Good News for Opioid Addicts: Reckitt’s Requests Rejected by the FDA

This week’s issue of Alcohol and Drug Abuse Weekly ran a front page article about the FDA’s recent ruling on Reckitt Benckiser’s requests. Reckitt, the manufacturer of buprenorphine (Suboxone and Subutex), had submitted a Citizen’s Petition to the FDA, asking them to refuse to approve any form of buprenorphine that didn’t have additional child-resistant safety measures.

Last year, Reckitt said they were taking the tablet form off the market because of increased risk for pediatric exposure with tablets as compared to the newer film form of Suboxone. Cynics (like me) said this was an attempt to hide profit motives behind claims of concern for children. The film is still under patent, while the patent for the tablet form had already expired. This Citizen’s Petition was felt by some (like me) to be an additional smokescreen, invented to prevent the release of a generic competitor.

In their ruling at the end of February of this year, the FDA said the scientific and regulatory concerns raised by Reckitt’s petition weren’t valid. They said there was no proof of Reckitt’s claim that the unit-dose packaging of the film reduced pediatric exposures. The FDA noted that the new REMS (Risk Evaluation and Mitigation Strategy), put in place for buprenorphine and other opioids, could have caused the decline in pediatric exposures. The FDA has also made efforts to educate physicians about overdose potential in children. The FDA also pointed out that many drugs dangerous to children are packaged in bottles, rather than unit –dose packaging. Also, the FDA pointed out that Reckitt received the pediatric overdose information two years before they announced they would voluntarily stop making the tablets due to pediatric overdose concern. This delay undermined their claim of making the change for patient safety.

The FDA criticized Reckitt for making these safety claims, yet still selling the tablets. In fact, the FDA has asked the Federal Trade Commission, the FTC, to investigate the United Kingdom-based Reckitt-Benckiser for possible anticompetitive business practices.

I admired Reckitt Benckiser when they first released Suboxone. At last, a drug company was willing to take a chance on manufacturing a medication to treat addiction. Since drug addicts often don’t have insurance or money, this is not usually a lucrative market. They took a financial risk. They funded, or helped to fund, many of the training programs doctors needed to get licensed to prescribe Suboxone. Reckitt provided free treatment for a few indigent patients per doctor with their Here to Help program. They provided telephone support to addicts entering Suboxone treatment, at no cost, though few addicts used this benefit.

But over the last few years, Reckitt Benckiser has lost credibility with me. I feel they’ve become heavy-handed, and have pressured doctors to prescribe only the films, saying it’s less likely to be sold on the black market and less likely to be misused than the tablets. That may be true, but some patients don’t like the film, and would leave treatment if it’s the only available medication. And many addicts have written in to this blog, claiming to be able to dilute and inject the films more easily than the tablets. At the same time, the prices of the Suboxone tablets skyrocketed, in an attempt to force patients to switch to films. Reckitt of course also discouraged doctors from prescribing the less expensive generic monoproduct buprenorphine, which costs less than half of the name brand manufactured by Reckitt.

Then there was that whole pediatric overdose issue. After that, my opinion of Reckitt fell. They lost credibility with me.

The two drug companies that make the generic form of Suboxone say their tablets should be available in pharmacies within a month. Actavis, based in New Jersey, is the third largest manufacturer of generic medications. The other manufacturer, Amnel Pharmaceutical, is also based in New Jersey and is the 7th largest generic manufacturer. Amnel’s press release describes their tablet as being cheaper than Suboxone, with a “pleasant orange flavor.”

I can’t wait to see how much these generics will cost. I’d expect them to be a little more expensive than the generic monoproduct buprenorphine. In my area, that generic sells for around three to four dollars per pill, less than half what the name brand Suboxone costs now.

The release of these two generics will likely mean more patients will be able to afford addiction treatment. The more affordable treatment becomes, the more patients will take advantage of help for their addiction.

Huzzah for the FDA! This was a good decision.

Reckitt-Benckiser to Stop Manufacturing Suboxone Tablets

This week, officials of Reckitt-Benckiser, the pharmaceutical company that manufactures Suboxone and Subutex, announced its plan to stop manufacturing Suboxone tablets. The drug company says the tablets will be phased out over the next six months. According to their press releases, the company decided to discontinue manufacture of Suboxone tablets, “Because of strong evidence that the tablet form of Suboxone is linked to significantly higher rates of pediatric exposure as compared with…the film.”

Reckitt Benckiser says they are basing their action on data from the Poison Control center from September that showed there were around 8 times as many accidental Suboxone exposures in children with tablets versus films. They say they are taking action in the interest of public health.

The drug company says that since the films and tablets are clinically interchangeable, patients presently taking tablets won’t be adversely affected.

In the most recent issue of Alcohol and Drug Abuse Weekly, a spokesman for the company said per 10,000 Suboxone patients, there were .71 pediatric exposures to the film and 6.25 pediatric exposures to the tablets. These numbers were statistically significant. (1)

I believe their data. It makes sense that children would have a harder time opening one of those foil packets of Suboxone film than opening a prescription bottle of tablets. Plus, with a bottle there’s more than one dose available for ingestion, while one packet yields only one potential dose. The tablets also have an orange-y smell and taste, and may be more appealing to young children than other types of pills.

I also think Reckitt Benckiser’s film is a better product than their tablet. Most of my patients do prefer the film, saying it dissolves faster and tastes better.

However…maybe I’m too cynical when it comes to drug companies, but I don’t believe pediatric exposure is the only reason the drug company is ceasing manufacture of the tablets. I think it’s also a financial decision. The film’s patent doesn’t expire for more than ten more years, while the tablet’s patent has already expired. The Reckitt Benckiser rep for my area told me months ago that the company was considering taking the tablets off the market.

I think the recent data about pediatric overdose with tablets gave RB a great excuse to pull their tablets off the market, “For the kids…” The drug company would be open to criticism if they pulled the tablets for a purely financial motive, but who could criticize a drug company for trying to prevent the death of children? I do wonder how pediatric overdose rates of Suboxone tablets compares with other prescription opioids, but after scouring the internet can’t find that information.

I wondered how RB’s decision will affect my patients. I’m worried about a small number of my patients who, for whatever reason, didn’t like the films. These patients are all doing great in their recovery, and show no sign of medication diversion. They aren’t “bad” patients trying to scheme a way to misuse medications. Many of them have been in stable recovery, assisted by Suboxone tablets, for more than three years. All tried the film when it was released, and found it lacking. Some patients didn’t like how the films were crumbling, a problem that seems to have resolved over the last six months. I have about twenty-five people in my practice who prefer Suboxone tablets to films.

Today in my office practice I saw three patients of these patients. All of them, by the way, keep their medication locked up and safely away from children. I explained the situation to them, and told them I would like to switch them to the film, because the tablets were going to be phased out over the next six months. Two grudgingly said they would switch but wanted to wait until it was absolutely necessary. The third said he’s prefer to switch to the generic buprenorphine tablets, because he hated the film and didn’t feel like it worked nearly as well.

Overall I don’t like to prescribe generic buprenorphine in the office, because it has higher street value and is easier to misuse. Since the generic buprenorphine has no naloxone in it, it can be injected. I don’t usually prescribe it unless the patient has no insurance, is stable in their recovery with no recent IV drug use, and can’t afford name brand Suboxone. In my area, the generic buprenorphine tablets are less than half the cost of either Suboxone film or tablet. For some patients, being able to buy the cheaper generic has made it possible for them to afford to remain in treatment. Their other option would be to go to the methadone clinic, and many patients prefer treatment in an office setting, obviously.

My patient today has been in recovery for three years. He has a sponsor, goes to 12-step meetings several times per week, has never had a positive drug screen the whole three years, has a stable home, wife, kids, and also finds time to help his aging parents. I’m going to prescribe generic buprenorphine tablets for him.

This won’t be the right answer for all my patients. Some will have to try the Suboxone films again, and I hope that will work for them.

Because of this pediatric overdose information I’m going to ask every patient – on films or tablets – how they store their medication, to make sure it’s safe.

http://www.alcoholismdrugabuseweekly.com/

Barring Healthcare Professionals from Working while on Buprenorphine

While buprenorphine has been prescribed for many patients over the last 10 years, there’s still controversy about whether healthcare professionals should be allowed to work while on buprenorphine.

In an article in March 2012 Mayo Clinic Proceedings, Hamza and Bryson  cite studies that support their conclusion that medical professionals should not be allowed to work while taking buprenorphine as maintenance for opioid addiction. The authors say studies show that people taking buprenorphine have some impairment when performing safety-sensitive tasks that are required in practice as a physician. (1)

I read this article with great interest, since I have been prescribing buprenorphine and telling my patients they won’t be impaired while taking a maintenance dose. Wanting to know if I am misleading patients, I scrutinized the studies cited in this paper.

I’m not sure the authors’ conclusions are backed up by the studies they cite.

The most worrisome misinterpretation was the Schindler et al study. The Mayo study by Hamza and Bryson interpreted the Schindler study thusly: “significant differences were found between them [methadone and buprenorphine groups] and the controls.” But when I read the original study, the authors’ conclusion was really the opposite: “The synthetic opioid-maintained subjects investigated in the current study did not differ significantly in comparison to healthy controls…” (2)

Hmmm…I’m confused.

When I looked at other articles cited by Hamza and Bryson, I discovered that what I read didn’t match Hamza and Bryson’s conclusions of what I read.

Three of the studies cited in the Mayo article (Pickworth et.al., Jensen et. al., and Zacny et.al.) all looked at healthy volunteers who were given buprenorphine, then tested to see if they were impaired. In other words, these test subjects weren’t opioid dependent. All three studies showed impairment, and I don’t doubt it, because opioid-naïve subjects would be expected to feel a great deal of opioid effect with their first dose of buprenorphine. But studies of opioids-naïve subjects given buprenorphine don’t seem applicable to opioid-addicted patients on buprenorphine for maintenance.

The Rapeli et al study looked at methadone and buprenorphine patients in early recovery, so these groups would be expected to be different than those on established maintenance therapy.

Soyka et al compared opioid addicts on buprenorphine and methadone at 2 weeks, then at 8-10 weeks. This study also had a control group. The patients on methadone and buprenorphine had impaired cognition on testing compared to the controls, but they improved with length in treatment. This study was randomized but not blinded. This means patients and researchers knew who was on methadone, buprenorphine, and who was a control subject. Interestingly, in a later letter to the editor defending their conclusions, Hamza and Bryson mistakenly claimed the study was double-blinded, but clearly it was not.  Also the study was relatively small, since only 46 patients completed the study. The purpose of the study was to see if methadone was more impairing than buprenorphine. The authors of the Soyka study didn’t conclude the buprenorphine group was impaired to the point they were unable to work, only that they performed better than methadone patients.

One study, by Messinis et al, did compare abstinent heroin addicts on naltrexone with opioid addicts on maintenance buprenorphine, and showed the buprenorphine group had more cognitive impairment than the naltrexone group in cognitive functions. To me, this is the main study that speaks to the actual issue of impairment. It gives a basis to require more studies be done. However, the small size of the study, 18 patients, limits the impact of this study. (3)

The ideal study to resolve this issue would be a double blinded prospective study of opioid-addicted healthcare professionals who are randomized either to abstinence-base treatment or buprenorphine maintenance treatment. Then cognitive abilities can be compared at various times during recovery, like 3 months, 6 months, 1 years, and 2 years. Such a test is unlikely to be done, since most addicted professionals enter abstinence-based recovery, and have a high rate of success.

I do think medication-free recovery is the ideal. I acknowledge that’s my bias, even though I strongly believe medication-assisted treatment is a life-saving option. But then, medication-free treatment is the ideal for all diseases. If a patient can achieve good blood pressure control by changing her diet and exercise, I think most of us would agree that’s a superior outcome to taking blood pressure medication to achieve the same result.

Most doctors and dentists have the resources to afford the prolonged inpatient treatment needed for medication-free recovery. The monitoring required for continued licensure is additional leverage and accountability that most opioid addicts don’t have after leaving inpatient treatment. These factors produce excellent recovery rates in these healthcare professionals, much better than that achieved by the average opioid addict.

But no recovery works for everyone. If a healthcare professional has failed traditional abstinence-based recovery, but is able to do well on medication-assisted recovery with buprenorphine, is the data strong enough to say such a recovering person on a stable dose of buprenorphine can’t work in healthcare?

We must be careful about this decision. If the decision is going to be based solely on patient safety, and not on a bias against medication-assisted recovery, then healthcare professionals on opioids for acute or chronic pain must also logically be removed from the workforce, unless we can prove they don’t have cognitive deficits from prescribed opioids. And what of other medications, like benzodiazepines, which are more likely than opioids to cause impairment?

If professional monitoring boards rely on the evidence cited by this study to refuse to allow healthcare professionals on buprenorphine to return to work, they leave themselves open to accusations inconsistent safety standards if they allow other healthcare professionals to work while being prescribed opioids or benzodiazepines.

It would be a mammoth task to monitor every healthcare professional who is prescribed a controlled substance. But if a professional on stable a dose of buprenorphine can’t work safely, how can we assume a surgeon who takes legitimately prescribed opioids for back pain is safe to work?

Frankly I suspect most of the posturing about the dangers of healthcare workers on buprenorphine is really an attempt to remove medication-assisted recovery as a treatment option for healthcare professionals. I don’t know if the mayo article authors, Hamza and Bryson, have any underlying bias against medication-assisted treatments, or perhaps biases favoring abstinence as the only worthy treatment goal. I don’t know these two people at all. But my impression is that they have taken a sweeping position supported by shaky evidence. The studies they cite are evidence enough to call for larger studies, but don’t seem adequate in themselves to deny a potentially life-saving treatment to a healthcare professional.

1. Hamza H, and Bryson E, “Buprenorphine Maintenance Therapy in Opioid-Addicted Health Care Professionals Returning to Clinical Practice: A Hidden Controversy, Mayo Clinic Proceedings., 2012, 87(3);260-267
2. Schindler SD, et al, “Maintenance therapy with synthetic opioids and driving aptitude, European Addiction Research, 2004; 10(2):80-87acol.
3. Messinis et al, “Neuropsychological functioning in buprenorphine maintained patients versus abstinent heroin abusers on naltrexone hydrochloride therapy”. Hum. Psycholpharm. 2009;24(7):524-531

Taper Off Suboxone: Using the Films

When my Suboxone patients are ready to taper off the medication, I prefer to use the film. Since the film is no longer crumbling, patients can take sharp scissors or a knife and cut the films into smaller pieces roughly equal in size, ideal for a taper. Yes, I know the manufacturer says we shouldn’t cut the film or the tabs, because they have not done studies to see if the medication is equally distributed throughout the entire film or tablet. But cutting is a great way to taper, it seems to work, and everybody’s been doing it since Suboxone came out in 2003.

Most of my patients who successfully tapered off were on Suboxone at least two years, and did the work of counseling before attempting a taper. Most recent studies show high relapse rates if tapered too soon, probably because it takes time to get the essential counseling and make life changes that support a new life without drugs.

How long should the ideal taper take? It depends on the patient’s tolerance of opioid withdrawal symptoms. I’ve been telling patients four to six months is an average taper. I’ve been decreasing the dose by 2 mg every 2 weeks, until the patient is at 8mg or less. Most patients tolerate that fairly well, though patients differ markedly in their tolerance of withdrawal. At any time in the taper, if the patient starts feeling more withdrawal than they can tolerate, we can go back up a little, or plateau at a dose for a month or so.

Below 8mg, I reduce the dose more slowly, since each milligram is a bigger percent of the whole dose. I’ve been trying to decrease patients by 2mg every 4 weeks. This way when I see them every month, we talk about how they’re feeling, and if they’ve had a relapse (With any relapse to opioids, we go back up on the dose and work more on relapse prevention). For an 8mg film, this can be accomplished easily, by cutting the film into fourths. That’s a 25% drop in a month, or around 6.25% drop per week, at least at first. It’s common to have to stay on 4 or 2 mg for longer than a month.

Once the patient is down to 2mg, I switch to the 2mg film, and again have the patient divide it into fourths. I still try to drop by one-quarter of the film per month, meaning a half of a milligram decrease each month.

Sometimes we seem to get stuck at a dose. For example, I have a patient on a 2mg tab, which can be cut in half but is too small to reliably cut into fourths. He’s been trying to drop to 1mg but can’t tolerate staying at that dose for more than a day or two. So at his last visit, we decided he would alternate 1mg per day with 2mg per day. He did better with that, and now we are trying two days of 1mg and one day of 2mg, in a cycle every three days.

Then today, in my latest issue of American Journal on Addictions, there’s an article that throws a monkey wrench into my ideas around tapering.

This article has case reports of four patients who stopped Suboxone suddenly, unplanned. They were on doses ranging from 12mg per day to 30mg per day, and all four had only one or two days of mild opioid withdrawal, then felt fine.  The author concluded that these patients, “Showed no objective signs of opiate withdrawal following abrupt discontinuation of chronic buprenorphine/naloxone treatment…” The authors postulated that a prolonged taper might actually be harder on patients than stopping suddenly at a higher dose, based on these four case studies and other doctors’ impressions. Three of the four patients returned to buprenorphine/naloxone treatment when they had the opportunity, for fears of relapse, and the fourth was felt not to be appropriate for continued treatment with buprenorphine.

Could this be true? Might it be easier for patients to stop at a higher dose, rather than taper to a lower dose? Intuitively, a taper seems to be the best way to avoid withdrawal symptoms, but what if buprenorphine is different? It is an unusual drug. It’s a partial opioid agonist at the mu receptors, but it also has action on other opioid receptors. Might the action at other types of receptors be responsible for what was seen in those case studies? What about the monoproduct, Subutex?

The article’s authors conclude by recommending further studies comparing intensity of opioid withdrawal in patients undergoing rapid taper or sudden discontinuation versus patients undergoing a slower 28-day taper.

I’m so intrigued by these case reports that I’d love to see a large randomized trial to answer these questions. I have seen a few patients stop taking medication suddenly at higher doses and they said they didn’t have bad withdrawals…but then I have had many others who stopped suddenly and had terrible withdrawals.

Patients on Suboxone or Subutex, what do you think?

1. Westermeyer, Joseph MD, et. al. “Course and Treatment of Buprenorphine/naloxone Withdrawal: An Analysis of Case Reports,” American Journal on Addictions, 2012, Vol. 21 (5) pp. 401-403.

Update on Suboxone Films

In the past, I’ve blogged about how some of my patients were having problems with their Suboxone films. When they opened the foil packets, the films were broken into pieces or so fragile they broke when handled. But now over the last two or three months, my patients tell me the films are no longer breaking or fragile, making them easier to use.

I’m glad. The Reckitt Benckiser drug company, manufacturer of Suboxone, wants doctors to switch patients to film because it dissolves faster, is easier to use, is less dangerous to children because the package is so hard to open, and it’s less likely to be snorted. They also say it’s harder to divert and has less value on the black market. And they say tablets are more likely to trigger patients who were addicted to tablets.

There’s validity to much of that, but I believe the biggest reason they want patients to switch is because their patent on the film runs for at least seven more years. Call me cynical.

About half of my patients who tried the film didn’t like it. Nearly all were patients in good recovery, stable for months to years, and if they wanted to tablets rather than the film, I was OK with that. When the film became crumbly, a few more patients wanted to switch back to the tablets.

Now, I’m more enthusiastic about the films. I can prescribe the film with more confidence since they no longer crumble. I prefer to use the films for patients tapering off Suboxone. I know the drug company says the films (and tablets) shouldn’t be cut, but of course everyone has been cutting both. With sharp scissors, the films can be cut into equal and small portions, ideal for a gradual taper of the dose.

I have more success with tapers in patients taking the film. In my next blog, I’ll talk about some of the “recipes” for taper my patients and I have used.

Pain Management on Buprenorphine

I had a bit of writer’s block this week. I was pondering what topic I should tackle next on my blog. Then I got a phone call from a dentist’s nurse, and voila, problem solved.

I’m going to change the name and description of my patient to protect her identity.   “Sally” has been doing great the entire six months she’s been my patient. Sally was ready for recovery. Over the last ten years, she’s been to multiple inpatient programs, for up to three months at a time, for treatment of her opioid addiction. She had achieved some time in abstinent recovery, ranging from a few weeks up to nine months, but relapsed because she never felt normal off all opioids. She continued to have low-grade nausea, fatigue, and felt achy most days. When she saw me last summer, she’d been in a terrible relapse for around eight months, and had been injecting the opioid pills prescribed by a local pain clinic. Her husband was supportive, and appropriately worried Sally was going to die of an overdose.

Sally wanted to start Suboxone, but wasn’t expecting much from it. She’d investigated Suboxone on the internet, and thought her opioid tolerance was too high for this medication to work. However, but she wanted to try every option before entering a methadone treatment center. I also suspected Suboxone wouldn’t be strong enough, but agreed with her that it would be worth a try.

She felt normal within the first week. We started with 4mg on the first day, and then went to 8mg on day two. When we went to 16mg on day three, Sally was amazed and relieved that she felt back to normal. She didn’t feel high and she didn’t feel in withdrawal.

She hasn’t looked back since. Every urine drug screen, done nearly every visit, has been positive only for Suboxone. She goes to 12-step meetings, has a sponsor, and does service work at her home group. She’s relatively happy, though she still takes an anti-depressant to prevent a relapse of her depression, which has been severe in the past.

Anyway, I say all of this to point out how well she’s doing. She’s also getting her physical health concerns addressed, and started seeing a dentist to get her teeth fixed. She had neglected them during active addiction, and needed a great deal of work done. She opted for dental implants.

At her last visit, we discussed pain management after her procedure. The pain from many dental procedures can sometimes be managed with anti-inflammatories, but I knew dental implants were more complicated.  I told Sally I’d like to talk with the doctor who will be managing her post-operative pain. I wrote down my cell number for Sally to give to her doctor, rather than my office number, to allow her dentist to get in contact with me more easily. I told Sally to stop her Suboxone 36 hours pre-procedure, so that her opioid receptors wouldn’t be so blocked that short-acting opioids would be ineffective. We planned for her husband to hold the bottle of pain pills, and dispense as directed by her oral surgeon. I instructed her how to make the change back to Suboxone once she no longer needed pain medication. I planned to see Sally one week after the procedure, so I could make sure she was OK, and back on Suboxone.

I heard nothing until this morning. I got a call on my cell phone from Dr. “X’s” nurse. She said Dr. X had just finished the procedure, but didn’t feel comfortable prescribing opioids for an addict. Dr. X preferred for me to handle her post-operative pain.

I felt my temper flare immediately. “Gee, I wish your doctor had called me before the procedure so we could talk about this. Since I don’t do oral surgery, I don’t know how much pain patients usually experience. Surgeons usually manage their own patients after surgery. What does Dr. X usually prescribe for patients after this procedure?”

“Thirty pills of oxycodone 10mg. But the doctor wasn’t comfortable giving that many. He’s willing to give her only 15 pills.”

“You know, I gave her my cell number so your doctor could call me before the procedure. It’s better to decide all of this prior to the surgery, don’t you agree?”

“We don’t have time to call everyone.”

“But you called me today.” I felt a familiar twitch in my right eyelid. “Look, it’s OK for him to prescribe what he usually prescribes. After all, she will have as much pain as any other patient. In fact, because of her opioid tolerance, she may need a bit more than an average patient. We’ve talked to her husband and he’s going to hold the pill bott…”

She interrupted me, saying, “The doctor doesn’t want to get into some big deal, writing for a bunch of pain pills for an addict. The doctor wants you to take over prescribing for pain.”

“I know he does…” it came out as an evil splutter because I was thinking about how much Sally was probably paying this guy, who should have told her in advance that he wasn’t going to prescribe post-op pain medication. I know dental implants are not cheap and probably not covered by insurance. And I suspected this dentist, to whom she was likely paying a big pile of money, looked down on Sally because of her history of addiction. I felt anger.

“You know,” I said, spittle gathering at a corner of my mouth, “You know, it isn’t ethical to withhold pain medication if you do a procedure that causes pain.  I can understand he doesn’t want to write large amounts for an extended time, but we’re talking about an acute pain situation that will last what, about a week? He knows that better than me. He needs to prescribe what he usually does to any other patient. We’ve already talked to Sally about precautions to prevent a relapse.”

The dilemma was solved because apparently, a doctor was listening to our conversation at the nurse’s elbow. He indicated to the nurse that he would be willing to prescribe the usual amount. I was miffed that the doctor didn’t talk to me himself, but he may not have been the one who did Sally’s procedure. At any rate, that was what I wanted anyway, so I tried to be helpful and give them information for future use.

“You can call me any time about patients with both pain and addiction. It’s more complicated to treat them, but with proper safeguards it can be done without too much trouble…”

“Ok thanks. Thanks for talking to us.”

At that point it sounded like the nurse would rather get on with her work day than listen to me try to explain how addiction is a medical problem that can be managed just like any other chronic disease.

I was angry because the dentist didn’t call me before the procedure, and because he wasn’t honest with the patient. He neglected to tell her about his plans to write for less than usual the amount of pain medication. I was sad because I suspected that he looked down on this nice lady her because of her history of addiction…but not so much that he wouldn’t take her money for fixing her teeth.

It’s a shame, because that dentist could have learned something from Sally, like how she’s a funny, warm person who has courageously overcome a devastating and life-threatening illness.

Campy Fun: Buprenorphine Babe and Methadone Man

You’ve got to check out this website: http://www.methadoneman.org/

You’ll find Youtube clips of Methadone and Buprenorphine Babe as they fight the evil Mr. Stateside Stigma, the wiley Mr. Red Tape, and Mr. Thought Control. In the three clips, MM and BB describe some of the most common obstacles opioid-addicted patients face when trying to get proper treatment. The duo relates facts about the success of methadone and buprenorphine programs in the treatment of addiction, specifically how these medications reduce HIV rates and reducing death rates. MM and BB encouraged medication-assisted treatment advocates to speak out in favor of the medications, which now have over forty years of proof that they work.

My personal favorite villain was the Evil Mr. Stigma, because I encounter it so often in the rural counties where I work. All the villains look alike, which is appropriate, since they’re all based in fear.

Also on this site is a link where you can sign a petition to officials at the United Nations, advocating for increased access to these life-saving treatments. There’s also information on the 2011 Harm Reduction Conference, as well as the biennial International Aids Conference, next held in 2012.

You can also download a graphic, “The Adventures of Methadone Man and Buprenorphine Babe.”

Wonder if my clinic would buy me a “metha-bupa-porter” to get to work? It would sure save time and gasoline!

Misuse of Suboxone: What Should We Do?

I’ve been discouraged by the number of people who write to this blog indicating that they abuse Suboxone by snorting or injecting. I know that’s a small number of people, compared to the thousands that have used Suboxone to get their lives back, and who are in excellent recovery, but it still depresses me.

What should the addiction medicine community do? What should the government do, if anything? What about law enforcement?

In this country, most law enforcement people see abuse of Suboxone the same as any other street drug. For them, it’s usually black and white. If it’s not prescribed for you, or if you’re using it in a way that’s not prescribed, it’s a crime for which you should be prosecuted.

Harm reduction proponents see the situation wholly differently. Since Suboxone is usually safer than other illicit opioids (note I said safer, not safe), even when it’s misused, why not allow the illicit use? In fact, why not hand out Suboxone tablets to anyone proven to be an opioid addict? If the addict snorts or shoots Suboxone, at least he’s not shooting heroin, a much more dangerous drug. True, that person is susceptible to medical complications from injecting and snorting, but this would be true for any other opioid. And some studies indicate that most of the illicit Suboxone is bought by addicts either self-medicating in order to stay out of withdrawal, or giving the medication a try before making the financial commitment to go to a doctor’s office for a legitimate prescription.

In a purely scientific world, I would agree with the harm reductionists. But that’s not the world we live in. We should be sensitive and alert to political forces that would like to annihilate our present freedom to prescribe Suboxone from a doctor’s office. Doctors – and their patients – have to be good stewards of this freedom, by taking whatever measures are appropriate to keep Suboxone out of the hands of illicit users.

 So what can doctors do to reduce Suboxone diversion?

• Tablet counts and film counts. When I get a new patient, I have in my monitoring agreement that I will occasionally call them to go to their pharmacy (Some patients drive up to forty minutes one way to see me, so it’s more convenient to go to their pharmacy than to my office. Most pharmacists are happy to help.) for medication counts. If the count is short, either the patient is taking more medication than prescribed, or diverting it. Decreased diversion is the drug manufacturer’s big selling point for the films, rather than the tablets. They say that since each box has a lot number, if a patient has sold or given away some of their films, they can’t just buy replacement films to replenish before their count, like can be done with tablets. The lot numbers have to match. I can see where in theory that can be true…but I can also think of some ways to easily get around that, which I won’t post here.
• Urine drug screens to make sure buprenorphine is present in the urine. Screening should be done anyway, to check for other drug use. Doctors doing urine drug screens should, of course, have buprenorphine on their test panel. In the past this was an expensive test, but not at present. My on-site test kits cost less than $10 when bought in bulk, and test for buprenorphine, methadone, opiates, oxycodone, THC, cocaine, methamphetamine, and benzodiazepines. (I have individual test cassettes for other drugs, when indicated.) Obviously, if there’s no buprenorphine in the urine, we have a problem.
• Check the prescription monitoring program in your state. If the patient is getting prescriptions for other opioids, like morphine or oxycodone, it’s possible the patient stops Suboxone and uses these opioids between doctor visits. The other possibility is that they sell these other opioids, also not an acceptable situation, since it fuels other addicts’ addictions.

What can patients do to help keep Suboxone away from illicit users?

• Don’t share your medication. Even if someone you care about is in withdrawal, help him to get care from a legitimate source. Don’t endanger him and yourself by sharing medication. And of course…don’t sell your medication. Duh.
• Make sure you keep your Suboxone in a lock box, or other safe place. Not only will this keep your medication away from children, but also from addicts looking for opioids. Many patients new to recovery haven’t yet cut off ties with all drug users, and other addict “friends” may be looking for medication.
• If you know of a Suboxone patient who’s selling medication, tell their doctor. You don’t have to call the police to get them into legal hot water, but you should do all you can to stop the illegal sale of any prescription medication. After all, a patient selling Suboxone is endangering your right to get convenient, office-based treatment.
• Family members: please call your loved one’s doctor if any part of their Suboxone prescription is being sold or given away to other people. Because of confidentiality, we may not even be able to confirm that your loved one is a patient, but we can always take information from you. We may do pill counts or other things to confirm what you are telling us, and then take action.

What are the possible consequences of continued diversion of Suboxone? Some authorities are talking about changing the DATA 2000 law. Others are clamoring for buprenorphine to be re-scheduled into a schedule II opioid, which would disqualify it under DATA 2000 for use in an office. It would still be available at an opioid treatment program. And many OTPs (opioid treatment programs) do now offer buprenorphine.

I advocate for continued availability of office-based buprenorphine treatment, but now I believe some patients should start at an OTP, and transfer to office-based program only if they do well. Some patients are so strongly addicted to other drugs that they don’t do well in office-based treatment.

I now work at a wonderful opioid treatment program that offers both buprenorphine and methadone upon admission. I’ve switched a few selected patients to my office-based practice. This means I see them and write a prescription for them to fill at a pharmacy, no longer chaining them to daily OTP dosing. I still see them at regular intervals, usually every one to two weeks. These patients can still contract with the OTP for individual counseling and drug testing. This allows the OTP to have a wider variety of treatment options for their patients, gives me a stable patient, and gives patients who are doing well more freedom and treatment at a lower cost. Win, win, win.

I hope more OTPs will begin to offer buprenorphine as a real option to methadone, so that patients who don’t do well in office-based programs can still be on buprenorphine. And I hope they direct the stable patients to office-based programs.

Information on Crumbly Suboxone Films

I called Reckitt-Benckiser for information about the crumbling Suboxone films reported by my patients. I spoke with a nurse who was familiar with the problem. She said that around the end of May of this year, the drug company began getting reports of crumbling Suboxone films. As it turns out, three lots of film were affected, with problems of dry and crumbling films. R-B asked pharmacies to pull the affected lots from their shelves for return to the company. Apparently there was a malfunction during manufacturing of affected lots starting with an “M” or “L.” The nurse I spoke with acknowledged that some pharmacies may still be inadvertently dispensing films from the affected lots, but the problem has been fixed and shouldn’t recur with future lots.

She said the company reported this problem to the FDA, and also did analysis of crumbling films returned to R-B. She says the scientists’ tests showed that despite the crumbling, the appropriate amount of buprenorphine was released from these films. However, she recommended that patients return crumbling films to their pharmacy. The pharmacy should replace them, and Reckitt-Benckiser will credit the pharmacy. This goes only for unused films, however. Used films will not be replaced, for obvious reasons. Patients can also call Reckitt-Benckiser at 1-877-782-6966 for more information. You should have the lot number off the box or film envelops to report problems.

I’m pleased with the company’s responsiveness to problems. I was pleasantly surprised with the amount of knowledge the nurse at R-B had about addiction.

Drug tests and Suboxone (buprenorphine)

Even some treatment professionals and medical professionals have mistaken ideas about drug testing for buprenorphine.

Because it’s a man-made opioid, buprenorphine won’t show as an opiate on a drug screen. It won’t cross-react with tests for oxycodone or hydrocodone. A specific test for buprenorphine must be done in order to detect its presence. In the past, this test was expensive, but now can be added to a drug test fairly cheaply.

I test for buprenorphine because I need to make sure my patients are taking their medication, and haven’t given it or sold it to someone else. Fortunately, I’ve never had a patient to whom I’m prescribing Suboxone have a urine drug screen that didn’t show the medication.  

My patients ask me if the Suboxone I prescribe for them will show up on employment testing, and I answer no, it’s unlikely. Most employers don’t check for methadone, and are even less likely to check for buprenorphine. Employers won’t know unless you tell them you’re on Suboxone. (Methadone, like Suboxone, has to be tested for on a separate test, and won’t show as an opiate.)

Should you tell them? That’s a question you’ll need to answer for yourself. Ordinarily I’m an advocate of honesty, but because Suboxone is usually prescribed to treat opioid addiction, disclosing this information more or less informs them you’ve had a problem with addiction. Is that your employers business? No, I think not, unless it’s a “safety sensitive” job, and even then it’s often not appropriate to tell your employer.