Diversion of Opioids from Pharma Supply Chain

Diversion of opioids from supply chain –  by Alex Kacik  | September 16, 2017

For years, opioid tablets in the pharmaceutical supply chain have been diverted in massive batches of hundreds of thousands of pills.

This brings to mind that when Slick Willie Sutton was asked why he robbed banks (as opposed to bank customers), ihe said: “because that’s where the money is”. The pharmaceutical supply chain is where the most opioid pills are.

there has been a major push to pinpoint the vulnerabilities in a fragmented pharmaceutical supply chain to stem the flow of illicit prescription drugs.  

Public officials and regulators are hopeful that an onslaught of lawsuits will hold bad actors accountable for neglecting red flags and recoup millions of taxpayer dollars spent in detaining, treating and rehabilitating opioid abusers. 

While the U.S. Drug Enforcement Administration is working on a new monitoring guidance for suspicious prescriptions, there has been a lack of clarity about the reporting requirements under the Controlled Substances Act and how distributor responsibilities and expectations have shifted over time, some experts said.

“The role of pharmacies, PBMs, distributors and hospitals in how and when they alert the DEA isn’t clearly defined,” Schneider said.

The numbers tell the story, Hanly said.

“If you are selling 10,000 OxyContin pills a month to CVS through West Virginia and then it goes up to 100,000 and eventually 500,000, something is going on there. These companies have an obligation through the federal Controlled Substances Act to report to the DEA and it seems that oftentimes they didn’t do that.”

Distributors denounce those types of allegations. They are not responsible for the proliferation of opioid prescriptions in the U.S., said John Parker, senior vice president of communications at the Healthcare Distribution Alliance, the industry representative for drug distributors.

Oh, yes they are.

“Many stakeholders in the supply chain — including physicians, pharmacists, manufacturers, distributors, federal and state regulators, law enforcement, and others — share responsibility for opioid abuse and misuse in our country. “

“Primary pharmaceutical distributors are solely responsible for the safe and efficient distribution of all medications, including controlled substances, from drug manufacturers to licensed pharmacies and other healthcare providers.”

from https://www.hda.org/news/facts-about-rx-distributors-and-the-opioid-crisis

Also, see Case of Large-Scale Opioid Diversion Puts Hospitals on Alert.

“Further, because of our role, we cannot and should not interfere in the doctor-patient relationship.

That said, we do work closely with law enforcement and report all sales of controlled opioids to the DEA.

Law enforcement has no business interfering with a doctor-patient relationship.

Regulatory rigor

The DEA has tried to limit opioid distribution by curbing its quota system, which it sets to meet the medical, scientific, research, industrial, export and reserve demands.

To make a dent in the real opioid crisis, the DEA should “limit opioid distribution by curbing its quota system” for illicit opioids, but they are afraid to do that.

Cartels and drug dealers have guns and aren’t afraid of using them, making the pursuit of illicit drugs far, far more dangerous than sitting in a chair in front of a computer terminal, scrolling through listings of our prescriptions.

Members of the DEA are COWARDS.

The agency institutes a quota system for controlled substances that was designed to limit the quantities of drug ingredients and eliminate diversion from “legitimate channels of trade.”

While the DEA has recently reduced its production quota of opioids by 25% or more last year, that isn’t enough, public officials said. Consequently, that has made it difficult to source the drugs for those who truly need them and led to a surge in heroin use, critics said.

The Joint Commission released new pain assessment and management standards on Aug. 31 that will require hospitals to provide nondrug pain treatment options such as chiropractic therapy and give physicians and pharmacists access to Prescription Drug Monitoring Program databases. They must also better monitor high-risk patients who are prone to opioid addiction.

The changes came after a crackdown on wholesalers in the state that were supplying pill mills. Pharmacists in Florida now have to enroll in substance abuse and prevention classes when renewing their licenses, said Wayne Russell, vice president of pharmacy at Premier.

To further limit the spread of opioids, their uses should also be narrowed from the “open-ended” chronic long-term pain treatment to cancer and traumatic injuries, and the drugs should be administered in a controlled hospital setting, they said.

Here’s the problem: They don’t want “open-ended” prescriptions that are necessary for chronic illness.

They have decided that opioids are only for people with terminal diseases and cancer, and then only while it’s active and not for the lasting pain after it’s in remission.

“Policy and enforcement have not kept pace with the consolidation of the supply chain and distribution of medicines, particularly with online sales,” she said. “We need to harmonize domestic and international regulations and increase transparency.”

Under the recently implemented Drug Supply Chain Security Act, manufacturers will need to create individual serial numbers for every prescription, which ideally would help determine where the drugs came from and how they got to the patient.

This rule is only recent, meaning they’ve been ignoring supply chain “leaks” of hundreds of thousands of pills while prosecuting doctors and individuals for just a handful of pills.

“We will start to get a lot more visibility in not only the flow of these drugs but understand who held them and where they traveled along the supply chain, said Paul Cianciolo, who heads health systems development for TraceLink, a company that provides a digital track-and-trace network for the pharmaceutical supply chain.

I’m amazed that they’ve let this go on so long as the overdose crisis ravaged the country.

Leading the change

Yet, they have to strike a delicate balance between restricting the harmful drugs while still allowing access to those who need them.

“It’s probably going to get worse before it gets better,” she said. “Fentanyl is killing the majority of the people here (in Cincinnati). Until we get less people on opioids and heroin and get them into treatment, the safe prescribing habits will need time to catch up. I see that as maybe 10 years down the line.”

But neither fentanyl nor heroin are prescription drugs.

Alex Kacik is the hospital operations reporter for Modern Healthcare in Chicago. Aside from hospital operations, he covers supply chain, legal and finance. Before joining Modern Healthcare in 2017, Kacik covered various business beats for seven years in the Santa Barbara, California region. He received a bachelor’s degree in journalism from Cal Poly San Luis Obispo in Central California.