Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.06 - Drug Distribution Control

Current through Rules and Regulations filed through June 27, 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.