Author Archive

Trump’s Opioid Speech

 

 

 

 

 

 

At least five or six people asked me what I thought about the President’s address in which he declared the opioid crisis a public health emergency. I didn’t watch his address, but I did read a transcript of his speech.

When people insert the comment, “Believe me,” into what they are saying, I tend not to believe them. Perhaps it’s an occupational hazard, but that’s what I consider a “tell.” Just like the phrase, “I’m not gonna lie to you,” my brain assumes there’s a whooper of a lie headed my way.

However, the “believe me” phrase could be just a verbal tic on President Trump’s part, like the word “very” which he said eighteen times in his speech. Yes, I counted. I don’t know why that annoys me so much, except maybe I expect a more diverse vocabulary from the President. It’s very, very, very annoying.

I applaud his effort. He said some good things, and the overall message of his speech was that the U.S. has a problem, we need to do something about it, and here’s what I’m going to do to help. I could nitpick about the accuracy of some of the things he said, but I think he’s sincere in his desire to help people overcome substance use disorders.

But isn’t it disingenuous to tell people you plan to get approvals for treatment at the same time you are ending Obamacare? People need insurance to pay for medical care, so how will the 10 million or so who had insurance under Obamacare pay for treatment?

It was also disingenuous for him to say he’s “directing all executive agencies to use every appropriate emergency authority to fight the opioid crisis,” and that we should expect to see “Approvals that will unlock treatment for people in need and those approvals will come very, very fast…”

Money is being released quickly, from the 21st Century CURES Act, passed by Obama in December of 2016 and made available to states by April of this year. That is fast, for government money. I didn’t like Trump taking credit for legislation passed before he became president.

But those are trivial irritations compared to what’s important. Perhaps President Trump will pass legislation that gives people access to treatment for opioid use disorder. I hope that access will be for evidence-based treatment, and not for a “just don’t start” sort of campaign. We already endured the “Just say no” of Nancy Reagan. It’s not bad as far as it goes, and might prevent people from experimentation with drugs, but it’s of little use once opioid use disorder develops.

After President Trump’s speech, I am cautiously optimistic. I’ll have to see details before I get too excited, though. With so much at stake, I do hope the President allows experts to guide his policies. If we shoot a missile at opioid use disorder, let’s be sure it’s pointing in the right direction.

 

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Temporary Grace: the CURES Act

 

 

 

 

 

 

The 21st Century Cures Act, signed into law by President Obama late in his presidency, provided money to help people with opioid use disorder get treatment. In April of this year, states got this money, in the form of STR (state targeted response to the opioid crisis) grants. Eighty percent of this money is to be spent for treatment, meaning more people with opioid use disorder should be able to access treatment.

And this is happening.

In North Carolina, the money was allotted to LME/MCO organizations. These organizations also manage our Medicaid dollars in various regions of the state. As I understand it, these organizations help to decide which treatment programs receive CURES dollars.

Our opioid treatment program (OTP) immediately applied for access to this money for patients. Since we’ve already gone through the vetting process to be approved to accept Medicaid patients by our LME/MCO agency, it didn’t take long to become approved for CURES dollars.

We’ve admitted around eighty people on the CURES grant who had no other way to pay for treatment. To qualify for CURES, they needed to apply for Medicaid, and then bring in the refusal letter, saying that they didn’t qualify to receive Medicaid. (Being a red state, in North Carolina a person can be making very little money at their job and still not qualify for Medicaid.)

These eighty people, instead of having to pay their daily treatment fee, have it paid for them through the CURES grant.

This is fantastic. This is wonderful. We’ve re-admitted many patients who were in treatment with us in the past, but who dropped out for financial reasons. We’ve admitted patients with long-standing opioid use disorder who have never been able to afford treatment. It is thrilling to see these patients stop using opioids and start to engage in treatment. The great majority of patients admitted under CURES have shown improvement.

It’s not all been roses, though. Some of these patients are extremely ill with long-neglected mental and physical health issues. It’s been a challenge to find places to refer them for primary care. Some patients have burned bridges with many of the primary care doctors in the area. Others with serious health issues refuse to see a doctor. Substance use disorder isn’t the only disease with denial. I sense these patients are often scared to hear a bad diagnosis from a doctor, and prefer to ignore their ailments.

Some people admitted with CURES dollars have severe mental illness, to the point that it can interfere with treatment and affect other patients. We’ve tried to strike a balance between helping patients with serious mental illness, while still maintaining a safe and comfortable treatment program for our patients. Often these patients refuse to be referred to the facility that contracts with our LME to provide mental health care. In other words, their mental illness interferes with their ability to get care for their mental illness. It can be terribly frustrating. I’m not a psychiatrist, and I’m not qualified to help them with these serious conditions.

We’ve admitted a handful of homeless people with opioid use disorder under the CURES grant. Our small town has one facility that will house people for up to two weeks, so at best that’s a very short-term solution. We can refer them to neighboring towns, but they don’t have transportation to dose with us every day, so they must transfer their care for opioid use disorder to another facility approved for CURES money. Some homeless people would rather live outside in a familiar area than move to a different town. With winter coming, it’s a grave concern.

Our patient census shot up relatively quickly, and our OTP has growing pains. We are struggling to hire more personnel, particularly to reduce wait times for dosing. I don’t have time to see every patient as I would like to, so the company I work for is looking for a physician extender to help me.

As is human nature, some people try to take advantage of grant money. I’ve had a few “patients” start on sublingual buprenorphine, only to see them attempt to divert their dose. When I confront them, and tell them I’m no longer willing to prescribe buprenorphine but would be willing to switch them to methadone, they get angry and leave. I believe – but can’t prove – these people intended to get buprenorphine to sell on the black market, where it goes for around $30 for an 8mg tablet.

We also must live with the uncertainty that this grant could be snatched away by a president intent on undoing everything the last president did. I tell patients benefitting from the CURES grant to look at this opportunity as a temporary thing, and that if possible, they need to try to find a way to pay for treatment themselves if the grant falls through. I hope it doesn’t, but the future of healthcare overall is in a period of transition, and opioid use disorder treatment is no exception.

Our whole staff feels more stress, and I try to remind them – and myself – of the larger picture. Experts say only 10-20% of people with opioid use disorder are presently getting help for their illness, and now with CURES, I believe that we are reaching a chunk of those who haven’t had care in the past.

It’s an opportunity that I’ve never seen in the sixteen years I’ve worked treating opioid use disorder. Despite our growing pains, we will continue to do all we can to access treatment dollars for people who can’t afford it otherwise. This CURES program should have this same effect across the country, enabling people with opioid use disorder enter treatment, often for the first time.

 

Subcutaneous Buprenorphine Injections for Treatment of Opioid Use Disorders

 

 

 

 

 

I’ve blogged in the past about studies conducted on CAM2038, a new preparation of buprenorphine that can be given in a subcutaneous injection weekly or monthly. I think this delivery system holds great promise for the treatment of opioid use disorder.

Earlier this year, pharmacokinetic data from healthy volunteers showed that blood levels with the subcutaneous injections equaled the levels provided by sublingual means. This data supports the idea that the injections should provide therapeutic levels in patients with opioid use disorder. [1]

Later this year, a Phase II study was published in JAMA Psychiatry. Weekly subcutaneous preparation of buprenorphine was administered to 47 subjects with opioid use disorder. These patients were not seeking treatment, but had agreed to take part in this study, and all were diagnosed with opioid use disorder, either moderate or severe.

These subjects were given dose of either 24mg or 32mg one week apart, and had complete suppression of opioid withdrawal at both doses. The subjects were then challenged with varying doses of hydromorphone, and had sustained blockade of response to the hydromorphone. [2]

The six-month implant, brand name Probuphine, hasn’t been widely prescribed. As I predicted, the confusion over cost, insurance coverage, and implantation regulations have so complicated Probuphine’s use that mainstream medical providers aren’t considering its use. Also, it’s only indicated for patients on 8mg or less of sublingual buprenorphine, and patients have concerns about what will happen if it doesn’t work well. They ask if their insurance companies would pay for supplemental buprenorphine if the implant doesn’t work as well for them. I don’t know for sure, but I’m guessing they would not pay for supplemental medication.                                                                                                                                                                                                                                                                                                                                                                                                                 My biggest concern with Probuphine was that patients may be less inclined to come for counseling sessions if they have had a six-month implant that keeps them feeling normal. They have no monthly incentive to see their physicians. Many physicians require counseling as a condition for ongoing monthly prescription for sublingual buprenorphine.

I like the idea of injections for weekly or monthly buprenorphine. If it works as well or better than sublingual buprenorphine, it could be the solution to some difficult problems.

  • It would save time for my patients on buprenorphine at the opioid treatment program. One of the complaints we hear is of the regulations surrounding treatment in our setting. Unlike in the office-based setting, buprenorphine prescribing at the opioid treatment program demands we follow the sometimes onerous rules of both state and federal laws governing opioid treatment programs.
  • It would resolve our diversion dilemma.But injections can’t be diverted, so far as I’m aware.
  • Because buprenorphine has a high street value in my community, patients are sometimes tempted to spit out their medication to sell it, or even to inject it into themselves. We don’t want this, given the high rates of complications with intravenous use. We don’t want patients to sell medication because it hurts our reputation in the community. We don’t want to be known as suppliers of illicit buprenorphine.
  • It would be a godsend for patients who have to go to jail unexpectedly.
  • Most of the time, jails won’t bring incarcerated patients to the OTP for their daily dose of buprenorphine (or methadone), so they suffer opioid withdrawal and are at risk for relapse upon being released, with increased risk of overdose death. But if we can give them a monthly or even weekly shot, it will keep them feeling better, and serve as a blocker if they do leave jail and use illicit opioids like Opana or oxycodone or heroin.
  • Patients wouldn’t have to think about taking medication each day; with the injections they wouldn’t have to take a dose of anything each day, just show up for weekly or monthly injections given to them by a medical professional
  • Subcutaneous injections are much less complicated to administer than Probuphine, with rods that require a minor surgical procedure to implant, then explant six months later.The FDA plans to discuss this new preparation of buprenorphine at their advisory committee meeting November 1, 2017. Several days prior to this meeting, data to be discussed at this meeting should be available online for interested readers. [3]If this new option is approved by the FDA, it can give us yet another tool with which to treat patients, always a good thing.
  • 1. Albayaty et al., Advanced Therapeutics, 2017, Feb; 34 (2)

 

  • 2.Walsh et al., JAMA Psychiatry, 2017;74(9):894-902.

 

Maximum Daily Dose of Buprenorphine

Hser et al., 2014, Addiction

 

 

 

 

 

I’d like to thank my readers for their patience during my recent break from blogging. Now that I’m rested, it’s time to start barbequing some sacred cows.

First on my list: limiting the dose of sublingual buprenorphine to 16mg per day.

Recently I’ve heard from physicians who have been told 16mg of sublingual buprenorphine is the highest daily dose that should be prescribed, because studies show that opioid receptors in a human brain are saturated at that dose in most people. While this is true, limiting all patients to 16mg or less neglects research from real life patients.

Some governmental agencies have gone as far as forbidding daily doses higher than 16mg. For example, the Virginia Board of Medicine passed a regulation earlier this year that the highest dose that physicians could prescribe was 16mg per day. In Tennessee, patients can’t go above 16mg per day unless they are seen by an addiction specialist physician.

However, the FDA has approved doses up to 24mg SL per day. Who is right? Did the FDA get it wrong? Are patients who want to go higher than 16mg all drug seekers? Or do all such patients plan to sell their excess medication?

If you read the REMS document created by the manufacturer of Suboxone film, it says the target dose should be no higher than 16mg per day, and that doses higher than 24mg haven’t been shown to provide additional benefit. That leaves a question mark about dosing between 16 and 24mg.

The American Society of Addiction Medicine (ASAM) issued a statement addressing the tendency of state prescription monitoring programs to assign MME (morphine milligram equivalents) values to buprenorphine doses. In that statement, issued earlier in 2017, they said, “The US Food and Drug Administration (FDA) approves dosing to a limit of 24 mg per day. There is some evidence regarding the relative efficacy of higher doses.” [1]

If ASAM says 24mg is OK for some patients, and the FDA has already approved that dose, that’s good enough for me…assuming the patient truly needs a higher dose.

Some patients do better on a dose of 24mg than on 16mg. I work at an opioid treatment program where we observe the patients taking their doses on site, and we pay close attention to any attempt at diversion of the dose. Therefore, we have no question about whether a patient is taking less than the dose I’m prescribing.

When I see new patients within a week or two of admission, I ask how they are feeling. Some patients dosing at 16mg per day of buprenorphine describe symptoms consistent with opioid withdrawal by late evening. I increase their dose above 16mg when I also see physical signs of withdrawal, like large pupils, sweaty palms, and the like. Many patients feel improvement to the point we don’t have to consider switching to methadone.

I increase these patients’ doses because I am sure they are getting their full dose each day, and because I see signs of withdrawal with my own eyes. I know experts say a dose of 16mg is “supposed” to block all the opioid receptors according to studies of this drug, and I believe that is true for many patients. I also think there are patients for whom increasing the dose above 16mg provides benefit, and can eliminate the need to switch to methadone.

Not that there’s nothing wrong with methadone. It has a proven track record, but it does have more medication interactions than buprenorphine, and is more dangerous with certain medical problems.

Methadone patients were under-dosed for years, when physicians had the misperception that no patient needed more than 70mg per day to treat withdrawal. With further studies and information, we know that’s not true, and best evidence shows most patients need between 80-120mg, and sometimes much more than that.

I think in years to come, we will see that by limiting patient doses to 16mg, we are under-dosing some buprenorphine patients.

Why are so many agencies trying to keep buprenorphine doses low?

First, the U.S. has a “less is more” attitude regarding medication-assisted treatments for opioid use disorder. Given the existing bias against these medications, of course some peoples’ attitudes will be grudging acceptance of the medications, but trying to limit the doses to be as low as possible.

Second, there’s the very real concern about diversion of buprenorphine. The more buprenorphine that’s being prescribed and dispensed, the more that may end up being diverted to the black market. I know this is true.

However, opinions can differ regarding the potential harm of providing more buprenorphine to the black market. Some experts might think since buprenorphine is one of the safest opioids manufactured, increased black market access could help save lives. Though many more people embrace harm reduction now than ten years ago, we are not yet in a place where the law-and- order types would allow a serious conversation about this.

Third, I’m worried that some decisions about dose maximums for buprenorphine may be driven by cost. In a state where many patients prescribed buprenorphine products are on Medicaid, higher doses would cost the state more. The same would be true for managed care organizations and the insurance companies and the like. I hate to sound cynical, but financial concerns often drive medical decisions.

By now you know my opinion; if a patient dosing with buprenorphine 16mg SL per day reports withdrawal symptoms and has physical signs that match these symptoms, I’m willing to increase the dose to 20 to 24mg per day. We have a pretty good study, by Hser et al., 2014, that shows higher treatment retention rates with higher doses. Plus, the FDA has already approved doses up to 24mg per day. [2]

I’m cautious about take home dose in patients at the opioid treatment program. If the patient has a history of injecting drugs, I’d like them to have more time in stable recovery before granting take homes. For patients on 24mg per day, I may do more frequent pill counts and bottle recalls, as a precaution against drug diversion. But I’m not sure a patient on 16mg is any less likely to sell part of her prescription than a patient dosing at 24mg.

  1. https://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2016/10/11/public-policy-statement-on-morphine-equivalent-units-morphine-milligram-equivalents
  2. Hser et al., “Treatment Retention among Patients Randomized to Buprenorphine/naloxone Compared to Methadone in a Multi-site Trial,” Addiction, 2014, Jan; 109(1) 78-87.

 

Taking a Break

Hurricane Harvey and Other Emergency Situations

 

Hurricane Harvey

 

 

 

 

 

We all felt heartbroken as we watched the plight of citizens of Houston and other locations deal with the latest weather emergency. I worry most about debilitated senior citizens, children, and animals, all of whom won’t understand what’s happening. I’ve prayed for all people affected by the storm, but that didn’t feel like enough, so I donated to an emergency relief fund.

I said special prayers for patients on medicated assisted treatment. By that I mean any patient who can’t get much needed medications during the flood for serious illnesses. That includes patients with diabetes, heart disease, depression, asthma, opioid use disorder, and many other illnesses.

After Katrina, my state pushed for all opioid treatment programs (OTPs) to formulate emergency planning for their patients for these situations. In New Orleans, patients on methadone (there weren’t many patients on buprenorphine in 2005) had no way to get their medication, and no way to contact their home clinic for confirmation of their dose if they were re-located to a new area with a new OTP. It was only one aspect of the giant disaster that was Katrina.

I thought about what our OTP would do if struck by weather so bad that the facility shut down.

We have a disaster plan, and we just updated it a few weeks ago, coincidently. It’s easier now, since we have a sister OTP located about an hour away. Since both are owned by the same company, sharing data should be simple. We use a server that stores data off-site and can be accessed off-site. Obviously, electronic data retrieval has grown much more sophisticated since Katrina in 2005.

Since my OTP has about nine times the number of patients as our newer sister program, we would need to transport medication to meet the needs of the extra patients routed there for their dose. I feel like that could be easily accomplished, though we’d have to get the approval of the DEA and follow protocols already arranged for these situations.

There are several other OTPs, all about forty-five to ninety minutes’ drive away, surrounding my work site. Patients living closer to those programs could be easily dosed at those facilities as well, if needed. I have a good relationship with the medical directors of those programs, and I feel sure they would go out of their way to help in an emergency. I know I would do the same if they suffered an emergency.

Office-based buprenorphine patients are a little easier. There’s a number of ways to accommodate these patients, since prescriptions could be called in to pharmacies in a pinch. I have records of my office-based patients’ phone numbers both on paper an stored electronically, so if my office can’t open I can still communicate with them for alternative arrangements, assuming phone systems are operable.

Several weeks ago, my fiancé (who also provides counseling for my office-based patients) and I drove to my office practice but forgot the keys to the front door. No problem, we thought, our health services manager, Daniel, will have his keys. Nope. He forgot too. OK, we thought, we can get the landlord, who has an office at the front of our building, will have a master key. Nope. She was out of the country.

It was a pleasant day, not too hot and still shady on the bench in front of my office door where I was sitting. While the other two went in search of another person who may have a master key, my first patient arrived. I explained the situation and asked him if he minded if we conducted the session outside. He thought that was a splendid idea, so we had a very nice fifteen-minute chat. He was doing well, as he has been for about ten years. I couldn’t do a drug screen, but I didn’t make that into an obstacle. At the end of our visit, he gave me his pharmacy’s phone number and I called in his prescription. By the time my second patient arrived, the others had found a key and we proceeded as usual.

In other words, creative solutions to problems can be easy. However, we do need to plan for how to handle situations such as floods, power outages, and other emergencies.

I spent some time on the internet trying to find something about how OTPs in Houston were handling the storm, and how their patients were faring, but so far, I can’t find anything. I hope someone in that area can tell the rest of the nation what happened, so we can better learn how to handle medical issues during emergencies. 

Avoiding Overdoses

August 31: Overdose Awareness Day

 

 

 

“I’m not gonna overdose. I know my limits.”

I really hate hearing these words. Usually patients say this in response to my concerns about their pattern of drug use while I’m prescribing methadone or buprenorphine. But many patients feel like they are the experts. They can’t imagine making a deadly mistake with their drug use. But I’ve heard this phrase, or something close to it, from at least five people who are now dead from overdoses.

I was reminded of this situation after reading an article in the latest issue of Journal of Addiction Medicine. Najman et al. wrote an article titled “When Knowledge and Experience Do Not Help: A Study of Nonfatal Drug Overdoses.”

The author of the study looked at nonfatal overdoses in Australia in 2013, where overdose deaths have risen steadily since 2007. In that country, unlike the U.S., heroin use is declining while pharmaceutical opioid misuse is rising.

This study looked at nonfatal overdoses in people who inject drugs. These people, identified by the needle and syringe exchange programs in Australia, were interviewed about the circumstances surrounding these overdoses, in order to get a better understanding of the risks. A total of 50 people were interviewed for this study.

Most of these people were male, middle-aged, single, and unemployed. Nearly all were smokers. Half had a diagnosis of liver disease and almost all reported a mental health diagnosis. Most injected pharmaceutical opioids, though some also injected heroin and methamphetamine. These were very experienced drug users, with an average of 21 years of intravenous drug use.

Surprisingly, more than half of the study subjects were in some form of treatment for substance use disorder. This finding is contrary to other studies, which have found being in treatment lowered the risk for overdose. Around 46% were in medication-assisted treatment with either methadone or buprenorphine. However, some of the overdoses happened on days that the person missed dosing for some reason, and substituted another opioid such as heroin or fentanyl. Thirty-two percent of study subjects dosed with either methadone or buprenorphine in the twenty-four hours prior to experiencing their overdose.

Most of these overdoses happened in private homes, and around half received some sort of folk remedy for overdose such as being slapped, put into cold water, or being shaken. Naloxone kits weren’t routinely being distributed at the time of this study.

When asked about the cause of their overdose, many the subjects said they were impaired by alcohol or benzodiazepines. Over half said they used benzodiazepines within twenty-four hours of their overdose. Of the 50 subjects, 64% said they had been prescribed anti-anxiety medications sometime in the year prior to overdose, and 38% said they’d been prescribed sleeping pills. Another 36% said they’d been prescribed some sort of tranquilizer in the year prior to overdose. I’m assuming many of the subjects were prescribed more than one of these groups of medications.

Alcohol was not as prominent as sedative medications as contributory cause of overdose; only 34% of subjects said they had some amount of alcohol in the twenty-four hours prior to their overdose.

Over a third of subjects had used fentanyl, a very powerful opioid, leading up to the overdose.

The authors of the study concluded that these experienced drug users were aware of common risks for overdose, yet drug intoxication from sedatives such as alcohol or benzodiazepines may have clouded the user’s thinking when injecting opioids. They also found that unexpected availability of drugs contributed to overdoses.

It’s an interesting study, and a little disturbing to me, particularly the data about overdoses in people who were enrolled in medication-assisted treatments. It does underline the importance of daily dosing of MAT, and the importance of avoiding alcohol and benzodiazepines in patients on MAT.

And if you didn’t know…August 31 is International Overdose Awareness Day.