Reducing Supply of Opioids Will Not Stop Drug Diversion

By Roger Chriss, Columnist

Drug diversion is a massive problem. It plagues the entire drug supply chain, from manufacturer through wholesaler and distributor, to drug stores and dispensaries, all the way to consumers. It is particularly important for opioid pain medications because of the ongoing opioid crisis.

It is well established that the non-medical use of pharmaceutical drugs is an increasing public health concern. Most pharmaceutical drugs used non-medically are obtained from family and friends. There is little to no organized crime involved. And importantly, doctor shopping is rare.

An under-appreciated issue here is scale. According to the DEA, less than 1 percent of legally prescribed opioids are diverted. The sharing or selling of individual prescription pills is small compared to the impact of diversion higher up in the supply chain. For instance, Effingham Health systems just agreed to pay a $4.1 million settlement as a result of a DEA investigation into reports that tens of thousands of oxycodone tablets were believed to have been diverted for four years.

Similar reports about large-scale diversion abound. The Associated Press reported incidents of diversion at about 1,200 VA facilities rose from 272 in 2009 to 2,926 in 2015.

And in 2013 Walgreens was charged $80 million for poor record-keeping and dispensing violations that let millions of doses of controlled substances to enter the black market.

In 2007, the Drug Enforcement Administration estimated that prescription drug diversion in the United States was a $25 billion-a-year industry. About one of every four thefts of methadone and OxyContin were attributed by the DEA to employee pilferage at pharmacies, hospitals and other healthcare facilities.

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More recently, a 2017 survey by Porter Research, 96 percent of healthcare workers said drug diversion occurs frequently in healthcare. And 65 percent believe most diversion goes undetected.

Pill mills are even worse. In the book “American Pain,” journalist John Temple describes the impact of Florida pill mills on the east coast a decade ago.

“Florida pumped millions upon millions of doses of those narcotics—oxycodone, mostly—northward, not through a major criminal organization like the cartels of Mexico, but via thousands of individuals who streamed up and down Interstate 75 or flew from Tri-Sate Airport in Huntington, West Virginia, to Miami International, on a flight nicknamed the Oxy Express,” Temple wrote.

And none of this is remotely new. In the book “Dark Paradise,” historian David Courtwright explains: “Diversion from maintenance programs posed a real danger, given that perhaps half of all licitly manufactured barbiturates and amphetamines ended up on the black market.”

So the claim by Attorney General Jeff Sessions that "It’s a common sense idea: the more a drug is diverted, the more its production should be limited” is both simplistic and misguided.

Sessions is assuming that limiting production will reduce diversion. But economic theory suggests the opposite may be true. Reducing supply leads to scarcity, which generally increases value. This in turn may create stronger incentives to divert more opioids into the black market.

Moreover, there is no evidence that people who divert medication are aware of and responding to DEA production quotas. Instead, the consensus is that people divert what they need and think they can get away with. In other words, diversion is an exercise in what economists call the “Tragedy of the Commons,” in which individuals each use a collective resource for their own benefit without regard for the effects on others.

And Sessions’ idea implies that reducing production won’t have any effect on medical practice. But there is an abundance of evidence to the contrary. There is an ongoing shortage of injectable opioids at hospitals around the country. And despite claims to the contrary, opioid analgesics cannot always be replaced or substituted with other pain relievers.

Thus, more intelligent and nuanced approaches are needed. For instance, the NIH is sponsoring research to use advanced data analytics to detect drug theft and diversion in hospitals. Similar efforts at wholesalers, distributors, pharmacies and dispensaries are worth considering.

So while diversion is a major problem, it is neither new nor limited to individual consumers with prescriptions for opioids or other medications that have a street value or abuse potential. The seemingly obvious response of reducing supply could easily backfire. Instead, securing the entire supply chain, from manufacturer through distributor to point-of-sale to consumers, is a vital step in making sure that only the intended recipients of pharmaceutical drugs have access to them.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

DEA Opioid Cuts Could Affect Terminally Ill Patients

By Pat Anson, Editor

Steep cuts in the production of opioid pain medication planned by the U.S. Drug Enforcement Administration could worsen drug shortages and affect pain patients receiving end-of-life hospice care.

“Yes, I think that’s absolutely possible. And very, very concerning,” says Judi Lund Person, VP of Regulatory and Compliance for the National Hospice and Palliative Care Organization.

The DEA announced earlier this week that it is reducing production quotas for almost every Schedule II opioid pain medication next year by 25 percent or more. The quota cuts include opioids such as hydrocodone, oxycodone, fentanyl, hydromorphone and morphine – many of which are used to give pain relief to patients in palliative and hospice care.

The DEA said the cuts are needed to prevent the diversion and abuse of opioids, and because opioid prescribing has been in decline for several years.

But Person says some patients in palliative care – who are generally disabled and chronically ill, but still living at home  – are already having trouble getting their opioid prescriptions filled.

“We’ve had patients who’ve had a lot of trouble finding a pharmacy that carries certain opioids,” she said

Person is worried that the DEA’s production cuts will also make it difficult for hospices to obtain opioids for terminally ill patients. Her organization, which represents about 4,000 hospice facilities in the United States, is still examining the possible impact of the opioid cuts.

“What does that do for patients at the end of life who need these drugs? That, I think, is one of our biggest questions,” Person told PNN.

“Living and working in the Washington area, the pressure is on so much around the opioid addiction crisis, and looking for any and all opportunities to see if we can correct that. It doesn’t surprise me in any way that this is happening. Now, what we’ll do about it and how we switch over to other drugs that will be available is a completely different question. I don’t know what we’ll do.”

Person says there are 1.4 million Medicare patients in hospice care and several million more receiving palliative care.

Many chronic pain patients who are not in palliative or hospice care say opioids are already hard to get, because many doctors are reluctant to prescribe them and some pharmacies claim they’re out of stock.

“I am really, really scared about my future and others. So many others are already suffering needlessly. How many more are going to be thrown under the bus?” asks Rich Martin, a Nevada pharmacist who was forced into early retirement by chronic back pain. “I take hydrocodone for my rescue doses, 5 times a day, and I almost always use them unless I am totally sedentary. I think hydrocodone is being reduced by 36 percent. 

“Opioids across the country have already been reduced or stopped parabolically downward. This whole quota thing could collapse to where there is indeed inadequate opioids for treatment of legitimate pain patients.  Then pharmacies may actually be telling the truth when they say they are out of opioids.”

The DEA says its opioid quotas are sufficient to provide “adequate and uninterrupted supply for legitimate medical need,” and could be adjusted if problems develop.

“DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls,” the DEA said in a press release.

“This is a step in the right direction,” Sen. Dick Durbin (D-Illinois) said in an interview with WGN Radio. Durbin was among a group of senators that urged the DEA to lower the quota for opioids.

“Clearly there is more (opioids) than is necessary to alleviate pain. I’m the glad the DEA stepped up. It’s the first time.”

GAO Questions DEA’s Competency

Many Americans may not be aware of the significant role DEA plays in regulating the nation’s drug supplies. Drug manufacturers apply to the DEA every year to produce opioids and other controlled substances, and the agency determines how many – the quota – each drug maker can produce.

But in a recent series of highly critical reports, a congressional watchdog agency questioned the DEA’s competency in regulating pharmaceutical drugs.

In March 2015, the DEA was criticized in a lengthy report by the Government Accountability Office (GAO) for its inability to deal with drug shortages, a problem so serious it was called “a risk to public health.”

The GAO said that between 2001 and 2013, there were 87 “critical” shortages of controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. 

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the GAO report states.

A second GAO report in July 2015 faulted the DEA for heavy-handed tactics during pharmacy investigations. Many pharmacists said they were worried about being fined or having their licenses revoked, and blamed the DEA for poor communication and unclear rules. 

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report said. 

What has the DEA done in the last year to correct these problems? 

Of the 11 recommendations made by the GAO to improve the quota system and prevent drug shortages, the DEA has fully implemented only two of them.

One of the problems the DEA failed to address is the timeliness of its release of production quotas. Under guidelines set in 2006, the DEA is supposed to set quotas for controlled substances on or before May 1 of each year, to give drug manufacturers enough time to adjust their production schedules for the following year.

“DEA officials attributed this lack of compliance to inadequate staffing and noted that the agency’s workload with respect to quotas had increased substantially,” the GAO said in a report this summer.

“We could not confirm whether DEA’s lack of timeliness in establishing quotas had caused or exacerbated shortages because of concerns about the reliability of DEA’s data, among other things. However, by not promptly responding to manufacturers’ quota applications, we concluded that DEA may have hindered manufacturers’ ability to manufacture drugs that contain schedule II controlled substances that may help prevent or resolve a shortage.”

The quotas for 2017 were released on October 5 -- the 10th straight year that DEA has missed the quota deadline.

DEA Cutting Opioid Supply in 2017

By Pat Anson, Editor

It’s going to get even harder for chronic pain patients in the United States to get prescriptions refilled for hydrocodone, oxycodone, morphine and other opioids classified as Schedule II controlled substances.

The Drug Enforcement Administration has announced plans to reduce the amount of almost every Schedule II opioid pain medication manufactured in the U.S. by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, is being reduced by a third.

The DEA’s order, which is being published in the Federal Register, comes just seven months after the Centers for Disease Control and Prevention released guidelines that discourage primary care physicians from prescribing opioids from chronic pain. The guidelines have had a chilling effect on many patients and their doctors, who have reduced opioid doses or stopped prescribing them altogether.

Opioid prescribing was falling years before the CDC and DEA acted. According to IMS Health, hydrocodone prescriptions in the U.S. plunged by 22 percent from nearly 120 million in 2014 to 93.5 million in 2015.

The “established quota” for hydrocodone in 2017 is being reduced to 58.4 million prescriptions under the DEA order.

“The purpose of quotas are to provide for the adequate and uninterrupted supply for legitimate medical need of the types of schedule I and II controlled substances that have a potential for abuse, while limiting the amounts available to prevent diversion,” the DEA said in a press release.

“Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those companies that apply for it.  DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls.”

The DEA has been under growing political pressure to reduce the supply of opioids. A group of U.S. senators sent a letter to the agency this summer demanding that opioid quotas be reduced.

We urge DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic,” said the letter from Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV).

“Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.”

Although opioid pain medication is routinely blamed by politicians, federal agencies and the media for the nation’s so-called opioid epidemic, recent studies in several states have found that most drug overdoses are actually caused by illegal opioids such as heroin and bootleg fentanyl. There are also increasing signs that pain patients unable to get opioids legally are turning to pain medication sold on the streets, some of it counterfeit and laced with fentanyl.

Efforts to restrict the supply of opioids may only be making things worse.

Law enforcement agencies in West Virginia recently said a federal crackdown on opioids – dubbed the Bluefield Pill Initiative -- may have contributed to a recent spike in heroin cases, according to the Bluefield Daily Telegraph.

“We are seeing an increase in heroin because pills are in fewer quantity,” said Sgt. J.S. McCarty, who heads a local crime task force. “Without pills an opioid addict’s only choice is heroin.”