Addiction to Rx Opioids Falling

By Pat Anson, Editor

A new report from health insurance giant Blue Cross Blue Shield highlights a little-known and rarely reported aspect of the opioid crisis: Addiction to opioid pain medication is declining, not increasing.

Blue Cross Blue Shield (BCBS) said 241,900 of its members were diagnosed with opioid use disorder (OUD) in 2017, a rate of 6.2 for every 1,000 BCBS members. The rate fell to 5.9 in 1,000 members in 2017, a decline of nearly 5 percent. The insurer said it was the first drop in the eight years BCBS has tracked diagnoses of OUD.

"We are encouraged by these findings, but we remain vigilant," said Trent Haywood, MD, senior vice president and chief medical officer for BCBS said in a statement.

"More work is needed to better evaluate the effectiveness of treatment options and ensure access to care for those suffering from opioid use disorder."

BCBS attributes much of the decline to a 29% drop in opioid prescriptions for its members since 2013.  A longtime critic of opioid prescribing hailed the findings as a sign of change.

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"It means that there's light at the end of the tunnel," psychiatrist Andrew Kolodny, MD, the founder and executive director of Physicians for Responsible Opioid Prescribing (PROP) told BuzzFeed.

"Unfortunately though, the genie is out of the bottle," said Kolodny, a former medical director of the addiction treatment chain Phoenix House. "Millions of Americans are now struggling with opioid addiction. Unless we do a better job of increasing access to effective treatment, overdose deaths will remain at record high levels and we'll have to wait for this generation to die off before the crisis comes to an end."

Admissions for Addiction Treatment

The BCBS numbers should be taken with a grain of salt, since they include all types of opioid addiction, including those linked to heroin, illicit fentanyl and prescription opioids. A more accurate way to track addiction to opioid medication would be admissions to publicly-funded treatment facilities for “non-heroin opiates/synthetic abuse” – a category that excludes heroin, but includes hydrocodone, oxycodone, fentanyl and other painkillers.

A database maintained by the Substances Abuse and Mental Health Services Administration (SAMHSA) shows that treatment admissions for prescription opioids peaked in 2011 at 193,552 admissions and fell to 121,363 by 2015 – a significant decline of over 37 percent. It seems likely that admissions for painkiller abuse have fallen even further since 2015, as opioid prescriptions have continued to plummet, and more pain patients are abandoned or denied treatment.

The SAMHSA data also reveals another trend: While the number of people seeking treatment for painkiller, alcohol and marijuana abuse has declined, admissions to treatment facilities for heroin addiction have soared. In 2010, there were 270,564 admissions in which heroin was identified as the primary substance of abuse. By 2015, that number had grown to 401,743 admissions – an increase of nearly a third.

ADMISSIONS TO ADDICTION TREATMENT FACILITIES

SOURCE: SAMHSA

Admissions for heroin addiction now surpass those for other substances, yet much of the nation’s spending and law enforcement resources remain targeted on opioid prescriptions. Many public health officials also cling to the myth the heroin epidemic was triggered by opioid overprescribing, even though heroin admissions outnumber painkiller admissions by a 3 to 1 margin.

“Epidemiological data show that as widely prescribed opioids became less accessible due to supply side interventions, heroin use skyrocketed,“ psychiatrist Nora Volkow, MD, director of the National Institute on Drug Abuse, recently told OpioidWatch.  Volkow was an early supporter of the CDC opioid guideline, one of the first supply side interventions, a strategy that she now characterizes as "naive."

“Expecting that declines in rates of prescribed opioids could, by themselves, stem the tide of the opioid crisis is naïve and an oversimplification of the complex nature of the crisis," Volkow said. "Legitimate questions have been raised about whether some pain patients might now be undertreated, and whether tightened prescribing practices over the last few years has contributed to the surge in overdose deaths from heroin and especially fentanyl.”

A recent study by SAMHSA found that deaths linked to illicit fentanyl and other synthetic opioids surpassed overdoses involving pain medication in 2016.  The study also found that drugs used to treat depression and anxiety are involved in more overdoses than any other class of medication.

Counterfeit Pill Problem ‘Getting Worse by the Day’

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 22 states, according to a new report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy and healthcare organizations. Counterfeit pills laced with fentanyl have now been found from coast to coast in 43 states.

“This updated report shows that the illegally-imported fentanyl problem is getting worse by the day,” said Dr. Marvin Shepherd, chairman of the PSM Board.

Fentanyl is 100 times more potent than morphine. It is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is typically mixed with heroin or cocaine. Rogue manufacturers also press it into counterfeit prescription pills such as Vicodin, Percocet and Xanax.

Unsuspecting buyers – including pain sufferers looking for relief -- often have no idea what they’re getting.

According to a recent CDC report, drug deaths involving fentanyl (19,413) surpassed overdoses linked to prescription opioids (17,087) in 2016.

COUNTERFEIT PERCOCET

COUNTERFEIT PERCOCET

“The annual count of overdose deaths from prescription opioids has remained constant since 2011, but deaths from fentanyl poisoning have spiked since then. As fentanyl-laced pills mimicking legitimate medication have flooded the illicit drugs supply, prescription drug users have been poisoned by the counterfeits,” the PSM report found. 

“The tally of deaths because of counterfeit pills made with fentanyl is probably undercounted because lab protocols lagged behind this shift and weren’t testing for fentanyl.”

The pills are difficult to trace, as Minnesota prosecutors admitted last week when they announced that no criminal charges would be filed in the accidental overdose death of Prince. The music icon died two years ago after taking counterfeit painkillers that were “an exact imitation” of Vicodin.

“Prince thought he was taking Vicodin and not fentanyl,” said Carver County Attorney Mark Metz, adding that dozens of counterfeit pills were found in Prince’s home, many of them stored in aspirin bottles.

Investigators were unable to determine how or where Prince obtained the fake pills, but they are readily available online for anyone who cares to look. According to one report, there are as many as 35,000 online pharmacies operating worldwide. Many do not require a prescription and are selling counterfeit medications. Their customers include some pain patients who are no longer able to obtain opioids legally from doctors and are looking for other sources.

‘Criminals Are Pretty Smart’

“They’re looking, maybe innocuously, for medicine online. They’re searching for ‘fentanyl online’ or ‘Percocet buy.’  Not because they want to buy medicine on the Internet, but rather they just want to find medicine,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies, an industry supported non-profit.

“The criminals are pretty smart. They know that there’s a market out there and they know they can offer these medicines to patients for good reasons, bad reasons or otherwise that are looking for those medicines. And they are going to get duped because they are very likely buying from a website that is selling it illegally.”

The National Association of Boards of Pharmacy recently evaluated 100 websites selling medications and found that almost all were operating illegally and selling drugs without a prescription. Over half (54%) were selling controlled substances and 40% were offering drugs that are frequently counterfeited with fentanyl.

The marketing and selling of counterfeit medicine goes beyond just online pharmacies. Drug dealers are increasingly using Facebook, Twitter and message boards to reach customers. PNN recently received this sales pitch from one dealer:

"We have pharmaceutical drugs for your health illness especially for Chronic Pain, Anxiety, Depression, Panic Disorder. ADHD, Xanax Bars, Narcolepsy pills, Antidepressants, Antipsychotics, Benzodiazepines, Narcotics, Opiates, weight loss/fat burner. We do overnight secure shipping."

Warning unsuspecting buyers about the easy availability of these drugs poses a dilemma for law enforcement and policy makers.

“We have ethical tension around all of this. On the one hand, we certainly don’t want to be educating people that you can buy controlled substances or prescription drugs on the Internet without a prescription, counterfeit or otherwise. That’s just dangerous. But we also don’t want to be in a position of not warning them or not making a policy response to the fact that this currently exists,” Baney told PNN.

It is relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards. You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

DEA Cutting Rx Opioid Supply in 2018

By Pat Anson, Editor

The U.S. Drug Enforcement Administration is going ahead with plans to reduce the supply of many opioid painkillers by 20 percent next year. That’s in addition to steep cuts in opioid production quotas the agency imposed in 2017.

In a notice quietly published this week in the Federal Register, the DEA said it would reduce the supply of many commonly prescribed Schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, and fentanyl. The agency said demand for the medications had dropped.

In proceeding with the cuts, which were first proposed in August, the DEA dismissed warnings from three drug makers that the reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

The DEA received over 100 public comments on its proposal, most of them expressing concern that any further reduction in opioids would adversely impact the availability of prescription painkillers.

“I am 75 years old, have metastatic prostate cancer in my bones and have to take high doses of fentanyl patches and morphine tablets for the chronic, intractable pain. Please do not further reduce the supply of my critical medicine,” wrote Bill Daniel.

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“Please stop this misguided attempt to save people from themselves. If demand is down, it's because you bullied physicians into prescribing less, not from a genuine market conditions,” wrote one anonymous poster.

“You want to cut my access to the medication I'm legally prescribed by my pain management doctors! Would you consider the same for people deemed disabled due to other illnesses? You are going to cause millions of us to either commit suicide due to unbearable pain or turn to street drugs,” said Christa Rood.

The DEA said comments such as these dealt with medical issues that were “outside of the scope” of its order and did not offer any new data for the agency to consider.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Those cuts were not sufficient to stop the opioid epidemic, according to two letters sent to the DEA by a group of U.S. senators. The first letter, sent in July, urged that "further reductions... are necessary to rein in this epidemic.”

A second letter, sent in September, said there was "no adequate justification for the volume of opioids approved for the market." The senators asked to DEA to make the 2018 cuts in the opioid supply at least as deep as they were in 2017. 

Opioid prescriptions have actually been in decline for several years.  According to the Centers for Disease Control and Prevention, opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

In recent years, heroin and illicit fentanyl have emerged as the driving forces behind the overdose crisis, which killed an estimated 64,000 Americans in 2016. Despite that, federal efforts to prevent overdose deaths remain largely focused on reducing the use of prescription painkillers.

The CDC, for example, is spending $4.2 million on an Rx Awareness campaign in four states; running ads on billboards, radio, newspapers and online that warn about the risks of prescription painkillers. Although a recent CDC study found fentanyl was involved in over half the overdoses in ten states, the agency says it has no plans to include fentanyl or heroin in its awareness campaign.

“Our aim with this campaign is to prevent prescription opioid overdose deaths, since prescription opioids continue to be involved in more overdose deaths than any other drug. Based on studies of people entering treatment, the majority of people with opioid use disorder (including heroin use disorder) still start with prescription opioids,” CDC spokesperson Courtney Lenard said in an email.

CDC Launches New Campaign Against Rx Opioids

By Pat Anson, Editor

The Centers for Disease Control and Prevention has launched a new awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the increasing role of heroin and illicit fentanyl in the nation’s overdose crisis.

The Rx Awareness campaign uses videos, online advertising, billboards, newspapers and radio ads designed to increase awareness “about the risks of prescription opioids and stop inappropriate use.” The campaign will initially run for 14 weeks in Ohio, Kentucky, Massachusetts, and New Mexico, with a broader release expected as additional states receive funding through CDC programs. No estimate of the cost of the campaign was released.

“The U.S. Department of Health and Human Services (HHS) is committed to using evidence-based methods to communicate targeted messages about the opioid crisis and prevent addiction and misuse in every way we can,” HHS Secretary Tom Price, MD, said in a statement. 

But little "evidence" is actually presented in the Rx Awareness campaign, which primarily uses slogans and emotional, “real-life accounts” of people recovering from opioid addiction or who have lost loved ones to a prescription opioid overdose.

“Prescription opioids can be addictive and dangerous,” a woman says in an online banner ad.

“One prescription can be all it takes to lose everything,” a man says in another ad.

Although addictive behavior typically starts during adolescence, the Rx Awareness campaign is targeting adults aged 25-54 who have used prescription opioids at least once either medically or recreationally.

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“We learned that adults between the ages of 45 and 54 had not yet been targeted by a broad-reaching campaign. This information was reinforced by surveillance data indicating that the population with the highest fatality rate from opioid overdoses was non-Hispanic white adults ages 45–54,” the CDC said in an unusually detailed explanation of the marketing research behind the campaign.

“We also found a need for communication efforts to deliver primary prevention messages to younger audiences ages 25–35, who are less likely to experience chronic pain but may be exposed to opioids for other reasons, such as having a sports injury or undergoing a dental procedure.”

The four states initially being targeted all have soaring rates of opioid overdoses, but in recent years most of the deaths have been linked to heroin and illicit fentanyl, not prescription opioids. 

The latest report from the Massachusetts Department of Public Health, for example, shows prescription opioids were involved in only 15 percent of opioid-related overdose deaths in the state during the first quarter of 2017. Fentanyl was involved in 81 percent of the Massachusetts deaths and heroin in 39 percent of them. 

But fentanyl and heroin are not even addressed in the Rx Awareness campaign, because the CDC didn't want to risk “diluting” its primary message.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC said.

One of the video testimonials featured in the campaign is the story of Steve Rummler, a Minnesota man with chronic back pain who became addicted to painkillers. Rummler died of a heroin overdose at the age of 43.

His mother Judy, who appears in the video, founded the non-profit Steve Rummler Hope Foundation, an anti-opioid activist group. The Rummler foundation is the “fiscal sponsor” of Physicians for Responsible Opioid Prescribing (PROP), a designation that allows PROP to collect tax deductible donations using the foundation’s non-profit status. PROP founder Andrew Kolodny, MD, is listed as a member of the Rummler foundation's medical advisory committee, as is PROP President Jane Ballantyne, MD.

The CDC said it developed the videos and other campaign material using a “mixed-method design integrating data from in-depth interviews and a quasi-experimental, one-group retrospective post-then-pretest (RPTP) survey was used to assess target audiences’ responses to campaign messages.”

In the other words, the campaign is driven by marketing research -- not Secretary Price's "evidence-based methods." The CDC said most participants in focus groups thought the campaign material was "attention grabbing, believable and meaningful." Many also said they would share the video testimonials with others.   

“This campaign is part of CDC’s continued support for states on the frontlines of the opioid overdose epidemic,” said CDC Director Brenda Fitzgerald, MD. “These heartbreaking stories of the devastation brought on by opioid abuse have the potential to open eyes – and save lives.”

CVS to Limit Opioid Prescriptions

By Pat Anson, Editor

CVS Health has announced plans to further restrict the filling of opioid prescriptions at its pharmacies by limiting the dose and supply of opioids for acute pain to seven days. The new policy only applies to customers enrolled in the CVS Caremark pharmacy benefit management program, which provides pharmacy services to over 2,000 health and insurance plans.

CVS said its opioid policy would “give greater weight” to the Centers for Disease Control and Prevention's opioid prescribing guideline, which discourages doctors from prescribing opioids for chronic pain.

“The CDC Guideline should become the default approach to prescribing opiates, a scenario in which physicians would have to seek exceptions for those patients who need more medication or longer duration of therapy,” Troyen Brennan, MD, CVS’ Chief Medical Officer wrote in a post on Health Affairs Blog.

But the new CVS policy actually goes beyond the voluntary recommendations of the CDC guideline, which was only intended to give advice to primary care physicians who treat chronic pain.

Beginning February 1, CVS will limit all opioid prescriptions for acute pain to seven days. For both acute and chronic pain, opioid doses must not exceed 90mg morphine equivalent units and patients will be required to try immediate release formulations, before using extended release opioids.

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The policy will apply to all 90 million CVS customers enrolled in commercial, employer or Medicaid health plans. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide.

In announcing the policy, CVS rejected complaints that it and other healthcare providers were adopting a “heavy-handed, cookie cutter” approach to patient care – decisions best left between a patient and their doctor.

“To be sure, prescriber autonomy and respect for the physician-patient relationship are of paramount importance. However, there is little evidence to show that past opioid prescribing habits are necessary or appropriate, and there is a great deal of evidence that they have produced significant harm,” said Brennan.

“We see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse,” said Larry Merlo, CEO of CVS Health. 

“With this expansion of our industry-leading initiatives, we are further strengthening our commitment to help providers and patients balance the need for these powerful medications with the risk of abuse and misuse.”

 

Opioids Have Been Costly for CVS

Patient safety may not be the only factor behind CVS’ decision to limit opioid prescriptions. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

As PNN has reported, CVS recently agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the painkiller hydrocodone by employees.

In 2016, CVS also paid a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged opioid prescriptions. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

As a result of these and other fines, CVS pharmacists were already under pressure to be wary of filling opioid prescriptions. Many started calling doctors to make sure the prescriptions were legitimate and some even refused to fill the prescriptions of longtime customers.

Alcohol Sales Continue

CVS was widely praised for its decision to stop selling cigarettes a few years ago, a move that cost the company $2 billion in lost tobacco sales.  According to Marketplace, the company has also removed transfats from its branded food products and reduced displays of candy near its cash registers.

The healthier offerings apparently do not apply to alcohol, however, a substance that causes far more addiction, death and health problems than opioid medication. This week an advertising flier for CVS stories in California prominently displays a selection of inexpensive beer, wine and hard liquors.

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CVS did not respond to a query from PNN about whether it intends to limit the amount and frequency of alcohol purchases, as it is planning to do for opioid pain medications.    

CVS Health (NYSE: CVS) stock has fared poorly in the past year and company insiders have sold nearly $100 million in shares. Among the sellers, according to Barrons, was CEO Merlo – who has sold $26 million in shares so far in 2017, including $20 million in September alone.

Petition Calls on FDA to Ban High Dose Opioids

By Pat Anson, Editor

A group of anti-opioid activists has filed a citizen petition with the Food and Drug Administration, asking the agency to remove most high dose opioid pain medications from the market.

The petition would apply to all opioid pills that exceed a daily dose of 90mg morphine equivalent units (MMEs), which the Centers for Disease Control and Prevention set last year as the highest recommended dose for primary care physicians and their patients.  

Such a ceiling, if adopted by the FDA, would take all OxyContin 80mg tablets off the market, as well as many other high-dose oral painkillers. A single OxyContin 80mg tablet, according to the petition, is equivalent to 160 MME.

Another example cited in the petition would be immediate release oxycodone 30mg tablets. If four such pills are taken daily, as they are often prescribed, that adds up to 180 MME.

The petition claims high dose opioid pills raise the risk of overdose and addiction, and are especially harmful to children.

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“These products are just too dangerous, there's no need for them," said Pete Jackson, who lost his teenage daughter to an OxyContin overdose.

"These are not medicines. These are lethal weapons that should be removed from the market," said Andrew Kolodny, MD, an addiction treatment specialist and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), one of five anti-opioid activists who signed the petition. None are considered experts in pain management.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states. “For patients that may have difficulty swallowing it is important to note that opioid analgesics are available in liquid preparations, sublingual preparations, patches and suppositories.”

Opioids ‘Can Be Appropriate’

In a rare acknowledgement that opioids "can be appropriate" for some pain patients, Kolodny and the other petitioners wrote that "the benefits of prescribing high doses may outweigh the risks when treating severe pain from a life-limiting illness."

But then they make the dubious claim that flooding the market with lower-dose pills will somehow be safer. Reducing the potency of painkillers would mean patients need more to get pain relief – resulting in more pills being prescribed, stored in medicine cabinets, and possibly stolen or diverted – hardly a prescription for reducing abuse.

Having to take more pills could also be risky to patients.  

"With a very large number of pills to manage, they are going to be at more risk of taking the wrong number of pills and of having some of those pills swiped by others without them noticing," Stefan Kertesz, MD, an Alabama primary care physician, told the Associated Press.

“Given the significance of the nation’s opioid crisis, this petition and issue should be discussed by the scientific experts at FDA and we look forward to participating in such a discussion,” Purdue Pharma, the maker of OxyContin, said in a statement. “It is critical that we seek the appropriate balance of treating pain severe enough that requires opioid treatment for which alternative treatments are inadequate, with efforts combating the opioid crisis.”

The FDA had no immediate comment on the petition.  Any U.S. citizen can file a petition with the agency to seek the removal of a drug or medical device for safety issues.

In June, the FDA asked Endo Pharmaceuticals to take Opana ER off the market because it was being abused, the first time that sales of an opioid painkiller have been halted. FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said in June.

To make a comment on the PROP petition to the FDA, click here.

Is China Doing Enough to Stop Fentanyl Smuggling?

By Pat Anson, Editor

China has been an "incredible partner" in cracking down on illicit fentanyl and other synthetic opioids, according to Health and Human Services Secretary Tom Price.

"When a particular drug is identified as being a problem, China has been an incredible partner in helping to stop the production of drugs like fentanyl in China," Price told The Associated Press during a visit to China this week.

A closer look suggests otherwise. Mexican drug cartels continue to smuggle alarming amounts of fentanyl – usually produced in China -- into the U.S. and Canada, where it is often mixed with heroin or turned into counterfeit painkillers.

Consider these recent news reports:

The Mexican military last Saturday seized 63.8 kilograms of fentanyl (over 140 pounds) at a checkpoint just yards from the U.S. border near Yuma, Arizona. The newspaper El Financiero reported the powdered fentanyl was found hidden inside a tractor trailer rig, along with nearly 30,000 tablets made with the chemical. The shipment had an estimated street value of $1.2 billion – by far the largest seizure ever of illicit fentanyl.

A week earlier, DEA agents confiscated 30,000 more counterfeit pills at a traffic stop near Tempe, the largest seizure of fentanyl tablets in Arizona history. The Tucson News reported the drugs were connected to the Sinaloa drug cartel.   

The fake pills were designed to look like oxycodone -- an "M" and a "30" were stamped on the blue tablets.

"This massive seizure removed thousands of potentially lethal doses of this powerful narcotic off the streets," said DEA Special Agent in Charge Doug Coleman. 

COUNTERFEIT PILLS SEIZED IN TEMPE, ARIZONA (DEA PHOTO)

COUNTERFEIT PILLS SEIZED IN TEMPE, ARIZONA (DEA PHOTO)

It doesn’t take much fentanyl to kill someone – the chemical is 50 to 100 more potent than morphine. Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying on the black market.  Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.  

New Jersey’s Attorney General said this week that a suspected drug dealer arrested in March with 14 kilograms of fentanyl – less than a quarter of what was seized in Mexico last weekend -- was enough “to kill more than half the population of the state.” The “super potent” fentanyl, believed to have been shipped from China, “could have yielded upward of five million lethal doses," according to Attorney General Christopher Porrino.

“Fentanyl is commonly mixed with heroin or cocaine for sale on the street, or is sold in powder compounds or counterfeit pills disguised as heroin, oxycodone or Xanax,” Porrino’s office said in a statement.  “Given the tiny size of a lethal dose, drug users are dying because dealers are careless about how much fentanyl they put in such mixes and pills."

Federal prosecutors say a drug ring busted earlier this year in San Antonio, Texas produced hundreds of thousands of counterfeit pills laced with fentanyl and sold them over the Internet to customers all over the country. DEA agents believe several people may have died after ingesting the pills, which were disguised to look like oxycodone, Adderall or Xanax.  

According to the San Antonio Express News, at least 70 packages of fake pills being shipped through the U.S. Postal Service were intercepted. Another 120 packages ready for shipment were seized when the drug ring was finally shutdown, along with four commercial pill press machines. Prosecutors say the fentanyl was obtained from China.

“I’ve never seen a case like this,” said Assistant U.S. Attorney Joey Contreras. “The quantities they’re able to distribute, and in anonymity, are staggering.”

China has promised before to crackdown on illicit manufacturers of fentanyl.  In February, China’s National Narcotics Control Commission announced that it was “scheduling controls” on four fentanyl-class substances. The move came after several months of talks with U.S. officials and was widely praised by the DEA.

“These actions will undoubtedly save American lives and I would like to thank my Chinese counterparts for their actions on this important issue," Acting DEA Administrator Chuck Rosenberg said in a news release.

President Trump’s opioid commission is taking a dimmer viewer of China’s efforts. In its interim report to the president last month, the commission warned that illicit fentanyl was “the next grave challenge on the opioid front” and that stronger efforts were needed from China to stop fentanyl smuggling.

We are miserably losing this fight to prevent fentanyl from entering our country and killing our citizens. We are losing this fight predominately through China. This must become a top tier diplomatic issue with the Chinese; American lives are at stake and it threatens our national security,” the commission said.

DEA Proposes Further Cuts in Opioid Supply

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has proposed an additional 20 percent reduction in the manufacture of many opioid painkillers, including oxycodone, hydrocodone, codeine and morphine. The proposed cuts in the opioid supply, which would be effective in 2018, are in addition to those imposed by the DEA in 2017.   

“Demand for these opioid medicines has dropped,” the DEA said in a news release, citing sales data released by the QuintilesIMS Institute, which tracks prescription drug use. About 7 million fewer prescriptions were filled for hydrocodone in 2016, the fifth consecutive year that hydrocodone prescriptions have dropped.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said DEA Acting Administrator Chuck Rosenberg. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

Many pain patients tell PNN that demand for opioid medicine has not dropped, but that doctors are increasingly reluctant to write opioid prescriptions because of increased oversight by the DEA, insurance companies, and federal and state regulators.  

“It is discrimination, plain and simple. I have a well-documented chronic pain condition. Social Security has deemed me 100 percent disabled,” wrote Lora Lemons. “No other chronic condition that requires medication to combat the disease is flagged the way pain producing diseases are.”

“I am prepared to commit suicide if my pain meds are drastically cut,” wrote a woman who has adhesive arachnoiditis, a chronic and disabling spinal condition. “We don't want to die, but the legislators in the federal and state governments are going to force it for those in intractable pain.”

“No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our doctors are afraid to treat us humanely and adequately,” said Candi Simonis.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Despite those deep cuts, the DEA remains under political pressure to combat the overdose epidemic by reducing the opioid supply even further. Last month, a group of 16 U.S. senators wrote to Rosenberg saying additional cuts “are necessary to rein in this epidemic.”

The DEA published notice of its intent in the Federal Register and is accepting public comments on the proposal until September 6.

Click here to post your comment on the 2018 production quotas.

FDA Study Calls for More Aggressive Opioid Regulation

By Pat Anson, Editor

A new report commissioned by the U.S. Food and Drug Administration is calling for a sustained and coordinated national campaign to combat the opioid crisis, including more aggressive regulation of opioids by the FDA and a “cultural change” in the prescribing of opioid medication,

The report by a special committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) focuses primarily on restricting the supply of prescription opioids, not illicit opioids such as heroin and fentanyl, which are now driving the so-called opioid epidemic.

"The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin," said committee chair Richard Bonnie, a Professor of Medicine and Law at the University of Virginia.

“This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them. This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing. We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel."

The report estimates that at least 2 million people in the U.S. have an “opioid use disorder” involving prescription opioids -- meaning they are addicted to prescription painkillers -- and almost 600,000 have an opioid use disorder involving heroin.

Although opioid prescribing has been declining and the number of overdose deaths from prescription opioids has remained relatively stable in recent years, deaths from illicit opioids such as heroin have tripled in the past decade.

NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINES

NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINES

The report claimed that many people who normally would use prescription opioids have transitioned to heroin because of the declining price of heroin and the introduction of abuse-deterrent formulations that make opioid medication harder to snort or inject. The Centers for Disease Control and Prevention (CDC) has said there is no evidence to support the theory that legitimate patients are transitioning to heroin.

"Evidence does not support the hypothesis that initiatives intended to reduce opioid prescribing increase illicit opioid-related overdose at a population level," Deborah Dowell, MD, of the CDC recently wrote in the Annals of Internal Medicine.

The NASEM committee recommended that further efforts be made to restrict the supply of opioid medication, even though there is “limited evidence” that steps taken so far are working and may, in fact, be harming patients.

“Although more research is needed, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community may help curtail access. Importantly, however, none of these studies investigates the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed,” the report states.

The NASEM report also recommends broader insurance coverage of non-opioid treatments.and better education of physicians in pain management.

“The committee’s recommended changes to provider education and payer policy should be accompanied by a change in patient expectations with respect to the treatment and management of chronic pain. Attention is not being paid to educating the general public on the risks and benefits of opioid therapy, or the comparative effectiveness of opioids with nonopioid or nonpharmacologic therapies,” the committee said.

The committee also recommended that the FDA conduct a full review of currently approved opioids and that it consider “public health considerations” in all of its regulatory decisions. Such a policy would require the agency to not only consider the safety and efficacy of opioids for legitimate pain needs, but also their impact on addicts and the illicit drug market.

“I was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments,” FDA commissioner Scott Gottlieb, MD, said in a statement.  “Among these important new actions is our work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs.”

Last month the FDA asked that the opioid painkiller Opana ER be removed from the market, not because it was harming legitimate pain patients, but because addicts were abusing it and spreading infectious diseases through infected needles. It was the first time the agency has taken steps to remove an opioid from the market.

“These are just some of the important efforts we have underway. But to make a meaningful impact, this epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach. As underscored in the NASEM report, the scope of this epidemic is so large, it’s going to require a coordinated effort that includes federal, state, and local partners,” Gottlieb said.

The NASEM study was funded by the FDA.

Poorly Treated Pain Linked to Opioid Misuse

By Pat Anson, Editor

A provocative new study has found that untreated or poorly treated pain is causing many young adults to self-medicate and turn to the black market for pain relief. The research adds to a growing body of evidence that efforts to limit opioid prescribing are leading to more opioid misuse and addiction, not less.

The study, published in the Journal of Addiction Medicine, involved nearly 200 young adults in Rhode Island who used opioid pain medication “non-medically” – meaning they didn’t have a prescription for opioids or used them in a way other than prescribed. About 85 percent had experienced some type of injury or health condition that caused severe pain.

Three out of four said they started misusing opioids to treat their physical pain. Most went to see a doctor to treat their pain, but about a third -- 36 percent of the women and 27 percent of the men -- said their doctor refused to prescribe a pain medication.

“In addition to being denied medication to treat severe pain by a physician, a significant percentage (20%) of young NMPO (non-medical prescription opioid) users who reported experiencing a high level of pain did not try to obtain treatment from a doctor for reasons including the belief that they would be denied prescription painkillers and/or having no health insurance,” said lead author Brandon D.L. Marshall, PhD, of Brown University School of Public Health.

“Pervasive negative perceptions of healthcare providers (and/or the medical system in general), and also issues related to accessing healthcare resources, may also underlie the high prevalence of professionally unmitigated physical pain in this population of young adults who use NMPOs in Rhode Island.”

Participants were between the ages of 18 and 29, used opioids at least once non-medically in the past 30 days, and were enrolled in the Rhode Island Young Adult Prescription Drug Study (RAPiDS). Most also used heroin, marijuana, cocaine, LSD or another illegal drug more than once a week.

“Although this is a small study and we can't draw conclusions from it, I do think it sheds light on what can be unintended consequences if we are not willing to treat pain in people with increased risk factors and co-morbid mental health disorders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “These results may reflect the increased number of physicians who are unwilling to prescribe an opioid if there are risk factors or maybe just unwilling to prescribe an opioid.  It also shows that a consequence of not treating severe pain in people who also have significant risk of abuse may lead to illicit drug use and more harm."

Participants in the study who did not see a doctor for their pain had a variety of reasons:

  • 48% Thought they could handle the pain or manage it with over-the-counter drugs
  • 25% Thought they would be denied a prescription painkiller
  • 40% Don’t like seeing a doctor
  • 25% Had no health insurance

This was not the first study to find a correlation between poorly treated pain and drug abuse. A 2012 study of young adults who misused opioids in New York City and Los Angeles found that over half self-medicated with an opioid to treat severe pain. One in four had been denied a prescription opioid to manage severe pain.

A recent study of 462 adults who injected drugs in British Columbia found that nearly two-thirds had been denied prescription opioids. Nearly half had also been accused of drug seeking.

A recent survey of over 3,100 pain patients by PNN and iPain found that 11% had obtained opioids illegally for pain relief and 22% were hoarding opioids because they weren’t sure if they’d be able to get them in the future. Large majorities believe the CDC opioid guidelines were failing to prevent opioid abuse and overdoses (85%), and were harmful to pain patients (94%).