W

ASHINGTON — A Senate report released Thursday lays out systematic failures in the reporting system for suspicious opioid orders, faulting some drug distributors and manufacturers for their roles and criticizing the Drug Enforcement Administration for a years-long lull in enforcement actions.

The findings, the latest in a series of reports from Sen. Claire McCaskill (D-Mo.), the top Democrat on the Senate’s leading oversight committee, pointed in particular to disparities between two leading drug distributors: McKesson and AmerisourceBergen.

The two distributors shipped nearly identical volumes of opioids to Missouri between 2012 and 2017: roughly 650 million doses each.

advertisement

But the number of orders each company flagged to authorities as suspicious were nowhere close: 224 from AmerisourceBergen and 16,714 from McKesson.

Taken together, the “Big Three” group of distributors, including Cardinal Health, sent 52 dosage units for each of the state’s citizens in 2015.

Newsletters

Sign up for our Daily Recap newsletter

Please enter a valid email address.

“It’s staggering. Over six years we averaged 260 pills for every man, woman, and child in Missouri,” McCaskill said in a statement. “The opioid crisis these pills have fueled is a failure of policy and oversight by the government and a failure of basic human morality on the part of many pharmaceutical companies and distributors — a failure that has destroyed families and communities all over our state.”

Suspicious painkiller shipments have been a focus for lawmakers working to stem the opioid crisis, ranging from a contentious House hearing to McCaskill’s ongoing investigations and even surfacing Wednesday at a confirmation hearing for Jim Carroll, President Trump’s nominee as “drug czar.”

McCaskill’s latest report found that “certain major distributors and manufacturers have consistently failed to meet their anti-diversion obligations.”

While the report did not directly allege violations of the Controlled Substances Act, it also highlighted differences between how pharmaceutical companies that manufacture opioids worked with the DEA. Endo Pharmaceuticals flagged hundreds of orders and conducted further internal reviews but concluded none was suspicious enough to report to the DEA; Mallinckrodt Pharmaceuticals, meanwhile, reported every order it flagged regardless of what its internal review found.

Nonetheless, McCaskill’s report said, the DEA had estimated that Mallinckrodt “failed to report at least 43,991 opioid orders.”

Citing a previous $35 million settlement reached with Mallinckrodt, the report also noted the Justice Department’s finding that the company had “failed to design and implement an effective system to detect and report ‘suspicious orders’ for controlled substances.” McKesson agreed to pay a $150 million settlement after the Justice Department reached the same conclusion about its distribution procedures.

A spokesman said Mallinckrodt had disagreed with the allegations yet chose to settle “to eliminate the uncertainty, distraction, and expense of litigation” and that the company had worked diligently with McCaskill’s office and the DEA. 

The report acknowledges Mallinckrodt takes a robust (or as the report states ‘conservative’) approach to its suspicious order monitoring obligations, and in the period covered by the report provided nearly 1,000 suspicious order reports to the U.S. DEA while other manufacturers reported none,” the spokesman said. 

Much of the conversation on Capitol Hill regarding opioids has centered on particularly egregious examples of opioid oversupply — which lawmakers have blamed on drug manufacturers, distributors, pharmacies, doctors, and the DEA itself.

The Justice Department, which oversees the DEA, on Wednesday sought to curb that supply, releasing the final version of a rule that would allow it to factor predicted drug diversion into the formula it uses to award “quota” to manufacturers, a proposal that drew skepticism when first announced in April.  

Polling has consistently shown Americans believe the opioid crisis should be a high priority for the federal government. McCaskill, who is running in a competitive re-election race in her home state, has made oversight of companies that manufacture and distribute painkillers a priority this Congress. And while most of her work has focused on the problem nationally, much of Thursday’s report was specific to Missouri.

But the report also singled out Teva Pharmaceuticals, among the world’s largest drug manufacturers, for not complying with McCaskill’s document requests. Sen. Ron Johnson (R-Wis.), who chairs the Senate Homeland Security and Governmental Affairs Committee, denied McCaskill’s request to subpoena the company in January, and told STAT in May that he believed holding opioid manufacturers and distributors accountable for their actions was largely a job for the courts, not Congress.  

“The two overlapping trends described in this report — disparities in industry compliance behavior and declining DEA enforcement — suggest, at the very least, a connection between weak DEA oversight and varying anti-diversion efforts,” the report read.

In an email, a spokeswoman for AmerisourceBergen pointed to the company’s detailed daily reports to the DEA, and stressed that the DEA has not provided guidance as to whether it prefers human-reviewed or algorithm-based reporting.

Regarding the variation in the number of suspicious orders reported, AmerisourceBergen’s order monitoring program involves two key steps,” the spokeswoman wrote. Flagging orders for review using our complex computer algorithm and conducting a detailed investigation of every single flagged order. We believe this process makes our suspicious order reports to the DEA highly precise and actionable.

A McKesson spokeswoman declined to comment on the report Wednesday, prior to its release, but said the company had invested heavily in its anti-diversion program and advocated for policy changes it felt would help address overprescribing. Representatives for Teva and Endo did not immediately respond to requests for comment.

Leave a Comment

Please enter your name.
Please enter a comment.

  • “The opioid crisis these pills have fueled”
    Oh, give it a break, lady. Substance abuse and addiction have been around since the beginning of time. Most who have studied this substance agree that abuse and addiction rates have stayed relatively the same throughout history.

    The majority of overdoses are caused by heroin spiked with licitly-manufactured fentanyl, along with other substances, including benzos produced by “research chemical labs” located in China (and other areas).
    “4 out of 5 heroin users began with prescription opioids” … The media and government love to spout this study, however, they leave out something very important:

    The subjects of this study began with the non-medicinal use of prescription opioids, most of which were obtained in an illegal manner. (The title of the study should have clued them in – “Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States”)

    This means the subjects of this study were already exhibiting the behavior associated with substance abuse and addiction by using the substance (prescription opioid-based medication) for the sole purpose of achieving a high.

    For the majority, substance abuse and addiction begins with the recreational use and misuse of a potentially-addictive substance (regardless of substance), NOT legitimate medicinal use. In fact, even the National Survey on Drug Use and Health determined:

    “less than 4 percent of people who had abused prescription opioids started using heroin within 5 years” and

    “those who transition to heroin use tend to be frequent users of multiple substances (polydrug users).”

    Recent studies have also determined that the percentage of those who entered substance abuse treatment and used heroin as their “initiating opioid of abuse” rose from 8.7% in 2005 to 33.3% in 2015. In other words, more and more people are using heroin without ever being exposed to opioid-based medication.
    The mere exposure and consumption of alcohol does not cause alcoholism. If it did, the majority of Americans would be alcoholics, as most of us have consumed even a small bit of alcohol at one point in our lives.
    Perhaps we should start limiting the amount of alcohol each adult can purchase in a year to end the beginning of alcoholism. How about limiting the amount of junk food each of us can purchase and eat each day to end food addiction, which can lead to major health issues.
    Ban gambling and shopping since both of those activities can lead to gambling addiction and shopping addiction. Need I mention restricting the amount of sex each adult can have per week to end sex addiction?
    https://archive.samhsa.gov/data/2k13/DataReview/DR006/nonmedical-pain-reliever-use-2013.pdf
    https://www.drugabuse.gov/publications/research-reports/relationship-between-prescription-drug-heroin-abuse/heroin-use-rare-in-prescription-drug-users
    https://www.ncbi.nlm.nih.gov/pubmed/28582659

  • DEA hoped to put some CEOs in jail for failing due diligence even after discipline. DEA lawyers prevented this. Then Congress passed a law making it near impossible. 46 former DEA agents work to help protect corporations and their CEOs (Whistleblower, 60 Minutes).

  • Were the prescriptions primarily written for Medicaid patients and did the increase coincide with the start of the ACA?

Sign up for our Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.

Privacy Policy