Tag: Overdose

Washington Post Revelation of Pain Pill Distribution Only Helps to Fuel the False Narrative

The Washington Post recently received access to a database maintained by the Drug Enforcement Administration that tracks the manufacture and distribution of every prescription opioid in the country. It reported that 76 billion pills were distributed throughout the US between 2006 and 2012, with higher volumes shipped to the areas that were most hard hit with opioid-related overdose deaths. 

This is being offered as proof that the overprescribing of prescription opioids caused the overdose crisis. But this flies in the face of other powerful evidence. Research reported in the Journal of Pain Research last February that examined data from the National Survey on Drug Use and Health as well as the Centers for Disease Control and Prevention show there is no correlation between the number of pain pill prescriptions and “past-month nonmedical use” or  past-year diagnosis of “pain reliever use disorder” among adults. This was corroborated by a study published by the Cato Institute the same month.

Research from the University of Pittsburgh shows overdose deaths from nonmedical use of licit and illicit drugs have been on a steady exponential increase since the 1970s, with no evidence of slowing. The only changes over the decades pertain to the particular drug in vogue during any period. In the early part of this century, the drugs in vogue were diverted prescription opioids. 

To be sure, the lure of easy money offered by a black market fueled by drug prohibition brings out the worst in people, and doctors and pharmacists were no exception. Some doctors and pharmacists leveraged their professional licenses and teamed up with regional drug dealers to supply nonmedical users with large quantities of their preferred drug. But the blame for such behavior should be placed where it belongs: drug prohibition.

Those unethical health care providers were the exception, not the rule. And they were providing drugs to mostly nonmedical users, sometimes under the guise of providing patient care. Meanwhile, the nonmedical use of prescription opioids peaked in 2012, as heroin became cheaper and more available than diverted pain pills. The prescription of high-dose opioids peaked in 2008 and the number dropped more than 58 percent by 2017. Yet the overdose rate accelerated as the prescription numbers decreased, because nonmedical users migrated to more readily available heroin and fentanyl. By 2015 there was already evidence that heroin was becoming the new drug in vogue, as up to one-third of heroin addicts undergoing rehab stated they initiated drug use with the opioid heroin.

The CDC released preliminary estimates of 2018 opioid-related overdose deaths July 17, and they suggest the death toll may be tapering off slightly, down to 47,590 from roughly 49,000 in 2017. One aspect of these numbers the media failed to report was that 67 percent of those deaths involved illicit fentanyl, one-third involved heroin, and just under one-third also involved cocaine. About one-fourth of opioid-related overdose deaths involved any prescription pain killer, and more than three quarters of them also involved heroin, fentanyl, cocaine, or tranquilizers. 

The overdose problem has never been a product of doctors treating patients for pain. It has always been a product of (a growing population of) nonmedical users accessing drugs in a dangerous black market fueled by drug prohibition. While the possible downturn or leveling off in the mortality rate is encouraging, this can largely be attributed to the adoption of harm reduction measures, such as naloxone distribution and needle-exchange programs, which need to be more widely-adopted.

The number of opioids prescribed greatly increased during the early part of this century, as doctors were–rightly–encouraged to be more concerned with alleviating pain and patients were–rightly–assured that opioids in the medical setting have a low overdose and addiction potential. That meant more pain pills were available for diversion to the black market for nonmedical use. And, as mentioned above, there were some doctors and pharmacists who were unethical and unscrupulous. But, at the end of the day, there is no correlation between the number of pills prescribed and the incidence of nonmedical use or use disorder.

The continued obsession about the number of pain pills being prescribed causes patients to go undertreated for their pain and will not make one IV drug user pull the needle out of their arm.

Will Congress Finally X-Out the “X” Waiver?

Members of Congress are growing more appreciative of the benefits of Medication Assisted Treatment in addressing the overdose crisis. Two bills presently under consideration—one in the Senate and one in the House—are the latest evidence of that awareness. 

Medication Assisted Treatment for opioid use disorder is one of the most widely-accepted and least controversial of the tools in the harm reduction tool box. The strategy involves placing the patient on an orally-administered opioid that binds with enough opioid receptors to prevent painful withdrawal symptoms while, at the same time, not producing cognitive impairment or euphoria. The approach has been around since the 1960s and has greatly reduced overdose deaths as well as the spread of deadly infections from dirty needles.

One of the oldest and most well-known examples of MAT uses the synthetic opioid methadone, which is classified by the Drug Enforcement Administration as Schedule II (known medical use with a high potential for abuse or dependence). A more recent form of MAT uses the Schedule III opioid buprenorphine. Schedule III drugs have less potential for dependence or abuse than those in Schedule II. Like methadone, buprenorphine is permitted to be prescribed for the treatment of pain, but not for MAT without obtaining DEA permission.

As I have written here, federal policy regarding methadone MAT makes no sense. Health care practitioners have been permitted to prescribe methadone in oral or non-oral forms to treat pain for decades. Yet they are not permitted to prescribe methadone for opioid withdrawal management or for MAT for opioid use disorder outside of a DEA-licensed and regulated methadone clinic. These clinics must also obtain state licenses. Patients are required to take the methadone in front of a member of the clinic staff. 

These regulatory requirements have been great obstacles to providers wishing to establish methadone clinics, and even greater obstacles to patients seeking methadone MAT for their disorder. It also places onerous burdens on patients suffering from opioid use disorder who want treatment. The requirement to take the medication in the presence of clinic staff each day demands a certain amount of scheduling discipline that many addicts have difficulty achieving. It also implies that addicted patients cannot be trusted with an outpatient supply to take as directed —which is a further blow to the already shattered self-esteem that helps perpetuate substance use disorder. And patients living in remote areas underserved by methadone clinics are unrealistically expected to travel long distances each day to take their methadone in the presence of clinic staff. This problem can be alleviated by allowing health care practitioners who can already prescribe methadone for other reasons to prescribe it to outpatients for withdrawal management and MAT, as has been the case in Canada, the UK, Australia and other countries for decades.

Buprenorphine, on the other hand, may be prescribed on an outpatient basis for MAT. Research has been inconclusive with respect to the relative effectiveness of methadone versus buprenorphine for MAT. Most clinicians believe there is no one-size-fits-all answer. Depending upon the patient and the circumstances, one drug might work better than the other. In recent years buprenorphine has been combined with the overdose antidote naloxone in an oral form, commonly known by the brand name Suboxone. When taken orally, naloxone is inactive. If buprenorphine/naloxone is crushed and injected, the naloxone counteracts the buprenorphine, preventing the user from achieving any “high.” But most users of non-prescribed diverted Suboxone report they are self-medicating to avoid opioid withdrawal, and that the Schedule III buprenorphine is a poor substitute for the “high” they get from heroin and other more powerful opioids.

A major force behind the black market for buprenorphine is the fact that there is an acute shortage of practitioners to whom people with substance use disorder can go for buprenorphine MAT. Again, this is because of onerous federal restrictions. Under the Drug Addiction Treatment Act of 2000, practitioners wishing to treat substance use disorder with buprenorphine are required to obtain an “X waiver.” Providers must take an 8-hour course in order to have the ”X” added to their DEA narcotics prescribing license. There are also strict limits on how many patients a practitioner can treat at any given time, as well as restrictions on nurse practitioners or physician assistants wishing to obtain the X waiver. These have combined to create an acute lack of buprenorphine MAT providers. According to the Substance Abuse and Mental Health Services Administration, less than 7 percent of practitioners have jumped through the hoops and obtained X waivers. The shortage is particularly severe in rural areas. Nationally, only 1 in 9 patients with opioid use disorder are able to obtain buprenorphine MAT.

For this reason, health care practitioners interested in treating opioid use disorder, as well as other harm reduction advocates, have called for ending the requirement of an X waiver to use buprenorphine for MAT. In France roughly one-fifth of general practitioners treat people with substance use disorder in their offices without any further licensing or education requirements. It has contributed to a dramatic reduction in France’s overdose death rate.

Fortunately, members of Congress seem to be getting the message. Senators Lisa Murkowski (R-AK) and Maggie Hassan (D-NH) have introduced a bill that would eliminate “the separate scheduling requirement for dispensing narcotics in Schedules III, IV, and V for maintenance or detoxification treatment.” In the House, Representative Paul Tonko (D-NY) introduced HR 2482 in May which does the same. HR 2482 has 75 co-sponsors, 15 of whom are Republicans.

It should be a lot easier for providers to help the many patients seeking help from their disorder but are are unable to find it. This legislation should help. Congress should also look at reforming laws surrounding methadone, so it can be prescribed in practitioners offices as well. But first things first.

 

 

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Senators Manchin and Braun Are Attempting to Practice Medicine Without a License—And Fighting the Wrong War

Senator Joe Manchin (D-WV) and Mike Braun (R-IN) are still trying to address the fentanyl and heroin overdose crisis—soon to be joined by a methamphetamine and cocaine overdose crisis—by denying chronic pain patients access to pain relief. They have just introduced a bill they call The FDA Opioid Labeling Accuracy Actwhich would “prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of ‘around-the-clock, long-term opioid treatment’ until a study can be completed on the long-term use of opioids.”

Set aside the fact that most pain specialists agree that, in some cases, long-term opioid therapy is all that works for some chronic pain patients. The 2016 guidelines on opioid prescribing put forth by the Centers for Disease Control and Prevention have already been misinterpreted and misapplied by legislators and regulators, leading to forced and rapid tapering off of opioids in many chronic pain patients, causing many to resume lives immobilized by pain, and in many cases, seek relief in the black market or by suicide. It has gotten so bad that the CDC recently issued a “clarification” in April, reminding regulators that the guidelines were only meant to be suggestive, not prescriptive, and did not in any way mean to encourage the rapid tapering of patients on chronic opioids for pain management. Johns Hopkins bioethicist Travis Rieder, PhD delves deeply into this subject and relates his own experiences in his book, In Pain.

What the senators fail to recognize is that patients are not one-size-fits-all. Different patients respond to pain and to pain management differently. Their proposed legislation, if passed, will only serve to exacerbate the unnecessary suffering of patients in pain that the CDC is trying to undue with its guideline clarification.

Meanwhile, they should take a look at the government’s own numbers. The data show there is no correlation between the number of prescriptions written and the incidence of non-medical use of prescription opioids or prescription pain reliever use disorder. And less than 10 percent of opioid-related overdose deaths in 2017 involved prescription pain relievers unaccompanied by other drugs such as cocaine, heroin, alcohol, or fentanyl.

The continued war on patients by politicians and regulators will not get one IV heroin user to take the needle out of their arm. Senators Manchin and Braun need to recognize that the overdose crisis has been on a steady, exponential increase since the 1970s and shows no signs of stopping—and that its ultimate cause is drug prohibition

If they want to get serious about addressing the problem, they should switch their focus to harm reduction. A good way to start would be to repeal the “Crack House” statutes that prevent cities and states from establishing overdose prevention sites called “safe injection facilities.”

New Evidence From British Columbia Provides a Strong Case for Harm Reduction Strategies

A study published last month in the peer-reviewed journal Addiction by researchers at the British Columbia Centre for Disease Control and the British Columbia Centre on Substance Use found that harm reduction strategies were responsible for the province’s opioid-related overdose death rate being less than half of what it otherwise would have been between April 2016 and December 2017.

The researchers noted that 77 percent of opioid-related overdose deaths during that time frame involved illicit fentanyl. Vancouver has long been a major port of entry for fentanyl and fentanyl analogs, produced in China and other parts of East Asia, often using historic seaborn drug trade routes

During the 23 months ending December 2017 there were 2,177 overdose deaths in British Columbia, according to the British Columbia Centre for Disease Control. Using mathematical modeling methodology to estimate monthly overdose and overdose-death risk along with the impact of harm reduction interventions, the researchers concluded an estimated 3,030 overdose deaths were averted.

The three harm reduction strategies investigated were take-home naloxone kits, safe injection sites, and “opioid agonist therapy”— known in the U.S. as Medication Assisted Treatment (which includes methadone, buprenorphine, hydromorphone, and heroin assisted treatments in British Columbia). The researchers employed counterfactual simulations with the fitted mathematical model to estimate the number of deaths averted for each harm reduction strategy as well as the three strategies in combination. 

While the harm reduction strategies combined for more than 3000 deaths averted, the number of lives saved by each strategy taken in isolation broke down as follows: 

  • 1,580 (1,480-1,740) deaths averted by take-home naloxone
  • 230 (160-350) deaths averted by safe injection sites
  • 590 (510-720) deaths averted due to opioid-agonist therapy

All three interventions worked in synergy to greatly reduce the death rate, but the widespread distribution of naloxone saved the most lives. 

Michael Irvine, the study’s lead author, told Canadian Broadcasting Company reporters that in recent years the overdose crisis has been driven by a prevalence of fentanyl and fentanyl analogs. 

Among the developed nations, Canada has been one of the hardest hit by the overdose crisis on a per capita basis, with overdose deaths in Vancouver, BC approximating those of some of the worst-hit states in the U.S. as recently as 2017. This recent study gives us reason to conclude that, had British Columbia not embraced harm reduction strategies, the per capita overdose rate would have far-exceeded that of the U.S.

Canadian policymakers are being urged to curtail the prescription of opioids to patients in pain, despite the fact that more than three-quarters of overdose deaths involve fentanyl and, as in the U.S., the majority of overdose deaths involve multiple other drugs as well, including cocaine, heroin, benzodiazepines, and alcohol. This approach is driven by the failure to recognize there is no correlation between the number of prescriptions written for patients and the incidence of non-medical use of prescription opioids or prescription opioid use disorder. 

The Canadian government has also given in to pressure by the U.S. government to double down on its war on drugs. But in the U.S., researchers have learned that overdoses from the non-medical use of licit and illicit drugs has been on a steady exponential increase since the 1970s–the only variation being which particular drug is in vogue in any particular era–with no evidence of any slowing. It appears to be a result of sociocultural and psychosocial factors. There is no reason to believe things are much different in Canada.

Efforts to approach this problem by doubling down on supply-side interventions and the War on Drugs are doomed to fail—and will only cause more people to die. Fighting a war on drugs is like playing a game of “Whac-a-Mole.”

If the British Columbia experience should teach policymakers anything, it should be that harm reduction is the most effective way to end the overdose crisis. Ending prohibition would be the most consequential form of harm reduction.

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CDC Provisional Drug Death Numbers Show Slight Improvement. Credit Harm Reduction.

Provisional data released by the Centers for Disease Control and Prevention suggest the annual overdose death rate may be levelling off or even slightly declining. The data predict a drop in the death rate to 69,096 for the 12-month period ending November 2018, down from 72,300 predicted deaths for the 12-month period that ended November 2017. These provisional findings represent a 4.4 percent drop in the national overdose rate. 

The drug overdose death numbers include deaths due to natural and semi-synthetic opioids, synthetic opioids other than methadone (fentanyl and its analogs), methadone, methamphetamines and other stimulants, cocaine, and benzodiazepines. For example, opioid-related deaths accounted for 47,600 of the 70,237 overdose deaths reported by the CDC for the year 2017. The final report for the year 2018 should be available in December of this year.

The possible slowing or decrease of the overdose rate is likely due to the fact that many state policymakers have begun to recognize the wisdom of harm reduction, a realistic acceptance of the fact that there will never be a “drug-free” society, that seeks to reduce the risks associated with non-medical use of licit and illicit drugs. As I have written here, harm reduction has long been an approach employed by health care professionals in modern and developed societies. 

The provisional report from the CDC shows the most dramatic improvements in states that have expanded the availability of the opioid overdose antidote naloxone, allowed for the expansion of needle exchange programs, and increased the licensing of Medication Assisted Treatment (e.g., methadone, buprenorphine) programs. In fact, the greatest improvement was seen in Ohio, which has aggressively promoted these harm reduction measures. Ohio had been an epicenter of opioid-related overdose deaths. The provisional numbers for the year ending November 2018 show a 23.3 percent decrease in overdose deaths. The states that have made the most progress are those that have increased the focus on harm reduction strategies.

Despite these encouraging signs, the overdose rate continues to and is likely to remain high. As researchers at the University of Pittsburgh have discovered, overdoses related to the non-medical use of licit and illicit drugs have been on a steady, exponential increase since the 1970s. The only changes that have occurred over that time period pertain to which drugs came in and out of vogue for non-medical users. 

Despite policymakers obsession with doctors prescribing pain medication to their patients, the government data show no correlation between the number of prescriptions and non-medical use or substance use disorder. In recent years deaths from fentanyl and heroin have come to represent the majority of fatalities reported by the CDC with cocaine, methamphetamines, and other stimulants showing a recent surge as well. And benzodiazepine-related deaths are also on the rise.

The driving force behind these deaths has always been drug prohibition. Ending the endless and unwinnable war on drugs would be the greatest exercise of harm reduction.

An Encouraging Sign for Harm Reduction Advocates

A New Hampshire high school student who is remarkably knowledgeable about the various harm reduction strategies that are underused to address the overdose crisis engaged Senator Cory Booker (D-NJ) in a discussion of the subject during a campaign stop in Littleton, NH. The video of the exchange is here.

Senator Booker, who is seeking the Democratic nomination for President in 2020, is a former mayor of Newark, NJ, a city with major drug overdose problems. He had a sophisticated conversation with the student and agreed with her on the need for safe syringe programs. At about 1:50 into the video Booker was asked if he would support needle exchange programs and safe injection sites. He responded that as mayor of Newark he established the needle exchange program in that city and “fully supports” establishing safe injection sites.

As I detail in my Policy Analysis on harm reduction, both needle exchange programs and safe injection sites have been shown for decades to reduce the spread of HIV and hepatitis, reduce overdoses, and increase the number of addicts obtaining rehab. 

While needle exchange programs are legal in the US, and are even promoted by the Surgeon General, the Centers for Disease Control and Prevention, and the American Medical Association, many states have anti-paraphernalia laws that inhibit their creation.

Safe injection sites exist in over 120 cities in Europe, Canada, and Australia, and have been in use for over 30 years. One even operates in the US clandestinely, because federal law prohibits safe injection sites in this country. Several cities are attempting to establish safe injection sites in the US, including Seattle, San Francisco, Boston, and New York. In Philadelphia, a nonprofit that includes former Pennsylvania Governor Edward Rendell on its board is attempting to establish a “Safehouse” in that city, funded entirely with private money, but is being thwarted by the Department of Justice.

While the Senator seemed to wrongly accept the mistaken narrative that the opioid manufacturers are to blame for much of the problem, it is gratifying to learn that Senator Booker has an appreciation for harm reduction in general, and needle exchange and safe injection sites in particular. And, to his credit, he has also expressed enlightened views regarding cannabis legalization

As more members of Congress join the growing ranks of mayors of major US cities in endorsing safe syringe programs, momentum will hopefully build for states to remove any remaining obstacles to needle exchange programs and for Congress to remove the federal obstacles to safe injection sites.

The Secret Safe Injection Facility That Is Saving American Lives

I have written herehere, and here about efforts by a nonprofit in Philadelphia named “Safehouse” to establish a Safe Injection Facility in the neighborhood of Kensington, where IV drug use is rampant and out in the open, and overdoses are soaring. That effort is being impeded by threats from the Department of Justice that it will enforce federal law prohibiting such sites. The specific law at issue is known as the “Crack House Statute,” passed in the 1980s. Leaders in other major US cities who also want to set up Safe Injection Facilities, including SeattleSan FranciscoNew York, and Boston, are closely monitoring the situation before proceeding with their own plans.

In my Policy Analysis on harm reduction I wrote of the impressive results that Safe Injection Facilities (also called “safe consumption sites” and “overdose prevention sites”) have had throughout much of the developed world since the 1980s. Now in operation in over 120 cities in Europe, Canada, and Australia, these facilities have dramatically reduced the spread of HIV, hepatitis, and other blood-borne diseases, dramatically reduced overdose deaths, and have brought many addicts into rehab programs. Darwin Fisher, the Program Coordinator of “Insite” in Vancouver, BC, the oldest Safe Injection Facility in North America (since 2003), gave an impressive presentation of how that facility has worked to save lives at Cato’s conference on harm reduction last March. You can see that presentation here.

The Policy Analysis also mentioned a Safe Injection Facility secretly operating in the US since 2014, notwithstanding the federal prohibition. A 2017 paper in the American Journal of Preventive Medicine that kept the name and location of the site confidential, reported it was well-accepted by the community, had at least four documented overdose reversals, and had no deaths associated with its operation. Dr. Barrot Lambdin, a senior epidemiologist with RTI International, an independent non-profit research institute in North Carolina, gave a data update on this secret Safe Injection Facility at an international conference on harm reduction held in Porto, Portugal on April 29, 2019. He did not disclose the name or location of the facility. 

One objection raised by residents of communities where these sites are proposed is that they don’t want to see IV drug users on the streets of their neighborhoods. But proponents respond that Safe Injection Facilities actually bring such people indoors, injecting their drugs out of the view of the community. Dr. Lambdin reported that since the facility’s opening in September 2014, nearly 8,400 public injections were prevented. 

Dr. Lambdin also reported the number of overdose reversals has now increased to 26.

Because the site is illegal, it is only able to operate part time—five or six days a week for eight or ten hours a day. And it accepts participants by invitation only. The surrounding community has cooperated by helping the facility maintain secrecy.

So here is an example of a Safe Injection Facility saving lives, and well-accepted by the surrounding neighborhood, in spite of federal impediments. Imagine how many more lives it could save if it could operate around the clock, out in the open, and advertise for walk-ins. Imagine how many hundreds or even thousands of lives would be saved if the “Crack House Statute’ was repealed.

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