Research Third-Party Logistics Providers Beforehand

Before contracting with companies, independent pharmacies should take a hard look at their third-party logistics providers of pharmaceutical drugs or wholesalers to ensure they are dealing with legitimate entities and do not get caught in the crosshairs of an investigation.

Consider Woodfield Distribution, LLC (WDSrx), and Woodfield Pharmaceuticals, LLC, also known as WDSrx, a third-party logistics provider of pharmaceutical drugs, including for manufacturers, and wholesalers of highly regulated opiates.

In a massive sting operation, the Drug Enforcement Administration (DEA) recently seized a large number of controlled substances from the wholesaler and suspended its operations.¹ The agency seized
27 tractor trailer–loads of opiates. Assembling in the parking lot of the Houston Astros Triple-A baseball team at Constellation Field, dozens of DEA agents gathered in preparation for what would be one of the largest narcotic seizures in recent history.²

“We are taking custody of product that has a high likelihood of diversion, and we are going to safely secure it in another location,” Erik Smith, associate special agent in charge of the DEA’s Houston, Texas, division, told Fox 26 Houston.³

The DEA is no stranger to the diversion of controlled substances and has been dealing with this trend for a long time. Essentially, diversion entails the unauthorized routing of highly addictive and dangerous opiates into an illegal marketplace for illegal sale to individuals who do not need it for a legitimate medical purpose.

An ongoing DEA audit has tracked tens of millions of doses delivered to WDSrx over the course of the past 3 years, according to Smith.³ The volume of controlled substances that are unaccounted for is substantial and represents a clear and present threat to public safety, he said, adding, “This is really the foundation of the opioid crisis in the United States.”³

Fox 26 Houston reported that WDSrx was unable to account for large quantities of pharmaceutical-grade amphetamines, as well as opiates, such as codeine; phenobarbital; and tramadol, according to the DEA.³

It would be prudent for industry drug manufacturers and wholesalers to take proactive measures to ensure that drug diversion does not take place in the supply chain. To that end, various monitoring systems are available in the marketplace.

Typically, outsourced solutions for suspicious monitoring programs are either fully managed software programs or “homegrown” systems. Many companies opt to choose a “homegrown” system for a variety of reasons, such as the amount of money already invested and concerns about data security.

Fully managed software programs may either sit in the cloud or be on-premises software. The benefit of fully managed software programs is simple: Manufacturers and wholesalers are not tasked with developing new algorithms and capabilities to keep up with DEA expectations, federal or state regulations, or industry trends.

An example of recent regulation changes includes the federal Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which requires that potentially suspicious or “flagged” orders must be investigated and dispositioned by a company within 7 days. If that does not occur, the order must be deemed suspicious and reported to federal and state authorities accordingly. DEA expectations and industry trends can be much more complex. For example, a more recent best practice is to programmatically analyze customer order history, instead of using thresholds, and use morphine milligram equivalent benchmarks when evaluating orders.⁴

“The task of effectively monitoring suspicious orders while keeping up with ever-evolving regulations and trends is a gargantuan task. Outsourced solutions for suspicious monitoring, like Pharma Solutions NavigateSOM [suspicious order monitoring], and for state compliance, like Pharma Solutions ATLAS, [give] drug wholesalers and manufacturers the ability to cost-effectively mitigate compliance risk,” Sumeet Singh, CEO of Pharma Solutions USA, Inc, said in an interview.

WDSrx released a statement in connection with the DEA action, saying, “Woodfield Distribution, LLC, has been [maintaining] and continues to maintain active discussions with the DEA to address areas of concern related to governance and oversight of business operations. The alleged violations are being taken seriously by Woodfield Distribution, LLC, and every effort and attention is being made to resolve this situation in a timely and efficient manner for our clients in the near term.”³

Ned Milenkovich, PharmD, JD, is the chairman at Much PC, a health care law practice in Chicago, Illinois.

REFERENCES

1. DEA Houston serves ISO on Woodfield Pharmaceuticals & Distribution. United States Drug Enforcement Administration. News release. DEA. August 11, 2021. Accessed August 27, 2021. https://www.dea.gov/press-releases/2021/08/11/dea-houston-serves-iso -woodfield-pharmaceuticals-distribution
2. Bauman A. DEA suspends operations, seizes millions of pills from Sugar Land company. Houston Chronicle. August 12, 2021. Accessed August 27, 2021. https:// www.houstonchronicle.com/news/houston-texas/ crime/article/DEA-suspends-operations-seizes -millions-of-pills-16382171.php
3. Groogan G. DEA makes massive drug seizure in Fort Bend County. Fox 26 Houston. August 11, 2021. Accessed August 27, 2021. https://www.fox26houston.com/news/ dea-makes-massive-drug-seizure-of-tractor-trailer-loaded-with-opiates-in-fort-bend-county
4. Drugs of abuse. DEA. 2020. Accessed August 27, 2021. https://www.dea.gov/sites/default/files/2020-04/ Drugs%20of%20Abuse%202020-Web%20Version-508%20compliant-4-24-20_0.pdf