5/6/2023 1 Comment Seashore drugs![]() ![]() Prescription written by a prescriber outside of the pharmacy’s trade area.Red flags that pharmacies and pharmacists need to be aware of include, but are not limited to: 1 Under DOJ’s theory, ignoring the presence of red flags may constitute filling prescriptions that are not issued for a legitimate purpose and that are not written by prescribers acting in the normal course of their professional practice, all in violation of 21 C.F.R. One questionable legal theory supported by the government is establishing pharmacy liability under the CSA for ignoring red flags that might indicate drug abuse or drug diversion. Pharmacies Pursued for Ignoring Prescription “Red Flags” These efforts, led by DOJ and the Drug Enforcement Agency (DEA), are already underway across the country. In 2020, DOJ announced it would pursue aggressive enforcement against pharmacies and pharmacists who violate the Controlled Substances Act (CSA) by abdicating their responsibility to ensure opioids and other controlled substances are not diverted for unlawful purposes. However, recent enforcement efforts by DOJ have now unambiguously demonstrated its intent to target pharmacies and pharmacists. To date, these efforts primarily focused on prescribers, manufacturers, and distributors. The complaint said that “King refused to address these concerns on the grounds that he had no control over what happened outside the pharmacy.In response to the opioid crisis, the Department of Justice (DOJ) has made it a priority to target different components of the opioid supply chain for their contributing roles to the crisis. In another instance, employees reported patients trading drugs in front of the store. In some instances, pharmacist technicians would inform KING of the earlier refusal, but KING would fill the prescription anyway.” “Those customers, however, would return when KING was working and KING would fill them-i.e., the same prescription that another SEASHORE pharmacist refused to fill. “Some SEASHORE pharmacists recognized the red flags associated with controlled-substance prescriptions being presented by individuals and sometimes refused to fill them,” the complaint said. ![]() Prosecutors blamed upper management for many of these issues, writing that King allegedly took affirmative steps to bypass concerned employees. “Defendants nevertheless repeatedly dispensed opioids and other controlled substances to doctor-shopping individuals,” the complaint said, “including people who had received controlled-substance prescriptions from ten or more prescribers in the previous five years, and to at least one person who had received controlled-substance prescriptions from twenty-six separate prescribers during the previous five years.”Īccording to the complaint, multiple Seashore patients who acquired opioids “died from prescription drug overdoses within days after Seashore handed them their pills.” They also accuse Waggett and King of ignoring clear signs of “doctor shopping,” saying that pharmacists had access to patients’ prescription histories through North Carolina’s Controlled Substance Reporting System. Prosecutors allege that Waggett and King routinely filled prescriptions written by doctors hundreds of miles away in Florida and dispensed opioids with dosages 2-3 times higher than what the Centers for Disease Control recommends. “Defendants ignored and otherwise failed to take sufficient steps to resolve these red flags before filling the prescriptions.” ![]() ![]() “From on or about through at least October 2019, Defendants knowingly filled prescriptions for controlled substances that presented significant red flags with respect to their medical legitimacy and/or with respect to whether they were written by a practitioner in the usual course of professional treatment,” read the complaint. ![]()
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7/14/2023 01:49:32 am
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