EXECUTIVE SUMMARY 4TH ANNUAL TRACEABILITY AND THE DRUG QUALITY AND SECURITY ACT CONFERENCE

Transcription

1 EXECUTIVE SUMMARY 4TH ANNUAL TRACEABILITY AND THE DRUG QUALITY AND SECURITY ACT CONFERENCE

2 CONTENTS INTRODUCTION 3 PRESENTATIONS 4 FOR MORE INFORMATION 8

3 INTRODUCTION: If you weren t able to join us this year, here is what you missed at ExL Pharma s 4th Annual Traceability and the Drug Quality and Security Act Conference With the latest on how to enhance supply chain processes to protect brands and comply with global serialization, pedigree, and track and trace regulations, this annual summit, which was held May in Philadelphia, brought together some of the most experienced industry experts to assess the Drug Quality and Security Act (DQSA) and its impact on the industry. Presenters offered best practices designed to optimize and protect supply chains via relevant industry-specific case studies and examples. Topics covered at the conference included meeting new requirements requirements of the Drug Quality and Security Act and how the DQSA affects supply chain processes, best practices to create and enhance traceability and verification programs, an introduction to the FDA s secure supply chain pilot program, an update on global developments and regulations as well as collaboration with wholesalers and dispensers and putting long-term strategies into place. In addition, the conference shared FDA draft guidance for the industry on how to enhance supply chain security, how to leverage serialization as a corporate asset, implementing risk mitigation strategies to prevent counterfeiting and diversion, and more. Following are session summaries and highlights from the 2014 conference 3

4 PRESENTATIONS Highlighting recent developments in the regulatory landscape, Understand the Impact of the Drug Quality and Security Act and How it Affects Supply Chain Processes clarified differences between DQSA and CA requirements. Presented by Gabrielle Cosel, Pew Charitable Trusts, and Bill Fletcher, Pharma Logic Solutions, the session helped attendees outline processes that need to be in place for 2015 and highlighted the new deadlines for lot traceability, verification, serialization and requests for information. The duo encouraged trading only with authorized trading partners and offered clear definitions and dates for upcoming changes in the industry. The presentation Best Practices to Implement a Global Serialization Program and Handle Multiple Mandates by Bob Celeste of GS1 discussed the company s data exchange, which easily allows product information to flow through the supply chain and reminded that businesses of all sizes need a common language, possible through the use of standards. He encouraged companies to go fast by going slow, which entails getting the basics right and thinking holistically. Increased visibility can lead to a wealth of benefits. ACCRUING BENEFITS EPCIS - GS1 S ANSWER TO INCREASED VISIBILITY The results are: visibility efficiency security collaboration for business convenience value safety satisfaction for patients GS1 US Work Closely with Wholesalers and Dispensers to Meet New Requirements and Put a Long-Term Strategy in Place was a panel discussion moderated by Carl Accettura of PharmoRx Therapeutics with the following panelists: Mike Daly of Valeant Pharmaceuticals; Dick Rogers of Rx Trace; and Priya Gopal of Novartis. The panelists highlighted the expectations of wholesalers, discussing some of the letters manufacturers have received from several wholesalers recently, as well as the benefits of paper vs electronic and the challenges that the notification requirements entail for manufacturers. The panel addressed how to capture transaction information, history and statements as well as the importance of developing verification and notification procedures for suspect products and the ability to retain samples of these products upon request. They also covered details on laying the groundwork for an interoperable, electronic tracing of products at the package level, and strategies for capturing and exchanging data efficiently. 4

5 SESSION SUMMARIES Outline the FDA Draft Guidance for the Industry on Methods to Enhance Supply Chain Security from Gabrielle Cosel of the Pew Charitable Trusts and Dick Rogers of RxTrace explained the recent FDA draft guidance with regards to suspect and illegitimate products. The duo s presentation also outlined processes and outlined steps to implementation while detailing a variety of guidance expected in According to an industry survey, improving supply chain visibility is the biggest benefit of implementation while a variety of challenges, both internal and external, exist, in particular, costs and lack of standard architecture. InvesIgaIon, verificaion, and noificaion DefiniIons: Suspect and IllegiImate Product SUSPECT PRODUCT. The term suspect product means a product for which there is reason to believe that such product (A) is poten)ally counterfeit, diverted, or stolen; (B) is poten)ally inten)onally adulterated such that the product would result in serious adverse health consequences or death to humans; (C) is poten)ally the subject of a fraudulent transac)on; or (D) appears otherwise unfit for distribu)on such that the product would result in serious adverse health consequences or death to humans. ILLEGITIMATE PRODUCT. The term illegi)mate product means a product for which credible evidence shows that the product (A) is counterfeit, diverted, or stolen; (B) is inten)onally adulterated such that the product would result in serious adverse health consequences or death to humans; (C) is the subject of a fraudulent transac)on; or (D) appears otherwise unfit for distribu)on such that the product would be reasonably likely to result in serious adverse health consequences or death to humans. Carl Accettura shared a case study from Braeburn Pharmaceuticals Capturing Strategic Business Value: Designing a New Product s Supply Chain to be the Safest in the Market. He outlined how the company leveraged serialized track & trace data commercially to support the business brand and a secure supply chain while designing a traceable web-based event repository solution to enhance the new Rx launch, creating an end-to-end commercial brand solution. With serialization initiatives in particular, he discussed piloting an intuitive, user-friendly serialization system to create a secure distribution model to generate a virtual chain of custody with serialized epedigree while enhancing physician practices and enrollment. 5

6 SESSION SUMMARIES Bill Fletcher of Pharma Logic Solutions presented a regulatory and strategy supply chain master class on Making the Right Business Decisions in Light of the Drug Quality and Security Act (DQSA) to help prepare organizations for item-level serialization and traceability and provide the latest information on requirements. He noted that global trade will drive counterfeiting to areas of the world that lack traceability regulations and that packaging alone does not thwart counterfeiting. Variations in product identification/uniqueness in other countries necessitates some agility in data systems. Key elements of the new law are that it defines supply chain participants and their requirements for managing and passion transaction information; it establishes rules for providing transaction information for investigations and suspect product notifications as well as rules for trading with authorized supply chain participants. DQSA also adds a new requirement to uniquely identify prescription drug products and their shipping cases using serialization and defines steps that will be taken to move the industry to certified chain of custody pedigree within 10 years. The right strategy, vendor selection and functional design are key to successful implementation. Beyond The Drug Quality And Security Act - why this Legislation Falls Short of a Safe and Secure Supply Chain by Walter Berghahn of the Healthcare Packaging Council shared his organization s mission to advance the use of complianceprompting packaging to improve medication adherence and patient health outcomes. In general, packaging is designed to protect patients and help them take medication, protect the product from the environment, protect the product and patient from unscrupulous players in the supply chain, and protect our healthcare system from unwanted costs and unnecessary patient harm. Supply chain security is all about the right patient, right drug, right dose, right time and safe drug. Even a 1 percent error rate among 4 billion prescriptions means 40,000,000 potential impacts. Functional packaging is critical to getting it right. The 99% good Manufacturers Distributors Physicians Pharmacists But 1% bad in a system of 4 billion prescriptions means 40,000,000 potential impacts 6

7 SESSION SUMMARIES Implementing the FDA s Secure Supply Chain Pilot Program was the focus of a session offered by Brad Elrod of Pfizer. In a typical pharmaceutical supply chain, many transport assets and people are involved in getting pharmaceuticals from cradle to table, which is why the FDA launched its Secure Supply Chain Pilot program to implement aspects of the FDA Safety and Innovation Act. The program is designed to create regulatory/entry simplification and process improvements that eliminate may proceed time and increase supply chain predictability. It was also intended to provide a measurable reduction in inventory through decreased lead time in supply chain agreements and decrease double handling at logistics centers as well as faster resolution of issues around short supply compounds. Pharmaceu)cal Supply Chain Customs API Manufacturing Port of Arrival Road Finished Product Manufacturing/Packaging Interna<onal Ocean/ Air/Road Warehouse / Customer Warehouse/ Logis<cs Center Port of Departure Many Transport Assets and People Are Involved in Getting Pharmaceuticals From Cradle to Table??? Road Warehouse Customs 1 7

8 UPCOMING EVENTS: 5TH TRACEABILITY AND THE DRUG QUALITY AND SECURITY ACT CONFERENCE May 5-6, 2015 in Philadelphia Join us in Philadelphia at our annual conference to make sure you have everything in place to be able to respond to FDA inquiries within 48hrs to avoid high fines and work effectively together with your wholesalers and dispensers. Our expert speaker faculty of leading supply chain experts provides valuable insights what processes to put in place now to comply with the requirements in 2017 and leverage serialization benefits to secure an advantage in the market place. Hear how they have managed to provide business value through serialization and pedigree beyond regulatory compliance. This interactive forum discusses best practices for track and trace and lessons learned from implementing an integrated global supply chain security program, which improves transparency, secures your supply chain and protects your brand, while leveraging business benefits. Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact, Matthew Halvorsen, Business Development Manager at or mhalvorsen@exlevents.com 8