Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits

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Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits

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Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits

Summary

The top three wholesalers in the US, AmerisourceBergen Corporation, Cardinal Health and McKesson Corporation, accounted for 86.7% of the overall US pharmaceutical market in 2011 and combined revenue of $295.2 billion. Various supply chain models are followed across the pharmaceutical industry, such as traditional wholesaler models, limited distribution models and direct distribution models. Pharmaceutical companies are now focusing on supply chains as a value-adding process rather than viewing them as a money drain, which was the scenario in the past. Managing a supply chain is a complicated task, as there are a number of issues that can affect performance and disrupt product and information flow.

Counterfeits have emerged as the greatest threat to the smooth functioning of the supply chain in the US. The recent case of fake Avastin entering the legitimate supply chain has raised concerns over administrative abilities, and the Food and Drug Administration (FDA) has taken numerous steps to track and trace counterfeits. The state of California has implemented the E-pedigree model and announced implementation deadlines for wholesalers, manufacturers and pharmacies. In 2009, 1,742 drugs were recalled by FDA, for a range of reasons such as quality of raw materials, defective labeling, packaging issues and contaminated products. Over-the-counter (OTC) and generic products account for the most recalls.

Scope

- Key issues facing the pharmaceutical supply chain in the US

- Analysis of strategies adopted by pharmaceutical manufacturers and wholesalers to remain competitive

- Key parameters which are considered for rejuvenating the existing supply chain

- Profiles of key pharmaceutical supply chain management companies

- Emerging technologies being developed for anti-counterfeit operations.

Reasons to buy

- Analyze the requirements for regulatory compliance for pharmaceutical supply chain management

- Pinpoint key uncertainties facing the pharmaceutical supply chain in the US

- Develop strategies for implementing lean technology in the pharmaceutical supply chain

- Develop risk mitigation strategies

1 Table of Contents1 Table of Contents 61.1 List of Tables 81.2 List of Figures 82 Pharmaceutical Supply Chain in the US - Introduction 103 Pharmaceutical Supply Chain in the US - Introductory Issues 113.1 Evolution of Supply Chain Management 113.2 The Pharmaceutical Supply Chain - Operational Issues 133.2.1 Demand Management with Adequate Forecast Tools to Reduce Inventory Levels 133.2.2 Optimum Inventory Levels Help to Maintain Flow of Working Capital 133.2.3 Supply Chain Performance Visibility in Pharmaceutical Supply Chain Management 133.3 Key Uncertainties in Production Planning and Scheduling 143.3.1 Forecasting Managers have to Deal with the Uncertainty in Demand for Existing Drugs 143.3.2 Uncertainties Experienced by Pipeline Drugs 153.4 Different Supply Chains in Pharmaceutical Industry 153.5 Reverse Logistics Evolving as a Significant Part of the Pharmaceutical Supply Chain 153.6 High Costs Due to Drug Callbacks 163.6.1 Recall Management could Prove Effective if Visibility in the Supply Chain Increases 173.7 Risk Management in Pharmaceutical Supply Chain Management 183.8 Radio Frequency Identification Technology to Play an Important Role in Improving Performance Visibility of the Pharmaceutical Supply Chain 204 Pharmaceutical Supply Chain in the US - Supply Chain Models 214.1 Pharmaceutical Supply Chain Models 214.1.1 Traditional Wholesaler Model 214.1.2 Limited Distribution Model or Specialty Pharmacy Distribution Model 224.1.3 Direct Distribution Model 234.2 Steps to Rationalize Existing Supply Chain 244.3 Cold-chain Storages to Play Critical Role in Supply Chain Management 254.4 Case Study - Implementing Lean Six Sigma to Revamp Pharmaceutical Company Performance 265 Pharmaceutical Supply Chain in the US - Securing a Supply Chain 275.1 Food and Drug Administration's Role in Addressing Counterfeiting Issues 275.1.1 Case Study: How Counterfeits were Identified at the Border 275.1.2 Case Study: Wholesale Distributor Involved in Diversion Schemes 285.1.3 Case Study: Pharmacies and Pharmacist Involved in Drug Diversion of Samples 295.2 Counterfeiting 315.2.1 Case Study: Fake Cases of Cancer Drug Avastin Raises Issues of Secured Supply Chain Management 315.3 New Technologies Affecting the Performance of the Supply Chain 325.3.1 E-pedigree Track-and-trace Systems 325.3.2 California E-pedigree Implementation Model 345.3.3 Automation of Reports and Consolidated Orders System Reporting 345.3.4 Unique Device Identification for Improving the Traceability of Medical Devices 345.3.5 Radio Frequency Identification, Electronic Product Codes and Physical Mark up Language a Tested Anti-counterfeit Technology 355.4 Anti-counterfeiting Technology Classification 355.5 Overt Technology 365.5.1 Holograms/Diffractive Optical Elements 365.5.2 Optical Variable Device 365.5.3 Sequential Product Numbering 365.5.4 Security Graphics 365.5.5 Product Marking 365.5.6 Color-shifting Security Inks and Films 365.5.7 Film Wrappers 375.5.8 Shrink Seals and Bands 375.5.9 Breakable Caps 375.5.10 Sealed Tubes 375.6 Covert Technologies 375.6.1 Invisible Printing and Watermarks 375.6.2 Hidden Marks and Printing 375.7 Forensic Markers 385.7.1 Chemical Taggants 385.7.2 DNA Fragments 385.7.3 Micro-particle Taggants (Nanotaggants) 385.7.4 Isotope Ratio 385.8 Mass Serialization/Track-and-trace Technologies 395.8.2 Anti-counterfeiting Technologies and their Impact on Pharmaceutical Companies 405.9 Case Study: Sproxil to Benefit from Mobile Technology 415.10 Top Anti-counterfeiting Companies and their Innovative Technologies 415.10.1 Reed-Lane, Inc 415.10.2 Cortegra Group Inc 425.10.3 Nanolnk Inc 435.10.4 TraceLink Inc 445.10.5 Axway 455.10.6 Innovatum Inc 465.10.7 Vetter Pharma International GmbH 476 Pharmaceutical Supply Chain in the US - Legislative Specifications of Pharmaceutical Traceability Enhancement Code Act 486.1 Title l: Immediate Provisions to Enhance Patient Safety 486.2 Title ll: Development of RxTEC System 486.3 Title lll: Enhanced FDA and State Authorities 486.4 Title lV: RxTEC System Assessment 486.5 Title V: Uniform National Policy 487 Pharmaceutical Supply Chain in the US - Wholesale Sector 497.1 Market Leaders in the Wholesale Sector 497.2 Trends Seen Across the US Wholesale Industry 497.3 Prescription Drug Marketing Act of 1987 507.4 Market Share of Wholesalers 507.5 McKesson 517.5.1 Company Profile 517.6 AmerisourceBergen 527.6.1 Company Profile 527.7 Cardinal Health Inc 537.7.1 Company Profile 538 Pharmaceutical Supply Chain in the US - Pharmacy Sector 548.1 The US Pharmacy Sector 548.2 Market Share of Different Channels in the US Pharmaceutical Supply Chain 548.3 Market Share of Top Three Chain Drug Stores in the US 559 Pharmaceutical Supply Chain in the US - Appendix 569.1 Market Definitions 569.2 Abbreviations 569.3 Bibliography 579.4 Research Methodology 589.4.1 Coverage 589.4.2 Secondary Research 599.4.3 Primary Research 599.4.4 Expert Panel Validation 599.5 Contact Us 599.6 Disclaimer 60

1.1 List of Tables

Table 1: Pharmaceutical Supply Chain in the US, Storage and Handling Regimes of Blockbuster Products, 2012 25Table 2: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Overt Features, 2012 36Table 3: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Covert Features, 2012 37Table 4: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Forensic Markers 38Table 5: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Track-and-trace Technologies, 2012 39

1.2 List of Figures

Figure 1: Pharmaceutical Supply Chain in the US, Evolution of Supply Chain Management, 2011 11Figure 2: Pharmaceutical Supply Chain in the US, Implementation of Lean Supply Chain Management, 2011 12Figure 3: Pharmaceutical Supply Chain in the US, Key Uncertainties Faced by Manufacturers, 2012 14Figure 4: Pharmaceutical Supply Chain in the US, Number of Drug Callbacks, 2006-2011 16Figure 5: Pharmaceutical Supply Chain in the US, Impact of Vioxx Withdrawal on Merck's Share Prices, January 2003–December 2005 17Figure 6: Pharmaceutical Supply Chain in the US, Risk Management Benefits, 2012 18Figure 7: Pharmaceutical Supply Chain in the US, Risk Evaluation Procedure, 2012 19Figure 8: Pharmaceutical Supply Chain in the US, Working of Radio Frequency Identification Technology, 2012 20Figure 9: Pharmaceutical Supply Chain in the US, Structure of a Traditional Distribution Channel, 2012 21Figure 10: Pharmaceutical Supply Chain in the US, Structure of a Limited Distribution Channel, 2012 22Figure 11: Pharmaceutical Supply Chain in the US, Structure of a Direct-to-pharmacy Distribution Channel, 2011 23Figure 12: Pharmaceutical Supply Chain in the US, Cold-chain Storage Forecast, $bn, 2011-2016 26Figure 13: Pharmaceutical Supply Chain in the US, Counterfeit Drugs Identified, 2011 27Figure 14: Pharmaceutical Supply Chain in the US, Wholesale Distributor Involved in Diversion Schemes, 2011 28Figure 15: Pharmaceutical Supply Chain in the US, Pharmacies and Pharmacist Involved in Drug Diversion of Samples, 2011 29Figure 16: Pharmaceutical Supply Chain in the US, Types of Trades Associated with Suspected Counterfeits, (%), 2011 30Figure 17: Pharmaceutical Supply Chain in the US, Counterfeit Avastin Case Study, 2012 31Figure 18: Pharmaceutical Supply Chain in the US, E-pedigree in a Pharmaceutical Supply Chain, 2012 32Figure 19: Pharmaceutical Supply Chain in the US, Paper-based Pedigree in a Pharmaceutical Supply Chain, 2011 33Figure 20: Pharmaceutical Supply Chain in the US, California E-pedigree Implementation Model, The US, 2012 34Figure 21: Pharmaceutical Supply Chain in the US, Classification of Anti-counterfeit Technologies, 2012 35Figure 22: Pharmaceutical Supply Chain in the US, Platform for Protecting Pharmaceutical Value Chain, 2012 40Figure 23: Pharmaceutical Supply Chain in the US, Company Overview, Reed-Lane Inc, 2012 41Figure 24: Pharmaceutical Supply Chain in the US, Company Overview, Cortegra Group Inc, 2012 42Figure 25: Pharmaceutical Supply Chain in the US, Company Overview, NanoInk Inc, 2012 43Figure 26: Pharmaceutical Supply Chain in the US, Company Overview, TraceLink, 2012 44Figure 27: Pharmaceutical Supply Chain in the US, Company Overview, Axway, 2012 45Figure 28: Pharmaceutical Supply Chain in the US, Company Overview, Innovatum Inc, 2012 46Figure 29: Pharmaceutical Supply Chain in the US, Company Overview, Vetter Pharma International GmbH, 2012 47Figure 30: Pharmaceutical Supply Chain in the US, Market Share of Wholesalers, (%), 2011 50Figure 31: Pharmaceutical Supply Chain in the US, Company Profile, McKesson, 2011 51Figure 32: Pharmaceutical Supply Chain in the US, Company Profile, AmerisourceBergen, 2011 52Figure 33: Pharmaceutical Supply Chain in the US, Company Profile, Cardinal Health Inc, 2011 53Figure 34: Pharmaceutical Supply Chain in the US, Market Share of Different Prescription-dispensing Channels, (%), 2011 54Figure 35: Pharmaceutical Supply Chain in the US, Market Share of Top Three Chain Drug Stores, 2012 55

Companies mentioned

Reed-Lane, Inc

Cortegra Group Inc

Nanolnk Inc

TraceLink Inc

Axway

Innovatum Inc

Vetter Pharma International GmbH

McKesson

AmerisourceBergen

Cardinal Health Inc

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