Answers To Frequently Asked Questions
1. Who is qualified to prescribe SUBOXONE or SUBUTEX?
Meet one or more of the following training requirements:
* Hold a subspecialty board certification in addiction psychiatry from the American Board of medical Specialties.
* Hold an addiction certification from the American Society of
* Hold a subspecialty board certification in Addiction Medicine from the American Osteopathic Association.
* Have completed not less than 8 hours of authorized training on the treatment or management of opioid-dependent patients. This training may include classroom situations, seminars at professional society meetings, electronic communications, or other media. The American Society of Addiction Medicine, The American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, and the American Psychiatric Association are all authorized to provide this training. Details and website addresses can be found in the section below.
And meet both of the following criteria:
* Have the capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy.
* Agree to treat no more than 100 patients at any one time in their individual or group practice.
2. When and where are training sessions being held?
Each of the above organizations has scheduled training sessions. You may contact them directly at the addresses below, or visit their web sites. Additionally, you can call the toll-free SUBOXONE help line at 1-877-SUBOXONE (1-877-782-6966) or log on to our Web site www.suboxone.com.
The American Academy of Addiction Psychiatry
7301 Mission Road, Suite 252
Prairie Village, KS 66208
Telephone: (913) 262-6161
The American Society of Addiction Medicine
4601 North Park Ave. Arcade Suite 101
Chevy Chase, MD 20815
Telephone (301) 656-3920
Web site http://asam.org
The American Psychiatric Association
1400 K Street N.W.
Washington, DC 20005
Telephone (888) 357-7924
Web site: http://www.psych.org
American Osteopathic Association
142 East Ontario Street
Chicago, IL 60611
Telephone (800) 621-1773
3. I am already qualified. What do I do next?
The Drug Addiction Treatment Act (DATA) requires that before you begin prescribing SUBOXONE or SUBUTEX you must notify the Secretary of Health and Human Services of your intent to treat patients with these products. The agency within the Department of Health and Human Services to be notified is the Substance Abuse and Mental Health Services Administration (SAMHSA). Notification is handled within SAMHSA by the Division of Pharmacologic Therapies (DPT) within the Center for Substance AbuseTreatment (CSAT). For convenience CSAT has developed a form that may be used for your notification. A copy is enclosed in this package. You may complete the notification form online or download the form by visiting CSAT’s web site at http://www.dpt.samhsa.gov. The form may also be downloaded from http://www.suboxone.com. If you prefer, you may also notify by letter if you include all of the required information.
All forms (or letters) should be mailed or faxed to:
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
Attn. Opioid Treatment Waiver Program
5600 Fishers Lane, Rm. 12-105
Rockville, MD 20857
FAX: (301) 443-3994
Call CSAT/DPT if you have any questions about the notification process or need help completing the form. They can be reached at (301) 443-7745.
3.What happens after my notification is sent to CSAT?
CSAT will communicate with the Drug Enforcement Administration (DEA), review your notification and then notify DEA that you are qualified as required by the DATA. The DATA
allows 45 days for this review process. No later than at the end of that 45-day period, DEA will issue a unique identification number indicating that you are a qualifying physician under the DATA.
DEA is developing regulations that will require this number along with your existing DEA registration number to be included on all prescriptions issued for the treatment of opioid dependence under the DATA; therefore it is strongly recommended that you include this number when you write prescriptions for Subutex and Suboxone for the treatment of opioid dependence.
CSAT will send you a letter notifying you of the new DEA identification number that will be assigned. You will subsequently receive a revised DEA registration certificate (showing both numbers).
4. Do I have to wait 45 days before treating patients?
The DATA envisions physicians notifying CSAT as soon as they are qualified, but makes provision for those who find themselves in the position of being qualified and needing to treat a patient, but not having notified CSAT In this case, you must first notify CSAT and DEA of your intent before treating the patient; this can be done electronically on the internet by checking the appropriate box, or by faxing in the form included in this package to CSAT at:
5. During the traing sessions, as well as in the product information and CSAT Guidelines, it is recommended that patients be given initial doses under supervision. It is not my normal practice to keep a stock of controlled subtances in my office. How do I get Suboxone or Subutex for use in the office?
State laws vary regarding stocking of controlled substances. Information on State requirements can be found on our website, If you have a routine supplier of products such as vaccines, or injectable products that you use in your office, that supplier will be able to provide you with SUBOXONE and SUBUTEX. If you do not have a normal supplier of such products we will facilitate the establishment of a relationship with a supplier. Please complete the enclosed pre-addressed request formand mail it to us. Alternately, you may call our toll-free SUBOXONE Help Line at 1 877-SUBOXONE(1-877-782-6966) or log onto the Website www.suboxone.com. In those States where permitted, we will provide you with an initial supply of SUBOXONE or SUBUTEX for induction use.
6. What storage and record-keeping requirements are associated with maintenance of a supply of SUBOXONE and SUBUTEX in my office?
For a full listing of requirements for a specific State you may call our toll-free SUBOXONE Help Line at 1 877 SUBOXONE (1-877-782-6966) or log on to our Web site www.suboxone.com.Generally, you will be required to keep the medications in a secure environment. They should be kept in a locked compartment with limited access. You will also be required to maintain a written record of the disposition of all doses. Usually this can be done with the maintenance of a logbook in which you record all incoming doses and account for each dispensed dose as it is used. This record must be kept current at all times. Additional requirements may be in place in your State.
7. While I appreciate the convenience of maintaining a supply of SUBOXONE and SUBUTEX in my office for induction purposes, the situation at our office precludes such an arrangement. How do I manage supervised induction doses without maintaining such a supply in my office?
For those physicians who do not wish to maintain a supply of SUBOXONE or SUBUTEX in their offices, where State law and regulation allows, we will provide coupons for you to provide to your patient for their initial doses. In this circumstance, you would write a prescription only for the initial dose of SUBOXONE or SUBUTEX.
If pharmacy delivery services are available, you may choose to arrange to have the dose delivered to your office; if not give the prescription, and a coupon, to the patient (or, if available, to a trustworthy family member accompanying the patient) with instructions that the prescription is to be taken to the pharmacy, filled,
It is recommended that you call or fax ahead to ensure availability of the medication and to reduce patient waiting time. You should instruct the patient that on his or her return to the office the induction dose will be administered, and that he or she will be monitored in your office. The pharmacist should reiterate this instruction upon filling the prescription.
You may wish to limit the prescription to one days’ dose, and repeat this method (with or without the coupon) for the first several days of treatment before providing a prescription for several days’ supply at one time. Further information regarding this program and a supply of coupons is available by calling our toll-free SUBOXONE Help Line at 1 877 SUBOXONE (1-877-782-6966) or log on to our Web site www.suboxone.com.
8. Will these coupons and prescriptions be valid at any pharmacy, or will I need to refer patients to a specific store?
Generally, a pharmacy near your office is recommended for patient convenience. If possible, it is advisable to identify a pharmacy that will deliver initial doses to your office, so that patients do not have to leave and return for induction dosing. Alternatively, it is recommended that you avail yourself of any call-in or fax-in prescription services provided, to reduce patient waiting time.
If you do not currently have a commercial or professional relationship with a pharmacy in your area, we will be pleased to assist in facilitating the establishment of such an arrangement, and to help identify pharmacies with delivery service. Please call our toll-free SUBOXONE Help Line at 1 877 SUBOXONE (1-877-782-6966) or log on to our Web site www.suboxone.com.
9. Are there special confidentiality issues I should consider?
Remember that you may be communicating with the pharmacist to verify prescriptions for a particular patient. As you may know, there are special federal regulations concerning the confidentiality of substance abuse treatment, records (42 CFR Part 2) and the privacy of health records (HIPAA). To ensure that you will be able to communicate with the pharmacist to confirm the validity of a SUBOXONE or SUBUTEX prescription, it is recommended that you have the patient sign a release of information at the time of the office visit.
A sample consent form with all the elements required under 42CFR Part 2 is included with this booklet as an attachment. It is particularly important to obtain the patient’s consent if you elect to phone or FAX in prescriptions, as this constitutes disclosure of the patient’s treatment.
When the prescription is directly transmitted by the physician, there are also prohibitions on the further redisclosure of patient identifying information by the pharmacist. 42CFR Part 2 does not apply when it is the patient who delivers the presciption to the pharmacist, without direct communication from the physician to the pharmacist.
To learn more about these regulations, visit the SAMHSA website www.hipaa.samhsa.gov, or call 1-866-BUP-CSAT
10. I’m familiar with general principles of addiction treatment, but this is my first experience with office-based prescription of this type of medication. What precautions should I take in my practice to prevent diversion and abuse?
You should consider the following suggestions:
* Initiate treatment with supervised administration, progressing to unsupervised administration as your patient’s clinical stability permits.
* Limit the use of Subutex to supervised use, wherever possible. Recall that the Suboxone product contains naloxone, which Subutex does not. The naloxone in Suboxone is likely to precipitate withdrawal symptoms when injected by individuals dependent on heroin, morphine, or other full opiate agonists. Therefore, it is expected that Suboxone will be less attractive to "street addicts" and less likely to be diverted. Therefore it is strongly recommended that Suboxone be used whenever unsupervised administration is planned.
* Have plans in place to deal with patient requests for replacement of prescriptions or supplies of medication that are described as lost or stolen.
*Keep tight control of your prescription pads. Never leave them in the examination room, even inside a desk drawer. Never sign an incomplete prescription blank.
* Write all numbers (quantity and strength) in both numbers and letters – like you write your checks.
* Establish a relationship with the pharmacies you expect to be filling your prescriptions for SUBOXONE or SUBUTEX and discuss potential diversion problems and controls with them.
* Request photo (or other) I.D. and Social Security number and maintain copies in patient’s record.
* If you suspect an attempt to divert prescription medications, call your local police department.
11. Where can I get more information on treating patients with Subutex and Suboxone?
* Refer to the physician package insert for prescribing information. Additional recommendations may be found in treatment guidelines available for free from the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration. To obtain a copy please call our toll-free SUBOXONE Help Line at 1 877 SUBOXONE (1-877-782-6966) or log on to our Web site at www.suboxone.com . Additional information is also available on the CSAT web site at www.dpt.samhsa.gov
* Refer to the package insert for full information on the adverse events seen during the clinical trials using buprenorphine for opiate addiction treatment. Note the important precautions and warnings to share with patients, such as the risk of fatal respiratory depression when buprenorphine is combined with other depressants. Also note other important safety issues such as the fact that buprenorphine should be administered with caution in the elderly or debilitated patient, and those with severe impairment of hepatic, pulmonary or renal function; and that buprenorphine may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery, especially during drug induction and dose adjustment.
* General information on the treatment of addiction is available through;
Substance Abuse and Mental Health
Office of Pharmacologic and Alternative Therapies
CSAT, Rockwall II Building, Suite 740
5600 Fishers Lane
Rockville, MD 20857
Web site: www.dpt.samhsa.gov
Compiled and Edited: Deborah Shrira Published: 30 September 2007