Pharmacists’ “Corresponding Responsibility” Part I: The Legal Requirements and Part II: The Legal Consequences

Part I

Corresponding Responsibility Introduction

This post is Part I of a two-part series on the corresponding responsibility. This first post will cover the legal requirements related to pharmacists’ corresponding responsibility. The second post will then discuss the legal consequences for pharmacies and pharmacists when controlled substance prescriptions are dispensed without fulfilling the corresponding responsibility. Identifying and resolving red flags may feel burdensome for pharmacy personnel who are already over-worked pharmacy personnel and for pharmacies who already wrestle with impossible thin margins for individual prescriptions, but it must be prioritized. My hope is that these two blog posts help ease that burden and bring clarity to DEA’s requirements,

Disclaimer: The information provided in DeKo Law blog posts is for general informational and educational purposes only and does not constitute legal or regulatory advice. Do not rely solely on this content for compliance. Instead, consult with qualified legal counsel or regulatory professionals for advice regarding your obligations under the CSA and DEA’s regulations.

Please contact DeKo Law if you need a legal assessment of your existing corresponding responsibility practices, which will identify areas of risk and potential non-compliance. That assessment would include legal advice and recommendations on how to further strengthen those practices, particularly in this post-COVID telemedicine environment. Likewise, contact Brinks DEA Consulting if you have needs regarding the implementation of your corresponding responsibility policies or if you need assistance with mock inspections or audits of your red flag dispelling activities.

What is the “Corresponding Responsibility”?

While practitioners are principally responsible for ensuring they only issue lawful prescriptions, pharmacists have a unique regulatory obligation to carefully evaluate those prescriptions, determine whether they are lawful and, ultimately, exercise their professional judgment to either dispense or refuse to dispense controlled substances pursuant to those prescriptions. Pharmacists’ duty to scrutinize controlled substance prescriptions is not just good practice — it’s the law.

“The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 C.F.R. § 1306.04(a). To perform their corresponding responsibility, pharmacists are required to identify and dispel all “red flags” associated with an individual prescription. The presence of a red flag “means that there is a potential concern with the prescription, which the pharmacist must address and resolve….” Gulf Med Pharmacy, 86 Fed. Reg. 72,703 (Dec. 22, 2021). Ultimately, a pharmacist fails to satisfy their corresponding responsibility when they dispense prescriptions with “at least one red flag that [they] did not attempt to resolve and that could not have been resolved.” Jones Total Health Care Pharmacy, LLC v. DEA, 881 F.3d 823, 830 (11th Cir. 2018).

If a red flag cannot be dispelled or if a pharmacist “knows or has reason to know that the prescription was not written for a legitimate medical purpose,” then she must not fill the prescription. Medic-Aid Pharmacy, 55 Fed. Reg. 30043, 30,044 (DEA July 24, 1990). Thus, even if a prescription appears valid on its face, the pharmacist must use professional judgment to ensure that it was issued for a legitimate medical purpose.

What is a “Red Flag” and Why Don’t I See it in the CSA or DEA’s Regulations?

Generally speaking, the term “red flag” refers to certain indicia of diversion associated with a prescription, which must be evaluated and resolved before dispensing. Red flags do not automatically mean a prescription is invalid — but they must be resolved before dispensing. A pharmacist “may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid.” Holiday CVS, L.L.C., 77 Fed. Reg. 62,316, 62,341 (Oct. 12, 2012)

However, neither the CSA nor DEA’s implementing regulations define, acknowledge or refer to the term “red flag.” Instead, the “red flag” doctrine has been developed over time merely through DEA’s administrative case law and, while the doctrine has become a cornerstone of pharmacies’ DEA regulatory compliance, it has never been formally adopted through the Administrative Procedure Act, including its notice-and-comment requirements.

As DEA has acknowledged, “there is no place where pharmacists can find a comprehensive list of ‘red flags’ because the red flags are changing in various parts of the country.  Jones Total Health Care Pharmacy LLC, 81 Fed. Reg. 79209 (Nov. 10, 2016). DEA believes recognizing red flags is “common sense on a pharmacist’s part” and DEA cannot publish a definitive list of red flags because “[p]harmacy practice isn’t a checkoff list, and the red flags change.” Id. Instead, over time and through administrative case law, DEA has cultivated a variety of common red flags that are dynamic and fact-specific in how they manifest themselves, which often depends on a pharmacy’s specific business model, the pharmacy’s geographical location (e.g. rural or urban) and the patient population served by a pharmacy.

It is important to consult with legal counsel (i.e. DeKo Law or another firm with comparable expertise) on whether your pharmacy is monitoring for red flags relevant to your business. It is also important to consult with legal counsel to ensure that you have an appropriate and defensible application of the red flags that are being monitored (e.g. understanding what distance triggers red flag obligations for your pharmacy—25 miles vs. 100 miles). In working with outside counsel, be aware of the following red flags most commonly cited by DEA:

• Pattern Prescribing: Prescribing the same controlled substance in identical or substantially similar quantities to multiple individuals indicating a lack of individualized therapy.
• Distance: The geographical distance between the practitioner and the patient or between the pharmacy and the patient is a reason to suspect that a prescription may have been authorized in violation of the practitioner’s standard of practice.
• Dosage Strength and Duration: Receiving prescriptions for immediate-release opioids, such as hydromorphone and oxycodone, for several months at a time is a red flag of abuse or diversion…because immediate-release medication should only be used to treat short-term, acute pain, and patients with legitimate chronic pain would eventually be switched to safer, long-term pain medication.
• Cash Payment: A tactic that permits an individual to avoid scrutiny associated with the use of insurance as part of the payment process.
• Shared Address: Multiple persons with the same address presenting the same or substantially similar controlled substance prescriptions from the same practitioner.
• Therapeutic Duplication: Medications in the same category that work on the same receptor site that alleviates the same symptoms.
• Early Refills: Early refill red flag could easily be resolved with a notation documenting that hospice agency’s refill policy.
• Cocktail Prescribing: A practitioner prescribes (via one or more prescriptions) cocktail medications. Cocktail medications are combinations of controlled substances that are widely known to be abused or diverted, and when taken together, significantly increase a patient’s risk of death or overdose.

While DEA has refused to publish any list of “red flags” for which it will hold registrants accountable, a number of state Boards of Pharmacy elected to do so through the promulgation of regulations or the issuance of guidance materials. For example, the following states published lists of red flags for their licensees:

·       California – The BOP’s Brochure on the Corresponding Responsibility

·       Indiana – The BOP’s March 10, 2014 Corresponding Responsibility Guidance

·       Kansas – The BOP’s Best Practices for Using K-TRACS

·       Kentucky – The BOP’s Pharmacy Practice FAQ 

·       Texas through the BOP’s promulgation of Texas Admin. Code 22 § 291.29

How Do Pharmacists Dispel Red Flags?

Before a pharmacist dispenses controlled substances, it must first dispel all red flags associated with the prescription, which requires the pharmacist to take affirmative steps capable of resolving the concerns it has identified with the prescription. Those steps often include things like:

• Call the prescriber’s office to confirm authenticity of the prescription and validate its intended use.
• Check the state Prescription Drug Monitoring Program (PDMP) for the patient’s recent controlled substance fills.
• Confirm patient identity and ask clarifying questions about their therapy.
• Review the patient’s profile for duplications, interactions, or inconsistencies.
• Consult medical records, if available.
• Speak with the prescriber to clarify diagnosis, treatment goals, or dosage rationale.
• Counsel the patient respectfully to understand their medication use and expectations.

Documentation of pharmacists’ efforts to dispel red flags is critical, particularly when pharmacists ultimately decide to dispense the medication. Thus, pharmacists should carefully document on the face of the prescription, in the electronic file or on some other record that can be linked or appended to the prescription information such as: the specific red flag(s) identified, all verification steps (calls made, PDMP check results, prescriber discussion) and the clinical rationale for the decision.

Conclusion

Pharmacists are the final checkpoint in the controlled substance distribution chain. By exercising sound judgment when handling controlled substance prescriptions, taking affirmative action to fully resolve red flags and documenting their investigative efforts, pharmacists are able to protect themselves and their pharmacies against administrative liability, civil liability and, in certain instances, criminal liability, all of which will be discussed in Part II of this corresponding responsibility series.

Part II

This post is Part II of a two-part series on the corresponding responsibility. Part I titled “Pharmacists’ “Corresponding Responsibility” Part I: The Legal Requirements” covered the legal requirements related to pharmacists’ corresponding responsibility. This post discusses the legal consequences for pharmacies and pharmacists when controlled substance prescriptions are dispensed without fulfilling the corresponding responsibility. Identifying and resolving red flags may feel burdensome for pharmacy personnel who are already over-worked pharmacy personnel and for pharmacies who already wrestle with impossible thin margins for individual prescriptions, but it must be prioritized. My hope is that these two blog posts help ease that burden and bring clarity to DEA’s requirements,

Disclaimer: The information provided in DeKo Law blog posts is for general informational and educational purposes only and does not constitute legal or regulatory advice. Do not rely solely on this content for compliance. Instead, consult with qualified legal counsel or regulatory professionals for advice regarding your obligations under the CSA and DEA’s regulations.

 Pharmacies and pharmacists should appreciate who can be held liable for non-compliance because, in many cases, they both have skin in the game. For that reason, it is in the interests of both pharmacies and pharmacists to work in tandem toward full compliance regarding their controlled substance dispensing decisions. This post discusses the various types of liability pharmacies and pharmacists face for violations of the corresponding responsibility.

Administrative Liability

DEA’s regulations make clear the corresponding responsibility “rests with the pharmacist” (21 CFR § 1306.04(a)); however, the pharmacy is the DEA registrant responsible for all conduct carried out under its registration. Therefore, pharmacies alone remain administratively liable for violations of the corresponding responsibility. As discussed in prior posts, DEA can pursue various types of enforcement action in response to violations, including LOAs, MOAs, ISOs and OTSCs. At the end of the day, should DEA decide to pursue administrative action in response to pharmacists’ dispensing of controlled substances in the face of red flags (i.e. failure to perform their corresponding responsibility), it can only be directed at the DEA-registered pharmacy.

Considering the administrative liability they face for non-compliance, pharmacies must partner with their staff pharmacists, invest in tools that support their corresponding responsibility efforts and monitor how effective pharmacists’ efforts are in practice. Every pharmacy that dispenses controlled substances should develop and maintain robust policies and procedures (and regular internal training on their implementation) to ensure their staff pharmacists understand what red flags they are responsible for identifying and what they must do to adequately dispel such flags when identified.

Consider engaging DeKo Law and Brinks DEA Consulting to advise on your potential administrative risk with your current dispensing practices and to support you in bringing your practices into compliance.

Civil Liability Under 21 U.S.C. § 842

For cases that DEA refers to DOJ for prosecution, pharmacies could face crippling civil liability under 21 U.S.C. § 842(a)(1) for violations of DEA’s corresponding responsibility requirement. See e.g. Cherokee Nation v. McKesson Corp., No. CIV-18-056-RAW, 2021 WL 1200093, at 6 (E.D. Okla. Mar. 29, 2021) (“pharmacies, not merely pharmacists, have obligations to ‘resolve red flags’ before dispensing controlled substances concerning suspicious prescriptions”); Heartland Pharmacy, Inc. v. Rosen, No. 21-14037-CV-MIDDLEBROOKS, 2021 WL 650350, at 4 (S.D. Fla. Feb. 18, 2021); United States v. Howen, No. 121CV00106DADSAB, 2022 WL 18420744, (E.D. Cal. Aug. 9, 2022). Moreover, in assessing the pharmacy’s role in ensuring its pharmacists fulfill corresponding responsibility obligations, federal courts have held they must implement policies and systems that provide pharmacists with adequate tools and training necessary to fulfill their corresponding responsibility. See In re Nat’l Prescription Opiate Litig., 589 F. Supp. 3d 790; Cty. of Lake v. Purdue Pharma, L.P., 477 F. Supp. 3d 613; Cnty. of Lake v. Purdue Pharma, L.P., 589 F. Supp. 3d 739.

It is worth taking a minute to consider just how significant this liability can be. Civil penalties for violations of 21 U.S.C. § 842(a) generally take the form of monetary penalties that are paid by the defendant to the government. The CSA provides a maximum civil penalty of $25,000 for dispensing violations under 21 U.S.C. § 842(a). 21 U.S.C. § 842(c)(1)(A). However, this penalty amount is adjusted every year for inflation so, in reality, the inflation-adjusted amount is now $82,950. To make matters worse, DOJ almost exclusively pursues this maximum penalty amount and it does so on a per violation basis. As an illustration, if DOJ alleges a pharmacy dispensed 100 prescriptions in violation of the corresponding responsibility requirement, the pharmacy’s potential civil liability is $8.3M.

While there is much less convincing federal case law on the issue, some within DOJ have taken the position that pharmacists are also civilly liable for their failure to perform their corresponding responsibility—even  though the requirement only exists in DEA’s regulations and pharmacists are not DEA registrants.  In short, the argument for pharmacist liability is with how Congress drafted the CSA’s penalty section. Unlike other provisions of 21 U.S.C. § 842(a) that limit their application to “any person who is a registrant,” the provision specific to dispensing violations applies to “any person who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of section 829 of this title.” 21 U.S.C. § 842(a)(1). Some have taken the position that, since 21 U.S.C. § 842(a)(1) was not limited only to persons who are “a registrant,” civil liability can be extended to pharmacists as well as pharmacies.

In reality, it is extremely rare that pharmacists (particularly those who do not own the pharmacy itself) are held civilly liable for violations of the corresponding responsibility requirement—penalties are almost always limited to the pharmacy. Nevertheless, we have defended individual staff pharmacists in cases where DOJ decided to only pursue civil penalties against the dispensing pharmacist and not the pharmacy. So, it is critical that pharmacists appreciate this risk and understand the penalties they could face for violations.

If you’re a pharmacy or pharmacist, don’t wait until you’re facing penalties or lawsuits. Contact DeKo Law for expert guidance on reducing risk in your dispensing practices and for representation if you’re under investigation or facing civil action. Protect your business before problems arise.

Criminal Liability Under 21 U.S.C. § 841

Whereas civil liability is often concentrated on pharmacies rather than pharmacists, courts have more commonly imposed criminal liability under 21 U.S.C. § 841(a)(1) against both pharmacies and pharmacists. See United States v. Moore, 423 U.S. 122, 122, 96 S. Ct. 335, 336, 46 L. Ed. 2d 333 (1975) (“by its terms § 841 reaches ‘any person’; [i]t does not exempt (as it could have) ‘all registrants’ or ‘all persons registered under this Act.’”); United States v. Hayes, 595 F.2d 258, 259 (5th Cir. 1979) (“when a pharmacist fills a prescription that he knows is not a prescription within the meaning of the regulations he is subject to the penalties of § 841”).

While § 842’s civil penalties are generally geared toward DEA registrants, § 841’s criminal penalties are not. The scope of § 841 extends to any person knowingly engaging in unlawful activities with controlled substances, which could include DEA registrants, pharmacists, illicit drug dealers, transnational gangs, etc. The question of whether a person faces criminal liability turns on whether that person intentionally and knowingly violated the CSA. In the context of corresponding responsibility violations, a pharmacist could only be held criminally liable if he knew the underlying prescription was unlawful and he knew it was unlawful to dispense the controlled substances and he still decided to dispense them. In other words, criminals know they are breaking the law. Pharmacies and pharmacists should only concern themselves with potential criminal liability if they know they have been illegally dispensing controlled substances.

 Conclusion

Pharmacists are the final checkpoint in the controlled substance distribution chain. By exercising sound judgment when handling controlled substance prescriptions, taking affirmative action to fully resolve red flags and documenting their investigative efforts, pharmacists are able to protect themselves and their pharmacies against administrative liability, civil liability and, in certain instances, criminal liability.

 Please contact DeKo Law if you need a legal assessment of your existing corresponding responsibility practices, which will identify areas of risk and potential non-compliance. That assessment would include legal advice and recommendations on how to further strengthen those practices, particularly in this post-COVID telemedicine environment. Likewise, contact Brinks DEA Consulting if you have needs regarding the implementation of your corresponding responsibility policies or if you need assistance with mock inspections or audits of your red flag dispelling activities.