Current through Rules and Regulations filed through March 20, 2024
The following regulations shall be followed in the absence of a
pharmacist:
(1) General. Access to
drugs in the absence of a licensed pharmacist shall be limited to specifically
authorized licensed medical personnel consistent with policies and procedures
of the Director. Such areas shall be sufficiently secure to deny access by
unauthorized persons. The Director shall, in conjunction with the appropriate
committee of the narcotic treatment program clinic, develop a list of the drugs
to be accessible and shall ensure that:
(a)
Such drugs available therein, are properly labeled, with drug name, strength,
lot number and expiration date;
(b)
Only prepackaged drugs are available therein, in amounts sufficient for
immediate therapeutic requirements;
(c) Whenever access to such area shall have
been gained, written physician's orders and proof of use for controlled
substances are provided;
(d) All
drugs therein are inventoried no less than once per week. A system of
accountability must exist for all drugs contained therein; and
(2) Written policies and
procedures are established to implement the requirements of this
subsection.
(3) Emergency Kits.
Drugs may be provided for use by authorized licensed health care personnel by
emergency kits, provided such kits meet the following requirements:
(a) Drugs included. The Director and the
medical staff of the clinic shall jointly determine the drugs, by identity and
quantity, to be included in the emergency kits. Such drugs shall also be
approved by the Board or its authorized agent;
(b) Storage. Emergency kits shall be stored
in limited access areas and sealed to prevent unauthorized access, and to
insure a proper environment for preservation of the drugs within
them;
(c) Labeling-exterior. The
exterior of emergency kits shall be labeled so as to clearly and unmistakably
indicate that it is an emergency drug kit and is for use in emergencies only.
In addition, a listing of the drugs contained therein, including name,
strength, quantity, and expiration date of each drug shall be attached. Nothing
in this section shall prohibit another method of accomplishing the intent of
this section, provided such method is approved by the Board upon a
recommendation of the GDNA.
(d)
Labeling-interior. All drugs contained in emergency kits shall be labeled in
accordance with such state and federal laws and regulations which pertain
thereto; and shall also be labeled with such other and further information as
may be required by the medical staff of the clinic to prevent misunderstanding
or risk of harm to the patients;
(e) Removal of drugs. Drugs shall be removed
from emergency kits only pursuant to a valid physician's order, by authorized
licensed clinic personnel, or by a pharmacist for the clinic
pharmacy;
(f) Notification.
Whenever an emergency kit is opened, the pharmacy shall be notified; and the
pharmacy shall replace or re-stock and reseal the kit within a reasonable time
so as to prevent risk of harm to patients. In the event the kit is opened in an
unauthorized manner, the pharmacy and other appropriate personnel of the
facility shall be notified;
(g)
Inspections. Each emergency kit shall be opened and its contents inspected by
the pharmacy at least once every ninety (90) days. Upon completion of
inspection, the emergency kit shall be re-sealed.
(4) Access to pharmacy. Whenever any drugs
are not available from an after hours safe or emergency kit(s), and such drugs
are required to treat the immediate needs of a patient whose health would
otherwise be jeopardized, such drugs may be obtained from the pharmacy pursuant
to the physician's order and the requirements of this subsection.
(a) At any given time, there may be only one
licensed health care professional who is designated in the policies and
procedures, to have access to the pharmacy and to remove drugs
therefrom.
(b) Such licensed health
care professional shall be designated in writing by the Director of the OTP
clinic pharmacy and shall, prior to being permitted to obtain access to the
pharmacy, receive thorough education and training by the Director or his or her
designee in the proper methods of access, removal of drugs, and records and
procedures required.
(c) Such
licensed healthcare professional shall at a minimum record on a suitable form
the name of any drug, the strength, amount, date and time removed from the
pharmacy and his or her signature and title.
(d) Such licensed healthcare professional
shall place the container from which the drug is removed in a conspicuous place
in the pharmacy to be promptly reviewed and inspected by a
pharmacist.
(e) Procedures. The
Director, in conjunction with the medical staff of the clinic, shall develop
and implement written policies and procedures to insure compliance with the
provisions of this subsection.
O.C.G.A. Secs.
16-13-34, 26-4-27, 26-4-28, 26-4-87, 26-4-110, 26-4-111.
