The U.S. Centers for Disease Control and Prevention (CDC) estimates that 91 Americans die every day from opioid overdose.[1] From 1997 to 2007, U.S. physicians increased the number of opioid prescriptions by >600%, with drug distribution through the pharmaceutical supply chain increasing from the equivalent of 96 to 700 mg of morphine per person. 40% of opioid overdoses are due to 10% of patients who are prescribed opioids; these individuals seek care from multiple doctors and divert drugs to others who use them without prescriptions. Of non-medical users, 76% report the use of drugs prescribed to someone else, with only 20% acquiring them from their own doctor.[2]<\/p>\n Significant national resources are now being focused on the problem. In 2013, the Drug Supply Chain Security Act (DSCSA) was passed, requiring pharmaceutical companies to keep detailed track drugs from manufacture to the patient. According to DSCSA provisions, unit-level traceability will be fully enforceable in ten years.[3] Similarly, patients are now being tracked as well, and the Prescription Drug Monitoring Act of 2017 is currently under consideration \u2013 an initiative that would impose strict compliance with electronic databases that provide physicians with information regarding a patient\u2019s controlled substance prescription history.[4]<\/p>\n TraceLink: Seizing an opportunity<\/strong><\/p>\n According to DSCSA, pharmaceutical companies and their contractors must begin tracing large pallets of drugs in November 2017. By 2023, the granularity will increase substantially, requiring distributors to engage with an interconnected network through which drugs are tracked.<\/p>\n To capitalize on these requirements, TraceLink was born.[5] The new company is leveraging pressure induced by the law to digitize the pharmaceutical supply chain, creating a track-and-trace network for drugs. Its system uses bar codes to serialize products, then integrates the drug\u2019s supply chain data into its network \u2013 including the type of drug, where it was made, and when it was shipped. Pharmaceutical companies and distributors then utilize the network to share data and comply with DSCSA regulations. The eventual goal would be \u201ccomplete visibility of every step [of the supply chain], from manufacturer to patient.\u201d[6]<\/p>\n Serialized products in the pharmaceutical supply chain<\/strong><\/p>\n TraceLink\u2019s interoperable network currently boasts more than 257,000 supply chain members on its cloud-based system. DSCSA mandates that manufacturers, wholesale distributors, repackagers, hospitals, and pharmacies all communicate with one another. Critical points of communication include product identification (electronically-read barcodes), tracing, verification, detection (of potentially counterfeit drugs), notification (to the FDA), and wholesaler and third-party logistics providers licensing.[7] In the short- and medium-term, the company\u2019s U.S. strategy is centered around the progressive rollout of DSCSA. For example, while the law is in effect for pharmaceutical companies in 2017, the serialization deadline for hospitals and pharmacies is not until 2020 \u2013 suggesting that the company will target different segments of the supply chain in coming years. As such, they will increasingly manage a more complex network of inputs \u2013 from serial number creation to management of transaction histories for complete end-to-end tracking of drugs. Similar laws will take effect internationally, such as EU 2016\/161, which requires member states to implement a drug authentication process by February 2019.[8]<\/p>\n Recommendations: Security risks and EHR integration<\/strong><\/p>\n While TraceLink\u2019s business is propelled by domestic and international laws, the most glaring concern is the threat of hackers. The pharmaceutical supply chain contains enormous amounts of sensitive data including medical records, insurance claims, and employee information. There is significant risk in TraceLink\u2019s interconnected system, which can be accessed by all players in the supply chain. Beyond hackers, \u201cinsiders\u201d (whether malicious or ignorant) also pose a threat, and experts recommend strict background checks, regimented security protocols, and limited access whenever possible.[7] The company should invest heavily in security systems given its centralized localization of the industry\u2019s data.<\/p>\n Furthermore, TraceLink should consider ways of integrating drug supply chain data with hospital electronic health records (EHR) systems. Data interoperability among hospitals in the U.S. is extremely poor, as EHR adoption is fragmented across multiple products. As a result, hospitals are often unable to communicate with one another, and the ability to track drugs may be limited at this step. Enabling EHR integration with the TraceLink system may ease the burden on providers and help improve traceability \u2013 particularly for drugs like opioids subjected to significant diversion.<\/p>\n What\u2019s next?<\/strong><\/p>\n Going forward, TraceLink aims to integrate the international drug supply chain\u2019s data. Will the company be able to meet each country\u2019s unique regulatory demands? Can it keep such a highly accessible and integrated system safe? What other regulations or initiatives will be necessary to curb the opioid epidemic and hold the pharmaceutical supply chain accountable to appropriately high standards?<\/p>\n (799 words)<\/p>\n References<\/strong><\/p>\n [1] Centers for Disease Control and Prevention (CDC). \u201cOpioid overdose: Understanding the epidemic.\u201d 30 Aug 2017. https:\/\/www.cdc.gov\/drugoverdose\/epidemic\/index.html<\/a><\/p>\n [2] Centers for Disease Control and Prevention (CDC). \u201cCDC grand rounds: prescription drug overdoses \u2013 a U.S. epidemic.\u201d MMWR Morbidity and Mortality Weekly Report. 2012 Jan 13;61(1):10-3.<\/p>\n [3] U.S. Food and Drug Administration (FDA). \u201cDrug Supply Chain Security Act (DSCSA).\u201d 13 Oct 2017. https:\/\/www.fda.gov\/Drugs\/DrugSafety\/DrugIntegrityandSupplyChainSecurity\/DrugSupplyChainSecurityAct\/<\/a><\/p>\n [4] The President\u2019s Commission on Combating Drug Addiction and the Opioid Crisis. \u201cFinal Report.\u201d 1 Nov 2017. https:\/\/www.whitehouse.gov\/sites\/whitehouse.gov\/files\/images\/Meeting%20Draft%20of%20Final%20Report%20-%20November%201%2C%202017.pdf<\/a><\/p>\n [5] Crook, J. \u201cTraceLink, helping the pharma industry trace and track drugs, lands $51.5M from Goldman Sachs.\u201d 20 Nov 2016. https:\/\/techcrunch.com\/2016\/11\/30\/tracelink-helping-the-pharma-industry-trace-and-track-drugs-lands-51-5m-from-goldman-sachs\/<\/a><\/p>\n [6] Weisman, R. \u201cWith its software, TraceLink capitalizes on drug counterfeiting crackdown.\u201d 11 Sept 2016. https:\/\/www.bostonglobe.com\/business\/2016\/09\/11\/with-its-software-tracelink-capitalizes-drug-counterfeiting-crackdown\/gBGYcbVcv5z2Xf2DvmqZAK\/story.html<\/a><\/p>\n [7] Roberts SJ. \u201cThe necessity of information security in the vulnerable pharmaceutical industry.\u201d Journal of Information Security. 2014 Oct;5:147-53.<\/p>\n![\"\"](\"https:\/\/d3.harvard.edu\/platform-rctom\/wp-content\/uploads\/sites\/4\/2017\/11\/20170311_woc100_0.png\")
<\/a><\/a>