It looks the DEA might think so.
Robert L. Corso, Special Agent in Charge of the Detroit Field Division, Drug Enforcement Administration (DEA) announced yesterday the immediate suspension of the federal controlled substance registration of Keysource Medical, a wholesale supplier of pharmaceuticals.
According to the DEA news release -
“Pharmaceutical companies have a responsibility to ensure that the drugs they sell don’t end up in the hands of drug traffickers or businesses that are conducting their business illegally,” said Corso. “Prescription drug abuse in Florida, southern Ohio and northern Kentucky has risen to epidemic proportions, and Keysource Medical, should have known based on the large, frequent quantities, that their customers were diverting oxycodone into arenas that were not legitimate. This action is another reminder that the DEA is working hard to hold accountable those companies who choose to operate outside the law. [my bold]
I don't know the whole story behind this suspension, but I would think that the normal daily business activities of being a wholesaler, such as following legal protocol, verifying pharmacy licensure, accurate record keeping, and maintaining inventory control would be appropriate.
Why should a wholesaler be expected to investigate when one pharmacy happens to order more narcotics than another pharmacy? Why is it up to them to verify the legitimacy of their customer's orders? It seems to me that's too difficult a requirement, and that the DEA is expecting too much from pharmacy wholesalers.
Suspicion of diversion doesn't equal knowledge. There are actual patients with legitimate pain issues, and there will always be a pharmacy at the top of the quantity-ordered list.
The DEA has copies of the same records and it should be their responsibility to investigate if they think a pharmacy is diverting narcotics. It's the DEA's job to determine possible criminal activity. They have the authority, tools, training, and funding to investigate each pharmacy to "knowingly" find out if they're diverting or not.
Just like a pharmacist shouldn't be held liable for a patient's abuse of his or her medications, I think a wholesaler shouldn't be held liable for the criminal actions of one or more of their customers. It's slippery slope my friends.
I'm all for putting a stop to the increasing abuse of prescription narcotics and for holding the criminals accountable. But it's also very important to ensure that the innocent aren't punished for performing their roles in providing appropriate health care. What do you think?
I agree with you. I don't see how DEA can expect a wholesaler to know if a pharmacy is doing wrong without looking through their prescription records?
ReplyDeleteI would think if a wholesaler had a suspicion that it would be reported to the DEA to investigate. But like you said, the DEA already has that information.
ReplyDeleteIs the DEA telling them they shouldn't supply the drugs only because they ordered too much?
I'm not sure that I agree with it, but here's the DEA's reason for shutting down KeySource via WKRC's Rich Jaffe - Pill Pipeline: DEA Targets Local Company
ReplyDeleteDEA has lifted the suspension....you can verify by checking the updated DEA registry.
ReplyDeleteSounds similar to the Harvard Pharm case from Michigan last year.....feds going too far with this? Looking at ARCOS data, numbers for Florida don't seem to add up to the Oxycodone capital of the planet. I'm a little confused!
rich jaffe's article is garbage and full of bad information. how does he get away with it?
ReplyDeleteI'm still baffled by how it's supposed to be the wholesaler's responsibility to investigate and ensure that their customers are filling prescriptions legitimately, but the DEA keeps going after them. Here some more recent news -
ReplyDeleteCardinal Health Inc. Seeks Restraining Order to Avoid Disruption in Controlled Medicine Shipments from Florida
Indeed, here we are again. Same scenario, different (and much larger) company. The DEA has run amok, and hopefully, enough negative publicity will be generated to pique the interest of an investigative reporter. Unfortunately, the public may not care...that is, unless wholesalers give up and stop selling Oxy altogether. Then, patients and doctors will begin to yell, and heads will roll at the DEA.
ReplyDeleteI thought this a pretty important topic that seemed to slip under the radar of many pharmacists. Although it took a while, it's nice to see a heralded pharmacist-lawyer address this issue.
ReplyDeleteDEA and Corporate Responsibility: An Opinion from Jesse Vivian, RPH, JD - "It seems the DEA has assumed a new theory of liability against distributors and dispensers of controlled substances: prosecute them for handling "too much" controlled drugs."
You know, I'm all against drug abuse and the crime that comes with it. But, things are starting to get out of hand with DEA enforcement.
ReplyDeleteNow they're considering the delivery companies to be part of the problem too. FedEx, UPS probed on illegal shipments of prescription painkillers
Wow! Shipping company UPS agreed Friday to pay $40 million to end a federal criminal probe connected to deliveries it made for illicit online pharmacies. The U.S. Department of Justice announced that the Atlanta-based company would also "take steps" to block illicit online drug dealers from using its delivery service.
ReplyDeleteSource: UPS to pay $40 million to end federal investigation into illicit drug deliveries
Mark R. Trouville, Special Agent in Charge, Drug Enforcement Administration (DEA), Miami Field Division, and Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, announced that Walgreens Corporation (Walgreens), the nation’s largest drug store chain, has agreed to pay $80 million in civil penalties, resolving the DEA’s administrative actions and the United States Attorney’s Office’s civil penalty investigation regarding the Walgreens Jupiter Distribution Center and six Walgreens retail pharmacies (collectively “Registrants”) in Florida.
ReplyDeleteSource: DEA - Walgreens Agrees to Pay a Record Settlement of $80 Million for Civil Penalties under the Controlled Substances Act, Largest fine paid by a DEA registrant
It feels like the DEA is just enjoying the benefits of being a bully. They are getting money from all of these companies (because the companies don't want to fight the government) and now they are getting "free" help in doing THEIR jobs. When is the media going to take a closer look at the scheming going on at the DEA? It is the DEA's job to do ALL of this - not the wholesalers, not the pharamacies...and maybe not even the pharmacists. The DEA and the DOCTORS writing the scripts are to blame...but the doctors can't pay the DEA nearly as much money.
ReplyDeleteIt looks like someone was listening to your complaints TBarnes. And now you'll know (allegedly) how they got so good at their investigative probes. A Domestic Surveillance Scandal at the DEA? Agents Urged to Cover Up Use of NSA Intel in Drug Probes
ReplyDeletePerhaps a little off tangent, but interesting none-the-less.
ReplyDeleteAccording to the ACLU, the Drug Enforcement Administration thinks people have “no constitutionally protected privacy interest” in their confidential prescription records, according to a brief filed last month in federal court. That disconcerting statement comes in response to an ACLU lawsuit challenging the DEA’s practice of obtaining private medical information without a warrant. The ACLU has just filed its response brief, explaining to the court why the DEA’s position is both startling and wrong.
Read more at: The DEA Thinks You Have “No Constitutionally Protected Privacy Interest” in Your Confidential Prescription Records
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ReplyDeleteJason: With all due respect, I think you should read the laws [21 USC 823(b) and 21 CFR 1301.74(b)] before condemning them and those whose job it is to enforce them. The Congress was well aware of the issues you and the others raise when it enacted the statute in 1970 and the courts -- up to and including the Supreme Court -- have consistently confirmed the constitutionality of the law. Rumors, innuendoes and ACLU-inspired discontent aside, the issue regarding pharmaceutical controlled substances and the pharmacist's and wholesaler's responsibilities to prevent diversion are well settled, my friend. Again, read the law, It's all right there in black and white. Knowledge is the antidote for fear and stupidity.
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ReplyDelete