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 physician's drug order is executed,
from the time the practitioner transmits the order either orally, in writing,
or electronically to a licensed health care professional to the time the
ordered drug is administered to the patient or delivered to the patient for
self-administration. No drugs can be dispensed or administered without a
physician's medication drug order.
(2) Responsibility. The Director shall be
responsible for the safe and efficient distribution, control, and
accountability for drugs. The other professional staff, including the
physicians, at the OTP clinic shall cooperate with the Director in meeting this
responsibility and in ordering, administering, and accounting for the drugs and
devices so as to achieve this purpose.
(a) The
Director shall establish written policies and procedures for the distribution
of medications including emergency kits, etc. to achieve this goal.
1. The drugs must be identified up to the
point of administration;
2. The
pharmacy must receive a direct, electronic (only for drugs to be administered
on site) or mechanical copy of a physician's order before the first dose of
medication is dispensed as defined by the clinic stat order policy.
3. At a minimum, the pharmacy must maintain a
patient profile for each OTP clinic patient for use in prospective and
retrospective drug reviews, for comparing with the central registry as required
by the DHR and to report violators to the GDNA and DHR, for discharge from
another OTP, and for urine or blood tests to check for drug positive test
results.
4. Records of all
transactions of the OTP clinic pharmacy, such as daily drug dosing summaries,
daily drug inventory sheets, patient medication profiles, and bulk drug
inventory records must be maintained by the clinic pharmacy as may be required
by law, and as may be necessary to maintain accurate control over and
accountability for all drugs and devices within the scope of the clinic
practice.
5. All drug invoices must
be attached to their accompanying DEA form 222 order form and must be filed
separately from all other drug records. A biennial inventory of all controlled
substances on hand must be taken every two years from the date of the pharmacy
opening for business. This inventory must be an accurate count of all such
drugs, signed in indelible ink by the pharmacist taking the inventory and dated
on the date it is taken.
6. Any
drug compounded by the pharmacy must be accounted for by use of a compounding
log form. This form, at a minimum must display the date the drug was
compounded, the name of the drug, the strength, quantity made, manufacturer's
lot number, manufacturer's expiration date, and the signature of the pharmacist
compounding the drug.
7. Nothing in
this section shall prohibit the use of computerized records, where such records
meet all other requirements of the law. An OTP clinic pharmacy may not dispense
or administer prescription medications other than OTP program medications;
and
8. The pharmacy must participate
in those aspects of the OTP clinic patient care evaluation program which relate
to drug and device utilization and effectiveness.
(b) All records must be maintained by the
pharmacy for a minimum of two years and be readily retrievable upon request by
an agent of the Board.
(3) Labeling:
(a) For use inside the clinic, all drugs
dispensed by an OTP clinic pharmacy, including those for use in an after hours
safe or emergency kit shall be dispensed in appropriate containers and
adequately labeled so as to identify at a minimum:
1. Brand name or generic name of the
drug;
2. Drug strength;
3. Lot number assigned by either the drug
manufacturer or the clinic pharmacy; and
4. Expiration date assigned either by the
drug manufacturer or the clinic pharmacy.
(b) Any drug container dispensed by the
pharmacy for take-home use by an OTP clinic patient must display a label which
contains at least the following:
1. Patient
name;
2. Name of the prescribing
physician;
3. Name, address and
telephone number of the OTP clinic pharmacy;
4. Drug name (either brand or generic
name);
5. Drug strength;
6. Date of dispensing;
7. Expiration date of the drug as determined
by the pharmacy;
8. "Federal
Caution" for controlled substances;
9. Clinic Pharmacy serial number for that
specific prescription drug order;
10. Any other labeling or information as
required by the DEA;
(c)
All take-home medication dispensed by the pharmacy, including one-time use
containers, must be in child-proof containers which meet the requirements of
the U.S. Consumer Product Safety Commission.
(4) Discontinued drugs. The Director 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 substances.
(a) Nothing shall prohibit the use of
controlled substance drugs issued via proof of use forms for general or
emergency use for specific patients. Proof of use controlled substances forms
shall be provided by the pharmacy.
(b) Each proof of use form shall display the
name of the patient to or for which it has been issued and an indication that
the drugs are for general or emergency use and a serial number. The form shall
also show the date the form was issued and the signature of the pharmacist
issuing the form and the signature of the licensed medical practitioner
receiving the form for storage in the after-hour safe. A detachable receipt
reflecting all the previous information must be returned and filed by the
pharmacy as a safeguard to prevent drug diversion.
(c) Each proof of use sheet shall provide
space to record the administration information necessary to account for each
dose of medication. This information shall specify at a minimum:
1. Drug name, strength, and dosage
form;
2. Dose
administered;
3. Name of
prescriber. This shall include, at a minimum, the first initial and complete
last name of the prescriber;
4.
First and last name of the patient;
5. Date and time of administration to
patient;
6. Signature of individual
administering the dose, which shall include at a minimum, the first and last
name and title;
7. Documentation of
destruction of all unused portions by two signature verifications of licensed
healthcare professionals;
8. Proof
of receipt of medication bearing identifying serial numbers;
9. Date the medication was issued and date
the proof of use form was returned.
(6) Any OTP clinic pharmacy licensed by the
Board may make on-premises destruction of small quantities of controlled
substances prepared for oral administration provided:
(a) The controlled substance is the remainder
of a single-dose unit; and,
(b) The
single-dosage unit from which the ordered dose was prepared is the nearest
possible size to the dose ordered.
(7) Perpetual inventory of Schedule II
controlled substances shall be required and accountability of said drugs shall
be by an appropriate form indicating at a minimum the date used, name of
shipper or drug recipient, corresponding serial number of a drug order, invoice
or proof of use form, and quantity received or issued.
(8) Recall. The Director 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.
(9) Suspected adverse
drug reactions. All suspected adverse drug reactions shall be reported
immediately to the ordering physician, the pharmacy, and to the appropriate
committee of the clinic. An appropriate entry on the patient's pharmacy profile
shall also be made.
(10) Security.
All areas occupied by an OTP clinic pharmacy shall be capable of being locked
by key or combination, so as to prevent unauthorized personnel access except by
force. Such areas shall meet the security requirements of all applicable
Federal and State laws and rules. Only those persons so authorized shall be
permitted to enter these areas.
(a) All drugs
shall be stored in designated areas within the clinic pharmacy or all
dispensing medications shall be stored in designated areas within the clinic
which are sufficient to insure proper sanitation, temperature, light,
ventilation, moisture control, segregation, and security. Drug storage areas
shall be locked or otherwise secured when licensed health care professionals
are not present.
(b) Storage for
Schedule II controlled substances shall be in an enclosed room or space with
controlled limited access capable of showing forced entry is preferable.
However, a safe or a lockable metal cabinet that is permanently affixed to the
structure is acceptable.
(c)
Whenever any area of an OTP clinic pharmacy is not under the personal and
direct supervision of authorized licensed personnel, such areas shall be locked
and secured.
(11)
Reports and records. The Director 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, the GDNA or its designated agents. All such records
shall be maintained for a minimum of two years. These shall include, at a
minimum, the following:
(a) Patient profile,
chart or other appropriate record;
(b) Proof of use forms for controlled
substances;
(c) Reports of
suspected adverse drug reactions;
(d) Inventories of after hours safe(s) and
emergency drug kits,
(e) All
perpetual inventories maintained by the pharmacy, and all other records
pertaining to controlled substances, including a biennial controlled substances
inventory;
(f) Such other records
and reports as may be required by Federal or State laws and/or rules;
(12) The compounding, labeling and
quality control of large volumes of opioid treatment medication is the
responsibility of a pharmacist and shall be prepared within the on-site
pharmacy.
O.C.G.A. Secs.
16-13-34, 16-13-41, 26-3-8, 26-4-27, 26-4-28, 26-4-80, 26-4-86, 26-4-87, 26-4-110, 26-4-111.
