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Sunday, January 23, 2022
Department of Justice
U.S. Attorney’s Office
Southern District of California
FOR IMMEDIATE RELEASE
Thursday, January 20, 2022
San Diego Pharmacy Pays $105,000 Penalty for Illegitimately Dispensing Opioids
SAN DIEGO – San Diego’s Balboa Pharmacy has paid $105,000 to resolve allegations that it illegally dispensed opioids and other dangerous drugs to its patients, according to a settlement agreement signed by Balboa Pharmacy and the United States. The settlement stems from the United States’ continued efforts to combat the opioid epidemic on all fronts, including this investigation of whether Balboa Pharmacy illegally dispensed opioids to its patients in violation of the federal Controlled Substances Act.
The Controlled Substances Act states that pharmacists have a responsibility to only fill prescriptions that are written for a legitimate medical purpose while acting in the usual course of professional practice. The United States alleged that Balboa Pharmacy failed to meet its responsibility when it filled opioid prescriptions without resolving—or often even attempting to resolve—“red flags” that the prescriptions raised. “Red flags” are indications that a prescription may be invalid. According to the settlement agreement, Balboa Pharmacy filled prescriptions without resolving the following commonly known red flags:
large quantities of opioids well above guidelines for treating patients, which sometimes exceeded a daily Morphine Milligram Equivalent of 100;
dangerous combinations of drugs, including duplicative therapy; opioids and benzodiazepines (e.g., Valium, Xanax); and opioids, benzodiazepines, and muscle relaxants (e.g., Soma), a combination that is colloquially referred to by drug abusers as the “trinity” because of the rapid euphoric effects of this combination of drugs;
patients who received prescriptions from multiple prescribers, which sometimes were for the same types of controlled substances or for dangerous combinations of drugs; and
filling prescriptions for patients early, which includes filling a patient’s prescription before the patient’s earlier prescription for the same drug ran out.
The investigation exemplifies the Department of Justice’s willingness to investigate pharmacies that may be filling dangerous prescriptions without first confirming the legitimacy of each prescription. Public health experts have long warned health care providers that overdose risk is elevated in patients receiving medically prescribed opioids, particularly those receiving high dosages. Pharmacists should carefully track the potency of opioids dispensed to patients by noting the Morphine Milligram Equivalent (MME, also commonly referred to as Morphine Equivalent Dose or MED) of prescribed opioids. Among other things, tracking MMEs advances better practices for pain management by reinforcing the need to consider alternatives to using high-dosage opioids to treat pain, and to appropriately justify decisions to use opioids at dosages that place patients at high risk of addiction, abuse, and overdose. Furthermore, dispensing high dosages increases the risk that patients will divert opioids.
“Pharmacies are the last line of defense protecting the public from addictive opioids and other controlled substances,” said U.S. Attorney Randy S. Grossman. “This office will pursue pharmacists who carelessly disregard red flags, opting instead to rubberstamp questionable prescriptions. We will continue to use all available tools to combat the serious opioid epidemic.” Grossman thanked the prosecution team and investigators for their excellent work on this case.
In addition to the settlement agreement, the DEA and Balboa Pharmacy entered into a Memorandum of Agreement in October 2021 in which Balboa Pharmacy agreed to, among other things, develop policies and procedures and training that address the identification and resolution of “red flags.”
“This investigation is a reminder that all pharmacies have a responsibility to ensure that prescriptions are issued for a legitimate medical purpose,” said DEA Special Agent in Charge Shelly S. Howe. “Failure to do so allows prescriptions to become subject to abuse and diversion, fueling the ongoing opioid epidemic. DEA will continue to hold pharmacies, such as Balboa Pharmacy, accountable.”
To report a tip directly to a DEA representative regarding medical personnel writing suspicious opioid prescriptions and pharmacies dispensing large amounts of opioids, call (571) 324-6499, or visit the DEA’s website (https://www.deadiversion.usdoj.gov/) and click on “Report Illicit Pharmaceutical Activities.”
Assistant U.S. Attorney Dylan M. Aste of the U.S. Attorney’s Office for the Southern District of California handled this matter along with DEA investigators.
The claims resolved by this settlement are allegations only and there has been no determination of liability.