The World Health Organization estimates that counterfeit drugs make up 10-30% of the global pharmaceutical supply.  To address this epidemic and help protect patients from harmful counterfeit drugs, the U.S. FDA enacted the Drug Supply Chain Security Act (DSCSA) in 2013. The DSCSA requires pharmaceutical companies to serialize and track drug packages throughout the complex supply chain to prevent counterfeit drugs from entering.  To comply with DSCSA, pharmaceutical manufacturers must label each drug package with a unique serial number and implement a process to verify product serial numbers by late 2017.  Wholesalers and dispensers must implement serial number verification processes by 2019 and 2020, respectively. By 2023, pharmaceutical manufacturers, wholesalers, and dispensers must launch a secure electronic system to record tracking information each time a drug package changes ownership in the supply chain. 
Figure 1 depicts the strategy that Pfizer, a world-leading pharmaceutical company, is implementing to comply with DSCSA serialization and tracking mandates. 
In addition to preventing counterfeit drugs from reaching patients, DSCSA mandates provide an opportunity to transform the pharmaceutical supply chain through digitization. Real-time visibility of product flow through the entire supply chain can help pharmaceutical companies improve demand prediction, inventory management, product transportation efficiency, and supply disruption management. 
Despite the obvious supply chain benefits, the DSCSA digitization mandates have created significant challenges for pharmaceutical companies like Pfizer. Costly capital investments are required to label and scan product barcodes. Packaging line updates for serialization can take 18 months at Pfizer and can cost up to $1 million. [3, 5] Pfizer also faces the challenge of developing a single product information system across its complex network of information systems that result from several recent global acquisitions. 
Perhaps the most significant challenge surrounding pharmaceutical digitization is cybersecurity of shared product data.  Sensitive operational data (i.e. demand, supply, and pricing information) must be secured to maintain the integrity of Pfizer’s supply strategy.  Also, complete end-to-end visibility of the supply chain requires access to confidential patient prescription records for point of sale information. To fully integrate the supply chain and accurately assess end-user demand, Pfizer must navigate the legal obstacles protecting patient records by developing a secure information system that ensures data confidentiality and security. 
Pfizer’s Journey to Digitization
To comply with DSCSA, Pfizer has implemented a serialization process where each U.S. drug package is labeled with a barcode containing the serial number and lot traceability. Packaging line updates were completed as modular builds to address the high cost of implementation.  Pfizer has also deployed a cloud-based information system to share product serial numbers and tracking data with its contract manufacturers.  Through the launch of Pfizer’s Highly Orchestrated Supply Network (HOSuN), Pfizer and its manufacturers now have visibility to the status of serialized products in the supply chain, enabling more accurate demand planning.  Pfizer globally standardized its supply network to address the challenge of integrating multiple complex information systems. 
Within the next few years, Pfizer will be implementing a “TrackiT” mobile app to provide full real-time visibility of all product shipments, even when in transit. Users will also receive notifications when urgent attention is needed.  This app will further improve supply chain efficiency and help overcome the challenge of identifying urgent information in the abundance of data. Pfizer is also beginning to train wholesalers and dispensers on the new supply information system and is monitoring their progress towards implementing product tracking procedures. 
Pfizer is currently partnering with Chronicled, Inc. and LinkLab LLC to investigate the use of blockchain technology for the electronic tracking system required across the supply chain by 2023.  Blockchain technology uses a decentralized data storage system and therefore offers superior data security compared to other existing solutions.  A blockchain-based database could enable Pfizer to include end-user patient data in the supply information network by ensuring data confidentiality and security. A secured prototype database has been developed, but the full solution is likely several years out. 
As Pfizer continues to develop product blockchain technology, the company should work with its government counterparts to establish the requirements around patient data use, confidentiality, and security within a shared supply network. These agencies could potentially prohibit Pfizer from including end-user patient prescription data in its supply network, which would greatly limit demand assessment capabilities. Pfizer should also prioritize sharing best practices with wholesalers and dispensers, because an effective supply information network requires all players to maintain proficient tracking procedures.
Digitization is transforming the pharmaceutical world by protecting patients from counterfeit drugs and improving supply chain efficiencies. But – will counterfeiters respond with ways to bypass the serialization system? The future with blockchain technology appears bright, but is it secure enough to keep cyberhackers out for years to come?
 Anthony Vecchione, “Blockchain Tech Could Track Pharmacy Supply Chain,” Drug Topics, November 2017, http://drugtopics.modernmedicine.com/drug-topics/news/blockchain-tech-could-track-pharmacy-supply-chain, accessed November 2017.
 Ann Marie Polak, “The Drug Supply Chain Security Act (DSCSA): Prior Work and Future Directions,” The Pharmaceutical Distribution Security Alliance (PDSA), February 2017, https://www.nacds.org/wp-content/uploads/2017/02/Drug-Supply-Chain-Security-Act.pdf, accessed November 2017.
 Peggy Staver, “Serialization Implementation and Traceability,” Pfizer, October 2016, https://www.gs1.org/sites/default/files/docs/events/2016/beijing/Pharmaceutical_Traceability_Manufacturer%26Wholesalers2510.pdf, accessed November 2017.
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 Evren Ozkaya, “Pharma’s Digital Supply Chain Transformation,” Pharmaceutical Manufacturing, April 2017, https://www.pharmamanufacturing.com/articles/2017/pharmas-digital-supply-chain-transformation/, accessed November 2017.
 “Digitizing the Supply Chain: Why Pfizer is Investing in IoT, Drones and Personalized Medicine,” Internet of Business, January 2017, https://internetofbusiness.com/digitizing-supply-chain-pfizer-iot/, accessed November 2017.
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hl=en&sa=X&ved=0ahUKEwiyxpPDj7_XAhUQ8YMKHeKBDAE4ChDoAQgxMAI#v=onepage&q=pfizer%20serialization&f=false, accessed November 2017.
 “Pfizer 2016 Annual Review – Transforming Delivery of High Quality Products,” Pfizer, 2016, https://www.pfizer.com/files/investors/financial_reports/annual_reports/2016/transforming-delivery-of-high-quality-products/index.html, accessed November 2017.
 “Finalist Supply Chain Awards 2017: Pfizer Global Supply Chain,” Supply Chain Award, October 2017, http://www.supplychainaward.be/gallery/documents/finalist_sca17_pfizer.pdf, accessed November 2017.
 “Pharma Exploring Blockchain to Increase Supply Chain Security,” Material Handling & Logistics, 2017, Business Premium Collection, http://search.proquest.com.ezp-prod1.hul.harvard.edu/docview/1942526264?accountid=11311, accessed November 2017.
 “MediLedger to Explore Use of Blockchain for DSCSA Compliance,” PTSM: Pharmaceutical Technology Sourcing and Management, Volume 12, Issue 11, October 2017, http://www.pharmtech.com/mediledger-explore-use-blockchain-dscsa-compliance, accessed November 2017.