CHARLESTON — While a retired high-ranking official with the Drug Enforcement Administration said drug distributors’ neglect in reporting suspicious opioid pill orders was part of a systemic failure, the defendants said the real issue was with the regulator’s practices.
The official — Joe Rannazzisi, head of the Office of Diversion Control for the DEA from 2006 to 2015 — testified Tuesday in Charleston at the ongoing opioid trial. Cabell County and Huntington are accusing the “Big Three” drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of fueling the opioid crisis by sending excessive shipments of opioids into the area for eight years before a reduction in the number of pills shipped made users turn to illicit drugs.
The defendants point to the DEA, doctors and West Virginians’ poor health as the culprits. The DEA sets the amount of pills that are able to be manufactured in a year, they said, and has data from all distributors to know what pills were going where. Because of this, the regulator could have prevented the opioid crisis years before it raged.
The question asking “Which came first, the chicken or the egg?” is a central dilemma in the case. Which came first: The DEA annually raising opioid pill shipment quota limits, or the distributors increasing the amount of opioids they shipped?
Rannazzisi testified the quotas were set based on a scientific formula involving the number of prescriptions and other items to make sure there were enough drugs to fill prescriptions and use for research, but to also make sure there was not stock sitting on pharmacy shelves waiting for robbers.
He said lowering quotas was a risky business. Cutting quotas would not deter people with opioid use disorder, it would only create a shortage, leaving patients hurting. The DEA must maintain enough drugs so the real patients are cared for, he said.
But that’s what the DEA did. In October 2016 it announced it was reducing the quota by 25% or more in 2017. Hydrocodone, for example, was reduced by 66%.
Rannazzisi said the need for hydrocodone had decreased dramatically after new regulations were made for doctors, who were no longer allowed to call in orders. They had to write prescriptions.
While the distributors said the DEA blocked them for years from getting shipment data, Rannazzisi testified Tuesday it was the distributors who had more data, which included prescriber information, dispensing numbers and more.
He pointed to excessive order reports they would receive from the distributors, generally monthly, but sometimes more frequently. He held up one monthly report, a stack of paper inches thick containing hundreds of transactions, but he said there was no information about the pharmacies or why it was suspicious.
“There’s nothing in here that has any information of why it would be deemed suspicious,” he said. “These have no value because all it is is reporting transactions over a threshold.”
Rannazzisi said each of the three defendants failed in their duty to monitor and report to the DEA suspicious orders made by pharmacies due to systematic failures within their individual suspicious monitoring systems.
The DEA conducted meetings with the defendants in 2005 to ask them to rein in their distribution practice after seeing an increase in the number of pills shipped to internet pharmacies.
During testimony before Congress, Rannazzisi had testified people ordering via internet pharmacies received 100 to 120 pills at a time, far more than they would obtain from family and friends or by stealing from a medicine cabinet.
A 2006 letter was sent to the defendants by Rannazzisi after their meeting reiterating what had been discussed — essentially that they had a responsibility to conduct due diligence to avoid filling suspicious orders that might be diverted into the illegal market.
It added the distributors could not rely on the fact a person placing the order is a DEA registrant and turn a “blind eye” to other suspicious circumstances.
“Just because you give someone a driver’s license, doesn’t mean they aren’t going to speed,” Rannazzisi said.
Following the meetings, the DEA did a review of its pill shipping data system to see if the flow of pills was reduced. It was not.
McKesson continued to distribute large volumes. In 2005, the DEA sent a memo to McKesson alerting them to six problematic pharmacies. From Oct. 10-21, 2005, those pharmacies were shipped 252,000; 254,000; 158,000; 520,000; 500,000; and 404,000 pills.
A meeting followed the memo, he said.
“They shuffled papers and looked around. One gentleman gave me a sort of smile and said ‘I guess you got us,’” he said. “I was horrified at that statement. They said we can’t tell you why.”
He said McKesson later told the DEA its suspicious order monitoring system was not picking up generic drugs in the hydrocodone class.
“It’s a systemic failure,” he said.
Immediate suspension and show cause orders followed for McKesson’s Florida Lakeland distribution center in August 2006. Rannazzisi said he felt McKesson’s failure was not limited to just that facility because its suspicious order monitoring program was used nationally, but the DEA did not have the resources to devote to look at each of the company’s distribution centers at one time.
At least three similar actions followed and eventually a settlement was reached with McKesson.
Rannazzisi said the agreement included a note that the DEA did not approve any suspicious order monitoring program to draw a line in the sand for the distributors, who he believed thought they had approved it previously.
There was also a show cause and immediate suspension order issued against AmerisourceBergen in 2007 for similar actions. After the 2005 meeting with the DEA and distributors, AmerisourceBergen sold over 5.2 million dosage units of hydrocodone to pharmacies the DEA had warned them against.
He found there was a systemic issue with AmerisourceBergen’s system too, since it, too, used its suspicious order monitoring system nationwide. The same was true for Cardinal Health, Rannazzisi said. Immediate suspension orders were issued in 2007 and 2012 for the company.
McKesson attorney Paul Schmidt said Rannazzisi did not personally review distributors’ suspicious order monitor systems, participate in on-site visits, or speak to any distributors but McKesson in 2005. Rannazzisi said Tuesday he did not know of any investigations showing the defendants had shipped orders they believed were suspicious.