On The Docket
David B. Brushwood, BSPharm, JD
Regulations promulgated by DEA establish a corresponding responsibility for pharmacists not to knowingly fill an invalid controlled substance prescription, by which they mean that a pharmacist “either knew or had reason to know” of a prescription’s invalidity. DEA uses the concept of unresolved “red flags” to prove that a pharmacist had a “reason to know” that an order for a controlled substance was invalid.
DEA has never incorporated the phrase “red flags” into a regulation and has never explained how the agency expects pharmacists to recognize or resolve a “red flag.” It is only through reports of enforcement actions taken by DEA against pharmacists and pharmacies that it is possible to learn, after the fact, what DEA expected of the defendant pharmacy and pharmacist.
A recently reported DEA enforcement action included a new requirement that a pharmacist’s resolution of red flags should be documented to meet the corresponding responsibility.
It is a standardless responsibility in the sense that the agency did not, and does not, provide standards explaining who must document, where to document, how much to document, or how long to retain documentation.
Background
In this recent case, DEA sought to revoke the DEA registration of the defendant pharmacy. The pharmacy was alleged to have filled controlled substance prescriptions without resolving 5 red flags:
- What the DEA calls “cocktail medications,” meaning an opioid, a benzodiazepine, and a skeletal muscle relaxant prescribed together
- “Improper opioid dosing for pain management” based on the pharmacy having filled prescriptions for immediate-release opioids to be used 4 times daily rather than sustained-release opioids to be used twice daily
- Patients traveling “long distances” to have their prescriptions filled
- Cash payments for opioids
- “Black market pricing” that was above what the DEA considered to be the market rate
An expert witness pharmacist testifying for the government said that she saw no evidence indicating that these red flags had been resolved. She reviewed the prescription records of several patients and she consistently testified that she “would not have filled the subject prescriptions without addressing, resolving, and documenting the red flags discussed.”
An expert witness testifying on behalf of the pharmacy stated that the standard of care “does not require a pharmacist to document in writing any specific resolution of ‘red flags,’” and he referred to the phrase “red flags” as “a DEA slang term.” He stated that the law “merely states what exercise a pharmacist is supposed to perform professionally in the process of evaluating the prescription, not what is required documentation.”
Rationale
The prosecutors contended that the court “should infer that the absence of the subject documentation resolving red flags demonstrates a failure to resolve the red flags.” In the law, this is often called the “adverse inference” rule. The court held that the application of this rule was “appropriate in this case,” and that “the absence of subject documentation as resolution of red flags suggests no resolution occurred.”
The judge recommended that the pharmacy’s DEA registration be revoked, and the agency administrator ordered the revocation based on this recommendation.
Takeaways
This case illustrates a clash of cultures. In a science-based health profession, the absence of evidence is not considered evidence of absence. For example, simply because a patient’s drug therapy does not seem to be working does not mean it isn’t working.
On the other hand, law enforcement may take the position that the absence of evidence is evidence of absence. In other words, if it isn’t documented, then it didn’t happen.
It is unlikely that DEA will provide any explanation of how, where, by whom, or how much, documentation of red flag resolution is required. The profession, through its governmental and non-governmental organizations, now has the opportunity to develop those standards. ■