The Car Dosing Cart

Nurse Sylvia behind the Car Dose Cart

 

 

 

 

 

 

 

 

 

 

 

 

 

 

At our opioid treatment program, we’ve been dosing some patients in their cars, either because the patients have fragile health and we’re trying to keep them away from crowds, or because they have COVID infections, possible COVID infections, or have been exposed to someone with COVID infection.

In order to give more protection to our nurses while they deliver a dose to a patient in a car, one of our excellent employees, Jerry, created the Car Dosing Cart (Patent is pending.) as pictured above

As you can see, it’s made from a wheeled cart. Plexiglass sheets were attached to the front and sides of the cart, with a cut-out for a window just large enough to push a dose of methadone or buprenorphine toward the patient seated in the car. Just below the top level, there’s a second shelf where the patient can push their lock box onto the cart so that it can be filled with take home doses. The rest of the car is enclosed in plastic which is taped on three sides to the cart.

It’s genius.

The nurses feel protected while using it, and there’s enough surface area for everything they need. It’s wheeled, so it can be pushed easily out of the pharmacy, out our front door and to the curb outside. It’s the next best thing to a take-out window.

Per protocol, nurses never go by themselves to the parking lot to administer a dose. For security, another staff member accompanies him or her, both to discourage theft, and to provide a second set of eyes to vouch that the dose was given to the patient for whom it was intended. All of this is documented in the patient’s chart.

The idea for the Car Dosing Cart was born after a case staffing, when the staff asked me to allow car dosing for all our patients who work at a local poultry plant, after they had a large outbreak of COVID 19 infections.

I balked at this idea, feeling there were too many patients involved. I also worried the nurses would be more exposed to patients when dosing them in their cars. But as the number of cases at the poultry plant soared, I had second thoughts. I asked other doctors working at opioid treatment programs for advice. They recommended car dosing all poultry plant employees, who could unintentionally spread COVID infection. I backtracked my initial decision and we started to car dose many more patients.

That’s when Jerry invented the Car Dosing Cart.

Thus far, the cart is working very well. It’s stocked with everything the nurses might need, like cups, tissues, gloves, etc.

We will car dose patients for as long as the state allows, for as long as we have consistently elevated number of new cases of COVID 19 in our county and state.

I’m so grateful for the courage, compassion, and creativity of all our staff at our opioid treatment program.

Misuse of COVID 19 Extra Take Home Doses?

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

COVID Scare

Cartoon style illustration of a sign or symbol that says ban, stop coronoavirus or COVID-19 being stamp out and prohibited on isolated white background.

 

 

 

I’ve had a rough week.

I’ve been so careful. I’ve worn an N95 mask every day at work, removing it only briefly when I need to eat or drink. I’ve wiped my office multiple times per day with cleaning wipes, not forgetting my cell phone, computer keyboard or door handles.

I haven’t gone anywhere, except once to the pharmacy for my blood pressure pills, and even then I used their drive- through. And I made several short trips for groceries, wearing my mask while inside.

That’s why I was so surprised when, shortly after going to bed one night early last week, I got a shaking chill more suitable to being on an icy Tibetan mountaintop rather than my snug bed.

It grew worse. I ached in every part of my body. I was too cold to get out of bed for more covers but eventually had to do so. While I was up, I went to the bathroom and ratted around trying to find a thermometer.

When I found one, my temp was 98.8. I laughed at myself. I am such a silly goose, imagining I’m ill when I’m not. But my symptoms continued with my chills and when I checked again a half hour later, the thermometer read 101.2.

My beloved fiancé was asleep in the bed next to me. I had to get some distance between us and moved to the upstairs guest room. I didn’t want to make him sick. I took some Tylenol and tried to get some sleep. But then the dry cough started, and later, some diarrhea.

As I lie in bed, feeling like I was wearing a jumpsuit of muscle aches, I thought, “This is it. I’ve got The COVID.” (That’s the way we say it here, “The COVID,” not COVID 19 or Coronavirus.)

I didn’t sleep any that night, and the next morning told my fiancé to stay away, I was sick. I sent emails to work supervisors telling them of my condition and that I could not come to work. My fiancé arranged COVID testing for the next day.

My fever jumped between 100.4 and 101.9 even with generous amounts of Tylenol and Advil.

But then the diarrhea got worse. My sweetie said, “Maybe you just have one of those 24 hour stomach flus.” I pooh-poohed him. I felt too bad for this to be a mere GI virus. Besides, the fever was lasting much too long for that and I had no nausea.

Then, about 48 hours after it started, I felt better. My fever started to come down, though the diarrhea grew ferocious. The cough never developed into anything. I took my COVID test and two days later, got the results: NEGATIVE

All I suffered from was  probably viral enteritis and a vivid imagination.

It’s easy to get carried away with any illness in the middle of the COVID 19 pandemic, especially if it’s accompanied by fever. At one point, I wrote my last will and testament. I laugh about it now, but I felt so bad, and my pessimism seemed to rise with my fever.

At least I got a chance to see what wonderful people are in my life.  At work, I was told not to worry about anything, and arrangements were made for another physician to do admissions for our OTP. I still handled the minor things by phone. My co-workers sent me encouraging emails and prayed for my wellness. My fiancé took great care of me – at a distance of course – and friends and family brought food and sent funny emails.

Right now, I feel very, very grateful. I’m now in my usual state of good health, which is wonderful. I’ll be able to get back to work this week, at a job I enjoy, with people I love. I have fantastic friends and family, and my life partner, the love of my life, didn’t get sick because of me.

And I don’t have The COVID.

Methadone Induction: Be Careful

Graphic illustrating how methadone blood level rises over five days with no dose change

 

 

 

This blog is written with gratitude to Thomas Payte M.D., a leader in the field of Addiction Medicine, who passed away in 2019.  Many years ago, I listened to an ASAM (American Society of Addiction Medicine) lecture by Dr. Payte (on cassette tape, which shows how long ago this was) that changed the way I did methadone induction.

At the time I started working at an opioid treatment program, I felt much empathy for the patients suffering opioid withdrawal when I admitted them to treatment. With the best intentions, I wanted to help them get out of withdrawal as quickly as possible, so I started them at doses higher than I probably should have and increased their doses daily. The other physicians I worked with practiced in a similar way, so I thought that was the way it should be done.

We had patient induction deaths. I learned some things the hard way, but also started going to ASAM conferences and listening to ASAM lectures, which was when I had the good fortune to hear Tom Payte.

Decades later, I can’t be sure exactly what he said, but this is what I remember:

He cautioned that induction deaths were relatively rare but devastating. If we start every patient on 30mg, eventually a patient will die during induction. That shook me up, because not only was I starting patients on 30mg, quite often I was dividing their dose on Day 1 to get a total of 40mg. He said patients inherently metabolize methadone at very different rates, and sooner or later a slow metabolizer would arrive for induction, and rapid increases in dosing during induction would be fatal.

Dr. Payte wasn’t unsympathetic to patient misery in opioid withdrawal. He just reminded me that we must temper compassion with science.

Today, induction guidelines look very different from the way I was practicing back when I started. I have changed my induction practices a great deal over the years as I’ve learned more.

Physicians who work at opioid treatment programs have so much more information available now than when I started in this field. It’s so easy to get colleague input about problems: at a national level, there’s the PCSS system, which stands for Providers Clinical Support System, a system for providing information and even mentors for providers who would like them (https://pcssnow.org/)

At our state level, the North Carolina Governor’s Institute has contracted with me and with Dr. Eric Morse, so that we can be available for questions from providers at any opioid treatment program in the state at any time.

Recently, at an organizational level, our Acadia programs in North Carolina arranged for a monthly phone call for physicians and physician extenders to discuss problems and concerns on a monthly phone call.

ASAM has all sorts of guidelines and position statements (asam.org). SAMHSA has publications to help physicians (https://store.samhsa.gov/)

Because of all this help that’s available, there’s no reason for any provider working at an opioid treatment program in the U.S. to be ignorant of current methadone induction recommendations.

I recently blogged about ASAM’s newly updated guidelines for the treatment of opioid use disorders. In those guidelines, initial dose of methadone, “ranges from 10 to 30mg, with reassessment as clinically indicated (typically in 2 to 4 hours)…” and then goes on to say, “methadone…generally should not be increased every day.” The guidelines recommend methadone be increased no more than 10mg approximately every 5 days.

If you are a provider who is starting every patient at 30mg and then increasing the dose daily, stop it. You are going to have an overdose sooner or later.

And although these guidelines did say that benzodiazepine use should not be a reason to suspend or withhold treatment with methadone or buprenorphine, they did make it clear that use of sedative-hypnotics with these medications increases the risk of serious side effects.

In other words, we shouldn’t deny treatment to patients with a co-occurring benzodiazepine use disorder, but we can’t admit them and carry on like their risk is the same as other patients who aren’t on benzodiazepines. Consider lower methadone starting doses and consider slower rates of induction for these more fragile patients. Consider closer observation and more frequent drug screening

The provider has a lot more work to do when a patient is using benzodiazepines. First, that provider needs to figure out, if possible, how extensive that patient’s use is, and decide the appropriate setting for methadone induction. That may need to be at an inpatient facility.

Second, since benzodiazepine prescribing guidelines recommend these medications not be prescribed for longer than three months, except for end-of-life care, an ongoing prescription must be explained. The prescribers of benzodiazepines must be talked to. In my area, most of the benzodiazepines are prescribed by a handful of practitioners.  When I talk to these prescribers, they say the patient complains of anxiety, indicating they think this justifies ongoing benzodiazepines.

That’s not good enough. Benzodiazepines aren’t first-line medications for anxiety disorders. Like opioids did for pain, it appears benzodiazepines make people more anxious when they are used long-term. Benzodiazepines make post-traumatic stress disorder worse, and they complicate ordinary grief reactions. Yet many patients are prescribed benzodiazepines for these reasons.

Third, a plan must be formulated to reduce the risk for the patient. In most cases, this means a reduction in benzodiazepine use by some method. If the patient can control their use of benzos, their prescriber can gradually lower their dose. Most of the time the patient can come off benzodiazepines, or at least get by with much less of these medications. In the meantime, a more appropriate medication for anxiety can be started for better treatment of anxiety.

In many cases, the patient needs trauma-focused therapy to address old issues. Many, perhaps most, of our patients have experienced serious physical, sexual, or emotional trauma in their lives. Appropriate counseling and medication can be just as life-changing for patients as can treatment for their opioid use disorder.

Since alcohol is as big a risk as benzodiazepines, the same cautions during methadone induction need to be taken for patients with alcohol use disorders. Start with lower doses and increase more slowly.

More cautious induction must be considered for medically fragile patients: those with underlying pulmonary disease, lower body weight, those on multiple medications, and the “elderly” over fifty years old. And be sure to ask about opioid use over the preceding week. If a patient was admitted to a detoxification unit, or just got out of jail or a hospital, their opioid tolerance will be lower, and the patient needs a lower methadone starting dose.

If their admission drug screen is negative for opioids, stop for a moment to consider what this means. Does the patient really have opioid use disorder? Has the patient taken an opioid recently that doesn’t show on your drug screen? Or has the patient been unable to use opioids for the last several days? If the latter is true, consider a lower starting dose.

Don’t do cookie-cutter inductions. Carefully evaluate each new patient and gather all the data that you can, including history and physical, old records, the prescription monitoring program, and other treating physicians to help you make the best decisions possible. There will always be that pull…trying to get the patient out of opioid withdrawal so they can stop using dangerous illicit opioids….while trying to provide safe methadone induction.

I’ve written mostly about methadone induction because it’s much trickier than buprenorphine. Methadone is much less forgiving during induction than buprenorphine. With buprenorphine induction, just make sure you don’t start too soon and make your patient sick. At times I wish all my patients could do well on buprenorphine, but that’s not possible. We will never have one medication that works well for everyone. Many patients never feel right on buprenorphine, or it isn’t strong enough to treat their opioid use disorder.

I’m more cautious with methadone induction prescribing now than when I started many years ago. This is from a combination of experience and learning from experts. I strongly recommend the latter form of learning; it’s much less painful.

Update on COVID 19 at an Opioid Treatment Program

 

 

 

This pandemic hasn’t struck all places in the U.S. at the same time. Back when I was watching the horrors faced by New York City, I felt relief things weren’t like that in my rural community, but also worried we would eventually face something similar.

Now COVID 19 has come to town. For now, it hasn’t been as awful as I saw on the news in the cities, but we’ve had many more people testing positive.

Part of this could be that testing has really ramped up. Early in the pandemic, not much testing was being done, either because there weren’t many test kits or because local health department officials were following the CDC’s relatively restrictive testing guidelines. As I’ve posted before, we had a few patients hospitalized with respiratory failure who weren’t tested for COVID 19. I read their hospital records. They were tested for influenza and when those tests were negative, were told to assume that they had COVID and isolate for two weeks.

After people who work at the meat processing plant in our county tested positive for COVID, suddenly there’s been extensive testing for people who work there.

According to our local paper, the total number of COVID 19 cases remained at four known cases from April 5 until April 21. During the last weeks of April, the number of people testing positive rose slowly, then more quickly. As of today, with businesses re-opening under Phase 1, we have two hundred and sixty-one people in our county testing positive for COVID 19, out of a population of around sixty-eight thousand people.

Our opioid treatment program had to decide how to respond to this new information. Last week, the staff petitioned me dose all our patients who work at this facility in their cars. They wanted potentially infected people to be kept out of our facility. I balked, thinking the risks of car dosing those people outweighed the benefits. Now, after talking to some other doctors about the situation, I’ve changed my mind. We intend to car dose all patients who work in high-risk environments with multiple people testing positive, like the meat packing plant.

It’s not as bad as it sounds. Many of these patients have been stable for months or years and were already on advanced take home levels. Under the blanket exception allowed by federal and state authorities, a significant minority of the only come once per month. Others need to come daily, with most patients coming to the OTP a few times per week.

Our facility got some N95 masks from our parent company. I’ve worn mine for the last three weeks. It still works, though the elastic is getting frayed. We also got a few hundred paper masks that are somewhat helpful. We’ve asked patients to wear masks or other face coverings while at our opioid treatment program. Nearly all patients have supported our request, but a few grumbled about it. We won’t refuse to dose patients who don’t wear masks, but we encourage them to do so. I still bring my Breath Buddy respirator mask to work with me each day, in case I need to see a patient sick with acute COVID 19 symptoms.

Every few hours, there’s an announcement over our intercom to ask for help wiping down our waiting room. Any staff member who isn’t busy with patients comes to pitch in and wipe down chairs, keypads, door handles, bathrooms, etc, with antibacterial liquid meant to murder Coronavirus. It doesn’t take long with many people helping. It’s become part of the daily routine. Patients have voiced repeated appreciation for our actions, which makes me feel good.

I’ve been dealing with patients who appear to have mismanaged their extra take home doses. Around nine patients have had some problem with their take homes. Some patients returned early, when they should still have take home doses, and can’t explain what happened. Some have had bottles missing, lost, spilled, or damaged in some fashion. No one has died from extra take homes, and so far as I know, there have been no close calls with overdoses among our patients from extra take homes.

In most cases, I can’t be sure what happened. The situations came to light either when patients returned early, or when they had drug screens that didn’t contain the medication we are prescribing. In one case, the patient said she was doing fine with weekly take homes, but when she suddenly got 27 take homes under the blanket exception for our COVID 19 situation, she was unable to take them as prescribed. She took extra medication compulsively, even though it didn’t make her feel any different. She ran out of medication a week early. I was happy she told us what happened, and we dropped her back to weekly take homes. Thankfully, she was on buprenorphine and not methadone.

I’m sure these nine cases are the tip of an iceberg. Most patients likely won’t tell us if they’ve mismanaged their extra take home doses.

Patients are at risk both ways: if we decrease the number of take home doses, their risk of contracting COVID 19 increases; however, extra take home doses (especially methadone) can de-stabilize patients accustomed to more accountability with their dosing. We try our best to balance the risks.

We’re still doing intakes for patients, both to methadone and buprenorphine. These patients must dose daily during their induction onto medication, as do patients who aren’t doing well, who have continued alcohol or benzodiazepines drug use.

I feel uneasy about the Phase 1 opening of businesses this week, because we are only now seeing the number of cases increase. I know this could be from accelerated testing recently, and that we must live with some degree of risk.

No matter what happens, our OTP plans to continue to be open for admissions and established patients. We want out patients to know we aren’t closing, that we will be here to provide care for our patients.

We plan to keep doing all we can to keep our patients healthy, both from opioid use disorder and from COVID 19.

Update of the ASAM National Practice Guidelines for the Treatment of Opioid Use Disorder

 

 

 

 

Last week I got the updated guidelines from ASAM (American Society of Addiction Medicine) regarding the treatment of opioid use disorder with medications. This new focused update replaces the 2015 guidelines, with minor and major changes, based on new scientific literature and expert opinion. The committee responsible for the revision was composed of some of the most knowledgeable experts in our field. I’m grateful for their efforts and read these new guidelines in detail.

I made note of some newer statements that stood out to me, either because I agree with them so vehemently, or because I’m not enthusiastic about them. For the latter, I need to adjust my thinking and my practices, something that’s never comfortable.

Starting with Part 1, which covers the assessment of the patient and the diagnosis of opioid use disorder, I saw this new recommendation: while a comprehensive assessment of a new patient is critical, it shouldn’t delay treatment with medication. In other words, these guidelines give us permission to get some data after treatment initiation. Assessment should be an ongoing process as OTP (opioid treatment program) staff get to know a new patient and their unique needs.

It takes time to get data from a new patient for a comprehensive assessment. On day one, patients usually feel lousy. They are in withdrawal and anxious for relief. However, some state regulatory authorities dictate we formulate a person-centered treatment plan on that first day. Then there are consent forms, release of information forms, and educational procedures we must do for new patients. We are mandated to get personal information on the first day about their past traumas, legal problems, sex lives, housing situations, and the like. If counselors don’t get that information, the program risks censure by regulatory authorities and we also risk not getting paid by insurance companies or Medicaid.

In other words, this guideline is wonderful, but OTPs will need buy-in from the agencies that oversee the function of OTPs.

Next, a major revision to existing guidelines says that current use of benzodiazepines or other sedatives shouldn’t be a reason to suspend or withhold treatment with methadone or buprenorphine. The new guideline says harm from untreated opioid use disorder can outweigh the risks of combining treatment medications with sedatives, and that a risk-benefit analysis should be done, and extra support given to the patient to minimize overdose risk.

This revision isn’t a surprise. OTP providers have talked frequently over the past several years about the increased risk of overdose since fentanyl appeared on the scene. Like so many of my colleagues, I’ve gradually changed my practice. I’ve admitted patients with known benzodiazepine use disorder to treatment with buprenorphine or methadone. After admission, we work with the patient, trying to figure out strategies to help reduce or eliminate benzodiazepine use.

I’ve been happy with some results. Some patients have done very well, much better than I feared. Other patients haven’t done as well, and I worry about them.

Each case is different. A patient who uses an occasional benzodiazepine doesn’t worry me as much as a patient who comes to our facility so impaired on benzodiazepines that she can’t be dosed safely. I worry about patients when friends or family members call to say their loved one fell asleep at dinner, and about patients who have auto or other accidents likely caused by sedative use. I worry about patients who got fired from their job due to impairment. All of these incidents speak to a severe lack of control over benzodiazepine use.

For these patients, continuing methadone may not be the right treatment plan. They may need to switch to buprenorphine, or even better, to depot naltrexone (Vivitrol). These patients need extra help and counseling. Most also need better treatment for underlying anxiety disorders.

Ideally, I’d send patients with uncontrolled benzo use to inpatient treatment, to taper them off benzos safely while they do an induction onto methadone. We now have state-run facilities that offer this service, at least in theory. In real life, it takes weeks to get a patient admitted, and they don’t stay long. One patient with severe alcohol use disorder stayed two days. The facility that takes patients in our catchment area is overwhelmed with too many patients who need admission compared to their small number of beds.

The guidelines do advocate a balanced approach; in another section, they recommend using caution when prescribing sedatives including benzodiazepines to patients who are prescribed methadone or buprenorphine, due to the risks of serious side effects and interaction.

Next, I saw an interesting statement in the guidelines, which was that opioid use disorder is diagnosed based on the history given by the patient. You would think that would be obvious, but OTPs have been criticized in the past for “taking the patient’s word” about their opioid use disorder. We have other data that we consider besides patient history; for example, the physical exam findings, presence of opioid withdrawal signs, multiple opioids on the prescription monitoring program, old records from other treatment programs, and collateral information from family. But patient history is the foundation of the diagnosis of opioid use disorder.

Another new guideline statement was that all FDA-approved medications should be available to patients seeking treatment for opioid use disorder.  I heartily agree with this. I think OTPs that offer only methadone are behind the times. We offer all three medications at the OTP where I work. However, depot naltrexone (brand name Vivitrol) is logistically difficult to start at an outpatient facility, because few patients can refrain from opioid use long enough to start naltrexone. It’s easier to start on an inpatient unit, where patients are physically separated from illicit opioids. Vivitrol is covered by Medicaid, but it’s still costly for patients with no insurance, even with the patient assistance program.

The guidelines say there should be no time limit for medications used to treat opioid use disorder. That statement was much needed. Even today, too many OBOT (office-based opioid treatment) providers push patients to taper off buprenorphine products to meet an arbitrary timeline, and that’s not in patients’ best interests.

Here’s one that may be controversial: The new guidelines repeatedly state, in various sections, that a patient’s “decision to decline” psychosocial therapy shouldn’t delay treatment with medication to treat opioid use disorder.

This is big:  In other words, if a patient won’t or can’t participate in counseling, the patient should still be able to get treatment with medication. Patients can benefit tremendously from counseling, but the medication reduces the risk of overdose death, a worthy goal. Medication shouldn’t be withheld from patients who decline counseling help.

That’s a frequent dilemma of office-based opioid treatment physicians. I’ve talked to many doctors and we feel guilty if we don’t insist our patients get counseling of some kind, whether it’s individual, group, or 12-step recovery. While we still need to encourage patients to participate in counseling, we no longer need to feel guilty for writing buprenorphine prescriptions for patients who decline it. Science says the medication benefits patients, even without counseling.

Another guideline says the opioid dosing guidelines developed for chronic pain, which talk about MMEs, or morphine milligram equivalents, don’t apply to treatment medication. This is a pet peeve of mine. How it irritates me to see a high “overdose risk score” on my state’s prescription monitoring program for a patient who is doing well on a stable dose of buprenorphine/naloxone for over five years! Despite this recommendation that MMEs can’t be applied to medications like methadone and buprenorphine, our PMP insists on doing just that. I heard this was going to be changed, but it hasn’t…yet.

In Part 3, the guidelines state that opioid withdrawal management (what has been traditionally been called detox) is not recommended without ongoing treatment. The risk of overdose and overdose death increases when opioid withdrawal management is used without any other treatment options, such as ongoing maintenance medication.

I’m in the “Amen!” corner for this statement. Are there any other treatments that have been used over and over, with less than a 10% chance of being effective, for any other chronic illness? And worse than low efficacy, this treatment (detox only) increases the risk of death after the treatment is done. If we did that for any other chronic illness, malpractice attorneys would parachute from the sky in their haste to file lawsuits.

In Part 4, about methadone, induction recommendations say that for most patients, initial dose should be in the range of 10 to 30mg, with re-assessment as clinically indicated in 2-4 hours. In patients with no or low opioid tolerance, they recommend initial doses of 2.5 to 10mg. They also say methadone should be increased by no more than 10mg every five days, based on patient symptoms of opioid withdrawal.

The guidelines say that methadone daily doses usually range from 60 – 120mg per day, but that some patients need doses lower than that and some higher.

Part 5, about buprenorphine, pushes for the acceptance of doses higher than 16mg per day. In the past, many experts said no patient should ever need doses higher than 16mg per day. Now, the updated guidelines say, “Evidence suggests that 16mg per day or more may be more effective than lower doses.” Well yeah. I don’t know why it’s taken so long for the experts to get on board with that. (You can check out my blog entry of October 8, 2017)

I’ve touched on only a few of the many points in the guidelines. You can read them in full at this website: https://www.asam.org/Quality-Science/quality/2020-national-practice-guideline

I think the guidelines were well-researched, well-written, and much needed. Thank you, ASAM, for your continued efforts to help providers give good care to our patients.

Book Review: “American Overdose: The Opioid Tragedy in Three Acts”

 

 

 

 

This last year, publishers churned out books about the U.S. opioid use disorder epidemic with some regularity. I’ve already reviewed some of the more well-known, such as “Fentanyl, Inc.;” “American Pain;” Dopesick;” and “Dreamland.” Published in 2010 and far ahead of its time, “Painkiller,” by Barry Meier, had an updated second edition released in 2018. All these books are worth reading.

“American Overdose,” written by Chris McGreal, is a little different. Instead of long stories about particular people who became addicted to opioids, this author dug into the history of factors that set up this tragedy and how it evolved. He describes how prominent people and agencies that should have protected us either ignored the problem or had weak and inadequate responses.

He divided his book into three parts: “Dealing” was about the factors that contributed to the opioid epidemic and the people who tried to warn of impending problems; “Hooked” was about the failures to act after the epidemic was well underway; “Withdrawal” describes how changes finally were made to the opioid prescribing landscape, and the heroin epidemic that followed as an unintended consequence of tighter controls on prescription opioids. This section also talks about our task of trying to repair the damage done by a few decades of opioid epidemic.

The author gives the names of individual people who left their mark, for good and for bad, on the opioid epidemic. He also names specific organizations that lit the match and fanned the flames of the opioid disaster. Other people who have written or talked about the opioid epidemic have refrained from blame, saying that though people were wrong, they had good intentions and it isn’t helpful to blame. If that’s your outlook… this book probably isn’t for you. He names and blames people, often individuals who are leaders of organizations.

He specifically focused on Purdue Pharma’s drug OxyContin as the “most powerful narcotic painkiller ever released for routine prescribing.” He’s right about his claims, and prescribing data tells the story. OxyContin was heavily promoted to rural areas, and specifically to rural Appalachian areas. These places have the highest prescribing rates, the highest opioid use disorder rates, and the highest opioid overdose death rates.

I remember attending ASAM’s (American Society of Addiction Medicine) “Pain and Addiction: Common Threads” course in 2004 or 2005.  Purdue Pharma was still a major sponsor of that conference. (Later, due to the objections of ASAM’s members, drug companies were no longer allowed to sponsor whole conferences, but were allowed to have small informational booths at the conference, should attendees wish to talk to them). I remember how a physician was chided for mentioning OxyContin by name as a factor in our region’s burgeoning opioid addiction problem. He was told that people weren’t misusing only OxyContin, and that other brands like Percocet and Lortab were also involved, so we shouldn’t point the finger at one drug company.

Those of us working in the field knew bullshit when we smelled it. Maybe there were more combination oxycodone/acetaminophen pills sold, but they didn’t have the opioid firepower of an OxyContin 40mg, let alone an Oxy 80, and – for a brief time – an Oxy 160mg. From 2001 when I started at an OTP until around 2010, the drug my patients mentioned, nearly without fail, was OxyContin. I was working in rural and small-town Western North Carolina at that time: Hickory, Concord, Statesville, Gastonia, and Marion. What I saw every day did NOT match what the drug company shills were saying.

Books like McGreal’s and earlier sources have since examined the facts behind how Purdue Pharma operated, how they made misleading statements about the addiction potential for patients prescribed their drug, and how they blamed people who got addicted as causing their own troubles.

In 2007, relatively early in the epidemic, a U.S. attorney in Virginia, John Brownlee, was able with much difficulty and resistance to get Purdue to admit to felony misbranding of OxyContin. The three top executives pled guilty to misdemeanors and the company paid $600 million in a settlement.

If you think this slowed Purdue and caused them to re-think what they were doing…nope. There’s a great deal of evidence to show you would be wrong. In 2003, representatives of Purdue told Congress that they were working on an abuse-deterrent formulation of their OxyContin, but they didn’t re-formulate until 2010. The patent on OxyContin was due to expire in 2013, so re-formulating meant the new patent would last until 2030.

The Sackler family, owners of Purdue Pharma, is mentioned only briefly near the end of the book.

The book took great pains to point out how Big Pharma paid to influence decisions made by the government at all levels, and how Big Pharma sought to silence well-intentioned people who worked a government regulatory bodies about what was happening in the beginning of the epidemic.

The book spends much ink dwelling on the failings of the FDA (Food and Drug Administration). The author traces the FDAs weakening status from the days of HIV. After the FDA was criticized for its slow pace for approval of new medications, the FDA created pathways for drugs to get approved more quickly. Big Pharma took notice and took advantage. In 1992, a deal was struck between pharmaceutical companies and the FDA that said the drug companies would pay fees to fund the approval of their drugs. As time passed, the FDA became more dependent on these fees. However, the FDA continues to insist that the fees did not buy influence.

The author says that this money, combined with the money pharmaceutical companies spent lobbying members of Congress, changed the atmosphere at the FDA from that of a watch dog to that of a business partner, eager to please the drug company partners. This attitude weakened their response to the opioid epidemic.

The FDA’s response to the approval of two new opioids, Opana and Zohydro, underlined this new attitude. For Opana, the FDA agreed to let the pharmaceutical company do drug safety trials with “enriched enrollment,” which means the drug company had permission to exclude any trial subjects that appeared to develop signs of addiction or misuse from the final data presented to the FDA. This meant that the very people who might overdose and die from the drug were excluded from studies, which will skew safety data, making a drug look safer than it is. After Opana was approved by the FDA in 2006, it became popular with people who sought to crush and inject or snort the drug. More than a million prescriptions per year were written for this drug before it was ultimately taken off the market in its easily abusable form.

Injected Opana was associated with an outbreak of patients in Eastern Tennessee with a specific blood disorder called thrombotic thrombocytopenic purpura (TTP), and an outbreak of HIV infections in a small town in Indiana.

Zohydro ER sought FDA approval in 2012. This medication contained hydrocodone at up to ten times the dose found in hydrocodone pills already being sold. Like OxyContin and Opana, it could be crushed to be snorted or injected. But the drug company making Zohydro, Zogenix, promised it would watch for any sign their medication was being abused, and wouldn’t allow it to be abused like OxyContin had been. The FDA’s advisory committee wasn’t convinced and voted against approval of Zohydro. However, the FDA unexpectedly went against the recommendations of its own advisory committee and approved the drug.

The book gives a quote from a physician who was on the FDA’s advisory committee, and who was in a position to know: “…The FDA puts pharma’s interests first.”

The deeds of Doctors Acting Badly are described in detail in the book. Prescribers of pain pills, claiming they are trying to alleviate pain while “seeing” and prescribing to more than a hundred people per day, acted as essential links in the chain. Without them, the streets couldn’t have been flooded with prescription opioids. I feel the most disappointment and distain towards these providers.  I think they knew they were doing wrong but didn’t care.

Don’t get me wrong. Plenty of good doctors work at pain clinics. But those are not the ones described in this book.

The doctors in McGreal’s book did things like prescribe “more than 2 million pills to 4,000 patients in over 101 days…” (p 102). It’s impossible to give good care seeing that many patients per day. In fact, in some cases the prescriptions were pre-signed and other staff members filled them out, so patients weren’t even seen by the physician.

Many of these physicians went to jail and/or lost their medical licenses.

But these weren’t the only doctors who contributed to the opioid epidemic. There were others, experts in pain management, who fueled the opioid prescribing frenzy by touting benefits of opioids for chronic pain, though safety data was lacking at that time. Some of these physicians also had financial connections with the drug companies manufacturing prescription opioids.

These experts talked at medical conferences sponsored by drug companies. With the mantle of authority that the podium gives, they taught other medical professionals that the risk of developing opioid use disorder was negligible for patients prescribed opioids for chronic pain. Even after it was apparent these patients often did develop addiction, these experts claimed prescribers needed to maintain a balanced approach and chose patients more wisely. The “bad” patients who were prone to misuse the opioids should be separated from the “good” patients who could take them as prescribed.

I think the doctors who jumped on the crowded bandwagon to prescribe opioids for chronic pain did what they thought was right, but their thinking was clouded by the benefits they gained personally. The science wasn’t strong enough to support the claims made by the pain medicine experts and the drug companies who sometimes funded them.

The role of the Centers for Disease Control and Prevention’s (CDC) is mentioned briefly. While individual physicians collected data about opioid overdose deaths and tried to sound an alarm, weak leadership at the CDC did not encourage the FDA to act upon the science the CDC had collected. It wasn’t until 2009, when Dr. Tom Frieden took over as CDC director, that he focused national attention on our escalating opioid situation. He was perhaps the first head of a governmental agency to take the opioid epidemic seriously, and to call it an epidemic. Even though the CDC joined the fight against opioid epidemic late, at least they did begin to participate.

The book helped me understand the role of the major drug distributors in our nation’s opioid epidemic. I the past, I thought the big companies like McKesson, AmerisourceBergen, and Cardinal were merely supplying pills to pharmacies who asked for them. I wasn’t sure why they were wrong to merely supply pills where there’s a demand. But the author says the law requires that drug distributors of controlled substances must report suspicious orders of controlled substances and cease deliveries until the DEA investigates. It’s part of the job if you want to distribute potentially addicting medications.

In chapter 15, titled “A Free Pass,” I read how distributors blatantly disregarded their legal obligations to report unusual orders of opioids. As early as 2008, the big three distributors were warned they must comply with the law and were fined millions of dollars. And even after that, some of the companies continued to provide large shipments of opioids to suspicious customers with little legal repercussions.

In fact, in West Virginia, these drug distributors delivered 780 million doses of prescription opioids over a six-year period. That was enough for 433 pills for every person living in the state. And during those six years, overdose deaths rose dramatically. In the small town of Kermit, West Virginia, population of 406 in 2010, 9 million pain pills were delivered and sold over two years. That area had several well-known pill mills, shuttered long ago, and an unethical pharmacy that would fill any prescription for the right price. Looking at those kinds of numbers, the distributors had to be willfully blind instead of purely unaware.

If you want recommendations about treatment, don’t look in this book. Treatment isn’t covered in the book.

Compared to our present COVID19 pandemic, one might be tempted to dismiss the problem of the opioid use disorder epidemic. But remember this: the U.S. saw 350,000 overdose deaths from 1999 to 2016 from opioids and opioids in combination with other drugs. By 2018, around 200 people per day were dying from drug overdoses, and overdoses were the most frequent cause of death for Americans under fifty.

This is the best book around if you want to understand factors that caused the opioid epidemic and factors that allowed it to continue for so long. It’s far more comprehensive that I can describe in a review, so get a copy and read for yourself.

 

COVID 19 and the Treatment of Opioid Use Disorder

 

 

 

 

I’m getting cranky. I know I have plenty of company, figuratively speaking of course. Life’s restrictions chafe at my mood, making me grumble more than usual.

I have nothing to grumble about, I know. Every night I thank God that all the people I love are safe and well and don’t have COVID19. I haven’t lost anyone I love and I’m so fortunate to be living out in the country where we don’t deal with the horrors I’ve seen on the evening news.

And yet, being human, I slip from gratitude to petulance when I see all our COVID snack foods are gone. We just re-upped a week ago. Who is eating all these snacks?

Work had annoying moments last week. Even though we were busier, and I had a few admissions to do each day, I still had down time. We’re out of sanitizing wipes, so I couldn’t make the rounds at our OTP, wiping down surfaces. I had to be content with squirting hand sanitizer on my desk, door handles, and other surfaces. But it’s not the same and leaves some surfaces sticky and unpleasant.

We have no N95 masks, so I wore a Breath Buddy mask this week. (The above picture is of me in my Breath Buddy mask.) The Breath Buddy is a respirator dust mask that I bought to wear when I carve chunks of quartz into bowls and other shapes. I’ve gotten used to wearing the hot and bulky thing, but I’m not used to trying to make myself heard while wearing it, and that was a little taxing and annoying. I think it also annoyed some patients who had to strain to hear me.

I saw several patients last week who relapsed on the extra take home medication they received due to the COVID pandemic. These patients didn’t die and likely won’t have any long-term harm, but one patient was especially demoralized by this setback. I felt very bad for her, because she probably wouldn’t have relapsed without the extra take home doses.

But on a positive note, we don’t have any patients who were diagnosed with COVID 19 with certainty, so far. Several were hospitalized with respiratory failure and tested negative for influenza, so they were told to act as if they had COVID 19, but they weren’t tested for it. It’s hard to know what to make of this. We are giving them extra take homes, and dosing them in their cars, depending on their stability.

I feel we have been generous with extra take home doses of methadone and buprenorphine during the COVID 19 situation. But some patients saw me last week to grumble that they should have received more take homes, or that another patient they know got a few more take-home doses than they did, and that it wasn’t fair. This irritated me but I tried to hear them out, then explained that we did a great number of extra take homes very quickly for an emergency situation and that we may have made some mistakes, but that nearly every patient got extra take homes, except for the extremely unstable. I told these patients I would re-assess their take- home status.

I had a great deal of problems with my attempts to do telehealth with my office-based buprenorphine patients this week. Nearly half of the attempts at connection were so poor that we couldn’t communicate, and I had to call them on the phone instead. It didn’t help that our power went out at our house, so we were running on our generator, which may have affected my internet connection.

All in all, I am doing better than I’m feeling, as I suspect most of us are. I even baked my own COVID snacks. I love to bake scones, but was a little tired of them, so I made the dough as usual but added the only fruit-based thing I could find: a leftover can of cranberry sauce from Thanksgiving. Unfortunately, they came out of the oven looking like something from a crime scene. Fortunately, they tasted great.

We will make due with what we have, until more normal times return.

COVID19 and Medication-assisted Treatment of Opioid Use Disorder

Pretty But Dangerous

 

 

 

As the COVID19 debacle drags on, treatment for patients with opioid use disorder continues to evolve in some ways.

Last week, I saw my office-based patients via telemedicine rather than in my private office. It went well, for the most part, but out of the fifteen people I saw, two had such bad connections that I could barely communicate. The picture blurred, the voice distorted, and I felt frustrated.

I think patients with poor connectivity may not have the bandwidth to do telemedicine. I don’t know if this is a problem that’s easily fixable. I may have to resort to phone calls only in these cases. In fact, phone calls would have been much better than the telemedicine on these two patients.

However, I also gained some insights into my patients’ lives. I got a small peek into their everyday lives, in some cases. I saw how they dress while at home and saw a few details about their home in the background of the picture. Several seems much more relaxed than when I see them in my office. Others were more tense, struggling with the technology.

Overall, patients appreciated the convenience of telemedicine and appreciated not having to expose themselves to the outside world, with possible Coronavirus floating around. I know I did.

At the opioid treatment program where I work, I came to the facility on my usual days, but things have been slow. I didn’t have any patients wanting to do intake this week and saw only a handful of patients each day for other reasons, mostly dose adjustments.

Patients have not had to wait to dose at all, except for Monday. That day we had many people with extra take homes coming back to dose with us and to get more take homes. Our nurse manager is fine-tuning the schedule, to even out the number of people dosing on site as much as possible. I told him he has a very hard job, trying to juggle nearly 600 patients so that everyone has the least amount of wait time. Other than Monday, we had negligible wait times.

We renewed our blanket exception requests for extra take homes with the state, and I think this is something we will renew every two weeks until the COVID19 mess is over with.

Our rural county, population of a little over 68,000 people, has two confirmed COVID cases. However, few tests have been done. According to an article in our local paper, our Health Department has done 28 tests, with 24 negatives and four pending. This number didn’t count any testing done at the local hospital, though, where the two positive tests were done.

I’ve read the hospital records of a few of our OTP patients who went to the hospital over the last two weeks with acute respiratory failure, cough and fever. It appears they were given COVID precautions but were not tested. They were told to quarantine, though. We’ve dosed those patients in their cars and given take homes to keep them away from the OTP. Initially we decided we would do this only for confirmed cases, but that idea appears unworkable, both because not many patients are being tested, and because of the delay in results of a week or more. We must act as if those patients have COVID 19.

I find the reluctance to test patients with symptoms to be odd.

I’ve heard that local testing policies are based on CDC recommendations: people with symptoms who have traveled to areas with active COVID infections are being tested, and people who have been in close contact with known COVID patients are being tested. Perhaps reluctance to test any patient with symptoms is based on a lack of test kits. I don’t know, but I’m repeatedly struck by this reluctance to test. Even nurses with symptoms have not been tested for COVID.

We continue to wear what masks we have – paper disposable ones that we re-use day after day, or hand-sewn cloth masks that can be laundered frequently. We have sanitizing wipes and take turns wiping down doorknobs, chairs, reception counters, etc. We practice social distancing among staff and patients. We use our homemade hand sanitizers and wash our hands with soap and water too.

Patients can have either in-person sessions, sitting at least six feet from their counselors, or have phone sessions. Counselors are trying to call patients with extended take home doses weekly. That can be a problem, given than many of our patients have the disposable phones and they change numbers frequently. If they can’t be reached, counselors document that they tried to call, and we try to get a working phone number the next time the patient comes to dose on site.

We are doing all we know to do to keep our patients and ourselves safe.

We have weekly teleconferences for program directors and medical directors of OTPs. There’s been much debate around telemedicine capabilities. Under federal regulations, physicians (or other providers) can’t admit methadone patients to an OTP unless they have an onsite admission process. However, OTPs can admit patients to buprenorphine via telemedicine. I think regulators feel buprenorphine is much safer, and office-based providers even do home inductions, so an on-site interaction isn’t needed. But with methadone, which is more dangerous to start, particularly in the first two weeks, the provider needs to see the patient in person, face-to-face. That’s the way the federal regulation reads at present.

There’s a petition floating around OTP circles, asking SAMHSA to re-consider their block on methadone admissions via telemedicine. If this petition succeeds in changing federal regulations, prescribers still must obey their state laws on this topic.

I am not in favor of telemedicine admissions to methadone. I’m aware this isn’t a popular opinion at present, and I understand the benefit of making admission to OTPs as easy as possible and eliminating barriers.

However, I’ve been working at OTPs for nineteen years, and I’ve had methadone patients die during induction under the best of circumstances. Methadone is a different breed of cat than buprenorphine, and even though induction overdose deaths are still rare, they are devastating when they do happen. I think I could miss subtle signs of sedative intoxication via telehealth, which could make a big difference in my decision to start treatment. It may be difficult to discern subtle withdrawal signs. If there’s another medical professional on site to do the exam, that could fill in some information gaps, but will this professional be an RN? It would be (in my state) outside the scope of practice for an LPN, and certainly could not be done by a counselor.

We talked about the prohibition of telehealth admissions for methadone on our OTP phone call today, and most providers voiced the opinion that it would be perfectly safe to do this, so I’m clearly in the minority with my opinion. Fortunately for now, I’m able to work on site at my OTP, so it’s not an issue.

On our phone call, there were some interesting ideas about what OTPs are doing around the country. One state apparently asked agencies to agree to share staff. That is, if one OTP has all their nurses out sick and unable to work, a nurse or two could be brought in from another OTP that has all of its staff able to work. That would be great, and such a policy would be in the best interest for all patients… but would require a great deal of cooperation between organizations that are accustomed to competition.

We talked about financial hardship policies; in other words, what to do about patients who, suddenly out of work, can’t pay for treatment. Some programs said they would work with such patients and try to help them make a budget or agree to a financial contract. Some programs agreed to allow patients to charge part of their daily fee, to be paid back later. Our OTP is allowing patients to charge for take home doses, hoping they will be able to pay again at some point. It sounds as if other programs are doing similar.

Unfortunately, state funding for patients unable to pay, under the SORs grant, was set to run out of money in early May, at the worst possible time for our patients who’ve just been laid off from work due to COVID 19 shutdowns. It now appears that some extra money may be found, but there’s much uncertainty now. I pray it works out, because we have many patients who are doing well in treatment, at risk for relapse if their grant for treatment runs out.

 

Twined leather rug

My most recent rug