Providing Quality Care Amidst Legal Parameters
As healthcare professionals, how do we legitimately provide high-quality patient care within today’s legal parameters when encountering precarious clinical and social situations?
US drug overdose deaths have skyrocketed to levels never conceived in previous decades, with a US adult dying from a drug overdose every 6 minutes. All the while, prescription opioid prescribing and dispensing has plummeted back to 20th-century levels. Perhaps the healthcare solutions of today are still not addressing the healthcare concerns of 25 years ago.
The fact is, healthcare professionals (HCPs) – including pain management physicians, clinical pharmacists, and advanced practitioners – have an indirect role within the healthcare supply chain and, sometimes, an indirect role in the overall drug diversion illegal drug supply chain.
All HCPs must aim to prevent prescription drug diversion, misuse, and abuse. The intersection of the healthcare supply chain and the illegal drug supply chain is a reality. Educating patients about the appropriate storage and disposal of all prescription medications (not just controlled substances) can save lives. More important, licensed HCPS must also consider what many in the medical field call “DEA Red Flags” in respect to the prescribing and dispensing of controlled substances.
Imagine a society without checks and balances trying to manage controlled substances. If prescribers rely on dispensers to check things, while dispensers rely on prescribers to check things, this could lead to a situation where no one is double-checking anything. Instead of pointing fingers, the goal should always be to use our clinical knowledge and experience to select the safest and most effective treatment options for each patient, while remaining within set safety parameters.
While the adage, great power comes great responsibility dates back to Cicero’s 45 BC parable, the Sword of Damocles, it reverberates today, particularly in our healthcare space.¹ We simply call it “corresponding legal responsibility” as per our federal regulations, which state:²
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.
The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rest with the pharmacist who fills the prescription.
However, when a patient presents with one, or even multiple “DEA Red Flag” concerns. what is a clinician to do? The following sections are meant to provide some guidance and perspective.
Why We Need the US DEA
Stepping back a bit, the US Drug Enforcement Agency (DEA) is meant “to enforce the controlled substances laws and regulations of the United States.”³ The agency’s Diversion Control Division regulates and registers actors in the supply chain of controlled pharmaceutical products, including manufacturers, distributors, pharmacies, and practitioners. According to the division’s website, its mission is “to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.”⁴ The division’s activities include “establishment of national drug production quotas” and “computerized monitoring and tracking of the distribution of certain controlled substances.”⁵
In a 2006 DEA Dispensing Controlled Substances for the Treatment of Pain policy statement,⁶ the agency recognized that the overwhelming majority of prescribers (and dispensers) of controlled substances do so for legitimate medical purposes, and thus have no reason for concern of “scrutiny by Federal or State law enforcement officials.” In that very same document, the DEA confirmed that it had increased aggregate production quotas for opioid medications during the 1990s (these quotas continued through the early 2010s).⁷ Would DEA repeat that production quota today?
At the time of this writing, there were no active civil or criminal cases against the DEA, although West Virginia’s Attorney General momentarily sued the US DEA based directly on these previous opioid production quotas in 2020, only to have the case dropped once the agency responded with lowered quotas.⁸
Even though the overwhelming majority of prescribers (and dispensers) of controlled substances continue to do so for legitimate medical purposes, the stark reality is that “pill mills” (ie, licensed HCPs and facilities found to be guilty of criminal activity) still exist.
Without the DEA, who would find the kilograms of fentanyl being shipped into and throughout our country day in and day out? Who would arrest and facilitate the nullification of a professional healthcare license of a prescriber and/or dispenser if said person was found to be committing a crime? In my view, the DEA is a necessary federal effort – and one that provides an immense opportunity for improvement and collaboration with HCPs.
Moreover, our society needs DEA red flags (and this author would argue, a comprehensive list of all efforts that facilitate further review) documented in plain English within professional healthcare journals, rather than being alluded to within courtroom case documents and educational videos, such as those of the National Association of Boards of Pharmacy (NABP).¹⁰˒¹¹
Until such documents exist, we must rely on cases and lessons learned. Below are considerations based on the author’s clinical and consulting experience.
DEA Red Flags to Consider, and When Possible, Avoid
For Prescribing Physicians
cash-only paying patients (ie, no use of insurance even if available)
prescribing of the same combination of highly abused drugs
prescribing the same, typically high quantities of pain drugs to most every patient
having a high number of prescriptions in general issued per day and out-of-area patients¹¹
For State Boards of Pharmacy, Pharmacies, and Pharmacists
dispensing a high ratio of controlled to non-controlled drugs
dispensing high volumes of controlled substances generally
dispensing identical prescriptions (same drug in the same quantity) prescribed by the same prescriber to many patients
dispensing to out-of-area patients
dispensing to multiple patients with the same last name or address
filling sequentially numbered prescriptions for controlled substances from the same prescriber
filling prescriptions for controlled substances for one patient from multiple practitioners
dispensing for patients seeking early prescription fills/refills¹¹
A prominent 2012 case, Holiday CVS, LLC d/b/a/ CVS Pharmacy Nos. 219 and 5195,¹⁰ describes a “red flags” test in which the DEA would need to prove three things before acting upon a pharmacy’s license to dispense controlled substances:
the pharmacy must have dispensed a controlled substance
a red flag should have been recognized at or before the time the controlled substance was dispensed
the suspicion was not dispelled prior to filling the prescription
This case illustrated the absolute responsibility of prescribers and dispensers (particularly dispensers in this case) to conduct obligated efforts to validate prescriptions.
Additionally, it is an expected best practice for pharmacists to not only offer patient counseling as required by OBRA 1990 law, but to proactively counsel (discuss) any and all dispensed prescriptions with respective patients.
Although these identified controlled substance red flags are extensive for both prescribers and dispensers, there remain many additional situations that provoke further review as well. See the table below.
| Prescribers and Dispensers | |
|---|---|
| Prescribers | |
| Dispensers | |
How to Proceed with Suspected Concerns
If a provider or dispenser is uncertain even after due diligence is performed when reviewing a patient care scenario, further effort and communication may be needed to clarify the patient’s situation. Prior to initiating that important conversation, a clinician should research all aspects of the respective patient-related scenario including opening communications with any other respective healthcare professionals involved directly or indirectly with the patient case and decide upon the need for the conversation to be witnessed or not.
General best practices to consider when proceeding with suspected concerns:
eliminate personal or judgmental biases
proceed with a calm, collected, knowledgeable, and well-researched approach
“false positive” concerns are a reality
no one is privy to one’s life/story until shared
How to Proceed with Confirmed Concerns
If abuse or diversion is confirmed, treatment can continue with alternative therapies (eg, non-controlled substances and non-pharmacological treatments). The patient should be referred to a substance use disorder or addiction specialist/program or an entity that can facilitate that connection, and law enforcement should be contacted if concern for the safety of anyone exists. Respect for all those directly or indirectly involved in the specific patient case should be upheld always, while also ensuring both a procession within mandated laws and an appropriate level of patient care.
General best practices to consider when proceeding with confirmed concerns:
treatment can continue with alternative therapies
refer to an addiction specialist or entity that can facilitate connection
contact law enforcement if there is a concern for anyone’s safety
reference the patient and provider agreement/contract
avoid patient abandonment
ensure universal respect while upholding federal and state laws
DEA Reporting
When it becomes necessary to report confirmed drug diversion-related situations to the DEA, the following options are available:
1-877-RX-Abuse (1-877-792-2873)
https://apps.deadiversion.usdoj.gov/rxaor/spring/main?execution=e1s1
Steps Forward and Practical Takeaways
In many conversations across the country, too many licensed healthcare professionals are beyond concerned about losing their respective state professional licenses when providing care for individual patients with pain management scenarios that place them as “outliers” relative to guidelines and best practices in pain management. They wonder, do one-off clinical care situations propel one into a criminal realm?
Meanwhile, pill mills continue to exist. Patients in pain continue to struggle. So, what is the best next step and in what direction should clinicians navigate?
Perhaps one best practice for utilizing known DEA red flags and general controlled substance concerns is to recognize the flags and concerns. It is expected that pain management clinicians will come across patient scenarios from time to time where multiple red flags or concerns are raised and need to be addressed, but this should not be the norm. At the same time, it is important to acknowledge that certain patients will need to utilize controlled substance prescription medications that are, in fact, by definition, worthy of higher scrutiny, yet not avoidance.
Our patients, like us, are human, and thus, all different. Healthcare silos, cookie-cutter treatment plans, and “right” or “wrong” scenarios are ineffective. We need to truly weigh the benefits and risks of each patient case, while keeping an eye out for any of our own, or even of our colleagues, concerning trends. Perhaps the answer to so many clinicians’ ponderings as to how to review DEA red flags has been in front of us all along: with knowledge and compassion.
Editor’s Note: This article is based in part on the author’s presentation at PAINWeek 2022 titled “Hell’s Kitchen: How We Address DEA Red Flags.”