Drug manufacturers and distributors will now be able to access a Drug Enforcement Administration (DEA) database that monitors controlled substances from the point of manufacture all the way through to the point of sale (e.g., practitioners, pharmacies, hospitals/clinics).
The Automated Reports and Consolidated Orders System (ARCOS) will now be open to over 1500 registered drug manufacturers and distributors. DEA-registered manufacturers and distributors will be able download information on controlled substance distribution, such as the number of distributors and the amount each sold to a prospective customer in the previous 6 months. The data available in ARCOS is anonymized and does not contain specific information on sales to patients.
This enhanced level of access was mandated in the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (or the SUPPORT for Patients and Communities Act). In a press release, the DEA noted that manufacturers and distributors have “consistently expressed” their desire for assistance in meeting requirements for reporting suspicious orders. Using this tool, a manufacturer’s query indicating a large number of suppliers selling unusual quantities of opioids to a prospective purchaser could potentially represent a “red flag”.
The DEA collects ~80 million transaction reports a year from manufacturers and distributors of prescription drugs. Manufacturers and distributors of controlled substances have been required to report inventories, acquisitions and dispositions to the DEA since 1971.
The agency stated that the new provision could “help drug manufacturers and distributors identify, report and stop suspicious orders of opioids.”
For more information visit DEA.gov.