Current through Rules and Regulations filed through March 20, 2024
(1)
General. A drug distribution system is the entirety of that mechanism by which
a prescription drug order is executed, from the time the practitioner transmits
the order either orally or in writing to an authorized health professional to
the time the ordered drug is administered to the patient or delivered to the
patient for self-administration.
(2) Responsibility. The Director of Pharmacy
shall be responsible for the safe and efficient distribution, control, and
accountability for drugs, including IV solutions and irrigation solutions. The
other professional staff of the hospital shall cooperate with the Director of
Pharmacy in meeting this responsibility and in ordering, administering, and
accounting for the pharmaceutical materials to achieve this purpose. The
Director of Pharmacy shall establish written procedures for the distribution of
parenteral medications to achieve this goal. Accordingly, the Director of
Pharmacy shall be responsible for, at a minimum, the following:
(a) The compounding, admixture, and quality
control of large volume parenterals is the responsibility of a pharmacist and
shall be prepared under a Laminar Flow Hood or utilizing such other equipment
to protect the integrity of the product, within the pharmacy department.
Individuals who prepare or administer large volume parenterals must have
special training to do so. These functions of IV admixture compounding shall be
done primarily by the pharmacy department with exceptions allowed for
specialty-care areas such as Intensive Care Units, Cardiac Catheterization
Laboratories Intensive Care Units, etc., during emergency situations, or during
unattended hours of the pharmacy department. When any part of the above
functions (preparing, sterilizing, and labeling parenteral medications and
solutions) is performed within the hospital but not under direct pharmacist
supervision, the Director of Pharmacy shall be responsible for providing
written guidelines and for approving the procedures to assure that all
pharmaceutical requirements are met;
(b) All drugs must be identified up to the
point of administration;
(c) It
shall be the responsibility of the pharmacist on duty to sign the invoice(s),
including signature, legible Georgia pharmacist license number, and date, for
all controlled substances upon receipt and verification;
(d) The pharmacy must receive a direct copy,
electronic or mechanical copy of a practitioner's order before the first dose
of medication is dispensed except as defined by hospital stat order
policy;
(e) Utilization of a
pharmacy-generated patient profile. The patient profile shall be the official
record of medications dispensed to the patient. The patient profile or the
ability to generate such profile electronically shall be under the control of
the Director of Pharmacy for a period of two (2) years. The patient profile
shall contain at a minimum:
1. Given and last
name of the patient;
2.
Age;
3. Sex;
4. Provisional diagnosis;
5. Room number;
6. Drug product dispensed, date dispensed,
strength, dosage form, quantity and directions, and identification of
dispensing pharmacist;
7.
Identification or differentiation of controlled substances;
8. Intravenous therapy;
9. Selected medical data;
10. Drug history interview (when possible);
and
11. Sensitivities and allergies
to drugs and foods;
(f)
Manufacture of drugs, if applicable;
(g) Establishment of specifications or use of
compendia specifications for procurement of drugs, chemicals, devices and
biologicals, subject to approval of the appropriate committee of the
hospital;
(h) Participation in the
development of a drug formulary for the hospital;
(i) filling and labeling all containers from
which drugs are to be administered, after visual screening to determine that
same are neither adulterated nor misbranded;
(j) Maintaining and making available a
sufficient inventory of antidotes and other emergency drugs. Current antidote
information, telephone numbers of regional poison control center(s) and other
emergency assistance organizations, and other material and information as may
be deemed necessary shall be maintained;
(k) Records of all transactions of the
hospital pharmacy as may be required by law, and as may be necessary to
maintain accurate control over the accountability for all pharmaceutical drugs,
devices and materials. Nothing in this section shall prohibit the use of
computer hard copy, where such copy meets all other requirements of the
law;
(l) Participation in those
aspects of the hospital patient care evaluation program which relate to
pharmaceutical drug, device and material utilization and effectiveness;
and
(m) Efficient messenger and
delivery service to connect the pharmacy with appropriate parts of the facility
throughout the normal workday.
(3) Labeling.
(a) For use inside the hospital, all drugs
dispensed by a hospital pharmacy, including those for standard ward inventory,
shall be dispensed in appropriate containers and adequately labeled so as to
identify at a minimum, brand name or generic name, strength, lot number, and
expiration date.
(b) For use
outside the hospital, all drugs dispensed by a hospital pharmacy to patients
about to be discharged or on leave of absence shall be labeled with the
following information:
1. Name, address, and
telephone number of the hospital pharmacy;
2. Date and identifying serial
number;
3. Patient's given and last
name;
4. Name of drug, (brand or
generic) and strength;
5.
Directions for use by patient;
6.
Name of prescribing practitioner;
7. Required precautionary information
regarding controlled substances; and
8. Such other and further accessory
cautionary information as may be required or desirable for proper use by and
safety of the patient.
(c) Drugs added to parenteral solutions.
Wherever any drugs are added to parenteral solutions, whether within or outside
the direct and personal supervision of a licensed 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 the identity of the person so adding.
(4) Discontinued drugs. The Director of
Pharmacy shall develop and implement policies and procedures to insure that
outdated drugs and containers with worn, illegible, or missing labels are
returned to the pharmacy for proper disposition.
(a) Full doses of controlled substances
prepared for administration and not given must be destroyed by a licensed
pharmacist or a licensed nurse and one witness. Any portions of controlled
substances discontinued and taken from a medication delivery device shall be
destroyed by a licensed pharmacist or a licensed nurse and one witness. The two
persons witnessing the destruction must sign the destruction record at the time
of destruction. The destruction record shall be returned to the pharmacy and
must be signed by the pharmacist who is ultimately responsible for the accuracy
of the information contained therein.
(b) In accordance with the policies and
procedures developed by the Director of Pharmacy, discontinued non-controlled
substances dispensed to hospital patients shall be returned to the pharmacy and
evaluated by the licensed pharmacist to assure the integrity of the medication.
If the integrity can be assured, the medication may be returned to the
hospital's drug distributions system for re-issue. When the integrity cannot be
assured, the medication must be separated immediately from the regular drug
inventory and destroyed or transferred to a reverse distributor with a current
license issued by the Board. The following method of destruction of
non-controlled substances is approved by the Board for medications dispensed to
hospital patients or patients residing in nursing homes or long term care units
which are part of a hospital facility;
1.
Placed in a secure storage area at the facility separated from other
medications. The drugs may be destroyed at the facility by the pharmacist and
another licensed healthcare practitioner designated by the facility. However,
before the destruction can take place, it must be verified that an inventory
has been taken and recorded. The facility must maintain a written record of the
destruction and the inventory for a two year period. This record shall include
at a minimum the date, time, and personnel involved with the destruction and
the method of destruction; or
2. If
the drugs are to be transferred to a reverse distributor with a current license
issued by the Board, a record of the following must be maintained by the
hospital pharmacy for a minimum of two years:
(i) An inventory of the drugs to be
transferred including the names of the drugs; the dosage form(s) of the drugs
and the quantity of the drugs; the inventory shall be verified by a pharmacy
representative and a representative of the reverse distributor;
(ii) The date and time the drugs were taken
from the pharmacy;
(iii) The name,
Board permit number, address and telephone number of the destruction firm
removing the drugs;
(iv) The name
and signature of the responsible person representing the reverse distributor
who is physically removing the drug(s);
(v) The name and signature of the pharmacist
representing the pharmacy transferring the drug(s) to the reverse
distributor.
(c) The following methods of destruction of
controlled substances are approved by the Board of Pharmacy:
1. A securely attached wooden or metal
cabinet within a locked limited-access area shall be used to store the drugs
until the drugs are destroyed. When controlled drugs are discontinued or the
patient expires, the medication shall be pulled from the active stock
immediately and inventoried and verified by a pharmacist along with another
licensed healthcare professional. The inventory must be recorded into a
permanent record and the drugs shall then be placed in the aforementioned
cabinet. This medication shall remain within the locked cabinet until such time
as it is removed for destruction.
2. The pharmacist shall establish a form,
which shall include the following data:
(i)
Date of discontinuance or inventory date;
(ii) Name of patient;
(iii) Name of pharmacy;
(iv) Identifying serial numbers;
(v) Name and strength of the drug;
and
(vi) Quantity of the drugs in
container(s) at the time of inventory.
3. A licensed pharmacist or licensed nurse
and one witness must destroy the drugs.
4. Inventory of the drugs included in the
final destruction must be taken with one copy retained by the facility. The
inventory shall be certified by the two witnesses present at the destruction in
the following format:
"We, whose signatures appear below, certify that these
controlled substances have been reconciled, accounted for, and destroyed at
___________________ (location) on _________ (date) at __________
o'clock."
Name of drug
Strength of drug
Dosage form
Quantity of drug
__________________________
(Signature and Title)
__________________________
(Signature and Title)
__________________________
(Signature and Title)
5. The Board and/or the GDNA may prohibit any
pharmacist or hospital pharmacy from utilizing this method.
(d) A method of off-site destruction
allowable by the Board is as follows:
1. The
drugs to be destroyed shall be immediately removed from the active stock and
stored in a separate and secure location in the pharmacy until the drugs are
transferred. When the drugs are transferred to a reverse distributor licensed
by the Board, an inventory must be recorded and include the following
information: the names of the drugs, the dosage forms of the drugs and the
quantities of the drugs taken and witnessed by an authorized representative of
the hospital pharmacy and the responsible person representing the reverse
distributor.
2. A receipt including
the date and time the drugs were taken from the pharmacy; the name, Board
permit number, address and telephone number of the reverse distributor removing
the drugs; the inventory of the drugs; the name, signature and title of the
responsible person representing the reverse distributor; and the name,
signature and title of the pharmacy representative transferring the drugs. This
receipt/record must be maintained by the hospital pharmacy for a minimum of two
years.
(5)
Prescription drug orders. Drugs may be dispensed from the hospital pharmacy
only upon written orders, direct or mechanical copies thereof, of authorized
practitioners.
(a) Authorization. The
appropriate committee of the hospital shall, from time to time as appropriate,
designate those practitioners who are authorized to issue prescription drug
orders to the pharmacy.
(b)
Abbreviations. Orders employing abbreviations and chemical symbols shall be
utilized and filled only if such abbreviations and symbols appear on a
published list of accepted abbreviations developed by the appropriate committee
of the hospital.
(c) Requirements -
Prescription drug orders for drugs, devices or materials for use by
in-patients. Prescription drugs orders for use by in-patients shall, at a
minimum, contain:
1. Patient name and room
number;
2. Drug name, strength,
directions for use; and
3. Date and
practitioner's signature.
(d) Requirements - Prescription drug orders
for drugs, devices or materials for use by outpatients. Prescription drug
orders for drugs, devices or materials for use by outpatients shall, at a
minimum, contain all of the information required by Rule
480-13-.06(5)(c), and in addition include:
1. Quantity to be
dispensed;
2. Practitioner's
address and Drug Enforcement Administration identification code, if applicable,
and
3. Patient's address, if
applicable.
(6)
Accountability of controlled drugs.
(a) Proof
of use of controlled drugs on standard ward inventory. Proof of use of
controlled substances and such other drugs as may be specified by the
appropriate committee of the hospital, shall be submitted to the pharmacy, on
forms provided by the pharmacy. Proof of use forms shall specify at a minimum:
1. Name of drug, strength, and dosage
form;
2. Dose
administered;
3. Name of authorized
practitioner. This shall include, at a minimum, the initial and last
name;
4. Given and last name of the
patient;
5. Date and time of
administration to the patient;
6.
Signature of the individual administering, which shall include at a minimum,
the initial, last name, and title;
7. Documentation of the destruction of any
and all unused portions by two signature verifications;
8. Proof of receipt of the medications that
bears identifying serial numbers; and
9. Date the medication was issued and the
date that the proof of use form was returned to the
pharmacy.
(b) Anesthesia
departments that obtain controlled drugs from the hospital pharmacy must show
accountability of the controlled drugs by proof of use as defined
above.
(c) Use of computer
generated hard copy is permitted where such copy meets all other requirements
of the law.
(d) Any hospital
pharmacy licensed by the Georgia State Board of Pharmacy and in which
controlled substances are administered to patients, may make on-premises
destruction of small quantities of controlled substances prepared for
parenteral and oral administration provided:
1. The controlled substance is either a whole
dose or a partial dose of a single-dosage unit; and
2. The single-dosage unit from which the
ordered dose was prepared is the nearest possible size to the dose
ordered.
(e) Perpetual
inventory of Schedule II substances shall be required and accountability of
said drugs shall be by a proof of use form.
(7) Recall. The Director of Pharmacy shall
develop and implement a policy and procedure to assure that all drugs within
the hospital included on a recall are returned to the pharmacy for proper
disposition.
(8) Suspected adverse
drug reactions. All suspected adverse drug reactions shall be reported
immediately to the ordering authorized practitioner, the pharmacy, and to the
appropriate committee of the hospital. An appropriate entry on the patient's
medical record shall also be made.
(9) Records and reports. The Director of
Pharmacy shall maintain access to and submit, as appropriate, such records and
reports as are required to insure the patient's health, safety and welfare.
Such records shall be readily available and subject to inspections by the Board
of Pharmacy, the GDNA or its employees. These shall include, at a minimum, the
following:
(a) Patient profile;
(b) Proof of use;
(c) Reports of suspected adverse drug
reactions;
(d) Inventories of night
cabinets and emergency kits/crash carts;
(e) Inventories of the pharmacy;
(f) Biennial controlled substances
inventories;
(g) Alcohol and
flammables reports; and
(h) Such
other records and reports as may be required by state Law and the Rules and
Regulations of the Board of Pharmacy.
(10) Standard ward inventory (floor stock).
The pharmacy department may distribute drugs within a hospital for the purpose
of establishing and/or maintaining a standard ward inventory. Such drugs may be
distributed only upon a signed requisition from a nurse or other authorized
representative of said hospital or by an inventory replacement system. These
drugs may be administered only pursuant to a practitioner's order. This
practitioner's order will be forwarded to the pharmacy and these medications
will be recorded on the pharmacy patient profile. A record of administration of
drugs administered to patients in ancillary areas such as but not limited to
the operating room, emergency room, anesthesiology, and x-ray shall be
forwarded to the pharmacy and these medications shall be recorded on the
patient profile. A survey of usage trends of each standard ward inventory shall
be prepared monthly. Such records shall be retained for a period of two
years.
(11) Emergency room
dispensing. An authorized practitioner may, when drugs or controlled substances
are not otherwise available from a licensed pharmacy, dispense an emergency
amount of medication, but only sufficient quantities until such time as
medication can be obtained from a pharmacy licensed as a retail pharmacy.
Nurses or other unauthorized personnel may not dispense medication from the
emergency room. The total act of dispensing shall be performed by an authorized
practitioner in accordance with Pharmacy Laws, Rules and Regulations. Such
medications shall be labeled as required in Section
480-13-.06(3)(b).
O.C.G.A.
§§
26-4-27, 26-4-28, 26-4-110.
