Arkansas Administrative Code › Agency 060 - STATE MEDICAL BOARD › Rule 060.00.15-003 - Amendment to Regulation 21 Governing Anorexiant Drug Guidelines

Current through Register Vol. 49, No. 6, June, 2024
Short term treatment of obesity with Schedule III and
			 IV drugs.
A physician will be considered as exhibiting gross negligence or
			 ignorant malpractice if he prescribes Schedule III and IV scheduled drugs under
			 the Uniform Controlled Substance Act for obesity, except in conformity with the
			 requirements as set below:
1.
		  Anorexiant drugs listed on Schedule III and IV under the Uniform Controlled
		  Substances Act shall not be dispensed or prescribed for the treatment of
		  obesity, except in conformity with the following minimal requirements. Schedule
		  II drugs may not be used in the treatment of obesity (see Regulation 7 of the
		  Arkansas State Medical Board.)
2.
		  The physician should be knowledgeable in the pathophysiology and treatment of
		  obesity. An established physician/patient relationship should exist. The
		  patient should be age 18 or older, or have written consent from parent or
		  guardian. The medication should only be an adjunct to a comprehensive weight
		  loss program focused on appropriate nutrition education, a change in lifestyle,
		  counseling, and an individualized exercise program. The physician should
		  determine whether or not the patient has made a substantial good faith effort
		  to lose weight through diet and alteration of lifestyle prior to beginning drug
		  therapy. The treating physician shall take a complete history of the patient
		  and shall give a complete physical examination. The physical examination shall
		  include checking the blood pressure and pulse, examining the heart and lungs,
		  recording weight and height, and administering any other appropriate diagnostic
		  tests. The history and examination shall be sufficient to determine if the
		  patient has previously been drug dependent, to determine if there is a
		  metabolic cause of the obesity which would make anorexiant drugs inappropriate
		  (e.g. hypothyroidism) and to determine if other contraindications to use of the
		  drugs exist. The treating physician shall enter each of those findings in the
		  patient's records.
3. The physician
		  should discuss with the patient different approaches to the treatment of
		  obesity, and the risks and benefits associated with each approach. Risks should
		  include potential side effects (e.g. cardiovascular and pulmonary
		  complications, as outlined in the package insert), as well as the potential for
		  lack of success with weight loss. The physician should be aware of potential
		  drug interactions between anorexiants, and other centrally acting drugs. The
		  treating physician shall prescribe a diet for weight loss and appropriate
		  counseling regarding lifestyle change, and record these changes on the patient
		  record. Consideration on the use of anorexiant medications should take into
		  account the degree of overweight, and concomitant medical conditions. The body
		  mass index (BMI) should be used as a guide to determine the degree of
		  overweight. The BMI is defined as the weight (kg) divided by the height (meters
		  squared). A chart to determine BMI is enclosed. In general, anorexiant
		  medication should only be used if the BMI is more than 27. In the case of
		  concomitant obesity-related medical conditions, anorexiant medications may be
		  considered with a BMI above 25. Obesity related medical conditions include
		  diabetes, hypertension, dyslipidemia, cardiovascular disease, sleep apnea,
		  psychological conditions, disc disease and severe arthritis of the lower
		  extremities.
4. The treating
		  physician shall prescribe a daily dosage that does not exceed the dosage
		  recommended in the manufacturer's prescribing information for the drug
		  prescribed or dispensed, unless peer reviewed medical literature exists in
		  support of this cause.
5. The
		  treating physician shall not dispense or prescribe more than a 30-day supply
		  for a patient on the first visit. The patient shall be weighed at each visit
		  prior to dispensing or prescribing an additional supply of the drug and the
		  weight shall be entered in the patient's record.
6. At the time of each return patient visit,
		  the treating physician shall monitor progress of the patient. The patient's
		  weight, blood pressure, pulse, heart and lungs shall be checked. The findings
		  shall be entered in the patient's record. In addition to any side effects of
		  the medications, the physician should perform appropriate exams and tests to
		  monitor the safety of any weight loss. This may include a more detailed dietary
		  questionnaire, serum electrolytes, blood glucose, and other tests deemed
		  appropriate. The Rule and Regulation for patients who are no longer obese for
		  such period of time as to allow the patient to adapt to a lifestyle change for
		  no more than an additional sixty (60) days.
7. Except as otherwise provided by this
		  regulation, Schedule III or IV anorexiant drugs are only recommended for
		  short-term use (e.g. 90 days). However, the treating physician may extend
		  therapy beyond 90 days under the following conditions:
a. When the anorexiant drugs are indicated
		  for treatment of diseases other than obesity; and
b. When, in the physician's professional
		  judgment, the treating physician is observing and recording significant
		  progress or benefit from the drugs and no adverse effects occur that are
		  related to the treatment. These observations shall be documented in the
		  patient's record.
c. When the drug
		  involved has been FDA approved for longer use or maintenance.