Study Finds Only 1.3% of Overdose Victims Had Opioid Prescription

By Pat Anson, PNN Editor

It’s long been a popular belief that prescription opioids fueled the nation’s opioid crisis and play a major role in overdose deaths. The CDC’s 2016 opioid guideline says as much.

“Sales of opioid pain medication have increased in parallel with overdose deaths,” the guideline states. “Having a history of an opioid prescription is one of many factors that increase risk for overdose.”

But a new study by researchers in Massachusetts has turned that theory on its head. Prescription opioids are usually not involved in overdoses. And even when they are, the overdose victim rarely has an active prescription for them – meaning the medications were diverted, stolen or bought on the street.  

“Commonly the medication that people are prescribed is not the one that’s present when they die. And vice versa. The people who died with a prescription opioid like oxycodone in their toxicology screen often don’t have a prescription for it,” says lead author Alexander Walley, MD, a researcher at Boston Medical Center and Associate Professor of Medicine at Boston University School of Medicine.

Walley and his colleagues analyzed nearly 3,000 opioid overdose deaths in Massachusetts from 2013 to 2015, a period when heroin overdoses were surging and the first wave of illicit fentanyl was entering the black market.

Toxicology screens showed that multiple drugs were involved in most of the overdoses, with heroin detected in 61% of the deaths and fentanyl in 45% of them.

Prescription opioids alone were detected in only 16.5% of the overdoses.

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The researchers didn’t stop there. They wanted to know if the people who died had prescriptions for the opioid medications that killed them. To their surprise, only 1.3% of them did.  

“We were able to link individuals who died of an overdose to their prescription monitoring program records.  So we could see how many people who died of an opioid overdose had been prescribed a medication at the time of their death. It turns out that was a minority of the patients,” Walley told PNN.

“If it were only the opioids we prescribed that were killing people, then we would have a perfect match between what we prescribed and what people were dying from. But that only happens 1.3% of the time.”

Rx Opioid Myths Exposed

Walley’s study, published in the journal of Public Health Reports, is one of the first to compare overdose toxicology reports with data collected in Prescription Drug Monitoring Programs (PDMPs). The findings strongly suggest that patients with legitimate prescriptions rarely overdose. And they provide a more nuanced and detailed view of what we usually hear about opioid-related overdoses.

For example, only 6% of those who died with oxycodone in their system had an active prescription for it, meaning the other 94% were taking oxycodone that was diverted or perhaps leftover from an old prescription. Active prescriptions for tramadol, morphine, hydrocodone and hydromorphone were found in less than 1% of the people who died with the drugs in their system. 

Interestingly, active prescriptions for two opioids used to treat addiction --- methadone and buprenorphine (Suboxone) – were found in about 3% of overdoses linked to the drugs.

Massachusetts pain patient David Wieland says the study findings confirm what he has long believed about the opioid crisis.

“The results of this study show that PROP (Physicians for Responsible Opioid Prescribing) and the anti-opioid zealots have been misleading the public for years, as it completely blows the myths they have been spinning out of the water,” Wieland said. “For years they have constantly blamed the majority of these overdose deaths on prescription pain medication. Even as prescribing numbers decreased and overdoses only skyrocketed, they still pushed forward with their lies and propaganda.”

Wieland says his own doctor bought into the myths, insisting that 75% of all overdose victims were pain patients who died by taking their opioid medication as prescribed.

“This was his excuse to further take me completely off my medication,” said Wieland. “Think I'm going to have to send this study to him along with a note reminding him about the supposed facts he tried to shove down my throat.”

Dr. Walley says regulators and public health officials should also take note, and that public education campaigns should not solely focus on the risks of prescription opioids. The CDC’s Rx Awareness campaign, for example, warns people about the abuse of prescription opioids, but says nothing at all about illicit opioids.

“Policy makers may too narrowly focus efforts on preventing the misuse of prescription opioids and devote inadequate resources to addressing heroin and illicit fentanyl use,” Walley said. “I think we can see that we don’t just have a prescription opioid problem. We have an illicit opioid problem. And I think our policy should reflect that.”

8 of 10 Doctors Won’t Take New Patients on Opioids

By Pat Anson, PNN Editor

Nearly three quarters of primary care doctors (72%) worry that chronic pain patients will use illicit drugs if they lose access to prescription opioids, according to a new survey by Quest Diagnostics. And 77% believe the stigma surrounding drug addiction impairs patient care.

Despite those concerns about patient stigma and illegal drug use, the online survey of 500 physicians found that 8 out of 10 are reluctant to take on new patients who are currently prescribed opioids.

“Quest Diagnostics undertook this research so that we could provide insights into the evolving drug crisis and the potential role of physicians’ perspectives about their patients in drug misuse and use disorders,” said Harvey Kaufman, MD, Senior Medical Director, Quest Diagnostics.

“We found that primary care physicians, who are on the front lines of the drug epidemic, are well-intentioned but under-prepared and may miss some of the drug misuse risks affecting their patients.”

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Quest compared the survey results to an analysis of 4.4 million drug tests ordered by physicians for patients prescribed opioids and other controlled substances. The findings suggest that many physicians have a poor understanding of their patients’ drug use.

For example, Quest found that over half of patients (51%) showed signs of misusing a prescribed drug, yet 72% of physicians believe their patients take controlled medications as prescribed.

Quest broadly defines drug “misuse” by including the absence of a prescribed medication. Many patients choose not to take a drug because they can’t afford it, don’t like its side effects, or feel they don’t need it. Patients required to have drug tests are also not representative of the general population.

Other key findings:

  • 62% of doctors believe the opioid crisis will morph into a prescription drug crisis

  • 24% of patients combined legal medications with other non-prescribed drugs or illicit substances

  • 95% of doctors are confident in their ability discuss drug misuse with patients, but only 55% actually do

  • 70% of doctors wish they had more training on how to taper patients off opioids.

  • 75% of doctors wish they had more training on addiction

The Quest lab tests also found concerning results about the misuse of gabapentin (Neurontin), an anti-convulsant drug increasingly prescribed to treat pain. Over 13% of patients showed signs of misusing gabapentin in 2018, making it the mostly commonly misused prescription drug.

Nearly 8 out of 10 doctors (78%) said they often prescribe gabapentin as an alternative to opioids, but only 34% were concerned about its misuse.

“A vast majority of physicians recognize the need for more tools to prevent opioid drug misuse and substance use disorders, and that is why many are tightening opioid prescribing and turning to gabapentin as an alternative,” said pain specialist Jeffrey Gudin, MD, Senior Medical Advisor, Quest Diagnostics.

“While gabapentin may not have opioids’ addictive potential, it can exaggerate euphoric effects when combined with opioids or anxiety medications. This drug mixing is dangerous.”

Gabapentin and pregabalin (Lyrica) belong to a class of nerve medication known as gabapentinoids. A recent study found gabapentinoids increase the risk of suicide, overdose, traffic accidents and injuries in younger people. Sales of gabapentinoids have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

Feds Warn About Rapid Opioid Tapers

By Pat Anson, PNN Editor

Federal health officials are once again urging doctors not to rapidly decrease or abruptly stop prescribing opioid medication to chronic pain patients.

In an editorial published in the Journal of the American Medical Association (JAMA), three federal health officials warn that sudden opioid tapering significantly increases the risk of harm to patients, resulting in increased hospitalizations and emergency room visits.

“There are concerning reports of patients having opioid therapy discontinued abruptly and of clinicians being unwilling to accept new patients who are receiving opioids for chronic pain, which may leave patients at risk for abrupt discontinuation and withdrawal symptoms,” the editorial warns.

The editorial was written by Deborah Dowell, MD, of the Centers for Disease Control and Prevention, Wilson Compton, MD, of the National Institute on Drug Abuse, and Brett Girior, MD, of the U.S. Public Health Service. Dowell is one of the co-authors of the CDC’s controversial opioid guideline, which has been widely used as an excuse by doctors, insurers and pharmacies to impose mandatory limits on prescribing.  

Even before its release in March 2016, pain patients and advocates warned the CDC guideline would result in rapid tapering, patient abandonment and suicide.

But not until April of this year – after three years of needless deaths and suffering -- did the FDA and CDC start urging doctors to be more cautious in their tapering.

It then took another six months for the Department of Health and Human Services (HHS) to produce a 6-page guide for doctors on how to taper patients.

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“The HHS guide and current guidelines emphasize that tapering should be individualized and should ideally proceed slowly enough to minimize opioid withdrawal symptoms and signs. Physical dependence occurs as early as a few days after consistent opioid use, and when opioids have been prescribed continuously for longer than a few days, sudden discontinuation may precipitate significant opioid withdrawal,” the JAMA editorial warns.

The HHS tapering guide urges doctors not to dismiss pain patients and to share decision making with them when developing a taper program.

“If the current opioid regimen does not put the patient at imminent risk, tapering does not need to occur immediately. Take time to obtain patient buy-in,” the guideline cautions. “There are serious risks to non-collaborative tapering in physically dependent patients, including acute withdrawal, pain exacerbation, anxiety, depression, suicidal ideation, self-harm, ruptured trust, and patients seeking opioids from high-risk sources.”

The guide suggests tapers of 5% to 20% every four weeks, although slow tapers of 10% a month may be appropriate for patients taking opioids for more than a year.

A recent study of tapering in Vermont found only 5 percent of patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering. Many of those patients were hospitalized for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure.

Another recent study at a Seattle pain clinic found that tapered patients had an unusually high death rate, with some dying from suspected overdoses.

Meanwhile, not a single word of the CDC opioid guideline has changed since federal health officials finally acknowledged it was harming patients and needed clarification.

Health Canada Supports Use of Prescription Heroin to Treat Addiction

By Pat Anson, PNN Editor

Canada’s national health agency -- Health Canada – is supporting efforts to expand the use of pharmaceutical-grade heroin in treating opioid addiction.

A treatment center in Vancouver, BC is currently the only clinic in North America that provides diacetylmorphine -- prescription heroin – to opioid addicts. Other clinics may soon follow, after last month’s publication of the first clinical guideline for using injectable diacetylmorphine and hydromorphone to treat people with severe opioid use disorder.

Heroin is classified as a Schedule I controlled substance in the United States, making it illegal to prescribe for any purpose. But pharmaceutical grade heroin is legal in Canada, UK and several other European countries, where studies have found it is an effective way of treating — or at least managing — opioid addiction.

In a statement to PNN, Health Canada said it supports using diacetylmorphine to help create a safe drug supply for addicts who use dangerous street drugs and have failed at other forms of treatment.

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“Many stakeholders have been calling for a secure and predictable supply of pharmaceutical-grade opioids as an alternative to the contaminated illegal drug supply. Studies have shown that prescription opioids, such as injectable hydromorphone and diacetylmorphine (prescription-grade heroin), have been successful in helping to stabilize and support the health of some patients with opioid use disorder,” said Jennifer Novak, Executive Director of Health Canada’s Opioid Response Team.

“Health Canada has taken steps towards this objective, including making prescription opioids used in the treatment of severe opioid disorder more easily accessible to healthcare practitioners, reducing regulatory barriers, funding guidelines for opioid use disorder treatment, and supporting safe supply pilot projects in British Columbia.”

Pain patients and their advocates bristle at Health Canada’s willingness to liberalize the use of heroin to treat addiction – while it supports policies that limit access to opioid pain medication.

"While it's necessary to make every effort to keep those suffering from substance abuse alive, why has this come at the cost of pain patients' lives? Health Canada blamed these patients for overdose deaths they played no part in and consequently they can no longer access their necessary medicine. The most severe have been sent spiraling back into more suffering, disability, suicide, and to purchase street drugs out of sheer desperation,” says Ann Marie Gaudon, a PNN columnist, pain patient and advocate. 

“Health Canada acts like a hero trying to save those addicted while simultaneously refusing to admit that they have indeed added to the death toll by adding pain patients. Where is their help? It is nowhere to be seen in the homes of Canada." 

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the second highest rate of opioid prescribing in the world.   

In an effort to reduce the supply of prescription opioids, Canada adopted an opioid guideline in 2017 that is very similar to one released by the U.S. Centers for Disease Control and Prevention a year earlier. Both guidelines have had a negligible impact on the overdose rate, while pain patients on both sides of the border lost access to opioid medication or had their doses reduced to ineffective levels.

“Health Canada recognizes that some people who live with chronic pain have been unable to access opioid medications when needed to manage their pain,” Novak said. “We know that opioid medications are an important tool in the management of pain for some Canadians and are working with stakeholders and partners to promote opioid prescribing practices that balance the benefits and harms of these medications based on the individual needs of each patient.” 

Asked what Health Canada is doing to improve healthcare for pain patients, Novak said the agency was providing $3 million in funding to improve education in pain management for physicians, nurses, pharmacists and social workers.  

Three million dollars is a tiny fraction of the $253 billion spent on healthcare in Canada in 2018.

"It's a pittance but the very sad part is that it's all going right back into the same people and programs that made this whole mess to begin with,” says Gaudon. “Nothing new, no help on the horizon for those whose lives have been shattered. They talk as if they are doing something but they truly are not. It's pure rubbish."

Fentanyl Overdoses Spike in Seattle

By Pat Anson, PNN Editor

Public health officials in the Seattle area are warning about a spike in fentanyl-related overdoses that have killed at least 141 people in King County since June. As in other parts of the country, many of the deaths involve counterfeit oxycodone pills laced with illicit fentanyl.

Three of the recent overdose victims in King County are high school students who took blue counterfeit pills stamped with an “M” and a “30” – distinctive markings for 30mg oxycodone tablets that are known on the street as “Mexican Oxy” or “M30.”

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“Teenagers who are not heroin users are overdosing and dying,” said Brad Finegood of Public Health – Seattle & King County. “Do not consume any pill that you do not directly receive from a pharmacy or your prescriber. Pills purchased online are not safe.”

Gabriel Lilienthal, a 17-year-old student at Ballard High School in Seattle, died Sept. 29 from a fentanyl overdose.

“Gabe died from a fake OxyContin called an M30,” the teen’s stepfather, Dr. Jedediah Kaufman, a surgeon, told The Seattle Times. “With fentanyl, it takes almost nothing to overdose. That’s really why fentanyl is a death drug.”

Fentanyl is 50 to 100 times more potent than morphine. It is prescribed legally to treat severe pain, but in recent years illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the production of counterfeit pills. Illicit drug users often have no idea what they’re buying.

As PNN has reported, counterfeit oxycodone pills laced with fentanyl are appearing across the country and have been linked to hundreds of deaths. Yet this emerging public health problem gets scant attention from federal health officials, who are currently focused on an outbreak of lung illnesses associated with vaping that has resulted in 18 deaths.

‘Enough to Kill San Diego’

In San Diego last month, DEA agents found five pounds of pure fentanyl in the apartment of Gregory Bodemer, a former chemistry professor who died of a fentanyl overdose. Prosecutors say that amount of fentanyl was “enough to kill the city of San Diego” or about 1.5 million people.

Also found in Bodemer’s apartment was carfentanil, an even more powerful derivative of fentanyl, along with a pill press, powders, liquids and dyes used in the manufacture of counterfeit medication.  

Bodemer’s body was found in his apartment Sept. 27. Rose Griffin, a woman who also overdosed at the apartment and recovered, has been charged with drug possession and distribution.

Bodemer was an adjunct chemistry professor at Cuyamaca College in 2016. He had previously worked as a chemistry instructor at the U.S. Naval Academy in Annapolis, Maryland.

Opioid Breathalyzer Test Developed

By Pat Anson, PNN Editor

Chronic pain patients have grown accustomed to having their urine -- and sometimes their blood and hair – analyzed for opioids and other drugs.

Someday soon they could be taking opioid breathalyzer tests.

In a small pilot study, researchers at the University of California, Davis have developed and successfully tested a device that collects minute droplets in breath that can be analyzed in a laboratory for morphine, hydromorphone (Dilaudid) and other opioids.

“Exhaled breath collection represents a painless, easily available, and non-invasive technique that would enable clinicians to make quick and well-informed decisions,” said lead author Cristina Davis, PhD, chair of the Department of Mechanical and Aerospace Engineering at UC Davis. "There are a few ways we think this could impact society."

While ostensibly developed to help doctors care for patients and monitor their drug use, Davis and her colleagues say opioid breathalyzer tests could someday be used in addiction treatment and by law enforcement during roadside field sobriety tests.

They reported their findings in the Journal of Breath Research.

IMAGE COURTESY OF CRISTINA DAVIS, UC DAVIS

IMAGE COURTESY OF CRISTINA DAVIS, UC DAVIS

“Breath offers the opportunity to collect a diagnostic biospecimen non-invasively and, eventually, a way to obtain near real-time results almost anywhere. Though this study did not utilize portable analytic systems, future breath drug detection platforms used to identify targeted compounds will be available for point-of-care use. This will enable opioid detection in many settings including roadside, drug treatment facilities, field emergency response, home, and rural areas with limited access to healthcare,” Davis wrote.

Nine patients receiving opioids for cancer pain at the UC Davis Medical Center participated in the pilot study, along with three healthy people used as a control group. Participants exhaled through a glass tube surrounded by dry ice that captured and froze breath condensate. The breath samples was then analyzed in a lab using mass spectrometry and compared to opioid metabolites in blood samples and in doses given to patients.

"We can see both the original drug and metabolites in exhaled breath," Davis said.

Fully validating the breath test will require more data from larger groups of patients. UC Davis researchers are working towards the development of real-time, point-of-care breath tests that can be broadly used to detect opioids and other drugs.

Point-of-care (POC) urine drug tests are widely used by doctors to screen patients for illicit drugs and to make sure they’re taking medications as prescribed. Physicians like the immunoassay test strips because they can be performed in their offices, are inexpensive and give immediate results.

However, as PNN has reported, POC test results are wrong about half the time – and frequently give false positive or false negative results for drugs like marijuana, oxycodone and methadone.  Experts say doctors should never base a treatment decision or discharge a patient solely on the results of one POC test, and that confirmatory testing should always be performed by a laboratory. 

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.