AmerisourceBergen subpoenaed in diversion probe17-Aug-2012
US drug wholesaler AmerisourceBergen has been subpoenaed by federal authorities in an ongoing investigation into the diversion of opioid painkillers and other controlled medications that are open to abuse.
The development is the latest in a nationwide investigation into drug diversion as levels of prescription painkiller abuse across the US have been escalating, causing almost 21,000 deaths in 2009, according to the most recent government statistics.
Brands often abused include Abbott Laboratories' Vicodin (hydrocodone/acetaminophen), Purdue Pharma's OxyContin (oxycodone) and Endo Pharmaceuticals' Opana (oxymorphone).
Most states (the only exception is Missouri) have introduced monitoring programmes to try to address the problem, which outstrips the level of abuse seen with illegal drugs such as heroin cocaine.
AmerisourceBergen revealed in its latest quarterly filing with the Securities & Exchange Commission that it received a subpoena from the US Attorney's Office in New Jersey back in May asking for documents concerning its "programme for controlling and monitoring diversion of controlled substances into channels other than for legitimate medical, scientific, and industrial purposes".
It said at the time it had also been subpoenaed by the Drug Enforcement Administration (DEA) in connection with the matter, with requests for documents relating to specific customers' purchases of controlled substances.
The US set up its tracking system in 2009 to try to keep a lid on diversion, and as a result was able to identify certain states - and also individual physicians' offices - that seemed to be accounting for an inflated amount of opioid analgesic prescriptions, often relying on websites to process prescriptions and orders.
As a result some states such as Florida are no longer 'hot spots' for diversion, although it seems some of the top-prescribing doctors have now set up shop elsewhere, including in Missouri.
One of AmerisourceBergen's rival distributors - Cardinal health - agreed to suspend shipments of controlled drugs from a Florida distribution facility earlier this year as part of a settlement with the federal authorities over alleged diversion.
The DEA had sought a closure of the facility in Lakeland and suspension of sales of opioid painkillers from pharmacies operated by the CVS chain in the Orlando area.
According to the DEA the two pharmacies collectively ordered three million oxycodone dosage units in 2011, when the national average was just 69,000 per pharmacy. Cardinal Health has since halted shipments to the pharmacies.
It previously suspended approval for distribution of controlled substances including hydrocodone from a Cardinal Health facility in Auburn, Washington, after it became concerned about the volume of material being shipped.
Last month, a group of doctors, researchers and public health officials sent a Citizen's Petition to the US FDA asking it to revise the labelling for opioid painkillers so the drugs can only be used for severe pain, are subject to a maximum daily dose and can only be given for 90 days at a stretch unless prescribed for cancer pain.
AmerisourceBergen is remaining tight-lipped on the federal case, merely saying that it is "is in the process of responding to the subpoenas and is cooperating fully with the USAO and the DEA".
Meanwhile, in June, the wholesaler was one of a number of companies cited in a compliant by the Attorney General of the State of West Virginia alleging that it failed to provide effective controls and procedures to guard against diversion of controlled substances.
Making a case for serialisation
The scale of painkiller diversion and abuse in the US - it is estimated that around 6 million people are illicitly using pain drugs - provides yet another compelling argument for a national, federally-mandated track-and-trace system for medicines based on 'unique identifiers' such as serial numbers on packaging and even - potentially - on unit doses in some cases.
The recently-introduced FDA Safety and Innovation Act (FDASIA) failed to include such a track-and-trace system even though a group of stakeholders had pushed for it as the wording of the act was being debated and agreed.
Rumours are that lobbyists may seek to attach traceability requirements to other legislation currently being drawn up, such as the Pandemic and All-Hazards Preparedness Act which is up for re-authorisation after being approved by the Senate in March.
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