In one recent case, the U.S. Court of Appeals for the Eleventh Circuit upheld DEA’s revocation of a Florida pharmacy’s registration on the basis of the pharmacist–owner’s alleged failure to meet what DEA refers to as a pharmacist’s “corresponding responsibility.” The alleged factual basis of the revocation was that the pharmacist had “repeatedly ignored obvious and unresolvable red flags of diversion.”

The “obvious and unresolvable” red flags noted by the court were as follows: “1) individuals traveling long distances to fill prescriptions; 2) prescriptions for drug ‘cocktails,’ known for their abuse potential, such as oxycodone and Xanax; 3) individuals who arrived together with identical or nearly identical prescriptions; 4) purported pain patients with prescriptions for immediate-release rather than long-acting narcotics; 5) cash purchases; and 6) doctors prescribing outside the scope of their practice.”

The pharmacist challenged the DEA revocation as arbitrary and capricious. The appellate court disagreed, noting that from February 2010 to July 2012, the pharmacy “filled [more than 100] prescriptions that had at least one red flag that [the pharmacy] did not attempt to resolve and that could not have been resolved.” The court did not explain how a pharmacist should attempt to resolve a red flag that cannot be resolved.

The court rejected testimony of the pharmacist’s expert witness, who testified that pharmacists were unaware of the concept of unresolvable red flags. The court instead credited contrary testimony of the government’s expert witness, who testified that “the concept of red flags has long been recognized as a reflection of the norms of the pharmacy profession.”

Revocation of the pharmacy’s DEA registration was affirmed

DEA has a singular responsibility to prevent drug diversion. Pharmacists, on the other hand, have a dual responsibility to meet the needs of patients in pain and to prevent drug diversion.

Pain patients and drug diverters do not identify themselves to pharmacists. Rather, pharmacists must identify them through an evaluative process. This process may lead to resolution of an apparent red flag. Yet, if red flags are legally unresolvable, the evaluative process will fail, and many pain patients will be denied medication they need.

The concept of unresolvable red flags, as applied to this case, raises several important questions. For example: How long a distance must a patient travel for there to be an unresolvable red flag? Can the combination of an opioid and a benzodiazepine never be resolved? Is there no possible way to resolve the contemporaneous arrival of patients with “nearly identical” prescriptions?

Are immediate-release opioids an unresolvable problem for pain patients? Is cash payment for medication unresolvable regardless of any explanation? How does a prescriber’s scope of practice create an unresolvable problem?

Perhaps more fundamentally, pharmacists need to know whether an unresolvable red flag invalidates a prescription. If so, which red flags are resolvable, and which red flags are unresolvable? Or, maybe all red flags are unresolvable. If that is the case, it would be helpful to have a comprehensive list of all red flags.

Regulated professions deserve to know the legal standard against which their conduct will be measured. The concept of unresolvable red flags puts pharmacists in an untenable position, where their only option may be to reject prescriptions on the basis of concerns that could be resolved.