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
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