While the Trump administration continues to dither on how to marshal federal resources to address the ongoing opioid-abuse crisis, the Drug Enforcement Administration continues to keep a watchful eye on drug distributors—and manufacturers—over their trade practices. The topic has come to be called “suspicious order monitoring” (SOM), and while that enforcement strategy has been a part of DEA since the early 2000s, there is supposed to have been a closer coordination between DEA and distributors following passage of the Ensuring Patient Access and Effective Drug Enforcement Act, in 2016. However, guidance from DEA is still pending.
SOM, as DEA has defined it in prior regulatory postings, obliges distributors and retailers to use statistical methods to identify “excessive quantities” of controlled substance orders. But “excessive” can be an ambiguous when, say, a pharmacy that manages prescriptions for a large health system is lined up against a corner store in a small town. (Maddeningly, DEA also points to “ordering the same controlled substance from multiple distributors,” as a suspicious action—as if the major distributors can get together to share data on a common customer.)
QuintilesIMS Compliance Solutions (formerly, BuzzeoPDMA) has had long experience in addressing SOM requirements. In a newly published white paper, it recommends five points to beef up current SOM programs:
1. A defensible SOM model, which identifies unusual order sizes or frequency, via statistical analysis rather than arbitrary thresholds.
2. Appropriate due diligence, including “Know Your Customer” activities, such as site visits.
3. Appropriate review and/or investigations of “pended” orders. Because labeling an order “suspicious” triggers a set of reporting requirements, QuintilesIMS recommends using a term like “pended” to indicate potentially suspicious orders. A next step is launching an internal investigation.
4. Clear, comprehensive SOM standard operating procedures (SOPs).
5. Management support and employee training.
The white paper is available here.