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Keeping a Watchful Eye Out for Potentially Suspicious Orders
How an algorithm-based approach to suspicious order monitoring can help companies better protect purchasers from acquiring controlled substances for illegal purposes
Mark Caverly, Sr. Consultant, U.S. Regulatory Compliance, IQVIA
Jun 10, 2022

Achieving compliance with controlled substance requirements can be a painstaking process that requires deep attention to detail and a lot of hard work. Companies not only have to rigorously follow the requirements set in the U.S. Drug Enforcement Administration’s (DEA) 21 CFR 1301.71(a) and (b), but they also need to document in detail steps taken to demonstrate compliance when auditors come knocking. That includes proving processes designed to detect and prevent diversion of products into the illicit market.

Attempts to illicitly acquire controlled substances can be constant and complex. If companies that manufacture and distribute these substances want to be reasonably assured that their products won’t end up in the wrong hands, they have to be proactive and rigorous in their compliance strategy.

Algorithm on alert

One of the biggest challenges in creating a compliant environment is understanding exactly what is required. DEA doesn’t endorse any specific method of assessing controlled substance orders. However, in my experience as a regulatory adviser, I’ve found the best approach starts with using a model based on algorithms. 

Algorithm-based models take guess work and unconscious bias out of the compliance process by leveraging statistics to compare customers’ purchases against their past histories. These algorithms can almost instantly determine whether someone has ever acquired a specific active ingredient or products in a specific drug family, and if they are making purchases of unusual size, pattern, and frequency.

It embeds a proactive, data-driven method into the environment to make it easy to flag unusual orders and trigger alerts for additional review. 

The U.S. Government Accountability Office (GAO) confirmed the value of an algorithm-based approach in its recent report, Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. The report reviewed DEA’s own use of industry reported data and suggested DEA could “conduct more analyses using automated computer algorithms to help identify questionable patterns in the data.” These include using algorithms to identify unusual volumes of deleted transactions, unusual volumes of drugs that were disposed of, and unexpected trends in distribution or drug purchases in a given geographic area. 

The GAO report authors conclude that such algorithm-based analyses could “potentially help DEA proactively identify suspicious activities or registrants that may warrant investigation.” DEA agreed with the finding and provided documentation of recently enhanced programs using algorithms.  

Compliance needs a champion

However, even the best algorithm-based approach to suspicious order monitoring will only add value if everyone on the team supports its use. 

A successful program requires staff with a broad knowledge base working daily on the nuts and bolts of the process, with support by intermediate and upper-level staff to maintain compliance, lower risk profiles, and reduce the potential for diversion and abuse. To get there, the leadership team has to champion the process and actively promote its value to the people responsible for day-to-day compliance activities. Team members will also need rigorous training on how the technology works, what suspicious activities to look for, and the implications of not catching illicit orders. 

Without well-trained employees and management-support, suspicious order monitoring programs won’t fully deliver the oversight necessary to prevent these purchases from occurring.

Compliance with controlled substance requirements requires constant attention to detail, commitment from the team, and lot of hard work. But it is the foundation for creating a safe environment that benefits patients, communities, and the organizations that produce these products. Proactively implementing an effective compliance program is the best way to protect your organization and all of the individuals your organization serves. 

To learn more about algorithm-based models for DEA compliance, visit the IQVIA Commercial Compliance page on our website.

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