Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

We blogged in February 2022 about the Drug Enforcement Administration’s (“DEA’s”) revocation of Gulf Med Pharmacy’s registration after finding that it failed to exercise its corresponding responsibility by repeatedly filling controlled substance prescriptions that exhibited “obvious red flags of diversion without documenting the resolution of those red flags.”  Last December we blogged on the $275,000 civil penalty imposed by the U.S. District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.”

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution.  Coconut Grove Pharmacy; Decision and Order, 89 Fed. Reg. 50,372, 50,377 (June 13, 2024). The Coconut Grove decision introduces no new red flags, but further clarifies DEA’s expectations, especially in the context of Florida’s standard of care.  After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. §823(g)(1).  Id. at 50,372.

Prescribing Red Flags

In the Gulf Med decision, DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.”  Gulf Med Pharmacy; Decision and Order, 86 Fed. Reg. 72,694, 72,703 (Dec. 22, 2021).  The presence of a red flag does not prohibit a pharmacist from filling a controlled substance prescription but “means that there is a potential concern with the prescription, which the pharmacist must address and . . . make a record of its resolution, assuming it is resolvable.”  Id.

The Florida Administrative Code codifies prescribing red flags and establishes a standard of care for pharmacists.  The government’s expert testified that any red flag associated with a controlled substance prescription must be resolved and that resolution documented before dispensing.  89 Fed. Reg. 50,372 at 50,372-73.  DEA noted that “red flag” as used in the Coconut Grove decision refers to “‘things to look for’ identified in [Florida Administrative Code § 64B16-27.810].”  Id. note 13.

Coconut Grove

The expert reviewed the records of seven patients whose prescriptions were filled over almost two years and found no resolutions of red flags.  Id. at 50,373.  Finding no documentation identifying nor resolving the red flags associated with the prescriptions, the expert opined that Coconut Grove’s dispensing “fell below the Florida standard of care” and the pharmacy failed to meet its corresponding responsibility.  Id.

Coconut Grove had noted “verified” on the prescriptions which DEA found “is not sufficient to identify and resolve any red flags that may be present.”  Id. at 50,374.  The ALJ found, and DEA agreed, that the standard of care in Florida requires any red flags for a prescription or a patient must be resolved before dispensing and resolution must be documented.  Id.  Coconut Grove’s failure to do this “render[ed its] dispensing practices outside the usual course of professional practice and in violation of the Florida standard of care.”  Id.

Red Flags at Issue

a.  Prescription Drug Cocktails

The government’s expert opined that a combination of drugs in different classes or drugs with synergistic effects is a “drug-drug interaction red flag.”  Id.  He observed that the Food and Drug Administration has issued a Black Box warning to avoid opioid and benzodiazepine combination “because both drug classes affect the central nervous system, cause respiratory depression, increase the risk of overdose, and have an ‘exponentially higher effect on the body’” when taken together.  Id.  The expert specifically found that:

• Patient A.R. simultaneously filled prescriptions for oxycodone-acetaminophen 10-325 and tramadol, immediate-release opioids, with alprazolam;
• Patient J.C. filled temazepam prescriptions at Coconut Grove and oxycodone prescriptions at a different pharmacy; and
• Patient M.W. filled oxycodone prescriptions at Coconut Grove and alprazolam prescriptions at a different pharmacy.

The expert also found that Patient J.C. simultaneously filled prescriptions for the stimulant methylphenidate and benzodiazepine, a depressant.

b.  Immediate-Release and High Dosage Opioids

The government’s expert asserted that opiate prescriptions alone can create a “therapeutic duplication” red flag when two separate immediate release opioids are prescribed in their highest strength version.  Id.  In addition, “incorrect drug dosage or duration of drug treatment” occurs when immediate-release opioids for treating acute pain are prescribed for chronic pain over extended periods of time.  Id.  The expert cautioned about prescribing 90 Morphine Milligram Equivalents (“MMEs”) per day or greater and that filling immediate-release opioid prescriptions month after month for an extended period constitute red flags.  Id. at 50,374-75.

Specific to Coconut Grove, Patient A.R. filled prescriptions for oxycodone-acetaminophen 10-325 with tramadol, and oxycodone, two immediate-release opioids, and Patient J.K. filled prescriptions for oxycodone-acetaminophen 10-325 also with oxycodone.  Id. at 50,375.

Coconut Grove dispensed immediate-release opioids for extended time periods as the expert found that:

• Patient A.R. filled prescriptions for oxycodone-acetaminophen and tramadol for approximately two years;
• Patient J.K. filled prescriptions oxycodone and oxycodone-acetaminophen 10-325 for a year and a half;
• Patient C.S. filled prescriptions for hydromorphone at its highest strength when an extended strength version was available for over a year and a half;
• Patient J.L. filled prescriptions for high-strength oxycodone 30 mg. monthly for a year and half; and
• Patient M.W. filled prescriptions also for oxycodone 30 mg. monthly for a year. Id.

As for high dosage opioid prescriptions, the expert found that:

• Patient A.R. filled prescriptions for oxycodone and acetaminophen 10-325 and tramadol together totaling 120 MMEs per day;
• Patient C.S. filled prescriptions for the highest strength of hydromorphone (8 mg.) totaling up to 260 MMEs per day;
• Patient J.L. filled prescriptions for the highest strength of oxycodone (30 mg.) totaling approximately 135 MMEs per day;
• Patient M.G. filled prescriptions for oxycodone 30 mg. totaling between 135 and 270 MMEs per day; and
• Patient M.W. filled prescriptions for oxycodone 15 or 30 mg. totaling between 90 and 265 MMEs per day. Id.

c.  Alternating Between Cash and Insurance

According to the government’s expert, patients paying for prescriptions with insurance and for others with cash is a red flag for those paid with cash.  Id.  For these, the expert found that Patient J.C. paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. paid cash for oxycodone at Coconut Grove while using insurance for alprazolam at a different pharmacy.  Id.

The expert opined that these red flags, like the others, needed to be resolved before Coconut Grove dispensed.  Patient J.C.’s physician had told Coconut Grove’s Pharmacist-in-Charge that the patient only had limited insurance.  When the pharmacist noted “verified” on the prescription, the expert opined that “is not sufficient to actually resolve a red flag.”  Id.

Public Interest Factors

The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest.  21 U.S.C. § 824(a).  In making the public interest determination for Coconut Grove, DEA agreed with the ALJ’s finding the Government’s evidence showed that the pharmacy’s continued registration would be “inconsistent with the public interest” under two of the five factors of 21 U.S.C. § 823(g)(1).  Factor B was the pharmacy’s experience with dispensing or conducting research with respect to controlled substances while Factor D was compliance with applicable state, federal, or local laws relating to controlled substances.  21 U.S.C. § 823(g)(1)(B), (D).

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws.  Id. at 50,376.  “A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice” and “[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.”  21 C.F.R. §§ 1306.04(a), 1306.06.  DEA regulations also establish that “[t]he 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).  A pharmacist is prohibited “from filling a prescription for a controlled substance when he either knows or has reason to know that the prescription was not written for a legitimate medical purpose.” 86 Fed. Reg. 72,694 at 72,694.

Florida’s Administrative Code requires pharmacists prior to dispensing to “review the patient record and each new and refill prescription . . . to promote therapeutic appropriateness by identifying: (a) Over-utilization or under-utilization; (b) Therapeutic duplication; (c) Drug-disease contraindications; (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; (f) Drug-allergy interactions; [and] (g) Clinical abuse/misuse.”  Fla. Admin. Code § 64B16-27.810(1).  It also requires upon recognizing any one of these that “the pharmacist shall take appropriate steps to avoid or resolve the potential problems which shall, if necessary, include consultation with the prescriber.”  Id. at § 64B16-27.810(2).  The Administrative Code requires that pharmacies maintain a “patient record system,” that “provide[s] for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs” and “shall record any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review.”  Fla. Admin. Code § 64B16-27.800(1), (2).  The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information.  Id. at § 64B16-27.800(2).  It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.”  Id.

Lastly, the Florida Administrative Code states that in filling “valid prescriptions for controlled substances,” pharmacists should “exercis[e] sound professional judgment,” and “dispens[e] controlled substances for a legitimate medical purpose in the usual course of professional practice” considering “each patient’s unique situation.”  Fla. Admin. Code § 64B16-27.831.

DEA agreed with the ALJ’s analysis that Coconut Grove’s dispensing fell below Florida’s standard of care and, therefore, was outside the usual course of professional practice by dispensing controlled substance prescriptions to the seven patients without properly addressing and resolving the red flags of abuse and/or diversion.  These red flags included drug cocktails, immediate-release and high dosage opioids, and patients alternating between paying for prescriptions with cash and insurance.  DEA agreed with the ALJ, finding that the pharmacy repeatedly violated federal and state law relating to controlled substances, Factors B and D weighed in favor of revoking the pharmacy’s registration, and continued registration was inconsistent with the public interest.