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Red flags turn yellow: DEA immediate suspension order is dissolved

On The Docket

David B. Brushwood, BSPharm, JD

The Scales of Justice.

A West Virginia pharmacy received an Immediate Suspension Order (ISO) from DEA, abruptly suspending the pharmacy’s registration to dispense controlled substances. The pharmacy filed a motion with a federal judge to dissolve the ISO.

Background

The judge noted that an ISO can be issued when a DEA registration poses “an imminent danger to the public health.” There must be a “substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of registration.”

The pharmacy had dispensed both buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone) to treat opioid addiction, as part of what the judge called “medication-assisted treatment.” According to the judge, “DEA assumes that prescriptions for Subutex to patients who can tolerate naloxone are always indicative of potential illicit use.”

DEA based its case on the familiar “red flags” argument. The court quoted an assistant U.S. attorney who said that “the fact that it was Subutex was the primary triggering red flag.” The ISO also cited six additional red flags, such as:

Multiple prescriptions were from out-of-state prescribers.
Approximately 96% of prescriptions were paid for with cash.
The patients traveled long distances to western Pennsylvania to obtain prescriptions.
Most patients traveled a significant distance to the pharmacy.
Many prescriptions were filled piecemeal over time.
The prescribers appeared to be “pattern prescribing.”

Rationale

In his analysis of the DEA position, the judge first noted that FDA does not contraindicate the prescribing of Subutex for patients who can tolerate naloxone. “Therefore, the DEA administrator’s repeated treatment of Subutex prescriptions as conclusively indicative of abuse and diversion is not supported.” The judge continued, “if the premise that Subutex prescriptions for patients who can tolerate naloxone demonstrates imminent danger to public health and safety is faulty, then the information contained in the ISO is of little value.”

The judge said, “The practical reality and context of West Virginia turn these additional flags from red to yellow.” The judge explained that the lack of available local treatment for substance use disorder forces West Virginians to seek treatment outside the state. Because many West Virginians do not have health insurance, or their insurance will not cover Subutex, they are forced to pay out of pocket.

The judge concluded, “These additional ‘red flags’ taken together may raise some degree of suspicion regarding the pharmacy’s practices, but none of them are facts supporting a finding that the pharmacy practices presented an imminent danger to public health and safety.”

The judge described the imminent danger to public health and safety that is posed by shutting down access to substance use disorder treatments. The judge said, “We cannot solve addiction to opioids solely through criminal law enforcement. This epidemic also requires medical intervention.”

The judge concluded that DEA “must show more than suspicion that these prescriptions indicate abuse and diversion that would rise to the level of a danger to public health and safety. The government does not point to a single instance of abuse and diversion of Subutex, or any other medication, by a patient who filled their lawful prescription at the pharmacy.”

The judge granted the pharmacy’s motion to dissolve the ISO.

Discussion

This case makes several important points about controlled substance diversion from a pharmacy, such as:

If the primary triggering red flag is faulty, then the information is of little value.
Practical realities and context can turn red flags to yellow flags.
FDA, not DEA, determines appropriate therapeutic uses of approved medications.
In a diversion case, the government must identify specific instances of abuse, not mere suspicion that abuse and diversion have occurred.

Future litigation will determine if these points are relevant only to an ISO within the context of opioid abuse treatment or have broader applicability.