The DEA’s Use of Prescription Data to Target Suspicious Orders

The DEA’s Use of Prescription Data to Target Suspicious Orders

The Drug Enforcement Administration (DEA) collects data on the sale and purchase of controlled substances and prescription drugs, including opioids, from manufacturers and distributors. They use this data to support investigations into diversion of drugs into the illegal market and to identify leads for field offices, but there are some issues with how useful the data is.

DEA’s Drug Diversion Efforts

The DEA is responsible for enforcing the Controlled Substances Act (CSA) to prevent diversion of controlled substances while ensuring they are available for legitimate medical purposes. To do this, they collect data on the distribution and dispensing of controlled substances through a few different reporting systems:

• Manufacturers and distributors must report the total quantity of each controlled substance distributed to each pharmacy or practitioner on a regular basis.
• Manufacturers and distributors must design systems to identify “suspicious orders” of controlled substances and report those to DEA upon discovery.
• Pharmacies must provide dispensing data for certain controlled substances to state Prescription Drug Monitoring Programs (PDMPs).

This data is intended to help DEA investigators identify if controlled substances are being diverted into illegal channels. However, recent government reports have identified issues with the data that limit its usefulness.

Problems with Suspicious Order Reports

DEA regulations require manufacturers and distributors to identify and report “suspicious orders” of controlled substances. But the definition of suspicious orders is vague, simply including orders of “unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”

A 2020 Government Accountability Office (GAO) report found that this vague definition makes it hard for companies to design effective monitoring programs. It also makes the data less useful to DEA investigators trying to identify diversion schemes.

For example, a distributor might report an order from a pharmacy as suspicious just because it is larger than normal. But the order could be completely legitimate if the pharmacy is stocking up before a holiday weekend when demand is higher.

Without more specific criteria, DEA gets flooded with too many reports of “suspicious” orders that turn out to be false alarms. Investigators then can’t effectively focus on reports that are more likely to indicate real diversion is happening.

Underutilized Database

To address this issue, DEA launched an online Suspicious Orders Report System (SORS) database in 2019. This centralized repository was intended to standardize and improve suspicious order reporting per the SUPPORT Act.

However, the 2020 GAO report found that only 8% of registered manufacturers and distributors were using SORS. The vast majority continue submitting paper reports to local DEA field offices, meaning data is still fragmented across multiple regional databases.

Without getting companies to actually use the centralized SORS database, it limits DEA’s ability to analyze national patterns and trends to identify high-risk customers. This reduces the usefulness of the data for proactive diversion enforcement.

Inconsistent Reporting to PDMPs

In addition to the distribution data, DEA also relies on dispensing data from state Prescription Drug Monitoring Programs. Every state except Missouri now has a PDMP that tracks prescriptions for controlled substances.

Pharmacies upload dispensing information to the PDMP, which allows prescribers and pharmacists to identify patients obtaining controlled substances from multiple providers (“doctor shopping”). PDMPs can also help identify prescribers writing large volumes of opioid prescriptions.

However, a SAMHSA report notes that reporting requirements vary widely between states. Some states require daily reporting while others only require weekly or monthly reporting. Some states also do not require reporting of cash prescriptions or medications dispensed by veterinarians.

This inconsistent reporting means there are gaps in the PDMP data available to DEA investigators and local law enforcement. It reduces the ability to identify diversion schemes on a national level versus just within state lines.

Potential Solutions

To improve the usefulness of data for proactive diversion control, experts recommend some steps for DEA:

• Issue clearer definitions and standards for identifying suspicious orders.
• Improve training for industry on how to design and operate effective monitoring programs.
• Incentivize use of the SORS database by all registrants to enable national trend analysis.
• Work with states to establish more consistent PDMP reporting requirements.
• Increase data sharing with local law enforcement to enhance investigations.

While DEA has taken some steps to improve its data collection, there are still opportunities to enhance these systems. More robust data would support DEA’s efforts to proactively identify and stop diversion of controlled substances into illegal channels.

References

GAO Report: Drug Control – Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders
DOJ OIG Report: Review of DEA’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids
SAMHSA Report: Prescription Drug Monitoring Programs: A Guide for Healthcare Providers