Consent for Treatment with Buprenorphine v1.02

 

 

Buprenorphine (Suboxone, Subutex, Zubsolv, Bunavail, generic buprenorphine sublingual, etc.) is an opioid medication approved by the Food and Drug Administration (FDA) for treatment of people with opioid dependence.  Probuphine is a buprenorphine pellet implant lasting 6 months, but the cost is very high, over $10,000 per year, and is only useful for those on very low dose (2-4mg a day) sublingual buprenorphine.  A new form of once a month buprenorphine for addiction, Sublocade, was approved in November 2017 and is described below. Opioids are controlled substances by the DEA that are addictive, and include heroin, morphine, oxycodone, oxymorphone, morphine, codeine, hydrocodone, hydromorphone, fentanyl, and others. Buprenorphine can be used for detoxification or for maintenance therapy from these opioid drugs.  Maintenance therapy can continue as long as medically necessary, however the ultimate goal with buprenorphine (or combination drugs such as Suboxone) is gradual reduction in the dosage until abstinence from all opioid use is achieved.  The reality is that in some cases this is not possible, and reduction in dosage may reach a level beyond which severe cravings or side effects occur.    In fact, studies have shown 90% will return to heroin or prescription opioid use (recidivism) after a rapid taper from buprenorphine.  Continued use of the use of buprenorphine at stable doses has a much lower level of recidivism, of less than 20% after long term stable dose buprenorphine treatment. Therefore we will work with you to find a balance in such cases where minimal doses possible are used while avoiding recidivism (returning to prescription opioid or heroin use).  The duration of required usage of buprenorphine depends on many factors including whether you are engaged in counseling, home and social support network solidity, remaining completely free and clear of contacting friends that are using opioid narcotics illegally or in a way not prescribed, total avoidance of any contact with prior prescription opioid suppliers or illegal drug suppliers, goals in life you are working to achieve, and control of cravings for opioids. Some patients will require only a 60 day treatment with buprenorphine while others require years of treatment. Counseling has been shown to significantly improve the treatment outcomes of treatment with buprenorphine.  Similarly, a strong support system at home, with others in the household being supportive and avoiding illicit drugs, heroin, or prescription drug abuse themselves is a factor in your success.  Peers (friends) who are also supportive and avoid using illicit drugs including heroin and are not engaging in prescription drug abuse are important factors in your success in avoiding recidivism.  Contrarily, hanging out, even briefly with those friends who continue to abuse prescription opioids or are using illicit drugs is a strong predictor of your failure in buprenorphine treatment.

 

Buprenorphine itself is an opioid, but it is not as strong an opioid as heroin or morphine.  However, the use of buprenorphine is not simply substituting one opioid for another due to some of the unique properties of buprenorphine such as a ceiling effect of respiratory depression and limited pain reduction, regardless of increasing the doses of buprenorphine.  This is called a partial agonist effect. Buprenorphine also has the property of displacing other opioid narcotic drugs from the opioid receptors in the spine and brain, therefore buprenorphine given to a person that has recently taken heroin or a prescription opioid may induce withdrawal symptoms that can be quite severe. Buprenorphine treatment long term can result in physical dependence of the opiate type, however when stopping buprenorphine suddenly, the withdrawal is generally less intense than with heroin or methadone.  If buprenorphine is suddenly discontinued, some patients have no withdrawal symptoms; others have symptoms such as muscle aches, stomach cramps, or diarrhea lasting several days.  To minimize the possibility of opiate withdrawal, buprenorphine should be discontinued gradually, usually over several weeks or more.

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Other medications used for treatment include naltrexone oral and Vivitrol that block the opioid receptor from all other opioids including buprenorphine and heroin.  Naltrexone is take every 2-3 days while Vivitrol is a monthly injection.  Probuphine is a new implantable form of buprenorphine to give a constant low dose buprenorphine level for 6 months. 

 

Physical dependency on an opioid such as heroin or prescription narcotic is commonly associated with withdrawal on sudden discontinuation of the drug.  Physical dependency (chemical dependency) is seen in patients taking long term stable doses of prescription opioids for the treatment of pain.  Addiction on the other hand, is compulsive use of a drug to achieve euphoria or use of high doses of whatever drug is available to avoid withdrawal.

 

If you are dependent on opiates, you should be in as much withdrawal as possible when you take the first dose of buprenorphine.  It you are not in withdrawal and have taken prescription opioids or heroin in the last 48 hours, buprenorphine may cause significant opioid withdrawal.  Because induction with buprenorphine is not an exact science, on initiation of buprenorphine treatment, there may be some induced withdrawal effects, although it is desirable to minimize these effects, which is achieved by appropriate dosing.  For those already taking buprenorphine, it is not reasonable to force a person to go into withdrawal in order to obtain this medication.  However a risk of buprenorphine treatment is that if prior to being treated in our program you have been taking any other opioids, with or without buprenorphine, you may induce withdrawal syndrome (quite painful, abdominal cramps, retching, diarrhea, muscle aches, etc.)  The induction or initiation technique for buprenorphine depends on the circumstance regarding its prior use.

 

Some patients find that it takes several days to get used to the transition from the opioid they had been using to buprenorphine.  During that time, any use of other opioids may cause an increase in symptoms.  After you become stabilized on buprenorphine, it is expected that other opioids will have less effect.  Attempts to override the buprenorphine by taking more opioids could result in an opioid overdose.  You should not take any other medication without discussing it with me first. You cannot sell or give away buprenorphine products prescribed by our clinic, obtain benzodiazepines (see below), or use alcohol or heroin or prescription opioids with the buprenorphine.

 

Combining buprenorphine with alcohol or some other medications may also be hazardous.  The combination of buprenorphine with medication such as Valium, Librium, Ativan has resulted in deaths.

 

The form of buprenorphine (Suboxone) you will be taking is either a combination of buprenorphine with a short-acting opiate blocker (Naloxone), or is pure buprenorphine, the decision of which is prescribed is dependent on clinical issues in conjunction with financial concerns.  If the Suboxone tablet were dissolved and injected by someone taking heroin or another strong opioid, it could cause severe opiate withdrawal.  Suboxone, Bunavail, or Zubzolve are the preferred medications by SAMHSA, a Federal Government Agency and will be used if financially affordable.

 

Buprenorphine tablets or films must be held under the tongue until they dissolve completely.  Buprenorphine is then absorbed over the next 30 to 120 minutes from the tissue under the tongue. Buprenorphine will not be absorbed from the stomach if it is swallowed.

 

Buprenorphine will cost from $2-$10+/day just for the medication.  If you have medical insurance, you should find out whether or not buprenorphine is a benefit.  In any case, my office fees must be kept current.  If you run out of buprenorphine by taking too much, lose part of the prescription, or have part of the prescription stolen, there will be no early refills of the medication.  Safeguard the medication.

 

Monthly visits are required for the Algos Addiction Treatment program as are urine drug screening, a face to face visit with Dr. Whitworth, and evaluation that includes querying the INSPECT program for any other opioids or controlled substances you may have been prescribed. Counseling on opioid use and addiction is provided at each visit by Dr. Whitworth, but in some cases it is necessary (but always advisable if financially feasible) to engage in formal psychiatric or drug addiction counselor sessions or 12 Step programs.  These are recommended for all patients and will be required for some. 

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Sublocade is a newly approved (Nov 2017) alternative form of buprenorphine that is obtained by physicians directly from pharmacies or manufacturers, then injected subcutaneously into patients once a month. Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is a drug-device combination product that utilizes buprenorphine and the Atrigel Delivery System in a pre-filled syringe. It is injected by a health care professional (HCP) under the skin (subcutaneously) as a solution, and the delivery system forms a solid deposit, or depot, containing buprenorphine. After initial formation of the depot, buprenorphine is released by the breakdown (biodegradation) of the depot. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval. The safety and efficacy of Sublocade were evaluated in two clinical studies (one randomized controlled clinical trial and one open-label clinical trial) of 848 adults with a diagnosis of moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film (absorbed under the tongue). Once the dose was determined stable, patients were given Sublocade by injection. A response to MAT was measured by urine drug screening and self-reporting of illicit opioid use during the six-month treatment period. Results indicated that Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared to the placebo group.

The most common side effects from treatment with Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents less than 17 years of age. Clinical studies of Sublocade did not include participants over the age of 65.  More information about sublocade is found here.  Because the drug costs $1580 per month, regardless of whether the 100mg or 300mg dosage is used (300mg Sublocate equals about 30mg suboxone or buprenorphine per day at steady state after more than one injection), Algos will participate in the program, but because we cannot be guaranteed insurance company coverage, would have to have you arrange for payment for the medication, and are happy to write the script/ and obtain preapproval for the medication.  It is likely most insurers will NOT cover this medication for several years given the cost per month being 3 times that of Suboxone and nearly 15 times the cost of buprenorphine tablets per month. 

 

ALTERNATIVES TO BUPRENORPHINE TREATMENT

Some hospitals and clinics have specialized drug abuse treatment units can provide detoxification and intensive counseling for drug abuse.  Some outpatient drug abuse treatment services also provide individual and group therapy, which may emphasize treatment that does not include maintenance on buprenorphine or other opiate like medications.  Other forms of opioid maintenance therapy include methadone maintenance.  Some opioid treatment programs use naltrexone, a medication that blocks the effects of opioids, but has no opioid effects of its own.  Our clinic offers oral and injectable naltrexone as an alternative to buprenorphine treatment.

 

BENEFITS TO TREATMENT WITH BUPRENORPHINE: 1. Goal is elimination of the drug or drugs causing addiction, instead using a more stable partial opioid agonist buprenorphine, that doesn’t give a person a “high” or euphoria, but prevents withdrawal and reduces craving for opioids.  2.  Elimination of illegal activities of buying opioids from friends or dealers, or stealing opioids, thereby lessening the risk of arrest and prosecution for drug acquisition related crimes.  3. Eliminates the need to seek other drugs such as methamphetamine to prevent withdrawal effects  4. Eliminates the need to use heroin that may be laced with fentanyl and has caused many overdose deaths. 

 

RISKS OF USE OF BUPRENORPHINE:  Risk level during pregnancy is undefined but may result in spontaneous abortion, neonatal abstinence syndrome, low birth weight, delayed development after birth, and birth defects.  Other risks include liver toxicity, respiratory depression or death if combined with alcohol or benzodiazepines (e.g. Xanax, alprazolam, Klonopin, clonazepam, Restoril, temazepam, Valium, diazepam, Ativan, lorazepam, etc.), severe central nervous system depression (CNS) when taken in combination with other drugs that cause CNS depression (e.g. Seroquel, sedatives, sleeping aids),  opioid type physical dependence, withdrawal syndrome, impairment in driving or operating machinery, orthostatic hypotension, elevation of cerebrospinal fluid pressure, biliary or gall bladder attacks, headaches, constipation, nausea, vomiting, sweating.  If you develop hepatitis or reduced liver function there is a risk of overdose with buprenorphine.  

 

SIDE EFFECTS OF BUPRENORPHINE PRODUCTS:   STOP TAKING OR REDUCE DOSAGE AND GO TO THE ER OF YOUR NEAREST HOSPITAL: difficulty breathing, confusion, excessive drowsiness, extreme dizziness when getting up from a lying down position, irregular heart beat, blue lips or fingernails   

DISCUSS WITH YOUR PHYSICIAN AT THE NEXT VISIT: Constipation, headache, nausea, difficulty urinating, vomiting, trouble sleeping, flushing of the face, sweating

 

CHILDREN:  The medication should be secured in child proof containers and kept out of the reach of children.  If a child does somehow obtain this medication and takes it by mouth, then get as much as you can out of the child’s mouth then call 911 to have the child taken to the hospital.  Children have overdosed on buprenorphine accidentally.

 

PRECAUTIONS: There is a significant risk of death or overdose of children should they obtain buprenorphine, therefore extreme precautions should be taken to avoid their acquisition of the drug.  It should be safely stored away, out of reach, and preferably in a safe or lock box.  It should not be left on the shelf with other medications since it may be stolen or taken by others.  It should only be stored in a child proof container.  If a child is exposed, call 911 immediately.  Buprenorphine use if known to others, will mark you as a target for robbery.  Do not tell anyone you are taking buprenorphine unless absolutely necessary.  Giving away or selling buprenorphine poses a legal risk (felony) but is also unsafe to give to others, even if they are currently taking buprenorphine, prescription opioids, or heroin. 

 

COMPLIANCE WITH TREATMENT: 

• The use of heroin, other illicit drugs including methamphetamine, cocaine, LSD, spice, china white, or continued use of opioid prescription drugs will require more frequent office visits (increased cost), mandatory counseling sessions by a psychiatrist/psychologist/social worker/or drug addiction counselor (by choice of the physician), dose reduction, referral for inpatient detoxification, or referral to a methadone clinic.  We want you to succeed in eliminating illicit drugs and prescription opioids from use and will engage you with higher level and more intensive treatment for addiction if illicit drugs or prescription opioids are being used.  

• You should also attempt to use one pharmacy for the buprenorphine if possible.  Only Dr. Whitworth will prescribe any opioid medication including Suboxone or equivalent, buprenorphine, or any other controlled substance. 

• You may NOT receive cough medicine containing controlled substances or pain medication from any prescriber for any purpose without discussing with Dr. Whitworth.  

• Due to the potential for overdose death, you may not receive Xanax, Klonopin, Ativan, Restoril, Prozac, Paxil, Elavil, Seroquel, Soma, Ambien, or any other sedating drugs without first discussing with Dr. Whitworth and obtaining his assent.  

• You must notify Algos Addiction Treatment if you develop or begin treatment for liver disease or liver failure or if you begin taking any drugs for the treatment of HIV or AIDS.

• Office visits are mandatory and will occur every 3-6 weeks.  There will be no early fills on scripts.

• Behavioral therapy is an integrated and critically important component of the treatment program and is deemed necessary by the federal government.  Algos Addiction Treatment will either provide such treatment or refer for such treatment.

 

AUTHORIZATIONS:  I authorize Dr. Whitworth or staff to communicate with a designated psychiatrist, psychologist, social worker, addiction treatment specialists, with other physicians currently treating you, hospitals treating you, or pharmacists in an emergency only.   Any specific non-emergent authorizations will be handled using a CFR 42 Consent Form. 

 

AGREEMENTS:  I agree to avoid all illicit (illegal) substances, agree to undergo pill counts, bupivacaine (Suboxone) strips counting, urine drug screens, urine drug testing, blood testing,