Three companies shipped approximately 1.6 billion doses of powerful prescription opioids to Missouri pharmacies from 2012 to 2017, according to a congressional report seeking the root causes of the opioid epidemic.
The report, released by Sen. Claire McCaskill (D-Mo.), shows that drug distributors Cardinal Health, McKesson Corp. and Amerisource Bergen funneled the equivalent of about 260 opioid pills for every person in Missouri in the six-year period, during which time the opioid epidemic raged there — and nationwide.
The Senate Committee on Homeland Security and Governmental Affairs’ minority report also shows that the number of suspicious orders the companies reported to the Drug Enforcement Administration varied by company. Under the Controlled Substances Act, companies are required to report unusually large or suspicious orders to the DEA as a way to help prevent the pills from being funneled to the black market.
The data, which the companies provided to the committee, shows that McKesson and AmerisourceBergen each shipped approximately 650 million opioids to Missouri. McKesson reported 16,714 suspicious orders from 2013 to 2017, while AmerisourceBergen reported 224 from 2012 to 2017. Cardinal Health shipped about 325 million pills and reported 5,125 suspicious orders to the DEA.
“The disparities exist despite the fact that each company employs similar strategies to prevent diversion,” the report states, noting that the companies use analytics to measure and report suspicious orders.
“Something is wrong here,” McCaskill said in an interview. “There is no way you have this divergence of reporting between the three major distributors.”
Health-care distributors said comparing the total amount of opioids shipped against the number of suspicious order reports does not take into account factors such as geography and rates of prescribing among different providers.
Cardinal Health was fined $44 million in 2016 to resolve allegations that it failed to report suspicious orders of narcotics. In 2008, Cardinal paid a $34 million fine to settle similar allegations. McKesson agreed to pay $150 million in fines in January 2017 to resolve allegations that it failed to report suspicious orders. In 2008, the company paid a $13 million fine for similar allegations.
Despite the huge fines, the report said that DEA enforcement efforts have declined since 2011, and the DEA issued just 12 immediate suspension orders to distributors between fiscal 2007 and 2017. Former DEA officials reported that the “revolving door between the agency and the distribution industry created an institutional resistance to issuing immediate suspension orders,” according to the report. The DEA did not respond to a request for comment Wednesday.
The report also cites a Washington Post report about how members of Congress allied with drug distributors to pass a law — the Ensuring Patient Access and Effective Drug Enforcement Act — that bowed to industry and undermined efforts to slow the flow of pain pills nationwide.
McCaskill’s report also looked at suspicious order-reporting in Missouri from 2012 to 2017 by four generic manufacturers, according to data the companies volunteered to the Senate: Allergan, Mallinckrodt, Endo and Teva. Mallinckrodt reported 905 suspicious orders from 2012 to 2017 and Endo none. Teva and Allergan’s numbers are unknown. The companies did not respond to requests for comment.
John Gray, president and CEO of the Healthcare Distribution Alliance, which represents distributors, said more needs to be done to address overprescribing. He said the alliance has supported congressional efforts to fight the epidemic and its members have urged Congress to “prioritize a range of policy solutions” to respond to the opioid crisis.
“At the same time, the recent report from Sen. McCaskill relies on debunked, inaccurate statements without acknowledging the need for broader reforms across the pharmaceutical supply chain,” Gray said.
In a statement, AmerisourceBergen said it files daily reports of controlled substance sales, and provides the DEA with detailed information about the quantity and type of orders and where they are going. It said it regularly reports suspicious orders. The company said it flags orders using a complex computer algorithm and investigates each flagged order. It noted that the number of suspicious orders has no bearing on a company’s compliance with the Controlled Substances Act.
McKesson said in a statement that it has not seen the final report. The company said it has invested “significant resources” in an anti-diversion program and has “blocked and reported more than a million suspicious orders nationwide” since 2008. Allergan said it produces a fraction of a percent of the nation’s opioid products and supports the responsible use of medications.
Mallinckrodt last year paid a $35 million settlement for failure to report suspicious orders and record-keeping violations. In a statement, the company said it disagreed with the allegations, yet settled the case. It said Mallinckrodt has “invested millions of dollars in a comprehensive initiative to address opioid abuse and misuse.”
The report shows that the highest number of suspicious order reports came from rural Missouri counties, many of which border other states. Buchanan County, which borders Kansas, and Barry and Howell counties, which both abut Arkansas, have some of the highest numbers.
“This report confirms what many of us believe, that we have a welcome mat out for drug dealers from surrounding states,” McCaskill said. “That’s the only thing that would explain this type of density of opioids being shipped” to border counties.
Missouri is the only state that does not have a prescription drug monitoring program; such programs allow medical professionals to flag overprescribing and suspicious prescriptions.
“Certainly the fact that we have not had a statewide system” is problematic “because people who are trying to acquire these drugs on the black market know they have much less of a chance of getting caught up in this process in Missouri than they do in Arkansas or Kentucky or Illinois or Iowa,” McCaskill said.
Counties that have high Medicare Part D opioid prescribing rates based on 2015 data also had a high number of suspicious order reports, the report said.
“It’s easy sometimes to forget that these are real people and real families that are struggling both with overdose deaths and addiction and it’s easy to make this about data,” McCaskill said. “When you’re traveling around the states and visiting with people one on one, you’re constantly reminded what a big deal this is.”