Section 112.80  Use of Narcotics and Psychotropic Medications in Department Facilities

a)         In accordance with Section 5.1 of the Mental Health and Developmental Disabilities Administrative Act [20 ILCS 1705/5.1], a listing of medication with maximum dosages shall be issued yearly by the Mental Health and Developmental Disabilities Services Pharmacy and Therapeutics Committee.  This list of narcotics and psychotropic medications shall represent the official listing of such medications authorized for use in Department facilities.

1)         For the purposes of this Section, "psychotropic medications" refers to medications:

A)        used for antipsychotic, antidepressant, antimanic and/or antianxiety purposes as listed in the American Hospital Formulary Service (AHFS) Drug Information Manual (American Society of Health-System Pharmacists, 7272 Wisconsin Avenue, Bethesda, Maryland 20814 (2000) (AGENCY NOTE:  this document is published annually and updated quarterly)); the Physician's Desk Reference  (PDR) (Medical Economics Company, Five Paragon Drive, Montvale, NJ 07645-1742 (2000) (AGENCY NOTE:  this document is published annually)); and the Drug Facts and Comparisons (Facts and Comparisons, 111 West Port Plaza, Suite 300, St. Louis, Missouri 63146-3098) (2001) (AGENCY NOTE:  this document is published annually and updated monthly)); or

B)        where there is a body of peer reviewed medical literature supporting its use.

2)         "Narcotics" refers to those medications listed as narcotics in the references in subsection (a)(1)(A).

b)         The Department shall establish a Pharmacy and Therapeutics Committee under the auspices of Mental Health and Developmental Disabilities Services, which shall serve as the vehicle for compliance with 20 ILCS 1705/5.1 as it relates to the establishment of medications that may be utilized within Departmental institutions.  The Pharmacy and Therapeutics Committee shall consist of the Administrator of Mental Health and Developmental Disabilities Services, the Chief of Clinical Services for the Office of Mental Health, the Clinical Director for the Office of Developmental Disabilities, the Nursing Coordinator for the Office of Mental Health, the Nursing Coordinator for the Office of Developmental Disabilities, a facility medical director from the Office of Mental Health, a facility medical director from the Office of Developmental Disabilities, the Deputy Director of Pharmacy Services, and the Manager of the Bureau of Pharmacy and Clinical Support Services.  The Chairperson of the Pharmacy and Therapeutics Committee shall be the Manager of the Bureau of Pharmacy and Clinical Support Services or his/her designee.  The Chairperson shall appoint, as necessary, additional members representing a broad scope of disciplines.  The Pharmacy and Therapeutics Committee shall review, at least annually, all medications within the pharmaceutical classes appearing on the Central Formulary, relative to their clinical efficacy and safety for either retention or removal from usage within the Department.  The Chairperson may incorporate recommended changes to the Department's Central Formulary based upon his/her professional judgment.  The Chairperson may, based on his/her professional judgment, order the immediate discontinuation of the use of a medication within the Department's State-operated facilities if it is withdrawn from marketing in the United States or when the U.S. Food and Drug Administration rescinds its approval for marketing in the United States, or when the Pharmacy and Therapeutics Committee recommends discontinuation based on information from Department experience with the medication, or from the medical literature, that the medication lacks clinical efficacy or is unsafe.

c)         The official departmental listing of medication that contains those medications utilized as narcotics and psychotropic medications is the Department's Central Formulary. It shall be updated at least annually and forwarded to each State-operated facility.  An additional listing shall be supplied to each State-operated facility that will contain, for each listed psychotropic and narcotic, the Department's maximum daily dose and other criteria relative to safe, effective pharmacotherapies.

d)         Medications not appearing in the Department's Central Formulary that are newly approved for marketing and labeled for psychotropic indications by the U.S. Food and Drug Administration within the previous 12 months shall be prescribed only on the written interim authorization of the Chairperson of the Department's Pharmacy and Therapeutics Committee.   The use of any such medication shall be requested by submission of Form IL 462-0705, Formulary Addition Request Form 705. At its next scheduled meeting, the Department's Pharmacy and Therapeutics Committee shall review the medication and shall approve or disapprove the use of the medication in Department facilities on the basis of available scientific information.  Written notice of the Committee's decision will be given to facility directors, facility medical directors and facility pharmacy directors.

e)         Medications not appearing in the Department's Central Formulary that are approved for marketing by the U.S. Food and Drug Administration, but are not labeled by the U.S. Food and Drug Administration for psychotropic indications, whose use for psychotropic indications is listed in the professional references identified in subsection (a), shall be prescribed only on the written interim authorization of the Department's Chairperson of the Pharmacy and Therapeutics  Committee based upon the submission of Form IL 462-0705A, Non-Formulary Request Form 705A . The Pharmacy and Therapeutics Committee shall review the medication at its next scheduled meeting for permanent approval or removal on the basis of available scientific information and shall give written notice to facility directors, facility medical directors and facility pharmacy directors of its decision.

f)         Medications appearing in the Department's Central Formulary that are approved for marketing by the U.S. Food and Drug Administration, but are neither labeled for psychotropic indications by the U.S. Food and Drug Administration nor listed as having psychotropic indications in the professional references identified in subsection (a), for which there is medical literature supporting  their use for psychotropic indications, may be prescribed by the attending physician for up to three calendar days.  The attending physician shall document the reason for such use in the recipient's medical record and shall notify the facility's medical director of the use no later than the next working day after administration of the medication.  If the medication is to be utilized for more than three calendar days, authorization shall be obtained from the facility's medical director who is responsible for applying to the Chairperson of the Pharmacy and Therapeutics Committee for authorization. The facility medical director may authorize continuation of the use of the medication for up to seven calendar days beyond the initial three-day period (total of 10 calendar days), at which point medication must be discontinued without the authorization. The written response of the Chairperson of the Pharmacy and Therapeutics Committee, or his /her designee, shall be filed in the recipient's medical record together with a copy of the medical director's application.

g)         Use of any medication not authorized pursuant to subsections (a) through (f) for psychotropic purposes is prohibited, unless its use has been approved for research in writing by the Chairperson of the Mental Health and Developmental Disabilities Services Pharmacy and Therapeutics Committee, based upon the Committee's review and authorization of the research.

h)         Based upon peer-reviewed professional literature and clinical evaluations of facility Formulary Addition Request Forms, the Pharmacy and Therapeutics Committee shall develop and maintain the Department's official formulary of medication that may be used within Department in-patient facilities.

(Source:  Amended at 25 Ill. Reg. 10834, effective August 2, 2001)