Archive for the ‘Controlled Substances’ Category

Tramadol and Tapentadol: Ultram and Nucynta

aaanucynta

Tramadol, the generic for the brand name Ultram, is a pain reliever that has actions on several types of brain receptors: the mu opioid, serotonin, norepinephrine, NMDA, and other receptors.

Because it stimulates the mu opioid receptors, it can cause feelings of pleasure as well as pain relief. Tramadol is a pared-down version of codeine, and it is far less active at the mu opioid receptors than its metabolite. Because it takes time for the tramadol to be metabolized in the liver to its first metabolite, some experts thought it wouldn’t appeal to addicts, who prefer an immediate high. Overall this is probably true, and tramadol has a much lower rate of addiction than other opioids, but it still causes addiction in some patients.

Some of tramadol’s pain relieving properties may also be produced by its actions on serotonin and norepinephrine receptors, since tramadol’s pain relieving capability is only partially reversed by a pure opioid antagonist like naloxone.

When this medication was first released, it wasn’t a controlled substance. That is, the DEA didn’t control it strictly like medications that can cause addiction. Now, it’s a Schedule IV drug, in some states. It does have some benefit for pain relief, but also some risk of addiction, though lower than that of hydrocodone, for example.

Tramadol is usually dosed in 50mg pills, one or two every six hours, giving the maximum dose of 400mg per day. Recreational use of this medication (to get high) is dangerous, since it causes seizures at doses higher than 400mg. In susceptible patients, it can even cause seizures at lower prescribed doses.

I’ve seen patients in tramadol withdrawal who were so sick it frightened me. This drug can produce a severe withdrawal. If a patient taking high doses stops taking tramadol suddenly, some patients have opioid withdrawal symptoms like sweating, nausea, diarrhea, high blood pressure and heart rate, and severe muscle and joint pains. The sickest patient I’ve ever seen in opioid withdrawal had been using only tramadol, in doses of around 600mg per day. She had fever to 103 degrees, and dehydration from the diarrhea and vomiting. That patient needed hospitalization.

Besides the opioid-withdrawal symptoms, some of these patients also have withdrawal symptoms similar to those seen when certain serotonin-affecting antidepressants, like Paxil and Celexa, are stopped suddenly. They can have fairly severe anxiety, depression, mood swings, and restlessness. Many times they have weird sensory experiences, often called “brain zaps,” or the sensation of electric shocks throughout the body. They can have seizures during this withdrawal.

If the patient had only physical dependency and no addiction, the dose of tramadol can usually be tapered slowly over a few weeks to months, as an outpatient. But if the patient has not only physical dependency but also the disease of addiction, the obsession and craving for the medication will usually prevent a successful outpatient taper, unless a dependable non-addict holds the pill bottle, and dispenses it as prescribed.

Traditional treatment for tramadol addiction starts with detoxification. As above, that can rarely be done as an outpatient, so medical inpatient detoxification admissions for five to seven days can be helpful. However, since tramadol acts so much like an opioid, patients ready to leave detox probably need to go on to an inpatient residential treatment center for at least thirty days. Intensive outpatient treatment probably isn’t enough support for these addicts. But that’s only my opinion, since I haven’t found any studies describing success rates with tramadol addicts.

Opioid maintenance medications like methadone and buprenorphine do stop the opioid-type withdrawal symptoms from tramadol, but there’s no information about the use of maintenance medications in these patients. Most doctors working in clinics won’t start a patient on maintenance medications unless the patient is also using other opioids.

Often, methadone patients at the opioid treatment centers where I work are given tramadol by their primary care doctors who think it’s a low risk medication for opioid addicts. It probably is lower in its risk for abuse, but it can cause withdrawal in patients on stable, blocking doses of methadone. [1]

Tapentadol, sold under the brand name Nucynta, is becoming a drug of abuse in my area. It is a schedule II drug, presumably because it has a higher abuse potential than tramadol. Tapentadol stimulates opioid mu receptors, and also acts as a norepinephrine re-uptake inhibitor, like some antidepressants.

Unlike tramadol, tapentadol is not a prodrug; that is, it doesn’t have to be metabolized to be active at the opioid receptor. For that reason, pain relief starts within thirty minutes of swallowing the drug. Also unlike tramadol, it has little action at the serotonin receptor. It’s marketed for use in patients with moderate to severe pain, and can be useful in patients who don’t respond to more traditional opioid medications.

If you check various drug use forums, some people clearly are able to inject the tapentadol, and even the extended-release formulation, which was manufactured to be more abuse-resistant.

I saw my first patient who was addicted to Nucynta a few years ago, and have seen other patients similarly afflicted since then. Usually, Nucynta isn’t the only drug that’s being misused, but one of many.

The bottom line is this: if you are in recovery from addiction (alcohol or drugs), this medication should be used with caution. Let your doctor know that you’re in recovery from addiction. If you must take a potentially addicting medication, be careful, and let all of your doctors know about all of your medications. Let a dependable non-addict hold the pill bottle and dispense as prescribed.

  1. Leavitt, MA, PhD, “Methadone-Drug Interactions,” Pain Treatment Topics, Addiction Treatment Forum, January 2006

 

Can Patients on Buprenorphine Get a Commercial Driver’s License?

CDL

I’ve been seeking an answer for some months now, and it appears to be: “It depends.”

One of my most successful office-based buprenorphine patients was due to renew his commercial driver’s license (CDL). He’s had his CDL for years, and has never had a serious accident. He’s been a stable patient of mine for around four years, and his last illicit opioid use was ten years ago. He started his recovery at a methadone clinic, and then transitioned to another buprenorphine doctor’s office-based practice before he transferred to me four years ago.

He’s held a commercial driver’s license (CDL) all of those years.

Since he has done so well, we’ve discussed the pros and cons of starting a slow taper off buprenorphine. Due to recurring pain issues, he would probably require intermittent opioid medication if he tapered off buprenorphine. Ultimately, we decided he would have a better quality of life and a lower risk of a relapse to uncontrolled opioid use if he remains on buprenorphine indefinitely.

Like so many of my patients, once his addiction was treated, he excelled at his job, and he’s received several promotions over the past few years. However, even though he doesn’t drive a truck every day, he’s still required to keep a CDL in order to keep his job.

When he went for his usual Department of Transportation driver’s exam this year, he was turned down for his CDL. He was told that people on narcotics can’t get a commercial driver’s license.

The Department of Transportation has undergone some changes over the past few years. Back when I was in primary care, any doctor could fill out the DOT form for a patient to get a CDL. Some doctors were rather slap-dash in their efforts, and I suppose that’s why doctors now have to quality to do these CDL exams. Starting a few years ago, doctors must take a training course and pass a test in order to register to do DOT exams. All such doctors are listed on the National Registry of Certified Medical Examiners.

When he was asked about his medications, he lied and told them he wasn’t on any medications. He was conflicted about this; he wanted to tell the truth, but was afraid that if he did so, his livelihood would be in danger. We discussed this issue at one of his visits, and I told him what I knew at the time. Patients maintained on methadone can’t get a CDL if they reveal that to the medical examiner, and I doubted buprenorphine would be viewed any differently. I also told him the DOT doesn’t test for buprenorphine. He passed all DOT exams in the past because the examiner didn’t know he was on maintenance medication. DOT doesn’t test for anything but marijuana, cocaine, opiates, amphetamines, and PCP. (Yes, you read that right. PCP.)

The DOT test will detect opiates, that is, substances derived from the opium poppy, but won’t detect synthetic opioids like methadone, buprenorphine, fentanyl, and the like.

I also told my patient that I did not feel he was impaired from the buprenorphine I prescribed, as he had a tolerance to any sedating effect it could have. I told him I’m much rather meet him on the road than a driver who took Ambien the night before. And I told him it was ultimately up to him to decide what to tell the DOT examiner.

So my patient didn’t tell the DOT examiner that he was on buprenorphine. He was afraid if he did tell the examining doctor, his employer would find out and he would be fired. He was also afraid he wouldn’t be able to get his CDL if he told the truth. As it turns out, he was correct.

As expected, my patient’s DOT drug screen was negative for all substances. However, this examiner checked the state prescription monitoring program, where he saw my patient’s prescriptions for Suboxone. So the examiner denied my patient his CDL.

I felt so badly for my patient. Here he was, as successful as a person can be in recovery, being turned down both because he is taking buprenorphine, and also because he didn’t tell the DOT examining doctor that he was taking buprenorphine.

I wanted to advocate for my patient, and in a misguided effort, wrote a letter to my state’s DOT. It was a great letter, emphatically worded, with data references, but I sent it to the wrong place. Eventually, my patient got a letter from the state DOT saying it was fine with them that he keep driving, but that suitability for a CDL wasn’t under their purview. When I called for more information, they told me I needed to contact the Federal Motor Carriers Safety Administration (FMCSA).

It took repeated calls (six) to this government agency before I was able to talk to someone, but finally I reached a person who gave me the scoop. Her name was Angela, and she told me that if my patient was on methadone, there was no way he could get a CDL. She also said that with buprenorphine, it was decided on a case-by-case basis, and that I would need to talk to the physician doing my patient’s DOT exam, and that the decision was ultimately up to this person. She also said my patient had the right to seek a second opinion about his CDL.

OK, I thought. Now we’re getting somewhere. Before my patient spent time and money talking to a doctor for a second opinion, I thought I should try talking to the first doctor who had turned him down. This doctor was on staff at the same teaching hospital where I did my residency in Internal Medicine about a billion years ago, so I hoped he would be educated and open to the facts I wanted to present.

After all, I thought, science was on my side. Studies have not shown differences of reaction times and driving abilities between patients maintained on buprenorphine and normal controls. There is no evidence that I’m aware of that shows maintained patients shouldn’t be behind the wheel. That fact, plus my patient’s successful recovery should convince this doctor.

It did not.

I’ll spare my readers painful details, but this doctor was not open to what I had to say. I felt like this doctor was so hung up on the fact that my patient had lied that he couldn’t hear anything else I was saying. Yes, I told him, my patient did lie, but he did so out of fear that his boss would find out about his substance use disorder, and that he would lose his job. He has a wife and kids to support, and I think many people would lie in similar circumstances.

After I had harped on that for some time, this doctor said that people prescribed narcotics can’t get a CDL, that was that, case closed.

When doctors say things like that, I get confused. I hate the term “narcotic,” because it means different things to different people. To some, it means opioids. To others, it means illicit drugs. If we look at the root of the word, “narco,” which means sleep, a narcotic is a substance that puts people to sleep.

So what does the FMCSA mean when they use the word “narcotic?”

For the purposes of my conversation with this doctor, it meant my patient would not be getting his CDL.

I went to the website of the FMCSA to see exactly the wording of their statement. Here it is:

If a driver uses a drug identified in 21 CFR 1308.11 (391.42(b)(12)) or any other substance such as amphetamine, a narcotic, or any other habit forming drug, The driver is medically unqualified. There is an exception: the prescribing doctor can write that the driver is safe to be a commercial driver while taking the medication. In this case, the Medical Examiner may, but does not have to certify the driver.”

I thought 21 CFR 1308 would give me more exact information, but when I found it on the internet, it does not. It’s just the law that categorizes potentially addicting drugs into Schedules 1-5.

Does this mean that any person filling a controlled substance can’t get a commercial driver’s license? Really? Will there be any people left to drive trucks if everyone prescribed a controlled substance is excluded from driving?

Or will this unfairly apply only to patients on medication-assisted treatment? I don’t know.

Anyway, my patient took a copy of the letter I had written for him to another DOT examining physician, for a second opinion. This doctor granted him a time-limited CDL, and my patient is OK for now.

For now. He’s still worried about his job security in the future, and so am I. Several of my patients are on buprenorphine, and I worry if they will also be denied. I’m happy to advocate for them – assuming they are doing well – but it feels a bit unfair to me.

I have patients on methadone and buprenorphine through our opioid treatment program (OTP). They can get CDLs without problem, because their data is more protected than my office-based patients. OTP data is not posted on the prescription monitoring program in my state because privacy laws prevent this. There has been talk recently about changing this law. But for now, a patient attending the OTP, on the same medication as my office-based patient who was initially denied his CDL, can be granted a CDL because OTP records are held to a higher standard of confidentiality.

The Veterans Administration, where large quantities of controlled substances are prescribed, does not (yet) report to the state prescription monitoring program, so those patients’ medications also would not be revealed to a DOT medical examiner.

It’s a weird world.

If my patient is turned down in the future for his CDL, would he qualify for disability? It seems like that should be the case, and that’s another question I have.

But my patient wants to work. He doesn’t want to go on disability.

I understand that driving commercially is a safety-sensitive job, and people doing those kinds of jobs aren’t granted the same confidentiality about drug use and addiction as people doing other jobs. It’s the same in other safety-sensitive jobs, like medical professionals, pilots, and the like. I drive frequently, and I do want all drivers to be safe.

But I would like for decisions about who can drive and who cannot to be made on the basis of science and fairness, not on persona bias or happenstance.

Addiction Medicine: News Briefs

News Briefs

Following are several short news updates I thought might interest readers:

Heroin Vaccine

In a blog I posted in 2013, I mentioned a new heroin vaccine being developed. Last fall, the researcher got a 1.6 million dollar grant to continue research studies on the vaccine.

Kim Janda, researcher at the Scripps Institute in California, created the vaccine. The idea behind the vaccine is that it tricks the body into making antibodies against a substance, in this case heroin. After the person has formed these antibodies, if heroin is used, antibodies bind to the drug and keep it from attaching to brain receptors. Since heroin can’t bind to the brain’s pleasure receptors, the person has no euphoric effect from heroin.

Every type of opioid needs a specific antibody to be created, so Dr. Janda plans to try to create a vaccine against oxycodone and hydrocodone, too.

Such vaccines could be another tool with which to fight opioid addiction, but would need to be combined with psychosocial counseling for maximum effectiveness. The vaccine prohibits the opioid from attaching to mu opioid receptors, but would not alleviate cravings for opioids. It would have no effect on withdrawal symptoms, either.

Thus far, the vaccine looks promising in rat studies. We have no human data, and researchers in Virginia Commonwealth University will be helping with primate studies. If these are as successful, human trials could then begin, meaning it would take years to come to market, if it is successful.

I wonder if the vaccine can be overridden. In other words, is it possible to inject so much heroin that all the antibodies are used? If so, could extra heroin still cross the blood-brain-barrier to cause euphoria? I don’t know. Stay tuned for more data.

Frontline: Chasing Heroin

Did everyone get a chance to watch the PBS Frontline segment about opioid addiction and its treatment? You can watch the entire show at: http://www.pbs.org/wgbh/frontline/film/chasing-heroin/

I missed this program when it originally aired on 2/23/16, but watched it last weekend, and I’m glad I did. It was very good.

The program started by giving the history of opioid addiction in our country, and the factors that lead to the over-prescribing of opioids starting in the late 1990’s. The program described the inappropriate marketing of OxyContin, the pain management movement, and mistakes about assumed rates of opioid addiction in patients prescribed opioids long-term.

The program showed how many people who were addicted to prescription opioids eventually switched to cheaper and more potent heroin. They described the usual progression from snorting or smoking heroin to injecting it.

Heroin addiction currently disproportionately affects the white middle class, unlike past decades, when heroin was seen as an inner-city, minority problem. Some of the people interviewed rightfully pointed out possible racism of our current focus on the problem of opioid addiction. Since the white middle class got addicted, people are talking about how to fix this epidemic. When minorities were affected, not so much attention was lavished upon the affected population.

The show interviewed key people in this nation who know much about addiction and its treatment. Barry Meier, who wrote the book “Pain Killer” back when it was not considered proper to criticize Purdue Pharma, was interviewed, as was Sam Quinones, who wrote, “Dreamland.” (I reviewed this book recently on my blog, saying it did a great job of explaining how heroin has quietly swept across the U.S.)

Dr. Thomas McLellan, former deputy director of the ONDCP (Office of National Drug Control Policy) spoke about addiction, and Nora Volkow, from NIDA, was interviewed about the disease aspect of addiction. She explained how addicting drugs damage the brain, making it harder to stop using drugs once they’ve been started.

Robert DuPont, our first Drug Czar, was interviewed and he gave some historical perspective.

Facts from experts are helpful, but real stories from affected people have more emotional power. The program followed several opioid-addicted people as they sought help. Their paths through addiction and attempts at treatment illustrate many of the problems of our present treatment system, or rather lack of system.

I was mostly pleased with how the program handled medication-assisted treatment with methadone and buprenorphine (Suboxone/Subutex, etc.). The program showed the story of a community in Washington State, hard hit with heroin addiction, which voted not to allow a methadone clinic to become established, a classic example of the NIMBY attitude. One of the people who objected to the methadone clinic then had a son who became addicted, and the program showed his gradual change of mind about addition treatment programs.

The program said what we in the field know too well: MAT is an evidence-based and proven form of treatment, yet it remains “controversial” to many people working in addiction treatment.

I felt that issue could have been pushed farther and examined in more depth, but of course that’s my bias.

Toward the end of the show, an interviewer asks a doctor something to the effect of, “…so you can prescribe OxyContin to as many patients as you want, but you can only prescribe Suboxone to one hundred people???” The doctor answers yes, that’s what the law says.

Touché.

Also towards the end of the show, they discussed Seattle’s LEAD program. I liked to hear a law enforcement officer say, “We can’t arrest our way out of this problem.” Given that LEAD is based on harm-reduction principles, the program showed that though LEAD helps a great many people, other people don’t choose to participate in drug addiction treatment.

Thank God that law enforcement is starting to admit law enforcement can’t fix addiction.

Addiction Medicine Finally Recognized as a Medical Specialty

Earlier this month, the American Board of Medical Specialties (ABMS) announced that Addiction Medicine achieved specialty status.

It’s hard to explain quite what this means, but I’ll try. Addiction Medicine is now formally recognized as a specialty field of medicine with a distinct arena of clinical knowledge, grounded in evidence-based information. Board certified Addiction Medicine physicians should now be recognized as experts in this field.

It is also hoped that recognition of Addiction Medicine as a specialty will result in medical students and residents getting more training about drug use and abuse, and addiction prevention and treatment. We already have fellowship training programs for Addiction Medicine, and hopefully these will expand, to train more physicians in this specialty.

According to the information sent by the American Board of Addiction Medicine, addiction and risky substance use accounts for about a third of all hospital costs, and is responsible for twenty percent of all deaths in the United States. Slightly fewer than four thousand of us are certified by the American Board of Addiction Medicine, so more doctors are needed in this important field of medicine.

I am so grateful to all of the people who worked so hard to get this recognition of Addiction Medicine. I know this is something the members of the American Society of Addiction Medicine have been striving toward for over a decade. Thanks to all of you!

 

The Opioid Summit

aaaaaaaaaaaaaaaopioidsummit

Last week I went to a conference in Statesville, NC, called the Opioid Summit. It was hosted by Partners Training Academy, which is part of Partners Behavioral Health. This is an agency that provides mental health and substance abuse treatment for part of North Carolina.

I did not have extraordinarily high expectations for this conference. I’ve gone to plenty of such conferences around the state. The state-wide meetings are good, and regional meetings are decent, too. But I saw they had Dr. Thomas McLellan as a lunch speaker on the topic of integrating addiction care into mainstream medicine, and I wanted to hear him. Besides, it’s nice to socialize with people in this field I haven’t seen for a while.

My expectations were far exceeded.

We had five breakout groups in session at the same time, and on a whim, I went to the one titled, “Law Enforcement Innovation.” I told my friends I was headed to that one, and they thought it was odd. “Why? You know law enforcement doesn’t like MAT!”

But I knew there had to be a reason he was on the schedule, and I knew the speaker. He and I served on the North Carolina Board of Nursing advisory committee at the same time a few years ago, and I thought he was a pretty good guy, and knowledgeable. He was our state’s SBI Special Agent in Charge of drug diversion crimes back then.

Now he’s retired from the SBI, and is working for NC’s Harm Reduction Coalition, heading their LEAD program in Wilmington, NC. The presentation he made to a room full of social workers, drug addiction counselors, doctors, and policemen and women was excellent.

Mr. Varney explained the Harm Reduction Coalition’s new program in Wilmington, NC, called LEAD, which stands for Law Enforcement Assisted Diversion. This is a pre-arrest program that diverts people caught committing low-level crimes to drug addiction treatment and other services, based on their needs. This shunts them away from incarceration. These people are given a chance to avoid jail time and a criminal record if they want to undergo an evaluation by a case manager. The case manager decides what services are needed, and arranges the referrals. They are directed to drug addiction treatment including MAT, mental health services, housing assistance, food pantries…whatever they need.

Of course, the biggest drug addiction challenging our state and our nation is to opioids. According to Mr. Varney, North Carolina had around thirteen hundred drug overdose deaths last year, and 25% of those were from heroin. He didn’t give a breakdown of how many LEAD participants had opioids as a main drug of use, but it’s likely to be a majority.

Mr. Varney pointed out that it costs taxpayers $65 to incarcerate one person in minimum security for one day. That’s almost $24,000 per year. For comparison, the daily cost of the LEAD program is about $29 per day for the most intensive treatment, but then drops to around $17.50 per day for continuing participation. Most incarcerated people have committed low-level crimes to support drug use and drug addiction. In North Carolina, around eighteen thousand are incarcerated per year.

LEAD differs from drug court because LEAD participation starts before arrest, while drug court monitors people after they plead guilty. Since it’s spear-headed by the Harm Reduction Coalition, the program adheres to harm reduction principles. This program is intended to be non-judgmental and non-coercive, and is intended to offer a way to reduce the harm done to individuals and their community from drug use or drug addiction.

LEAD also differs from other programs because it requires the cooperation, participation, and communication from many organizations. First, law enforcement officers in the field must believe in this program to be willing to talk to the people they encounter in their job. Then, case managers help match each participant with needed resources. Representatives from those resources meet with case managers several times per month to discuss each participant’s progress.

I know what you are thinking…that’s great, but will it allow patients to enter medication-assisted treatment with buprenorphine and methadone? Yes. Mr. Varney specifically identified medication-assisted treatment as a necessary component of this program, particularly since so many of the would-be arrestees have opioid addiction.

Sometimes I hear what I want to hear, and I can’t remember his exact words, but regarding MAT, he said something like, “I’m not here to debate the science of medication-assisted treatment with methadone and buprenorphine but take it from me, it has to be part of this program to help these people.”

It was all I could do to keep from shouting “Hallelujah!”

I was delighted to see a top cop, the ultimate law enforcement officer, endorse treatment with methadone and buprenorphine. I sat in the audience grinning for several minutes.

The program in Wilmington, NC, is just getting started, but similar program in Seattle and Santé Fe have had success with LEAD programs.

Santé Fe had the highest overdose death rate in the nation, and since they started a program similar to LEAD, people who finished a treatment program had markedly less recidivism.

All parties benefit from having LEAD available. The person facing arrest gets an opportunity to get his needs assessed and be connected with needed help, instead of going to jail and getting a criminal record. Police benefit because they turn over an individual to a case manager instead of spending three hours arresting that person. Society benefits because it costs less to treat than incarcerate.

Everyone wins.

Right now, funding is the biggest obstacle to developing programs like LEAD. Hopefully someday, after LEAD has more data to show it works, taxpayer money could be earmarked for similar programs. Right now, funding comes from grants and from the cities that have established these programs.

I am delighted to see such an innovative program start in North Carolina. Since it is operated by the Harm Reduction Coalition, I know it will be well-run. I’m eager to see data from this program after it’s been active a few more years.

And yes, Dr. McLellan’s presentation was excellent, as usual.

 

Diversion of Prescribed Medications

aaaaaaaaa

 

 

 

I hope all my readers had a great holiday.

I followed my own advice about avoiding burnout and took eleven days off work. That’s the most days in a row that I’ve taken off for many years, and it was great. I went on a short but fun cruise of the Bahamas, during which I rested, spent time with family, read, ate great food, and tried to tan. (I know the sun is not a friend to the skin of pale people, but I just wanted a tiny bit of color. Instead, I think I bleached out to a lighter shade of pale.)

I also took a vacation from blog-writing, so I looked at previous blog entries I’ve written but never posted, to have something for my blog this week.

Toward the end of last year, I was intrigued by an article in my local newspaper. The newspaper published a story about the arrests of thirty or forty local residents on drug-related charges on the front page. In this article, a representative of the county’s Sherriff’s office narcotics unit said he estimated that ninety percent of people arrested for illegally selling prescription pain pills got them from doctors outside the county.

That seemed odd to me. My perception, shaped as it is by my work in the county’s only opioid addiction treatment program, has been just the opposite – that physicians in the area prescribe a great deal of the illegally sold controlled substance pills.

Indeed, I would be idealistic if I assumed that none of my own patients have ever sold their buprenorphine take home doses, despite my best efforts to prevent this.

Curious, I asked our state’s Injury and Violence Prevention branch of the NC Division of Public Health about how our county compares with other counties, in number of prescriptions written per capita. This last part is important, because more heavily populated counties have higher numbers of prescriptions, but only because there are more people living in the county.

One of the epidemiologists wrote me the next day, and said in 2014, there were 280 controlled substance prescriptions written for every 100 people living in my county. This compared with a state-wide rate of 201 controlled prescriptions per 100 people. He said that while our county was in the top 20 counties for number of controlled substances prescribed per capita, it was not number one in the state.

Since opioid treatment programs do not report any data to state prescription monitoring programs, none of my prescribing data would be captured in this information, with the exception of a dozen office-based buprenorphine patients I see in this county. Patients in office-based addiction practices do have their prescriptions reported to the state’s prescription monitoring website.

Anyway, back to my county’s prescribing rate…The prescribing rate quoted above is for all controlled substances, not only opioids. It includes opioid pain pills, benzodiazepines (Xanax, Valium, Klonopin), potentially addicting sleeping pills (zolpidem, or Ambien), and stimulants (amphetamines like Adderall, also Ritalin, Provigil, Nuvigil).

So the county has one of the highest prescribing rates of the state. That doesn’t necessarily mean any of the prescribed medications are diverted to the black market. However, past studies do show that higher prescribing rates are associated with higher diversion rates. But perhaps this county is different, as the sheriff’s office stated.

Furthermore, mere numbers can’t tell us if doctors are prescribing appropriately or not. Perhaps people living in my county have a higher-than-normal need for opioids, benzodiazepines, sleeping pills, and stimulants…

Food for thought, which I haven’t completely digested yet.

 

The Benzo Conversation

Glass head full of pills

Not all of my patient interactions are easy. One of my colleagues, after reading my blog, remarked, “It sounds like you have really easy patients.” While that’s true for the most part, of course there are more difficult patients, as in any practice. Some patients, eager to get into treatment to stop opioid addiction, may not be at all ready to stop other drugs of addiction. That’s not a deal-breaker for me, unless those drugs could be fatal when mixed with methadone or buprenorphine. This means the use of alcohol, benzodiazepines, and sedatives of other kinds must be discussed in detail.

I’ve noticed a conversational merry-go-round that I call “the benzo conversation.” I’ve had versions of this conversation more times than I can remember.

This conversation occurs during my initial assessment of a new patient presenting for medication-assisted treatment. I always look on my state’s prescription monitoring program for each new patient on the day of admission. If they have prescriptions for benzodiazepines (like Xanax, Valium, or clonazepam), or other sedatives (Soma, Ambien, etc.) I need information about the pattern of use. Is my patient taking his prescribed daily dose? Is he then physically dependent on benzodiazepines? Is he selling them? Is he giving part of the prescription away, and taking the rest? Does he binge on benzos for the first few weeks of the month, and then run out for several weeks? Or is he bartering the benzos for opioids, and not taking any of them, despite filling a large prescription each month?

I really don’t care if the patient is breaking the law or not; I just want to get the complete picture of my patient’s health status.

Following is a typical conversation with a new patient whom I will call “Bob.”

Bob sought admission to our methadone maintenance treatment program for his opioid addiction. He had snorted pain pills for six years, and wanted help. He had little if any denial about his opioid addiction. He denied taking any prescription medications, saying he got all his opioids off the street, used no other drugs or medications, and had no other medical problems.

However, when I checked his name on my state’s controlled prescription monitoring program, he was filling a prescription for Xanax 2mg, ninety per month, from a local Dr. Feelgood. This prescription had been filled every month for the last four years. My patient’s admission urine drug screen also tested positive for benzodiazepines.

As part of my initial history and physical, I asked him about the Xanax prescription. I explained to Bob that benzos have the potential to cause a fatal overdose when mixed with opioids. I told him that benzos are especially risky with methadone, and I was concerned about his use of them.

Bob said, “Oh, I don’t use benzos now. I haven’t used Xanax for years.
“But you’ve been prescribed it every month and picked up the last prescription of ninety pills just two weeks ago.”
“Yes, but I don’t take them. I quit them long ago.”
“And you do have benzos in the urine sample you gave us.”
“Well, that’s probably from a little piece of Valium I used four days ago.”
“Ummm…, Valium’s also a benzo, in the same family as Xanax, so when you say you’ve stopped, that doesn’t make sense to me.…”
“As I told you, I don’t take benzos anymore.”
“But four days ago is pretty recent.”
“No,” he said, getting a little worked up. “As I’ve already told you, I stopped benzos years ago!”
“So what do you do with the Xanax pills you pick up at the pharmacy every month?”
“I don’t know. They’re in the house somewhere. But I don’t take them.”
“So you have…how many bottles do you have at home?”
“Bunches, I don’t know.”
I could tell I was annoying him, but this as an important clinical issue, so I pushed on.
“Would you be willing to bring all those bottles in tomorrow so the nurse can watch you dispose of them?”
He sighed deeply, annoyed by my questions. “Yes. I suppose I can. Now can I get my dose?”
“No, I’ll leave an order for you to be able to start tomorrow after you bring in the medication to dispose, since you tell me you haven’t taken them. I worry about a fatal overdose if methadone were combined with all that Xanax you have at home.”
Now he was mad. “I don’t have any Xanax at home! I’m not going to overdose! I know what I’m doing.”
“Will you give me permission to call the doctor prescribing the Xanax, so we can talk about your entry into treatment here? Maybe your doctor would be willing to taper your dose so that we can make it safer for you to be in treatment with us.”
“No! I don’t want everybody to know my business. My doctor is friends with my ex-wife and if she finds out I’m being treated for addiction, she’ll cause trouble. He can’t find out.”
“I’m sorry, but that’s a deal-breaker for me. I’m not going to prescribe methadone for you unless I can talk to your other doctor. It’s just too risky. All of your doctors need to know all medications that you’re on.”
“So you’re telling me to go back out there and use drugs? That I can’t get help unless my ex-wife finds out I’m an addict?” The veins in his neck were standing out.
“No. I’m not telling you to use drugs. I’m telling you…
“I want my money back, since I’m gonna have to go buy dope again ‘cause you won’t help me. It’s just not right. I came here to get help.” He stalked off toward the receptionist, where I heard him demanding his money back, despite the hour he spent with a counselor and the time spent with me in an evaluation. (For some reason, patients who don’t get admitted to the program don’t feel they should have to pay for their evaluation)

This was a difficult, tense conversation, and one I’ve had too many times to count. This patient wasn’t a bad guy, but he was not ready to address his benzodiazepine use. The outcome wasn’t what I’d hoped, and this patient didn’t come into treatment.

There’s no way I could know what this patient was doing with his benzodiazepine prescription. I couldn’t tell if this patient was telling the truth, in denial, or lying. Without being able to talk to his prescribing doctor, I wasn’t willing to start medication-assisted treatment. This didn’t mean he didn’t need treatment, only that perhaps a different form of treatment will be safer for him. I wish I could have given him information about other treatments, but he left too quickly and too angrily.

Sometimes patients tell me I’m violating their privacy by looking at their information on the prescription monitoring database. I tell them I don’t see it that was at all, since they are asking me to prescribe a medication that could have a fatal interaction with other medications. Not only is it my business, it’s my responsibility.

Some doctors would fault me for not admitting this patient despite his refusal to allow me to talk to his prescribing doctor, given the increased risk of death for patients in active opioid addiction who are not in any treatment. But I would feel terrible if I’d admitted this patient and he died during the first few weeks of a methadone/benzodiazepine overdose. Either way, there’s a lot at stake, and I feel stress about these decisions.

The Billionaire Pill

aaaaaaaaaaaaaaaa

In a recent Forbes magazine article about this nation’s twenty richest families, the Sackler family was number sixteen on the list. The Sacklers are estimated to be richer than the Mellons, Rockefellers, and Busches. (http://www.forbes.com/sites/alexmorrell/2015/07/01/the-oxycontin-clan-the-14-billion-newcomer-to-forbes-2015-list-of-richest-u-s-families/

You say you don’t know the Sackler family? I’ll remind you. They own one-hundred percent of Purdue Pharma, a pharmaceutical company best known for manufacturing their block-buster drug OxyContin.

This is a bitter pill for me to swallow.

I started working in the field of opioid addiction treatment in 2001. At that time, nearly every opioid addict I saw was using OxyContin as their main drug. Opioid addiction in general and OxyContin addition in particular plagued many small towns and rural areas where I worked.

OxyContin was widely prescribed for pain. This powerful drug was advertised as “The one to start with and the one to stay with,” during sales pitches to rural physicians. OxyContin flooded the black market. Opioid addict quickly discovered OxyContin’s time-release coating could be easily defeated, and the pill was often snorted or injected for the rush of opioid euphoria it produced.

I was certainly not the only doctor to notice the rise of OxyContin addiction.

Barry Meier’s book Pain Killer: A “Wonder” Drug’s Trail of Addiction and Death (Rodale Books, 2003), tells the story of small town doctors trying to get the attention of Purdue Pharma, the government, or anybody else who could help change the destruction OxyContin was doing to Appalachia around that time.

I remember attending a pain and addiction conference around sometime around 2003 or 2004. At the end of the lecture explaining how opioids could be prescribe safely, a doctor from Virginia dared to ask the experts something along the lines of, “What are we going to do about OxyContin?” I thought to myself that I was glad someone had finally said what I was thinking.
This was a long time ago; I don’t remember exact words, but my memory is that he was soundly rebuffed for daring to mention one specific drug by name. He was scolded and told that the real problem was with opioids in general, and one drug company (who happened to have some of the lecturers on their payroll) should not be singled out as the problem.

I remembered wishing those experts could spend a day at my treatment program talking to the OxyContin addicts.

Eventually, the U.S. General Accounting Office asked for a report about the promotion of OxyContin by Purdue Pharma. By 2002, prescriptions written for non-cancer pain accounted for 85% of the OxyContin sold, despite a lack of data regarding the safety of this practice. By 2003, primary care doctors, with little or no training in the treatment of chronic non-cancer pain, prescribed about half of all OxyContin prescriptions written in this country. By 2003, the FDA cited Purdue Pharma twice for using misleading information in its promotional advertisements to doctors. [1, 2] Purdue Pharma also trained its sales representatives to make deceptive statements during OxyContin’s marketing to doctors. [3]

Testifying before Congress in 2002, a Purdue Pharma representative said the company was working of re-formulating OxyContin, to make it harder to use intravenously. This representative claimed it would take several years to achieve this re-formulation. The re-formulated OxyContin was finally approved by the FDA in 2010, eight years later. Currently, this medication forms a viscous hydrogel if someone attempts to inject or snort the medication. It isn’t abuse-proof; probably no opioid will ever be so, but it is much more abuse-deterrent than the original.

Did Purdue Pharma drag their feet in this re-formulation? Experts like Paul Caplan, executive director for risk management for the drug company, said there were issues about the safety of incorporating naloxone into the pill to make it less desirable to intravenous addicts. He also pointed out that some delay in approval was due to the FDA.

For comparison, Sterling Pharmaceutical, when it became widely known patients were abusing their pain medication Talwin, re-formulated within a year, adding naloxone to the medication and reducing its desirability on the black market. Since this was in the 1980’s, I would assume there was less technology to help back then, compared to 2002.

I’ll let readers draw their own conclusions.

In May of 2007, three officers of Purdue Pharma pled guilty to misleading the public about the drug’s safety. Their chief executive officer, general counsel, and chief scientific officer pled guilty as individuals to misbranding a pharmaceutical. They did no jail time but paid $34.5 million to the state of Virginia, where the lawsuit was brought.

The Purdue Pharma Company agreed to pay a fine of $600 million. Though this is one of the largest amounts paid by a drug company for illegal marketing, Purdue made 2.8 billion dollars in sales from the time of its release in 1996 until 2001.

None of the Sackler family members were charged, because they were not involved in the day to day running of the company.

And now the Sackler family is worth billions.

1. General Accounting Office OxyContin Abuse and Diversion
report GAO-04-110, 2003.
2. United States Senate. Congressional hearing of the Committee
on Health, Education, Labor, and Pensions, on Examining
the Effects of the Painkiller OxyContin, 107th Congress, Second
Session, February, 2002.
3. Washington Times, “Company Admits Painkiller Deceit,”
May 11, 2007, accessed online at http://washingtontimes.
com/news/2007/may/10/20070510-103237-4952r/prinnt/ on
12/18/2008.

Follow

Get every new post delivered to your Inbox.

Join 757 other followers