization may fall short of being the solution to protecting patients from illegitimate medications. Can you address that?
Peter Sturtevant：No single action or process can guarantee prevention of falsified medicines reaching patients. The industry as a whole has agreed that authentication and chain of custody are the correct measures for supply chain stakeholders to strengthen pharmaceutical security.
迄今为止，大多数序列化软件公司已经存储了云中的数据。通过要求将要嵌入2D条形码中的完全序列化数据元素，DSCSA使得不良演员更加困难，以便通过供应链重复该产品代码并将假冒产品移动。我们希望看到由于未来四年的全部DSCSA实施增加而导致的改善。
已经有几个成功的飞行员来管理利用市场上商业验证路由器服务（VRS）和查找目录（LD）服务的验证返回的验证。一些软件公司已成功利用区块链技术来管理产品验证。在市场中出现了一个适度的不同VRS解决方案，强烈建议供应链合作伙伴探索各种选项。
HCP：Who within an organization should be tasked with handling these requests? Will this all be a digital/software solution? At conferences, we’ve heard brand owners asking if they will need to set up websites or call centers to handle these, and who will field the requests if they get them from doctors/pharmacists?
Peter Sturtevant：Generally, the dispenser returns a product directly to the wholesaler, which verifies the item through their own central database, or needs request verification from the manufacturer. The process for verification of saleable returns occurs outside of the doctor’s or pharmacist’s purview.
HCP: Relatedly, what promise do you see in current or developing anti-counterfeiting efforts/technologies?
Peter Sturtevant：希望是序列化将通过更容易地验证供应链中的任何地方的产品。随着新验证消息传递标准跟踪可销售返回的改进也可能积极影响行业筛选非法产品的能力。
HCP：与电子商务和温度敏感的出货量有什么具体的编码/序列化挑战公司？
Peter Sturtevant：There are companies that have cold chain measurable barcode technology to identify temperature excursions (deviations from given instructions)—so it will be known if a vaccine, for example, deviates from its specified safe temperatures, and for how long that deviation occurs. The technology exists but is not yet required by law in the U.S. The temperature and time-sensitive data can be embedded in a 2-dimensional (GS1 DataMatrix) barcode so that the paper it is printed on actually changes colors if there is an excursion.
HCP: While serialization is not mandated for food, can this industry benefit by the experience gained in the pharmaceutical industry to meet serialization compliance?
Peter Sturtevant：我们了解其他行业，如食品和饮料，正在积极探索SerializationAS，它是执行高效和准确的产品召回的关键工具，以及跟踪其他供应链数据，使得贸易伙伴可以知道产品的位置，并且在旅行中何处通过供应链。通过过去的食物欺诈丑闻，如骑士和一些海鲜欺诈仍然新鲜的消费者仍然是新鲜的，食品行业从实施挑战和成功中学到目前正在经历的挑战和成功是非常有益的。
GS1 USis committed to providing appropriate standards that the healthcare industry can leverage to improve patient safety and ensure the best possible outcomes. We work diligently with industry manufacturers all the way to dispensers to help ensure an efficient and secure supply chain.
