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Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare INFORMED CONSENT FORM PRACTICE: Dr. Sarfaraz Jasdanwala, MD. DATE: BUPRENORPHINE TREATMENT FOR OPIOD ADDICTION Buprenorphine is an FDA approved medication for treatment of heroin or other opioid addiction. Buprenorphine can be used for detoxification or for maintenance therapy. Maintenance therapy can be continued as long as medically necessary. There are other treatments for opiate addiction, including methadone, naltrexone and some treatments without medications that include counseling, groups and meetings. PATIENT RIGHTS AND CONFIDENTIALITY As a patient getting treatment for a substance use disorder, your personal and medical information is protected under the United States Confidentiality Law. This law states that your doctor is NOT allowed to tell anyone the reason you are being treated without your permission. Doctors and treatment programs that provide addiction treatment are not even allowed to tell anyone whether or not you are a patient. With your approval, sometimes called consent, your doctor may let others, such as your insurance company or your family, know about your treatment. No information will be shared unless you sign a consent form, which will include the name of the doctor or treatment provider, the person/group to whom your information is going, the purpose of the disclosure, how much information may be communicated, when the consent form expires, and the date. Even if you sign a consent form, you have the right to change your mind at any time. If you do change your mind, your doctor will not share any additional information with others. The confidentiality law is strict, but it will not keep you from getting good treatment. Exceptions were written into the law to make sure that patients get excellent care. For instance, information can be shared among treatment staff in order to provide you with better treatment. Also, the law takes into account unexpected things that might happen. For instance, if there is a medical emergency and if they need to know, the medical personnel treating you can be told that you are receiving maintenance treatment for a substance abuse disorder. Ask your doctor if you have more questions about confidentiality or consent. See the attached form detailing code 42 CFR and HIPAA regulation regarding confidentiality for additional information. 1 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare STAGES OF TREATMENT, BENEFITS AND EXPECTED OUTCOMES If you are dependent of opiates – any opiates – you should be in as much withdrawal as possible when you take the first dose of buprenorphine. The first dose of buprenorphine will be given to you at the office under supervision. If you are not in withdrawal, buprenorphine can cause severe opiate withdrawal. For this reason, you should take the first dose in the office and remain in the office for a minimum of 2 hours. We recommend that you arrange not to drive after your first dose, because some patients get drowsy until correct dose is determined for them. If you have not taken opiates for a long time, the first dose can be given at home based on the clinical judgment of your doctor. Some patients find that it takes several days to get used to the transition from the opiate they had been using to buprenorphine. During that time, any use of other opiates may cause an increase in symptoms. After you become stabilized on buprenorphine, it is expected that other opiates will have less effect. Attempts to override the buprenorphine by taking more opiates could result in opiate overdose. You should not take any medication without discussing it with the physician first. BUPRENORPHINE: PHARMACOLOGY, SIDE EFFECTS AND INTERACATIONS WITH OTHER MEDICINES Buprenorphine is a partial opioid agonist approved by the FDA in October 2002 for the treatment of opioid addiction. It is a DEA schedule III drug, and can be used in an officebased setting for the treatment of opioid addiction. It has a slow onset (about 2 hours) and long duration of action (24 to 48 hours). Buprenorphine is metabolized mainly in the liver. Although buprenorphine has not been shown to be damaging to the liver, your doctor will monitor your liver tests while you are taking buprenorphine with a blood test. Combining buprenorphine with alcohol or other sedating medications is dangerous. The combination of buprenorphine with benzodiazepines (such as ValiumR, LibriumR, AtivanR, XanaR, KlonopinR, etc.) has resulted in severe respiratory depression and DEATHS. Common side effects of buprenorphine include but are not limited to: Sedation Headache Insomnia Pain Withdrawal from opioids 2 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare Dizziness/ vertigo Diaphoresis (sweating) Nausea Constipation Diarrhea Rhinitis Asthenia (weight loss) Depression Anxiety Vasodilation (Dilation of blood vessels in the your body) Hypotension (Low Blood Pressure) Hypoventilation (Decreased Breathing) Rigors (Chills) Vomiting Miosis (Constriction of your pupils) Serious side effects of buprenorphine include but are not limited to: Respiratory Depression Respiratory Arrest (stopping of breathing) Bronchospasm (Spasm of the air pipes in your lung) Anaphylaxis (severe allergic reaction) Angioedema (swelling of your internal organs like tongue, wind pipe) Hypotension (low blood pressure) Severe bradycardia (slow heart rate) Seizures Adrenal Insufficiency (inadequate function of the adrenal gland – a gland which produces important hormones in your body) Androgen deficiency with long-term use (decrease in the production of the male sex hormone) Hepatotoxicity (liver damage) Withdrawal symptoms if abrupt discontinuation. 3 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare HOW YOU WILL TAKE YOUR MEDICINE The form of buprenorphine you will be taking is a combination of buprenorphine with a short acting opiate blocker (Naloxone). It will maintain physical dependence, and if you discontinue it suddenly, you will likely experience withdrawal. If you are not already dependent, you should not take buprenorphine, it could eventually cause physical dependence. Buprenorphine sublingual films/tablets or buccal film must be held/left in place until they dissolve completely. You will be given your first dose at the clinic, and you will have to wait as it dissolves, and for two hours after it dissolves, to see how you react. It is important not to talk or swallow until the film/tablet dissolves. This takes up to ten minutes. 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. If you swallow the film/tablet, you will not have the important benefits of the medication, and it may not relieve your withdrawal. Most patients end up at a daily dose of 16 mg to 24 mg of buprenorphine (Suboxone, other formulation doses differ a little) (this is roughly equivalent to 60mg of methadone maintenance). Beyond that dose, the effects of buprenorphine plateau, so there may not be any more benefit to increase in dose. It may take several weeks to determine just the right dose for you. The first dose is usually 4 mg (Suboxone). If you are transferring to buprenorphine from methadone maintenance, your dose has to be tapered until you have been below 30 mg methadone for at least a week. There must be at least 24 hours (preferably longer) between the time you take your last methadone dose and the time you are given your first dose of buprenorphine. Your doctor will examine you for clear signs of withdrawal, and you will not be given buprenorphine until you are in withdrawal. 4 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare OFFICE POLICIES- WHAT WILL BE EXPECTED FROM YOU AS A PATIENT WHILE UNDERGOING TREATMENT FOR OPIOID ADDICTION. POLICIES FOR OPIOID TREATMENT APPOINTMENTS Late for Appointments: Patients who are more than 30 MINUTES late for appointments must be RESCHEDULED. A limit of 2 times late will be tolerated. After being late twice, patients will not be rescheduled; they will be seen at the next regularly scheduled time. These policies will be reviewed with the patient each time they are late for an appointment. Missed Appointments: 24-hour notice is required for cancellations. Later notice is considered a missed appointment. Patients may miss 1 appointment without penalty. We will call to check on patient's status and reschedule. If we cannot reach you by phone a letter will be mailed to you. With subsequent missed appointments, the patient will be considered noncompliant with treatment and will be terminated from the practice with a one month notice and information on other treatment centers where they can avail assistance. These policies will be reviewed with patients each time they miss an appointment PATIENT/PHYSICIAN CONTACT To reach the physician or a designated representative, please call phone service at 573739-9806 and describe the nature of your problem. For all emergencies call 911. PAYMENT OF FEES Payment is accepted in the form of CASH ONLY, except for patients getting referred from outside facilities. The Fees for initial evaluation is $400. THIS IS REQUIRED FOR ALL PATIENTS The Fees for induction visit is $400. NOT ALL PATIENTS REQUIRE INDUCTION TO SUBOXONE. THIS IS ONLY FOR PATIENTS WHO ARE ACTIVELY USING OPIOIDS IN ANY FORM. The fees for follow up visits is $200 Initial evaluation is not a guarantee you will be accepted to the program Determination of program eligibility will be made AFTER the initial evaluation based on the clinical judgement of the treating physician. Payment is expected ON THE DAY OF TREATMENT. We will provide records of treatment for patients to submit to insurance companies. 5 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare Patients may have one appointment with non-payment and thereafter, treatment will be discontinued with a recommendation for a less expensive treatment, e.g., methadone clinic. PRESCRIPTION POLICIES Office visits are required for renewal of prescriptions. Early renewal of prescriptions is not permitted. Lost prescriptions or medications will not be replaced. Requests for extra pills will not be honored. Patients are limited to using one pharmacy for their buprenorphine prescriptions. Patients who use more than one pharmacy will be warned for first instance. Further use of more than one pharmacy will result in discontinued treatment. The patient is limited to one prescribing physician. This will be checked for each patient at least monthly and more often for patients who have been noncompliant. Patients who obtain buprenorphine from another doctor/clinic will have their treatment at this clinic discontinued. TREATMENT POLICIES AND EXPECTATIONS OF PATIENTS This section describes policies for office based opioid treatment in this practice. Patients are expected to adhere to the following expectations. Non-compliance will result in the consequences that are described in the subsequent sections. Treatment Goal: The outcome of treatment for most patients in this practice will be long -term maintenance on buprenorphine. POTENTIAL BENEFITS AND RISKS OF OFFICE-BASED OPIOID TREATMENT (OBOT): The potential benefits and disadvantages and risks that must be discussed with each patient include the following: Potential Benefits: 1. Control of withdrawal symptoms when quitting opioid use 2. Supports patients with opioid use disorder in quitting other opioid use 3. Helps with long term abstinence from opioid abuse. Potential Disadvantages and Risks: 1. Patients become physically dependent on buprenorphine 2. May experience some opioid-related side effects including constipation and, particularly when increasing dosage, mild sedation 3. 3. Potential drug interactions with other substances, especially sedating drugs and alcohol 6 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare SUBSTANCE USE Patients will be instructed to stop taking other opioid medications unless specifically instructed to take it. Patients are required to disclose the use of any psychoactive substance(s) to the physician. This means the use of consciousness altering drugs including narcotics, euphoriants, hallucinogens, marijuana, and designer drugs whether illicit or licit. If patients are discovered to have not disclosed the use of psychoactive substances: Remind patients of the policy for the first instance and increase frequency of UDTs. Discontinue treatment if there is a second instance of non-disclosure of use of psychoactive substance. Patients are required to avoid use of substances that may cause an adverse interaction with prescribed medications. This includes psychoactive substances. If patients are discovered to have used substance(s) with adverse interactions: Remind patients of the policy for the first instance and increase frequency of UDTs. Discontinue treatment if there is a second instance with referral to a higher level of care. DEPRESSION SCREEENING Patients will be asked a 2-question depression screening at each appointment and positive responses will receive further assessment. URINE DRUG SCREENING POLICIES Baseline urine drug tests (UDTs) are required for all patients in the opioid treatment program. Periodic UDTs are required for all patients. A MINIMUM of 1 to 2 UDTs will be performed per year for each patient. Additional UDTs will be completed for some patients having higher risk. UDTs may be scheduled or unannounced. Patients must bear the costs of UDTs. The cost of a UDT in office is $30. The payment for UDT is in the form of CASH ONLY for all patients except for those being referred from outside facilities. The consequences of problematic UDT results include: 1. SENDING THE URINE FOR CONFIRMATORY TESTING. The testing facility will bill the patient’s insurance directly for the confirmatory testing. Patient with no insurance will be directed to financial assistance if eligible. 2. Increased frequency of UDT for the first episode. 3. Possible dose adjustment for opioid use. 4. Counseling referral if they are not already in substance use counseling. 5. Discuss the problem with the patient. 7 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare 6. Second instances of problematic UDT results will result in discontinued treatment. TAKING MEDICATION AS INSTRUCTED Patients are required to take medication as instructed by the physician; for example, they may not crush or inject the medication. If patients take medication other than as instructed: o Discuss the problem with the patient for the first episode. o Discontinue treatment with 2nd episode. o Patient dose changes are not permitted without consulting the physician. If patients change their dosage on their own: o Remind the patient of the policy for the first episode. o Discontinue treatment if there is a 2nd episode. 1. 2. 3. 4. 5. 6. 7. SAFE STORAGE AND NON-SHARING OF MEDICATIONS Patients must agree to safe storage and non-sharing of medications. Patients who share medications will have treatment discontinued immediately. Patients who lose medication due to unsafe storage will be reminded of the policy for first instance, and have treatment discontinued if there is a second instance. MANDATORY FOLLOW-UP VISITS o Patients must return for follow-up visits as scheduled. Initial Follow up visits will be weekly After short term stabilization of dosage Follow up visits will be bi weekly. After long term stabilization the follow up visits could be as far out as monthly based on clinical progress. For patient already getting addiction treatment who join the program, the initial visits could be scheduled for longer intervals. The above mentioned intervals are generalized estimates. THE ACTUAL FREQUENCY OF VISITS ARE DETERMINED ON A CASE BY CASE BASIS AND ARE BASED ON THE CLINICAL JUDGMENT OF THE TREATING PHYSICIAN. CRITERIA FOR CONSIDERING TREATMENT SUCCESSFUL No intoxication from any substance use Physical, psychosocial, and work-related functioning improved No suffering from withdrawal No experience of drug cravings Following treatment protocol Adherence to treatment agreement Adherence to the treatment agreement and treatment plan RELAPSE POLICIES 8 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare Relapse to using opioids will not be grounds for stopping treatment the first time, but treatment structure will be increased, including more frequent appointments. A second episode of using opioids will result in the addition of further additional treatment structure, such as involving a third, responsible party. A pattern of non-compliance with treatment will plus continued use will result in discontinued treatment. If patients stop taking buprenorphine, they can have re-induction after an office visit where a revised treatment agreement is signed. Patients who have been dismissed from treatment and return with new motivation can be given one second chance with increased treatment structure. PILL COUNTS Periodic pill counts are required of patients who are described as high risk at the initial or subsequent appointments. If the results of the pill count are problematic or if the patient fails to comply: Discuss the problem with the patient for the 1st episode. Discontinue treatment if there is a 2nd episode. COUNSELING AND OTHER TREATMENTS Counseling and other treatment participation is required for patients with psychiatric diagnoses. We will be in contact with your counselor about your compliance and participation in counseling and behavioral modification program. Consequences of not participating in recommended counseling or other treatments: o Warning 1st three instances o Discontinue treatment 4th instance PATIENT CONDUCT Behaviors that will result in permanent dismissal from treatment include violence, stealing from the clinic, dealing drugs, or carrying weapons Other behavior that will not be tolerated: o Arriving intoxicated for appointments o Disruptive behavior o Dealing drugs o Sustained payment problems Consequences for these behaviors include the following: o Warning for the first episode. o Discontinue treatment at 2nd instance. 9 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare TREATMENT FOR PREGNANT WOMEN We are not sufficiently skilled or staffed at the present to involve pregnant patients in our treatment program. If you are pregnant and/or are expecting to get pregnant in the near future – talk to your doctor and we will provide you with resources to contact a specialized opioid treatment program that has the capabilities for managing pregnant patients. If you become pregnant while on a stable dose of buprenorphine, contact your doctor immediately – we will provide you with resources to contact a specialized opioid addiction treatment program. We will also refer you an OBGYN doctor that can help you manage your pregnancy. We will be checking your urine for pregnancy at the initial appointment and along with subsequent urine testing for drugs. COMMUNITY RESOURCES, COUNSELLING AND SUPPORT SERVICES: 1. SOUTHEAST BEHAVIORAL TREATMENT CENTER 573-729-4103 2. BHG SPRINGFIELD TREAMTENT CENTER – METHADONE AND SUBOXONE 417865-8045 3. PASEO CLINIC, KANSAS CITY 816-512-7143 I am requesting that Dr. Jasdanwala to provide treatment for addiction. I understand that controlled substances may be used during therapy. The doctor is at liberty to add any requirements or stipulations as he sees fit at any time. This does not have to be in writing. You are free to find a new doctor any time you wish. I freely and voluntarily agree to accept this treatment agreement, as follows: (1) I agree to keep, and be on time to all of my scheduled appointments with the doctor and/or his assistant. A “no show” fee will be assessed. (2) I agree to conduct myself in a courteous manner in the physician’s or clinic’s office. (3) I agree to pay all office fees for this treatment at the time of my visits. Failure to do so is cause for immediate termination of services. (4) I agree not to arrive at the office intoxicated or under the influence of drugs. If I do, the staff will not see me, and I will not be given any medication until my next scheduled appointment. Immediate termination may ensue. Urine drug screens and medication 10 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare counts will be random (5) I agree not to sell, share or give any of my medication(s) to another person. I understand that such mishandling of my medication is a serious violation of this agreement (and the law) and would result in my treatment being terminated without recourse for appeal. (6) I understand that the use of buprenorphine/naloxone (Suboxone, etc.) by someone who is using opioids could cause them to experience severe withdrawals. Stopping buprenorphine in itself can cause prolonged opiate withdrawals. (7) I agree not to deal, steal, or conduct any other illegal or disruptive activities in, or in the vicinity of, the doctor’s office. (8) I agree that my medication (or prescriptions) can only be given to me at my regular office visits. Any missed office visits will result in my not being able to get medication until the next scheduled visit. (9) I agree that the medication I receive is my responsibility and that I will keep it in a safe, secure place. I agree that lost or stolen medication(s) will not be replaced regardless of the reasons for such loss. It is to be kept out of the reach of children. (10) I agree not to obtain medications from any physicians, pharmacists, or other sources without informing Dr. Jasdanwala. I understand that mixing buprenorphine with other medications, especially benzodiazepines, can result in death or disability. I also understand that a number of deaths have been reported in persons mixing buprenorphine with other drugs or alcohol. (11) I agree to take my medication as the doctor, or his assistant has instructed, and not to alter the way I take my medication without first consulting the doctor. (12) I understand that medication alone is not sufficient treatment for my disease, and I agree to participate in a patient education and a relapse prevention program, to assist me in my treatment. (13) I understand that my buprenorphine and/or other controlled substance treatment 11 Dr. Sarfaraz Jasdanwala, MD Ozark Healthcare may be discontinued, and I may be discharged from the practice if I violate any of this agreement or further requirements requested by the doctor. (14) I understand that there are alternatives to buprenorphine treatment for opioid addiction including: a. medical withdrawal and drug-free treatment b. naltrexone treatment c. methadone treatment The doctor will discuss these with me and provide a referral if I request this. I HAVE READ AND UNDERSTAND THESE DETAILS ABOUT BUPRENORPHINE TREATMENT. I CONSENT TO TREATMENT. SIGNED______________________________________________ DATE ______________________ WITNESS_____________________________________________ DATE ______________________ 12