Pursuant to Mississippi Code, Section
41-29-139(e), it
is unlawful for any licensee to prescribe, dispense or administer any
medication classified as Schedule II, pursuant to Section
41-29-115, for the exclusive
treatment of obesity, weight control, or weight loss.
Prescribing or dispensing a controlled substance for weight
reduction or the treatment of obesity should be based on accepted scientific
knowledge and sound clinical grounds. All such prescribing and dispensing must
be in compliance with applicable state and federal laws.
The licensee providing comprehensive treatment of obesity
must be present at the facility when he or she prescribes or
dispenses1 controlled substances for the purpose of
weight reduction or the treatment of obesity. A licensee may administer, order,
dispense or prescribe controlled substances for the purpose of weight loss or
the treatment of obesity only as an adjunct to a clearly documented
comprehensive program of behavior modification, comprehensive nutritional
education, and exercise or physical therapy intervention. The licensee must
comply with all of the following conditions:
A. An initial comprehensive evaluation is to
be conducted by and thoroughly recorded by the prescribing licensee prior to
the prescribing, ordering, dispensing or administering of any drug. Such
evaluation should include a thorough history and thorough physical exam of the
patient to include at a minimum:
1. Past
medical history, past surgical history, social history, family history, weight
history, dietary history, gynecological history, review of systems, allergies
and medications.
2. A physical exam
to include height; weight; blood pressure; pulse; % body fat or waist
circumference/weight hip ratio; lungs; heart; abdomen; and
extremities.
3. Appropriate testing
related to medical weight loss (CBC, comprehensive metabolic profile, lipid
panel, thyroid panel, EKG, if prior or present history of cardiac disease,
hypertension, diabetes, dyslipidemia, or strong family history of cardiac
disease age >60
4. The licensee
must determine and record the patient's Body Mass Index ("BMI"). No patient
should receive anorexic medications unless the patient has (i) a BMI of [GRETER
THAN OR EQUAL TO] 30.0 in a normal otherwise healthy patient, or (ii) a BMI
[GRETER THAN OR EQUAL TO] 27.0 in an individual with at least one associated
co-morbidity, or (iii) current body weight [GRETER THAN OR EQUAL TO] 120
percent of a well-documented, long standing healthy weight that the patient
maintained after the age of 18, or (iv) body fat [GRETER THAN OR EQUAL TO] 30%
in females, or body fat [GRETER THAN OR EQUAL TO] 25% in males, or (v)
waist-hip circumference such that the individual is known to be at increased
cardiovascular and/or co-morbidity risk because of abdominal visceral fat, or
presence of a co-morbidity condition or conditions aggravated by the patients
excessive adiposity. The indication for anorexic therapy must be documented in
the record and re-evaluated at each visit or with each prescription
refill.
5. Absolute
contraindications of Schedule III or IV anorectic drugs for purposes of weight
loss management are pregnancy, breast feeding, or severe allergic reactions to
these medications. Relative contraindications of Schedule III and IV anorectics
for the purpose of weight loss management are uncontrolled bipolar,
uncontrolled epilepsy, Part 2640, Rule
1.9, controls in all cases.
Physician assistants are not permitted to dispense medication.
uncontrolled hypertension, episodic tachyarrhythmia,
excessive stimulation, history of substance abuse, severe anticholinergic
effects, such as, extreme dryness of mouth or unmanageable constipation should
be addressed with licensee prior to starting weight loss medications. Schedule
III and IV anorectics can be used in conjunction with any other medications
deemed safe by the licensee.
B. The licensee must not utilize any
Schedules III, IV or V controlled substance when he or she knows or has reason
to believe an absolute contraindication exists or relative contraindication
exists that would be harmful to the patient.
C. A licensee is not permitted to prescribe,
order, or dispense controlled substances for the purpose of weight reduction or
treatment of obesity greater than a 30-day supply. Exempted from this
requirement are those licensees defined in Rule
1.2(M) and those
licensees treating patients resulting from a referral to those licensees
defined in Rule
1.2(M).
D. A patient continued on a controlled
substance for the purpose of weight reduction or the treatment of obesity must
undergo an in-person re-evaluation once every 30 days; however, those licensees
defined in Rule
1.2(M) may
re-evaluate patients once every 90 days. A recording of weight, BMI, blood
pressure, pulse, and/or any other test which may be necessary for monitoring
potential adverse effects of drug therapy should be completed at each visit.
Once medically established goals have been met for an individual patient, the
need for ongoing medication should be re-evaluated and documented in the
record.
E. Continuation of the
prescribing, ordering, dispensing, or administering of controlled substances
should occur only if the patient has continued progress toward achieving or
maintaining medically established goals and has no significant adverse effects
from the medication.
F. A licensee
must not utilize a schedule III, IV or V controlled substance or legend drug
for purposes of weight loss unless it has an FDA approved indication for this
purpose and then only in accordance with all of the above enumerated
conditions. The purpose of this rule is to prohibit the use of such drugs as
diuretics and thyroid medications for the sole purpose of weight loss.
Off-label use of any medication that does not have Food and
Drug Administration approval for use in the treatment of weight loss is
prohibited if administered solely for the purpose of weight loss. Thyroid
hormone, diuretics, vitamin B12, B1, B2, B6, methionine, choline, inositol,
chromium picolate, and human chorionic gonadotropin are examples of medications
that may not be used in this manner. This prohibition does not apply to FDA
categories of nutritional supplements sold without prescription.
Licensees may request the Board waive the FDA requirements
set forth in Rule 1.5(F) on a
per-medication or class of medications basis, for good cause. Temporary waiver
may be approved by the Executive Director until the request can be heard before
the Board.
1 Part 2640, Rule
1.9, controls in all cases.
Physician assistants are not permitted to dispense medication.
