Distributors under increased scrutiny from DEA

DEA crackdown on opioid abuse places increased attention on drug wholesalers and distributors

Deaths from prescription painkiller overdose have more than tripled over the past decade, killing more people than cocaine and heroin combined, according to CDC. In an effort to reduce prescription pain medication abuse, DEA is turning its attention to monitoring sales data from drug distributors and wholesalers, the primary source for products on pharmacy shelves. “This is part of the agency’s efforts to identify pharmacies receiving quantities of controlled substances that deviate from what DEA would expect,” said Joseph L. Fink III, BSPharm, JD, Professor, Department of Pharmacy Practice and Science in the College of Pharmacy at the University of Kentucky.

In light of DEA’s interest in selling practices, “distributors are taking more conservative stances with respect to quotas and what they may be willing to release to pharmacies and smaller branch distributors,” said James Ruble, PharmD, JD, Assistant Professor (Clinical), at the University of Utah College of Pharmacy.

This could potentially lead to an interruption in the availability of prescription pain medications. “It’s not a traditional drug shortage in the sense that there is a [problem] with raw source materials; it’s more of a shortage from increased levels of scrutiny with the distributors,” Ruble added.

Balancing act

The challenge, according to John M. Gray, President and CEO of the Healthcare Distribution Management Association (HDMA), is that the “health care industry is trying to combat the bad actors in the system while ensuring patients have access to the critical medications they need.”

Wholesalers and distributors who are members of HDMA are doing their part to ensure that controlled substances don’t end up in the wrong hands. HDMA members only sell controlled substances to locations or clinicians who hold valid state licenses and DEA registrations. These companies use sophisticated systems to detect suspicious orders.

“There are numerous factors, aside from volume, that our members consider when processing an order,” said Gray. These factors include pharmacy size, hours of operation, patient demographics, geographic proximity of urban areas, and proximity to hospitals, surgery centers, nursing homes, and other clinical settings.

“DEA receives information from distributors selling the controlled substances most likely to be abused to particular pharmacies or prescribers through its ARCOS [Automation of Reports and Consolidated Orders] System, yet it does not share this information across our industry in an aggregated fashion,” said Gray. “This is a complex issue that requires all supply chain stakeholders to collaborate extensively to help reduce this problem.”

Helping patients

An interruption in the availability of controlled substances is causing some legitimate pain patients “to look for the drugs themselves and sometimes that means going to multiple pharmacies or going out of town,” said Scott Strassels, PhD, Assistant Professor of Health Outcomes and Pharmacy Practice at the University of Texas at Austin College of Pharmacy. He advocates for talking to patients to see what’s going on.

If you still have a question about the prescription after talking to the patient, noted Strassels, “it never hurts to call the doc’s office to follow up and make sure everything is on the up and up.”

DEA’s enforcement decisions put pharmacists in the role of both “problem solver and patient advocate,” said Fink. “Pharmacists who know their patients well can discern legitimate need … but there can be no doubt that the actions of DEA have quite substantially interfered with access to needed analgesia by patients with highly legitimate need.”

No easy answers

As the story continues to unfold, one thing is clear; there is no simple solution.

“While pharmacists and pharmacies certainly have the ability and obligation to identify problematic behavior, higher than average comparative dispensing or ordering is a function of the prescriber–patient relationship,” said Chris Herndon, PharmD, Assistant Professor at the Southern Illinois University Edwardsville School of Pharmacy. “You can’t stop a flood by over-regulating the manufacturers and distributors of the sandbags.”