The current language lacks specificity and has posed a challenge for the industry to interpret. Over time, the enforcement posture has evolved. The three memoranda issued in 2006 and 2007 can be viewed as warning shots – indicating that DEA was planning more stringent enforcement. Shortly afterwards, cases were filed against several major wholesalers6 7. Since then, DEA has expanded its focus to cover the entire supply chain, with cases against manufacturers, wholesalers, pharmacies and retailers8 9. Some states are also increasingly requiring reports on suspicious orders of controlled substances.
A key factor in evolving enforcement has been the emergence of rogue online pharmacies offering controlled substances to consumers, including without prescriptions10. There followed pain clinics outside of the legitimate healthcare system, labelled as ‘pill mills,’ which added to the need for identifying, blocking and reporting such orders to DEA. Efforts to stop these activities moved from being reactive in trying to stop orders to being proactive and preventing orders before they reach their destination.
Proposed DEA rulemaking expected soon
A proposed rulemaking on SOM requirements is expected from DEA in the near future11. This is expected to add detail to current regulatory language referencing size, pattern and frequency of orders. The timing of publication of the latest DEA rulemaking remains uncertain; an updated draft was due by March 2023, a deadline that has now been missed. Earlier drafts have been issued on two occasions, including periods to allow for stakeholder comments.
Legislation sponsored by Rep. Diana Harshbarger (R-TN), titled the Block, Report, and Suspend Suspicious Shipments Bill, has also been introduced in the House12 13. This seeks to amend the Controlled Substances Act to require registrants to “exercise due diligence as appropriate,” and decline to fill the order “if the due diligence fails to dispel all of the indicators that give rise to the suspicion that…the drugs that are the subject of the order or series of orders are likely to be diverted.”14 DEA would need to be notified of all such orders and “suspicious indicators.” The bill also requires DEA to issue regulations within a year of enactment.
To stay up-to-date with the latest developments in this area, partnering and networking with others within the industry can be helpful, including developing peer networks, attending conferences, and gaining access to expert legal guidance. Tracking DEA memoranda, enforcement actions, and settlements is another useful way to understand current thinking.
Implementing defensible SOM systems
Looking ahead, entities should focus on being intentional about putting in place the building blocks of an effective and defensible SOM system. Leadership support is essential, coupled with a formalized approach based on algorithms and statistical measures. Staff should be fully trained on the system, with appropriate standard operating procedures developed and implemented.
For companies that lack internal resources in this area, a proven external partner can help ensure full compliance. IQVIA has worked in this area for 15+ years, including partnerships with 50+ distributors of controlled substances. IQVIA has an SOM technology system that uses algorithms to predict and document which orders are potentially suspicious due to differences from typical orders in size, pattern, or frequency. Using a sophisticated analysis of past ordering behavior, this system enables appropriate future ordering quantities to be predicted, helping companies defend themselves if faced with DEA actions. IQVIA has an unmatched record of positive interactions with regulators, and can construct and manage programs to meet distributors’ obligations. This places organizations in the best possible position to minimize the risk of noncompliance – and any associated reputational or financial harms.
References
- https://www.transparencymarketresearch.com/us-controlled-substance-market.html
- https://www.cancer.gov/publications/dictionaries/cancer-terms/def/controlled-substance
- https://ehs.ucla.edu/news/reporting-suspicious-orders-those-approved-distribute-controlled-substances
- https://www.deadiversion.usdoj.gov/faq/sors_faq.htm
- https://www.ecfr.gov/current/title-21/chapter-II/part-1301/subject-group-ECFRa7ff8142033a7a2/section-1301.74
- https://www.reuters.com/article/cardinal-dea/update-1-dea-suspends-a-cardinal-substance-control-license-idUKN2925615720071130
- https://www.justice.gov/archive/usao/md/news/archive/McKessonCorporationAgreestoPayover13MillionToSettleClaims.html
- https://www.dea.gov/press-releases/2020/11/17/pharmacy-pays-250000-resolve-controlled-substances-act-violations
- https://www.justice.gov/opa/pr/mckesson-agrees-pay-1-million-resolve-recordkeeping-violations-under-controlled-substances
- https://www.fda.gov/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters
- https://www.iqvia.com/locations/united-states/events/2022/10/iqvia-24th-controlled-substances-and-state-regulatory-conference
- https://www.congress.gov/bill/118th-congress/house-bill/501
- https://d1dth6e84htgma.cloudfront.net/susp_orders_02_xml_9c26eafe87.pdf?updated_at=2023-01-25T22:57:10.150Z
- https://www.deachronicles.com/tag/suspicious-orders/
