Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances.  On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.  Federal Court Orders San Antonio-Area Pharmacy and Pharmacist to Pay $275,000 Civil Penalty in Case Alleging Unlawful Opioid Distribution, Oct. 11, 2023 (DOJ Press Release).  Several weeks later, also based on ability to pay, the U.S. District Court for the District of Puerto Rico entered a consent decree requiring Drogueria Betances LLC (“Betances”) to pay $12,000,000.  Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 (DOJ Press Release).

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward.  Pharmacies and distributors should be aware of the noncompliant activity alleged in these cases and tailor their own compliance programs to include at least some of the requirements imposed by the courts.

This post examines the Zarzamora pharmacy and prescribing red flags decision.  Our post on the Betances distributor decision and suspicious orders will appear in the near future.

Part One:  Zarzamora and Prescribing Red Flags

The government alleged that Zarzamora Healthcare, dba Rite-Away Pharmacy and Medical Supply #2 and its pharmacist-owner (collectively “the Defendants”) repeatedly dispensed opioids and other controlled substances in violation of the CSA “by filling prescriptions while ignoring “red flags,” – that is, obvious indications that the prescriptions were not for any legitimate medical use.”  Zarzamora Press Release.  The government alleged that the Defendants specifically failed to exercise their corresponding responsibility to ensure that the controlled substance prescriptions they filled were issued for a legitimate medical purpose by practitioners acting in the usual course of their professional practice, and by filling the prescriptions outside the usual course of their professional pharmacy practice.  Consent Agreement and Final Judgment 2-3.  The government asserted additional allegations that are outside our scope.

Pharmacists’ Corresponding Responsibility

A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.”  21 C.F.R. § 1306.04(a).  The prescribing practitioner is responsible for proper prescribing and dispensing but a corresponding responsibility rests the pharmacist filling the prescription.”  21 C.F.R. § 1306.04(a).  A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties.  21 U.S.C. § 829; 21 C.F.R. § 1306.04(a).

DEA has interpreted pharmacists’ corresponding responsibility as prohibiting the filling of a prescription where the pharmacist or pharmacy “knows or has reason to know” that the prescription is invalid.  Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order, 77 Fed. Reg. 62,316, 62,342 (Oct. 12, 2012).  “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.”  Holiday CVS, 77 Fed. Reg. at 62,341.

DEA precedent has evolved to define corresponding responsibility as requiring a pharmacy to resolve red flags before filling a prescription: “[A] pharmacist or pharmacy 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, 77 Fed. Reg. at 62,341.  A red flag does not prohibit a pharmacist from filling a prescription but is a potential concern with the prescription that the pharmacist must address and resolve.  If the pharmacist can resolve it, they must make a record of the resolution.

Prescribing Red Flags

The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.”  Complaint ¶ 55.  The government further alleged that “Defendants deliberately ignored or were willfully blind to circumstances indicating that controlled substance prescriptions were not issued for a legitimate medical purpose or were issued outside the usual course of professional practice.”  Id.  By doing so they “violated the pharmacist’s corresponding responsibility under 21 C.F.R. § 1306.04(a), and Defendants acted outside the usual course of professional pharmacy practice in violation of 21 C.F.R. § 1306.06.”  Id.

The Zarzamora decision identifies the following as prescribing red flags at issue in the case:

1.  Unusual Amounts and Dosages

Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”).  Complaint ¶ 57.  (The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

2.  Lack of Individual Drug Therapy

Pattern prescribing can occur when physicians prescribe the same drugs, in the same quantities, in the same strengths to their patients, or a patient receives the same controlled substances repeatedly with no adjustment or change in therapy.  Complaint ¶ 58.  Individuals at the same household receiving the same or substantially similar controlled substance prescriptions likewise indicates lack of individual treatment.”  Complaint ¶ 59.

3.  Routinely Abused Controlled Substances

Dispensing controlled substances when a prescriber exhibits a pattern of routinely prescribing controlled substances known to be abused such as opioids, benzodiazepines, muscle relaxers, psychostimulants, and/or codeine-containing cough syrups, or any combination of these drugs.  Complaint ¶ 60.

4.  Prescriptions Containing No Diagnosis or Intended Use

Controlled substance prescriptions issued with a non-specific diagnosis or no diagnosis.  Complaint ¶ 61.

5.  Unusual Geographic Distances

Individuals travelling long distances to the pharmacy from their home, the prescriber or both, including passing other pharmacies.  Complaint ¶ 62.

6.  Controlled Substances Received from Multiple Providers

Individuals presenting controlled substance prescriptions from multiple prescribers may indicate “doctor shopping.”  Providers should be aware of the other drugs prescribed to their patients.  Complaint ¶ 63.

7.  Immediate Release Opioids

A prescription for immediate release (“IR”) opioids on a set schedule or for a certain length of time.  An extended release (“ER”) opioid in legitimate pain management generally accompanies an IR opioid, with patients taking the ER opioid on a set schedule and the IR opioid as needed.  Complaint ¶ 64.

Future Dispensing

The court mandated specific requirements for the pharmacy’s future dispensing , requiring reviews and monitoring of those activities for seven years.  The Consent Agreement permanently restrained and enjoined the Defendants from administering, dispensing, or distributing:

1. Any controlled substance earlier than two days prior to completion of the intended duration of the previous fill;
2. Concurrent opioid and gabapentin medications unless approved by the same prescriber and the pharmacy has a documented treatment plan on file describing the basis for concurrent use;
3. Concurrent opioid and benzodiazepine medications unless approved by the same prescriber and the pharmacy has a documented treatment plan on file describing the basis for concurrent use. In addition, the pharmacy must counsel the patient regarding the FDA Boxed Warning on concomitant use and provide a written copy;
4. One or more opioids for a patient that together exceed 90 MMEs per day, except for patients who have current treatment plans on file indicating the medications are necessary for end-of-life palliative purposes;
5. More than one prescribed IR opioid for a patient except for patients who have current treatment plans on file indicating the medications are necessary for end-of-life palliative purposes;
6. More than one prescribed ER opioid to a patient except for patients who have current treatment plans on file indicating the medications are necessary for end-of-life palliative purposes;
7. Oxycodone single-entity opioids in excess of 15 mgs.;
8. Any schedule II drug to a patient paying in cash, cash equivalents, or otherwise out-of-pocket, except where the pharmacy has documented that the customer is not covered by any insurance plan or other third-party payor for prescription services;
9. IR opioids for more than 90 days unless the pharmacy first obtains a written treatment plan from the prescribing physician;
10. Methadone in combination with other opioids unless the pharmacy first obtains a written treatment plan from the prescribing physician;
11. Opioids to any person unless the pharmacy first obtains a written treatment plan from the prescribing physician;
12. Controlled substances from multiple prescribers unless the pharmacy first obtains written documentation from each prescriber acknowledging treatment with the controlled substances by other prescribers;
13. Controlled substances totaling greater than 60 MMEs per day unless the pharmacist-in-charge (“PIC”) first provides counseling on the risk of overdose and has offered naloxone. (For patient counseling, the pharmacy must maintain a handwritten logbook containing patient’s name, date of birth, address, telephone number, date of counseling, and signed acknowledgment of counseling by the patient, the PIC, and an additional pharmacy employee as witness);
14. The following combinations, unless the pharmacy has contacted the prescribing practitioner and received verbal confirmation of issuing the prescriptions’ and the diagnoses supporting the treatment plan or a written, signed explanation of the purpose of the prescriptions:
    • Opioids and gabapentin, pregabalin, or topiramate;
    • A musculoskeletal agent and an opiate; or
    • An opiate and one or more opiate potentiators.

Consent Agreement and Final Judgment ¶ 10.a.-n.

Periodic Reviews

In addition, the Defendants must conduct periodic comprehensive reviews of controlled substance dispensing and compliance with the CSA and its regulations for seven years that include electronic prescription data and patient profiles, hardcopy prescriptions, treatment plans and correspondence with prescribers, and internal notes regarding resolution of red flags, and responses to questions or clarifications posed to any prescriber, as necessary.  Within one month of each comprehensive review, the pharmacy must prepare a written report identifying prescriptions filled that were not issued for a legitimate medical purpose or filled outside the usual course of the professional practice of pharmacy, and prescriptions in violation of the permanent injunction terms.  Consent Agreement and Final Judgment ¶ 14.a.-b.

The order also enjoins the pharmacist-owner from serving as a PIC at any other pharmacy for seven years.  Consent Agreement and Final Judgment ¶ 17.

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Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution.  Part Two will focus on the Betances decision and suspicious controlled substance orders.