Spokane, WA – Tick Klock Drug, a pharmacy in Colfax, Washington, agreed to pay a $20,000 Controlled Substances Act penalty and to institute corrective actions in order to address its failure to comply with the Controlled Substances Act and the Combat Methamphetamine Epidemic Act of 2005 in its pharmacy operations, announced Vanessa R. Waldref, the United States Attorney for the Eastern District of Washington.
To protect the public, the Controlled Substances Act and its implementing regulations place legal responsibilities on medical professionals to ensure that opioid medications and other controlled substances are prescribed, dispensed, and used for medically-appropriate purposes and in a safe manner. 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 to ensure that prescriptions are legitimate, safe, and medically appropriate. Additionally, the Combat Methamphetamine Epidemic Act of 2005 (CMEA) and implementing regulations impose requirements concerning a pharmacy’s sale of pseudoephedrine, which is commonly sold under the brand name Sudafed. Pseudoephedrine is a decongestant that can be used to manufacture methamphetamine, a Schedule II controlled substance and commonly-abused street drug. The CMEA places restrictions on the quantity of pseudoephedrine that can be sold to an individual over a 30-day period, and also requires pharmacies to maintain records, to display warning signs, to obtain a purchaser’s signature and verify the purchaser’s identity, to train employees concerning safe dispensing and sale of pseudoephedrine, and to annually certify compliance with CMEA requirements and regulations.
In the settlement announced today, Tick Klock Drug admitted that, between January and July 2022, it did not always appropriately exercise its corresponding responsibility when dispensing controlled substances. Tick Klock Drug admitted that during that time period, it filled controlled substance prescriptions written by physicians or other medical providers that contained “red flags”, i.e., indicia of fraud, drug-seeking, lack of medical necessity, potential for abuse or health risk, or potential for diversion, without appropriately resolving those red flags prior to dispensing the medications. These red flags included multiple patients for whom Tick Klock Drug filled prescriptions for a potentially dangerous and medically-inappropriate combination of an opioid, a benzodiazepine, and a muscle relaxant known as the “holy trinity”. Tick Klock Drug further admitted that between 2017 and 2022, Tick Klock Drug violated the CMEA by: (1) failing to certify compliance with the CMEA and implementing regulations; (2) failing to prominently display required warning notices in all appropriate locations; and (3) failing to obtain all purchaser signatures for sales of pseudoephedrine, including for sales to Tick Klock Drug employees. Finally, Tick Klock Drug admitted that it did not keep adequate records or appropriately account for the quantities of certain controlled substances.
“Pharmacies have a critical role to play in protecting the public and keeping our communities safe and strong,” said U.S. Attorney Waldref. “Pharmacies serve a vital gatekeeper function in keeping our residents safe and healthy, preventing the diversion of dangerous drugs, and combatting addiction. I’m grateful that Tick Klock Drug accepted responsibility and has entered into a robust agreement with the Drug Enforcement Administration (DEA) to ensure that it complies with its obligations going forward.”
In addition to the $20,000 civil penalty, Tick Klock Drug has entered into a Memorandum of Agreement (MOA) with the DEA. Under the MOA, Tick Klock Drug agreed to resolve all “red flag” prescriptions prior to dispensing any controlled substances. Tick Klock Drug is also required to conduct quarterly physical inventory audits and provide those to the DEA. These audits must be performed by a team that includes a licensed pharmacist. Additionally, Tick Klock Drug is required to provide training for its employees to ensure compliance with the Controlled Substances Act and CMEA going forward, and to document its training efforts. Finally, Tick Klock Drug further agreed to review and update its controlled substance policies and procedures, and that employees may not dispense controlled substances to themselves under any circumstances.
“This resolution would not have been possible without the exceptional investigative work by DEA Seattle Field Division’s Diversion Group, and I am so grateful for our longstanding partnership,” stated U.S. Attorney Waldref. “We will continue to work hand-in-glove with DEA Diversion Group and our law enforcement partners to protect our communities and public health and safety.”
“DEA’s core mission is to protect Americans and we need our partners in the healthcare community to help us by following the rules. When they do not, we hold them accountable, not to punish, but to encourage their cooperation and ensure that they are doing their part to keep people safe,” said David F. Reames, Special Agent in Charge, DEA Seattle Field Division. “We deeply appreciate our partnership with the United States Attorney’s Office in the Eastern District of Washington, without whom this success would not have been possible.”
The settlement was the result of a joint investigation conducted by the U.S. Attorney’s Office for the Eastern District of Washington and DEA’s Seattle Field Division, Diversion Group. Assistant United States Attorneys Dan Fruchter and Tyler H.L. Tornabene handled this matter on behalf of the United States.