Corresponding Responsibility of Pharmacies, DEA to Uphold Controlled Substances Act | ASPL 2024

When distributing medication in ordinance with the Controlled Substances Act (CSA), it is imperative that all pharmacists ensure each prescription they dispense is intended to serve a specific medical purpose for their patient. While the DEA does not define specific instances of red flags noticeable in the drug dispensing process, pharmacists have a duty to exhibit due diligence, document any red flags, and report how they resolved any suspicious events.

“The pharmacist should be looking for red flags by looking at all of the details on the face of the prescription, checking the [Prescription Drug Monitoring Program], running a public search for the provider to see if there are any disciplinary orders, talking to the patient, and calling the prescriber. That should attempt to resolve red flags by taking into account the bigger picture. Circumstances matter,” said Joel Ferre, JD, Assistant United States Attorney in Utah.¹

At the American Society of Pharmacy Law’s 50th Developments in Pharmacy Law Seminar, Ferre hosted a session titled “Corresponding Responsibility from the Perspective of Federal Law Enforcement.” He explored how the Department of Justice and DEA enforce the CSA, pharmacist and physician responsibilities when prescribing and dispensing medications, and the violations that should always be avoided to deter diversion.

First, Ferre discussed red flags in the dispensing of medications and how this buzzword carries a lot of weight but is not recognized as an official provision under DEA statutes and procedures.

Joel Ferre, JD, Assistant United States Attorney in Utah, hosted a session at the American Society of Pharmacy Law’s 50th Developments in Pharmacy Law Seminar. | image credit: Timon / stock.adobe.com

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“The term red flags that is often used in this context does not appear in the statute, does not appear in the regulation. In fact, you will not see an official DEA publication of any sort that uses the term ‘red flags’,” he said.

For pharmacists’ sake, as per the Department of Justice’s guidance, red flags are considered any signs of the diversion of prescription drugs, misuse in prescribing, or the prescribing of illegitimate drugs. When it comes to the DEA’s role in enforcing the CSA, they do not draw specific instances of red flags; for example, a pharmacist overprescribing opioids for a patient at risk of developing opioid use disorder. According to Ferre’s presentation, the DEA solely focuses on pharmacist and provider reports of diversion, misuse, and illegitimate prescribing.

After discussing how pharmacists should be observing and handling red flags in the pharmacy, he went on to discuss how corresponding responsibility and willful blindness work against each other when finding and reporting red flags.

“Corresponding responsibility is to assure prescriptions are legitimate. That is, [they are issued] for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. So, pharmacists, of course, have a corresponding responsibility to make sure that that happens also,” he continued.¹

When it comes to willful blindness, however, it is an action serving as the antithesis of pharmacist and physicians’ corresponding responsibility to ensure the distribution of medications with a specified medical purpose. He mentioned how the CSA observes a pharmacists’ knowingly filling illegitimate prescriptions as “willingful blindness.”

“I think never is the case where you have a pharmacist or a practitioner who will ‘actually know’ that the prescription they write is illegitimate or not issued in the usual course of professional practice. We typically have to rely on willful blindness…using circumstantial evidence to show that [the pharmacist or practitioner] knowingly violated the regulation and the statute,” continued Ferre.¹

Exploring how the DEA typically investigates pharmacies in failure of reporting red flags, Ferre mentioned the 1990 Bertolino court case. It involved the distribution of stimulants in the state of Pennsylvania. The DEA found over 18,000 prescriptions mostly filled by one physician.

“This is where you get [that] the statutory scheme plainly requires that pharmacists use common sense and professional judgment. There's been a recognition from the DEA that pharmacists must use common sense and have professional judgment…in seeking to resolve issues that appear with prescriptions,” said Ferre.¹ The decision stated that “the pharmacist closed his eyes to obvious abuse, ignoring the fact that his customers were purchasing far more medication than would be necessary for legitimate medical purposes.”

DEA investigations into pharmacists’ failure to report red flags have led to both civil and criminal trials. From fines reaching well over $200,000 and jeopardy of license revocation to the possibility of criminal punishment, failing to report and document illegitimate activity in the pharmacy can have dire consequences. To ensure the delivery of valued care in communities, providers and law enforcement alike must play their part in following all policies and procedures.

“I understand the demands the pharmacists are under. I can't even imagine, and my hope is that at least discussing some of this, you'll have a better understanding of what at least the DEA and other federal investigative agencies will look at when investigating complaints of diversion. More and more cases continue to hit my desk than when I started back in 2018, so the problems are still there and they continue to come,” concluded Ferre.¹

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Reference

1. Ferre J. Corresponding responsibility from the perspective of federal law enforcement. Presented at: 2024 Developments in Pharmacy Law Seminar; November 7-10, 2024; Phoenix, AZ.