Cardinal caught between DEA and pharmacies over diversion control

Cardinal Healthcare announced that it was discontinuing controlled substance shipments at its Stafford, Texas, distribution center to independent, Medicine Shoppe, and Medicap pharmacies. The facility is the fourth to curtail controlled substance shipments since November under pressure from the Drug Enforcement Administration.

"We are working with the DEA and have met with them to further discuss the situation and help them understand what we are doing and the progress we are making," Mark Hartman, senior VP supply chain integrity and regulatory operations for Cardinal Health, told Drug Topics. "We take this very seriously not just because of the DEA actions, but also because diversion is clearly hurting our industry and hurting people."

Cardinal is not the only wholesaler on the hot seat. In March, Bruce Roberts, R.Ph., executive VP and CEO of the National Community Pharmacists Association, wrote to the DEA complaining about the impact of DEA pressure on all wholesalers. "The DEA's policies result in restricting or preventing pharmacies from obtaining medications for patients with legitimate pain needs," he wrote.

Roberts also criticized DEA for "sweeping, non-specific directives," the closures of Cardinal's Florida and Washington distribution centers, and its targeting of community pharmacy. "It is no surprise that our members report overly broad, uneven, and punitive actions by various wholesalers," Roberts added.

A year ago the DEA suspended AmerisourceBergen's license to distribute controlled substances at its Orlando distribution center. During the suspension the company implemented additional controls to its monitoring system and its license was reinstated in August. According to Nora Beger, manager of public relations, new customers are prequalified, during which a threshold for controlled substances dispensing is established. Suspicious orders are investigated by its corporate security office and the DEA is notified. "We communicate with the customer when an order is put on hold," she said.

In a Security and Exchange Commission filing, McKesson noted it was in discussions with the DEA over claims that it filled customer orders for controlled substances that were not adequately reported. "We have been implementing improvements to our comprehensive controls and reporting procedures to avoid future claims of this type," the company noted in the filing.

Working in good faith

Not surprisingly, tightening controls has also drawn complaints from pharmacists. In two separate cases, independent pharmacies have sued Cardinal after it cut off their controlled substances. In December judges in two separate cases ordered Cardinal to restart its shipments to Community Drugstore, LLC and ApothecaryRx's Ken's Pharmacy location in Norman, Okla.

According to Lew Zeidner, CEO of ApothecaryRx, the company only sued as a final recourse to get Cardinal to restart controlled substance shipments. Ken's Pharmacy, which ApothecaryRx purchased in 2006, is located next to Norman Regional Health Center and fills a large number of prescriptions from the center. In December Cardinal stopped shipping controlled substances without notice and the pharmacy saw no other alternative. "We all have concerns about diversion, but there also needs to be due process," Zeidner argued.

Still, Zeidner insisted that Cardinal has been cooperative. "We have 11 other stores using Cardinal and we intend to continue using them," he said. "They appear to be working with us in good faith."

In other instances, pharmacists impacted by the closures have complained about problems with getting shipments on time. (See "Letters" Feb. 11, 2008) "We take very seriously the potential impact on speed of delivery," Hartman stressed. "If we can't meet our delivery schedules, we communicate with customers."