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9/11/2017 12:00 AM

Both medical and nonmedical (misuse or abuse) use of prescription opioids has been declining among adolescents, according to a study published in the April 2017 issue of Pediatrics. However, prescription opioid exposure is still common, with adolescents who reported both medical and nonmedical use more likely to have started with medical use. Medical use of prescription opioids among teens peaked in 1989 and 2002 and stayed level until a decline that began in 2013.

Both medical and nonmedical (misuse or abuse) use of prescription opioids has been declining among adolescents, according to a study published in the April 2017 issue of Pediatrics. However, prescription opioid exposure is still common, with adolescents who reported both medical and nonmedical use more likely to have started with medical use. Medical use of prescription opioids among teens peaked in 1989 and 2002 and stayed level until a decline that began in 2013.

The study, “Trends in Medical and Nonmedical Use of Prescription Opioids Among US Adolescents: 1976–2015,” is by Sean Esteban McCabe, Ph.D., and colleagues. McCabe is with the Institute for Research on Women and Gender at the University of Michigan.

Especially among male teens, there is a high correlation between medical and nonmedical use of prescription opioids.

Most medical users of prescription opioids do not move on to nonmedical use — this is true for adults and adolescents. However, most adolescents who report nonmedical use started with medical use.

There is a lack of research assessing long-term trends among adolescents, however. McCabe and colleagues wanted to determine whether there is a relationship over time in the medical use of prescription opioids and the nonmedical use. Medical use was assessed by asking whether the high school seniors had ever taken prescription opioids based on a doctor’s advice. They were told prescription opioids must be prescribed and sold in drugstores. Response options included “No,” “Yes but I had already tried them on my own” and “Yes and it was the first time I took any.” Nonmedical use was assessed by asking on how many occasions — if any — in their lifetime they had used prescriptions on their own, “without a doctor telling you to take them.” Response options ranged from “no occasions” to “more than 40 occasions.”

Results

Lifetime medical use (16.0 percent in 1976 to a peak of 20.4 percent in 1989, down to 13.2 percent in 1997) was more prevalent than nonmedical use (although not listed in the results nonmedical use was about 10 percent in 1976 down to about 7 percent in 2015; it rose sharply in 2002 due to a change in definition).

Prevalence of medical use was higher among white relative to black teens; the correlation between medical and nonmedical use was stronger for males than females and for whites than blacks.

Looking at long-term trends, the researchers found that the most prevalent pattern of exposure was medical use only without any history of nonmedical use. For teens who reported both medical and nonmedical use, the prevalent pattern was medical use first.

The prevalence of nonmedical use only was similar to that of nonmedical use following medical use.

Declines in both medical and nonmedical use among adolescents during 2013–2015 mirror the similar declines in opioid prescribing during that same time period, the researchers wrote.

Implications

One-third of the teens who reported using prescription opioids nonmedically were using their own leftover prescriptions. A different survey, the National Household Survey on Drug Use and Health, found that 62 percent of people who misuse prescription opioids do so for pain relief.

The correlation between nonmedical and medical use was twice as high for males as for females. The researchers suggested several possibilities. First, male nonmedical users are more likely to obtain prescription opioids from their peers, whereas female nonmedical users are more likely to obtain them from family members.

It’s more likely for male nonmedical users than for males to misuse prescription opioids to get high, whereas females are more likely to misuse them for pain relief, the researchers wrote. This could account for the stronger correlation between medical and nonmedical use among males relative to females, the researchers write.

The researchers suggest two interconnected for medical and nonmedical use of prescription opioids being more prevalent among white than black adolescents: (1) pharmacies in low-income ZIP codes are less likely to have sufficient opioids compared to pharmacies in white ZIP codes and (2) black adolescents are more likely than white adolescents to misuse opioids specifically for pain relief. If black adolescents are less likely to receive adequate treatment for pain, they are more likely to seek relief without the prescriptions; conversely, white adolescents might be getting overprescribed these medications, resulting in misuse.

The researchers recommend increased use of prescription drug monitoring programs, discussing the importance of proper storage and monitoring of prescription opioids with teens and parents, screening for substance use disorders, prescribing the lowest effective doses and avoiding concurrent prescription of sedatives.

Limitations include those involved with the Monitoring the Future study, upon which the data was based. First of all, the study is a long-self-report survey, subject to both recall bias and subject burden. It doesn’t ask about age of onset, dose, duration, pain condition or efficacy. It doesn’t ask about potential confounders such as opioid use disorders and family health history. Finally, students who dropped out or were absent on the survey day did not participate, and these students are more likely to report substance use. Finally, the results are limited in terms of causation, with more prospective studies needed to assess longitudinal associations between medical use and nonmedical use of prescription opioids.

Still, the findings provide evidence that there is a correlation among medical and nonmedical use of prescription opioids in teens, especially among males.

“Prescribing practices that increase vigilance and monitoring of prescription opioids among adolescents, including education about proper disposal when medical use has concluded, warrant more investigation,” the researchers concluded. (Monitoring the Future is an annual school-based survey conducted by the University of Michigan for the National Institute on Drug Abuse.)

9/11/2017 12:00 AM

Last month’s news that a Delaware court is allowing Dr. Reddy’s, a huge supplier of generic drugs based in India, to produce a generic version of buprenorphine-naloxone film resulted in an immediate response from Indivior, which makes Suboxone (buprenorphine-naloxone film) and has enjoyed a monopoly on it. Reckitt Benckiser (which Indivior spun off from in 2014) aroused outrage in the treatment field when generic versions of its Suboxone tablet came on the market, and it responded by pulling the tablets, making only its patented film available. Now, Indivior will appeal the court ruling.

Last month’s news that a Delaware court is allowing Dr. Reddy’s, a huge supplier of generic drugs based in India, to produce a generic version of buprenorphine-naloxone film resulted in an immediate response from Indivior, which makes Suboxone (buprenorphine-naloxone film) and has enjoyed a monopoly on it. Reckitt Benckiser (which Indivior spun off from in 2014) aroused outrage in the treatment field when generic versions of its Suboxone tablet came on the market and it responded by pulling the tablets, making only its patented film available. Now, Indivior will appeal the court ruling.

We asked Ed Silverman, senior writer and Pharmalot columnist at The Boston Globe’s STAT health and medicine site, what the next steps are for Dr. Reddy’s and any other company that wants to make generic buprenorphine-naloxone film. First, the generics have to be approved by the Food and Drug Administration (FDA). “If you’re the brand-name company and a generic company seeks FDA permission and files an application to market a generic version, the brand-name company goes to court to file a patent infringement lawsuit,” said Silverman. Recently, Scott Gottlieb, M.D., the new FDA commissioner, said the agency "would seek to accelerate reviews of generic applications so that more are approved,” he added. “That is definitely part of the equation.”

One question is how much less expensive the generic versions will be than Suboxone. Even if people still want to stay on Suboxone, or start on it, the price of a brand “typically comes down 70 to 80 percent within a few weeks or a few months” of introduction of a generic, said Silverman. “But it doesn’t always happen that way,” he said. Product choices could also depend on insurance coverage. And some plans get rebates for branded drugs that lower the costs, he noted.

Would the generic work as well as the brand? “Traditionally, a generic has to be proven bio-equivalent,” said Silverman. “That means it has to have a proximate effect on the patient. But the generic company doesn’t have to do lots of independent trials."

In the case of Suboxone, the costs of development were paid by the taxpayer, under the stewardship of the National Institute on Drug Abuse, with the pharmaceutical company sponsor pocketing the profits after marketing was approved.

“Although it is not possible to quantify precisely the financial impact that the launch of generic alternatives to Suboxone Film would have on the Company’s revenues generated from Suboxone Film in the US, or how quickly such an impact would take effect, the Company believes that it could potentially result in a rapid and material loss of market share for Suboxone Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market,” according to a statement from Indivior released Sept. 1. “Today’s news is disappointing to Indivior, given the belief that the Company has in its intellectual property for Suboxone Film,” said Indivior CEO Shaun Thaxter. “We will appeal the ruling and defend our intellectual property.… As always, our unwavering focus is on addressing the unmet needs of opioid dependent patients. On behalf of the millions of patients who struggle to overcome opioid addiction, the majority of whom need help but go untreated, we remain relentless in our pursuit to transform addiction from a global human crisis to a recognized and treated disease.”

8/28/2017 12:00 AM

Amid the many horror stories of pain patients being tapered off opioids or having the dose reduced, whether because their physicians are afraid of being investigated by drug enforcement or are misinterpreting federal guidelines as requirements, we wondered if there is any reason that these patients can’t be treated with methadone in an opioid treatment program (OTP) or with buprenorphine in an office-based OTP.

Amid the many horror stories of pain patients being tapered off opioids or having the dose reduced, whether because their physicians are afraid of being investigated by drug enforcement or are misinterpreting federal guidelines as requirements, we wondered if there is any reason that these patients can’t be treated with methadone in an opioid treatment program (OTP) or with buprenorphine in office-based opioid treatment (OBOT) program.

Six years ago, when prescription opioid addiction was rampant, we wrote about OTPs being able to treat patients for pain, as long as their primary diagnosis was opioid dependence, based on an interview with the Substance Abuse and Mental Health Services Administration (SAMHSA) (see ADAW, January 17, 2011). Since then, however, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition has come out, eliminating dependence as a pathology and replacing it with substance use disorder (SUD). For opioids, the diagnosis is now opioid use disorder (OUD).

”Circumstances in the field have changed,” said Melinda Campopiano, M.D., medical officer for SAMHSA’s Center for Substance Abuse Treatment, which regulates both OTPs and buprenorphine (for OUDs) prescribers. In an interview with ADAW last week. “The challenge for waivered providers and OTPs is that their use of controlled substances is meant to be for the treatment of opioid use disorder,” she said. ”That’s distinct from dependence.”

And while both methadone and buprenorphine can be used to treat pain outside of the context of an OTP or a buprenorphine prescriber, those formulations and the treatment methodology are different for pain, she said.

“The FDA approves different formulations of methadone and buprenorphine for different indications,” she said. “And the use of opioids for pain management is different than the use of opioids for addiction treatment.”

Also, Campopiano isn’t convinced that being qualified to treat patients with opioids for an opioid use disorder necessarily makes a provider qualified to treat pain with opioids. “I think many providers who are involved in treating patients with opioid use disorder have the knowledge base to treat pain, but I don’t think all of them do,” she said. “I wouldn’t want to push people outside of their skill set.” SAMHSA wants people with pain and people with substance use disorders to “get safe, appropriate treatment,” she said. “But I’m not sure it’s to anyone’s advantage to try to combine them.”

When people with pain develop OUD, and vice versa

There is one circumstance in which it does make sense to combine treatment, and that is for patients who have both an opioid use disorder and chronic pain, said Campopiano. “This is an important area for pain specialists and addiction treatment providers to cooperate and collaborate on in terms of patient care,” she said.

There is a lack of evidence for the effectiveness of opioid in chronic pain, noted Campopiano. But when that patient is being tapered, it would be a good idea to take a careful approach. “There aren’t hard and fast rules,” she said, adding that addiction, not pain, is her expertise. “But generally, this needs to be approached slowly and steadily, much in the same way as someone who was in treatment for an opioid use disorder who is ready to stop taking their medication.” There is a slight difference, because with the pain patient, "the question is physiological dependence, not addiction,” she said. For example, a pain patient tapering from a short-acting opioid is not the same as someone with an opioid use disorder trying to come off of heroin, which is also short-acting, on their own, she said.

There is also the pain patient who develops an OUD because of the prescribed opioids. These patients are the ones who should be treated for addiction, said Campopiano. She is particularly concerned about pain prescribers who discharge patients who are misusing their opioids — for example, running out of medication too soon or testing positive for illicit opioids. “When that prescriber who is treating someone with an opioid for chronic pain becomes aware of aberrant behaviors, more often than we would like, they are discharging that patient from care,” she said. This just sends someone who is not only opioid-dependent but also has a substance use disorder (SUD) out into the street, to suffer withdrawal on their own or to seek drugs elsewhere. “We would like to see more careful attention as to whether that person meets diagnostic criteria for SUD, and a facilitated transfer to care,” she said. “Risk management has eclipsed the patient safety and patients outcomes management.”

Other voices

We asked other experts about the use of buprenorphine or methadone for pain patients who are being tapered off their medication.

“It depends on the type and source of the pain,” said Charles O’Brien, M.D., Kenneth E. Appel Professor of Psychiatry and vice chair of psychiatry in the Perelman School of Medicine at the University of Pennsylvania. “Some patients may function well on long-term opioids, but the goal should be moving to zero dose and continuing cognitive behavioral therapy. Both methadone and buprenorphine can relieve pain, but the behavioral treatment is also essential.”

“The issues are what works and what is best for the patient,” said H. Westley Clark, M.D., Dean’s Executive Professor of Public Health at Santa Clara University. “The current belief is that there is little justification for chronic opioids. The question should be whether anyone can function well on chronic opioids. If they can function well without psychosocial decrements of function, they should not have to be treated by an addiction specialist. However, if an opioid-stable patient cannot receive treatment from primary care, then addiction docs should be involved. If a pain patient has both chronic opioids and illegal opioids, addiction doctors should be involved.”

“Without addressing the questions of legality, let me simply state that patients with chronic pain often respond well to buprenorphine therapy,” said Stuart Gitlow, M.D., M.P.H., American Society of Addiction Medicine immediate past president. “Given the safety profile of buprenorphine when compared to morphine-like alternatives, it appears quite reasonable to utilize buprenorphine as a treatment approach, particularly when non-opioid-related alternatives have failed. Further, given buprenorphine’s efficacy for long-term maintenance of patients with opioid use disorders, it would seem to represent a clear direction in patients with both opioid use disorder and chronic pain.”

The bottom line: Opioids for chronic pain “are more dangerous than we thought and not as effective as we thought,” said Campopiano.

In Case You Haven’t Heard
10/10/2016 12:00 AM

The Office of National Drug Control Policy (ONDCP) is asking everybody to change their language when talking about addiction. Actually, they prefer substance use disorder. They also say to stay away from words like “dirty,” “abuse” and “dependence.” All good. After all, even the Diagnostic and Statistical Manual of Mental Disorders no longer uses “abuse” or “dependence” (to describe a pathology), and only the worst kinds of people use the word “dirty” to describe a urine test that is positive for drugs. The ONDCP is even asking for comments on this, in what must be the most frustrating time of the year for substance use disorder treatment advocates who have been trying to pry pennies from Congress for the worst opioid epidemic the country has ever seen. If you want to comment, here’s the draft: https://www.whitehouse.gov/ondcp/changing-the-language-draft. We would like to put in a plug for a change that has been due for some time: “medication-assisted treatment.” What does that even mean? In the field of substance use disorders, we have medications approved for alcohol use disorders (acamprosate, naltrexone) and for opioid use disorders (methadone, buprenorphine, naltrexone). The ONDCP and, increasingly, Congress use “medication-assisted treatment” to mean treatment for opioid use disorders. There’s a huge difference between methadone, which is only dispensed in opioid treatment programs; buprenorphine, which, like methadone, is an agonist (or partial); and naltrexone, which most of the time means the patented extended-release version: Vivitrol. Now “MAT” is in the lexicon — of legislation and regulation — and nobody knows what it means. So can we stop using the phrase “medication-assisted treatment” and just call it medication?

In Case You Haven’t Heard
10/3/2016 12:00 AM

As syringe programs, safe-injecting facilities and harm reduction in general enter the mainstream, what does “harm reduction” even mean anymore? Does it still mean encouraging drug users to get treatment? We asked the policy director of the Harm Reduction Coalition these questions. He is concerned about drug users being left behind as the field gets more mainstream. “Harm reduction has always been grounded in reaching and engaging people who use drugs to support their health needs, including overdose and HIV risk but also substance use itself,” Daniel Raymond told ADAW last week. “So I hope that we’re moving towards building deeper relationships with the treatment and recovery communities so that we can support each other and create a stronger continuum of care.” Raymond also wants to see “more engagement with health care, housing and criminal justice/re-entry,” he said. “Harm reduction philosophy and strategies have a lot to offer and share with these sectors. More broadly, we’re looking at addressing the broader structural issues like stigma, trauma, homelessness and mass incarceration that intersect with substance use and multiply vulnerability and harm.” For more on Raymond’s concerns about mainstreaming the harm reduction agenda, see his piece on the Midwest Harm Reduction Institute’s annual conference, published last week: https://medium.com/@danielraymond/holding-space-for-the-unredeemed-harm-reduction-and-justice-1d70ca675f25#.pbn8uqhcy.

From the Field
9/19/2016 12:00 AM

Opioid addiction is a disorder of brain structure and function. It is an illness. And the most effective treatment for this illness is medication. And as with any illness, the medication that should be used is the one that proves most effective for that patient. And yet, there are those that argue we should limit the medications we use to fight this epidemic of opioid addiction and death.

We’re dying out there. Look at the number of overdoses that have occurred in the last month to heroin and to fentanyl- or carfentanyl-laced heroin. If something, anything, can be used to save lives, then please, let’s put ideology aside and let’s do that. When used as a medication, prescribed by a physician, diacetylmorphine — prescription heroin — stabilizes brain function and allows the person to become well, stay well and, most importantly, stay alive. And this treatment is for those that are refractory to the other medications used to treat this medical condition. Methadone and buprenorphine don’t work for them. So, because those treatments failed, should we just discard the people?

According to the NAOMI study, the countries that have established heroin treatment programs — Switzerland, the Netherlands, the United Kingdom, Germany, Spain, Denmark, Belgium, Canada and Luxembourg — have all reported positive results for those individuals who are refractory to methadone and buprenorphine treatment.

It sounds radical, the provision of heroin to those addicted to heroin. But do understand, a drug is just a drug. It just does what it does. This controversy over using heroin as a treatment to control opioid addiction — it’s not about the data. It’s not about the research. It’s about stigma, ideology and people protecting their turf.

In a previous ADAW issue, Robert Lubran, then with the Substance Abuse and Mental Health Services Administration, stated, “It’s not difficult to find individuals who will prefer access to heroin over methadone maintenance treatment” (see ADAW, Aug. 31, 2009). He seems to believe this is a bad thing. I do not. If we can get more people into treatment, if heroin treatment will do that, how many lives can we save? And every life is someone’s son, it is someone’s daughter, and we would not only be saving them but also their mothers and fathers from the devastating loss of their child. We should be doing everything we can to keep them alive. And, yes, that includes treatment with diacetylmorphine.

The NAOMI studies show that, for those refractory to methadone or buprenorphine, heroin-assisted treatment is effective, with retention rates of about 88 percent. But there seems to be a problem. The acceptance of this form of treatment is opposed by some in the treatment field.

This is not a game. This is not a “my treatment is better than your treatment” contest. This is about saving lives. Heroin can produce addiction, or it can be used to stabilize (with medication) an addiction. It is how we use it that determines its effects. In this epidemic, we have an obligation to do everything we can to save lives. If the use of heroin-assisted treatment will do that, and the data show that it will, then please, put the ideologies aside, put the financial interests aside, push back on the stigma and let’s do everything we can to reduce the harm of this epidemic to those who suffer from this disorder of brain structure and function we call opioid addiction. Because every death, every loss, is someone’s son or daughter, and their lives are precious too.

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  • Meet the Editor

    Alison Knopf
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    Alison Knopf is a professional journalist who began covering the addiction field in 1984 as founding editor of Substance Abuse Report. She has been the editor of Alcoholism & Drug Abuse Weekly since 2005.
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