Industry Adoption of RFID and Electronic Track & Trace Mike Rose
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Industry Adoption of RFID and Electronic Track & Trace Mike Rose
Industry Adoption of RFID and Electronic Track & Trace Mike Rose Vice President Johnson & Johnson Corporate RFID / EPC Global Value Chain February 8, 2006 A Secure Supply Chain: Our Collective Obligation The integrity of worldwide pharmaceutical supply has been challenged Joint responsibility to address this mounting public health concern We need to ensure the integrity of medicines delivered to our patients Existing industry practices must change © 2005 Securing Pharmaceutical Supply RFID and Electronic Track & Trace Johnson & Johnson’s Perspective Key Industry Questions Areas for FDA Guidance Proposed Industry Actions © 2005 Facts About Counterfeit Prescription Drugs1 More than 10% of drugs worldwide are counterfeit In 2000, FDA opened 6 counterfeit drug cases; in 2004, they opened 58 Increasingly sophisticated methods used to introduce counterfeit drugs into the legitimate US market Counterfeit products entered the supply chain where existing business practices were insecure and where legitimacy of business partners was unknown 1 FDA COMBATING COUNTERFEIT DRUGS - February, 2004 © 2005 A Secure Supply Chain: Our Collective Obligation Securing supply is one of the most critical issues for our industry We must – – – – Ensure that patients and healthcare professionals receive genuine products that are 100% pure to original form Have manufacturers, distributors and government work together to ensure patient safety Strive for continuous improvement • Policy • Process • Technology Acceptable practices of the past will not ensure the security of supply in the future © 2005 Major Areas of Concern Difficulty in identifying counterfeit drugs due to increased sophistication of perpetrators Numerous potential entry points to the legitimate supply chain Proliferation of Internet pharmacies poses new challenges requiring unique solutions No system in place to track & trace product (pedigree) © 2005 Specific Actions – RFID & Pedigree Joined MIT Auto-ID Labs Formed a Johnson & Johnson RFID Research Center, Tested various frequency of tags, Participated in industry pilots, and Led and participated in industry standards groups – EPCglobal HLS, Unified Drug Pedigree Council, etc. © 2005 No Single Solution Policy – – Uniform pedigree Responsibilities of parties Process – Changes to industry practices Technology – – – Track, trace, and authenticate Product differentiation/packaging Surveillance © 2005 Challenge Conventional Policy & Practices Tracking & tracing product flow is no longer optional We believe alternate source purchasing should be eliminated Repackaging operations should be regulated by FDA Returned goods should only be restocked after pedigree review and assurance that product has been stored/handled properly Stringent destruction requirements must be enforced © 2005 Implement New Technology Industry Wide Track & Trace Manufacturers tagging product is only a start A secure supply chain will also require that all parties involved in the distribution chain participate in authenticating products Authentication will require a continued investment in human and financial resources to maintain and update accurate pedigrees and to provide transparency throughout the supply chain Authentication of packages by supply chain parties are the foundation to electronic track & trace Continuing investments must be made to ensure system is not defeated by counterfeiters © 2005 Track & Trace Solutions RFID, Serialization, Pedigree We have been actively studying and piloting RFID and EPC Mass serialization has great potential for tracking & tracing of products – Serialized linear and 2D-data matrix bar codes can be used until RFID is more widely adopted Pedigrees using a uniform code will help protect the drug supply Our evaluations have demonstrated that no one party can solve the problem independently © 2005 RFID/EPC and Privacy Consumers should be given notice whenever RFID/EPC is deployed To the greatest extent possible, end users of our products should have the option of disabling or removing RFID tags when they are no longer needed RFID must be adopted in conformance with regulatory laws as well as our own consumer privacy and security policies © 2005 Key Industry Questions What business practices need to change? What technology standards are needed? What tag frequencies will be used? What information will be on the tag? Will the NDC number be included in the Electronic Product Code? How will the information be stored, secured and accessed? © 2005 Possible Areas for FDA Guidance Electronic pedigree information content, Utilization of digital signature to sign the pedigree, Inclusion of the NDC in the electronic product code, and Compatibility of bar code information with the information on the RFID tag © 2005 Proposed Industry Actions 1. Industry standards that specify how RFID will be deployed must be developed and broadly implemented. Continue EPCglobal standards process - tag frequency, product numbering, pedigree exchange, data access, data security, etc. 2. Business practices must be modified to ensure that all supply chain parties are reading the information on the RFID tag and properly maintaining and disclosing the electronic drug pedigree. 3. A comprehensive industry adoption program must be initiated, including representation from all supply chain parties with clearly defined milestones. © 2005 Moving Forward Together It is our responsibility to do everything we can to ensure that our patients get exactly the medication they are prescribed Manufacturers, Distributors, and Healthcare Providers must work together to find effective solutions to ensure patient safety © 2005