![\"\"](\"https:\/\/d3.harvard.edu\/platform-rctom\/wp-content\/uploads\/sites\/4\/2017\/11\/pfizer-2-1.png\")
\n<\/a><\/strong>Figure 1.<\/strong>\u00a0Serialized Product Information Flow through Pfizer Supply Chain [3]<\/p>\n
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. [4]<\/p>\n
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. [6]<\/p>\n
Perhaps the most significant challenge surrounding pharmaceutical digitization is cybersecurity of shared product data. [4] Sensitive operational data (i.e. demand, supply, and pricing information) must be secured to maintain the integrity of Pfizer\u2019s supply strategy. [2] 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. [6]<\/p>\n
Pfizer’s Journey to Digitization<\/h4>\n
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. [3] Pfizer has also deployed a cloud-based information system to share product serial numbers and tracking data with its contract manufacturers. [7] Through the launch of Pfizer\u2019s 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. [8] Pfizer globally standardized its supply network to address the challenge of integrating multiple complex information systems. [3]<\/p>\n
Within the next few years, Pfizer will be implementing a \u201cTrackiT\u201d 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. [9] 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. [3]<\/p>\n
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. [10] Blockchain technology uses a decentralized data storage system and therefore offers superior data security compared to other existing solutions. [10] 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. [11]<\/p>\n
What Next?<\/h4>\n
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.<\/p>\n
Digitization is transforming the pharmaceutical world by protecting patients from counterfeit drugs and improving supply chain efficiencies. But \u2013 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?<\/p>\n
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[1] Anthony Vecchione, \u201cBlockchain Tech Could Track Pharmacy Supply Chain,\u201d Drug Topics, <\/em>November 2017, http:\/\/drugtopics.modernmedicine.com\/drug-topics\/news\/blockchain-tech-could-track-pharmacy-supply-chain<\/a>, accessed November 2017.<\/p>\n [2] Ann Marie Polak, \u201cThe Drug Supply Chain Security Act (DSCSA): Prior Work and Future Directions,\u201d The Pharmaceutical Distribution Security Alliance (PDSA)<\/em>, February 2017, https:\/\/www.nacds.org\/wp-content\/uploads\/2017\/02\/Drug-Supply-Chain-Security-Act.pdf<\/a>, accessed November 2017.<\/p>\n [3] Peggy Staver, \u201cSerialization Implementation and Traceability,\u201d Pfizer, October 2016, https:\/\/www.gs1.org\/sites\/default\/files\/docs\/events\/2016\/beijing\/Pharmaceutical_Traceability_Manufacturer%26Wholesalers2510.pdf<\/a>, accessed November 2017.<\/p>\n [4] Peter Behner and Dr. Marcus Ehrhardt, \u201cDigitization in Pharma \u2013 Gaining an Edge in Operations,\u201d Strategy&<\/em>, 2016, https:\/\/www.strategyand.pwc.com\/media\/file\/Digitization-in-pharma.pdf<\/a>, accessed November 2017.<\/p>\n [5] Evren Ozkaya, \u201cPharma\u2019s Digital Supply Chain Transformation,\u201d Pharmaceutical Manufacturing<\/em>, April 2017, https:\/\/www.pharmamanufacturing.com\/articles\/2017\/pharmas-digital-supply-chain-transformation\/<\/a>, accessed November 2017.<\/p>\n [6] \u201cDigitizing the Supply Chain: Why Pfizer is Investing in IoT, Drones and Personalized Medicine,\u201d Internet of Business,<\/em> January 2017, https:\/\/internetofbusiness.com\/digitizing-supply-chain-pfizer-iot\/<\/a>, accessed November 2017.<\/p>\n [7] Fred A. Kuglin, \u201cPharmaceutical Supply Chain: Drug Quality and Security Act,\u201d 2015, https:\/\/books.google.com\/books?id=_80dCgAAQBAJ&pg=PA58&lpg=PA58&dq=pfizer+serialization&source=bl&ots=XXG9779KAd&sig=mK_Ie2AOpdh3kNUKSeZYvoK_kdo& [8] \u201cPfizer 2016 Annual Review \u2013 Transforming Delivery of High Quality Products,\u201d Pfizer, 2016,\u00a0https:\/\/www.pfizer.com\/files\/investors\/financial_reports\/annual_reports\/2016\/transforming-delivery-of-high-quality-products\/index.html<\/a>, accessed November 2017.<\/p>\n [9] \u201cFinalist Supply Chain Awards 2017: Pfizer Global Supply Chain,\u201d Supply Chain Award<\/em>, October 2017, http:\/\/www.supplychainaward.be\/gallery\/documents\/finalist_sca17_pfizer.pdf<\/a>, accessed November 2017.<\/p>\n [10] “Pharma Exploring Blockchain to Increase Supply Chain Security,” Material Handling & Logistics<\/em>, 2017, Business Premium Collection<\/em>, http:\/\/search.proquest.com.ezp-prod1.hul.harvard.edu\/docview\/1942526264?accountid=11311<\/a>, accessed November 2017.<\/p>\n
\nhl=en&sa=X&ved=0ahUKEwiyxpPDj7_XAhUQ8YMKHeKBDAE4ChDoAQgxMAI#v=onepage&q=pfizer%20serialization&f=false<\/a>, accessed November 2017.<\/p>\n