A drug increasingly being used to treat opioid addiction may be fueling a new epidemic of diversion, overdose, addiction and death in the United States.
The drug’s name is buprenorphine, but it is more widely known by its brand name – Suboxone – which for many years was sold exclusively by Reckitt-Benckiser, a British pharmaceutical company. Since Reckitt’s patent on Suboxone expired in 2012, several other drug makers have rushed to introduce their own formulations – hoping to grab a share of the $1.5 billion market for Suboxone in the U.S.
Two generic versions of buprenorphine were introduced earlier this year. And this month a Swedish drug maker began selling a menthol flavored tablet – called Zubsolv – that is designed to mask the bitter taste of buprenorphine. Other formulations of the drug include a film strip that dissolves under the tongue and a buprenorphine skin patch. One company is even developing a buprenorphine implant to be inserted under the skin.
“This is insanity,” says Percy Menzies, a pharmacist and addiction expert. “Buprenorphine is one of the most abused pharmaceuticals in the world.
“We took an abused drug and we said let’s use it to treat addiction to heroin and opiates.”
Last year patients filled about 9 million prescriptions for Suboxone or buprenorphine products, many perhaps not realizing they were taking another opioid to treat their opioid addiction.
Buprenorphine is a narcotic, a powerful and potentially addicting painkiller that was first approved as a treatment for opioid addiction in the U.S. in 2002. When combined with naloxone to make Suboxone, the two drugs can be used to help wean addicts off opioids such as heroin, Vicodin, OxyContin, and hydrocodone.
Naloxone blocks opioid receptors in the brain and will trigger sudden withdrawal symptoms when injected. It is added as a deterrent to prevent addicts from injecting Suboxone. When taken as a pill, naloxone is not absorbed into the body.
Over three million Americans with opioid dependence have been treated with Suboxone. Although praised by addiction experts as a tool to wean addicts off opioids, some are fearful the drug is overprescribed and misused.
A report by the Substance Abuse and Mental Health Services Administration (SAMHSA) found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the 30,000 hospitalizations in 2010 were for non-medical use of buprenorphine.
How many died from buprenorphine overdoses is unknown, because medical examiners and coroners do not routinely test for the drug.
“Suboxone is a fantastic detox agent. But you have to use it with great caution as a long term maintenance medication. In my clinic we use a lot of Suboxone, but only for detox,” says Menzies, who is president of Assisted Recovery Centers of America, which operates four addiction treatment centers in the St. Louis, Missouri area.
The problem with Suboxone, according to Menzies, is that many addicts have learned they can use the medication, not to treat their addiction, but to maintain it. Suboxone won’t get them “high” but it will help them smooth out withdrawal symptoms between highs.
“For a drug addict, the most uncomfortable, painful problem of their addiction is withdrawal. If I can somehow control my withdrawal, then I have complete freedom to use heroin,” Menzies told National Pain Report.
“It’s a perfect formula for drug addiction. They have very little interest in getting off the drug. Suboxone, in my estimation, has allowed a very significant number of people to maintain their addiction.”
“This was great drug for its intended use,” says Charlie Cichon, executive director of the National Association of Drug Diversion Investigators, a non-profit that educates health care providers about drug abuse and diversion.
“But the abusers found out that this was another drug that they liked. It’s not a drug that gets them on that high plain like the other drugs that they abuse. But if they can’t get that drug that they like, Suboxone is readily available and it keeps them at this mellow stage until they can get the next drug.”
Suboxone is so popular with addicts that it has turned into a street drug – to be bartered or exchanged for money, heroin or other illegal drugs. According to one estimate, about half of the buprenorphine obtained through legitimate prescriptions is either being diverted or used illicitly.
“We joke that there’s more Suboxone on the street than in pharmacies. Most of the heroin dealers are diversified now. They offer you a choice of Suboxone and heroin. And now with all these generic forms coming out, that is going to explode,” says Menzies.
“My concern is that, just as what happened with chronic pain, we had an explosion of generic oxycodone and hydrocodone being introduced. And look at the mess we had. We’re going to see the same thing happen with Suboxone and buprenorphine generic preparations.”
Drug makers are well aware of the potential for diversion and tampering. Orexo, the maker of menthol flavored Zubsolv, is selling the tablets in single dose “blister” packaging designed to reduce accidental ingestion by children.
And Reckitt-Benckiser, which took its Suboxone tablets off the U.S. market last year, now only sells Suboxone in individually wrapped film strips.
But experts say no amount of preparation and packaging can outsmart a determined drug abuser.
“When they had the pills available, the abusers would crush the Suboxone pills and make a yellow paste out of it,” says Chicon, explaining that the “paste” was sometimes smuggled into prisons after it was smeared on the pages of children’s coloring books.
“They’d have their little kids color in Mickey Mouse with crayons and they’d send the coloring book to prison to daddy or mommy. Daddy or mommy would know the pages that the Suboxone paste is on and they’d suck it or they’d sell it into the prison system,” Chicon told National Pain Report.
“Now they’re taking the yellow strips and they’re just taping them onto the pages as yellow squares or rectangles and then coloring around it. I have a coloring book page that has these strips on it that they’re getting into the prison systems. The abusers are always another step ahead of law enforcement.”
But the potential for abuse and diversion is no reason to stop treating addicts with buprenorphine, according to a commentary published in the journal JAMA Internal Medicine that calls for a “balanced approach” to the drug.
“Buprenorphine can and does cause harm, but those harms are outweighed by the serious health consequences and fatalities associated with opioid addiction itself,” wrote Robin E. Clark, PhD, and Jeffrey D. Baxter, MD, of the University of Massachusetts Medical School.
“Rather than overreacting to reports of buprenorphine diversion, policymakers should consider the actual harms that diversion may cause. Placing buprenorphine in the same category with more addictive and risky opioids distorts public policy and impedes effective treatment. Better education of prescribers and patients about the dangers of accidental ingestion by children, continued improvements in packaging and formulation of buprenorphine, and careful monitoring by prescribers and policymakers are all essential.”
Over 20,000 physicians in the U.S. are certified to prescribe buprenorphine. Percy Menzies wonders how many really understand the risks posed by buprenorphine.
“The Suboxone doctors, many of them have been very irresponsible, because they have no training in addiction,” Menzies says, explaining that the training often only amounts to a few hours of online education.
“It is shocking in this day and age that physicians are so incredibly ignorant about the pharmacology of buprenorphine preparations.”