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ORR # 2003-014 DEPARTMENT OF COMMUNITY HEALTH
DIRECTOR’S OFFICE MEDICINE - GENERAL RULES
Filed with the Secretary of State on January 12, 2005
The rule takes effect 7 days after filing with the Secretary of State
(By authority conferred on the director of the department of community health by section 17001 of 1978 PA 368, MCL 333.17001 et seq. and Executive Order Nos. 1996-1, 1996-2 and 2003-18, MCL
330.3101, 445.2001 and 445.2011)
R 338.2303 of the Michigan Administrative Code is amended as follows:
PART 1. GENERAL PROVISIONS
R 338.2303 Schedule 2 sympathomimetic amine drugs including amphetamines; standards of practice. Rule 3. (1) The board of medicine has determined that any of the sympathomimetic amine drugs, except amphetamine and its salts, designated in schedule 2 under the code or the rules promulgated by Michigan's board of pharmacy have negligible therapeutic value, have a high potential for physical and psychological addiction, have serious detrimental health effects when abused, are widely abused through intentional or misinformed acts in the medical and lay communities, and pose a health hazard and risk of improper medical treatment vastly disproportionate to any legitimate use of such drugs. The board has further determined that there are alternative treatment modalities to such drugs of at least comparable therapeutic value that do not pose similar risks. In accordance with these determinations, and except as provided in subrules (4), (5), and (6) of this rule on the prescribing of amphetamine and its salts, and except as provided in subrule (7) of this rule, the giving, selling, prescribing, or administering of any of the sympathomimetic amine drugs designated in schedule 2 under the code or the rules promulgated by Michigan's board of pharmacy constitutes a departure from, or failure to conform to, minimal standards of acceptable and prevailing medical practice.
(2) Except as provided in subrules (4), (5), and (6) of this rule on the prescribing of amphetamine and its salts, and except as provided in subrule (7) of this rule, the giving, selling, prescribing, or administering of any of the sympathomimetic amine drugs designated in schedule 2 April 2, 2004 under the code or the rules promulgated by Michigan's board of pharmacy is prohibited.
(3) A violation of this rule constitutes a violation of section 16221(a), (b)(i), (c)(iv), and (g) of the code.
(4) Recognizing that amphetamine and its salts are therapeutically effective in the treatment of hyperkinetic children, a physician may, by issuance of a written order for amphetamine and its salts, prescribe amphetamine and its salts for a hyperkinetic child, if the physician, before writing a prescription for amphetamine and its salts, has done all of the following:
(a) Taken a complete history.
(b) If the child is attending school, secured a report from the child’s school regarding the child's current and past behavior.
(c) Completed a physical examination, including a neurological examination.
A prescription for amphetamine and its salts ordered for a hyperkinetic child shall indicate on the prescription order, in the physician's own handwriting, the purpose for which the drug is being prescribed.
(5) Recognizing that amphetamine and its salts are therapeutically effective in the treatment of narcolepsy, a physician may, by issuance of a written order for amphetamine and its salts, prescribe amphetamine and its salts for narcolepsy, if the physician, before writing the prescription for a patient, has taken a complete history and physical examination, with appropriate studies of the patient, which establish that the patient suffers from narcolepsy.
A prescription for amphetamine and its salts ordered to treat narcolepsy shall indicate on the prescription order, in the physician's own handwriting, the purpose for which the drug is being prescribed.
(6) Recognizing that amphetamine and its salts are therapeutically effective in the treatment in adult forms of attention-deficit/hyperactivity disorder (ADHD), a physician may, by issuance of a written order for amphetamine and its salts, prescribe amphetamine and its salts for adult forms of ADHD, if the physician, before writing a prescription for amphetamine and its salts, has taken a complete history and physical examination, with appropriate studies of the patient, which establish that the patient suffers from adult forms of ADHD.
A prescription for amphetamine and its salts ordered to treat adult forms of ADHD shall indicate on the prescription order, in the physician’s own handwriting, the purpose for which the drug is being prescribed.
(7) Recognizing the need for innovative medical practices and the unpredictability of scientific developments, a physician may apply for a written waiver of the requirements of this rule by submitting a written request to the board. The request shall include all information necessary for a comprehensive evaluation of its merit. If the physician requesting the waiver demonstrates to the satisfaction of the board that a waiver would further legitimate medical purposes without undermining the purposes of this rule, the board may issue a written waiver with such terms and conditions as may be deemed appropriate.
