Archive for the ‘Governmental solutions to addiction’ Category

Access to Buprenorphine Will Expand; News About CARA

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Last week, the Department of Health and Human Services (HHS) announced it was raising the limit on the number of patients each doctor can treat for opioid use disorder with buprenorphine, from the present cap of 100 patients to 275 patients. However, each doctor must first meet criteria and complete an application procedure to be approved for this higher limit.

Initially, HHS wanted to increase the limit to 200 but for some reason ended up with 275. It’s still an arbitrary number, and opioid use disorder remains the only disease to have patient enrollment limits legislated for physicians.

HHS still wants physicians to meet extra requirements before they are approved to accept 275 patients, as I blogged about in my May 8, 2016 post:

  • Have professional coverage for after-hours emergencies.
  • Provide case management services
  • Use electronic medical records
  • Must use that practitioner’s state prescription monitoring program
  • Accept third-party insurance
  • Have a plan to address possible diversion of prescribed buprenorphine medication
  • Re-apply for permission to treat up to 275 patients every three years
  • Supply yearly reports about their practice and their buprenorphine patients

For some of the reasons I names in my May 8th blog, at this time I’m not planning to request permission to treat more than 100 patients.

This measure by HHS is a good and positive thing, and will help more desperate people get treatment. Just because I have a few objections to several HSS’s requirements doesn’t mean other doctors will feel the same way. I expect many physicians treating opioid use disorder will undergo the procedure to expand their patient limit.

 

Meanwhile, both the House of Representatives and the Senate passed the Comprehensive Addiction and Recovery Act (CARA) as of last week, and the bill is going before the President for his signature.

This bill, considered weak by some members of the House, contained only a fraction of the requested money to treat addiction. However, other advocates for addiction treatment say even a weak bill is better than none.

CARA’s content addresses the following:

Expand availability of naloxone to law enforcement and first responders, in order to quickly reverse opioid overdoses and prevent deaths. I think our own Project Lazarus helped get this ball rolling many years ago, and I’m so grateful my OTP has had support from them to give our patients naloxone kits!

Expand education and prevention efforts toward teens, parents, and aging people to prevent drug abuse and promote treatment and recovery.

Encourage states to improve their prescription monitoring systems. I hope some of that money will be directed to interoperability, meaning it will be easier to access a neighboring state’s prescription monitoring program. I also hope the Veteran’s administration will start reporting their data about prescribed controlled substances, too.

Prohibit the Department of Education from rejecting financial aid for people who have had past drug offences. I didn’t know people with drug offences on their record were denied governmental financial aid. If we want people to improve themselves and their life situations, why would we deny help for them? So this measure in CARA is great.

Expand resources to identify and treat incarcerated people with substance use disorders using evidence-based treatments.

Great idea, about forty years late.

Expand drug disposal sites to keep leftover meds out of the hands of children.

Just a question I’ve always had…Of all the tons of medication which have been collected at these disposal sites, has anyone ever studied how much controlled substances are collected?

Launch a “medication assisted treatment and intervention demonstration program.”

Not sure exactly what this will look like, but good luck with all of that.

I feel like I’ve beaten my head against the brick wall of prejudice and stigma against MAT in my community for four years. All I have is a headache…and resentment towards the medical community. I’d be very happy if someone else wants to take over for a while.

Launch a program to promote evidence-based treatment of opioid use disorder.

Well, yeah. it needs to happen. Actually it needed to happen about fifteen years ago, but whatever.

Director money towards law enforcement, to get people with substance use disorders help, rather than incarceration. CARA wants law enforcement to be able to work with addiction treatment services.

I indulged a private snicker at that last one. What a change from only a few years ago.

About six years ago, I was trying to educate people about medication-assisted treatment of opioid addiction. I thought I could help educate law enforcement personnel about addiction treatment, since they encounter it so much. I used the internet to find a journal for law enforcement.

I wrote to the editor, offering to write an educational article for their publication about opioid addiction treatment. My hopes weren’t especially high, but I wanted to give it a shot.

I was surprised when the journal’s editor took the time to call me in person. I was so excited!

Then the editor started talking to me like I was a naughty child. He asked what made me think it was appropriate to waste his time with such a query letter. He said I should have known better than to think any of his readers would be interested in the kind of thing I was offering to write, and he was calling to see what kind of person would be so unwise as to think otherwise.

I was stunned. I regret my reaction to him. I was so taken aback that I started apologizing to him, and said I was so sorry for bothering him and wasting his time.

In reality, he behaved like an asshole. If he didn’t want to waste time, he could have passed on the urge to call me to tell me how stupid he thought I was.

I wish I would have stuck up for myself in that conversation. I like to think I would handle it differently today.

Anyway, now, six years later, the government earmarked money to help law enforcement learn about opioid use disorder treatment.

While writing this article, I’ve come to realize I have bitterness towards people in law enforcement, medical fields, judicial, etc…when they denigrated my efforts to educate them about medication-assisted treatment for opioid use disorder.

I don’t want this bitterness. It’s too hard on me. It’s a weight that interferes with my enjoyment of life, and I’m going to release it.

The tide has begun to turn. We have legislation addressing the terrible opioid addiction problem we have, and money earmarked to help the problem. I want to be able to work with people who may have said bad things about medication-assisted treatment of opioid use disorders in the past. I want to work with those people without feeling resentment and without indulging in sarcasm.

I Get So Mad….

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A friend emailed me a video clip of former President Bill Clinton on a stage, talking with Senator Joe Manchin of West Virginia. This clip was from a talk given as part of the Clinton Global Initiative, and discussed the state’s present plague of opioid overdose deaths. West Virginia now surpasses all other states in per-capita deaths from opioids. (Yeah, they beat out Tennessee!)

Clinton talked first, about our nation’s situation with opioid addiction and overdose deaths. He emphasized that economically distressed small towns and rural areas were hardest hit. He also said the U.S. Senate recently voted to treat this like a public health problem instead of a criminal problem.

Then Senator Manchin starts to talk. At first, he admits that he used to be guilty, twenty years ago, of believing addiction as a crime and needed to be treated as such. He says that now, he knows it is an illness which needs treatment, and he doesn’t have enough treatment centers in his state for the large number of people who need treatment to get it.

So far, I’m with him.

He goes on to talk about a bill he’s introduced, called “Life Boat.” This is a proposed tax on every milligram of opioid produced and sold in the U.S., to create permanent funding for treatment centers around America.

Not a bad idea…

Then he talks about “Jessie’s Law,” named for the daughter of a friend who became addicted, got into recovery, had a sports injury, and was prescribed an opioid despite being in recovery. She had an antibiotic port for a bone infection, and she injected the OxyContin that was prescribed for her, and she died. Jessie’s Law says charts of addicts will be stamped with some sort of indication that the patient has a substance use disorder.

Uh, no. That’s a terrible idea, given the ignorance and stigma that medical professionals still have regarding addiction. Terrible idea.

At this point I see that Mr. Manchin probably doesn’t grasp the intricacies of addiction and its treatment.

Next, he says he’s pushing for legislation to help people convicted of non-violent crimes related to addiction to have their criminal records expunged. The expungement would be contingent on finishing one year of addiction treatment, and then another year spent working as a mentor to other addicts.

Then Senator Manchin said of addiction: “It’s an illness and it can be cured.”

He followed this statement by going down a verbal rabbit hole, describing the drug court of Judge Will Thompson. He described how wonderful this drug court was, and as an aside, said that this judge won’t accept the methadone clinics, despite the fact that, “The feds are pushing him hard.” Manchin said, “Suboxone, etc, he’s not for any of that. He says all you’re doing is extending this illness. It sustains the dependency.”

*SIGH*

Well, if it’s an illness, who better to cure it than a judge? I’m being sarcastic, of course.

Why do non-medical people agree addiction is an illness, and then think they know what works to treat it?

I now have a clue as to why West Virginia is number one in the nation in per-capita opioid overdose deaths…..

The Good, the Bad, and the Ugly

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The Good

 Probuphine

Probuphine was approved by the FDA. I’ve written about this medication in several other blog posts. Probuphine is an implantable form of buprenorphine that lasts for six months. It will be suitable for buprenorphine patients who are stable at 8mg per day or less.

I think logistical problems will prevent this medication from becoming mainstream. I hear it must be implanted in a surgical suite, which makes little sense. Maybe it’s more involved than I realize, but I had been under the impression it could be done in an office setting, like Norplant.

I’ve also read that the physician must purchase and store the Probuphine implant, which adds financial risk and DEA scrutiny to a buprenorphine physician’s already crowded schedule.

As I’ve said before, I predict Probuphine will be administered at a few specialty centers, but isn’t likely to be done by most mainstream addiction medicine doctors. Still, it’s another option that hopefully will work well for patients on less than 8mg per day.

Watch your language

The field of Addiction Medicine is pushing for non-stigmatizing language to be used by treatment professionals. Words are important, and some words carry hidden and pejorative meaning in the general public.

For example, I’ve always cringed when I hear the term “dirty” or “clean” urine drug screen. I have to quash my desire to be sarcastic towards the speaker. The proper terms are “positive,” meaning a substance was found in the urine, or “negative,” meaning a given substance wasn’t found in the urine. Addiction Medicine gurus continue to emphasize the importance of using proper clinical terms. I enthusiastically agree with their efforts.

Now experts in the field want to get rid of the term “addict” and “opioid addiction.” They want to replace those words with terms such as “person with opioid use disorder,” and “opioid use disorder,” respectively.

I understand the reason behind these recommendations, and I agree with them, but it’s going to be tough to replace a two-syllable word with a ten-syllable phrase.

Besides, when I say the word “addict,” I suspect I mean something very different than the average person using the word. In my mind, the word “addict” has come to mean “person with the disease of addiction who is probably more likeable and interesting than an average person.”  But then, I chose to spend my career treating these people, so of course I think that way.

Contrast that to an average person in the community, to whom the word “addict” means a bum in the gutter with a needle hanging out of his arm. Most of the time, people are surprised when then encounter real addicts, or to use the new term, people with an opioid use disorder. Because since anyone can develop opioid use disorder, these people usually don’t look different from the rest of us.

Government Support for Addiction Treatment

When the President of the United States endorses medication-assisted therapies, we have arrived. That’s old news now, since he has been discussing MAT in some of his addresses since last year, as a way of addressing the opioid overdose epidemic. But now the promised money is starting to become available.

Available grant money fueled plans for new, collaborative opioid use disorder treatment programs in our state…

One primary care low-cost clinic just started working with their local opioid treatment center to provide needed primary care to patients in that OTP. Referrals should flow both ways, with the OTP sending patients to the medical clinic for needed healthcare, and the medical clinic will detect opioid use disorders in their patients, and refer them for treatment at the OTP.

An exciting initiative to connect people involved with the criminal justice system with appropriate medication-assisted treatment is in the planning phase. With this program, prisoners being released and people under parole and probation will be evaluated by addiction medicine doctors. Where appropriate, they will be offered methadone, buprenorphine, or naltrexone, to better treat their illness, and they will get increased counseling.

Prescription Monitoring Programs Work!

I had a few spare hours last week, and was able to look at around 125 of my 450 OTP patients. I discovered only one patient with some questionable findings, and she’s scheduled to talk with me this week.

What a change from 2007, when over 20% of all my OTP patients had serious prescriptions for opioids, benzodiazepines, and/or stimulants. These were prescriptions about which I knew nothing. Patients had filled prescriptions and there was no way for me to know about it, until our prescription monitoring program came online in mid-2007.By the time I got access late in the year, I found data indicating over a fifth of our patients were filling prescriptions that could harm them with the methadone I was prescribing.

Over the last nine years, our system has improved, making it ever easier and more accurate.

The Bad

All Use of Methadone is Toxic?

Perhaps in response to my blog post that was critical of the medical examiners in North Carolina, a medical examiner called me.

My complaint in the June 5, 2016 blog is that any patient who dies while on methadone maintenance is said to have died from methadone toxicity, regardless of clinical information.

This doctor and I had a cordial yet frustrating conversation. The physician introduced himself and said he was calling me because he had promised to do so after I spoke with him last year about a patient of mine who had died. When we last spoke, the toxicology results had just been sent off. He called yesterday to tell me that the level of methadone in this patient was toxic, and that along with the cocaine found in her system, he was reporting cause of death as “Methadone toxicity, cocaine toxicity.” I already knew this from reading incident report data, but I didn’t interrupt him. I was hoping he would give me additional information, but he didn’t.

When he was done, I informed him, again, that she had dosed at 130mg of methadone for months in the several years prior to her death. At her request, we started a slow taper. She came down on her dose by 5mg every couple of weeks, and she had been dosing at 60mg for several weeks prior to her death. I asked him how, with that information, could he still say she died from methadone toxicity?

He didn’t have an answer, and just repeatedly said her methadone level was “toxic.” He read the level to me, and I told him that I have patients with trough levels  higher than that.  I told him toxic for an opioid-naïve patient may be just what one of my patients needs for stabilization.

I don’t think he ever heard what I was saying. He never got off the topic of drug levels, and implied perhaps she could have obtained methadone from another source.

I suppose this is possible, but unlikely. For this patient to have overdosed on methadone, she would have had to gotten a supply of the medication from another source. I know she didn’t get a prescription for it, since I checked the state prescription monitoring database. And why would she buy illicit methadone off the street when she could just ask to go back up on her dose if she were in withdrawal?

I appreciate that this doctor took the time to call me. He didn’t have to do that, and it probably wasn’t an easy conversation for him. I don’t doubt he’s conscientious at his job.

I only wish he could have heard what I was saying.

What I heard him was saying was more of the same: the medical examiners will base their decision about cause of death on the methadone level, and will not consider any clinical information from me, or presumably from any another other opioid treatment program physician, if a patient dies under my care.

This increases the risk of being a doctor at an opioid treatment program. Because no matter how cautious we are, we treat a group of people who die at higher rates than age-matched controls. Nearly all of our patients smoke cigarettes. Of course they can die from methadone overdose, but they also die at higher rates from cancer, heart disease, liver failure, and other medical problems created from a life time of drug use, including nicotine.

But we now know in advance that methadone will be blamed no matter what. And that’s bad news

The Ugly

Heroin Comes to Town

Last week, several people who should know and have no reason to lie told me heroin can be bought in Wilkes County. I am really sad to hear this.

Heroin has already invaded many small communities. It crept in after black market prescription opioids pain pills became scarce. Indeed, at my state’s yearly Addiction Medicine conference, most OTP doctors said they’ve been treating heroin use disorder for several years.

For some reason, the people I admitted to our opioid treatment program have thus far been around 98% pain pill addicts. Last week, more than half of the new patients were using heroin. One patient came to treatment because the first time he used heroin, he overdosed, nearly died, and woke up in the ambulance. That scared him enough to propel him into substance use disorder treatment.

You may question if heroin addiction is that much worse than pain pill addiction. I think it is, though I could be wrong about this. With pharmaceutical grade pain pills, the user has an idea, usually, of how strong the product is. There’s not much variation from one pill to another. But with heroin, the batch one day could have only a few percent of pure heroin, or 100% pure heroin. There’s no way to know. There’s no way to gauge how strong it is, unless the user dose a “tester shot.” This is when the user uses a small amount of the purchased heroin to see how strong it is. This tester shot is recommended by Harm Reduction Coalition as a way to reduce overdose risk.

Heroin manufacturers usually don’t care about quality control. The heroin could be cut with God knows what else. Some of these substances cause special problems, since they weren’t meant to be injected into the human body.

Quinine, for example, has been found as a contaminant. I’m not sure why it’s used to dilute heroin, but it is. Quinine can cause kidney damage, bleeding disorders, and severe allergic reactions. Some experts believe many heroin overdoses are really fatal allergic reactions to products used to cut the heroin. In the street parlance, adding substances to a drug is called “stepping on it,” meaning diluting it so it can go farther and make the seller more money.

Other regular heroin contaminants include caffeine, talcum powder, powdered milk, chalk, or flour.

Recently there’s been a tendency to include fentanyl in the heroin product, making it an even stronger opioid. This has caused many overdose deaths, particularly in the Northeast. I strongly suspect that’s what my patient with the near-fatal overdose injected.

 

 

 

 

 

 

 

 

 

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.

DATA 2000: I’m Not Bitter!

Denial

Recently discussion of expansion of the one hundred patient limit has been in the news. I lost interest in this topic several years ago, when I saw DATA 2000 standards being violated with impunity in my community. Given lack of adherence to DATA 2000 requirements, people who want buprenorphine have no problem getting it.

Is this good or bad? Maybe a bit of both.

At least three physician extenders in my area prescribe buprenorphine for patients with addiction on a regular basis, despite having no “X” number. I don’t know how this happens, but I do know the North Carolina Medical Board investigated this practice, took no action, and these same extenders, still with no “X” number, continue to prescribe buprenorphine for addiction.

Since present DATA 2000 regulations are being ignored, changes in those regulations are moot in my state, or at least in my area.

Do I sound bitter? Yes, I am, or at least I am intermittently. On most days, I’ve got my own patient challenges to deal with, so I don’t have time to worry about other doctors’ practices. But occasionally I do feel some resentment. It’s hard not to fret when other practices get away with things, while I follow regulations.

I also grumble when I’ve got to pick up the pieces for patients expelled from other buprenorphine practices for doing exactly what people with addiction do – take drugs.

I’ve had multiple patients seek admission to our opioid treatment program after they were “fired’ by these other practices. Now, I know I’ll do a better job than they ever did, but it’s a real pain in the ass to try to find out exactly what went wrong. I’ve been hesitant to believe patients’ versions, since they sound incredible, but so far, my patients have told the absolute truth.

Recently I admitted several patients after they were dismissed from the other practice for misuse of their opioids. These patients had been prescribed buprenorphine by the physician extenders, and were apparently doing well. Then on one visit, the nurse practitioner or physician assistant asked the patient about pain, and after being told some pain did remain, these patients were taken off buprenorphine and prescribed powerful opioids instead.

Even the patients thought this action was odd. These patients said they knew they would relapse, but due to their disease of addiction, were unable to refuse this jackpot of opioids when offered.

Events unfolded in a predictable manner. The patients went back into active addiction, and injected the oxymorphone they were prescribed. They ran out early, and when a pill count was demanded, they of course failed. Dismissed for being a bad patient, the confused patients came to the opioid treatment program where I’m left to try to figure out what the hell has gone on.

Thankfully, the people I’ve seen survived their relapses, and were able to re-stabilize on either buprenorphine or methadone. But I wonder how many other people have had worse outcomes.

Perhaps if buprenorphine prescribers had better education about addiction, such relapses could be avoided. That’s one big downside of ignoring DATA 2000 requirements.

After the Overdose

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I just read an astounding and completely believable study in a recent issue of the Annals of Internal Medicine. [1]

This study, done by Dr. Larochelle and associates at Boston University Medical Center, did a retrospective study of prescription opioid overdoses. They looked at patients who were being prescribed opioids long-term for non-cancer pain who had a non-fatal overdose. The study lasted from May 2000 until December 2012, and included over twenty-eight hundred patients. All of these patients had commercial insurance, and were between 18 to 65 years old.

This study found that after having a non-fatal overdose, 91% of these patients resumed getting prescription opioids, and that 70% got them from the same doctor.

The lead author said he was shocked to find so many survivors continue to be prescribed opioids after having an overdose from these very opioids. He had hoped after a near-fatal experience, prescribers would do something different to address pain, in order to prevent future overdose.(https://hereandnow.wbur.org/2016/01/13/opioid-prescriptions-after-overdosing)

From other studies, we know that the best predictor of a future overdose is a past overdose, which is why I ask every patient entering the opioid treatment program (OTP) if he has ever had an overdose.

The author of this study postulated that with our fragmented healthcare system, the prescribers may not have known the patient had an overdose. Not knowing about any problems, the doctor continued to prescribe opioids.

I have no problem envisioning how this happens.

Not long ago, one of my opioid treatment program (OTP) patients missed two days of dosing. Per our protocol, her counselor called her on the first day she missed dosing. The patient told her counselor that she had been admitted to the hospital for trouble breathing, and was being treated for asthma.

Also per out protocol, we request hospital records for every patient of ours who gets admitted to the hospital, and our patient gave permission for this.

When I got the records four days later, imagine my surprise when I read that she had respiratory failure due to an overdose. Her drug screen at the hospital was positive for methadone and also benzodiazepines, and indeed she was now positive for benzos at the OTP too. This information lead to a drastic change in this patient’s treatment plan.

If we had not called to see where our patient was, she could have returned in several days and not told us about her hospital admission.

Our local hospital did not call our OTP to tell us our patient was hospitalized with an overdose. Indeed, they didn’t call to tell us she was in the hospital. To my patient’s credit, she did tell them she was a patient of ours, since it was recorded in her hospital record.

When our patients are admitted to the hospital for medical reasons, the admitting doctors continue to prescribe the usual dose of methadone, and I am happy about that, but they don’t call us to confirm the dose. They take the patient’s word for what the dose has been, instead of making a quick phone call. I worry that someday, one of our patients, in a misguided effort to feel an opioid effect, will tell his hospital doctor he’s been dosing at a higher dose than he actually is, and catastrophe could ensue.

In contrast, the big teaching hospital an hour away, which is where our patients go when they are really sick, routinely calls to confirm each patient’s dose.

The Larochelle study seems to indicate there’s a lack of communication in other medical communities as well. Emergency department physicians may administer Narcan and revive a patient, but no one thinks to take the next essential step: call that patient’s prescriber about the drug overdose.

We can’t assume the patient, now revived from a near-death experience, will tell her doctor about what happened. If that patient has an addiction, she might keep quiet about prescription mishaps, fearing her supply of opioids may be cut off.

Family members might tell the prescribers, and that’s very helpful, but often patients are told the doctor can’t release any information. That is true, but the family can certainly give information to the doctor.

I know hospitals and emergency departments are busy. Healthcare professionals are all busy. We are being asked to do more and more in less and less time. But this is a communication issue, and it need not be a physician- to- physician communication. A nurse or even a social worker from the hospital could call or fax valuable information quickly. Privacy laws can be blamed for some lack of communication, but there are exceptions in life-threatening situations.

And please, let’s make medical records readable. Even when I finally get local emergency department records about one of my patients, I have a hard time deciphering them. I’ll admit to being a bit of a Luddite when it comes to electronic medical records, but partly because most electronic records are not all that helpful.

For example, on our local emergency department records, I quickly can find the results for Ebola screening (it’s on the first page, at the top), but often I am left scratching my head about what the doctor’s final diagnosis and treatment plan was for the patient.

We’ve got to fix this communication problem. It’s great when an overdose is treated and prevented. But let’s do just a little more, and communicate to the prescriber of the overdose medications.

It is life and death.

  1. Ann Intern Med. 2016;164(1):1-9. doi:10.7326/M15-0038

Purdue Pharma Settles Kentucky Lawsuit

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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.