TENNESSSEE RULES GOVERNING PHYSICIAN DISCIPLINE

http://www.state.tn.us/sos/rules/0880/0880.htm

RULES OF TENNESSSEE BOARD OF MEDICAL EXAMINERS

CHAPTER 0880-2

GENERAL RULES AND REGULATIONS GOVERNING THE PRACTICE OF MEDICINE July, 2006 (Revised)

880-2-.14 SPECIALLY REGULATED AREAS AND ASPECTS OF MEDICAL PRACTICE.

(1) Policy Statement - The scope of practice of physicians in Tennessee is broadly defined and includes many aspects which if not particularly regulated could lead to serious ramifications for the consuming public. This Rule is to designate specific areas in the practice of medicine for regulation the violation of which may result in disciplinary action pursuant to either T.C.A. §§63-6-214(b)(1) or 63-6-214(b)(4) or 63-6-214(b)(12).

(2) Pharmaceutical Dispensing - Physicians who elect to dispense medication for remuneration must comply with the following:

(a) All Federal Regulations (21 CFR 1304 through 1308) for the dispensing of controlled substances.

(b) Requirements for dispensing of non-controlled drugs are as follows:

1. Drugs are to be dispensed in an appropriate container labeled with at least, the following:

(i) Patient’s name.
(ii) Date.
(iii) Complete directions for usage.
(iv) The physician’s name and address.
(v) A unique number, or the name and strength of the medication.

2. Physicians may dispense only to individuals with whom they have established a physician/patient relationship. It shall be a violation of this rule for a physician to dispense medication at the order of any other physician not registered to practice at the same location.

3. Whenever dispensing takes place, appropriate records shall be maintained. A separate log must be maintained for controlled substances dispensing.

(c) It is not the intention of this Rule to interfere with the individual physician’s appropriate use of professional samples, nor to interfere in any way with the physician’s right to directly administer drugs or medicines to any patient.

(d) Dispensing or prescribing controlled substances in amounts or for durations not medically necessary, advisable or justified is considered to be practicing beyond the scope of the professional practice.

(3) Amphetamines, Amphetamine-Like Substances, and Central Nervous System Stimulants.

(a) It shall be a prima facie violation of T.C.A. §§63-6-214 (b)(1) and 63-6-214 (b)(12) to prescribe, order, administer, sell or otherwise distribute any amphetamine drug except:

1. For treatment of the following:
(i) attention deficit disorder;
(ii) drug-induced brain dysfunction;
(iii) narcolepsy;
(iv) dementia or organic brain syndrome with severe psychomotor retardation;
(v) Chronic depression refractory to other drugs. Such diagnosis must be included on the prescription.

2. When the licensee has applied for and received from the Board of Medical Examiners a written approval for the clinical investigation of such drugs under a protocol satisfactory to the Board. Any such approval by the Board of Medical Examiners will be filed with the Board of Pharmacy and disseminated by the Board of Pharmacy to any pharmacy which would fill prescriptions written during the research.

(b) The list of amphetamine drugs governed by subparagraph (3)(a) of this Rule includes the following controlled substances:

1. Amphetamine, its salts, optical isomers and salts of its optical isomers; (examples are Biphetamine, Dexadrine, Benzedrine and others).

2. Methamphetamine, its salts, isomers and salts of isomers; (an example is Desoxyn).

3. Any salt, any type of isomer and salts of such isomers, or any chemical element or any mixture, compound, material or preparation, containing any quantity of any of the substances listed above or their salts, any type of isomers and salts of such isomers, or chemical elements are also governed by this rule.

(c) It shall be a prima facie violation of T.C.A. §§63-6-214 (b)(1) and 63-6-214 (b)(12) to prescribe, order, administer, sell or otherwise distribute any amphetamine-like substance listed below, except when the licensee has applied for and received from the Board of Medical Examiners a written approval for the clinical investigation of such drugs under a protocol satisfactory to the Board. Any such approval by the Board of Medical Examiners will be filed with the Board of Pharmacy and disseminated by the Board of Pharmacy to any pharmacy
which would fill prescriptions written during the research.

1. The list of amphetamine-like substances governed by this rule are the following controlled substances:
(i) Phenmetrazine and its salts; (an example is Preludin)
(ii) Benzphetamine; (an example is Didrex)
(iii) Chlorphentermine; (an example is Pre Sate)
(iv) Phendimetrazine; (examples are Plegine, Bontril, Meltiat, Prelu-2, Adipost, Wehles, and others)
(v) Diethylproprion; (examples are Tenuate and Tepanil)
(vi) Mazindol; (examples are Mazandor and Sanorex)
(vii) Phentermine; (examples Ionamin, Fastin, Adipex and others), except as authorized pursuant to T.C.A. §63-6-214;
(viii) Fenfluramine HS; (an example Pondimin), except as authorized pursuant to T.C.A. §63-6-214.

2. Any salt, any type of isomer and salts of such isomers, or any chemical element or any mixture, compound, material or preparation, containing any quantity of any of the substances listed above or their salts, any type of isomers and salts of such isomers, or chemical elements, except as authorized pursuant to T.C.A. §63-6-214, are also governed by this rule.

(d) It shall be a prima facie violation of T.C.A. §§63-6-214 (b)(1) and 63-6-214 (b)(12) to prescribe, order, administer, sell or otherwise distribute any central nervous system stimulant listed below except:

1. For treatment of any of the following:
(i) attention deficit disorder;
(ii) drug-induced brain dysfunction;
(iii) narcolepsy;
(iv) dementia or organic brain syndrome with severe psychomotor retardation;
(v) Chronic depression refractory to other drugs. Such diagnosis must be included on the prescription.

2. When the licensee has applied for and received from the Board of Medical Examiners a written approval for the clinical investigation of such drugs under a protocol satisfactory to the Board. Any such approval by the Board of Medical Examiners will be filed with the Board of Pharmacy and disseminated by the Board of Pharmacy to any pharmacy which would fill prescriptions written during the research.

(e) The list of central nervous system stimulants governed by subparagraph (3)(d) of this rule are the following controlled substances:

1. methylphenidate; (an example is Ritalin)

2. pemoline (including organometallic complexes and chelates thereof; an example is Cylert)

3. Any salt, any type of isomer and salts of such isomers, or any chemical element or any mixture, compound, material or preparation, containing any quantity of any of the substances listed above or their salts, any type of isomers and salts of such isomers, or chemical elements are also governed by this rule.

(4) Prescription writing shall be governed by Tennessee Code Annotated, Section 63-6-236 and Title 53, Chapter 10, Part 2.

(5) Universal Precautions For The Prevention Of HIV Transmission - The Board adopts, as if fully set out
herein, rules 1200-14-3-.01 through 1200-14-3-.03 inclusive, of the Department of Health and as they
may from time to time be amended, as its rule governing the process for implementing universal precautions for the prevention of HIV transmission for health care workers under its jurisdiction.

(6) Authority of Physician to Prescribe for the Treatment of Pain - Purpose - The purpose of this chapter is to recognize that some dangerous drugs and controlled substances are indispensable for the treatment of pain, and are useful for relieving and controlling many other related symptoms that patients may suffer. It is the position of the board that these drugs may be prescribed for the treatment of pain and other related symptoms after a reasonably based medical diagnosis has been made, in adequate doses, and for appropriate lengths of time, which in some cases may be as long as the pain or related symptoms persist. The board recognizes that pain, including intractable pain, and many other related symptoms are subjective complaints and that the appropriateness and the adequacy of drug and dose
will vary from individual to individual. The practitioner is expected to exercise sound medical judgment in treating pain and related symptoms with dangerous drugs and controlled substances.

(a) Definitions. The following words and terms, as used in this rule shall have the following meanings in the context of providing medications for pain and related symptoms.

1. Abuser of narcotic drugs, controlled substances and dangerous drugs - A person who takes a drug or drugs for other than legitimate medical purposes.

2. Intractable pain - A pain state in which the cause of the pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief
or cure of the cause of the pain is possible or none has been found after reasonable efforts.

3. Non-therapeutic in nature or manner - A medical use or purpose that is not legitimate.

4. Prescribing pharmaceuticals or practicing consistent with the public health and welfare - Prescribing pharmaceuticals and practicing medicine for a legitimate medical purpose in the usual course of professional practice.

(b) No physician is required to provide treatment to patients with intractable pain with opiate medications but when refusing to do so shall inform the patient that there are physicians whose primary practice is in the treatment of severe, chronic, intractable pain with methods including
the use of opiates. If the patient requests a referral to such a physician, and the physician makes such a referral that referral shall be noted in the patient’s medical records.

(c) If a physician provides medical care for persons with intractable pain, with or without the use of opiate medications, to the extent that those patients become the focus of the physician’s practice the physician must be prepared to document specialized medical education in pain management sufficient to bring the physician within the current standard of care in that field which shall
include education on the causes, different and recommended modalities for treatment, chemical dependency and the psycho/social aspects of severe, chronic intractable pain.

(d) The treatment of persons with an acute or chronic painful medical condition who also require treatment for chemical dependency by a physician shall be governed by T.C.A. § 63-6-1107 (c) and (d).

(e) Guidelines - The Tennessee Board of Medical Examiners will use the following guidelines to determine whether a physician’s conduct violates T.C.A. §63-6-214 (b) (12) through (14) in regard to the prescribing, administering, ordering, or dispensing of pain medications and other drugs necessary to address their side effects.

1. The treatment of pain, including intractable pain, with dangerous drugs and controlled substances is a legitimate medical purpose when done in the usual course of professional practice.

2. A physician or surgeon duly authorized to practice medicine in Tennessee and to prescribe controlled substances and dangerous drugs in this state shall not be subject to disciplinary action by the board for prescribing, ordering, administering, or dispensing dangerous drugs or controlled substances for the treatment and relief of pain, including intractable pain, in the usual course of professional practice for a legitimate medical purpose in compliance with applicable state and federal law.

3. Prescribing, ordering, administering, or dispensing dangerous drugs or controlled substances for pain will be considered to be for a legitimate medical purpose if based
upon accepted scientific knowledge of the treatment of pain, including intractable pain, not in contravention of applicable state or federal law, and if prescribed, ordered, administered, or dispensed in compliance with the following guidelines where appropriate and as is necessary to meet the individual needs of the patient:

(i) After a documented medical history, which may be provided orally or in writing by the patient, and physical examination by the physician providing the medication including an assessment and consideration of the pain, physical and psychological function, any history and potential for substance abuse, coexisting diseases and conditions, and the presence of a recognized medical indication for the use of a dangerous drug or controlled substance;

(ii) Pursuant to a written treatment plan tailored for the individual needs of the patient by which treatment progress and success can be evaluated with stated objectives such as pain relief and/or improved physical and psychosocial function. Such a written treatment plan shall consider pertinent medical history and physical examination as well as the need for further testing, consultations, referrals, or use of other treatment modalities;

(iii) The physician should discuss the risks and benefits of the use of controlled substances with the patient or guardian;

(iv) Subject to documented periodic review of the care by the physician at reasonable intervals in view of the individual circumstances of the patient in regard to
progress toward reaching treatment objectives which takes into consideration the course of medications prescribed, ordered, administered, or dispensed as well as
any new information about the etiology of the pain;

(v) Complete and accurate records of the care provided as set forth in parts (i)-(iv) of this paragraph should be kept. When controlled substances are prescribed, names,
quantities prescribed, dosages, and number of authorized refills of the drugs should be recorded, keeping in mind that pain patients with a history of substance abuse or who live in an environment posing a risk for medication misuse or diversion require special consideration. Management of these patients may require closer monitoring by the physician managing the pain and consultation with appropriate health care professionals.

4. A decision by a physician not to strictly adhere to the provisions of paragraph 3 of this section will, for good cause shown, be grounds for the board to take no disciplinary action in regard to the physician. Each case of prescribing for pain will be evaluated on an individual basis. The physician’s conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient’s individual needs including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved.

5. If the provisions as set out in subparagraphs (1)-(4) of this section are met, and if all drug treatment is properly documented, the board will consider such practices as prescribing in a therapeutic manner, and prescribing and practicing medicine in a manner consistent with public health and welfare.

6. Quantity of pharmaceutical and chronicity of prescribing will be evaluated on the basis of the documented appropriate diagnosis and treatment of the recognized medical indication, documented persistence of the recognized medical indication, and properly documented follow-up evaluation with appropriate continuing care as set out in this rule.

7. A physician may use any number of treatment modalities for the treatment of pain, including intractable pain, which are consistent with legitimate medical purposes.

8. These rules shall not be construed so as to apply to the treatment of acute pain with dangerous drugs or controlled substances for purposes of short-term care.

 (7) Prerequisites to Issuing Prescriptions or Dispensing Medications - In Person, Electronically, and Over the Internet

(a) Except as provided in subparagraph (b), it shall be a prima facie violation of T.C.A. § 63-6-214 (b) (1), (4), and (12) for a physician to prescribe or dispense any drug to any individual, whether in person or by electronic means or over the Internet or over telephone lines, unless the physician, or his/her licensed supervisee pursuant to appropriate protocols or medical orders, has first done and appropriately documented, for the person to whom a prescription is to be issued or drugs dispensed, all of the following:

1. Performed an appropriate history and physical examination; and

2. Made a diagnosis based upon the examinations and all diagnostic and laboratory tests consistent with good medical care; and

3. Formulated a therapeutic plan, and discussed it, along with the basis for it and the risks and benefits of various treatments options, a part of which might be the prescription or dispensed drug, with the patient; and

4. Insured availability of the physician or coverage for the patient for appropriate follow-up care.

(b) A physician, or his/her licensed supervisee pursuant to appropriate protocols or medical orders, may prescribe or dispense drugs for a person not in compliance with subparagraph (a) consistent with sound medical practice, examples of which are as follows:

1. In admission orders for a newly hospitalized patient; or

2. For a patient of another physician for whom the prescriber is taking calls or for whom the prescriber has verified the appropriateness of the medication; or

3. For continuation medications on a short-term basis for a new patient prior to the patient’s first appointment; or

4. For established patients who, based on sound medical practices, the physician feels do not require a new physical examination before issuing new prescriptions; or

5. In compliance with paragraph (9) of this rule.

(c) It shall be a prima facie violation of T.C.A. § 63-6-214 (b) (1), (4), and (12) for a physician, or his/her licensed supervisee pursuant to appropriate protocols or medical orders, to prescribe or dispense any drug to any individual for whom the physician, or his/her licensed supervisee
pursuant to appropriate protocols or medical orders, has not complied with the provisions of this rule based solely on answers to a set of questions regardless of whether the prescription is issued directly to the person or electronically over the Internet or telephone lines.

(8) Code of Ethics - The Board adopts, as if fully set out herein and to the extent that it does not conflict with state law, rules or Board Position Statements, as its code of medical ethics the “Code of Medical Ethics” published by the A.M.A. Council on Ethical and Judicial Affairs as it may, from time to time, be amended.

(a) In the case of a conflict the state law, rules or position statements shall govern. Violation of the Board’s code of ethics shall be grounds for disciplinary action pursuant to T.C.A. § 63-6-214 (b)(1).

(b) A copy of the A.M.A. “Code of Medical Ethics” may be obtained from the Order Department of the A.M.A. at 515 N. State Street, Chicago, IL 60610 or by phone at 1-800-621-8335, or on the Internet at http://www.ama-assn.org.

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