Current through Rules and Regulations filed through March 20, 2024
(1) Dispensing of all drugs to the facility
shall be pursuant to a legal prescription drug order for an individual
patients. Standing medication orders shall not be allowed. Policies may be
established by the vendor pharmacist in conjunction with the appropriate
committee of the facility. All drugs supplied to the facility must be obtained
from a pharmacy having a retail pharmacy permit.
(2) For use inside the facility, all drugs
dispensed shall be dispensed in appropriate containers, as defined by the Food
and Drug Administration and the Consumer Protection Agency, and adequately
labeled with the following information:
(a)
Name, address, and telephone number of the pharmacy;
(b) Date of issuance and identifying serial
number;
(c) Full name of
patient;
(d) Brand and/or generic
name of drug, strength, and quantity dispensed;
(e) Directions for use, which may be placed
on the container label or on a Medication Administration Record available and
consulted at the time of the administration of each dose, provided, however,
that both methods may be utilized inside a single facility;
(f) Name of physician prescribing;
(g) Required precautionary information
regarding controlled substances;
(h) Such other and further accessory
cautionary information as may be required or desirable for proper use and
absolute safety to the patient; and
(i) Expiration date.
(3) If a unit dose drug distribution system
is utilized, the above information shall be readily available on the patient
medication profile. A drug distribution system in a long term care facility may
be regarded as a unit dose drug distribution system if:
(a) The pharmacist maintains medication
profiles on each patient and refers to these files each time a medication is
filled;
(b) Doses of solid oral
medications dispensed are pharmacy-prepared or manufacturer-prepared in
individually packaged and sealed doses which are identifiable and properly
labeled to include, at a minimum:
1. Brand
and/or generic name of the drug;
2.
Strength;
3. Lot number;
and
4. Expiration date.
(c) Doses of medication for
individual patients are placed into individual patient containers, bins,
compartments, or drawers and whenever possible, are subdivided by dose and
administration time and not to exceed a 72-hour supply. Drug distribution
systems which exceed a 72-hour supply must follow labeling requirements of
480-24-.04(2).
(4)
Partial filling of Schedule II drugs will be allowed but limited to 60 days
only.
(5) Drugs added to
parenteral, enteral, or irrigation solutions. Whenever any drugs are added to
such solutions, whether within or outside the direct and personal supervision
of a registered pharmacist, such admixture shall be labeled with a distinctive
supplementary label indicating the name and amount of the drug added, date and
time of addition, expiration date and time if applicable, and identity of the
person so adding.
(6) Prescription
drug orders.
(a) Drugs may be dispensed or
administered only upon orders of an authorized prescriber. For schedule II
drugs refer to the Georgia Controlled Substances Act, Code Section
16-13-41, and
Chapter 480-22 of the Board rules and regulations. For other drugs orders may
be received by the pharmacy by fax or delivery of:
1. A direct copy of a prescription drug
order;
2. Obtaining a signed
prescription drug order from the prescriber; or
3. A verbal or telephone order from an
authorized prescriber or duly authorized agent.
(b) The consultant pharmacist will verify
orders as required by current state and federal laws, rules and
regulations.
(c) For purposes of
recordkeeping under this chapter, all original prescriptions, those hard copies
written by a practitioner, telephoned to the pharmacist by a practitioner and
reduced to writing, or sent via facsimile machine or other electronic means
must be retained as a permanent record for two years in the retail pharmacy and
must be filed by the usually consecutively serial numbered prescription file or
by patient name or by any other means that assures a complete, retrievable and
accurate record. Any refill information subsequently authorized by a
practitioner must be maintained in the manner required by O.C.G.A. §
26-4-80(3).
(7) Emergency kits. Emergency kits
may be placed in licensed nursing homes by the pharmacy of the consultant or
vendor pharmacist provided the following guidelines are met:
(a) A record of the drugs to be kept in an
emergency drug kit be kept in the nursing home and the provider
pharmacy;
(b) Drugs shall not be
accessed for use from the emergency drug kit in an emergency situation without
a new prescription drug order from a licensed practitioner. A valid, signed
prescription drug order for any such drug must be issued to the vendor
pharmacy, supplying the emergency drug kit, within 72 hours of the drug being
taken from the kit.
(c) Emergency
drug 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 therein. The provider pharmacy shall develop a method to readily
determine if an emergency drug kit has been accessed without
authorization;
(d) An emergency
drug kit must be inventoried at least once a month by a pharmacist from the
provider pharmacy and sign a card attached to the kit indicating the date it
was inspected. The provider pharmacy must maintain an adequate record of such
inspections.
(e) Special Agents of
the GDNA shall have the authority to check emergency drug kits as well as the
records in the provider pharmacy to determine that drugs and records are
accurate and the emergency drug kit is being properly used;
(f) The provider pharmacy must apply on an
individual basis to the Board, in care of the GDNA Director, for approval to
place an emergency drug kit in each individual nursing home and a copy of this
approval will be kept on file in both the nursing home and the provider
pharmacy. Upon recommendation by the GDNA Director, the Board may revoke the
approval for an emergency drug kit in any nursing home where abuse or misuse of
drugs from the emergency drug kit is used for any purpose other than emergency
purposes;
(g) The Board shall have
the authority to approve on an individual basis the drugs and the amounts of
each individual drug allowed to be kept in an emergency drug kit. Any change in
the drugs and amounts kept in a kit must be submitted in writing to the GDNA
Director who shall make recommendations to the Board. After Board approval, a
copy of this approval will be maintained in the GDNA provider pharmacy file and
by the nursing home. Any emergency drug kit approval becomes null and void once
the approved pharmacy ceases to provide that kit.
(h) Each solid oral dosage form placed in an
emergency drug kit must be individually labeled with the name and strength of
the drug, lot number, expiration date, and other appropriate cautionary
information; and
(i) The exterior
of an emergency drug kit shall be labeled so as to clearly and unmistakably
indicate that it is an emergency drug kit and is for "EMERGENCY USE ONLY", and
the label shall be physically signed and dated by the pharmacist who sealed the
kit. In addition, a listing of the drugs contained therein, including the name,
address, and telephone number(s) of the provider pharmacy shall be attached to
both the exterior and the interior of an emergency drug kit.
(8) Accountability of scheduled
drugs and other specified drugs.
(a) Proof of
use. Proof of use of Schedule II, III, IV and V controlled substances and such
other drugs as may be specified by the appropriate committee of the facility,
shall be upon proof of use forms which shall specify at a minimum:
1. Name and strength of the drug;
2. Dose and route of administration for the
drug;
3. Name of ordering
prescriber;
4. Name of
patient;
5. Date and time of
administration to patient;
6.
Signature and title of individual administering, the medication; and 7.
Documentation of destruction of all unused portions of single doses shall
include signature verifications of two licensed authorized personnel.
(b) Container requirement. Any
medication that has to be counted and accounted for with proof of use forms
must be dispensed in a container that allows verification of individual doses.
Containers for solid oral doses must allow identification of individual doses
and individual accountability.
(9) Medications brought by patients. When
patients bring drugs into the facility, such drugs shall be sent to the vendor
pharmacist who shall handle these drugs in accordance with guidelines
established by the appropriate committee within the facility.
O.C.G.A. Secs.
16-13-21(23), 16-13-34, 16-13-35, 16-13-39, 16-13-41, 16-13-45, 16-13-72, 16-13-77, 26-3-8, 26-3-16, 26-4-27, 26-4-28, 26-4-29, 26-4-80, 26-4-110.
