1 in 4 Counterfeit Pills Have Lethal Dose of Fentanyl

By Pat Anson, PNN Editor

Illicit drug users who buy prescription pills online or off the street are playing a dangerous game of Russian Roulette, according to a new laboratory analysis by the U.S. Drug Enforcement Administration.

The DEA found that about one of every four counterfeit pills (27%) have a potentially lethal dose of fentanyl, a synthetic opioid that is 80-100 times stronger than morphine.

Counterfeit pills laced with illicit fentanyl are appearing across the country and have been linked to thousands of deaths. Many of the overdoses involve blue pills stamped with an “M” and a “30” – distinctive markings for 30mg fake oxycodone tablets known on the street as “Mexican Oxy” or “M30.”

Based on a sampling of 106 tablets seized nationwide between January and March 2019, the DEA found that 29 of the pills contained at least 2 mg of fentanyl, a potential lethal dose. At least one pill seized in California had 4.2 mg of fentanyl — more than twice a lethal amount.

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“Capitalizing on the opioid epidemic and prescription drug abuse in the United States, drug trafficking organizations are now sending counterfeit pills made with fentanyl in bulk to the United States for distribution,” said DEA Acting Administrator Uttam Dhillon. “Counterfeit pills that contain fentanyl and fentanyl-laced heroin are responsible for thousands of opioid-related deaths in the United States each year.”

The DEA laboratory analysis found fentanyl in 21% of the heroin samples tested. Fentanyl is often added to illicit drugs to boost their potency.

‘Enough to Kill Entire Population of Ohio’

In recent months, there have been outbreaks of fentanyl-related overdoses around the country. Law enforcement agencies are also seizing larger amounts of fentanyl from drug traffickers.

In September, DEA agents found a pill press and five pounds of pure fentanyl in a San Diego apartment. Prosecutors said that was “enough to kill the city of San Diego” or about 1.5 million people.

That seizure was overshadowed a few weeks later, when 45 pounds of suspected fentanyl were seized in Montgomery County, Ohio. A Homeland Security agent said that was "enough to kill the entire population of Ohio, many times over."  

Public health officials in Seattle recently warned about a spike in fentanyl-related overdoses that killed at least 141 people in King County, including several teenagers. Parents and students are being warned in public service announcements not to consume any pill not directly obtained from a pharmacy or prescriber.

Last week health officials in Virginia predicted the state would have a record number of drug overdoses in 2019. Most of the 1,550 projected overdoses involve illicit fentanyl.

As in other parts of the country, fentanyl related deaths have surged in Virginia, while overdoses involving prescription opioids have remained relatively flat for over a decade.

“In 2015 statewide, the number of illicit opioids deaths surpassed prescription opioid deaths. This trend continued at a greater magnitude in 2016, 2017, and 2018,” the Virginia Department of Health said in its latest quarterly report. “There has not been a significant increase or decrease in fatal prescription opioid overdoses.”

DEA Seeks to Cut Inventories of Opioid Medication

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has announced plans to significantly reduce inventories of opioid pain medication and other controlled substances that drug manufacturers are allowed to maintain. The inventory reductions are in addition to cuts in the production of opioids that the DEA is seeking in 2020.

The proposed regulations, published this week in the Federal Register, would limit “excess quantities of medications” being stored in inventory that might be vulnerable to diversion. Other rule changes would tighten DEA oversight of the manufacturing and distribution of controlled substances.

Under current regulations, drug companies are allowed to keep inventories on up to 50% of their annual sales quota for Schedule I and II controlled substances. That would be reduced to 30% under the proposed rules.

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“Practically speaking, this equates to a reduction from half of a year's sales supply allowed to be held as inventory to nearly four months,” the DEA said.

The agency said the smaller drug inventory “is not expected to increase the likelihood of drug shortages,” because more manufacturers are available to increase production if shortages develop.

“The DEA believes a reduction of inventory allowance to 30%, with flexibility to produce up to 45% at any given point in a year, would have minimal impact on registrants while continuing to provide adequate inventory for registrants to respond to fluctuations in demand in pharmaceutical markets,” the agency said.

Last year the DEA allowed drug manufacturers to increase the production of injectable opioids after shortages developed at U.S. hospitals. The shortages became so acute that some hospitals were forced to use acetaminophen and muscle relaxants to treat surgery and trauma pain.

The FDA still has morphine, hydromorphone and fentanyl solutions on its list of drug shortages and there are anecdotal reports of hospitals continuing to ration injectable opioids. 

‘You Are Hurting Pain Patients’

The public has 60 days to comment on the DEA’s inventory proposal. The comments posted so far are mostly from pain patients critical of previous actions by the DEA.

“Why, why, why do you all keep taking meds from people? You are hurting the pain patients who need this medication. Start taking the drugs off the streets not from our doctors,” wrote Christy Ashford.

“The DEA has waged a war against the sickest and weakest members of American society,” wrote Kirsten Klang. “They know that almost all of the fatalities have to do with the integration of counterfeit fentanyl than any other chemical. Yet, the DEA clamps down where it's easy to do so... even if it's wrong... just because it's easy!”

“I would like to know why the DEA thinks it needs more power over the United States citizens. I mean really, don’t they think that they have tormented enough doctors and their patients through this so-called opioid crisis?” wrote Sheryl Cox. “They say that they have no control over the prescriptions that our doctors give us, and that is an outright lie. They do control our doctors by arresting them and prosecuting them needlessly, sending them to prison, and most do not deserve this kind of treatment and abuse.”

The DEA began cutting the supply of opioid medication in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third.

Last month, the DEA proposed further cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances. If approved, the 2020 production quotas would amount to a 60% decrease in the supply of hydrocodone and a 48% percent cut in the supply of oxycodone since 2016.

Cuts in the supply of prescription opioids have coincided with a sharp increase in overdoses from counterfeit medication. In recent months, hundreds of people have died after taking “Mexican Oxy” – counterfeit oxycodone pills made with illicit fentanyl – which are being trafficked in the U.S. from coast to coast.

Report: DEA ‘Slow to Respond’ to Opioid Crisis

By Pat Anson, PNN Editor

DEA investigators should get easier access to prescription drug databases and electronic prescribing should be required for all opioids and other controlled substances, according to a new report from the Justice Department’s Office of Inspector General (OIG).

The 77-page report is sharply critical of the Drug Enforcement Administration for its slow response to the opioid crisis and said the agency was “ill-equipped” to monitor suspicious orders and prevent diversion of prescription opioids.

“We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000. We also found that DEA did not use its available resources, including its data systems and strongest administrative enforcement tools, to detect and regulate diversion effectively. Further, we found that DEA policies and regulations did not adequately hold registrants accountable or prevent the diversion of pharmaceutical opioids,” the report found.

The OIG report focused exclusively on prescription opioids and did not evaluate the significant role that illicit fentanyl, heroin and other street drugs play in the opioid crisis. About two-thirds of opioid overdoses involve illicit drugs.

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The report also contains some factual errors, such as the misleading but often repeated claim that “nearly 80 percent of people who began abusing illicit opioids during the 2000s started by abusing a prescription opioid.”

Less than one percent of legally prescribed opioids are diverted, but the report claims the “pervasive nature of prescription fraud” is so rampant that paper prescriptions for opioids should be prohibited. Instead, electronic prescribing should be mandated nationwide to prevent fraud and allow for better tracking of opioid prescriptions.

‘Puzzling’ Restrictions on Opioid Databases

The report also calls for greater law enforcement access to state run prescription drug monitoring programs (PDMPs). To protect patient privacy, several states require a subpoena or search warrant before giving DEA investigators access to their databases. The report calls the requirement “puzzling” and said it creates “significant challenges” for DEA investigators “who should be able to receive PDMP data and information.”

“We believe that the Department and DEA should continue to work with states to reach agreements that will enable DEA to have timely access to PDMP prescription data as needed… while also ensuring adequate protections for the important healthcare privacy interests of patients,” the report said.

Other recommendations from the report:

  • DEA should develop a national prescription opioid enforcement strategy

  • Require criminal background checks for all new prescribers and registrants

  • Re-establish a nationwide early warning network to identify emerging trends in drug abuse   

  • Expand DOJ opioid fraud units to additional U.S. Attorney’s Offices

In its response to the OIG, the DEA said the report “rightly identifies areas of improvement,” but said the agency has taken a number of steps to reduce the supply and diversion of prescription opioids.

The DEA said “only a minute fraction” of the more than 1.8 million registrants are involved in illegal activity. The agency said it had revoked about 900 registrations annually over the past eight years and reduced the supply of prescription opioids by 45 percent since 2017. Additional cuts in the opioid supply are proposed for 2020.

Feds Target Online Pharmacies

By Pat Anson, PNN Editor

The FDA and DEA have sent warning letters to four online networks for illegally marketing unapproved and misbranded versions of opioid pain medication. The letters are the latest step in what appears to be an expanding federal and private crackdown on online pharmacies and websites that offer alternative health products and information.

The four online networks, which operate at least 10 websites, are Divyata, Euphoria Healthcare, JCM Dropship and Meds4U. The letters warn the companies to immediately stop selling illegal opioids to consumers.

“We cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said acting FDA Commissioner Ned Sharpless, MD.

The FDA has issued letters of this type before, but this is the first time the agency has jointly issued warning letters with the DEA. The companies were given 15 days to respond.

“You knowingly or intentionally use the Internet to advertise the sale of controlled substances by directing prospective buyers to Internet sellers of controlled substances who do not possess a valid modified DEA registration,” one letter warns.

“Therefore, your websites are operating in violation of United States law, which may be enforced through criminal penalties and civil enforcement.”

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The letter to Divyata alleges the company sells the opioid painkiller tramadol as an “agony reliever that ties with receptors of the mind and sensory system to diminish dimensions of torment.”

Euphoria Healthcare was warned for selling the opioid tapentadol under the name “Aspadol Tab” and claiming it is used “to treat moderate to severe pain that occurs for shorter to longer periods of time.” The FDA has never approved a drug called “Aspadol Tab.”

As PNN has reported, the FDA has previously cracked down on rogue online pharmacies selling counterfeit drugs or illegal medication. Often the websites reappear under new names or move offshore. As many as 35,000 online pharmacies operate worldwide. The vast majority are not in compliance with U.S. laws and many do not require a prescription, according to the Alliance for Safe Online Pharmacies.

The federal crackdown is not limited to opioids or prescription drugs. This month the Federal Trade Commission warned three companies selling CBD oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses.

Google Warns Online Publishers

Internet companies have also taken steps to reduce the flow of online traffic and advertising revenue to websites that offer alternative health information and products.

Today Google informed thousands of online publishers enrolled in its AdSense advertising partnership that it would restrict advertising on websites that promote or have content about recreational drugs, unapproved pharmaceuticals or supplements. The policy not only applies to illegal drugs such as heroin and cocaine, but includes several alternative treatments for pain, such as marijuana, CBD, kratom and other herbal supplements.

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In effect, Google is telling online publishers their advertising revenue will be reduced or stopped if they provide information that Google considers inappropriate.

“Publisher restrictions identify content that is restricted from receiving certain sources of advertising. By content, we mean anything present on your page or app - including other advertisements and links to other sites or apps,” Google explained in a note to publishers.

“If your content is labeled with an inventory restriction, fewer advertising sources will be eligible to bid on it. In some cases this will mean that no advertising sources are bidding on your inventory and no ads will appear on your content.”

Pain News Network is a Google AdSense partner. We frequently publish content about kratom, CBD and other alternative pain treatments. It is unclear how Google’s advertising policy will affect PNN.

In addition to restrictions on advertising, recent changes to Google’s search engine algorithms have suppressed search results for hundreds of websites that offer alternative health information or products. As a result, many of these websites have already experienced a substantial drop in revenue and readers.

Facebook, Pinterest, Tumblr and other online social networks have also recently suspended or deleted dozens of alternative health pages for containing what Facebook considers “false, misleading, fraudulent, or deceptive claims or content.”

Pinterest said it relies on governmental bodies to decide what is appropriate. “We rely on information from nationally and internationally recognized institutions, including the CDC and WHO, to help us determine if content violates these guidelines,” Pinterest explained in an email to a website that was banned.

PNN’s account with Pinterest was suspended without warning in June for violating the company’s “spam policies.”  Our account was reactivated a week later with an apology.

“Sorry that your account was suspended. Occasionally good accounts get caught in the mix when we're looking for spammy accounts,” Pinterest said in an email.

Stop Demonizing the ‘Holy Trinity’     

Lynn Kivell Ashcraft, Guest Columnist    

If we are to have any hope of a rational, scientific discussion about the issues involved in both pain management and addiction treatment, we need to end patient shaming and the use of sensational language that has no basis in clinical practice.

First on my list is to stop using the term “Holy Trinity” when referring to the use of multiple medication classes to manage pain. It is a sensational propagandizing use of terminology that has no place in any meaningful clinical discussion.

Holy Trinity was a term coined by law enforcement when discussing the behavior of addicts. The original Holy Trinity – the so-called “Houston Cocktail” -- referred to the simultaneous ingestion of the short acting drugs hydrocodone (Vicodin), alprazolam (Xanax) and carisoprodol (Soma) by addicts. Other combinations of opioids, muscle relaxants and anti-anxiety drugs such as benzodiazepines are also used.

“The cocktail is commonly known on the black market as the ‘holy trinity’ and is particularly sought-after by addicts, but is also particularly dangerous,” is how the DEA describes the drugs in criminal complaints, search warrants and training guides.  

SOURCE: DEA TRAINING GUIDE

SOURCE: DEA TRAINING GUIDE

Taken together, the three drugs can be risky and cause respiratory depression, overdose and death. But when used under medical supervision, they enable individuals with painful and disabling conditions to improve their quality of life and restore bodily functions.

Holy Trinity was never used originally to refer to any medication combination prescribed by physicians caring for pain patients. But with the advent of the opioid crisis, the term is being used as a scare tactic by law enforcement and even some medical providers to deny patients a combination of medications previously used successfully.

The unintended consequence of this careless usage has been the deaths and needless renewal of pain and disability for patients who were being safely prescribed these medications.  

There is no one-size-fits-all treatment for chronic severe centralized pain. In fact, the current Pain Management and Dosing Guide from the American Pain Society lists opioids plus other central nervous system depressants and valium (a diazepine) as potential treatments for neuropathic pain.

It is well acknowledged that successful treatment often requires polypharmacy regimens tailored to the needs of individual patients to achieve pain relief and provide quality of life. The potential risks of using multiple medications can be reduced by prescribing both long-acting forms of these drugs and by directing patients to take them separately. 

To use the Holy Trinity as an inflammatory term is to demonize certain medications that have been abused by addicts while being used successfully by intractable pain patients. The use of this derogatory term has caused the undeserved transference of the deeply held negative societal bias against “addicts” onto some of the frailest and medically complex patients, many of whom are struggling to achieve some quality of life. 

According to the CDC, about 20 percent of adults in the U.S. have chronic pain and 8 percent have severe “high impact” chronic pain that frequently limits their life or work activities. The 2011 Institute of Medicine report puts the number of Americans with pain at 100 million, which is more than those living with diabetes, heart disease and cancer combined.

The difference between the two reports highlights some of the issues with using and understanding statistics.  However, no matter which report you use, both numbers represent a staggering number of Americans living in pain who deserve effective treatment.

Let’s lose the term Holy Trinity and allow doctors to prescribe whatever medications they deem necessary for the restoration of function and the relief of pain in their patients. Name calling and the use of disrespectful terminology doesn’t solve either the problem of addiction or the problem of pain.

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Lynn Kivell Ashcraft is an Analytic Software Consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project. 

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

DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” acting DEA Administrator Uttam Dhillon said in a statement.

“DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

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The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. To make a comment online, click here. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.

Lessons from the Opioid Database

By Roger Chriss, PNN Columnist

Last month The Washington Post made public for the first time a DEA database of opioid prescribing that shows “the path of every single pain pill” sold in the United States from 2006 to 2012.

The Post’s analysis showed that 76 billion pills flowed through the country and nearly 100,000 fatal overdoses occurred over a seven-year period.

Biospace explained that opioid manufacturers, distributors and retailers “allowed the drugs to reach the streets of communities large and small, despite persistent red flags that those pills were being sold in apparent violation of federal law and diverted to the black market.”

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The first lesson from the database seems obvious. Too many pills were prescribed, with opioid manufacturers, distributors and retailers failing to report suspicious orders and government agencies failing to oversee the prescription opioid supply.

“If you don’t start millions of opioid-naive people on opioids they don’t need, it translates … in the longer term into fewer overdoses,” Stanford psychiatry professor Keith Humphreys told the Post.

But this misses a key lesson. Although no drug should ever be used when it is not needed, this leaves open the obvious and essential question: How do we reduce risks in people who do need opioids?

We cannot ban opioids completely without returning to pre-Civil War medicine. But each year we have millions of car crashes, severe battlefield and workplace injuries, new cases of cancer, major surgeries and devastating long-term illness.

In the many commentaries on the opioid database, little has been said about improving prescribing safety. We need better ways to use opioids safely because sometimes we just don’t have any other option.

If it is true, as Julie Croft, an Oklahoma addiction treatment provider wrote, “We are all just one accident away from becoming addicted to painkillers” -- then we had better rapidly improve how we use opioids or come up with better alternatives since we have millions of accidents annually.

To this end, Yale and the Mayo Clinic were recently awarded a $5.3 million FDA grant to study patients with acute pain and their use of opioids.

Reduced Prescribing May Not Be Enough

The next lesson in the database is vulnerability to substance abuse. Dennis Scanlon, PhD, and Christopher S. Hollenbeak, PhD, note in the American Journal of Managed Care, that “although using government or regulatory mechanisms to prevent or significantly curb the supply of addictive narcotics is certainly valuable, there is also value in preventing or reducing addiction at its core.”

In other words, policies that reduce opioid prescribing may be helpful, but they may also not be enough. We need better tools and greater understanding of opioid prescribing. The National Institute of Drug Abuse currently estimates that 8% of people on long-term opioid therapy develop some form of opioid use disorder, while The BMJ estimates that less than 1% of surgical patients receiving opioids face a similar fate. These numbers may seem low, but every effort should be made to reduce them.

As bioethicist Travis Reider states in his book “In Pain” about his personal struggle with opioids: “The bottom line is that we are not, by and large, acting decisively in an evidence-based way to tackle the myriad problems raised by opioids. Although we don’t know everything about how to turn the corner on this crisis, we know a lot, and we’re simply not doing it.”

The last essential lesson from the opioid database is that opioid abuse and addiction came long before the crisis. The clichéd response that we “cannot arrest our way” out of the crisis needs to be extended to we “cannot simply restrict our way out” either. We need better prevention and early intervention for opioid use disorder, and improved management of the opioid supply chain so as to prevent theft and diversion.

The crisis is a fast-moving target, with prescription opioid levels having dropped significantly since 2012. Overdoses involving prescription opioids have also fallen, while deaths linked to illicit opioids like fentanyl, cocaine and methamphetamine are rising sharply. We will need far more than a prescribing database to guide policy moving forward.

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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.