Archive for the ‘Misuse of Suboxone film or tablet’ Category

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

aahuzzah

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.

Complications of Intravenous Buprenorphine (Suboxone, Subutex) Abuse

Endophthalmitis from IV drug use

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Since I started this blog, some of my readers have educated me about how frequently addicts use Suboxone and Subutex intravenously. I think some of these addicts have become blasé about the reality of complications that can occur from injecting a medication that’s not meant to be injected.

Like oral opioids, Suboxone and Subutex tablets and films aren’t sterile. Bacteria live everywhere, including inside an on oral medication. Since the medication is meant to be taken by mouth, these bacteria don’t harm the user when swallowed or used sublingually as intended. But when injected, these bacteria have the potential to cause catastrophic illness, depending on the nature of the bacteria.

Skin and bloodstream infections, endocarditis

Most commonly, we see cellulitis, a soft tissue infection, around the site of the injection. Sometimes the infection walls off and forms an abscess that usually must be drained. The infection can spread to the walls of the vein, causing angiitis. These infections can spread to the rest of the body, and can lodge in special areas that cause big problems. For example, endocarditis, an infection of one of the heart valves, occurs more commonly in IV drug users. It’s difficult to treat endocarditis, and requires lengthy antibiotic treatments. Sometimes this infection can destroy the heart valve and the patient may require surgical replacement of the valve. People can die from this serious infection.

Some of Singapore’s large population of intravenous heroin users switched to buprenorphine when it became available, but with that availability came an increase in complications from addicts who injected buprenorphine rather than use it as intended.

Researchers studied a series of one-hundred and thirty intravenous buprenorphine addicts that came to a Singapore hospital for treatment for infections. Of those, 31% had cellulitis. In nearly half of those patients, skin and blood cultures were positive for bacteria, most for Staph aureus. Twenty-four percent of the patients with skin infections eventually required surgical procedures, and the average length of stay in the hospital was eight days. (1)

A different study, also done in Singapore, looked at twelve consecutive patients admitted to the hospital with infective endocarditis from using buprenorphine intravenously. Eleven of the twelve patients had Staph aureus in their bloodstream, and five of them died. The average length of stay was 48 days, and multiple medical complications were noted. Three patients required open heart surgery. (2)

Fungal Endophthalmitis

Bacteria aren’t the only unwelcome travelers hitching a ride on a buprenorphine tablet. Fungal endophthalmitis is rare in people who have not had eye surgery, yet it is seen in intravenous addicts in general, and now specifically in addicts injecting sublingual tablets. At least four cases of endophthalmitis in intravenous users of buprenorphine tablets occurred within a year at one Australian hospital. These serious inner eye infections developed due to a type of Candida fungus usually found in the mouth. One of the patients admitted injecting a tablet that had been in her friend’s mouth for a short time, prior to diversion of the tablet to the patient. The oral candida species likely contaminated the buprenorphine tablet through this method.

In the 1980’s, a series of cases of candida endophthalmitis was seen in users of brown heroin. At that time, scientists thought the Candida came from lemon juice used to break down the heroin for injection. However, none of these four intravenous buprenorphine abusers used lemon juice. (3)

It is possible we will see more cases of fungal infections in patients who inject buprenorphine that has partially dissolved in another person’s mouth, due to the oral contamination of the pill.

Talc Granulomatosis

Tablets meant to be taken by mouth or sublingually (under the tongue) often contain talc as a filler. Heroin is sometimes cut with talc, to make more product to sell on the street. When these substances are injected, they can cause talc granulomatosis. Many addicts don’t get regular check-ups and most are reluctant to tell doctors about their IV drug use, even during serious medical problems. This condition is likely under-recognized because on the chest X-ray, talc granulomatosis looks like other interstitial lung diseases. The talc crystals lodge in the lungs, and cause an immunologic response. This in turn causes trouble breathing, dry cough, and low oxygen levels. Respiratory failure and death can occur in the worst cases, since there are no definite effective treatments. In some studies, patients with talc granulomatosis have improved when given corticosteroids, but tend to get worse again as soon as the medication is stopped.

Tablets meant to be used under the tongue aren’t sterile and aren’t suitable to be injected. Tablets diverted from patients who partially dissolve them in their mouths may be particularly hazardous due to contamination with mouth bacteria.  Addicts who inject tablets meant for orally use risk catastrophic health problems beyond overdose.

If you are an intravenous drug user, don’t fool yourself into thinking you’re safe because you use new needles and “works” each time. New needles do reduce the risk of contracting hepatitis and HIV, but oral pills still contain substances that were never meant to be injected.

  1. Ho et al., “Cutaneous complications among i.v. buprenorphine users,” Journal of Dermatology, 2009, Jan;36(1) pp22-
  2. Chong et.al., “Infective Endocarditis due to intravenous Subutex abuse,” Singapore Medical Journal, 2009 Jan;50(1):34-42.
  3. Alboltins et. al., letter to the editor, Medical Journal of Australia, April 18, 2005, Vol 182(8) p.427.

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.

Drug Tests for Patients on Suboxone or Methadone

“Why do I have to do a drug screen? Don’t you trust me?”

Lately a few of my Suboxone patients seem to be questioning the need for drug screens. Some of them resent the tests, and resent paying for them.

So why do I do drug tests?

  • It’s good medical practice. Like many chronic illnesses, relapses happen. It’s better to detect these as early as possible, to discuss what happened, and if/how we need to change their treatment. If a patient has relapsed to opioids, it may mean that I need to increase the dose of Suboxone, if they were still able to feel an opioid high. If the relapse was to other drugs, it usually means we need to increase the “dose” of addiction counseling.
  • There’s a gold mine of information in relapses. I ask my patient what happened immediately before the relapse. Was she around people who were using drugs? Did she use drugs to try to get rid of an unpleasant emotion? Did she use drugs because she became complacent? The answers can help decide how best to avoid relapses in the future. If a patient is fortunate enough to live through a relapse, she can get information she can’t get any other way.
  • Drug screening benefits the patient by giving them accountability. Some patients are less likely to relapse with accountability. I’ve had patients say that the thought of having to talk about a relapse is enough to keep them from using drugs. This surprises me, but I’m glad.
  • Drug screening also shows them I’m serious about their recovery. I’m not just going through the motions of writing a prescription and getting paid for the visit. I really want my patients to recover and get their lives back.
  • Patients in treatment don’t always tell me when they’ve relapsed. In order for addiction to thrive, lies must be told. Otherwise honest people sometimes tell outrageous lies while they are in the throes of addiction. I see this as part of the disease. It’s not about them. It’s not about me. It’s the addiction.
  • I’m not a human lie detector. In the past, I smugly thought I could tell if someone had relapsed, so drug screens just confirmed what I already knew. After more experience, I know that’s not true.
  • It’s the standard of care. Even if the other reasons aren’t compelling enough to do drug screens, the vaguely increased regulatory oversight of doctors who prescribe Suboxone should induce them do drug screens. I know if my charts are ever audited by the DEA (unlikely), my state’s department of health and human services, or my state’s medical board (more likely), I want to show I’m doing things in the proper manner.
  • I don’t want to prescribe medications that will be diverted to the black market. Some doctors say, with some justification, that buprenorphine is a safer drug than most other illicit opioids, and we should look at black market diversion of buprenorphine as a form of harm reduction. However, governmental types don’t see things that way. The DEA certainly doesn’t. I don’t want to prescribe buprenorphine to people with the criminal intent of selling part or all of it. When I do urine drug screening, if there’s no buprenorphine present, that’s a serious matter. If the patient isn’t using what I prescribe, it’s likely they are selling it. Since such diversion of Suboxone endangers the whole program, it’s essential to stop prescribing for people who sell their medication.

These are my reasons for drug screening. Since I’m not going to stop doing them, addicts who object to screening have had to find new doctors. New opioid addicts who come to my office are told, both verbally and in writing, that I do drug screening. They can make their own decision about whether they want to see me as their doctor or go elsewhere.

Smuggling Suboxone

I was intrigued by an article I saw on my internet homepage. It was titled: “When Children’s Scribbles Hide a Prison Drug”

http://www.nytimes.com/2011/05/27/us/27smuggle.html?_r=1&hpw

 This article describes unique ways Suboxone is being smuggled into jails. Law enforcement officials associated with both state and county jails from Maine and Massachusetts were interviewed. They say prisoners and their accomplices make Suboxone into a paste and smear it over the surfaces of papers sent to prisoners from their families. The article mentions the paste being spread over children’s coloring book pages, and under stamps. Suboxone films have been placed behind stamps or in envelope seams. Correctional officers now have to inspect material coming in the mail to prisoners much more closely.

 I had several thoughts. First, yet again, I’m struck by the creativity and cleverness of addicts. If only they could channel this energy in the right direction, amazingly good things could come to them, instead of the continued hardships brought by addiction.

 Then I felt sad that such actions described in the article would taint the reputation of a medication that has the potential to save lives, when used appropriately. Such illicit use of Suboxone gives ammunition to those who would prefer that office-based treatment with Suboxone didn’t exist.

 Then I wondered, how many of these prisoners have a legitimate prescription for Suboxone, but are denied their medication by prison officials? How many are legitimate patients of methadone clinics, also denied their medication while imprisoned, who know that Suboxone will alleviate some of the opioid withdrawal they are feeling? How many of these people are addicted to opioids, not in any kind of treatment, but who know Suboxone will treat their withdrawals?

At least one study supports the idea that many people use Suboxone illicitly not to get high, but to prevent withdrawal. Dr. Schuman-Olivier studied 78 opioid addicts entering treatment. Nearly half said they had used Suboxone illicitly prior to entering treatment. Of these people, 90% said they used to prevent withdrawal symptoms. These addicts also said they used Suboxone illicitly to treat pain and to ease depression.

Many law enforcement personnel and members of the legal community have strong biases against medication-assisted treatments. They don’t understand that addiction is a disease, and that methadone and buprenorphine are legitimate, evidence-based treatments. They have difficulty letting go of their idea that addiction is a choice that deserves blame, and have a punitive stance towards addicts. They have low opinions of addicts who are using drugs, but often have no better opinion of a recovering addict who has sought treatment and is doing well on replacement medications, like methadone or buprenorphine.

 But no matter what law enforcement personnel think they know, when they deny prescribed, life-saving medications, I believe they’re practicing medicine without a license.

The article mentions one woman who, with the aid of the Maine Civil Liberties Union, sued because her Suboxone treatment had not been continued while she was in jailed for a traffic violation. She settled out of court, but her lawyer made the excellent point that if inmates are denied their medications, they will try unlawful means to get it.

Other patients and their families have brought successful lawsuits against the jail facilities. In at least two cases, in the same Orange County, Florida jail, patient/prisoners were allowed to go through withdrawal for so long that they died. The estate of one person won a three million dollar judgment against the county. (1, 2)

I’m glad to see these lawsuits. I’ve heard appalling stories from many methadone patients, who were denied their medication while incarcerated. I’ve heard tales of jailers taunting these prisoners, when they became sick. There is no defense for such cruelty.

Orange County now works with local methadone clinics. If a prisoner is a current patient of a clinic, his clinic will send a week’s worth of medication in a locked box via courier. Nurses at the jail have the key to the box, and administer each day’s dose. The jail doctor consults with the medical director at the methadone clinic. Prisoners still have to pay out of pocket to get the medication, so the only cost to the jail is the time required for personnel to administer the medication. It’s certainly much cheaper than paying three million to the estate of a dead prisoner, not to mention much more humane.

I wish the county jails around the methadone clinic where I work would approach the problem of opioid addiction and treatment in a collaborative way. Sadly, only seven state prison systems offer medication-assisted treatment with methadone or buprenorphine.

Rikers Island, in New York City, gives us another example of how such a system could work. There, opioid-addicted prisoners charged with misdemeanors or low grade felonies can be enrolled in a program known as KEEP (Key Extended Entry Program). This program treats opioid addicts with methadone and counseling. Upon release from Rikers Island, these patients are referred to methadone treatment centers in the community. Seventy-six percent have followed through with their treatment, post-release. The results of this program show significant reduction in reincarceration and significant reduction in criminal activity. (3)

Drug courts trying to save money would be well-advised to look at the Rikers Island program. Studies have shown a cost savings of at least four dollars for every one dollar spent on methadone treatment. This money is saved because methadone patients require fewer days of hospitalization and other healthcare costs, and also because of reduction in criminal activity and incarceration costs. (3, 4)

I know from comments written to this blog that there are many more people abusing Suboxone than I previously imagined. For sure, some of the prisoners getting smuggled Suboxone are misusing it. But I don’t think the majority are using for anything other than prevention of withdrawal, since they are usually not offered any other effective treatment for this medical condition.

  1. “Outrageous: the death of Susan Bennett raises serious questions about the competence and quality of the jail’s nursing staff” Orlando Sentinel, editorial, March 27, 1998.
  2. Doris Bloodsworth, “Inmate begged for methadone” Orlando Sentinel July 12, 2001.
  3. Par`rino, Mark, “Methadone Treatment in Jail,” American Jails, Vol: 14, 2000, issue 2, pp 9-12.
  4. California Department of Drug and Alcohol Programs, 2004, California drug and alcohol treatment assessment (CALDATA) California Department of Alcohol and Drug Programs. California Drug and Alcohol Treatment Assessment (CALDATA), 1991-1993 [Computer File]. ICPSR02295-v2. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2008-10-07. doi:10.3886/ICPSR02295

 

Best Treatments for Addicts who Snort or Inject Suboxone

Suboxone misuse is much more common than I realized, as I’ve learned from people who write comments to this blog. These opioid addicts have described how they snort, inject, and even anally insert the Suboxone that’s meant to treat their addiction.

Not every addict can be treated with Suboxone from a doctor’s office. For some patients, the addiction is too strong, and they are unable to use the Suboxone as instructed. If a patient is injecting or snorting the medication meant to help them, they aren’t in recovery. These addicts need to be referred for another form of treatment. They aren’t being helped with Suboxone, except that perhaps it’s a little safer then other abused opioids, since at least there’s a ceiling on its opioid effects.

 What are the best options for these addicts? 

Most aren’t willing to go to inpatient detox followed by prolonged (one to six months) residential drug rehabilitation. It’s costly, and no one likes to be away from home for that long. However, this form of treatment can be life saving and gives the best chance of drug-free recovery.

Or they could enroll in an opioid treatment program, called OTP for short. In the past these facilities were called methadone clinics, because that was the only medication offered, but now many clinics also use buprenorphine. I’m glad to see this trend. For many patients, buprenorphine is a better drug. Patients tend to feel less medicated, and are less likely to feel any euphoria from buprenorphine. And the clinic gives patients more structure than I can from my office.

At OTP (opioid treatment programs) the patients are seen every day. Most clinics are open at least six or seven days per week. That way, patients can be given an observed dose each day. They won’t be able to misuse their medication, since a nurse places the tablet or film under the tongue, with buprenorphine. Methadone, dispensed as a red liquid, is swallowed each day in the presence of the nurse. Diversion to another person certainly isn’t impossible, but it’s much less likely to occur.

 So to all of the addicts now using Suboxone in unorthodox ways, snorting, injecting, and other ways, tell your doctor what you are doing. You can get your addiction treated by going to a clinic each day. Counseling is built into the opioid treatment program system. Patients there must see their counselors, and many clinics also make group sessions mandatory.

 I’ve become gradually more selective about who I’m willing to treat with Suboxone in my office. I’m more vigilant about medication misuse, since this blog taught me that it happens much more frequently than I previously thought. I now believe that only very stable opioid addicts should be treated in an office setting. Older addicts with jobs, families, and no other addictions appear to do the best in this type of treatment. From now on, if I have openings for new patients, I’m going to screen more rigorously. Many addicts have an addiction that’s too severe to treat with office-based therapy.

Use of Prescription Monitoring in Suboxone Patients

I enthusiastically use my state’s prescription monitoring program. This database is available only to physicians who have applied and been approved for access. It records all controlled substance prescriptions filled by a patient, the prescribing doctor, and the pharmacy where they were filled. This means it records prescriptions for opioids, benzodiazepines, anabolic steroids, most sleeping pills, and prescription stimulants. Any prescription medication with the potential to cause addiction will be listed. Medications such an antibiotics, blood pressure medication, etc, aren’t controlled substances, and aren’t list on the website. 

I use this database in several ways.

It can help me decide if a new patient is really addicted to opioids, and appropriate for treatment

If a new patient has a urine drug screen that’s negative for all the opioids, and has no record of getting prescriptions for opioids, I’ll have to see objective evidence of addiction before starting to treat him with Suboxone. But if the urine is negative, and I see monthly oxymorphone prescriptions (sometimes missed on urine drug screens) have been filled, it’s more likely this patient is appropriate for Suboxone treatment. Rarely, a misguided, misinformed person might claim to be addicted to opioids in order to be prescribed Suboxone. This happened once to me, with a patient who was addicted to Xanax, and was convinced Suboxone would cure her. I referred her to more appropriate care.

Using the database can help detect a relapse sooner

Most of the patients in my Suboxone practice (around 80%) are pill takers, not heroin users. When they relapse, it tends to be to prescription opioids, obtained from a doctor unfamiliar with their history of addiction. I check each patient on the state’s database just prior to each visit, and if there are medications on the site I didn’t know about, that will be the main topic of our visit. New medication on the database doesn’t always mean a relapse, so I need to listen to their explanation.

 When it does mean a relapse, the patient and I decide what to do next. Often, the patient decides to allow me to call the other doctor, agrees to increase her “dose” of counseling, and possibly her dose of Suboxone, if it was an opioid relapse. If there are repeated relapses, I may decide Suboxone, as an outpatient, doesn’t provide the support a patient needs. Then, I refer to another form of treatment. Usually this means to a long-term inpatient drug rehab, or to an opioid treatment center, where the patient comes to the clinic every day. Either way, I believe I’m able to address a relapse more quickly using the database.

 Frequently, Suboxone patients get prescriptions for benzodiazepines. That’s a problem for me. For a person without addiction, benzodiazepines can be helpful, mostly used short-term. But for people with addiction, they usually cause problems, sooner or later. People with a previous addiction to any drug, especially including alcohol, need to regard prescription benzodiazepines as high-risk medications.

 I try to be flexible, too. If a traumatic event has occurred in the life of a patient, I may OK benzodiazepines short-term, provided I can see the patient more often and have good communication with the doctor prescribing the benzodiazepines.

  I also have to remember the body reacts the same to a mixture of opioids and benzos, no matter why they’re taken.  Even though Suboxone is safer than methadone, it’s still not safe when mixed with benzos, when taken for any reason.

If this sounds wishy-washy, that’s because it is. So many situations arise in the lives of patients that one hard and fast rule just doesn’t exist. That’s the art of medicine.

 Is the patient filling Suboxone on time?

The database also shows me when patients are filling the Suboxone prescription. If I write a prescription today, but the patient doesn’t fill it for two weeks, what’s going on there? Has he relapsed for several weeks? Did he have a stockpile of Suboxone from a previous prescription? Was he unable to afford it until now? All these questions and their answers are important to guide treatment.

 It makes me happy.

It warms my heart to see a patient who had a long list of opioid prescriptions from multiple doctors before starting Suboxone, then after entering treatment, see only Suboxone. This occurs in the majority of my patients.

My state’s prescription monitoring program is one of the best tools to help patients that I’ve ever seen. I believe it’s saved many lives. I think it’s just as important as drug screening for my Suboxone patients. Of course, the best tool for recovery is the counseling. I prefer 12-step recovery, as that provides ongoing support even after Suboxone treatment, but any kind of counseling helps. The patients I see doing the best are the ones involved in both formal counseling, in group or individual settings, along with 12-step meetings.

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