A drug wholesale firm accused of fueling the opioid crisis could change its monthly pill shipment thresholds fluidly so it did not have to report large orders to its regulator, an AmerisourceBergen Drug Co. executive testified Tuesday.
Steve Mays, AmerisourceBergen’s vice president of regulatory affairs, testified to the system at the questioning of Cabell County attorney Paul T. Farrell Jr. on Tuesday at the Robert C. Byrd U.S. Courthouse during a trial before Senior U.S. District Court Judge David Faber.
Cabell County and Huntington accuse the “Big Three” drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of helping to fuel the opioid crisis by sending 127.9 million opiate doses into the county from 2006-14. A reduction in the amount of pills shipped around 2011 led its users to turn to illicit drugs, they argue.
The defendants say they’re the middleman and blame the U.S. Drug Enforcement Administration, which they said sets the amount of pills they could ship per year and would never communicate with them. They also blame doctors and a history of bad health among West Virginians for the shipments.
While the defendants have said they didn’t have access to what pills were shipped by other distributors at the time because of the DEA withholding information, Farrell on Tuesday pointed to a 2012 email between Mays and Senior Vice President Chris Zimmerman that said they didn’t want the DEA to share data between distributors because it might make AmerisourceBergen act and reject more orders.
Mays’ testimony Tuesday focused on defining what the company sees as a suspicious order. The DEA did not set the number of pills it would see as making a suspicious order at the time, and left it for the companies to decide privately. While the plaintiffs state the defendants had a duty to stop shipment of such orders, the defendants disagree.
At AmerisourceBergen, after 2007, the threshold for the baseline of pills a pharmacy was allowed to purchase each month was set by a national average of AmerisourceBergen customers. Anything more than three-times the national average was considered suspicious.
A 2009 memo showed the policy was that a small pharmacy could order 350,000 hydro- or oxycodone pills a year, a medium pharmacy, 760,000, and a large pharmacy over 1 million pills without triggering a suspicious-order alert.
The area’s population, health or other demographics were not mentioned as being factors.
Eventually, the policy evolved into being based on a customer’s business activity, its account and store size, and peer groups, such as small-, medium- or large-sized pharmacies. Now, there is a dashboard system where math is done to decide if an order is suspicious based on different aspects.
From 2007-13, there was a workflow for purchases, which split into two branches based on whether the order was suspicious. If it was, the warehouse could delete the order, push it through or hold it for corporate review. Corporate could then send it to the DEA if it was found to be suspicious. If it was not suspicious, they did not send it to the DEA. Mays said it was because the DEA did not want that information.
Tuesday morning, Farrell turned his focus to Safescript, a former downtown Huntington pharmacy, which, from 2006-14, averaged 35,551 oxycodone dosage units a month, about seven-times the national rate.
Average pharmacies receive 60,000 oxycodone doses a year, but Safescript received 426,000 before it was shut down in 2012 when its owner was found in a parked pickup with a woman, prescription drugs, blank pharmacy labels and suspected drug ledgers.
Farrell said only three of Safescript’s orders had been reported to the DEA from 2006-14. Mays said he believed there were more reported, but those additional orders had still been shipped to the pharmacy. The defendants have held during trial that they did not have a duty to stop orders under the law, and doing so put customer safety at risk.
In July 2007, Mays testified, Safescript could order 10,600 oxycodone “solids” before a suspicious-order report was triggered. From July 10-12 that year, the system flagged several orders that put it over the threshold.
By September of that year, AmerisourceBergen had increased Safescript’s threshold to 25,000. A day after that increase, it was increased again to 30,000. That rate permitted the pharmacy to dispense 360,000 pills a year, three per Cabell County resident per year, without it being flagged as suspicious.
In April 2009, the threshold was again increased, this time to 45,000, before it started to trend downward. It jumped back up to 40,000 in July 2011.
Mays said an AmerisourceBergen investigator or sales person can increase the thresholds with approval, but there should be documentation that explains why it changed. No explanation was given Tuesday morning.
“There should be a narrative or note on the file,” he said. “There should be documentation of that.”
Farrell showed other pharmacies and specific months during which they were over their monthly thresholds. Mays said there should be paperwork in their files about investigations into those months.
“The quantities would have been justified by the due diligence,” he said.
The totality of the picture would indicate it was not suspicious and that’s why the order was shipped, Mays said.
AmerisourceBergen did open an investigation into the pharmacy in June 2007. The investigation report said it was opened when the company purchased 21,000 hydrocodone doses in April 2007 when it had a 12-month average of 25,000.
That June, 33,000 hydrocodone pills were sold, when the national average was 6,500. The threshold should have been set off when the numbers hit more than three times the national average, Farrell said, but it did not.
The investigator did not complete his report until March 2008, Farrell said, and the company continued to ship pills to the pharmacy in the meantime. The investigator’s report said the pharmacy had started using another distributor after several of its orders were held by AmerisourceBergen.
In February 2012, an AmerisourceBergen investigator said Safescript was expected to voluntarily surrender its DEA license by Feb. 17, 2012.
“See everything, overlook a great deal, correct a little,” a Pope John XXIII quote, is what the investigator had in his email signature.
The DEA would do investigations of their facilities often, Mays said, with some taking an hour and others taking up to six months. Most of the time, there were no findings, but he said they typically do not receive documentation of that.
The DEA would bring students and other trainees from its Quantico, Virginia, training facility to review how AmerisourceBergen operated its warehouses. AmerisourceBergen attorney Shannon E. McClure said that shows the DEA had notice of what was going on at the facility, and could have investigated further had they seen anything out of line.
The DEA never told them they could not ship suspicious orders or corrected their protocols, Mays said.
“I would have gone back and rang the alarm bells,” he said.