Ala. Admin. Code r. 580-9-46-.01

General Medical And Pharmacy

This regulation establishes general medical and pharmacy standards for substance abuse treatment programs in Alabama, requiring physician supervision of all medical care, written emergency procedures, drug screening protocols, and strict controls over the storage, dispensing, and accounting of controlled substances and prescription drugs. Residential programs must ensure client access to emergency hospital care and have nursing coverage available around the clock. The rule also mandates DEA registration procedures and specific reporting requirements in the event of controlled substance loss or theft. Both outpatient and residential substance abuse programs are covered, as indicated by the chapter context (sibling sections address outpatient and residential detoxification).

Ala. Admin. Code r. 580-9-46-.01 - General Medical And Pharmacy 

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(1)
 The agency must demonstrate that all
 medical care aspects of the program are performed or supervised by a physician
 licensed to practice in the State of Alabama.

(2)
 The agency must have written medical
 procedures which describe the steps for the management of medical
 emergencies.

(3)
 All residential
 programs must demonstrate their client's accessibility to a local licensed
 hospital for the purpose of providing emergency hospital care.

(4)
 All substance abuse treatment programs
 must provide for, or be able to refer, clients for physical and/or laboratory
 examinations when clinically appropriate in accordance with the supervising
 physician's written medical procedures. However, programs are not required to
 provide uncompensated medical care.

(5)
 For those situations where drug screening
 by urinalysis is deemed appropriate and necessary by the program director, or
 supervising physician, the program must:
(a)

 Establish procedures which protect against the falsification and/or
 contamination of any urine sample;

(b)
 Provide assurance that no client will be
 discharged from treatment solely on the basis of a single positive urine
 analysis (not applicable to substance abuse residential programs).

(6)
 The agency must, at all times,
 meet applicable federal and state requirements regarding the storing and/or
 dispensing of "prescription legend" and/or "controlled substance" drugs
 (including, but not limited to: 
Code of Ala. 1975
,
 Section 
34-23-94
, 
Code of Ala.
 1975
, Section
 
20-2-1
 through
 
20-2-93
; Federal Controlled
 Substance Act of 1970; Indigent Drug Program Manual for Mental Health Centers,
 where applicable).

(7)
 Any agency
 storing bulk quantities of "controlled substance" or "prescription legend"
 drugs must document that one of the following Drug Enforcement Administration
 (DEA) registration procedures has been met: 
 
(a)
 The supervising or consulting physician
 for the program has registered the facility as one of his offices with the DEA
 Registration Branch, or;

(b)
 The
 program itself has been registered with the DEA Registration Branch when there
 is more than one physician involved with the program.

(8)
 The agency must demonstrate accurate
 accounting/ tracking procedures for all "controlled substance" and/or
 "prescription legend" drugs purchased/dispensed by the program. These
 procedures must additionally account for any client owned medication that is
 present in the facility. The following records must be kept on all such drugs
 received, and administered, or self-administered: 
 
(a)
 A medication log/running inventory on
 which the following information is recorded: 
 
1.
 Date on which drug(s) were placed in
 inventory;

2.
 Brand name/generic
 name;

3.
 Quantity/dosage of
 drug(s);

4.
 Date drug(s) were
 administered;

5.
 Initials/signature
 of nurse administering drug(s).

(b)
 A medication sheet for each individual
 client on which the following information is recorded each time drugs are
 administered:
1.
 Brand name/generic
 name;

2.
 Date/time drugs were
 administered;

3.

 Quantity/dosage;

4.

 Initials/signature of nurse administering drugs, or initial/signature of client
 when self medicating;

5.
 Client's
 name;

(c)

 Non-prescription medication allowed to be self-administered to a client in a
 substance abuse residential treatment program shall be recorded on the
 medication sheet.

(d)
 The agency
 must document that a reconciliation of the drug inventory, performed under the
 supervision of the program director or supervising physician, is performed
 according to the following:
1.
 At least
 semiannually;

2.
 Each time there is
 a change in the responsibilities among those individuals with designated access
 to the drug supplies.

(9)
 All "controlled substances" and/or
 "prescription legend" drugs kept in the facility must be stored in a locked
 cabinet or other substantially constructed storage that precludes surreptitious
 entry.

(10)
 All such storage units
 must be locked when not in use.

(11)
 Access to all "controlled substances"
 and/or prescription legend" drugs must be restricted to the absolute minimum
 number of employees needed to handle daily transactions of such
 drugs.

(12)
 A listing of those
 employees permitted access to the drugs will be on file at the agency. This
 listing should be displayed in the drug storage area.

(13)
 In the event of loss or the theft of
 controlled substances, the agency must perform the following: 
 
(a)
 Notify local law enforcement personnel
 immediately upon the detection of the loss;

(b)
 Notify the supervising physician
 immediately upon the loss if the supervising or consulting physician has
 registered the program as one of his offices with the DEA Registration
 Branch;

(c)
 Notify the DEA
 Registration Branch directly if the program itself has been registered with the
 DEA Registration Branch;

(d)
 Notify
 the Director, Substance Abuse Services Division, Department of Mental Health
 within 24 hours of the detection of the loss;

(e)
 Provide a subsequent written description
 of the events and extent of the loss to the Director, Substance Abuse Services
 Division, Department of Mental Health. This written description must be mailed
 within 72 hours from loss detection.

(14)
 For residential services, there shall be
 a registered nurse or licensed practical nurse as a full-time or part-time
 employee or a consultant to the provider who is responsible for supervision of
 delegation of medication assistance to the unlicensed personnel. Access to an
 on-call nurse must be available 24 hours/day, 7 days/week. Providers will
 implement policies and procedures approved by their Boards of Directors
 requiring full compliance with the Alabama Board of Nursings regulation
 
610-X-6-.15
 Alabama Department of
 Mental Health Residential Community Programs.

Notes

Ala. Admin. Code
 r. 
580-9-46-.01

New Filed: July 22, 1992.
 Extended: September 30, 1992. Extended: December 31, 1992. Certified: March 30,
 1993. Effective: May 5, 1993. Amended: Filed November 19, 2003; effective
 December 24, 2003. Amended: Filed September 5, 2007; effective October 10,
 2007.

Author:
 Substance Abuse Services Division

Statutory Authority:

Code of Ala.
 1975
, §
 
22-50-11
.

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