U.S. Sen. Claire McCaskill (D-Mo.) released her latest report on the opioid crisis in Missouri, “Fueling an Epidemic a Flood of 1.6 Billion Doses of Opioids into Missouri and the Need for Stronger DEA Enforcement".
The report found that 1.6 billion opioid doses made their way into Missouri between 2012 and 2017, and identified Phelps County as among the top counties with the highest rates of suspicious opioid orders in the state – orders of “unusual size of frequency based on local ordering patterns.”
The report is not a surprise for Phelps County, where the community has taken action to slow down the stream of opioids coming into the county where opioid-related overdoses followed by opioid-related deaths are a recognized theme.
Looking at the 45,000 residents that make up Phelps County, 3.6 million opioid pills were prescribed in the county with 81.3 per every man, woman and child, according to Center for Disease Control and Prevention’s most recent report that looks at the prescribing rate per 100 residents in the county.
The staggering number influenced the county to take into consideration joining the multidistrict litigation against the opioid distributors and manufacturers named in the report, which emerged from requests McCaskill made to the distributors—McKesson Corporation, AmerisourceBergen Corporation and Cardinal Health, Inc. Along with, the opioid manufacturers Allergan plc, Endo, Mallinckrodt and Teva Pharmaceuticals USA, Inc.
The three major pharmaceutical distributors in the U.S each recorded revenue of more than $125 billion in 2017, the report stated. The three distributors shipped around 1.6 billion dosage units of opioid products to Missouri between 2012 and 2017, and the volume of opioids equated to more than 260 dosage units for every man, woman and child in Missouri during that period. The peak year for opioid shipments within that six-year-period was 2015, and the three significant distributors shipped 52 opioid dosage units per person in the state.
Under the Controlled Substances Act (CSA), distributors carry a legal obligation to monitor and report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA). The profound amount of opioid products distributed in the U.S. makes compliance with CSA obligations a fundamental component to counteract the opioid crisis. The three distributors have consistently failed to meet their reporting obligations over the past ten years, according to the report.
Not only have the three distributors neglected to meet reporting responsibilities, as stated in McCaskill’s report, in some cases the three distributors have surrendered licenses for distribution facilities and paid escalating fines after the DEA and Department of Justice Investigations.
Opioid manufacturers have to abide by the same standards as the distributors with reporting responsibilities under the law, and the DEA has accused “at least one high-volume generic manufacturer of opioids: Mallinckrodt Pharmaceuticals” for failing to design an effective system to detect and report suspicious orders. This ended in a $35 million settlement with the company in 2017.
Also, Teva, and Allergan both appear as defendants in many of the complaints counties, and other governmental entities have brought against distributors and manufacturers in response to the opioid epidemic that Phelps County was asked to join.
Despite the highly refined methods and significant resources the three considerable distributors have deployed, their suspicious order reporting between 2012 and 2017 varied widely.
As stated in McCaskill’s report, McKesson and AmerisourceBergen, for instance, both shipped around 650,000,000 dosage units to Missouri in this five-year period, but McKesson reported 16,714 suspicious orders to DEA while AmerisourceBergen reported only 224; roughly 75 times fewer reports than McKesson.
Whereas, Cardinal Health shipped fewer than half of the total opioid dosage units AmerisourceBergen distributed to Missouri between 2012 and 2017. Cardinal Health reported 5,125 suspicious orders to the DEA, almost 23 times more reports than AmerisourceBergen.
The total suspicious orders McKesson reported also surpass both the AmerisourceBergen and Cardinal Health totals, even though the McKesson total only reflects company reporting to the DEA between August 2013 and December 2017.
Amongst pharmaceutical manufacturers, Mallinckrodt reported 905 Missouri orders to the DEA compared to ENDO reporting no orders between 2012 and 2017.
The report states that these different reporting results do not in any way indicate violations of the CSA by the companies involved, yet they do highlight the significance of ongoing outreach from the DEA to the industry regarding legal obligations for distributor and manufacturer registrants. Moreover to restore earlier standards for the use for Immediate Suspension Orders, the most important tool for deterring and punishing neglectful compliance by the DEA.
On the other hand, the senior vice president, John Parker, of Healthcare Distribution Alliance, the national trade association representing distributors including AmerisourceBergen, Cardinal Health and McKesson said:
— “The misuse and abuse of prescription opioids is a complex public health challenge that requires a collaborative and systemic response that engages all stakeholders.”
— "Distributors do not manufacture, prescribe, dispense or in any way, drive demand. Further, distributors cannot make medical determinations about patient care or provider prescribing."
— “Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated.”
— "Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”
— Distributors are logistics experts, tasked with the primary responsibility of delivering all medicines to licensed pharmacies and healthcare providers.
— The DEA is responsible for setting the annual production of controlled substances in the market, approving and regulating the entities allowed to prescribe and handle opioids, and sharing data with entities in the supply chain regarding potential cases of diversion.