(1) General. When a licensed pharmacist is
not physically present in the hospital and the pharmacy is closed, written
policies and procedures shall be prepared in advance by the Director of
Pharmacy for the provision of drugs to the medical staff and other authorized
personnel of the hospital by use of night cabinets and/or by access to the
pharmacy. The policies and procedures may include the use of remote order entry
pharmacist to ensure that in-patient needs are met at the hospital when a
licensed pharmacist is not physically present. All policies and procedures
providing for the use of night cabinets and/or access to the pharmacy when a
licensed pharmacist is not physically present shall be made available to the
Georgia State Board of Pharmacy, its designee, or a representative of the
Georgia Drugs and Narcotics Agency (GDNA), upon request.
(2) A hospital utilizing a remote order entry
pharmacist shall maintain a record of the name and address of such pharmacist,
evidence of current licensure in the State of Georgia, and the address of each
location where the pharmacist will maintain records of remote order
A hospital pharmacy
shall be authorized to utilize remote order entry when:
(a) The licensed pharmacist is not physically
present in the hospital, the hospital pharmacy is closed, and a licensed
pharmacist will be physically present in the hospital pharmacy within 24 hours
or the next business day;
at least one licensed pharmacist is physically present in the hospital;
(c) When it is a weekend and at
least one pharmacist is physically present in another hospital in this state
which remotely serves on weekends not more than four other hospitals under the
same ownership or management which have an average daily census of less than
twelve acute patients.
Before a hospital may engage in remote
order entry as provided in this paragraph, the director of pharmacy of the
hospital shall submit to the board written policies and procedures for the use
of remote order entry. The required policies and procedures to be submitted to
the board shall be in accordance with the American Society of Health-System
Pharmacists and shall contain provisions addressing:
(a) quality assurance and safety,
(b) mechanisms to clarify medication
(c) processes for reporting
documentation and record keeping,
(e) secure electronic access to the hospital
pharmacy's patient information system and to other electronic systems that the
on-site pharmacist has access to,
(f) access to hospital policies and
procedures, confidentiality and security, and
(g) mechanisms for real-time communication
with prescribers, nurses, and other care givers responsible for the patient's
remote entry record must comply with all recordkeeping requirements and shall
identify, by name or other unique identifier, the pharmacist involved in the
preview and verification of the order. The remote entry pharmacist shall
maintain records of any and all records entered for the hospital for a minimum
of two (2) years, and such records shall be readily available for inspection,
copying by, or production of upon request by the Board, its designee, or a
representative for the Georgia Drugs and Narcotics Agency (GDNA), upon
(6) If the board concludes
that the hospital's actual use of remote order entry does not comply with this
rule or O.C.G.A.
it may issue a cease and desist order after notice and hearing.
Night cabinets. Access to drugs, in the
absence of a licensed pharmacist, shall be by locked cabinet(s) or other
enclosure(s) constructed and located outside of the pharmacy area to which only
specifically authorized personnel as indicated by written policies and
procedures may obtain access by key or combination, and which is sufficiently
secure to deny access to unauthorized persons. The Director of Pharmacy shall,
in conjunction with the appropriate committee of the hospital, develop
inventory listings of those drugs to be included in such cabinet(s) and shall
(a) Such drugs are available
therein, properly labeled, with drug name, strength, lot number and expiration
(b) Only pre-packaged drugs
are available therein, in amounts sufficient for immediate therapeutic
(c) Whenever access
to such cabinet(s) has been gained, written practitioner's orders and proofs of
use for controlled substances must be 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
policies and procedures are established to implement the requirements of this
to pharmacy. Whenever a drug is not available from floor supplies or night
cabinets, and such drug is required to treat the immediate needs of a patient
whose health would otherwise be jeopardized, such drug may be obtained from the
pharmacy pursuant to the practitioner's order and the requirements of this
subsection. One nursing supervisor (registered professional nurse or licensed
practical nurse) in any given shift may have access to the pharmacy and may
remove drugs there from. Such licensed nurse shall be designated in writing by
the Director of Pharmacy of the hospital and shall, prior to being permitted to
obtain access to the pharmacy, receive thorough education and training approved
by the Director of Pharmacy, in the proper methods of access, removal of drugs,
and records and procedures required. The Director of Pharmacy, or designee,
shall document the nurse's competence following the education and training. In
addition, such licensed nurse accessing a closed pharmacy must receive specific
step-by-step instructions in a policy manual, approved by the Director of
Pharmacy, before accessing the pharmacy. At any time that a nurse is accessing
a closed pharmacy, the Director of Pharmacy must designate a licensed
pharmacist, not a remote order entry pharmacist, who is available to the nurse
by telephone, and who, in the event of an emergency, is available to come to
the hospital. When a nurse accesses drugs directly from the closed pharmacy,
the nurse must:
(a) provide a copy of the
(b) document on a suitable
form the name of the drug, the strength and amount of the drug removed, the
date and time it was removed, and sign the form.
(c) The container from which the drug is
removed shall then be placed conspicuously to be promptly reviewed and
inspected by the next pharmacist coming on duty. The Director of Pharmacy's
policies and procedures must provide that the next pharmacist physically coming
into the pharmacy must document that they have reviewed the drugs removed and
the orders filled.
Emergency kits/crash carts. Drugs may also be provided for use by authorized
personnel by emergency kits/crash carts, provided such kits/carts meet the
kit/crash cart drugs defined. Emergency kit/crash cart drugs are those drugs
which may be required to meet the immediate therapeutic needs of patients and
which are not available from any other authorized source in sufficient time to
prevent risk of harm to patients;
(b) Drugs included. The Director of Pharmacy
and the medical staff of the hospital shall jointly determine the drugs, by
identity and quantity, to be included in the emergency kits/crash
(c) Storage. Emergency
kits/crash carts shall be sealed and stored in limited access areas to prevent
unauthorized access, and to insure a proper environment for preservation of the
drugs within them;
(d) Labeling -
exterior. The exterior of emergency kits/crash carts shall be labeled so as to
clearly and unmistakably indicate that it is an emergency drug kit/crash cart
and is for use in emergencies only. In addition, a listing of the drugs
contained therein, including name, strength, quantity, and expiration date of
the contents shall be attached. Nothing in this section shall prohibit another
method of accomplishing the intent of this section, provided such method is
approved by an agent of the Board;
(e) Labeling - interior. All drugs contained
in emergency kits/ crash carts 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 hospital to prevent misunderstanding or risk of harm to
(f) Removal of drugs.
Drugs shall be removed from emergency kits/crash carts only pursuant to a valid
practitioner's order, by authorized personnel, or by a pharmacist of the
Notification. Whenever an emergency kit/crash cart is opened, the pharmacy
shall be notified; and pharmacy personnel shall restock and re-seal the
kit/cart within a reasonable time so as to prevent risk of harm to patients. In
the event the kit/cart is opened in an unauthorized manner, the pharmacy and
other appropriate personnel of the facility shall be notified;
(h) Inspections. Each emergency kit/crash
cart shall be opened and its contents inspected by a pharmacist at least once
every ninety (90) days. Upon completion of inspection, the emergency kit/crash
cart shall be re-sealed;
Procedures. The Director of Pharmacy shall, in conjunction with the medical
staff of the hospital, develop and implement written policies and procedures to
insure compliance with the provisions of this subsection.
(10) Authoritative, current antidote
information as well as the telephone number of the regional poison control
information center shall be readily available in areas outside the pharmacy
where these drugs are stored.
Nothing in this rule shall be construed to relieve the hospital pharmacy of the
requirement of having an on-site pharmacist to provide routine pharmacy
services within the hospital in order to qualify as a licensed
Ga. Comp. R. & Regs.
entitled "Absence of Pharmacist" adopted. F. Jan. 24,
1977; eff. Feb. 13, 1977.
Repealed: New Rule of same title adopted. F.
May 5, 1980; eff.
May 25, 1980.
Repealed: New Rule of same title adopted. F.
July 24, 2002; eff.
August 13, 2002.
Repealed: New Rule of same title adopted. F.
Mar. 13, 2008; eff.
Apr. 2, 2008.
Amended: F. July 26,
2010; eff. August 15, 2010.
Repealed: New Rule with same title adopted. F.
Dec. 14, 2012; eff.
Jan. 3, 2013.
Amended: F. Dec. 19,
2013; eff. Jan. 8, 2014.
Amended: F. May 9,
2019; eff. May 29, 2019.