医药供应链安全

由于生产商和分销商对供应链的控制不力，造假者和走私者迅速发展，擅长生产假药并将其混入合法供应链，导致许多假药未被发现。为了解决这个问题，世界卫生组织 (WHO)、欧盟 (EU) 和美国食品药物管理局 (FDA) 等全球组织正在共同努力，透过药品供应链安全来保护患者的安全。

2015 年和 2018 年，DSCSA（药品供应链安全法）制定了 10 年路线图，包括产品追踪、产品识别码、授权供应商和验证的执行和调整。该法的最后一部分是电子药品分销安全 (EDDS)。除此之外，EDDS 敦促所有人实施安全、电子和可互通的系统来交换交易文件（交易资讯(TI) 和交易声明(TS)），以实现处方药追踪。我们正在向我们的业务合作伙伴发出指示。

该报告调查了药品供应链的安全性，并提供了药品供应链的概述和安全性，以及进入市场的公司的概况。

目录

• 执行摘要
• 医药供应链安全
• 执行摘要
• 药品安全与药品保障
• 医疗保健诚信的典范转移
• DSCSA 的目的
• DSCSA 的实施
• 产品追踪概述
• 追踪与追踪
• 毒品安全的威胁
• 伪造
• 药品安全包装
• 追踪
• 防篡改包装
• 药品安全技术的实现
• 序列化
• Bluetooth
• 药品安全的无线选项
• 近距离无线通信
• 射频识别
• 无线架构
• 数位医疗保健和网路安全
• NFC的医疗应用
• UDI
• 医院库存追踪解决方案
• 住院管理
• 毒品安全的威胁
• 实体安全
• 区块链
• 伪造
• 光可变元件
• 水印
• 安全威胁
• 安全箔
• 光变油墨/变色油墨
• 凹版印刷
• 雷射打标
• 磁条
• 微/奈米印刷
• 隐藏影像
• 偏振影像
• 防伪油墨
• 奈米颗粒
• 药品安全包装
• 药品配送安全
• 追踪
• 单位剂量包装
• 全息图
• 光学变化墨水
• 变色油墨
• 药品安全技术的实现
• 互通性
• 序列化
• 规则
• 药品供应链安全法 (DSCSA)
• DSCSA 对药局和零售实体的要求
• 美国立法计划
• 自动报告和整合订购系统（ARCOS）
• 欧盟假药指令
• 成本估算与预测
• 市场进入者
• AlpVision
• Packaging and label protection
• Angstrom Technologies
• Advast Suisse AG
• Covectra
• LGPM Pharma
• Korber
• NucTech
• Imaging and Sensing Instrumental Methods
• RxScan
• TraceLink
• TrackTracerx
• VISIOTT Pharma Serialization Solutions
• 结论

The ineffective management of supply chains by manufacturers and distributors has allowed counterfeiters and smugglers to evolve rapidly and become very creative and excel in producing counterfeit medicines and inserting them into the legitimate supply chains, meaning that many fake medicines go undetected. To counter this issue, global organizations, such as the World Health Organization (WHO), the European Union (EU), and the US Food and Drug Administration (FDA), work together to protect the safety and security of patients through pharma supply chain security.

Evolution in Supply Chain Management

DSCSA (Drug Supply Chain Security Act) established a 10-year roadmap with enforcement and adaptations in 2015 and 2018 related to Product Tracing, Product identifiers, Authorized Trading Partners, and Verification. The last section of the law, is Electronic Drug Distribution Security (EDDS). Among other things, EDDS directs all trading partners to have in place a secure, electronic, and interoperable system for the exchange of transaction documentation [transaction information (TI) and transaction statements (TS)] to enable the tracing of prescription medications.

Features:

• Graphs, charts, tables and visualizations complement the analysis
• Forecasts, projections of future market activity are derived using standard modeling and statistical techniques.

What You Will Learn:

• Provides detailed analysis DSCSA strategies, and workflow component factors.
• Assesses key stakeholders, market dynamics and market demographics.
• Analyzes therapeutic demand drivers and evaluates readiness in key supply chain segments.
• Provides market data and forecasts.
• Profiles market sector participants, their market activities, business strategies, and corporate alliances and affiliations
• Assesses the importance of alliances and partnerships on DSCSA implementation.
• Evaluates the impact of supply chain security economic, technology, and regulatory factors.

Table of Contents

• Executive Summary
• Pharma Supply Chain Security
• Executive Summary
• Drug Safety vs Drug Security
• A Paradigm Shift in Healthcare Integrity
• DSCSA Objectives
• DSCSA Implementation
• Overview of Product Tracing
• Track and Tracing
• Threats to Drug Security
• Counterfeiting
• Packaging for Drug Security
• Track and Trace
• Tamper Evident Packaging
• Enabling Drug Security Technologies
• Serialization
• Bluetooth
• Wireless Options for Drug Security
• Near Field Communication
• RFID
• Wireless Architectures
• Digital Healthcare and Cybersecurity
• Medical Applications for NFC
• UDI
• Hospital Inventory Tracking Solutions
• In-patient Management
• Threats to Drug Security
• Physical Security
• Blockchain
• Counterfeiting
• Optical variable devices
• Watermark
• Security threats
• Security foils
• Optically Variable Inks/Color shifting Inks
• Intaglio printing
• Laser marking
• Magnetic strip
• Micro/nano printing
• Hidden imagery
• Polarization imagery
• Security inks
• Nanoparticles
• Packaging for Drug Security
• Drug Distribution Security
• Track and Trace
• Unit Dose Packaging
• Holograms
• Optically Variable Ink
• Color Shifting Inks
• Enabling Drug Security Technologies
• Interoperability
• Serialization
• Regulations
• The Drug Supply Chain Security Act (DSCSA)
• DSCSA Requirements for Pharmacies and Retail Entities
• United States Legislative Programs
• Automation of Reports and Consolidated Orders System (ARCOS)
• EU Falsified Medicines Directive
• Cost Estimates and Forecasts
• Market Participants
• AlpVision
• Packaging and label protection
• Angstrom Technologies
• Advast Suisse AG
• Covectra
• LGPM Pharma
• Korber
• NucTech
• Imaging and Sensing Instrumental Methods
• RxScan
• TraceLink
• TrackTracerx
• VISIOTT Pharma Serialization Solutions
• Conclusion