Ala. Admin. Code r. 580-2-9-.26

Indigent Drug Program

This regulation establishes operational requirements for the Alabama Department of Mental Health's Indigent Drug Program (IDP), which provides psychotropic medications to financially eligible consumers at community mental health centers. Operators must ensure consumers have a psychiatric diagnosis, are under physician care, receive direct services at least every 90 days, and are screened for third-party payer eligibility before IDP drugs are dispensed. The regulation also sets detailed pharmacy management standards, including licensed pharmacist staffing, controlled substance recordkeeping, inventory procedures, and DEA/Board of Pharmacy compliance.

Ala. Admin. Code r. 580-2-9-.26 - Indigent Drug Program 

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(1)
 A
 consumer in the Indigent Drug Program (IDP) must be under the care of a
 licensed physician who may be either in private practice or on the staff of a
 mental health center.

(2)
 Each
 consumer must have a psychiatric diagnosis established before any prescription
 is filled.

(3)
 Every consumer on
 the IDP must be an active consumer of the center even if medication is
 prescribed by a non-center physician.

(4)
 Each consumer should receive a direct
 service at least every 90 days. Case notes should be completed for each
 contact.

(5)
 All chemotherapy must
 be documented in the consumer records in accordance with section
 
580-2-9-.06
. Additional comments
 may be made on the service record and in the case notes.

(6)
 All prescribed medication issued by the
 IDP is subject to review by the mental health center's Medical
 Director.

(7)
 All consumers
 receiving psychotropic drugs shall be seen and evaluated by a licensed
 physician at intervals not to exceed a 6 month period.

(8)
 Approved dispensing agencies must use the
 IDP financial and clinical eligibility criteria as published by the Alabama
 Department of Mental Health. Exception: One-time only for prescriptions from a
 state institution, crisis stabilization program, for a documented emergency, or
 until compassionate need medication can be obtained.

(9)
 Financial information as well as clinical
 documentation in sufficient detail to determine eligibility for participation
 in the Indigent Drug Program will be in the consumer records. This information
 will be updated at least on an annual basis.

(10)
 All consumers of the Indigent Drug
 Program must be screened for third party eligibility. Consumers who qualify for
 Medicaid, insurance or compassionate need programs will not be furnished drugs
 that are available through these other sources.

(11)
 The provider shall have a policy that
 prohibits the sale of drugs.

(12)

 The provider shall establish a nominal dispensing fee to cover the costs of
 dispensing medication, including salary of the pharmacist, cost of containers,
 labels, etc. An additional charge may be assessed if it is necessary to mail
 any prescriptions.

(13)
 All records
 required by state and federal laws governing the storage and handling of drugs
 must be maintained.

(14)
 All
 prescriptions filled with drugs furnished by the State of Alabama for use in
 the Indigent Drug Program must be filled exclusively within the confines of the
 mental health center or its satellite facilities.

(15)
 The provider shall follow Alabama
 Department of Mental Health operating procedures relative to ordering, storage,
 and accounting for medication obtained and dispensed through the IDP.

(16)
 Pharmacies used for the IDP are licensed
 by the Alabama State Board of Pharmacy and are staffed either part-time or
 full-time, by a pharmacist registered in Alabama.

(17)
 The registered pharmacist, as the
 legally responsible person, shall compound (fill) and/or dispense all
 prescriptions.

(18)
 The state
 office must be advised of any changes in key personnel involved with the
 Indigent Drug Program and appropriate in-service training by the Coordinator of
 Community Pharmacy Services will be available, if needed.

(19)
 Adequate clerical support must be
 provided to insure that the necessary reports, records, etc., are
 executed.

(20)
 The Coordinator of
 Community Pharmacy Services must be notified of any planned change in the
 location of a pharmacy.
(a)
 In case of change
 of address of the center, the following are to be notified when the date of
 change is final:
1.
 Alabama State Board of
 Pharmacy.

2.
 Drug Enforcement
 Administration.

(b)
 Old
 Drug Enforcement Order Forms should be returned to the Drug Enforcement
 Administration, Registration Branch.

(c)
 New order form book for new address must
 be requested before placing orders for any Schedule II items to be shipped to
 the new address.

(21)

 The mental health center director shall sign an assurance that any drugs paid
 for through the IDP will be used only for persons who meet the clinical and
 financial eligibility criteria for the IDP. No drugs will be ordered for a
 mental health center until there is a current assurance statement on file with
 the Department of Mental Health.

(22)
 Drugs for the Indigent Drug Program must
 be kept separate from any other drug stock(s) or any other center
 supplies.

(23)
 Access to the
 pharmacy must be limited to the pharmacist and only the pharmacist shall have
 keys to the pharmacy. Pharmacy assistants may be in the pharmacy at the same
 time as the pharmacist.

(24)
 Drugs
 can be received only by an authorized representative in the absence of the
 Pharmacist and must be stored in a place that can be securely locked outside
 the pharmacy.

(25)
 There should be
 entries in the general ledger for drugs received and dispensed by each center.
 The value of the drugs must be included as part of the center's revenues and,
 when dispensed, as part of the center's expenditures.

(26)
 A physical inventory of drugs on hand
 should be taken at the close of business September 30 of each year. The value
 of the drugs on hand, using the prices reflected on the invoices of the prime
 vendor or those available from the state office should be determined. This
 inventory must be verified by spot checks of selected items by someone
 designated by the Center Director other than Indigent Drug Program
 personnel.

(27)
 Any pharmacy
 involved in the loss of controlled substances must notify the DEA regional
 office, the State Board of Pharmacy, and the Coordinator of the Community
 Pharmacy Service upon discovery of theft or significant loss. The DEA office
 will furnish a form to be filled out, along with instructions for completing
 the form.

(28)
 A prescription will
 be limited to 5 refills, or 6 months, whichever occurs first, unless the
 prescribing physician indicates more stringent directions. The quantity issued
 at any one time will not exceed a 33 day supply.

Notes

Ala. Admin. Code
 r. 
580-2-9-.26

New Rule: Filed June 14,
 2010; effective July 19, 2010.

Author:
 Division of Mental Illness, DMH

Statutory Authority:

Code of Ala.
 1975
, §
 
22-50-11
.

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