醫藥供應鏈安全

由於生產商和分銷商對供應鏈的控制不力，造假者和走私者迅速發展，擅長生產假藥並將其混入合法供應鏈，導致許多假藥未被發現。為了解決這個問題，世界衛生組織 (WHO)、歐盟 (EU) 和美國食品藥物管理局 (FDA) 等全球組織正在共同努力，透過藥品供應鏈安全來保護患者的安全。

2015 年和 2018 年，DSCSA（藥品供應鏈安全法）制定了 10 年路線圖，包括產品追蹤、產品識別碼、授權供應商和驗證的執行和調整。該法的最後一部分是電子藥品分銷安全 (EDDS)。除此之外，EDDS 敦促所有人實施安全、電子和可互通的系統來交換交易文件（交易資訊(TI) 和交易聲明(TS)），以實現處方藥追蹤。我們正在向我們的業務合作夥伴發出指示。

該報告調查了藥品供應鏈的安全性，並提供了藥品供應鏈的概述和安全性，以及進入市場的公司的概況。

目錄

• 執行摘要
• 醫藥供應鏈安全
• 執行摘要
• 藥品安全與藥品保障
• 醫療保健誠信的典範轉移
• DSCSA 的目的
• DSCSA 的實施
• 產品追蹤概述
• 追蹤與追蹤
• 毒品安全的威脅
• 偽造
• 藥品安全包裝
• 追蹤
• 防篡改包裝
• 藥品安全技術的實現
• 序列化
• Bluetooth
• 藥品安全的無線選項
• 近距離無線通信
• 射頻識別
• 無線架構
• 數位醫療保健和網路安全
• NFC的醫療應用
• UDI
• 醫院庫存追蹤解決方案
• 住院管理
• 毒品安全的威脅
• 實體安全
• 區塊鏈
• 偽造
• 光可變元件
• 水印
• 安全威脅
• 安全箔
• 光變油墨/變色油墨
• 凹版印刷
• 雷射打標
• 磁條
• 微/奈米印刷
• 隱藏影像
• 偏振影像
• 防偽油墨
• 奈米顆粒
• 藥品安全包裝
• 藥品配送安全
• 追蹤
• 單位劑量包裝
• 全息圖
• 光學變化墨水
• 變色油墨
• 藥品安全技術的實現
• 互通性
• 序列化
• 規則
• 藥品供應鏈安全法 (DSCSA)
• DSCSA 對藥局和零售實體的要求
• 美國立法計劃
• 自動報告和整合訂購系統（ARCOS）
• 歐盟假藥指令
• 成本估算與預測
• 市場進入者
• 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
• 結論

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