Archive for the ‘drug diversion’ Category

Shady Signs and the Corporate Practice of Medicine

Roadside Suboxone Advertisement

 

The roadsides of rural North Carolina have become littered with these signs advertising access to Suboxone prescriptions.

When I first saw one of these signs, I was appalled. These signs, more commonly used to advertise homes for sale or dating services, exude tackiness, when used to advertise for medical care. They are called “bandit” signs, for their often unauthorized use. As far as I can tell, these particular signs don’t violate any laws, when placed in the public road right-of-way, but they do seem dodgy. Their 1-800 number and the mention of “microloans” smacks of unprofessionalism to a degree rarely seen in medicine, even in these days. It reminds me of the more outrageous signage of the South Florida pain clinic scourge five or ten years ago.

 

South Florida pain management sign

One shady buprenorphine prescriber casts shade on all other prescribers. These signs make me feel embarrassed to be a doctor who prescribes buprenorphine, because the general public will lump all of us together.

I also felt embarrassed for my patients who take this medication for opioid use disorders. In fact, not long after I saw that first sign, one of my long-term patients, in relapse-free recovery for more than eight years, told me she felt mortified when she and her husband saw a similar sign while driving. She has had a spectacularly successful recovery, yet when her husband saw the roadside sign, he started criticizing her again for “still” being on that medication.

Out of curiosity, I went to the website advertised on the sign.

It’s scary.

They advertise a “mobile medical unit” that will “utilize church parking lots as much as possible,” for privacy reasons. The website says the clinic is staffed by a physician assistant and no medications are dispensed on site. Prescriptions for twenty-eight days will be called in and patients seen by telemedicine. (I assume this meant patients could get counseling via telemedicine.) Twenty-eight cities are highlighted on a NC map on the website, so presumably these are the target areas. The price listed for this monthly visit from a mobile medical unit was about twice what I charge my buprenorphine patients for a routine office visit, so it’s not cheap.

I suspect this business is not going to be owned or operated by a physician, though I could be wrong about that. From the way the content on the website is written, I can almost guarantee no one with medical training had a role in its composition.

This may be its downfall, since NC’s corporate practice of medicine act states that non-physicians aren’t allowed to own medical practices or employ physicians. This means that physicians employed by non-physicians are subject to sanction from the NC medical board.

Let us take a moment to go down this interesting rabbit hole known as the Corporate Practice of Medicine Act, or CPOM.

This antiquated law was a bit of legislation passed many decades ago, when lawmakers had the quaint and rather touching idea that physicians should be the only people to own and operate medical services, since they are the only people trained to know what’s best for the patient.

How can this law still exist, you ask, since about half of doctors’ offices are owned by hospital corporations? Because the medical board doesn’t enforce CPOM law for practices owned by non-profit entities, or for practices owned by hospitals. The medical board’s reasoning is that these hospital corporations, many of them for-profit, are likely to have the patient’s best interests at heart and therefore not be likely to make decisions based on profits alone, unlike other for-profit, non-doctor-owned entities. To me, that seems a bit arbitrary, but I’m not privy to their discussions on the matter.

Ten years or so ago, I quit working for a non-profit opioid treatment program to work for a for-profit OTP. Worried about the CPOM law, I called one of the NC medical board’s lawyers, to ask for information about the legalities of doing this. The board lawyer told me that if anyone reported a doctor for working for a for-profit, non-hospital agency, the medical board would “take action.” I tried to ask about specifics, and told him most of the opioid treatment programs in our state and in most states aren’t physician-owned. I asked if all of those programs were in violation. He kept saying that if they were reported, action would be taken.

He recommended I hire a lawyer who could give me specific legal advice, saying that since he worked for the medical board, he couldn’t give specific advice to the people whose licensure is controlled by that board. He gave me the name of a lawyer in private practice who used to work for the medical board and would be knowledgeable about these laws.

I called this lawyer and explained my situation and asked him how much it would cost to have him figure this out for me. To his credit, this lawyer gave me what felt like good information. He said I shouldn’t have to hire a lawyer to figure this out.

He said that since opioid treatment programs are ordered by law to have a physician as medical director, this puts them in direct opposition to the corporate practice of medicine act, and that this was an example of two laws contradicting each other. He said something to the effect that a medical facility that’s so closely regulated by the state can’t be outlawed by the state. This made sense. He said this needed to be figured out at a much higher level than me. He said it was an issue that needed to be worked out between the NC medical board and the state opioid treatment authority.

I liked that answer, since I wasn’t eager to shell out big bucks to hire an attorney. I contacted people at the state opioid treatment authority, and also the board lawyer to tell them what this attorney had said. Then I quit worrying about CPOM since, since this issue was too big for me to take on.

I doubt the issue has been resolved, because I still hear rumblings about how some opioid treatment programs are in violation of the CPOM. All I can say is that this is NOT a new topic, but it is a complicated one.

OK….. let’s pop our head back out of the rabbit hole, and talk about possible positives of having road signs advertising buprenorphine prescriptions.

Maybe the signage I find appalling is a means to harm reduction. We have mobile syringe exchange units, so why not mobile buprenorphine units? Far too many patients are dying of opioid overdose, so maybe roadside advertising is a novel way to reach people at risk for dying from this disease of opioid use disorder. Maybe we need to accept a little tacky advertising in the name of saving lives.

I don’t know – I know I don’t have all the answers. But I question the harm reduction motives of this particular business, based on how much they are charging, and their offer of “microloans.”

I hope somewhere in this business model there’s a conscientious physician tasked with overseeing quality of care. I hope that physician is truly involved, and not just providing a signature on a form every three months.

 

 

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Something New: Tianeptine

tianeptine

 

 

One of my doctor friends called me to ask if I’d seen any patients addicted to tianeptine. No, I had not. This was a new one for me, so I did some internet research for my readers.

Tianeptine is a medication used to treat depression, though some sources say it can be used for asthma and irritable bowel syndrome. Though structurally similar to tricyclic antidepressants, it exerts its action in a different way, via glutamate receptors. Other antidepressants are thought to work because they increase serotonin and norepinephrine levels, so tianeptine is novel in this sense.

Scientists know depression causes structural and functional changes in the brain, and some articles about tianeptine say this medication can reverse some of the stress-induced changes seen in depressed brains. We don’t fully understand all aspects of neurotransmitters and mood, and this medication shows us that serotonin and norepinephrine are not the only determiners of mood. [1, 2]

It’s an interesting medication, but not available in the U.S., Canada, or the United Kingdom. It is sold in Europe under the brand names Coaxil and Stablon. It appears to be more toxic to the liver than traditional antidepressants. And of course, if you Google tianeptine, you will see websites offering to sell it, with the fine of print of “not for human consumption,” with a wink and a nod, to protect the sellers, I assume. Mostly sites sell it in a powder form.

But what about this medication’s addictive potential? Why would people take it compulsively?

When I want to know how people are using various drugs, I go to several websites, including erowid, bluelight, and drugs-forum (www.erowid.org , www.bluelight.org , drugs-forum.com) On these sites, people record their experiences with various medications used for euphoria, and occasionally for other reasons too.

On these sites, people described a euphoria similar to opioids, though the described dose was usually far in excess of the recommended 12.5mg three times daily. One person took 500mg and described euphoria. Other people mixed it with other drugs, so it’s hard to know what effect the tianeptine had. Other people described a difficult withdrawal from tianeptine.

Kesa et. al., 2007, says tianeptine has some stimulating activity at the mu opioid receptors, thought it has a low affinity for those receptors. Apparently it takes high doses to produce euphoria, moderated through those opioid receptors.

In the Annals of Internal Medicine, 2003, Leterme et al describe five cases of tianeptine abuse. Withdrawal was said to be difficult, due mostly to anxiety.

Bence et al, Pediatrics, 2016, published a case study about a pregnant woman who was taking tianeptine, more than 650mg per day. Unexpectedly, her newborn had a withdrawal syndrome indistinguishable from opioid withdrawal, which was when her doctors discovered her tianeptine use. The baby was treated with morphine, and no mention is made of treatment for the mother until her next pregnancy, when she was admitted to a residential detox unit in her seventh month of pregnancy. Other than low birth weight, her second infant was delivered at full term with no withdrawal. Both children appear to have normal development.

From the collective experiences I read, it seems tianeptine is a weak opioid agonist, but at high doses gives an opioid effect. It sounds like people describe a typical opioid addiction after using these high doses daily for more than a few weeks. They described classic signs and symptoms of opioid withdrawal.

The doctor friend who first called me about this drug worked at an opioid treatment program. The tianeptine-consuming patient he was seeing wanted to be started on buprenorphine or methadone to treat tianeptine withdrawal. I told my friend I didn’t know enough about the drug to feel it was OK to try buprenorphine or methadone.

Since then I’ve done more research, and I suspect buprenorphine or methadone could help treat these patients, but I didn’t see any studies about their use for this addiction.

Particularly with methadone, if we prescribe it to people without a clear indication, they could later get nasty and angry about being started on methadone, a difficult drug to taper off of.

I’d like a need for a study of tianeptine-addicted patients, to see if using classic opioid use disorder treatment medications work for these patients.

Tianeptine could become the latest fad drug. Some drugs fade in and out of popularity, like the latest style of dress or music. I think this one could be a harmful fad, and we have no research about treatment.

  1. Kasper et. al., “Neurobiological and clinical effects of the antidepressant tianeptine,” CNS Drugs, 2008;22(1);15-26.
  2. McEwen et. al., “The neurobiological properties of Tianeptine (Stablon): From hypothesis to glutamatergic modulation,” Molecular Psychiatry 2010 March;15(3): 237-249.

Raising the Patient Limit on Buprenorphine Physicians: HHS’s New Proposed Rule

Expanding access

Last month, the Health and Human Services (HHS) department of the U.S. government posted new proposed regulations for doctors who prescribe buprenorphine (better known as Suboxone, Subutex, or Zubsolv) from office-based practices. This rule proposes to raise the number of patients that physicians can treat in their office practice from one hundred to two hundred. They did this to make more treatment available for people with opioid addiction, to combat opioid overdose deaths in our country,

This new proposed rule is now posted online at: https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders#h-63

Anyone can submit a comment about this proposed rule, until May 31, 2016.

I studied this proposed rule at length, and thought I’d give my blog readers my interpretation and my opinion of it.

First of all, I approve of the idea behind the proposed regulation. Too many people with opioid use disorder want treatment and can’t get it. Many doctors are at their one hundred patient limit and have been for some time.

I haven’t taken a new patient in months. And as I’ve grumbled about in previous posts, several practitioners in my area already have well over one hundred buprenorphine office patients. Rogue doctors are going to do what they do no matter what, but us law-abiding doctors would like permission to treat more patients.

This new proposed rule would allow physicians who have had a one hundred patient limit for at least one year to request permission to treat up to two hundred patients at one time.

However, this proposed rule is a little more complicated than it would appear on the surface. Medical practitioners have to meet certain criteria to get approval to treat up to two hundred patients.

First of all, as the regulation is written now, some physicians believe that physicians who are board-certified by the American Board of Addiction Medicine won’t qualify for approval to treat up to two hundred patients. The proposed new regulation says the physician must have “subspecialty board certification.” Apparently, some physicians feel that an exact interpretation of this means only psychiatrists with subspecialty certification in addiction medicine would qualify. I read on the American Society of Addiction Medicine’s website that they want members to protest this wording to allow ABAM-certified doctors to qualify too. Thirty-six hundred doctors, including me, are board certified by ABAM, while only about a thousand psychiatrists have subspecialty board certification in Addiction Psychiatry in this country.

I read the entire DHHS document online, but the way I read it, I thought ABAM certified doctors would definitely qualify, but then maybe I’m a little fuzzy about what, exactly, “subspecialty” means. I think HHS’s intention was to include ASAM/ABAM doctors.

Practitioners seeking approval to treat up to two hundred patients must meet other criteria. In simplified terms, they need to, among other things:

  1. Have professional coverage for after-hours emergencies.
  2. Provide case management services
  3. Have electronic medical records
  4. Use that practitioner’s state prescription monitoring program
  5. Accept third-party insurance
  6. Have a plan to address possible diversion of prescribed buprenorphine medication
  7. Re-apply for permission to treat up to two hundred patients every three years
  8. Supply yearly reports about their practice and their buprenorphine patients

Several of these requirements are fairly obvious and should be standard of care anyway. For example, coverage after hours should be provided no matter if the practitioner has one patient, two-hundred, or a thousand. And I can’t imagine any doctor would prescribe buprenorphine for a patient with opioid use disorder without checking the state prescription monitoring program.

Personally, every night before I see my office-based patients, I look at their data on the prescription monitoring program. That way, if I get any surprises, I can discuss this with my patient at their visit.

All practices should have a plan to detect diversion. In my patient agreement, patients understand they may be asked to do a pill count at any time. I’ve lost some patients who failed pill counts.

Yearly reporting requirements seem reasonable, depending on what the government intends to do with this data. I assume DHH intends to monitor the quality of the care that a buprenorphine physician is delivering, and monitor the results of this care. Such monitoring is to include: average monthly case load of the physician, percentage of patients who are receiving either psychosocial counseling or case management services; number of patients being checked on the state prescription monitoring program; sending year-end reports about the number of patients who have completed treatment, number who have been referred elsewhere, and the number of patients who no longer want this form of treatment.

Physicians can collect that data without too much problem, I think.

However, I worry about how this information could be misinterpreted. For example, if the people who will review these reports expect patients to “complete” treatment for a chronic disease such as opioid addiction, they may mistakenly conclude that doctors with higher numbers of patients who complete treatment provide better care than doctors with lower numbers of patients who complete treatment. In reality, the opposite may well be true, since the standard of care with medication-assisted treatment is maintenance, not detox.

I’m also concerned about submitting the number of patients getting counseling. For maintenance patients, how long should they receive counseling? To me, the answer should be “as long as they need it.” This should be highly individualized.

If patients have been stable on buprenorphine for more than three years, with relapse-free recovery, do they still need counseling? Some of my patients are in relapse-free recovery for longer than that, and they have productive jobs, happy home lives, and no mental health issues. Should I still insist they still go to counseling? I don’t think so, unless counseling can improve the quality of their lives.

I’m not talking about new patients, fresh into treatment. Nearly all of those patients need counseling. But what if they have no insurance, and can’t afford “official” counseling? Is 12-step attendance good enough to meet counseling requirements?

There’s no way to know how people evaluating yearly physician reports will view such topics.

Now let’s talk about some of the requirements which may be deal-breakers for me.

When I read about practitioners having to accept third-party payers, I thought nope, not gonna do it.

My practice is bare-bones. I have three employees: me, my fiancé, and a man who works my front desk for about six hours per week. It’s kind of a mom-and-pop practice. Patients pay me, and I give them receipts with the needed codes to fill with their insurance company so they can be paid back. Since I don’t mess with insurance, I can keep my office costs down, because I don’t have to pay for another person to file insurance. Technically it is not a cash-only practice, since I’m set up to take credit and debit cards, but I am cautious about accepting checks. I have learned the hard way not to accept a check from a new patient.

My fiancé, who is a licensed professional counselor and also a licensed clinical addiction specialist, does the counseling for some of my office patients. He also answers the 24-hour phone, and since we are together most of the time, it’s easy for him to talk to me about whatever is going on. He screens new patients and does scheduling. He also handles most of the prior authorizations for buprenorphine medications (since I tend to get angry and swear).

My other employee, Daniel, works in my office on the one day per week that I’m open. He is terribly overqualified for his job, since he is just finishing his Master’s degree in addiction counseling. He checks patients in, performs drug screens, records the results, checks patients out and takes their money, and schedules their next visit. Besides being smart and savvy, he also knows my patients are sick people getting well.

I have few expenses. My fiancé does all the computer work that I need, and the only bills I have are rent, electricity, and various office expenses.

If I decided to accept third party insurance, I’d have to add another employee. I’ve seen the nightmares that come with billing insurance, having worked in primary care for ten years. Insurance companies deny claims for frivolous and stupid reasons, and take their time paying doctors. I heard this year from a few colleagues that BlueCross/BlueShield, the primary payer in my state, in some cases waits longer than six months to pay doctors, and still denies many claims. I’d have to raise my rates to make up for this, making it more difficult for my patients with no insurance.

Right now I charge $85 to $100 per 20-minute visit. I feel strongly that people with addiction shouldn’t have to pay more to see their doctor than people with other chronic illnesses, so I keep my rates low, relative to other providers. About half of my patients are the working poor, who don’t qualify for Medicaid in my state, and also don’t qualify for Obamacare. They can still afford treatment, because I’m also willing to prescribe generic buprenorphine/naloxone, which is quite a bit cheaper than name brand medication.

Am I willing to take on the headache of accepting insurance in order to be able to treat a hundred more patients? I don’t know if I am. I plan to investigate it further, maybe talk to some other doctors who take insurance currently, to see how big a hassle it is to get paid.

Next let’s talk about electronic medical records (EMRs). EMRs sound better in theory than they work in practice. My doctor friends complain that they cost much money, are not designed to be physician-friendly, and take up more time than they save. They aren’t interoperable, so each practice has a different electronic record. To coordinate care with a provider outside of one specific system means the record still has to be printed out on paper to be faxed or mailed.

Do electronic records provide better care? I have my doubts. I’ve bitched about EMRs in prior blogs, describing how I’ve requested records on my patients from the local hospital. Those records show on the front page, without fail, that the patient has been screened for Ebola. But I have to look at many pages to try to find a final diagnosis and treatment plan from the emergency department physician. Sometimes I find it… and sometimes not.

Privacy is a big issue to some of my patients. I treat several people, prominent in their communities, who see me specifically because I don’t have electronic medical records. They are willing to travel more than an hour one-way to see me, both because they know their records aren’t computerized, and because my office is very private, in the back on a non-descript realty building. Some of these patients may be a little paranoid about their records, but maybe not.

If I worked in an office owned by a big hospital system, how many people could get access to read my records? We all know stigma against substance use disorders and mental health diagnoses exist. It could cause damage to patients with substance abuse issues if details about addiction treatment were leaked. Ironically, my patients who work in healthcare are the ones most concerned about their privacy, and maybe for good reason.

Besides, EMRs are expensive, and probably I couldn’t afford one for my small practice.

Those are my specific objections to the proposed rule. I understand why the authors of the rule included these requirements. HHS doesn’t want bad doctors, running buprenorphine pill-mills, to be able to qualify to treat more patients. But as I’ve complained about at length and repeatedly in my blog…those doctors already thumb their nose at patient limits. So this proposed rule is likely to be followed only by the doctors who are already conscientious about following rules and guidelines.

I’m glad and grateful the HHS proposed this new rule. But I’m not yet sure I will want to increase my patient limit, for the reasons described.

Buprenorphine: Current Practices

NCSAM

I just got back from the NC Society of Addiction Medicine annual conference. (Yes, I’ve been to several conferences lately.) One of the sessions I attended was a lively discussion of the current practices in office-based prescribing of buprenorphine, for opioid addiction.

The session was run by two experienced, knowledgeable addictionologists, who mediated topics and shepherded the dialogue. One physician works in North Carolina and the other in Tennessee. The room was packed with at least fifty people, most of us doctors who prescribe buprenorphine for addiction.

Deliberations were collegial but we didn’t agree on all issues, of course. Dissenting opinions were respected and debated.

The first topic I can recall was about how often buprenorphine patients need to be seen. Most practitioners agreed that new patients needed to be seen at least weekly initially. As stability develops, we gradually extend the time between visits to one month. One doctor opined that no patient should be allowed to go any more than one month between physician visits. When the moderator asked if anyone disagreed, I raised my hand, and the moderator asked me to explain.

With some trepidation, I told the audience that I had a super-stable group of patients in my practice. I inherited most of them from another physician who was one of the first in the area to prescribe buprenorphine. This group of patients all have over five years of stable and relapse-free recovery. A few have been in stable recovery for nearly ten years. These people work, and have happy and productive lives.

So yes, I do allow these patients to go two months between visits.

No one booed or hissed me, but I got the feeling I’m doing something with my patients outside the realm of normal for most doctors prescribing buprenorphine. Thankfully, the moderator made the point that we should use our clinical judgment and adjust treatment to best fit each situation, which made me feel better.

I was mulling this over later, and maybe I do have an unusual group of patients, who have been stable on MAT for so long. Some of these patients elected to stay on sublingual buprenorphine because they are doing so well on it, and they fear relapse if they taper off of it. Others plan to stay on buprenorphine because they developed addiction as a complication of chronic pain treatment. Happily, the buprenorphine works as well for their pain as it does for their addiction, so we get the two birds with the one stone.

There’s another unusual thing about these super-stable patients: almost all of them are deeply involved in 12-step recovery. Many were in Alcoholics Anonymous prior to their opioid addiction. They developed addiction to opioid pain pills after receiving prescription opioids for an acute or chronic pain condition. Once they started on buprenorphine to treat the opioid addiction, they continued going to Alcoholics Anonymous (a few go to Narcotics Anonymous).. Other patients didn’t start going to AA until after they entered MAT on buprenorphine.

I’ve had many people write comments to my blog, furious when I even mention 12-step recovery and MAT in the same sentence. But I have living proof in my practice of multiple patients on medication-assisted treatment of opioid addiction who have been able to make 12-step programs work for them.

Getting back to the conference…we spent much time discussing the monoproduct buprenorphine versus the combination product buprenorphine/naloxone. All of us agreed there’s a need for caution with prospective patients who insist they can take only the monoproduct (this is the equivalent of the brand name Subutex), because it does have a higher street value than the combination product.

Of course, there are people who inject the combination product (Suboxone film, Zubsolv, etc.), but overall, people seeking to inject buprenorphine are much more likely to prefer plain buprenorphine. Black market prices are higher for the monoproduct than the combination product, underscoring the preference for monoproduct.

One outspoken doctor said the monoproduct should rarely if ever be prescribed. Another doctor echoed my feelings on the matter when he said something to the effect that some patients really do have a bad reaction to the naloxone in the combination products, and if we are cautious, we can prescribe the monoproduct. However, the general opinion was that financial reasons weren’t sufficient to take the risk of prescribing the monoproduct.

I disagree with that, but kept quiet, already feeling like maybe I’m a bit too liberal.

I have had patients, stable on a buprenorphine combination product (usually brand name Suboxone films), who suddenly lost their health insurance. If such patients had negative drug screens for years, and no history of intravenous use, I switched them to the generic monoproduct because it’s the cheapest buprenorphine product on the market. These patients could not have stayed in treatment if I’d made them stay on the much more expensive brand names. Most of those patients prefer the films, and when they got new insurance, asked to switch back to the films.

I did not suspect these patients would sell their medication for profit. You have to know them, but these patients had stable jobs and no leanings toward criminality. And I am by no means a gullible person.

Since then, a generic combination product came onto the market. Still more expensive than the monoproduct, it’s less expensive than all the name brands.

Next we discussed how to deal with patients who say they are allergic to naloxone, and thus can’t take the combination product (Suboxone, Zubsolv) but only the monoproduct (Subutex).. Patients usually don’t mean an actual allergy, but rather intolerance to naloxone. These patients report headache, nausea, etc. when they ask their physician to prescribe the monoproduct. Of course, this raises suspicion with physicians that such patients plan to misuse the medication by injecting or snorting.

Should physicians just accept what patients say at face value, or should we say sorry, I only prescribe buprenorphine in combination with naloxone? After all, there’s no way to “prove” a headache or nausea. There’s no test we can order that will give any useful information. One doctor said he sent such patients to a neurologist for evaluation of the headache, or to a gastroenterologist to decide the cause of nausea. He says most patients fail to follow through, and so he weeds such prospective patients out of his practice that way.

An audience member suitably questioned this habit, asking how could a specialist be expected to determine if a medication caused headache or nausea? I think it’s kind of a sneaky way to get rid of patients who want buprenorphine monoproduct.

I have the same fears when fielding new calls from prospective patients. I’ve instructed my patient contact representative (who is also my office’s licensed professional counselor, after-hours contact person, pharmacy liaison, licensed clinical addiction specialist, prior approval wrangler, and fiancé) to tell these people that I do not prescribe the monoproduct to new patients. I have no problems saying “no” upfront to these patients, and try to explain why I’ve made this decision for my private practice (even though, as above, I have prescribed it for patients I know very well).

I use the monoproduct in the opioid treatment program where I work, because those patients dose with us every day until they have a period of stability. The dosing nurses roughly chop the tablets, to minimize diversion, and patients stay on-premises until the medication has dissolved, also to make diversion more difficult. These patients don’t get any take home doses until we feel they have stabilized.

We also discussed how long to keep patients on buprenorphine. The bottom line is that no one knows. Best outcomes are seen in patients who stay on buprenorphine, since there’s still a high relapse rate back to opioids in patients who stop buprenorphine. I ask my patients periodically if they wish to start a slow taper, if they’ve been stable for over a year. I don’t push them to taper if they’re not ready, but if they are, I recommend they taper slowly. From the discussion at this meeting, it sounds like most of my colleagues do the same.

We discussed the maximum daily dose of buprenorphine. According to studies, a daily dose of 16mg saturates most of a patient’s opioid receptors, and increasing the dose to 24mg only gives about a 4% increase in the number of covered opioid receptors. Some doctors say this shows buprenorphine should never be dosed more than 16mg per day.

However, about a third of the doctors in the room raised their hands when the moderator asked if they had any patients who seemed to require 24mg per day to stabilize.

I didn’t interject anything into the discussion, but I just went to a session at the national ASAM meeting where this same topic was discussed. While it’s true that basic pharmacology would indicate 16mg is probably the just as effective as 24mg in most patients, several studies have shown better patient retention in treatment when higher doses (24-32mg per day) are used.

It’s possible this isn’t a physiologic effect, but more of a mental process. We can’t be sure. But for whatever reason, if my patient does best at 24mg, I’ll allow her to stay on that dose.

For patients on higher doses, we need to make sure they aren’t diverting some of their medication. Patients sometimes ask for a higher dose than they need, in order to get enough medication to treat a friend, family member, or significant other. Some doctors call this “piggy-backing.” Even though it means a suffering addict is getting treatment, the piggy-backer won’t get any counseling. Also, law enforcement types use examples of diversion to demonstrate that buprenorphine is a bad street drug, contributing to the stigma against patients doing well in their treatment. Diversion threatens the whole concept of office-based treatment program.

All in all, we had two hours of lively interaction on the finer points of office-based prescribing of buprenorphine. I don’t think all doctors will agree about everything, but it’s nice to hear what other physicians are doing, to make sure I am not too far out of line with the standard of care.

Purdue Pharma Settles Kentucky Lawsuit

aaaaaaaaaaapurduekentucky

 

 

 

 

 

 
Since 2007, Kentucky has been litigating a case against Purdue Pharma, the manufacturer of OxyContin. Kentucky was the only state to opt out of a prior settlement offered by Purdue Pharma in 2007, preferring to litigate separately against the company, due to the devastation that state has endured from the opioid addiction epidemic.

Kentucky was offered $500,000 to settle with Purdue in 2007 lawsuit. Last month Purdue agreed to pay Kentucky $24 million to settle the case. This money is earmarked to pay for addiction treatment and prevention.

This does sound like a large sum of money, but it’s a drop in the sea of money Purdue has raked in from sales of OxyContin.

The turning point in the case may have been when Purdue Pharma lawyers were unable to get the case moved out of Pike County, Kentucky. Those lawyers probably knew county residents were likely to be bitter about the drug company’s antics, since the county’s overdose death rate is still extremely high.

In 2014, 51 people out of every 100,000 died from drug overdose, according to data on the state’s website (http://odcp.ky.gov/Pages/Overdose-Fatality-Report.aspx ) Of course, OxyContin is not the only reason for the overdose deaths, but citizens selected as jurors may have jumped at the chance to blame someone. Who better than a drug company? The company lawyers were facing the potential for an astronomically high judgement from jurors with the case heard in Pike County.

The drug company lawyers decided to play it safe, and settled for 24 million dollars. Purdue Pharma and its officials did not admit any guilt in this settlement.

This isn’t Purdue Pharma’s first legal loss. As you will recall from my July 8, 2015 blog post, Virginia won an award of $634 million from Purdue and from its top three executives after they pleaded guilty in May of 2007 to misleading the public about the drug’s safety. It was one of the largest awards against any drug company for illegal marketing…though Purdue made 2.8 billion dollars in sales from the time of its release in 1996 until 2001. How much the company made since 2001 is anyone’s guess but it has to be in the billions.

When I started working at my first opioid treatment program (OTP) in 2001, the only drug I heard about was OxyContin. The majority of the patients entering treatment used only Oxy’s, as they called them. Patients told me how easy it was to remove the time release coating, then crush the pills to snort or inject. All during this time, Purdue Pharma was touting their product as abuse-resistant.

Needless to say, their claims rang hollow in my ears, and the ears of other doctors treating addiction

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 for 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.

No one in the Sackler family, owners of Purdue Pharma, has been criminally charged with any crimes.

  1. General Accounting Office OxyContin Abuse and Diversion report GAO-04-110, 2003.
  2. 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. 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.

Diversion of Prescribed Medications

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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.

 

Opioids and Benzodiazepines Prescribed More Frequently in the South

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Last month, the CDC released information comparing rates of opioid and benzodiazepine prescriptions by state and by region. It did not surprise me to learn the South had the highest rates of benzodiazepine and opioid prescribing of the entire nation.

U.S. citizens already receive twice the number of pain pills per capita than our Canadian neighbors. But in addition to that difference, there’s a 2.7-fold difference between the state with the lowest opioid prescribing rate per capita (Hawaii) and the states with the highest rate per capita (Tennessee and Alabama tied for first place). [1]

The same held true for benzodiazepines, with even more difference in prescribing rates. In Hawaii, doctors prescribed benzodiazepines 19.3 times for every 100 people. But in Tennessee, doctors prescribed benzodiazepines 61.4 times for every 100 people. That’s over a three-fold difference between these states.

Alabama, Tennessee, and West Virginia were the top three prescribers for both opioid and benzodiazepines. We already know that higher prescribing rates are associated with higher overdose deaths rates from these medications. Incredibly, these three states were more than two standard deviations away from mean prescribing rates for the entire country.

Even more disturbing, Tennessee doctors prescribed oxymorphone (Opana) at an amount 22 times that of doctors in Minnesota.

That’s just bizarre. It could also explain why so many of the patients I admit to OTPs in the mountains of North Carolina mention Opana as their drug of choice.

The CDC authors of this report admit it’s unlikely there’s much difference in rates of disorders needing treatment with opioids or benzodiazepines. My interpretation of this statement is that it’s an indirect way of saying doctors in the South are overprescribing opioids and benzodiazepines. The authors allude to the problem of overprescribing in the South, mentioning that the South also has higher rates of prescribing for antibiotics, stimulants in children, and medications known to be high risk for the elderly.

How did my state of North Carolina compare to the rest of the nation? Our data isn’t as embarrassing as that for Tennessee, but there’s certainly room for improvement. In NC, doctors prescribed around 97 opioid prescriptions per 100 people, and 45 benzo prescriptions per 100 people.

Benzodiazepine co-addiction complicates induction onto methadone and buprenorphine done by opioid treatment programs for the treatment of opioid addiction, and this co-addiction also predicts poorer treatment outcomes. [2, 3]

This supports what I’ve long suspected: the treatment of opioid addicts with MAT is different in the South than in the West. My colleagues in California, inferring from the CDC’s report, don’t have to deal with benzodiazepine co-addiction as often as I do in the mountains of North Carolina. That co-occurring addiction changes the clinical picture, and makes induction onto methadone particularly more risky.

This is not the South’s finest hour. We must do more to educate doctors about appropriate prescribing, starting in medical school and continuing throughout the physicians’ professional careers. If doctors don’t start this change, someone else will surely do it for us.

1. http://www.cdc.gov/vitalsigns/opioid-prescribing/index.html
2. Brands et al, 2008, Journal of Addictive Disease
3. Eiroa-orosa et al, 2010, Drug and Alcohol Dependence