Arkansas Administrative Code › Agency 060 - STATE MEDICAL BOARD › Rule 060.00.98-001 - Regulation No. 21 - Anorexiant Drug Guidelines - Short term treatment of obesity with Schedule III and IV drugs

Current through Register Vol. 49, No. 6, June, 2024
A physician will be considered as exhibiting gross negligence or
			 ignorant malpractice if he prescribes Schedule HI 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 PDR), 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.
5. The
		  treating physician shall not dispense or prescribe more than a 30-day supply
		  for a patient on the first visit. Thereafter, not more than a 30-day supply
		  shall be dispensed or prescribed at the time of each 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 physician should discontinue the anorexiant
		  medications when the patient reaches his/her weight loss goals. These goals may
		  be defined as a body weight that is no longer "obese" (e.g. BMI of less than or
		  equal to 27), or an improvement in medical conditions (e.g. normalization of
		  blood glucose.) 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 in or IV anorexiant drugs are only recommended for
		  short-term use (e.g. 90 days). In addition, anorexiant drugs should not be
		  prescribed to a patient with a BMI of less than 27. 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.