Reproductive Health of Women in North Carolina’s Opioid Treatment Programs

 

 

 

 

 

The November/December issue of the Journal of Addiction Medicine, (Volume 13, Number 6), published a great article based on a 2017 survey of opioid treatment programs in North Carolina. This study was done by the University of Chapel Hill, and the article was titled, “Provision of and Barriers to Integrating Reproductive and Sexual Health Services for Reproductive-age Women in Opioid Treatment Programs.”

Of course, since this data is from my state of North Carolina, I read it with extra interest.

The article reminds us of what we know about women with opioid use disorders: they are more vulnerable to reproductive health issues. These women tend to have more pregnancies, with about 54% having four or more lifetime pregnancies, compared to 14% of women without opioid use disorder having four or more lifetime pregnancies. About 85% of the pregnancies of women with opioid use disorder are unintended, compared to around 45% for women without opioid use disorder. Women with opioid use disorders are less likely to use contraception and about five times more likely to have had an abortion.

Opioid use disorder increases the risk of gender-based violence and increases the risk of infections, for Hepatitis C and B, HIV, and sexually transmitted diseases. Adverse childhood events, termed ACEs, include stressful or traumatic life events, and are associated with reproductive health problems. Women with ACE history are much more likely to develop substance use disorders in general, including opioid use disorder, so a large portion of women enrolled in treatment at OTPs have this additional mental health burden affecting reproductive health.

Since medication is recommended for all patients with opioid use disorder, the authors of the article say pregnant and nonpregnant women with opioid use disorders could get care for reproductive health services within the opioid treatment program. They suggest this would be a way to reduce unwanted pregnancies, opioid-exposed pregnancies, sexually transmitted infections, and improve the overall health of women in these treatment programs.

The article described a survey sent to the medical directors and program directors of all forty-eight opioid treatment programs in the state, in order to assess the extent of reproductive health services offered to reproductive-age women enrolled in NC OTPs, as well as to explore perceived barriers to integrating such services into the care provided at OTPs.

Of the forty-eight OTPs surveyed, thirty-eight completed the survey. Of the programs that responded, 37% were private nonprofit organizations and 63% were private for-profit organizations. Thirty-four percent were in rural counties, 29% located in urban areas and 37% in suburban areas.

Only 21% of the responding OTPs offered female-specific programs.

Most OTPs accepted Medicaid, at 68%, and those programs served more women of reproductive age than did the non-Medicaid programs, which makes sense. The average length of treatment was longer for women in Medicaid program compared to non-Medicaid programs.

Twenty-one percent of OTPs offered non-prescription contraception, while only one program offered prescription contraception.

Only 89% of OTPs did on-site pregnancy tests, meaning 11% are not performing this simple and necessary test for patients.

To summarize this study, the OTPs of NC aren’t doing all they could to address female patient’s reproductive and sexual health issues.

I agree with this finding, and yet, I was a bit offended with the accompanying commentary in this issue of Journal of Addiction Medicine. Dr. Tricia Wright says that OTPs believe it’s outside the scope of their service to provide reproductive and sexual health services, and that this view is “dangerous and wrong.” She says such care is basic care and OTPs can and should do better for their female patients.

Now you’ve stepped on my toes and I’m going to have to step back.

I agree that more services should be provided, including female sexual and reproductive health. After all, as the article’s authors concluded, such efforts have the potential for great good. Increasing reproductive health of our female patients promotes health of children and families, and ultimately, society.

However, as this survey or providers discusses, there are obstacles to providing such services.

First, OTPs care for people with other equally important challenges. Our patients struggle with homelessness, lack of food, serious mental and physical health issues, all of which need addressed. Our resources are limited, both of time and money.

For example, a new patient injecting heroin might be homeless, with no way to afford food, and have serious mental health issues. Such a sick patient needs inpatient care which usually is not available. For example, our state-run program refused to admit a homeless diabetic because her blood sugars weren’t under control. They refused to admit an HIV positive patient because she wasn’t on proper medication for her HIV. Of course, with substance use disorders raging out of control, those goals weren’t realistic.

Our OTP takes care of many such challenging patients as best we can, because usually it’s their only option for care. Ultimately, we do hope to get them care for their other issues, in the form of referrals, because we don’t have the time or personnel to provide those services.

Second, OTPs may not have personnel with the expertise to manage reproductive health needs

I am trained in Internal Medicine. This means I could manage some simple primary care and even some uncomplicated gynecologic and mental health care for OTP patients. But my time is spent providing medication-assisted treatment to those patients. I would have to work additional hours if we provided primary care, probably at least double the hours that I now work. I would need a way to care for those patients for after-hours emergencies. I don’t work for free, and neither do the nurses. The company I work for would have to pay for this expense. They could bill Medicaid, but at least half our patients don’t have any insurance at all. Most uninsured patients get their OTP treatment paid for with grant money, but that doesn’t cover primary care services.

Many OTPs have a psychiatrist as a medical director. They could address mental health needs, but probably wouldn’t be comfortable doing and primary care, and certainly not reproductive health.

In order to meet even some of the reproductive and sexual health needs of just the female patients (ignoring male patients completely for some reason), additional providers would have to be hired. Who pays for that?

It makes more sense to me to have providers come to our OTP to provide essential services under one roof. One day could be for obstetric/gynecologic care. A local OB could come to our facility and see patients all day. Another day could be for a psychiatrist to come and treat patients, and maybe two days for primary care providers to see our OTP patients. It’s an ideal solution, except for finding willing providers, and a way to pay them.

Don’t even get me started on our patients’ dental care needs. We could hire a full-time dentist and keep her busy with only our opioid treatment program patients. But again, who would pay?

I get weary of unfunded mandates and recommendations for opioid treatment programs. I feel like much is expected of providers at opioid treatment programs, mainly because no other providers want to treat these patients.

Our patients often get superficial and substandard treatment from the local emergency department and local providers’ offices due to the stigma against people with substance use disorders in general. Part of this could be because some of our patients offend providers with their desperation and neediness. Patients enrolled at “that methadone clinic” face extra judgment from some providers, making it more difficult for our patients to access appropriate medical treatment.

It’s not feasible for OTPs to provide all the services that patients need, and certainly not fair to expect OTPs to provide this care for free because other providers don’t want to deal with our patients.

OTPs have and will pick up what pieces we can, but maybe it’s not fair to ask OTP providers to fix a broken healthcare system.

Buprenorphine Regulations

Map is from vox.com

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

• 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
• 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
• 24 (6%) patients dropped out of treatment.
• 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
• 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

https://www.asam.org/docs/default-source/public-policy-statements/statement-on-regulation-of-obot.pdf?sfvrsn=df8540c2_2

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.

More About Tennessee’s Buprenorphine Guidelines

Funding Information

 

 

 

 

Last week I was contacted by Dr. Tom Reach, one of the premier Addiction Medicine physicians in Tennessee, about last week’s blog entry. He supplied background information about the development of Tennessee’s office-based buprenorphine prescribing guidelines.

Dr. Reach contacted state Representative Matthew Hill about a proposed requirement for office-based buprenorphine providers that would have set treatment in that state back into the dark ages. The state legislation nearly approved legislation that would have required that all buprenorphine physicians apply for a certificate of need.

I know what you’re thinking. How could anyone in Tennessee, a state with one of the highest opioid overdose death rates in the whole U.S., even question the need for treatment? By now, surely even the slowest-witted people in the state know there’s a desperate need for opioid use disorder treatment.

This legislation wasn’t proposed because there were too many treatment facilities. It was proposed because bad treatment facilities were located in the areas of powerful legislators. It was also proposed because some areas of Tennessee have many office-based providers, while other areas have few. This legislation was proposed to control the quality and location of office-based buprenorphine prescribers.

Powerful legislators were sick of poorly run clinics, basically pill mills for buprenorphine, and these legislators believed a certificate of need process would weed out the bad providers. They hadn’t considered it would also limit the number of good providers, who probably couldn’t or wouldn’t want to go through an onerous certificate of need process.

Dr. Reach found out this bill was coming up for vote immediately. He flew into action immediately, educating Representative Hill about opioid addiction, its treatment with buprenorphine, and how treatment is best done. Then he quickly moved on to educated what sound like every member of the subcommittee voting on the certificate of need proposal.

It was a nail-biter.

Initially, only one out of the ten committee members opposed this idea to require certificate of need for OBOT treatment. After much conversation, half were still in favor of the requirement, but the other half had begun to believe it might not be good for the state. After more discussion, the committee eventually voted to table this discussion, and allow a panel of experts to gather more information and form a recommendation.

A coalition of stakeholders in the state was formed, but few members were physicians with experience treating opioid use disorder. Eventually, Dr. Reach was able to influence other members.

It turns out that the final document, about which I blogged last Sunday, was the result of a compromise between people with extremely different views about how medication-assisted treatment should be done.

While I think the guidelines are too restrictive…it could have been so much worse, had Dr. Reach not persisted in his efforts to educate other committee members. Also, the requirements initially ran to 78 pages, so the final 50 page document is comparatively brief.

Dr. Reach informed me that some buprenorphine providers in Tennessee have tainted public opinion about this medication and this form of treatment. He and other physicians, dedicated to providing quality care, are lumped together with prescribers running buprenorphine mills.

He says there are buprenorphine programs that get “patients” from West Virginia and Kentucky who drive to Tennessee, get prescriptions for the buprenorphine monoproduct, and sell them for $60 per 8mg tablet in their home states. These Tennessee programs have huge lines and run patients in and out, providing only prescriptions for medication and no counseling. No time is taken to get to know the patient and find out what’s going on with them, or how they are progressing in their recovery. Some programs don’t even do drug testing.

I commiserate with Dr. Reach. Bad programs damage the reputations of physicians dedicated to doing the right thing for their patients.

I still think there’s room in this conversation for harm reduction approach, which might say the more buprenorphine reaches the hands of people with opioid use disorder, the fewer people might die from opioid overdose. But Tennessee’s no Canada, and I doubt anyone could convince the law-and-order types that diverted buprenorphine could reduce heroin overdose deaths.

I am indebted to Dr. Reach, for his willingness to give background information about this whole issue in Tennessee. Thanks to his efforts, and the open-mindedness of committee members willing to be educated, patients with opioid use disorder in Tennessee have dodged a bullet. Yes, there are restrictions, but it could have been so much worse.

North Carolina legislators can learn from Tennessee’s experience. We can watch to see if these relatively restrictive Tennessee buprenorphine guidelines improve the quality of care in the state. And we also need to watch their numbers of opioid overdose deaths.

 

Tennessee’s New Guidelines for Office-Based Buprenorphine Prescribing

Advertisement for Buprenorphine Physician

I’ve spent a great deal of time puzzling through a document titled “Tennessee Nonresidential Buprenorphine Treatment Guide,” released early this year. This document was created, as it says on page 2 of the document, because of the “growing prevalence of individuals who have an opioid use disorder, an increased number of individuals using medication-assisted treatment with buprenorphine, and diversion issues associated with buprenorphine.”

I’ll give my readers a warning – this blog entry is dense with the finer points of Tennessee’s document, and it’s not light reading.

This document outlines the standards of care that Tennessee’s office-based buprenorphine prescribers will be asked to follow. The physicians’ licensing board, the Tennessee Board of Medicine, will use this document to assess the quality of care OBOT physicians provide.

It was written with the help of many experts: doctors from Tennessee’s psychological and psychiatric associations, doctors from the Board of Pharmacy, from Tennessee’s Department of Mental Health and Substance Abuse Services, from Tennessee Department of Public Health, from drug courts, law enforcement personnel, specialists from Vanderbilt University, the state medical association, nurses’ associations, physicians from the medical society and physicians actively practicing addiction medicine. The document is fifty pages long, probably because more than forty people helped write it.

This document acknowledges that buprenorphine can be a valuable tool to treat patients with opioid use disorder, when used appropriately. The guideline describes the consolidated opinion of these experts as to what constitutes appropriate use.

Moving on to the actual guidelines, the document first outlines what must be done before the patient enters treatment.

The physician must:

• Make sure the patient has opioid use disorder, and determine the length, severity, and consequences of use, including all prior treatments, if any, and the results of those treatments
• Must document other substances used, and the extent they are used, and how treatment for these substances will be incorporated into the treatment plan
• Must assess “process” addictions and decide how they can affect substance use disorders. This means assessing the patient for compulsive gambling, sexual practices, spending, or other impulsive and out of control behaviors.
• Must assess the patient’s other mental health and physical health conditions, and determine how, when, where these problems will be treated
• Must assess the patient’s social supports, employment status, housing situation, financial status and legal issues
• Determine the patient’s readiness for treatment
• Determine the patient’s wishes regarding pregnancy, if she is capable to becoming pregnant. She should be referred for long-acting birth control if she does not wish to become pregnant.
• The physician must check the state’s prescription monitoring website before initial prescription and before each office visit
• Must obtain an observed drug screen and document the results, prior to the start of treatment
• Must do proper patient selection, which means the patent is told about all options for treatment, the patient is willing to start this treatment, and that there are no reasons not to start the patient in treatment
• Signed agreement to start treatment must be obtained
• The physician must complete required elements about consent to treatment dealing specifically with pregnancy and NAS prevention

I say physician and not provider, because Tennessee won’t allow physician extenders like nurse practitioners and physician assistants prescribe buprenorphine, despite the changed federal rule that does allow extenders to prescribe. In other states, extenders first need to take a 24-hour course about opioid use disorder and its treatment with buprenorphine, compared to the 8-hr course physicians take. But Tennessee prohibits extenders from prescribing buprenorphine.

Anyway, Tennessee is recommending a thorough assessment of the patient prior to office-based treatment with buprenorphine. In fact, what they describe above is much like what’s called a diagnostic assessment in the substance abuse treatment world. It’s a full evaluation of the patient’s bio-psycho-social needs.

I don’t do this in my office-based practice. Right now, I schedule an hour’s visit with a new patient, enough time for me to do a standard history and physical exam, as I would for any other new primary care patients. I certainly do get a full history of the opioid use disorder, and other substance use, along with psychiatric and medical issues. I get a drug screen prior to treatment, and I always check the prescription monitoring program. But I don’t delve into process addictions, support systems, or figure out how all other issues will be treated. All of this can’t be done in an hour. But as I get to know my patients over the next few weeks, we talk about all of this, albeit in a more casual way.

However, this data doesn’t necessarily need to be collected by a physician. A trained and licensed therapist could go through much of the background information gathering, and pass this along to the physician prescribing buprenorphine. Plus, physician extenders can help the physician gather information about the patient; they just can’t prescribe the buprenorphine.

At the opioid treatment program where I work, counselors gather the data and compose a bio-psycho-social evaluation or diagnostic assessment. This is built into the system, and it’s done before the patient sees me. This whole intake process takes us about two to three hours, but is required at OTPs.

Next comes a section on how to provide care after the patient enters treatment:

• Women of childbearing age must do an observed urine screen for pregnancy upon admission, and then once per month. The woman must be asked about the possibility of pregnancy at each visit.
• All patients should be prescribed the combination product buprenorphine/naloxone, unless the patient is pregnant, nursing, or has a documented adverse reaction to naloxone. A physician can prescribe the buprenorphine monoproduct to no more than 5% of his total patients. Going over this limit will subject the prescriber to scrutiny by Tennessee’s medical board, the guidelines say.
• Under a section titled, “General dosing guidelines,” there is the statement, “Target buprenorphine dose range should be 6-12mg (or equivalent) per day.”

That requirement of monthly pregnancy screens sounds a bit…twitchy…to me. Of course, we want to know when a woman is pregnant as soon as possible, to get prenatal care started. But other medications, some of which actually cause birth defects during pregnancy, carry no requirements of monthly pregnancy testing (ACE inhibitors come to mind).

I worry Tennessee is allowing some of that “criminally pregnant” mindset into their guidelines. It feels like authorities in Tennessee strongly disapprove of women on medication-assisted treatments becoming pregnant. All things being equal, I think it would be best if they could delay pregnancy until off medication, but often that’s unrealistic. It should be the woman’s choice when she wants to start a family, and she shouldn’t be judged for getting pregnant while on medication-assisted treatment.

As for the prohibition of the buprenorphine monoproduct: the authors of this guideline appear to doubt the truthfulness of the many patients who say they feel better on the monoproduct buprenorphine than on the combination product buprenorphine/naloxone. I remain convinced that some patients do absorb some of the naloxone, leading to unpleasant symptoms of nausea, headache, and muscle aches.

Clearly, I hold a minority opinion. However, I’ve found some interesting data about the urine drug screens of patients on the combination product, all testing positive for naloxone. But I digress. That could be a whole other blog.

Why do these dosing guidelines say the target dose should beget dose of 6-12mg per day? The FDA has approved doses up to 24mg per day.

Again, it’s that “less is better” mindset. It’s as if Tennessee health officials have been forced to recognize medication-assisted treatment is necessary, but to show their underlying disapproval, they want physicians to be stingy with dosing.

We saw that same attitude with methadone in the past, too, before we had conclusive data showing better outcomes with adequate dosing.

Tennessee state law already says that any physician who prescribes more than 16mg per day for more than 30 days must document in the record why that dose is needed. I don’t know how that law is helpful, since the only reason to go above 16mg per day is that a lower dose didn’t suppress withdrawal signs and symptoms.

A buprenorphine prescriber who has a patient on more than 16mg per day for more than 30 days must either obtain consultation from an addiction medicine specialist or turn that patient over to such a specialist.

Next, this document gave very specific guidelines about benzodiazepine prescribing in patients on buprenorphine:

• Benzodiazepines should not be initiated in a patient with opioid use disorder if that patient has never been on them before, or if that patient has misused them in the past.
• Patients with a longstanding benzodiazepine prescription for a legitimate medical condition may be prescribed buprenorphine, but only with careful coordination of care with the prescriber, which must be documented
• The buprenorphine provider may take over prescribing the benzodiazepine if the patient is willing to start a taper
• If the patient with opioid use disorder also has a clear history of benzodiazepine use disorder, the duration and extent of that use must be clearly documented, and the patient may be switched to a long-acting benzodiazepine like clonazepam to taper the dose.
• Doses of benzodiazepines that are at, or higher, than the equivalent of clonazepam 2mg per day are considered to be on a “high dose.” Reasons for such a high dose must be documented, and these patients should be tapered as rapidly as possible to below that benzo equivalence.
• Patients on high dose benzodiazepine therapy for more than six weeks shall be managed by a physician who is board-certified in addiction medicine, or by a physician who has obtained a formal consult from such a specialist.

I’m going to refrain from commenting on this section, since I’m more rabidly opposed to benzodiazepines than many physicians.

OK, one comment.

Benzos are not first-line medications for anxiety disorders, and there are few indications for long-term (more than three months) benzo prescriptions, except possibly for end-of-life care. Besides, benzos have long-term side effects like increased incidence of dementia, falls, and the like.

Then the document shifts again to tasks that need to be completed upon admission:

• Each patient must get a mandatory infectious disease screening, to include, at a minimum, HIV and Hepatitis B and C, tuberculosis, and sexually transmitted diseases. This doesn’t have to be done in the physicians’ office; patients may be referred to the local health department.
• Each patient must be screened for the need for trauma-informed care, including an ACE (Adverse Childhood Event) score.
• Before initiating treatment, the patient must sign an individualized treatment plan, to be documented in the patient’s record.

Tennessee’s Health Department must be able to do all this infectious disease testing, which is great. In North Carolina, Health Departments do all except Hepatitis C testing, due to its expense.

After patients needing trauma-informed care are identified, does Tennessee have enough counselors trained to provide Trauma-focused therapy?

At our opioid treatment program, more than 70% of the females entering treatment need this care, but there are few places that provide it, and long wait times to get it. Is Tennessee better equipped? Where are these patients going to get this treatment?

After this section, we get down to the nitty gritty of actual treatment. The guidelines divide treatment into three phases: induction, stabilization, and maintenance. Here are the guidelines:

• During induction and stabilization phases, patients should have weekly office visits, one observed drug screen per week, counseling sessions every two weeks, at a minimum, and receive weekly case management services
• For patients in the maintenance phase for less than one year, they must have office visits every 2-4 weeks, counseling sessions at least monthly, have 12 random and observed drug screens per year, and receive case management at least monthly
• For patients on maintenance for more than one year, they must have office visits at least every two months, receive counseling monthly, get 8 random observed drug screens per year, and receive at least monthly case management services.
• The prescriber needs to document which stage of treatment the patient is in.

Finally, I think these guidelines, for the most part, are good. There’s nothing wrong with establishing a mandatory minimum of services to be given to patients with opioid use disorder. It’s just that in so many aspects, this guideline for office-based care is almost exactly what is required of care given at opioid treatment programs, even down to the number of required counseling sessions for each patient.

That’s kind of ironic, considering how viciously Tennessee fought to keep OTPs out of their state. After all, the first OTP in Eastern Tennessee, an area with one of the highest overdose death rates in the world, just got their first OTP in August of 2017.

Now, almost comically, we have Tennessee advocating for the type of care OTPs have been providing for decades.

We need to consider the intent of the DATA 2000 law. It was enacted to give patients with opioid use disorder a different treatment option with less restrictive requirements than those found at OTPs. Tennessee’s new guidelines don’t provide a less restrictive option for patients and their physicians in Tennessee.

I worked in primary care for about a decade before switching to addiction medicine. Primary care doctors, faced with Tennessee’s guidelines, well-intentioned as they are, won’t want the headache and responsibility of trying to meet this standard of care. Buprenorphine treatment will remain in the hands of specialists. I’m not saying this is good or bad – just that it may not be Tennessee’s intention. Time will tell.

Perhaps DATA 2000 was overly hopeful. Maybe all patients, or at least patients new to treatment, need tighter guidelines like Tennessee’s.

Or maybe (as I have come to believe) all these patients need to start treatment at an OTP, then transfer to office-based setting after they are stable for a year or so, where they can be treated with fewer restrictions and more flexibility, as DATA 2000 physicians could to do before these new guidelines were passed.

Here’s another important consideration: who will pay for this treatment? Who pays for the therapists, counselors, observed drug screening and pregnancy testing? Who pays for the complete bio-psycho-social work up and the treatment plan development and updates? There was no mention of this in the guidelines.

I know it sounds like I’m critical of Tennessee’s efforts, and I am, a little. But it’s an exceptional accomplishment to get all the people and organizations together who are interested in this problem, get them talking, and get them to agree on a set of guidelines. All participants are to be commended, because that’s not easy work.

Hopefully, the experts can be flexible enough to try something, re-assess, change things that don’t work well, and keep things that do work well.

Concerned people in North Carolina also will be watching and hopefully learning from Tennessee’s efforts.

Canadian Vending Machine To Dispense Hydromorphone

 

 

 

 

Last month the Washington Post newspaper reported that British Columbia officials plan to set up three vending machines to dispense hydromorphone to people with opioid use disorder.

Canada has struggled with opioid overdose deaths just like the U.S., and they declared their opioid use disorder public health emergency in 2016. Projected data from 2017 estimates four thousand Canadians died from opioid use disorder that year. (In the U.S., an estimated sixty-four thousand people died from overdoses in 2016.) The extremely potent drug fentanyl has been detected in around 83% of the Canadian overdoses.

In British Columbia, overdose death rates last year were estimated at 30 per 100,000 people, which is roughly the same as in Rhode Island. (Our highest state, West Virginia, had around 52 per 100,000).

I’ve blogged before about Vancouver’s heroin-assisted therapy (HAT). In a blog in 2013, I described results of trials in Vancouver and Montreal where pharmaceutical-grade heroin was provided, in specialized facilities, to people with opioid use disorder. Medical personnel were on site at the facilities in case of overdose, and new needles and equipment were provided to participants.

Vancouver’s results showed better retention in treatment with heroin-maintenance therapy (HAT) than patients enrolled in traditional medication-assisted treatment with methadone. Participants had lower rates of use for other illicit drugs, and lower rates of participation in criminal activities than patients not in any treatment. Overall, these programs reached a subset of people with opioid use disorder who would not consider more traditional treatments with methadone or buprenorphine.

These HAT programs work in urban settings, where people can come to a centralized facility manned with trained personnel. Logistically, this sort of facility is more difficult in more rural areas. Plus, since there’s no drug company manufacturing heroin, scientists had the idea of vending machines pre-set to deliver doses of pharmaceutical-grade, immediate release hydromorphone tablets. This medication would not be as hard to obtain for patients in the treatment program.

These machines will be set up to release two or three hydromorphone pills three times per day. The cost per patient would be around $3 per day.

This idea was based on a study published in 2016 in the Journal of the American Medical Association Psychiatry by Oviedo-Jones et al., that showed supervised injection of hydromorphone was non-inferior to supervised injection of heroin.

Pharmaceutical-grade hydromorphone reduces the risk of fatal overdose death from heroin, which is often cut with substances that can be lethal, like fentanyl. Plus, non-drug substances are frequently added to heroin to make the product go farther, exposing users to all sorts of contaminants.

Canada already has vending machines to dispense clean needles to drug users, so this idea takes the concept a step farther. I didn’t realize it, but while researching this article, I found that some cities in the U.S. also have clean needle vending machines. I think this is a wonderful idea, based on science that shows access to clean needles reduces spread of infectious diseases.

Of course, hydromorphone vending machines raised concerns. Law enforcement worried that the machines could be tampered with, and the hydromorphone stolen. Other people worry this medication could be sold on the black market. But the machines are supposedly difficult to break, more like ATMs than typical vending machines, and the small amounts dispensed each day per person are thought to make it less likely to sell these pills.

In Canada, harm reduction ideas do not cause the pearl-clutching outrage we tend to have in the U.S. Can you imagine a proposal in some state legislature for a vending machine to dispense hydromorphone? It probably would not be given a hearing.

In fact, we’ve taken the opposite route in the U.S. The pharmaceutical opioid oxymorphone, in the brand formulation Opana ER, was taken off the market because so many people were injecting it. In my area, six month ago, most new patients I admitted into treatment were using Opana as their main opioid drug. Over the past month, that has changed. Now, most patients are using heroin.

This has happened all over the U.S. – declining availability of prescription opioids fueled the sharp increase in heroin use, and with it, heroin overdose deaths.

I suspect Canada will see fewer heroin overdose deaths in areas with hydromorphone vending machines, but I’m not fully sold on their idea. I worry the medication dispensed by these machines may be diverted to new users, creating new cases of opioid use disorder. In the U.S., the increased access and availability of opioids starting twenty years ago was associated with increased rates of opioid use disorder, and got us into our present mess. Before I endorse the vending machine idea, I need research showing it won’t cause unintended harm.

I’m sure British Columbia health officials will track data that will show if this vending machine concept will work to reduce deaths. It’s an interesting concept, and we have a front row seat to watch what happens with our neighbors to the north.

The STOP Act of North Carolina

CDC DATA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In mid-2017, North Carolina Governor Roy Cooper signed the STOP (Strengthen Opioids Misuse Prevention) Act into law, and as of January 1, 2018, additional portions of the Act became effective.

The STOP Act has several parts, all of which are intended to reduce the epidemic of opioid use disorder by limiting excessive and inappropriate opioid prescribing.

Beginning last July, the STOP Act required physician extenders (nurse practitioners and physician assistants) working for pain management practices to consult with their physician supervisors prior to issuing any Schedule II or III opioids. Then, they must also consult with their physicians every three months while the opioid prescriptions continue.

Prior to this law, extenders had no requirements to consult with physicians prior to issuing these opioids or continuing them. Still, defining the meaning of the word “consult” is a little fuzzy…does it mean a face-to-face conversation, a phone conversation, or email communication? The NC medical board website doesn’t offer much concrete guidance about this.

Beginning last July, the STOP Act also said hospice organizations were to start telling families of patients who passed away while on strong opioids where the leftover medications could be disposed safely. The STOP Act also encouraged the distribution of naloxone kits for opioid overdose reversal, and streamlined the process by which prescribers could enroll delegates to query our state’s prescription monitoring program more easily.

By September 1, 2017, pharmacies were supposed to be reporting all controlled substance medications that they dispensed by the end of the business day. I don’t know if there are any penalties for not meeting that requirement, but I think we still have a way to go towards meeting this standard. Pharmacies also need to correct data quickly if they confirm it’s been entered in error.

This requirement pleases me a great deal, given my interactions with pharmacies over the years. On numerous occasions, when I’ve called about a goofy-looking entry for one of my office-based buprenorphine patients on the North Carolina Controlled Substances Reporting System (NC CSRS, our state’s prescription monitoring program), I’ve been told by pharmacists (usually a CVS) that the error can’t be corrected because it’s a system glitch. Now I can tell them they are required to fix the error!

But one of the most debated portions of the STOP Act took effect January 1, 2018. This was a provision that limits prescriptions for opioids for acute pain conditions to no more than a five-day supply. For post-operative pain, opioid prescriptions can be for up to seven days.

This doesn’t mean a physician can’t write a second prescription when needed. It only means the physician must see the patient again and carefully consider whether to write a second prescription, rather than OK more opioids with little thought.

Many people fear this law, worried they won’t get adequate pain control. However, it’s important to understand that this requirement will not apply to hospice patients and those in palliative care. This requirement is only for acute pain episodes: kidney stones, acute injuries, broken bones, and the like.

This portion of the STOP Act doesn’t apply to chronic pain conditions, either. Patients who are being prescribed opioids as part of an existing program to treat chronic non-cancer pain won’t fall under the five- and seven-day provisions.

However, parts of the STOP will eventually require prescribers to query the NC prescription monitoring program before starting opioids to treat chronic pain. Prescribers will need to review the patient’s prescriptions for at least the preceding twelve months. After beginning an opioid prescription, the physician will need to query the NC CSRS at least every three months., though there’s no deadline to start doing this yet.

Then in January 1, 2020, electronic prescriptions will be required for all targeted controlled substance prescriptions (Schedule II and III opioids).

Some people think the STOP Act is too severe, and will put patients at risk for under-treatment of pain. When medical practice is limited by legislation, opponents of the Act say, physicians are less able to use their clinical judgment and patients are all treated the same.

But this legislation is based on some crucial information.

In 2016, the Centers of Disease Control and Prevention (CDC) issued the CDC Guideline for Prescribing Opioids for Chronic Pain. This document, among other recommendations, stated that opioids are not the ideal way to treat chronic pain conditions, and that non-opioid treatments are preferred. Those guidelines also recommended that if opioids are used, reasonable goals should be set, and patients need to be informed about the risks of opioids. The Guidelines also gave specific recommendations for how to start opioid at a low dose, with short-acting agents, and ways to monitor patients to make this prescribing safer. [1]

Then last year, the CDC released information showing the risk of developing opioid use disorder increases with increased duration of opioid prescribing. This article, “Characteristics of Initial Prescription Episodes and Likelihood of Longer Term Opioid Use – United States, 2006-2015.” Shows us thought-provoking data based on a very large population study.

This interesting data showed that the risk of long-term opioid use increases sharply after the first five days of treatment, and again after the first thirty days of treatment. Therefore, limiting that first prescription to five days, as North Carolina legislature has done, makes good sense. This law is science-based, which isn’t always seen in legislation.

Treatment initiation with a long-acting opioid was associated with higher probability of remaining on opioids for longer than a year, underlining the importance of using short-acting opioids for acute pain situations.

More interesting, using tramadol initially to treat acute pain was associated with a significantly higher risk of remaining on opioid long-term. We need more studies to help clarify this, since many physicians perceive tramadol to be a lower-risk drug than simple opioid agonists like oxycodone or hydrocodone.

The authors of this article also looked at the cumulative dose of opioids given, and noted an increase in the likelihood a patient would remain on opioids long-term once they had consumed more than 700 morphine milligram equivalents.

This study was well-done. It was a random sampling of over a million patients over age 18 on a commercially insured health plan who were prescribed at least one opioid prescription between 2006 and 2015. Cancer patients, patients with a history of substance use disorder, and patients starting buprenorphine were excluded from the study.

Critics may ask how this data is relevant. They may say, for example, that just because a patient remains on opioids for more than a year doesn’t necessarily mean that person will develop opioid use disorder, and that’s true.

But at a population level, more opioid prescribes means more overdose deaths. Over the past fifteen years, the number of milligrams of opioids prescribed quadrupled. Mirroring that rate closely, our nation’s opioid overdose death rate quadrupled right along too.

Less available prescription opioids will mean less available to fall into the wrong hands. We know from NSDUH data that more than fifty percent of the time, the first opioids a youngster takes for experimentation are obtained from a friend or relative.

I support this law, and I’m hopeful the law will mean fewer medicine cabinets have leftover opioids lying about. I’m hopeful this will reduce youthful experimentation, which will reduce the risk for opioid use disorder.

Let’s stop making new patients, as we help established patients along their road to recovery

1. https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm

 

 

 

 

 

 

 

 

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 21^st 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.

 

Temporary Grace: the CURES Act

 

 

 

 

 

 

The 21^st 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.

 

After the Overdose

 

 

 

 

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

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

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

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

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

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

I have no problem envisioning how this happens.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

It is life and death.

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

Purdue Pharma Settles Kentucky Lawsuit

 

 

 

 

 

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

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

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

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

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

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

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

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

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

Eventually, the U.S. General Accounting Office asked for a report about the promotion of OxyContin by Purdue Pharma. By 2002, prescriptions written for non-cancer pain accounted for 85% of the OxyContin sold, despite a lack of data regarding the safety for this practice. By 2003, primary care doctors, with little or no training in the treatment of chronic non-cancer pain, prescribed about half of all OxyContin prescriptions written in this country. By 2003, the FDA cited Purdue Pharma twice for using misleading information in its promotional advertisements to doctors. [1, 2] Purdue Pharma also trained its sales representatives to make deceptive statements during OxyContin’s marketing to doctors. [3]

Testifying before Congress in 2002, a Purdue Pharma representative said the company was working of re-formulating OxyContin, to make it harder to use intravenously. This representative claimed it would take several years to achieve this re-formulation. The re-formulated OxyContin was finally approved by the FDA in 2010, eight years later. Currently, this medication forms a viscous hydrogel if someone attempts to inject or snort the medication. It isn’t abuse-proof; probably no opioid will ever be so, but it is much more abuse-deterrent than the original.

Did Purdue Pharma drag their feet in this re-formulation? Experts like Paul Caplan, executive director for risk management for the drug company, said there were issues about the safety of incorporating naloxone into the pill to make it less desirable to intravenous addicts. He also pointed out that some delay in approval was due to the FDA.

For comparison, Sterling Pharmaceutical, when it became widely known patients were abusing their pain medication Talwin, re-formulated within a year, adding naloxone to the medication and reducing its desirability on the black market. Since this was in the 1980’s, I would assume there was less technology to help back then, compared to 2002.

I’ll let readers draw their own conclusions.

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

1. General Accounting Office OxyContin Abuse and Diversion report GAO-04-110, 2003.
2. 2. United States Senate. Congressional hearing of the Committee on Health, Education, Labor, and Pensions, on Examining the Effects of the Painkiller OxyContin, 107th Congress, Second Session, February, 2002.
3. 3. Washington Times, “Company Admits Painkiller Deceit,” May 11, 2007, accessed online at http://washingtontimes. com/news/2007/may/10/20070510-103237-4952r/prinnt/ on 12/18/2008.