Insight Spring 2020

Spring 2020 | 22 Spring 2020 | 23 Michael Dodd, Pharm.D., Associate Director of Clinical and Pharmacy Regulatory Affairs Background In 2013, Congress enacted the Drug Quality and Security Act (DQSA). Title I of the bill, the Compounding Quality Act, provides compounding provisions in response to the 2012 fungal meningitis outbreak from the New England Compounding Center. 1 Title II, the Drug Supply Chain and Security Act (DSCSA), also commonly referred to as track and trace, addresses risks to patient safety associated with counterfeit drugs entering the United States prescription drug supply chain. 2 DSCSA outlines steps that manufacturers, repackagers, wholesale distributers, dispensers, and third-party logistic providers are to implement over a 10-year period in order to create an electronic system to track certain prescription drug products through the supply chain. The significance of DSCSA is that it will ultimately create a national, uniform system for tracking prescription drugs, which will provide electronic interoperable tracking through the supply chain. 3 Details With the goal of having a fully implemented interoperable system by 2023 for unit-level traceability, DSCSA is being phased in with many of the requirements having already taken effect, while forthcoming requirements take effect in the next few years. Trading partners have been working with the FDA to explore and evaluate methods in order to provide guidance to industry entities. DSCSA requires the FDA to establish standards, issue guidance, and develop pilot programs to support compliance and implementation. 4 Since 2015, trading partners were required to provide transaction documentation to subsequent purchasers for certain prescription drugs while allowing exemptions for other drugs. Transaction documentation may be provided in paper or electronic format and must be maintained for six years. 5 Transaction documentation consists of 3Ts: transaction information (TI), transaction history (TH), and transaction statement (TS). 6 In 2017, manufacturers were required to apply a DSCSA “product identifier” that includes the NDC, serial number, expiration date, and lot number. In November 2020, dispensers must only engage in transactions with serialized products, so pharmacies are only to accept products that contain the required product identifier. 7 DSCSA implementation can be broken into three phases: Phase 1: Lot-level traceability and verification of product and transactions (2015) Phase 2: Drug product serialization and enhanced verification of serialized product (2017-2020) Phase 3: Unit-level traceability (2023) 8 Key Provisions DSCSA includes provisions on product identification and verification, data sharing, detection and response to suspect illegitimate products, and record keeping. Key provisions are: y y Product identification: A unique product identifier (QR code) to be placed on certain prescription drug packages. y y Product traceability: The drug supply chain must provide chain of custody and transaction information. y y Product verification: Establish systems and processes to verify the product identifier on certain prescription drug packages. y y Detection and response: Quarantine and promptly investigate a drug that has been identified as suspect. y y Notification: Establish systems and processes to notify the FDA and other stakeholders if an illegitimate drug is found. y y Wholesaler licensing: Drug wholesalers must report their licensing status and contact information to the FDA. y y Third-party logistics provider licensing: Organizations that provide storage and logistical operations related to drug distribution are to obtain a state or federal license. 9 Pilot Projects Using Blockchain Technology Blockchain technology became popular in 2008 as Bitcoin started gaining prominence through cryptocurrency transactions. Blockchain offers a tamper-evident and tamper-resistant distributed digital ledger. 10 “Blocks” store information about transactions and who is participating in the transaction but are not owned by any single entity. 11 Each block is distinguished from other blocks by using a “hash” that acts as a unique The Drug Supply Chain and Security Act Feature fingerprint to tell it apart from other blocks. 12 So, once data is stored in a blockchain it becomes almost impossible to change it. FDA pharmaceutical pilot projects are underway with much of the focus on the utilization of blockchain technology as means to provide security and interoperability. For example, IBM, KPMG, Merck, and Walmart are a part of one blockchain interoperability pilot project, the results of which are expected to be published soon. 13 And as pilot projects continue, more guidance will be published, which will provide further insight. Summary With the overall goal to provide complete traceability by 2023 by means of electronic tracking in order to respond to a recall or to investigate a suspect or an illegitimate product, the overall structure and effectiveness of DSCSA remains to be seen. 14 To date, questions remain about technical implementation and viability, but as pilot projects continue, more white papers and guidance documents will be published to help the pharmaceutical supply chian become fully interoperable. Image Source: www.pharmaceuticalprocessingworld.com/experts-comment-on-fdas-dscsa-serialization-extension-manufacturers-now-have-until-2018 Sources: 1,2 Are you ready for the Drug Supply Chain Security Act? 07/09/2019. Web. Accessed 02/24/20. www.fda.gov/drugs/ drug-supply-chain-security-act-dscsa/are-you-ready-drug- supply-chain-security-act 3 Track and trace requirement will affect how you practice. Are you ready? Pharmacy Today. 02/18. Web. Accessed 02/24/20. www.pharmacytoday.org/article/S1042- 0991(18)30157-9/fulltext 4-6 Erich D. Brechtelsbauer , PharmD, Benjamin Pennell , PharmD. Et al. Review of the 2015 Drug Supply Chain Security Act. U.S. National Library of Medicine. 06/16. Web. Accessed 02/24/20. www.ncbi.nlm.nih.gov/pmc/articles/ PMC4911992 7 Godfrey, Bryant. Ready or Not, Here It Comes! The Drug Supply Chain Security Act Requirements Are Almost Fully Upon Us. Are You Prepared? Food and Drug Law Institute. 12/19. Web. Accessed 02/24/20. www.fdli.org/2020/01/ready- or-not-here-it-comes-the-drug-supply-chain-security-act- requirements-are-almost-fully-upon-us-are-you-prepared 8 FDA clarifies track-and-trace requirements for pharmacists. American Pharmacists Association. 08/11/17. Web. Accessed 02/24/20. www.pharmacist.com/article/fda- clarifies-track-and-trace-requirements-pharmacists 9 Chatterjee Bikash. Supply Chain Trends: Domestic and International Regulations. Pharmaceutical Outsourcing. 05/28/19. Web. Accessed 02/24/20. www.pharmoutsourcing. com/Featured-Articles/361295-Supply-Chain-Trends- Domestic-and-International-Regulations/ 10 Basta, Nicolas. Blockchain: the technology to make DSCSA work after 2023? 07/24/17. Web. Accessed 02/24/20. www.pharmaceuticalcommerce.com/information- technology/blockchain-technology-make-dscsa-work-2023/ 11-12 Reiff, Nathan. Blockchain Explained. Investopedia. 02/01/20. Web. Accessed 02/24/20. www.investopedia.com/ terms/b/blockchain.asp 13 Wolfdon, Racheal. Merck and Walmart Will Track Prescription Drugs On IBM Blockchain in FCA Pilot. Forbes. 06/13/19. Web. Accessed 02/24/20. www.forbes. com/sites/rachelwolfson/2019/06/13/merck-and-walmart- will-track-prescription-drugs-on-ibm-blockchain-in-fda- pilot/#6ee52410212e 14 Gibbons, Ashley. Pharmacy Requirements for DSCSA Deadlines. ComputerTalk. 10/19. Web. Accessed 02/24/20. www.computertalk.com/pharmacy-requirements-for-dscsa- deadlines/