WASHINGTON – The Drug Enforcement Administration (DEA) announces the launch of an enhanced system to help more than 1,500 registered drug manufacturers and distributors nationwide more effectively identify potential illicit drug diversion and combat the opioid epidemic.
On Oct. 24, 2018, President Trump signed into law the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” or the “SUPPORT for Patients and Communities Act” (Public Law 115-217). A provision in the bill amends 21 U.S.C. 827, requiring the Drug Enforcement Administration to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System (ARCOS) to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates.
ARCOS is a comprehensive drug reporting system that monitors the distribution of controlled substances from the point of manufacture through commercial drug supply chain channels to the point of sale to the retail level (e.g., practitioners, pharmacies, hospitals/clinics). ARCOS does not contain or collect any data on sales to ultimate users (i.e., patients).
In February 2018, DEA launched a new tool in its ARCOS Online Reporting System to assist drug manufacturers and distributors with their regulatory obligations under the Controlled Substances Act. The new statutory requirement in the SUPPORT Act builds upon this existing tool and DEA is releasing a further enhancement to its ARCOS Online Reporting System. The enhancement will allow DEA-registered manufacturers and distributors to view and download the number of distributors and the amount (anonymized data in both grams and dosage units) each distributor sold to a prospective customer in the last available six months of data. This resource is one of many steps DEA is taking to collaborate with its 1.8 million registrants to combat the ongoing opioid epidemic in the United States.
DEA regulations require distributors to both know their customers and develop a system to identify and report suspicious orders. Manufacturers and distributors have consistently expressed a desire for assistance from DEA in fulfilling these obligations and have requested ARCOS information to help them make informed decisions about whether new customers are purchasing excessive quantities of controlled substances. This new tool will provide valuable information for distributors to consider as part of their assessment. For example, if a query resulted in a large number of suppliers who have recently sold unusual quantities of opioid analgesics to a prospective purchaser, this may represent a “red flag” to the new distributor and foster a dialogue between that distributor and the pharmacy.