On October 24, 2018, President Trump signed HR 6, the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act”. The bill was a comprehensive attempt to respond to the pervasive opioid epidemic with which state and local governments have been coping for years.
A piece of this bill was focused on suspicious orders. The definition of suspicious orders existed in regulation, but HR 6 codified the language: “an order of a controlled substance of unusual size; an order of a controlled substance deviating substantially from a normal pattern, and; orders of controlled substances of unusual frequency”.
For many years, DEA registrants have been required to identify suspicious orders and notify a DEA Field Office when a suspicious order was found. The SUPPORT for Patients and Communities Act now requires that the DEA create a database into which registrants can enter suspicious order information, Suspicious Orders Reporting System (SORS). The Act gave the DEA until October 24, 2019 to comply, and the DEA did, with only one day to spare.
The intention behind the database is that patterns will emerge that were previously invisible to investigators and states. The information collected will be easier to provide to state and local officials who have been burdened with opioid related incidents. Furthermore, it will be easier, hopefully, for registrants to fulfill their obligation to notify the DEA, as this can now be done online. Entering suspicious order information into SORS will be considered sufficient for compliance with the notification requirement. And, the same log in information registrants use for ARCOS will work for SORS as well.
However, this system was created and launched without public comment or notice. It is unclear if registrants MUST use SORS or if they can continue notifying the DEA Field Office as they have been doing for years. The definition of “suspicious order” has remained rather vague, and it is indeterminate whether SORS will require specific evidence of the registrant’s belief that a suspicious order has been made or if the DEA’s “Know Your Customer” will be adequate.
Hopefully, HR 6 and the ensuing regulatory changes it mandates will make it easier for pharmacies to continue to play their key role in the reduction of substance use disorder.