Opioid Distribution Chain Participants Targeted by DOJ
As the opioid crisis continues to result in devastating consequences throughout the country, the U.S. Department of Justice (the “DOJ”) is broadening its opioid enforcement to all stakeholders involved in the opioid supply chain including, without limitation, pharmacies. Pharmacies are often the final gatekeepers before putting potentially dangerous opioid prescriptions in the hands of individuals. Given the pharmacies’ gatekeeper status, the DOJ has taken an especially hard stance against pharmacies, finding that many pharmacies have ignored their legal responsibility to prevent the diversion of narcotic painkillers for illicit uses. As a result, the DOJ, together with U.S. Attorneys’ Offices and the U.S. Drug Enforcement Administration (“DEA”), intends to pursue aggressive enforcement actions in the new year to punish pharmacies and all other actors within the opioid supply chain who have, in any way, contributed to the opioid crisis.
The DOJ’s announcement comes as the focus of a nationwide wave of opioid lawsuits increasingly shifts towards pharmacies which are, in general, being accused of dispensing opioids to patients without medical necessity. Most of the lawsuits have been brought by local governments in multi-district opioid litigations, but the DOJ’s statements signal that greater federal involvement is impending. The DOJ encourages everyone in the prescription opioid supply chain to work with it to identify wrongdoings and prevent the damage that the opioid crisis is causing. With that backdrop, it is critical for pharmacies to be aware of their responsibilities when it comes to filling and dispensing opioid prescriptions. More specifically, the DEA’s regulations (21 C.F.R. § 1306.04) emphasize that a corresponding responsibility rests with the pharmacist who fills and dispenses prescriptions for controlled substances. While the regulation does not define what is encompassed within the “corresponding responsibility” of a pharmacist, the DEA created the notion that a pharmacist must be aware of certain “Red Flags” which may surround the presentation of a controlled substance prescription before filling prescriptions for controlled substances including, without limitation, geographic anomalies, cash payments, and prescribed quantity and strength that are not in line with standards of practice.
How Frier Levitt Can Help
As enforcement efforts increase, every participant along the supply chain continuum potentially faces liability and, therefore, discipline by professional boards and regulatory agencies, civil liability, and/or criminal prosecution. The best way for participants to protect themselves is to adopt and implement a robust opioid compliance plan. For more information, contact us to speak to an attorney.