Ga. Comp. R. & Regs. 480-8-.06

Current through Rules and Regulations filed through October 29, 2024

Rule 480-8-.06 - Drug Distribution and Control

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.

Ga. Comp. R. & Regs. R. 480-8-.06

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.

Original Rule entitled "Drug Distribution and Control" adopted. F. Dec. 27, 1985; eff. Jan. 16, 1986.

Amended: F. Feb. 10, 1993; eff. Mar. 2, 1993

Repealed: New Rule, same title adopted. F. Sept. 28, 2001; eff. Oct. 18, 2001.