Current through Rules and Regulations filed through March 20, 2024
Drug Distribution and Control shall be as follows:
(a) General. A drug distribution system is
the entirety of that mechanism by which a practitioner's prescription drug
order is executed, from the time the prescriber transmits the order either
orally or in writing to an authorized health professional through the time the
ordered drug is administered to the patient or delivered to the patient for
self-administration.
(b)
Responsibility. The Director of Pharmacy shall be responsible for the safe and
efficient distribution control, and accountability for drugs. The other
professional staff of the prison clinic shall cooperate with the Director in
meeting this responsibility and in ordering, administering, and accounting for
the pharmaceutical materials so as to achieve this purpose. Accordingly the
Director shall be responsible for, at a minimum, the following:
1. The drugs must be identified up to the
point of administration;
2. The
pharmacy must receive a direct copy or mechanical copy of a physician's order
before the first dose of medication is dispensed except as defined by prison
clinic stat order policy;
3.
Utilization of a pharmacy-generated patient profile. This shall be the official
record of medications dispensed to the patient. The patient profile shall be
maintained under the control of the Director of Pharmacy for a period of two
(2) years. The patient profile shall contain at a minimum:
(i) Given and last name;
(ii) DOC I.D. Number or any other assigned
I.D. Number;
(iii) Date of
birth;
(iv) Sex;
(v) Dorm or permanent housing
assignment;
(vi) Drug product
dispensed, date dispensed, strength, dosage form, quantity and directions, and
identification of dispensing pharmacist;
(vii) Identification or differentiation of
controlled substances;
(viii)
Selected medical data; and
(ix)
Sensitivities and allergies to drugs and foods.
4. Maintaining no more than a 7 day's supply
of unit dose medication with prison clinic labeling or no more than a 30-day
supply of maintenance medication with retail labeling.
5. Establishment of specifications or use of
compendial specifications for procurement of drugs, chemicals, and biologicals,
subject to approval of the appropriate committee of the prison
clinic;
6. Participation in
development of a drug formulary for the prison clinic;
7. Filling and labeling all containers from
which drugs are to be administered, after visual screening to determine that
same are neither adulterated nor misbranded;
8. 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 such other materials and information as
may be deemed necessary shall also be maintained;
9. Records of all transactions of the prison
clinic pharmacy as may be required by law, and as may be necessary to maintain
accurate control over and accountability for all pharmaceutical materials.
Nothing in this section shall prohibit the use of computer hard copy, where
such copy meets all other requirements of the law;
10. Participation in those aspects of the
prison clinic patient care evaluation program which relate to pharmaceutical
material utilization and effectiveness, and,
11. Efficient messenger and delivery service
to connect the pharmacy with appropriate parts of the facility throughout the
normal workday.
(c)
Labeling. Labeling shall include:
1. For use
inside the prison clinic, all drugs dispensed by a prison 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.
2. For use outside the prison clinic or
institution, all drugs dispensed by a prison clinic pharmacy to inmates housed
outside the prison clinic or those about to be released or on leave shall be
labeled with the following information:
(i)
Name, address and telephone number of the prison clinic pharmacy;
(ii) Date and identifying serial
number;
(iii) Full name of
patient;
(iv) Name of drug, (brand
or generic) and strength;
(v)
Directions for use to the patient;
(vi) Name of practitioner
prescribing;
(vii) Require
precautionary information regarding controlled substances; and,
(viii) Such other and further accessory
cautionary information as may be required or desirable for proper use and
safety to the patient.
(d) Discontinued drugs. The Director of
Pharmacy 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 prison clinic pharmacy for proper disposition
according to the following:
1. The following
method of destruction of non-controlled substances is approved by the Board for
medications dispensed to patients residing in a prison facility. When
non-controlled drugs are expired, discontinued from use or the patient for whom
they are ordered expires, the drugs shall be immediately removed from the
active stock and inventoried by a pharmacist, along with another licensed
healthcare professional or a corrections officer. The completed inventory shall
be signed and dated by those two individuals. The original inventory shall be
maintained by the facility for two years, and a copy shall be kept with the
drugs until their final disposition. Once inventoried, these drugs can either
be:
a. Placed in a secure storage area at the
facility separated from edications with active orders. The drugs can 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 along with the
inventory for two years. This record shall include at a minimum the date, time,
personnel involved with the destruction and the method of destruction;
or
b. The drugs for destruction are
removed from the pharmacy by transfer to a reverse distributor with a current
permit issued by the Board and a record of the following is maintained by the
Prison Clinic for at least two years:
(1) 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;
(2) The date and time
the drugs were taken from the pharmacy;
(3) The name, Board permit number, address
and telephone number of the destruction firm removing the drugs;
(4) The name and signature of the responsible
person representing the reverse distributor who is physically removing the
drug(s);
(5) The name and signature
of the Pharmacist representing the pharmacy transferring the drug(s) to the
reverse distributor.
2. The following methods of destruction of
controlled substances are approved by the Board of Pharmacy:
(a) A securely attached wooden or metal
cabinet will be made available within a locked limited-access area. When
controlled drugs are discontinued or the patient expires, the medication shall
be pulled form the active stock immediately and inventoried and verified by a
pharmacist along with another licensed healthcare professional or a correction
officer. The inventory must be recorded into a permanent record and the drugs
shall then be placed in the aforementioned cabinet. This medication would
remain within the locked cabinet until such time that it is removed for
destruction.
1. The pharmacist will establish
a form, which shall include the following data:
i. Date of discontinuance or inventory
date;
ii. Name of
patient;
iii. Name of issuing
pharmacy;
iv. Identifying serial
numbers;
v. Name and strength of
drug; and
vi. Quantities of drugs
in containers when inventoried.
2. A licensed pharmacist must destroy the
drugs in the presence of at least two witnesses.
3. 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 all three witnesses present at the destruction
in the following format:
"We whose signatures appear below, certify that these
controlled substances have been recondiled, accounted for, and destroyed at
___________________________(location) on __________________________ (date)
___________________o'clock.
Name of drug
Strength of drug
___________________________________________________________________
(Signature and Title)
___________________________________________________________________
(Signature and Title)
___________________________________________________________________
(Signature and Title)
4. The Board and/or the GDNA may prohibit any
pharmacist or prison clinic facility from utilizing this method.
(b) 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 they are transferred. When the drugs are
transferred to a reverse distributor licensed by the Georgia Board, an
inventory including the names of the drugs, the dosage forms of the drugs and
the quantities of drugs is taken and witnessed by an authorized representative
of the prison clinic pharmacy and the responsible person representing the
reverse distributor.
2. The prison
clinic pharmacy must maintain a receipt/record with the following information:
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 prison clinic pharmacy for a minimum
of two years.
(e) Prescription Drug orders. Drugs may be
dispensed from the prison clinic pharmacy only upon written orders, direct or
copies thereof, of authorized practitioners.
1. Authorization. The appropriate committee
of the prison clinic shall, from time to time as appropriate, designate those
practitioners who are authorized to issue prescription drug orders to the
pharmacy.
2. 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 prison
clinic.
3. Requirements--orders for
drugs for use by inpatients. Orders for drugs for use by in-patients shall, at
a minimum, contain:
(i) Patient name and dorm
or permanent housing assignment;
(ii) Drug name, strength, directions for use;
and
(iii) Date and physician's
signature.
4.
Requirements--orders for drugs for use by outpatients. Orders for drugs for use
by outpatients shall at a minimum, contain all of the items required by Rule
480-8-.06(e)3., and in addition:
(i)
Dispensing quantity; and
(ii)
Practitioner's address and Drug Enforcement Administration permit number, if
applicable.
(f)
Accountability of Controlled Drugs--Proof of Use of controlled substances on
standard ward inventory. Proof of use of controlled substances and such other
drugs as may be specified by the appropriate committee of the prison clinic,
shall be submitted to the pharmacy, on forms provided by the pharmacy.
1. Proof of use forms shall specify at a
minimum:
(i) Name of drug, strength, and
dosage form;
(ii) Dose;
(iii) Name of ordering physician. This shall
include, at a minimum, the initial and last name;
(iv) Given and last name of inmate, DOC I.D.
Number, or any other assigned I.D. Number;
(v) Date and time of administration to
patient;
(vi) Signature of
individual administering the drug, which shall include at a minimum, the
initial, last name and title;
(vii)
Documentation of destruction of all unused portions by two signature
verifications of two licensed staff members;
(viii) Proof of receipt of medications that
bears identifying serial numbers; and
(ix) Date the medication was issued and the
date that the proof of use form was returned.
2. Use of computer hard copy is permitted
where such copy meets all other requirements of the law.
3. Any prison clinic pharmacy licensed by the
Board and in which controlled substances are administered to patients, may make
on-premises destruction of small quantities of controlled substances prepared
for oral administration provided:
(i) The
controlled substance is the remainder of a single-dosage unit; and
(ii) The single-dosage unit from which the
ordered dose prepared is the nearest possible size to the dose
ordered.
4. Perpetual
inventory of Schedule II controlled substances shall be required and
accountability of said drugs shall be by proof of use form.
(g) Recall. The Director of
Pharmacy shall develop and implement a recall procedure to assure that all
drugs within the prison included on the recall are returned to the prison
clinic pharmacy for proper disposition.
(h) 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 prison clinic.
An appropriate entry on the patient's record shall also be made.
(i) Records and reports. The Director of
Pharmacy 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 employees. These shall include, at a minimum, the following:
1. Patient profile;
2. Proof of use documents;
3. Reports of suspected adverse drug
reactions;
4. Inventories of night
cabinets and emergency kits/crash carts;
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 Rules and Regulations
of the Board of Pharmacy.
(j) Standard ward inventory (floor stock).
The pharmacy department may distribute drugs within a prison clinic 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 prison clinic or by an inventory replacement
system. These drugs may be administered only pursuant to a physician's order.
This physician's order will be forwarded to the pharmacy and these medications
will be recorded on the pharmacy patient profile. A survey of usage trends of
each standard ward inventory shall be made monthly. Such records shall be
maintained for a period of two (2) years.
O.C.G.A. Sec. 26-4-37,
26-3-4, 26-3-8, 26-3-16, 26-4-27, 26-4-28, 26-4-29, 26-4-80, 26-4-83, 26-4-110, 16-13-39, 16-13-41, 16-13-72, 16-13-73, 16-13-74.
