Some Pharmacies Won’t Sell Suboxone, But Street Dealers Do

By Nina Feldman, WHYY

Louis Morano knew what he needed, and he knew where to get it.

He made his way to a mobile medical clinic parked on a corner of Philadelphia’s Kensington neighborhood, in the geographical heart of the city’s overdose crisis. People call it “the bupe bus.”

Buprenorphine is a drug that curbs cravings and treats the symptoms of withdrawal from opioid addiction. One of the common brand name drugs that contains it, Suboxone, blends buprenorphine with naloxone. Combined with cognitive behavioral therapy, it is one of the three FDA-approved medicines considered the gold standard for opioid-addiction treatment.

Morano had tried Suboxone before — he had purchased some from a street dealer and had used it to get through his workday, when he couldn’t use heroin. It kept the misery of withdrawal sickness at bay.

Morano, 29, has done seven stints in rehab for opioid addiction in the past 15 years. So he had a sense of how the drug would make him feel. He’d always sort of thought of it as a crutch. But after a slip following his latest stint in rehab, he said, he committed to recovery.

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“I can’t do this anymore, and I need something,” Morano said.

The bupe bus — a project of Prevention Point Philadelphia, the city’s only syringe exchange program — is part of Philadelphia’s efforts to expand access to this particular form of medication-assisted treatment, known as MAT, for opioid addiction.

Morano was first in line at the mobile clinic. When the doors of the bus heaved open, Dr. Ben Cocchiaro waved Morano inside, where they squeezed into a tiny exam room.

Cocchiaro and Morano discussed how buprenorphine might help Morano’s recovery succeed this time, and whether he’d be open to seeing a therapist. Cocchiaro gave Morano instructions on how to take the medication, and then called a pharmacy to authorize a prescription.

Barriers to Treatment

To date, much of the research on barriers to buprenorphine access has focused on the fact that too few medical providers are certified to write the prescriptions. According to federal law, doctors must apply for a special waiver from the Substance Abuse and Mental Health Services Administration, or SAMHSA, to prescribe buprenorphine. To get the waiver, a doctor must undergo eight hours of training — and can prescribe the drug to a maximum of 30 patients at a time, to start. Given these constraints, many doctors don’t bother.

But pharmacists are also a part of the problem. Because they fill the prescriptions, pharmacists are the gatekeepers for the drug, and not all of them are willing to take on that role. Increasing pharmacists’ involvement in distributing buprenorphine might be just as important as persuading more doctors to prescribe it, according to Dan Ventricelli of the Philadelphia College of Pharmacy.

“We can write a bunch of prescriptions for people,” he said. “But if they don’t have a pharmacy and a pharmacist that’s willing to fill that medication for them, fill it consistently and have an open conversation with that patient throughout that treatment process, then we may end up with a bottleneck at the community pharmacy.”

Just a few blocks from the bupe bus in Kensington, Richard Ost owns an independent pharmacy. He said his store was one of the first in the neighborhood to stock buprenorphine. But after a while, Ost started noticing that people were not using the medication as directed — they were selling it instead.

Buprenorphine acts as a partial opioid agonist, which means it’s a low-grade opioid. When taken in pill or tablet form, it’s unlikely to cause the same feelings of euphoria as heroin would, but it might if it were dissolved and injected. Many people buy it on the street for the same reason Morano did: to keep from going into withdrawal between injecting heroin or fentanyl. Others buy it to try to quit using on their own.

“We started seeing people do it in our store in front of us,” said Ost. He said it’s unethical to dispense a prescription if a patient turns around and sells it illegally, rather than use it. “Once we saw that with a patient, we terminated them as a patient.”

Ost explained that the illegal market for Suboxone also meant customers trying to stay sober were being continually targeted and tempted.

“So if we were having a lot of people in recovery coming out of our stores, the people who were dealing illicit drugs knew that, and they would be there to talk to them and they would say, ‘Well, I’ll give you this’ or ‘I’ll give you that,’ or ‘I’ll buy your Suboxone’ or ‘I’ll trade you for this.’”

Ost said that eventually his staff didn’t feel safe, and that neither did the customers. He understands the value of bupe but said it just wasn’t worth it. He mostly has stopped carrying it.

Even those pharmacies that aim to stock buprenorphine can run into problems. Limits set by wholesalers require pharmacies to order the drug in small, frequent batches. Though pharmacies can apply for exemptions to order more at a time, or to have a higher percentage of their total stock consist of controlled substances, doing so invites a higher level of scrutiny from the wholesaler and, in turn, the Drug Enforcement Administration.

Another issue is that doctors and pharmacists receive different education about how long buprenorphine should be prescribed before tapering a patient off it. Many medical providers might prescribe the drug for long-term treatment, based on recent SAMHSA guidelines, while pharmacists may view longer courses of treatment as posing the risk of long-term dependency.

“It’s not even that they’re on different pages,” said Ventricelli of the College of Pharmacy. “It’s that they’re reading completely different books.”

If a patient going through withdrawal can’t get buprenorphine quickly, the stakes are high. Silvana Mazzella, associate executive director at Prevention Point, said that when it’s not available, patients are more likely to turn back to heroin or fentanyl.

“We’re in a situation where if you are in withdrawal, you’re sick, you need to get well, you want help today, and if you can’t get it through medication-assisted treatment, unfortunately you will find it a block away, very quickly, and very cheaply,” she said.

Doctors with Prevention Point have found a pharmacy near the bupe bus that will reliably dispense buprenorphine to their Philadelphia patients. It’s a neighborhood branch of a local chain, called the Pharmacy of America.

The head pharmacist, Anthony Shirley, said he’s comfortable filling the scripts because he trusts that the doctors at Prevention Point will write prescriptions only for patients who need the medication. He has heard firsthand from patients who say buprenorphine saved their lives.

“That’s something you can’t really put a price tag on,” Shirley said. For him, the calculation is simple: His store is in an area where many people need buprenorphine. That means it’s his job to get it to them.

This story is part of a partnership that includes WHYY, NPR and Kaiser Health News. KHN is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

FDA: Pain Patients Dependent On Opioids Are Not Addicted

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has released new guidance to drug makers to streamline the development of buprenorphine products to treat opioid addiction. Commonly known by the brand name Suboxone, buprenorphine has long dominated the market for addiction treatment.

Of importance to pain patients is a statement about the guideline by FDA commissioner Scott Gottlieb, MD, that seeks to clarify the difference between opioid addiction and patients who need opioids for pain relief.

Gootlieb said there is still stigma and misunderstanding – even in the medical and addiction fields – about the difference between opioid addiction and dependence.

“Because of the biology of the human body, everyone who uses a meaningful dose of opioids for a modest length of time develops a physical dependence. This means that there are withdrawal symptoms after the use stops,” Gottlieb said. “A physical dependence to an opioid drug is very different than being addicted to such a medication.

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“Addiction requires the continued use of opioids despite harmful consequences on someone’s life. Addiction involves a psychological preoccupation to obtain and use opioids above and beyond a physical dependence. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

Someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.
— Dr. Scott Gottlieb, FDA Commissioner

In recent years new and generic formulations of buprenorphine have been released in tablets, sublingual films, injections and implants, and the FDA is trying to promote the development of more of them.

The guidance released by the agency basically tells drug makers they may be able to submit new drug applications for buprenorphine products without conducting the safety and efficacy trials that are usually required for other medications.

“The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” Gottlieb said. “Our goal is to advance the development of new and better ways of treating opioid use disorder to help more Americans access successful treatments.”

There are currently only three drugs approved by the FDA for medication-assisted treatment (MAT) – buprenorphine, methadone and naltrexone. Physicians wishing to prescribe buprenorphine to patients must have a special certification from the DEA and are limited in the number of patients they can treat.

Buprenorphine is an opioid that is also used to treat pain. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

Some addicts have discovered that buprenorphine can also be used to get high or to ease their withdrawal pain from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

Opioid Painkillers Top Selling Drug in 10 States

By Pat Anson, Editor

If you live in Oklahoma, the drug you’re most likely to be prescribed is the opioid painkiller Vicodin -- or some other combination of hydrocodone and acetaminophen.

In Texas, the #1 drug is Synthroid (levothyroxine) – which is used to treat thyroid deficiencies.

In California, its Lipitor (atorvastatin) – a statin used to treat high cholesterol.

And Tennessee has the unique distinction of being the only state in the country where the addiction treatment drug Suboxone (buprenorphine/naloxone) is the most prescribed drug.

These findings are part of an interesting study by GoodRx, an online discount drug company, on prescribing trends in all 50 states. GoodRx looked at pharmacy and insurance data from around the country – not just its own customers -- from March 2017 to February 2018.

It then developed a map to show how prescription trends can vary by region and by state.

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Levothyroxine (Synthroid) is easily the top selling drug in the country. It’s #1 in 26 states (AR, AZ, CO, CT, FL, IA, KS, KY, LA, ME, MI, MN, MT, ND, NJ, NV, OR, PA, SD, TX, UT, VT, WA, WI, WV, WY).

Hydrocodone (Vicodin, Norco, Lortab) is #1 in 10 states (AK, AL, GA, ID, IL, IN, MS, NC, NE, OK), mainly in the South and Midwest. As recently as 2012, hydrocodone was the most widely prescribed medication in the country. Since then, hydrocodone prescriptions have fallen by over a third and it now ranks 4th nationwide.

Atorvastatin (Lipitor) is #1 in 5 states (CA, HI, MD, MO, VA) and so is lisinopril (MA, NH, NM, OH, RI), a medication used to treat high blood pressure.

There are a few outliers. New York, for example, is the only state that’s #1 in amlodipine (Norvasc), a blood pressure medication, and Delaware and South Carolina are the only states where the leading prescription drug is Adderall, a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD).   

That brings us to Tennessee, one of the states hardest hit by the opioid crisis. In 2012, doctors wrote 1.4 opioid prescriptions for every citizen in Tennessee, the second highest rate in the country. The state then moved aggressively to shutdown pill mills and expand access to addiction treatment -- which explains why Tennessee is #1 for Suboxone.

Prescriptions for opioid pain medication have dropped by 12% in Tennessee since their peak, but overdose deaths and opioid-related hospitalizations continue to climb, due largely to heroin and illicit fentanyl.  No other state even comes close to Tennessee in per capita prescriptions for Suboxone.  Addiction treatment has become such a growth industry that Tennessee has adopted measures to rein in the overprescribing of Suboxone.

What Makes Buprenorphine Risky for Pain Patients

By Jane Babin, Guest Columnist

Buprenorphine is the darling of the addiction treatment industry, rapidly replacing methadone as the "medication assisted treatment" of choice for opioid use disorder (OUD) and addiction.  

Unlike methadone, which can only be dispensed through an opioid treatment program, buprenorphine can be prescribed in the privacy of a physician's office and filled at a pharmacy.  As a class III controlled substance, prescriptions for buprenorphine can be phoned or faxed in, and scripts can be refilled up to 5 times in 6 months without a new prescription.

Class II controlled substances, like hydrocodone, oxycodone and morphine, require a new prescription each month and can neither be refilled nor phoned in.

The only federal limitations on prescribing buprenorphine for OUD is that a physician must complete mandatory education and treat only a limited number of patients (currently 275). 

Ironically, these restrictions do not apply when buprenorphine is prescribed off-label for pain, leading some physicians and patients to turn to buprenorphine for chronic pain as class II opioids become increasingly harder to get.

Yet without training on buprenorphine’s unique pharmacology and its implications, physicians treating chronic pain may be unaware of the risks it presents. Let me explain why.

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Buprenorphine’s Effect on Other Opioids

Buprenorphine is an opioid that acts as an agonist of the mu opioid receptor (MOR), which causes pain relief, just like class II opioids.  It also has side effects similar to other opioids, including tolerance, dependence, abuse potential, constipation, sedation and potentially fatal respiratory depression. 

What distinguishes buprenorphine from other opioids is that it is only a partial MOR agonist (50%).  Thus the effects of buprenorphine -- both pain relief and the undesirable side effects – don’t exceed half that of other, full agonist opioids.

Buprenorphine also has a ceiling of maximum effectiveness that reaches a plateau as the dosage is increased. That ceiling is well below what can be obtained with morphine and other opioids, but the side effects can still lead to death in opioid-naïve patients.  Buprenorphine has a long plasma half life, binds very strongly to MOR, and remains bound for extended periods of time.  Its usefulness in treating OUD is believed to lie in these properties, because it activates MOR sufficiently to curb drug craving, but not enough to elicit the euphoric effects that can lead to addiction. 

When an opioid that has higher analgesic potency, but lower MOR affinity, such as morphine or heroin, is also administered, buprenorphine wins the battle to bind and remains bound to MOR.  It can displace both heroin and naloxone from MOR, but neither can displace buprenorphine.  Naloxone can be effective when co-administered with buprenorphine -- as it is in combination drugs such as Suboxone -- but not after the administration of buprenorphine. 

Buprenorphine is also a kappa opioid receptor antagonist, which is thought to further reduce euphoria and addictive reinforcement. That’s great for patients with OUD, because it helps them resist the temptation to abuse opioids, and dampens or eliminates the euphoric effect of heroin or other opioids should they relapse.  

Increasingly, buprenorphine is being advocated for chronic pain patients.  With no more "proof" of efficacy for treating chronic pain than any other opioid, it has emerged as a less objectionable opioid because it appears safer in the eyes of addiction treatment specialists, such as Dr. Andrew Kolodny, who object to full MOR agonists for chronic pain. 

Yet safety is in the eyes of the beholder.  Despite its decreased abuse potential, buprenorphine can still be abused and cause overdoses because the ceiling effect for respiratory depression does not apply universally, particularly to opioid-naïve patients and children. Buprenorphine has caused the death of at least one child from unintentional exposure. 

Buprenorphine should not be used as the first opioid prescribed for chronic pain.  Because it cannot achieve the full analgesic effects that other opioids can, there is significant risk of buprenorphine leaving pain undertreated or even untreated.  A chronic pain patient on long-term buprenorphine therapy who experiences acute or breakthrough pain may not be able to get relief by taking another opioid.  Even more disturbing is the lack of pain control in patients who need surgery, have an acute injury from trauma or an acute painful medical emergency.

Buprenorphine Injection

Recently Indivior, a spin-off of Reckitt Benckiser Pharmaceuticals (which makes Suboxone), submitted a New Drug Application to the Food and Drug Administration on a subcutaneous injection formulation of buprenorphine. 

A once-a-month injection would be a significant advance for opioid administration because it would significantly reduce the risk of diversion.  A patient could hardly be accused of giving away or selling a drug that is deposited in his body, or of taking an incorrect dose.  

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For this reason alone, an opioid depot formulation for a chronic pain patient with monthly administration sounds very appealing.  It might eliminate the need for pain contracts, pill counts, urine drug testing, and other indignations chronic pain patients suffer every day.  Even if another medication was needed for breakthrough pain, and drug testing was deemed necessary, the depot formulation would provide a virtually indisputable level of medication that could serve as an "internal control" for test error.  Detecting the depot med at unexpected levels would alert the prescribing physician to the inaccuracy of the test rather than suggest misuse or abuse.

Nevertheless, buprenorphine is not the right opioid for once-a-month dosing.  In a 2015 paper, lead author Dr. Yury Khelemsky described a horrifying case that illustrates the dangers inherent in daily buprenorphine use.  In this case, a patient with a history of drug addiction who was being treated successfully with Suboxone suffered a broken neck that required emergency surgery.

During the procedure, the anesthetized patient began to move in response to surgical stimulation, i.e., due to pain.  Despite increasing the amount of two anesthetics, Propofol and Reminfentanil, the patient continued to move.  Only after receiving yet another drug (Ketamine) did the patient remain motionless during the delicate procedure.  During a subsequent back surgery following discontinuation of Suboxone and replacement with short-acting opioids, roughly half as much Propofol and Remifentanil provided adequate anesthesia without the addition of Ketamine. 

Khelemsky noted that as little as 8 mg Suboxone (one third of the daily dose the patient was receiving), blocks the activity of hydrocodone for up to five days, and recommended discontinuing buprenorphine at least 72 hours prior to elective surgery.  This is cold comfort to a patient requiring emergency surgery -- which could be anyone.  

An injectable depot formulation of buprenorphine would substantially increase the risk of severe and possibly untreatable pain in an emergency situation, since a depot, once injected, cannot simply be discontinued as a pill would be.  Indeed, surgery may be needed to remove the depot and halt continued administration, while existing amounts of long-acting buprenorphine in plasma may necessitate higher, riskier doses of anesthetic to surgically treat the acute injury -- all while risking inadequate pain treatment.

Inexplicably, the extensive prescribing information on a random sample of buprenorphine products contains no warnings to either patients or prescribers of the risk that pain relief from an acute medical condition, trauma or surgery may be inadequate, or that buprenorphine should be discontinued days or weeks before elective surgery. 

Ironically, one package insert warns that additional analgesia may be required during childbirth, yet it fails to warn of any other situation that may require analgesia, or how analgesia can be accomplished when considering the unique pharmacology of buprenorphine.  

This seems to reflect the mindset of Kolodny and others in the addiction treatment industry, who always seem to minimize the significance of even the most severe pain encountered by an individual when compared to the perceived societal consequences of addiction.  I wonder how many pain patients or addicts would choose such a long-acting opioid if they understood the possibility that their severe acute pain could not be controlled.

The FDA committee tasked with reviewing Indivior’s new drug application is taking public comments.  I urge anyone concerned about this new buprenorphine formulation, and the failure to warn of the possibility of untreatable acute pain when taking any buprenorphine product, to provide comments by clicking here.

Comments can be submitted through October 27, 2017.  If received by October 17, they will be provided to the committee, which is scheduled to meet on October 31.  Comments received after October 17 will be taken into consideration by the FDA. 

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Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California.

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.

Study: Suboxone Usually Fails To Stop Opioid Use

By Pat Anson, Editor

A drug widely prescribed to treat opioid addiction fails so often that two-thirds of the pain patients who took it during addiction treatment wound up getting opioid prescriptions again, according to a large new study by the Johns Hopkins Bloomberg School of Public Health.

Researchers analyzed pharmacy claims for over 38,000 people who were prescribed Suboxone (buprenorphine) between 2006 and 2013, and found that 67 percent of them filled a prescription for an opioid painkiller in the year after Suboxone treatment.

Nearly half of the patients – 43 percent -- filled an opioid prescription during treatment. Most patients continued to receive similar amounts of opioids before and after Suboxone treatment.

Suboxone is a combination of two different medications: buprenorphine, a short-acting opioid similar to methadone, and naloxone, an anti-overdose drug.

During most of the years analyzed in the study, Suboxone was the only combination of buprenorphine and naloxone that was available. It is now sold under several different brand names.

The Johns Hopkins study, which was funded by Centers for Disease Control and Prevention, found that about two-thirds of the patients who received Suboxone stopped filling prescriptions for it after just three months.

The findings, published in the journal Addiction, raise questions about the effectiveness of Suboxone and addiction treatment in general, at a time when the federal government is spending hundreds of millions of dollars to subsidize the addiction treatment industry.

"The statistics are startling," said lead author G. Caleb Alexander, MD, "but are consistent with studies of patients treated with methadone showing that many patients resume opioid use after treatment."

Researchers say the continued use of pain medication during and after addiction treatment suggests that many patients did not have well-coordinated treatment for their addiction or their chronic pain.

“There are high rates of chronic pain among patients receiving opioid agonist therapy, and thus concomitant use of buprenorphine and other opioids may be justified clinically. This is especially true as the absence of pain management among patients with opioid use disorders may result in problematic behaviors such as illicit drug use and misuse of other prescription medications,” Alexander wrote.

Prescriptions for Suboxone and other brands of buprenorphine have soared in recent years as the U.S. grapples with an “opioid epidemic” that was initially fueled by painkillers, but is now increasingly caused by heroin and illicit fentanyl. Sales of buprenorphine now exceed $2 billion annually and are likely to keep growing.

Last year the federal government nearly tripled the number patients that can be treated with buprenorphine by an eligible physician. Raising the limit from 100 to 275 patients was intended to give addicts greater access to treatment, especially in rural areas where few doctors are certified to prescribe buprenoprhine.

An additional $1 billion in funding for addiction treatment was approved by Congress last year under the 21st Century Cures Act. Much of that money will be used to pay for buprenorphine prescriptions.

Addicts long ago discovered that buprenorphine can be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked it as the third most diverted opioid medication in the U.S. in 2014. 

An Open Letter to President-Elect Trump

By Percy Menzies, Guest Columnist

Dear President-Elect Trump,

You will soon have an extraordinary opportunity to save thousands of lives with one stroke of the pen! I am talking about reducing overdose deaths from opioid overdoses. How is this possible?

We have three highly effective medications for the treatment of opioid addiction, but they are grossly under-utilized, largely due to accessibility. Two of the three drugs used to treat opioid use disorder have restrictions that have no place when overdose deaths exceed 30,000 per year. These restrictions made sense at a different time, but these barriers are now inadvertently contributing to overdose deaths.

I am specifically talking about buprenorphine, the most widely used medication in the battle against the opioid epidemic. This medication, better known by its brand name Suboxone, is an opioid with a very safe profile. Its unique pharmacology makes it almost impossible to overdose.

There are barriers to the use of this medication which made sense 14 years ago, when heroin was not a public health issue, but today they are a hindrance to saving lives.

Buprenorphine is the only drug that requires physicians to complete eight hours of training and then apply to the Drug Enforcement Administration to obtain a special exemption to prescribe it. It gets worse. Physicians can only treat 30 patients with this medication in the first year, and then they must obtain permission from the DEA to increase the limit to 100 patients. The physician also has to keep clear records and can expect a visit from a DEA agent to look at the records. 

This is a major deterrent and way too few physicians have bothered to obtain the required exemption. Any physician who has a DEA license can prescribe an FDA-approved controlled substance without restriction, but they have to deal with this barrier to prescribe buprenorphine. 

These restrictions were put in place to prevent buprenorphine from joining the opioid “pill mills” when few anticipated heroin sweeping our cities and towns. At the present time, there is no strategy in place to cut off or curtail the supply of heroin, or heroin that is laced with super potent opioids like fentanyl. Deaths from prescription opioids are declining, while deaths from heroin and fentanyl are climbing. Indeed, prescriptions for opioids drugs have fallen between 12 -25%, but the overdoses deaths have not declined. 

Yes, buprenorphine is being diverted, but most experts believe that is due to the lack of treatment. Patients desperately seeking treatment are purchasing the drug on the streets. Many experts believe that if patients have expanded and easier access to buprenorphine, the diversion will drastically reduce and more patients will be in treatment and get away from heroin.

Several steps have been taken to address this catastrophic problem, but these steps are woefully inadequate. Expansion of the needle-exchange programs and the widespread distribution of the opioid overdose drug naloxone (better known by the brand name Narcan) are welcome and should be expanded, but they are at best palliative in nature. These measures do little to address the underlying addiction.

The federal government is increasing the patient limits for buprenorphine for selected specialists from 100 to 275, and will also allow nurse practitioners and physician assistants to complete the required training and obtain the DEA exemption to prescribe buprenorphine. These are welcome steps, but fall far short of the response required to expand treatment and reduce deaths. 

You got elected on a law-and-order platform and a promise to reduce the flow of heroin coming in from Mexico. Almost 50 years ago, Richard Nixon got elected on a similar platform.  He too faced an unprecedented public health epidemic of heroin addiction – one that is nowhere close to what we are facing today.  

President Nixon is remembered for taking a bold measure, which at that time was controversial. He initiated the opening of methadone clinics, which for the first time provided evidence-based treatment for heroin addicts. This measure reduced overdose deaths, protected society from criminal activity, and allowed these patients to become productive members of society.  For the first time in the dark and checkered history of our nation, addiction was treated as a chronic healthcare issue and not a criminal activity. 

Nixon went a step further to curb the supply of heroin coming into this country. He put political pressure on France to shut down the illegal labs processing Turkish-grown opium into heroin. Turkey also complied with the strong U.S. demand to curb the illegal cultivation of opium. Who can forget The French Connection, the thriller movie about this operation.

Mr. Trump, you have an extraordinary opportunity to lift the present restrictions on buprenorphine through executive order, to lure patients away from heroin and drastically reduce overdose deaths. Your action would provide increased treatment and not just palliative care.

Furthermore, you are in the best position to bring pressure on Mexico to eliminate the opium processing labs and drastically reduce heroin coming into this country.  An epidemic is best treated when effective treatment is combined with eliminating factors contributing to the spread of the epidemic. In this case, it is the supply of heroin.

This one single action will earn you the gratitude of tens of thousands of families terrified at hearing a knock on the door informing them of the death of a loved one. You will also earn the gratitude of millions of patients suffering from chronic pain, who have been needlessly cut off from prescription opioids because of the overreaction of regulators and many physicians.

You will be remembered in history for a bold action that saved a generation from succumbing to a man-made epidemic.

Percy Menzies, M. Pharm, is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri.

He can be reached at: percymenzies@arcamidwest.com

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.

New Rule Expands Access to Buprenorphine

By Pat Anson, Editor

This week marks the start of a major expansion in access to buprenorphine – a medication that is both widely praised for treating opioid addiction and also blamed for fanning the flames of abuse and diversion.

The Department of Health and Human Services (HHS) updated a federal rule, nearly tripling the number patients that can be treated with buprenorphine by an eligible physician.

Raising the limit from 100 to 275 patients is intended to give addicts greater access to buprenorphine, especially in rural areas where few doctors are certified to prescribe the drug. According to HHS, over two million people who are dependent on heroin and other opioids could benefit from buprenorphine treatment.

“For too long, addiction specialists like me have had to turn patients in need away from treatment that might save their lives, not because we don’t have the expertise or capacity to treat them, but because of an arbitrary federal limit,” said Dr. Jeffrey Goldsmith, President of the American Society of Addiction Medicine .

But critics of the rule change say there will be a price to pay.

“Buprenorphine is one of the most abused pharmaceuticals in the world,” warns Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“Sales of buprenorphine formulations have exceeded $2 billion a year, but we have not had any lessening of heroin addiction. Increased access to buprenorphine and increased availability of potent heroin and heroin laced drugs like fentanyl will only exacerbate the problem.”

The problem with buprenorphine is that it’s an opioid that can be used to treat pain or addiction. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse. For many years the drug was sold exclusively under the brand name Suboxone, but it is now produced by several different drug makers and is sold in tablets, sublingual films and even an implant.

Addicts long ago discovered that buprenorphine can also be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

“Too many physicians erroneously believe that naloxone in the formulation makes the drug safe,” Menzies said in an email to Pain News Network. “Increasing the limit is definitely going to increase diversion. The majority of the physicians prescribing buprenorphine do not provide any comprehensive relapse prevention counseling, random drug testing, etc. In the absence of standards for treating addictive disorders, anything goes and will be no different than treating chronic pain.

“We saw the problem with prescription opioids when opioids were promoted as safe and non-abusable in the treatment of chronic pain. Very quickly the numbers grew into the tens of millions and the addiction exploded. The unintended victims were the patients in genuine chronic pain.”

Menzies uses buprenorphine as an initial treatment for opioid addiction in his clinics, but prefers another medication -- naltrexone -- for long-term maintenance therapy. He says doctors who rely on buprenorphine exclusively will, in effect, be sentencing their patients to lifetime use of the drug.     

"Financial Opportunity" for Doctors

HHS acknowledges there could be “unintended negative consequences” to increased prescribing of buprenorphine. One is diversion. Another is an increase in patient volume, physician profits and buprenorphine “pill mills” – which are already popping up in states like Florida. Patients typically pay cash for buprenorphine at those clinics and receive little or no addiction counseling or services.  

“This proposed rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine,” HHS said in an extensive analysis of the rule change. “We believe that this may translate to a financial opportunity for these physicians.”

HHS estimates the cost of treating new buprenorphine patients at up to $313 million in the first year alone. Many of the patients are low-income and the bills for treating them – about $4,300 annually for each patient – will often be covered by Medicaid. The additional cost of treating these patients, according to HHS, will be offset by the health benefits achieved by getting addicts into treatment, which the agency generously estimates at $1.7 billion.

The Obama administration asked Congress for nearly $1 billion in additional funding to help pay for addiction treatment, but didn’t get it in when Congress passed the Comprehensive Addiction and Recovery Act (CARA Act). The President reluctantly signed the bill into law anyway.

A little noticed provision of the CARA Act is that it expands access to buprenorphine even further. Currently only a trained and certified physician can prescribe buprenorphine, but CARA requires HHS to update its rules within 18 months to allow nurse practitioners and physician assistants to prescribe buprenorphine, provided they undergo training first.

How can buprenorphine diversion be prevented when access to it is rapidly increasing?

One solution proposed by Menzies is to change the classification of buprenorphine from a Schedule III controlled substance to a Schedule II drug – the same classification change that hydrocodone went through in 2014. Such a move would limit buprenorphine prescriptions to an initial 90-day supply and require patients to see a doctor for a new prescription each time they need a refill.

“We are caught between a rock and a hard place. We need to increase access to buprenorphine and it will lead to increased diversion and abuse, and therefore I am recommending changing the schedule,” Menzies said in his email to PNN.

“This is the psychotic state of affairs! No chronic condition/disease/disorder has ever been successfully treated with an addicting drug and we think we can do it for opioid addiction!”