FDA Warns Drug Distributor

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has sent a warning letter to a wholesale drug distributor rebuking the company for its handling of several tampering cases involving oxycodone and other medications.

The letter to the CEO of the McKesson Corporation involves incidents in 2016 when pharmacies notified the company about the tampering and theft of medications it had supplied them with.    

In one such case, a Rite Aid pharmacy in Michigan found that the seal to a bottle labeled as containing 100 tablets of oxycodone had been broken. Inside the bottle a pharmacist found 15 tablets of Aleve, a non-steroidal anti-inflammatory pain reliever.  Two other Rite Aid pharmacies also reported to the company that oxycodone bottles had been tampered with. McKesson investigated the reports and determined the tampering and thefts likely occurred while the bottles were in its possession.  

Similar tampering incidents involved drugs used to treat bipolar disorder, high blood pressure and HIV.

According to the FDA, McKesson did little to identify and quarantine other products in its distribution system that also may have been tampered with and failed to warn other pharmacies that illegitimate products were in the supply chain.

"This is simply unacceptable. A distributor’s failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a violation of the law," said FDA commissioner Scott Gottlieb, MD, in a statement.

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"But this is even more concerning given that we’re in the midst of a widespread opioid crisis. Opioids that leave the legitimate supply chain could end up being sold illegally, or a patient who was appropriately prescribed these drugs to treat pain may not get the treatment they need or may unknowingly take a medication that’s not meant for them."

The FDA did not say why it waited so long to send the warning letter or notify the public about the 2016 tampering incidents. McKesson is the first company to receive a warning letter under the Drug Supply Chain Security Act (DSCSA), which was enacted by Congress in 2013.

McKesson is one of the largest wholesale drug distributors in the country. It is being sued by dozens of states, cities and counties for its role in the opioid crisis. In 2017, McKesson was fined $150 million for failing to report suspicious orders for oxycodone, hydrocodone and other controlled substances. In 2008, the company agreed to pay $13.25 million in penalties for similar violations.

‘Confusing’ Email Warns of Drug Shortages in Florida

By Pat Anson, Editor

The Florida Department of Health is apologizing for a “confusing” email sent Friday that warned of possible prescription drug shortages in the state due to the recent suspension of a wholesale drug distributor.

Earlier this week, the McKesson Corporation agreed to pay a record $150 million fine for failing to track and report suspicious orders of opioid pain medication and other controlled substances.   As part of the settlement with the Drug Enforcement Administration, McKesson suspended sales of controlled substances from wholesale distribution centers in Colorado, Ohio, Michigan and Florida.

Late Friday morning, the Florida health department sent an email with the subject line “Emerging Health Threat” to pharmacists in the state warning of possible drug shortages.

“The DEA recently suspended McKesson Corporation’s sales of controlled substances from distribution in Florida. This suspension could impact your patients’ ability to fill their prescriptions and you may want to advise them about the potential implications. As a practitioner, you should be aware of the possibility of drug shortages and consider alternative treatment options when prescribing controlled substances.”

About six hours later, the health department sent out a second email, apologizing for the first one:

"A recent message that was sent out regarding the DEA’s suspension of McKesson Corporation’s sales of controlled substances from distribution in Florida was found to be confusing. This suspension will impact one distribution center in Florida and impacts only the handling of hydromorphone. The Florida Department of Health and Division of Medical Quality Assurance apologize for any confusion that may have resulted from that message.”

There was no explanation for why the first “confusing” email was sent or why there was such an abrupt change in tone in the second one. No press release was issued by the health department warning of possible drug shortages in Florida. 

A spokesperson for McKesson confirmed that the suspension of its Florida distribution center will only impact hydromorphone, an opioid medication sold under the brand names Dilaudid and Exalgo.

"We do not anticipate our pharmacy customers will experience any negative impacts as a result of the temporary suspension," wrote Kristin Hunter in an email to PNN.

"The Lakeland, FL distribution center will be suspended for one year from distributing hydromorphone ONLY (not ALL controlled substances). There will be no change to the distribution of non-controlled pharmaceutical and over-the-counter products. Customers that typically receive controlled substances from an affected distribution center are now being served by one of the other 28 DCs (distribution centers) in McKesson’s network with no interruption in service."

This is the second time McKesson has been accused of violating the Controlled Substances Act. In 2008, the company paid a $13.25 million fine after it failed to identify and report suspicious orders for opioid pain medication from independent and small pharmacies. 

As part of a settlement with the DEA, the company agreed to implement a system to detect such orders.

However, the DEA says McKesson “did not fully implement or adhere to its own program” and continued to supply pharmacies with “an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic.”

From 2008 to 2013, the company processed over 1.6 million orders for controlled substances in Colorado, but reported only 16 of them as suspicious, according to the DEA.

A pharmacist told WFTX-TV in Naples that suspending distribution centers and potentially disrupting the supply of opioids isn’t helpful because it only makes it harder for chronic pain patients to get their medications.

 "It's a terrible way of policing, essentially what they're going to try do is, rather than go in and physically shut down what they call 'pill mill physicians' or 'dirty doctors' they cut the supply," said Fort Myers pharmacist T. J. Depaola, who says some patients unable to get medication turn to the black market for pain relief.

"You have patients that were being treated for chronic pain; all of a sudden they couldn't get meds, they went to heroin because that's the closest thing to what they were on before."

Finding pain relief in Florida is already difficult. Because of the state’s crackdown on pill mills, many doctors are now unwilling to prescribe opioids and patients report pharmacies are often reluctant to fill legitimate prescriptions.  

A pharmacist who asked to remain anonymous told Pain News Network that many Florida pharmacies already operate under a strict quota system, in which they are allotted a certain number of painkillers per month. He predicted McKesson’s suspension will have a snowball effect, driving patients from one pharmacy to another in search of a dwindling supply of opioids.

“With the DEA restriction on McKesson hydromorphone supplied pharmacies, and with a shift of patient population to pharmacies using alternative suppliers, the latter pharmacies will now exceed the (quota) sooner and exhaust the supplies sooner. It is crazy,” he said.

Further tightening the supply are plans by the DEA to reduce the amount of almost every Schedule II opioid pain medication manufactured in the U.S. by 25 percent or more in 2017. The quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, is being reduced by a third. The DEA said it was cutting the opioid supply to prevent diversion and because of declining demand for painkillers.