Misuse of COVID 19 Extra Take Home Doses?

 

 

 

Opioid overdose deaths in North Carolina have risen recently, coinciding with the COVID 19 pandemic. Some state officials wonder if this increase is related to the increase in the number of take-home doses given by the state’s opioid treatment programs to our patients.

My own experience convinces me this increase is NOT related to opioid treatment programs take homes. When the toxicology results are known, I believe we’ll see the overdoses were due to fentanyl and its analogues, found in the heroin that’s currently being sold. I also think benzodiazepines will be a major contributing factor, possibly due to use fueled by anxiety brought by the changes the COVID 19 pandemic has brought to us.

We’re now three months into our COVID 19 response, so our OTP has given extra take home doses during this time. I’ve been pleasantly surprised at how few problems we’ve had. Thankfully, we’ve had no overdoses due to extra take home doses, and no deaths. Around half of our patients are on buprenorphine, and we were a little more liberal with extra take homes for those patients, given its better safety profile compared to methadone.

But we also gave many extra take homes to methadone patients, with no fatal outcomes, and so far, no overdoses.

Out of our present patient population of around five hundred and seventy-five people, only about a dozen have had problems with their take home doses. Of course, that’s probably the tip of the iceberg, since I’ll never know about most cases of medication diversion or misuse. But still, that’s much better than I expected. Other OTP providers report similar experiences.

In those dozen patients, most of came to my attention when they returned early to dose on site with us. Most returned a day or two early, saying they had no idea what happened to the doses for those days.

Why did I expect more medication misuse than we had? I worried because one of the hallmarks of addiction is loss of control. I worried that especially for patients relatively new to treatment, we could be setting them up to fail, by giving them more doses than they were used to managing. However, we had to weigh that risk against the risk of spreading COVID 19 to patients if we had a lobby full of patients dosing daily.

I underestimated my patients. Recovery is about regaining control and learning to manage impulses to misuse medications. Most patients rose to the challenge and took the extra doses just like prescribed. These extra take homes helped keep patients from crowding at the opioid treatment program and gave them more freedom to dose at home and stay safe.

Repeatedly, patients have voiced appreciation to our staff for the extra take homes and the other safety precautions enacted at our opioid treatment program. I’ve had ten or twelve people tell me they appreciated that our opioid treatment program was able to act to quickly to issue extra take home doses. I tell all of them it wouldn’t be possible without cooperation from our governmental agencies. Our state opioid treatment authority (SOTA) held frequent teleconferences early on and throughout the last three months to answer questions and give advice for how best to help patients dosing at opioid treatment programs. Our state’s Department of Health and Human Services has been very supportive of actions necessary to allow patients more freedom to dose at home, where they are safer.

Curiously, some patients told me they expected our opioid treatment program might close during COVID and they would be” out of luck” regarding dosing on their medication. That hurt my feelings a little bit. I told them we are a medical facility and of course we would remain open. We have remained open for business as usual with no change in our hours through the past three months.

Of course, catastrophe can hit anywhere, but each OTP is required to have an emergency plan for continued care of patients to limit disruption of care. If, for example, our OTP disappears into a giant sinkhole, (This is a thing in North Wilkesboro. One Taco Bell was eaten by a sinkhole but that’s an oddity for another time.) we have plans to get our patients dosed at a nearby facility until we are open again.

Our county had an outbreak of COVID 19 at the local poultry plant. According to the newspapers, around one-fourth of the two or three thousand workers tested positive for COVID 19. Fortunately, many didn’t have symptoms, but others got plenty sick. Thankfully, by now most have recovered and are back at work. If we had not given extra take homes, we could have had a catastrophic COVID outbreak at our opioid treatment program.

We’re not out of the woods yet. In fact, in North Carolina, we are still in the first wave on infection. The total number of people with COVID infection has risen, of course, with the increased number of tests done. However, more critically, the number of patients hospitalized with COVID has risen to an all-time sustained high. Every day last week, we broke records for the number of hospitalized COVID patients. This is an important indication of the burden of serious COVID illness in the state.

We are all sick of COVID. I am sick of hearing about it, talking about it, thinking about it. I’m sick of wearing a stupid mask and I’m tired of wiping my keyboard, cell phone, and stethoscope over & over. My hands are chapped from washing and using hand sanitizer.

But now is not the time to stop taking precautions.  We can’t let up know, at least not in my area, with increasing cases. We need to continue all the common sense precautions like social distancing, mask wearing, hand washing, etc. And we must continue to give take home doses to patients so they can stay safer at home. As far as I know, there are no plans to revoke the exception that allowed the emergency take home doses.

At our opioid treatment program, we will continue to monitor patients as best we can. We will continue to balance the safer-at-home strategies behind the extra take home doses with safety concerns about medication misuse. We will keep a watchful eye, but I do not think these doses are behind the uptick in opioid overdose deaths. As I said above, once the toxicology reports are back, we’ll have more information.

Revoking Methadone Take Home Doses

 

 

 

(The information presented has been changed to protect patient identity.)

Last week, staff at our opioid treatment program had a lively discussion about take home doses for a patient on methadone. She’s been in treatment for several years and was on take home level five, meaning she dosed on premises once per week and was given six take home doses. We needed to talk about revoking her take home levels because she was recently arrested for sale of a Schedule II narcotic.

The news of her arrest surprised us. She passed several bottle recalls, which is when we call a patient and give them twenty-four hours to return to the opioid treatment program with their take homes, so we can inspect them to make sure they haven’t been taken early or tampered with in any way. We do this because the state and federal regulations demand it and because it’s good practice. It’s like pill and film counts done by pain clinic providers and office-based buprenorphine providers. She hadn’t failed any of our bottle recalls.

As a treatment team, we discussed her situation at case staffing. (Twice a week, the nurses, counselors, and doctor meet to talk about the needs of newly admitted patients and the progress of other patients, among other things. We also discuss patient who are ready to advance in their treatment and get more take home doses, and those who aren’t managing their home doses as well as we’d like.)

Unfortunately, the patient in question had her picture published in the local paper along with an article describing her alleged criminal misdeeds. Both state and federal regulations say patients enrolled in opioid treatment programs aren’t allowed to receive take home doses if there is “recent criminal activity.” I suppose the officials think that if the patient is involved in criminal activity, there’s a risk the patient could sell take home medication on the street.

I understand this reasoning. And if the patient is accused of selling drugs, I don’t want to provide the patient with a drug they can sell.

But this regulation raises all sorts of questions. What constitutes criminal activity? Does driving to the treatment program without a license count as criminal activity? And what’s “recent”? Last week or last month would count to me, but what about a charge from two years ago that’s just come to trial?

And are we talking about criminal convictions only? Or is being arrested enough proof the person has been committing crimes? Sometimes criminal charges are dropped after more investigation.

What is the standard of proof that we need to use? Is an arrest alone enough to say the patient is engaging in criminal activity? Most patients, when confronted, insist that they have been set up by another person and that they don’t usually sell drugs, but were pressured to do so by a police informant who is trying to reduce their own legal woes.

I know this happens. Local police do use the people they’ve caught selling drugs to try to set up other people to do drug buys in order to charge them too. But if they allow themselves to participate in sales, that means they broke the law.

In my patient’s case, I was worried she had sold her methadone take homes. Eventually, she brought in a copy of paperwork she had been given by the police, and it appeared she’d been arrested for the sale of a handful of oxycodone pills.

But as her counselor said during case staffing, being charged isn’t the same as being convicted, and isn’t a person considered innocent until proven guilty? Another staff member said that applied to the criminal justice system, when a person may be denied their freedom, but in an opioid treatment program that standard of proof wouldn’t apply.

It’s a thorny issue. Patients must wait months to get take home doses, and after they’ve earned them, are extremely disappointed to have them revoked. I understand this; people need to plan their time, and dosing at the opioid treatment program claims time they could spend doing something else.

Some people will ask what’s the big deal? What’s a little more methadone on the street compared to the deadly fentanyl that’s covering the nation? It is a big deal to me, because methadone has (as Dr. Wartenburg says), “No sense of humor.” It’s easy to overdose and die with methadone because of its very long half-life. People take a little methadone, don’t feel much, take more, and by the time they feel a euphoria, they’ve taken a fatal dose.

It’s a dangerous drug to have on the street.

What if the patient were on buprenorphine instead of methadone? Since it is a considerably safer drug, would I still revoke take homes? In this situation, yes.

Opioid treatment programs want to keep our patients alive and to help them lead their best lives. And we also have an obligation to our communities to be good citizens. We don’t want to promote the black market use of any drug, and diverted buprenorphine, though safer than methadone, can still kill an opioid-naïve person or a child

When this patient was told that we were revoking levels, she blew up with rage. She felt she was being treated very unfairly, since no one had proven she’d done anything wrong. We tried to tell her this is a state regulation, but that didn’t help much. She said some choice words about our program, and they weren’t positive in nature.

After a few days, she’d cooled down some. She wasn’t happy, but she has dosed with us daily because she had no other choices.

Now she’s been at take home level one for over a month, dosing with us on site every day except Sunday. She wants her take home level back and I’m not willing to approve any more take home doses yet.

Some of the staff thought that was too harsh, and that she ought to be given a second chance. Other staff members agreed with me that it was too early for more take homes. What had changed, after all? She still didn’t see anything wrong with her behavior and blamed other people for her criminal charges.

I do listen to staff’s thoughts and opinions, but in the end the decision is mine. I need a good understanding of regulations, mixed in with common sense and compassion – for both the patient and our community. These are difficult decisions.

 

Patients with Prior Overdose Still Prescribed Opioids & Benzos

 

 

 

 

I read an interesting article in the latest issue of Journal of Addiction Medicine, titled “Prescribing of Opioids and Benzodiazepines Among Patients With History of Overdose,” by Griggs et al.

This article described a retrospective chart review of patients who had a previous history of opioid or benzodiazepine overdose. They identified patients who were prescribed either an opioid or benzodiazepine in a one-month period, in 2015, then reviewed their charts to see how many of these patients had a previous overdose. Then they studied the patients and prescribing situations to see what they had in common.

This study was done at a large healthcare system based in Charlotte, NC. The system is based at the same hospital where I did my residency in Internal Medicine about a billion years ago. OK, maybe it was only thirty-two years ago, but it feels like another lifetime. This hospital system has a robust Addiction Medicine department now, led by Dr. Stephen Wyatt, an addictionologist of national and perhaps international renown, who co-wrote this study.

The article began by reminding us of the recent increase in morbidity and mortality with opioid use disorder. Then it cited another article that I have written about (see my blog of January 23, 2016) authored by Larochelle et al., 2015, where it was found that in patients who survived an opioid overdose, 91% resumed opioid prescription within the next nine months.

Based on those previous findings, this study proposed to examine the prevalence of prior overdose among patients being prescribed benzodiazepines and/or opioids, and to examine patient and healthcare characteristics in these circumstances.

The study found 543 patients with prior opioid or benzodiazepine overdose history who were prescribed benzodiazepines or opioids during the designated month of the study. All the providers involved in this study use the same electronic medical record (EMR) which contained information about prior overdoses from 2007 forward, though no specific alerts appeared in the EMR.

Interestingly, opioids were involved in just under half of the overdose episodes among these identified patients, and benzodiazepines without opioids were involved in just over half of the overdoses.

Most of the identified patients received opioid or benzodiazepine prescriptions within two years of their documented overdose. Opioids accounted for around 72% of these prescriptions, with benzodiazepines accounting for around 23%, and 5% of the patients got both an opioid and a benzodiazepine, which is a particularly worrisome combination.

Of the patients prescribed opioids and/or benzodiazepines who had a prior overdose, 70% were between the ages of 35 to 64 years old. The leading cause, at 51%, of the prior overdose was unintentional, though 40% were suicide attempts. Many patients had mental health diagnoses: 54% had an anxiety disorder, 55% had depression, and 24% had bipolar disorder. Nearly a third, at 29%, had a diagnosis of substance use disorders.

Around a third of the opioid prescriptions were given for chronic pain issues, despite the prior overdose history. Over 25% of the opioid prescriptions were for more than 50mg daily morphine milligram equivalents. Around half of the patients had a prior drug screen in their record that was positive for marijuana, cocaine, or alcohol.

Most of the post-overdose prescriptions for opioids or benzodiazepines were given in outpatient clinics or emergency departments, but over a fourth of the prescriptions were issued after a medical phone call consultation. Only 5% of opioid or benzodiazepine prescriptions were issued from behavioral health providers, and less than 1% were from cancer care providers.

In the discussion section, the authors of this study voiced surprise that in a fourth of the patients, benzos and/or opioids were prescribed after a telephone consultation. The authors appropriately caution prescribers against this practice.

Having practiced in primary care for ten grueling years, I understand the telephone consult. Heaven help me, but sometimes I was tempted to allow medication to be called in because it would save me time and effort. It would also spare me the unpleasantness of having to see the patient in my office, and the extra time required.

I’m not intentionally being insulting to patients, but I felt patients who repeatedly asked for controlled substances were often miserable people who weren’t fun to take care of. They hurt, both physically and emotionally. I felt hopeless when I saw them, like nothing I could do or say would help them anyway, so where’s the harm in giving them a much-desired controlled substance?

Of course, now that I’m older, wiser, and better educated, I suspect many of these patients had treatable substance use disorder and/or mental health disorders.

The authors of the study concluded that providers for this patient group could have done a better job of identifying higher risk patients. The prescribers could benefit from an electronic tool, which according to the article is presently being developed, to support decision making processes and quantify the risk for a given patient.

I’ve talked in this blog before about the perils of labeling patients as “frequent flyers” or “drug seekers,” pejorative terms that create obstacles between needy patients and their providers. That old kind of labeling fosters the outdated idea that people with substance use disorders are bad, rather than sick. With that old system, patients can receive bad care, because providers stop thinking and start judging.

Instead, this article describes a better idea – one that provides information about the degree of risk for a given patient, before potentially harmful medications are prescribed. It sounds like this sort of tool can help providers mitigate risks for some patients, while not denying them appropriate medical care.

In other words, a high-risk patient with an acute pain situation, like a broken bone, may still need opioids, but fewer pills might be prescribed, with more frequent follow up, than patients at lower risk for overdose.

I don’t know if the tool this healthcare system developed is proprietary; I think I will ask for an example of how it works. I don’t work in primary care any more (addiction medicine is so much more fun), but I like to stay informed about these things.

New Data from State Prescription Monitoring Program

 

 

North Carolina’s Health and Human Services published a most interesting data set recently: http://www.ncdhhs.gov/divisions/mhddsas/ncdcu/Prescription-Rates-by-County

This interactive map shows information, by county, of the prescribing rates for opioids, benzodiazepines, and stimulants for the years 2012 through 2015. It also includes the average morphine milligram equivalents, or MMEs.

This data was gleaned from my state’s prescription monitoring program, called the North Carolina Controlled Substance Reporting System, abbreviated NC CSRS.

Quantifying MMEs, sometimes also called MEDDs, for morphine equivalent daily dose, is a way to quantify the potency of the opioids being prescribed. For example, since fentanyl is so potent that it’s prescribed in micrograms rather than milligrams, a prescription of 10mg of fentanyl would be very different than a prescription of 10mg of hydrocodone. So using MMEs, prescribed opioids are “translated” into the potency of that dose if it were morphine.

This data is important, since the risk of opioid overdose death risk increases when patients are prescribed higher MMEs. The Centers for Disease Control and Prevention (CDC) has said MME doses higher than 50mg per day should be used with great caution, since doses above this cut off are associated with higher risk of opioid overdose death.

I looked at my own county first, and found some puzzling data. For 2015, Wilkes County was fifteenth out of one hundred counties for the number of opioid pills prescribed per resident. The table said county residents were prescribed one hundred and two opioid pain pills per resident, giving an average of 1.3 opioid prescriptions per resident.

But when I looked at the 2012 data, Wilkes County averaged eighty-two pills per resident, giving an average of 1.1 opioid prescriptions per resident. In other words, the data showed more pills are being prescribed in 2015 than in 2012.

That’s disheartening.

A new pain clinic opened in late 2014, which could explain some of this data. Also, since this is data collected by the patient’s county of residence, perhaps county residents travel to physicians in other counties for prescriptions, and then bring them to Wilkes County to fill.

Then I looked at the MME, the abbreviation for morphine milligram equivalents.

Wilkes County was number one out of one hundred NC counties for highest total morphine milligram equivalents. That says our county’s residents are prescribed more opioid firepower per capita than any other county in the state.

Really? This data doesn’t feel right to me. My impression from the new patients I admit to the opioid treatment program is that area physicians are prescribing lower doses than in the past.

So I started thinking…the opioid addiction treatment program where I work has been growing, accepting more patients, and our census is a little higher than one year ago. But data from my opioid treatment program is not part of the prescription monitoring data, because we must adhere to a higher standard of confidentiality, given the stigma attached to medication-assisted treatment of opioid use disorders.

Except for the office-based buprenorphine patients. At present, they are not protected by higher levels of confidentiality and their data is part of the prescription monitoring program. I only have thirteen patients in that program in Wilkes County, but the pain clinic also prescribes much buprenorphine, for both pain and addiction.

Buprenorphine is an odd drug, since it is a partial opioid agonist with a ceiling effect at 16-24mg per day.

The American Society of Addiction Medicine published a paper giving instructions about how to calculate MME for methadone and buprenorphine. Their position paper on this issue (http://www.asam.org/docs/default-source/public-policy-statements/public-policy-statement-on-morphine-equivalent-units-morphine-milligram-equivalents.pdf?sfvrsn=0 ) says,

1. When used for the treatment of addiction, methadone and buprenorphine should be explicitly excluded from legislation, regulations, state medical board guidelines, and payer policies that attempt to reduce opioid overdose-related mortality by limiting milligram morphine equivalents (MME). Higher MME of these medications are necessary and clinically indicated for the effective treatment of addiction involving opioid.
2. State medical boards should not use MME conversions of methadone or buprenorphine dosages used in addiction treatment as the basis for investigations or disciplinary actions against prescribers.

In other words, when buprenorphine is used to treat addiction, translating the dose into MMEs is misleading. I would add that given the ceiling effect of buprenorphine, a partial opioid agonist, overdose is much less likely with this drug than with full agonists for opioid-tolerance people. And really, the risk for overdose death is the purpose for collecting MME data.

My state’s prescription monitoring program does use MMEs for buprenorphine. I’ve seen it on my office-based patient reports, and it annoyed me, knowing ASAM’s position statement about this issue. But I didn’t realize using MMEs for buprenorphine could potentially skew data until now.

What if residents of my county are prescribed more buprenorphine than other counties, both because it’s being prescribed appropriately for the high incidence of opioid use disorder in the county, and also because at least one physician group prescribes buprenorphine off-label for pain?.

To get an idea of how badly buprenorphine MMEs could skew data, I went back and looked at one of my office-based patients. The NC CSRS (our state’s prescription monitoring program) gave a MME of 360mg for a buprenorphine dose of 12mg.

That’s misleading. Morphine at a daily dose of 360mg would place a patient at infinitely more risk than buprenorphine at 12mg.

Just a few days ago, I sent an email to some of the smartest people in my state, asking them to consider this issue. As I was getting ready to post this, I heard back. The NC CSRS plans to separate office-based treatment data. I’ll update readers.

The Opioid Summit

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

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

My expectations were far exceeded.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Everyone wins.

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

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

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

 

Diversion of Prescribed Medications

 

 

 

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.

 

Tramadol and Nucynta

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

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

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

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

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

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

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

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

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

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

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

Tramadol is a synthetic, pared-down version of codeine. Interestingly, a structurally similar medication, tapentadol, has just been released, and is now being sold under the brand name Nucynta. That medication is a schedule II drug, presumably because of a higher abuse potential than we’ve seen with tramadol. Tapentadol stimulates opioid mu receptors, and also acts as a norepinephrine re-uptake inhibitor, like some antidepressants.

I saw my first patient who was addicted to Nucynta earlier this year. He had a history of opioid addiction in the past, had successfully tapered off methadone maintenance, but became re-addicted to opioids during a bout of back pain. He couldn’t stop taking Nucynta without abusing other illicit opioids to ease his withdrawal symptoms. Because he was using other opioids, I did admit him to methadone maintenance and he continues to do well on our program.

The bottom line is this: if you are in recovery from addiction (alcohol or drugs, this medication should be used with caution. Let your doctor know that you’re in recovery from addiction. If you must take a potentially addicting medication, talk to your sponsor and your support network. Go to extra meetings. Let a dependable non-addict hold the pill bottle and dispense as prescribed. If you have to take the medication for more than a few weeks, have your doctor taper your dose instead of stopping suddenly.

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

New Opioids

I’ve blogged about states that have passed new laws addressing the prescribing of opioids, but the manufacturers of prescription opioids medications also have made changes to help reduce the potential for medication misuse. Of course, opioids will never be misuse-proof, but at least it’s a little harder to misuse some of the newer ones.

Oxecta is a new immediate-release brand of the drug oxycodone. It’s formulated so that it breaks into chunks when crushed, instead of a powder. When it’s mixed with water, it forms a gel so that it can’t be injected. This pill contains sodium laurel sulfate, a substance that irritates the nose if snorted.

Lazanda is a new delivery form of a very potent opioid, fentanyl. This brand is designed to be used as a nasal spray, which I would expect to be very addictive. The preparation itself has no anti-abuse features, but in order to distribute, dispense, prescribe, or be prescribed this medication, parties have to sign an agreement and be enrolled with the drug company. This extra scrutiny is hoped to deter diversion by distributor, pharmacy, doctor, or patient. Physicians must take a training program specific for this brand, and be enrolled with the drug company as a prescriber, or pharmacies can’t dispense to the patient.

Patients also need to complete a patient-prescriber agreement. Many people (like me) think doctors aren’t likely to jump through these extra hoops to prescribe this particular brand, when other brands of the same medication are already on the market, though not in the form of nasal spray.

Remoxy, another brand of oxycodone, hasn’t yet been FDA approved. Supposedly, it’s resistant to injection or snorting, and also has been formulated to be resistant to alcohol extraction.

Drug companies are now required by the FDA to have plans to evaluate and mitigate the risks associated with the opioid drugs they manufacture, particularly if they make sustained release or long-acting opioid preparations. This cooperation by drug manufacturers is a necessary part of turning the tide of opioid addiction in this country.

Last year, Purdue Pharma re-formulated OxyContin, making it more difficult to crush to snort or inject.  I noticed a sudden drop-off in patients entering treatment for pain pill addiction who said OxyContin was their drug of choice. During the years 2002 through 2007, nearly all of the opioid addicts I admitted to treatment said OxyContin was their preferred drug. It became obvious that the re-formulation made a big difference.

Addicts can and will still abuse these medications orally to get high, but the new formulations really do reduce abuse by making pills less likely to be snorted or injected.