Archive for the ‘Controlled Substances’ Category

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.

Pharmaceutical Companies Still Behaving Badly

 

 

 

 

Reckitt Benckiser, the drug company that used to make the brands Suboxone and Subutex forms of buprenorphine, is now owned by a company named Indivior. Earlier this month, the company was fined a whopping $1.4 billion for fraudulent marketing of their brand Suboxone.

To put this in perspective, Purdue Pharma paid $600 million in 2007 for criminally misleading marketing of the drug OxyContin.

The suit against Indivior claimed that Reckitt Benckiser made false claims to physicians, saying their Suboxone film was safer and better than competitor’s tablet versions of the medication buprenorphine, and the risk of pediatric exposure was lower with the film than the tablet.

I blogged about this issue in May of 2012, saying that I thought the RB drug representatives were pressuring me to prescribe the films, and I felt their arguments lacked credibility. Here’s that blog post from seven years ago:

 

Pharmaceutical Companies Behaving Badly

I’ve been relatively supportive of the Reckitt-Benckiser pharmaceutical company until now. I’m impressed this drug company was willing to market a medication to treat opioid addiction. Other companies may not have wanted the stigma of producing a medication to treat addicts, and Reckitt has done a great many beneficial things for opioids addicts. In the past they sponsored eight-hour training sessions that doctors needed to get the special license to prescribe Suboxone/Subutex. They have a patient-assistance program that can help up to two patients out of a hundred get free medication, which a generous program. And their target patient population often lacks both money and insurance to pay for treatment.

But now they are starting to irritate me. At the ASAM conference last month, I heard doctors say how the Suboxone drug reps are starting to pressure them in to prescribing only the name-brand Suboxone film. I’ve encountered similar pressure, and it makes me cranky.

I know the score. Reckitt’s patent on the Suboxone and Subutex tablets has run out, and there are a few Subutex-equivalents now on the market, selling for about half the cost of the name-brand. Reckitt waited until both tablet’s patents were ready to expire to release the film, because the film will be protected under patent for years to come. From a business point of view, all that makes good sense. And of course, now Reckitt wants doctors to switch to the new and improved film.

But if the drug company salesperson starts telling me how harmful Suboxone tablets are to get me to switch patients to the film…they will lose credibility. Am I to believe the same medication, Suboxone tablets, which you were pushing so hard two years ago now is dangerous and must be replaced by films?? No. If the company believed this, why did they release the tablets in the first place? And why wait until the tablet patent expires to release their new “safer” form?

I like the Reckitt-Benckiser drug rep who comes to my office. Let’s call her Mary. Mary is intelligent and personable, as drug reps tend to be. She’s been helpful, and listened to my concerns about the film when patients reported it was flaking and crumbling, a problem that does seem to have resolved

But now, she’s annoying me. She goes into her company’s song and dance and I can’t help needling her. Here’s a reproduction of a portion of one of our latest conversations as I remember it.

“Doctor, are you at all concerned about the pediatric overdoses with the tablets?” Mary said.

“No I don’t often prescribe them to toddlers.”

Mary’s eyes get a little wide until I start to laugh.

“I’m not sure the films are safer than the tablets when it comes to pediatric overdoses.” I say. “I think it’s all about making sure the patient knows how to store them safely. I had a comment to my blog say the films were harder to keep track of than the tablets.”

“There have been pediatric overdose deaths with the tablets and none so far with the film.” Mary tells me in what I hear as a slightly accusatory tone.

“And the tablets have been on the market longer.” I counter, just to be contrary. I do think the films are less likely to cause accidental overdoses, because those packages are so hard to get open.

“And don’t you think the tablets are a relapse trigger? Nearly all patients had been addicted to opioid tablets and using them to get high. Now if you prescribe a tablet to treat the addiction…the sound of pills rattling in a bottle is a trigger for many addicts. If the patient has snorted pills, they may misuse the tablets and crush them into a powder to snort.”

What gall, I thought. “Mary, why didn’t you tell me all of this two years ago when you were encouraging me to prescribe more Suboxone tablets? Why didn’t you tell me then I was triggering my patients to snort pills and endangering their children?” She and I both know she was touting the healing properties of Suboxone tablets two years ago, right up until the film was released onto the market in the fall on 2010.

Mary was silent for a long moment, apparently at a loss for words. This is a rare thing to see in a drug rep. finally, she said with a laugh, “It’s hard to try to sell against yourself.”

The drug company says the film is less divertible than the tablets because of the unique ten-digit number on each pouch. This number can be traced back to the patient for whom it was prescribed. If a patient sells his medication and it’s eventually confiscated by police, the authorities can tell who it came from. Plus, if the doctor wants to do a film count, the patient won’t have the correct numbers on the foil pouches if he’s sold them. All of that’s true but doesn’t give the average addict/dealer much credit for intelligence. It’s likely the person wishing to sell Suboxone films would just open the pouch and remove the film, saving the pouch in case it’s needed later. The numbering of the pouches is a good idea, and according to some information I heard at the ASAM conference, it probably is a little less likely to be diverted. But pill and film counts don’t work unless doctors do them.

As far as the “snortability” of a tablet, I don’t know. I’ve been surprised by the number of blog commenters who snort their Suboxone tablets, so there’s some validity to the argument that the tablets are snortable and the films not snortable. But then I have had commenters say the film is easier to inject, so what do I make of that?

I must cautiously evaluate each patient. I have patients that I am certain would never even think of selling their prescription. I have had patients I think could possibly be selling. I’ve done pill counts on them and for the most part was pleasantly surprised their count was correct. Then I’ve had patients fail pill counts, and I will no longer prescribe for them.

Risks of medications must be balanced. I do agree the film is somewhat better because it dissolves faster, and early reports show it’s less desirable on the black market than the tablets are. But for some patients, that name brand is unaffordable. If they have no insurance and will have to drop out of treatment unless a cheaper alternative can be found, I feel it’s OK to use the generic tablets. I take more precautions with those patients and check their arms for track marks at office visits. I do more frequent pill counts. I do frequent urine drug screens. I don’t use generic buprenorphine in patients with a history of IV drug use.

Addiction treatment is expensive. If I can use caution and prescribe the generic to save a previously stable patient from dropping out of treatment because of the cost, I may do it, if the patient agrees to the above safeguards.

 

So now the chickens are coming home to roost in Indivior/Reckitt Benckiser’s coop…

I read the court document filed by prosecutors of the U.S. District Court in the Western District of Virginia (https://www.justice.gov/opa/press-release/file/1153066/download ). It’s an interesting read.

In this document filed in Abingdon, Virginia, the government says Indivior deceived health care providers and healthcare programs by saying that the film was safer and less susceptible to diversion. The document also says the drug company established a telephone program for patients to be connected to physicians who, in some cases, they knew were prescribing their product in a careless manner. The drug company also trained their representatives to tell providers that the films carried a lower risk of child exposure, despite a lack of evidence for that claim. In fact, some authorities at the FDA worried the films might be more dangerous and difficult to remove from a child’s mouth than a tablet, because they dissolve more quickly

In the end, Indivior/Reckitt Benckiser agreed to a negotiated fine of $1.4 billion, but admitted no wrongdoing, stating they had “acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct.” Thus far, it’s the biggest fine paid by a drug company related to the opioid epidemic.

As for me, I haven’t seen an Indivior/Reckitt Benckiser drug representative since 2012. After I posted the blog above, the RB representative for my area saw me one more time. She told me she was disappointed I had chosen to blog about our interaction in a public forum.

I hate I offended her, because she was a nice lady, but I think time has proven my criticisms about RB’s behavior to be well-founded.

When the DEA Raids Buprenorphine Doctors

 

 

I had another blog post ready to go this week, but I’m postponing it to blog about another situation.

So far this year, two well-known and respected Addiction Medicine physicians have had their offices raided by the DEA.

The first one occurred in March of this year. Dr. Stuart Gitlow, the past president of ASAM (American Society of Addiction Medicine), who has a small buprenorphine (Suboxone and other name brands) practice in Woonsocket, Massachusetts, was raided by the DEA.

According to news reports, [1] the DEA raided his home and office, looking at patient records for evidence of wrongdoing. They wouldn’t tell him what they were looking for, and wouldn’t comment to reporters later because, they say, the raid was part of an ongoing investigation.

I searched the internet for some sort of follow up story, but found none.

Dr. Gitlow is an unlikely target for a DEA raid. He is so famous for his work in the field of Addiction Medicine that he has a Wikipedia page. According to that page, he is a psychiatrist specializing in the treatment of addiction. He earned an MBA from University of Rhode Island, and went to Mt. Sinai School of Medicine where he earned his M.D. degree. He did a psychiatry residency at University of Pittsburgh, along with a Master’s degree in Public Health. Then he went to Harvard University for a forensic fellowship.

I’ve heard him give lectures at ASAM meetings and he’s as good as lecturers get. He teaches at the University of Florida, and he’s on the editorial board of the Journal of Addictive Diseases.

Dr. Gitlow confirmed in an interview that the DEA looked at patient records, but he had no idea what they were looking for.

Then in early May of this year, the offices of Dr. Tom Reach were raided by the DEA. Dr. Reach, like Dr. Gitlow, is an outspoken advocate of medication-assisted treatment.

A news article [2] described how Dr. Reach’s nine treatment centers were closed for the DEA inspection, disrupting patient care. Dr. Reach’s home was also raided. In the interview, he said he heard the DEA thought he was doing something wrong, but he had no idea what it could be.

They also looked for controlled substances, but Dr. Reach, like most buprenorphine physicians, has never stored these drugs on-site. The record keeping that is necessary for storing controlled substances is considerable. He doesn’t contract with public insurance, so it couldn’t be problem with that.

Dr. Reach said the DEA took hard drives and cell phones, making it harder to continue with patient care.

Dr. Reach was the past president of the Tennessee chapter of ASAM. Dr. Reach was one of several physicians who were on the expert panel convened last year to draft Tennessee’s new guidelines around physician prescribing of buprenorphine. He’s spent his own time at the Tennessee statehouse, advocating for patients with opioid use disorder and their physicians.

Thus far, no charges have been filed against either physician.

Both physicians are politically active. Dr. Gitlow ran unsuccessfully, twice, for state representative in Massachusetts, as a Democrat. Dr. Reach contributes money – some would say a large amount of money – to political candidates he supports. [3]

These two leaders in addiction medicine are far from the only doctors being raided. Dr. Larry Ley, who had several treatment programs in Carmel, a suburb of Indianapolis, was ultimately acquitted of felony drug charges that he faced. Law enforcement personnel, posing as patients, lied about their need for opioid use disorder treatment. Dr. Ley was then charged when he issued prescriptions for Suboxone. [4]

I thought it was a felony to obtain a prescription for a controlled substance under false pretenses. How can a DEA agent pose as a patient and lie about their substance use history to obtain a prescription? Wouldn’t that be an illegal act? Maybe that’s why Dr. Ley was acquitted.

In this case, it seems the county’s head of drug task force didn’t agree with the idea of medication-assisted treatment, saying, ““This type of ruse of a clinic perpetuates the problem because people are still addicted to the drug, and this is what is happening,” said the head of the drug task force, in a press conference held after Ley’s arrest. “This is not fixing the problem.” [4]

Dr. Ley had to close his treatment centers, was left penniless due to legal fees, and is now suing both the city of Carmel and the DEA for conspiring to force him out of business.

Meanwhile, the opioid overdose death rate in Indiana has risen by double digits.

The DEA is authorized to inspect buprenorphine practices at any time. If you are a long-time reader of my blog, you’ll recall my office was inspected in late 2012. I wrote about the experience in a blog post on 12/16/12. The agents were pleasant and cordial. They were willing to meet with me when patients were not scheduled, so it didn’t interrupt my practice at all. They asked about how many patients I had, asked to see copies of patient prescriptions, and asked if I stored any controlled substances on site (of course not). The two agents were polite and cordial.

What happened to Drs. Reach and Gitlow was very different. They were both raided by the DEA, with a warrant that says material can be seized. In a raid, the DEA is so convinced that there’s criminal activity that they take computers, cell phone, and records. Inevitably this disrupts the medical treatment of patients. For both Dr. Reach and Dr. Gitlow, patients had to be turned away from scheduled appointments because of the raids. As Dr. Reach pointed out in a newspaper interview, this can have very real and possibly fatal outcomes for patients depending on buprenorphine to provide stability and keep them from using illicit opioids like heroin.

For a DEA raid to take place, investigators have expectations of finding criminal activities. They would not raid for issues like overprescribing, substandard care and the like. These types of problems would be handled by the state’s medical board.

Of course, I don’t know the circumstances that lead to these DEA raids. It’s remotely possible that a Harvard-educated physician leader of ASAM is slinging dope on some corner of Woonsocket, Massachusetts, in his free time…but I doubt it.

The trouble with these DEA raids is that while they make the papers when they happen, no news releases state what was found. If no wrongdoing was discovered in the masses of material seized by the DEA, the public won’t hear about this. All that remains is the taint of criminal investigation.

I’ve been working with some organizations to try to get more office-based physicians interested in treating patients with opioid use disorder with buprenorphine, a potentially life-saving medication. I’ve reassured worried doctors that they won’t become DEA targets just because they prescribe buprenorphine. I told them that unless they store medication on premises, the chances of getting raided are very small.

I hope I haven’t erred in telling new doctors this. I legitimately thought the nation’s leading health experts are pushing treatment for opioid use disorders, to stem the tide of opioid overdose deaths we’ve been having oer the past twenty years.

Now, with raids on well-respected practitioners, I don’t know what to think.

  1. http://www.woonsocketcall.com/news/city-doctor-s-home-office-raided-by-fbi/article_1e4270a0-2bb5-11e8-be84-b7f0c2501d63.html
  2. http://www.wjhl.com/local/dea-agents-raid-watauga-recovery-centers-in-tn-va-and-nc/1156361147
  3. http://doctorsofcourage.org/ralph-thomas-reach-md/
  4. https://www.thedailybeast.com/addiction-doctor-dea-shut-me-down-so-mayor-could-clean-up-town?ref=scroll

Risk Factors for Long-term Opioid Use


The Centers for Disease and Control and Prevention published an important article in their Morbidity and Mortality Weekly Report on March 17, 2017, titled, “Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use – U.S., 2006-2015.”

You can read the article here: https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm

To summarize for my readers, this article describes a study from a very large pool of patients. This study, felt to represent the U.S. population with commercial health insurance, was done on patients with records in IMS Lfelink+database. With nearly 1.3 million subjects, this was a large study, giving it power to detect even small differences.

The study included patients over age 18 who received at least one opioid prescription during the time frame of June 1, 2006 through September 1, 2015. To be included, the patient had to have been free of opioid prescriptions for at least six months prior to receiving an initial opioid prescription. This patient pool was followed over time, to see what risk factors were associated with continued opioid prescriptions. The patient left the study if they de-enrolled from their insurance, or when the patient went for more than 180 days without any opioid prescriptions, or when the study ended.

Patients with cancer were excluded, as were patients with a substance abuse disorder, and patients who were prescribed buprenorphine for the treatment of substance use disorder, since those patients could be expected to have opioid prescriptions lasting longer than patients without those diagnoses.

The duration and dose of the first prescriptions were examined to see which patient or treatment factors were associated with longer opioid use and ongoing opioid prescriptions.

Out of all of the 1.3 million patients, 2.6% continued on opioids for more than one year. These patients were more likely to be female, have a pain diagnosis prior to the first opioid prescription, be older, and have public insurance such as Medicaid or Medicare. They also tended to be started on higher doses of opioids compared to the patients who used opioids for less than one year.

Of all of the patients who were prescribed opioids, 70% were prescribed opioids for seven or fewer days. Only around 7% were prescribed opioids for more than a month. The rest of the patients were prescribed opioids for one to four weeks.

Of the people initially prescribed seven or fewer days of opioids, only around 6% were still on opioids a year later. But 13% of the patients with an initial opioid prescription for eight or more days were still on opioids a year later. Actually, at around the fifth day, the study showed the biggest spike in likelihood of chronic opioid use. For patients with an initial opioid use episode of more than a month, around 30% were still prescribed opioids a year later.

The amount of opioid prescribed influenced risk of continued opioid use. Authors of the study found that a cumulative dose of more than 700 morphine-milligram equivalents were several times more likely to become chronic opioid prescription users than those patients prescribed less than this amount.

The study looked at regional differences too. Of the patients who continued prescription opioid use for more than three years, 38% lived in the South. Only 19% lived in the East, and Midwestern patient accounted for 31% of users of opioids for more three years. Western patients accounted for around 9% of these patients, and the rest couldn’t be classified as to area of the country for some reason.

I doubt this regional variation is from differences in medical issues of the patients. I suspect these differences are due to physician prescribing practices. I could be wrong. The study authors didn’t elaborate on this data. Maybe doctors in the South are getting it right, and doctors in other areas are undertreating pain. However, many southern states have high opioid use disorder rates, and high opioid overdose death rates. And relative to the entire world, the U.S. takes more than its share of opioid medications, as shown in the graph at the beginning of this blog.

Of course, this study doesn’t show cause and effect, just an association. Longer initial opioid prescriptions are associated with continuation of opioid prescriptions for more than a year; however, perhaps the conditions being treated in that group of patients were more severe.

This study looked to see if there was an association between which opioid was prescribed and the risk of long-term opioid use. Patients given prescriptions of long-acting opioids were more likely to have long-term use. That’s no unexpected, but the second most likely medication to be associated with long term use was tramadol.

Tramadol is still mistaken thought by many physicians to be a benign pain medication, unlikely to cause physical dependence or substance use disorder. But in this study, more than 64% of patients who were started on tramadol were still taking some sort of opioid one year later.

As an aside, I’ve seen a fair number of patients present for treatment of their opioid use disorder who used tramadol, usually with other opioids. And some of the worst withdrawals I’ve seen have been with tramadol, with high fevers along with other more typical opioid withdrawal symptoms.

This study’s authors recommended limiting the initial opioid prescription to less than seven days when possible, to reduce the risk of continued opioid prescription and use. Since their data found that a second opioid prescription roughly doubled the patient’s risk of being on opioids for more than a year, the authors also recommended serious consideration of the second prescription.

This study makes intuitive sense. It showed that the longer the number of days of the initial prescription, the greater than risk of the patient still being on opioids one year later.

But what surprised me was the degree of increased risk, even with only a second prescription, and even with only more than seven days prescribed.

Readers may ask, what’s the big deal about being on opioids for more than one year? That doesn’t necessarily mean the patient has opioid use disorder. That is correct, and this study isn’t saying these patients who became chronic users of opioid pain medication developed opioid use disorder.

However, as the authors say in their summary, previous research does show an increased risk for harm in patients on long-term opioid therapy.

In view of our current opioid overdose death problem, it would seem prudent to limit risk to patients. We can use this information, and be cautious about prescribing more than seven days of opioids. We (physicians) should carefully consider whether to give second opioid prescriptions, and be more cautious about prescribing tramadol and long-acting opioids.

New Data from State Prescription Monitoring Program

aaaaaaaaaaaaaaaaaapills

 

 

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.

Walmart in North Wilkesboro, NC, Refuses to Fill Buprenorphine Prescriptions

 

aaaaaaaaaaaaaaaaaawal

 

When one of my patients told me he could no longer fill his prescription for Suboxone films at Wal-Mart, I was puzzled. Surely this couldn’t be true, especially not in an area of the country where people die from opioid use disorder too frequently.

My patient said, and I have no way of verifying this information, that the DEA visited  the Walmart in North Wilkesboro, NC, and told them if they continue filling prescriptions from the doctor at the pain clinic, they would be accused of some sort of collusion. In response, the Wal-Mart – allegedly – decided not to stock any form of buprenorphine.

Yes, my fingers itched to call Walmart to determine if this was true.

Completely in keeping with Walmart’s reputation for efficiency, I was cut off the first two times I asked to speak to a pharmacist. On my third try, I left my cell number and asked the pharmacist to call me. Surprisingly, he did call, after only fifteen minutes or so.

I asked him if it was true that Walmart no longer fills buprenorphine prescriptions, and he said yes, that’s true. I asked was that for all forms of buprenorphine, including the films, Zubsolv, generics, etc., and he said yes, all of them. He was obviously reticent to give any further information. I asked him if that was for one doctor, and if my patients could still fill prescriptions there. Again, he answered that Walmart had decided not to stock any buprenorphine  products for any patient or doctor. Starting to feel a little riled, I asked him if he thought that decision would interfere with appropriate treatment of a potentially fatal illness, he just repeated Walmart had decided not to stock buprenorphine at all.

So that’s that, right?

I don’t think so.

At a time when Congress passed CARA, the Comprehensive Addiction Recovery Act, which contained specific provisions to increase access to buprenorphine, Walmart’s pharmacy refuses to sell buprenorphine?

At a time when Health and Human Services passes a new law enabling physicians to have up to two-hundred and seventy-five patients instead of only one hundred patients, Walmart’s pharmacy refuses to sell buprenorphine?

During the same week that NIDA, the National Institute on Drug Abuse, announces increased access to buprenorphine will help the opioid overdose epidemic, Walmart’s pharmacy refuses to sell buprenorphine?

Can buprenorphine be misprescribed and misused? Yes, of course it can. Not as often as all other opioid pain medications, but it can be misused. But I don’t know of any pharmacy that refuses to stock all opioids just because some patients misuse them. That’s not appropriate. Walmart hasn’t stopped selling prescriptions for Opana, oxycodone, hydrocodone, Xanax, Valium, or clonazepam.

So can’t we – and by we, I mean the brain trust that is Walmart –  think of a better option than refusing to sell buprenorphine to any patient, rather than pinpointing the real problem?

I wanted to hear the reasoning behind this decision, so I called Walmart’s corporate office, the division of Media Relations. I told the nice lady answering the phone that I was a doctor who treated addiction, and that I also had a blog. I told her about the local Walmart pharmacy’s unusual decision, and I wanted to hear Walmart’s side. I wanted to know the reason Walmart decided not to stock buprenorphine in the middle of an opioid use disorder crisis.

I waited on hold for a long while, and then the lady, Delores, said she didn’t have any information on this but that she would look into this and call me back. I gave her my cell phone and I’m still waiting.  Since this was all done on a Friday afternoon, I’m not surprised I didn’t get a return call yet.

I’m going to make some noise about this one. I’ll keep you posted.

In the meantime, I’m not going to spend any money at Walmart. I know Walmart won’t miss the couple of hundred dollars my family spends each month on household items and some groceries. But if you see me at Food Lion, Lowe’s Foods, or even better, the IGA, you’ll see a smile on my face as I check out. My decision won’t break them, but it will make me feel better.

Access to Buprenorphine Will Expand; News About CARA

aaaaaaaaaaa

 

 

 

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.