A federal district court in North Carolina has entered a consent decree of permanent injunction barring a pharmacy and two pharmacist employees from dispensing opioids and other controlled substances until they have taken specific steps to ensure that the drugs will not be diverted or abused (United States v. Asheboro Drug Co. Inc., No. 1:22-cv-522-CCE (M.D.N.C.)).

The three defendants — Asheboro Drug Co. Inc., an Asheboro, N.C.-based pharmacy; Isaac F. Brady III, a part-owner and pharmacist at the company; and his son, Isaac F. Brady IV, also a part-owner of the company and the pharmacist-in charge — also agreed to pay $300,000 in civil penalties over the course of three years.

Allegations Brought by DOJ

In a complaint filed July 8 in the U.S. District Court for the Middle District of North Carolina, the Department of Justice (DOJ) alleged that between January 2016 and at least October 2019, the three defendants “knowingly filled prescriptions for controlled substances that presented significant red flags,” which the government said were “obvious indications of drug abuse, drug diversion and drug-seeking behavior.”

The defendants “ignored or otherwise failed to take sufficient steps to resolve these red flags before filling the prescriptions,” the DOJ alleged.

The DOJ said that Asheboro Drug Co. and its pharmacists cooperated with the government’s investigation. According to a settlement agreement negotiated by the parties, the defendants did not admit any liability for the offenses alleged by the government.

Red Flags Allegedly Ignored

Among the red flags that the defendants allegedly ignored were the following:

Dangerous drug combinations/cocktails. The pharmacy and the two pharmacists allegedly dispensed combinations of controlled substances, including high-powered opioids combined with benzodiazepines, muscle relaxers and/or stimulants, “despite significant unresolved red flags regarding the prescriptions’ medical legitimacy.”

Long-term, high-dose opioids. The government noted in the complaint that opioids are not recommended for the long-term treatment of non-cancer pain, such as the pain caused by osteoarthritis, and that prescribers should be using the lowest effective dosages of opioids. Moreover, it said, pharmacists exercising their corresponding responsibility under 21 C.F.R. §1306.04(a) should question opioid dosages above 50 morphine milligram equivalents (MME) per day and should have substantial justification for dispensing doses exceeding 90 MME.

Despite these government guidelines, the defendants allegedly filled long-term prescriptions for high-dose opioids “with insufficient or no documentation justifying those dangerous doses.”

“Doctor shopping.” A patient’s history of obtaining prescriptions for controlled substances from multiple prescribers is a red flag of diversion or abuse, the DOJ noted in the complaint. That behavior may indicate that a physician stopped writing prescriptions for a person if the physician believed that the person was abusing controlled substances, and that the patient then sought out prescriptions for controlled substances from other prescribers. The behavior may also indicate that the patient is trying to make it harder for any individual prescriber to identify the patient’s drug-seeking behavior.

Despite the defendants’ ability to review a person’s prescription history through North Carolina’s Controlled Substance Reporting System, the DOJ alleged, they “nevertheless dispensed opioids and other controlled substances to doctor-shopping individuals, including people who had received controlled substance prescriptions from as many as nine different prescribers in the past three years,” the DOJ alleged.

Family members receiving similar prescriptions. Prescriptions for similar combinations of controlled substances written for members of the same family constitute a red flag indicating that the prescriptions may not be legitimate, according to the government. The complaint alleged that the three defendants “dispensed controlled substances, including similar prescriptions, to individuals of the same family” — for example, dispensing similar prescriptions for a husband and his wife “from overlapping physicians, for years.”

Early refill requests. The defendants allegedly filled prescriptions for patients before their current supplies of drugs from previous prescriptions had been exhausted, even when the patients “exhibited other drug-seeking behavior.”

The complaint detailed alleged case histories for five individuals demonstrating the defendants’ purported failure to heed these red flags.

‘Red-Flag Doctor’

Moreover, according to the government, a physician of whom Asheboro Drug’s employees were aware wrote similar or “pattern” prescriptions for all his patients, prescribed opioids long-term, and wrote prescriptions for patients who sought early refills or who appeared at the pharmacy together in groups.

The physician “appeared to ‘write anything,’” the complaint alleged, adding, “One employee reported hearing from customers that this doctor only accepted cash and had weekend evening clinics where he prescribed whatever patients wanted.”

The pharmacy employees also allegedly knew that the doctor “refused to do physician authorizations,” which were required at the time by North Carolina Medicaid “for coverage of daily MME above 120 or greater that 14-day supplies of any opioid.”

Nevertheless, the three defendants allegedly filled “a large volume” of the physician’s prescriptions “for years” and did not refuse to fill his prescriptions “under after a DEA audit.” Between January 2017 and May 2019, the physician “was responsible for more than three times as many prescriptions and dosage units as any other single provider in Asheboro,” the complaint reported.

Relief Sought

In its complaint, the government called for civil penalties for the defendants’ alleged violations of the Controlled Substances Act (CSA), which stemmed from filling prescriptions “that were not written for a legitimate medical purpose or were written outside the usual course of professional treatment, as evidenced by the numerous red flags defendants failed to resolve prior to filling such prescriptions.”

The DOJ also asked the court to enter a permanent injunction barring the defendants from any dispensing of controlled substances that did not comply with the CSA, DEA regulations, or any North Carolina statutes and regulations dealing with the dispensing of controlled substances.

Consent Decree

The 13-page consent decree, entered by the court July 12, specified that before dispensing any controlled substance prescriptions, the defendants must review the patient’s record in the North Carolina prescription data monitoring program and determine from the database records, the prescription, other available records, and other circumstances surrounding the presentation of the prescription whether the prescription was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of the practitioner's professional practice.

The defendants will also be required to identify “any indication that the prescribed controlled substance might be abused by the patient or diverted for an illegitimate purpose.” The consent decree specifies 10 red flags that the defendants must spot, but also requires their scrutiny not to be limited to the specified red flags.

In addition, the defendants must “document in detail any indicators of abuse or diversion and the steps [they] took to reasonably ensure” that the prescription was legitimate and that the controlled substances dispensed would not be abused or diverted. The specified documentation for each prescription must be submitted to the DEA according to a quarterly schedule.

The consent decree also bars the defendants from filling certain prescriptions, such as daily dosages exceeding 90 MME; any combination of an opioid, a benzodiazepine and carisoprodol; early refills for any controlled substances; any controlled substance for a patient who lives more than 30 miles from the pharmacy; and “any controlled substance paid for with cash despite the fact that the patient has insurance available to pay for the patient’s prescriptions.”

If there is any noncompliance with the terms of the consent decree, the DEA may order the defendants to correct the noncompliance, including directing them to immediately stop ordering, distributing or dispensing controlled substances. If the agency shuts down their controlled substance operations, the defendants’ DEA registrations will be deemed to have been surrendered for cause, the DEA may have immediate access to the pharmacy premises, and the agency may seize all controlled substances and controlled substance order forms.

No sooner than at least five years after entry of the consent decree, the defendants may petition the district court for relief from the consent decree’s requirements. The government will not oppose such a petition “if defendants have maintained a state of continuous material compliance with [the] decree, the CSA and its implementing regulations, and any North Carolina statutes and regulations pertaining to the distribution of controlled substances during the five years preceding defendants’ petition.”