Top Three Takeaways:
- Manufacturers that receive a verification request from a wholesaler/distributor or dispenser will be required to verify all serialized packages.
- Serialization ROI comes from increased patient safety, meeting DSCSA compliance and realizing greater supply chain efficiencies.
- Improvements in tracking of saleable returns with the new verification messaging standard may also positively affect the industry’s ability to screen out illegitimate products.
Healthcare Packaging (HCP):What is the current focus of Drug Supply Chain Security Act (DSCSA)?
Peter Sturtevant.:This year, the focus is shifting to wholesaler/distributors; 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 has just launched a new Messaging Standard in collaboration with GS1 US for the verification of serialized prescription products to meet the requirements for saleable returns. Developed and vetted by a global GS1 workgroup comprised of manufacturers, distributors and solution providers, this new standard specifies a lightweight messaging framework for product verification request and response. It will enable supply chain partners to verify that a product in their possession is suitable for forward distribution, helping them to determine whether to accept, reject or quarantine it.
HCP.: How can pharma manufacturers put serialization-related data to meaningful use within their companies to help demonstrate a Return on Investment (ROI)?
Peter Sturtevant.: The industry has made these investments to meet the requirements of the law with a goal of improving patient safety. According to the Patient Safety Network, adverse drug events are one of the most common preventable adverse events in all settings of care, accounting for nearly 700,000 emergency department visits and 100,000 hospitalizations[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]。Knowing this, how can we place a dollar value on saving lives?
In addition to checking off the regulatory box and improving patient safety, financial benefits of serialization may be realized through resulting efficiencies in the pharmaceutical supply chain including traceability, inventory management, secure supply chains, and contract management. Improved verification of saleable returns can further reduce supply chain costs, since products that can’t be verified must be destroyed, at a considerable cumulative expense.
HCP.:是序列化的最终目标，以提高患者安全性，降低国家的医疗保健费用吗？
Peter Sturtevant.:Most regulatory control in healthcare like DSCSA serialization 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.：有些人表示相信，序列化可能缺乏保护免受非法药物患者的解决方案。你能解决这个问题吗？
Peter Sturtevant.：没有单一的动作或过程可以保证预防伪造的药物到达患者。整个行业同意认证和监管链是供应链利益攸关方加强药物安全的正确措施。
To date, most serialization software companies already store the data in the cloud. By requiring fully serialized data elements to be embedded in a 2D barcode, the DSCSA makes it more difficult for bad actors to duplicate that product code and move counterfeit products through the supply chain. We hope to see resulting improvements as full DSCSA implementation increases over the next four years.
There have been several successful pilots to manage the verification of saleable returns utilizing Verification Router Services (VRS) and Lookup Directory (LD) services commercially available in the marketplace. Several of the software companies have successfully leveraged blockchain technology to manage product verification. A modest number of different VRS solutions are emerging in the marketplace, and it is highly recommended that supply chain partners explore the various options.
HCP.:组织内的世卫组织应任务处理这些请求？这一切都是数字/软件解决方案吗？在会议上，我们已经听到品牌所有者询问他们是否需要建立网站或呼叫中心来处理这些，并且如果他们从医生/药剂师那里获得请求？
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：相关，您在当前或开发反假冒努力/技术时看到的承诺？
Peter Sturtevant.: The hope is that serialization will help by making it easier to validate a product anywhere in the supply chain. Improvements in tracking of saleable returns with the new verification messaging standard may also positively affect the industry’s ability to screen out illegitimate products.
HCP.: What are the specific coding/serialization challenges companies face with e-commerce and temperature-sensitive shipments?
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：虽然序列化未被授权食品，但该行业是否可以通过制药行业获得的经验，以满足序列化遵守情况？
Peter Sturtevant.:我们知道其他行业，如食品和饮料，正在积极探索序列化，因为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，并一直都知道旅行通过供应链。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美国致力于提供适当的标准，即医疗保健行业可以利用以改善患者安全性，并确保最佳结果。我们努力与行业制造商努力一路卸车，以帮助确保高效和安全的供应链。
