Archive for the ‘pill counts’ Category

Pharmaceutical Companies Behaving Badly

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Officially an Epidemic

 

It’s official. Prescription drug abuse in the U.S. is now called an epidemic by the Centers for Disease Control and Prevention. In November, CDC officials released a new report of prescription drug addiction. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm?s_cid=mm6043a4_w

It’s really interesting reading.

The CDC points out that prescription opioid overdose deaths now outnumber heroin and cocaine overdose deaths combined and prescription opioids were involved in 74% of all prescription drug overdose deaths.

The breakdown of their data by state is particularly interesting. The states with the highest rates of opioid overdose deaths are, in descending order: New Mexico, with a rate of 27 deaths per 100,000 people, then West Virginia, Nevada, Utah, Alaska, Kentucky, Rhode Island, Florida, Oklahoma, and Ohio. Tennessee missed the top ten, but was still 13th highest in overdose deaths, with a rate of 14.8. North Carolina’s rate was 12.9 per 100,000 people, which put North Carolina 24th out of 50 for prescription overdose deaths. That’s too high, but much improved since 2005, when North Carolina was in the top five states for prescription opioid overdose deaths. The lowest opioid overdose death rate was seen in Nebraska, with 5.5 deaths per 100,000 people.

The CDC also analyzed information about the amount of opioids prescribed in each state. They measured kilograms of opioid pain relievers prescribed per 10,000 people in each state. The state with the highest rate had over three times the rate of the state with the lowest rate. It’s no surprise that Florida had the highest amount, at 12.6 kilograms per every 10,000. Illinois had the lowest amount, at 3.7 kilograms per 10,000 people.

The big surprise: Tennessee has the second highest amount of opioids prescribed, adjusted by population. (OK, they tied for second place with Oregon). Yep. Tennessee, the state that refuses to allow more opioid treatment centers to be built within its borders, has 11.8 kilograms of opioids prescribed per every 10,000 people.  But since I want to devote an entire blog entry to Tennessee’s backward outlook on addiction and its treatment, I’ll defer further comments about that state.

Sales of prescription opioid quadrupled from 1999 to 2010. According to the CDC, enough opioids were sold last year to provide a month of hydrocodone, dosed 5mg every four hours, for each adult in the U.S.

The CDC estimates that for every prescription overdose death, there are at least 130 more people who are addicted or abuse these medications, and 825 who are “nonmedical users” of opioids. (I’m still not sure how nonmedical users differ from abusers. To me, if it’s nonmedical, that’s abuse.) Not all of the 825 are addicted or will become addicted – but they are certainly at risk.

Just like what was found in other studies, people who abuse opioids are most likely to get them for free from a friend or relative. So if you are giving pain pills to your friends or family members, you are part of this large problem.

In 2008, 36,450 people died from prescription overdose deaths. That was nearly equal to the number of people who died in auto accidents, at 39,973. In fact, in seventeen states, the number of overdose deaths did exceed auto accident deaths.

The CDC authors conclude that the prescription opioid addiction isn’t getting any better, and in measurable ways, it’s worsened, with some states worse than others. The worst areas, not surprisingly, have higher rates of opioid prescribing that can’t be explained by differences in the population. To me, this means doctors in some states are overprescribing, or at least aren’t taking proper precautions when they do prescribe opioids.

In my next blog entry, I’ll explain how people and organizations in North Carolina have been working hard to deal with the prescription pain pill addiction problem. Based on information from the CDC, it appears my state has made some major progress, at least compared to one of our neighboring states.

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.

Dosing Methadone for Pain versus Addiction

Using methadone for pain is different from using methadone for addiction.

It’s illegal in the United States for a doctor to prescribe methadone for the purposes of treating addiction, unless she is working at an appropriately licensed Opioid Treatment Center. Some doctors don’t know this, and have had grumpy DEA agents pay them a visit. However, it is legal for a doctor to prescribe methadone for pain, as long as she has an appropriate DEA license.

Methadone is prescribed differently when treating pain than when treating addiction. This is because each dose of methadone has an analgesic (anti-pain) effect of about six hours. However, methadone’s opioid blocking effect lasts for twenty-four hours or more. This is why methadone for pain should be dosed multiple times per day, but methadone for addiction can be given once per day.

The dose of methadone often varies, too, depending on the disease being treated. Doses of methadone 10 to 20mg, dosed three to four times per day, are adequate to treat pain for many patients. When treating addiction, studies have shown that patients do better when the doses are high enough to block other opioids. Usually, this occurs at doses 80 – 120mg per day, given as one dose. The patient doesn’t become sleepy or sedated at this dose because the dose is raised gradually, allowing time for tolerance to build to the sedating effect.

Some patients prefer to stay at a low methadone dose, so they can still feel intoxication from illicit opioids like heroin or oxycodone. For example, one patient told me he liked keeping his dose around 60mg, which was high enough to stave off the worst of his withdrawal symptoms. But it was also low enough to allow him to feel high from an injection of heroin in the evenings. He resisted going up on his dose as recommended by his treatment team.

Doctors have to be very careful prescribing methadone for pain. The very characteristic of the drug that makes it effective to treat addiction, its long duration of action, also makes it dangerous to prescribe. Too many patients, experimenting with methadone for the purpose of getting high, die of a drug overdose. Tolerance to the euphoric effect of methadone develops more quickly than the tolerance to the sedative effects. People consume a fatal dose before feeling high.

Over the last decade, the incidence of overdose deaths from methadone rose sharply. Most of these deaths were from people taking methadone pills, dispensed from local pharmacies, and prescribed by doctors who were treating patients for pain. Along the way, many milligrams were diverted to the black market, with disastrous results. Some methadone was diverted from opioid treatment centers, but appears to be a fraction of the total.

Given the overdose potential of methadone, it should be used cautiously when prescribed by physicians for pain. Soon, doctors may be required to take a training course before they can prescribe the long-acting opioids. This training will educate doctors on how to recognize if a patient is developing the complication of addiction, and to identify evidence of drug diversion.

Pain Pill Addiction: Prescription for Hope

Finally, here’s the cover of my book about pain pill addiction and its treatment. It’s available at http://prescriptionforhope.com or you can order it from Amazon, and soon from Barnes and Noble.

My book contains much of what I’ve been blogging about. I wrote the book because there are so few sources of reliable information about the treatment of opioid addiction (pain pills). It seems  that abstinence-based programs don’t like to talk about medication-assisted programs, and some methadone clinics don’t let their patients know about other options. Methadone and buprenorphine can be life-saving when used appropriately, but they have some drawbacks, as well.

There’s not one single right answer for all opioid addicts. Some treatments work for some patients, but no treatment works for all patients. In my book, I present the data supporting treatment methods, so opioid addicts and their families can chose the best course.

If you like this blog, you’ll like my book. I also have a chapter in the book about the unjust stigma patients face when they are treated with medication-assisted methods. It takes a strong person to stay on a treatment that helps them, despite criticism from friends, family, law enforcement, and even unenlightened medical professionals.

Film Review: Suboxone

I had a chance to get more information about the new Suboxone film. I’ve decided I like it. It looks like one of those Listerine breath strips, and dissolves like one, too. When placed under the tongue, it dissolves faster than the tablets, but the taste is apparently about the same. The drug company’s representative brought me an inert (no active drug) film that’s supposed to taste exactly like the real thing. It was orange-flavored and bitterly sweet. While not terrible, it wasn’t tasty. But it was bearable. It dissolved very quickly, an advantage over the tablets.

I was concerned that my patients on 4mg or 12mg couldn’t use these films, as I heard they couldn’t be cut. But the drug company rep said the drug was evenly distributed on the film. Though the company’s official position was the film shouldn’t be cut into halves or fourths, it would probably work.  But she also reminded me that the drug company also says that about the tablets, but my patients use half-tabs frequently with no ill effects.

I don’t see any way the film can be snorted, though some creative and intelligent addict will probably find a way.

The films are contained in individual sealed pouches. Each pouch from the same box has the same number on it, meaning it would be very difficult to “fake” a pill (film) count if the doctor asked a patient to return to the pharmacy to make sure the appropriate amount of medication remains. If films from another box are substituted to make the count right, they will have different numbers. Very clever of the drug company. Oh, and the rep said the film would cost the same as the Suboxone tablet.

The film is available in pharmacies willing to stock it. If you are on Suboxone and want to try the film, be sure to ask your pharmacy to order it a few days before you think you will want to fill a prescription, to make sure they’ll have it.

I hope this delivery form is easier for patients and harder to divert or snort.

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