The Heat is On: Opioid Prescribing & Dispensing Compliance

Given the President’s designation of the country’s traumatic opioid epidemic as an emergency, and the just-released recommendations of the Presidential Special Commission on Opioid Abuse, Attorney General Sessions’ recent announcement of the DOJ’s pilot project to form an Opioid Fraud and Detection Unit, should surprise no one. Opioid addiction destroys lives, families and communities and we must deploy all available resources to eradicate the scourge as quickly as possible.

Initially focusing on the 12 most affected areas of the U.S., 12 designated, seasoned federal prosecutors will lead the charge to identify and prosecute providers who prescribe and pharmacists who dispense opioids improperly. The Unit will leverage the combined resources of the HHS, FBI, DEA, and state and local authorities, along with sophisticated data analytics. The 12 ‘initial target’ states are across the country, with half in the South and several in the Midwest.

From a compliance perspective, healthcare professionals’ duties are clear. The Controlled Substances Act imposes a “corresponding responsibility” on both providers and pharmacists to make sure that opioids are being given for a valid medical purpose. As the clinician, the provider must therefore exercise care to ensure that they are prescribing the correct drug for the correct patient at the correct time and in the right dose. Among other things, this requires seeing the patient initially and at proper intervals throughout the course of treatment, and documenting any observed red flags that might suggest improper use, like a suspicious Prescription Drug Monitoring Program (“PDMP”) report. In turn, the pharmacist, as the final gatekeeper to opioid medications, must also exercise care to ensure a correct drug/patient/time/dose. In practice, this means visually observing the patient for red flags, reviewing the prescription to confirm a proper medical purpose, and also checking the PDMP system.

Many wrongly assume that the corresponding responsibility duty applies a shared 50/50 obligation on the prescriber and the pharmacist. In fact, the more accurate allocation is to apply 100% of the duty to each of them. Moreover, if a federal government payor is involved, breaching this duty and billing for it could be considered a False Claim Act violation. So, while provider and pharmacist are indeed equal partners in each patient’s care, they are also each fully liable for any adverse consequences that might result from their failure of oversight or lack of care when treating with opioids. Beyond a general desire to help patients by rendering high quality care, this big liability is certainly compelling motivator to get things right.

There are a number of red flags that both providers and pharmacists should look for. These include:

• PDMP report reflects ‘doctor shopping’ or other drug seeking activity • Patient exhibits a high level of drug knowledge or request specific drugs/cocktails • Patient exhibits erratic behavior evidencing excessive drug use • Patient refers to opioids by street names • Patient has a long history of regular and/or high-dosage opioid use • Patient is under a nonstandard treatment regimen • Patient travels a long distance or with a group of patients for their appointment • Patient has never been referred to a pain management specialist • Patient has a history of lost or stolen prescriptions

In addition, pharmacists should also look for: • Patient pays cash when prescription is covered by insurance • Patient shows up at pharmacy right before closing time

If a pharmacist has any questions about a prescription, they should not hesitate to call the physician for clarification. All review efforts, including physician communication, should be documented in an electronic system or on paper to ensure a smooth, consistently performed process.

More than half a million Americans have died from drug overdoses since 2000, mostly from opioids. Over this time, overdose deaths have quadrupled and the most recent trending data shows no end in sight. The opioid epidemic is indeed a national crisis and must be dealt with as such. Careful provider prescribing and pharmacist dispensing are absolutely essential to these efforts.