Ga. Comp. R. & Regs. R. 480-33-.06 - Drug Distribution and Control

(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, in writing, or electronically 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 pharmacist-in-charge 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 clinic shall cooperate with the pharmacist-in-charge in meeting this responsibility and in ordering, administering, and accounting for the pharmaceutical materials so as to achieve this purpose. The pharmacist-in-charge shall establish written procedures for the distribution of medications including standard ward inventory, emergency kits, etc. to achieve this goal.
(a) The drugs must be identified up to the point of administration;
(b) The pharmacy must receive a direct, electronic (only for drugs to be administered on site) or mechanical copy of a practitioner's order before the first dose of medication is dispensed except as defined by the clinic stat order policy;
(c) Records of all transactions of the clinic pharmacy as may be required by law, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials within the scope of the clinic practice. Nothing in this section shall prohibit the use of computerized records, where such records meet all other requirements of the law. If an outpatient clinic pharmacy elects to dispense prescription medications other than outpatient prescriptions as defined herein, the pharmacy must meet all applicable State and Federal Laws and regulations and must also obtain a retail pharmacy permit; and
(d) Participation in those aspects of the clinic patient care evaluation program which relate to pharmaceutical material utilization and effectiveness.
(3) Labeling.
(a) For use inside the clinic, all drugs dispensed by a clinic 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) Drugs added to parenteral admixtures. Wherever any drugs are added to parenteral admixtures, 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 person preparing the admixture.
(4) Discontinued drugs. The pharmacist-in-charge shall develop and implement policies and procedures to insure that discontinued and outdated drugs and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition.
(5) Accountability of controlled drugs.
(a) Proof of use of controlled drugs on standard ward inventory and/or those issued for a specific patient. Proof of use of controlled substances and such other drugs as may be specified by the appropriate committee of the clinic, shall be submitted to the pharmacy, on forms provided by the pharmacy. Proof of use forms shall specify at a minimum:
1. Drug name, strength, and dosage form;
2. Dose;
3. Name of prescriber. This shall include, at a minimum, the given and last name;
4. Given and last name of patient;
5. Date and time of administration to patient;
6. Signature of individual administering, which shall include at a minimum, the initial, last name and title;
7. Documentation by two signature verifications of destruction of all unused portions;
8. Proof of receipt of medications that bears identifying serial numbers; and
9. Date medication was issued and the date that the proof of use form was returned.
(b) Anesthesia, surgical, diagnostic and treatment departments that obtain controlled drugs from the clinic pharmacy must show accountability of the controlled drugs by proof of use as defined above.
(c) Use of computer hard copy is permitted where such copy meets all other requirements of the law.
(d) Any outpatient clinic pharmacy licensed by the Georgia State Board of Pharmacy 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 the remainder of a single-dose 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.
(f) Recall. The pharmacist-in-charge shall develop and implement a recall policy and procedure to assure that all drugs within the clinic included on the recall are returned to the pharmacy for proper disposition.
(g) Suspected adverse drug reactions. All suspected adverse drug reactions shall be reported immediately to the ordering practitioner, the pharmacy, and to the appropriate committee of the clinic. An appropriate entry on the patient's record shall also be made.
(h) Records and reports. The pharmacist-in-charge shall maintain access to and submit, as appropriate, such records and reports as are required to insure patient health, safety and welfare. Such records shall be readily available and subject to inspections by the Board or its agents. These shall include, at a minimum, the following:
1. Patient profile, chart or other appropriate record;
2. Proof of use forms for controlled substances;
3. Reports of suspected adverse drug reactions;
4. Inventories of night cabinets, cabinets or enclosures; emergency drug kits; and standard ward inventories;
5. Inventories of the pharmacy;
6. Biennial controlled substances inventories;
7. Alcohol and flammables reports; and
8. Such other records and reports as may be required by law and the rules and regulations of the Georgia State Board of Pharmacy.
(i) Standard Ward Inventory. The outpatient clinic pharmacy may distribute drugs within a clinic for the purpose of establishing and/ or maintaining a standard ward inventory. Such drugs may be supplied only upon a signed requisition from an authorized licensed health care professional of said clinic or by an inventory replacement system. These drugs may be administered only pursuant to a practitioner's order and shall be documented in the patient's record. A record of drugs administered to patients in ancillary areas such as surgical suite, treatment rooms, anesthesiology and diagnostic areas will become a part of the patient's record and shall be retrievable by the pharmacy. A survey of usage trends of each standard ward inventory shall be made monthly. Such records shall be maintained for a period of two years.
(j) Security of controlled substances. Controlled drugs that are maintained as authorized standard ward inventory in patient care/ treatment areas outside the pharmacy shall be stored in secured cabinets or areas that provide a double lock system.

Notes

Ga. Comp. R. & Regs. R. 480-33-.06
O.C.G.A. Secs. 16-13-39, 26-3-8, 26-3-16, 26-4-27, 26-4-28, 26-4-37, 26-4-82, 26-4-100, 26-4-110.
Original Rule entitled "Drug Distribution and Control" adopted. F. June 7, 1995; eff. June 27, 1995. Repealed: New Rule of same title adopted. F. July 24, 2002; eff. August 13, 2002.

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