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Chapter 480-24 NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS

Rule 480-24-.01 Definitions

For purposes of these Rules and Regulations, the following definitions apply:

(a) Board. Board shall mean the Georgia State Board of Pharmacy.
(b) GDNA. GDNA shall mean the Georgia Drugs and Narcotics Agency.
(c) Hospice emergency drug kits. A hospice emergency drug kit shall mean an emergency drug kit placed by a provider pharmacy in a hospice licensed by the Department of Human Resources.
(d) Unit dose. A unit dose is a single dose of a medication(s), which is individually packaged, sealed, and properly labeled to maintain the integrity and the identity of the drug, and patient?ready at the time of dispensing by the pharmacist.

Rule 480-24-.02 Personnel

(1) Consultant Pharmacist. A consultant pharmacist is a pharmacist licensed to engage in the practice of pharmacy in this state who is responsible for developing, coordinating, and supervising pharmaceutical services in the nursing facility. These services shall include, at a minimum, review of each patient's drug regimen monthly and report of any irregularities to the Medical Director and Administrator of the nursing facility, written reports of pharmaceutical services, and monitoring of established policies and procedures for medication handling and storage.
(2) Vendor Pharmacist. A vendor pharmacist is a pharmacist licensed to engage in the practice of pharmacy in this state who is responsible for supervising the proper dispensing and delivery of drugs to a nursing facility. These services shall include, at a minimum, proper drug labeling, storage, transport, and record keeping in compliance with all federal, state and local laws and regulations.

Rule 480-24-.03 Physical Requirements

The vendor pharmacist shall establish standards to ensure that all drugs are stored in a manner sufficient to insure the proper sanitation, temperature, light, ventilation, moisture control, segregation, and security.

Rule 480-24-.04 Drug Distribution

(1) Dispensing of all drugs to the facility shall be pursuant to a legal prescription drug order for an individual patients. Standing medication orders shall not be allowed. Policies may be established by the vendor pharmacist in conjunction with the appropriate committee of the facility. All drugs supplied to the facility must be obtained from a pharmacy having a retail pharmacy permit.
(2) For use inside the facility, all drugs dispensed shall be dispensed in appropriate containers, as defined by the Food and Drug Administration and the Consumer Protection Agency, and adequately labeled with the following information:
(a) Name, address, and telephone number of the pharmacy;
(b) Date of issuance and identifying serial number;
(c) Full name of patient;
(d) Brand and/or generic name of drug, strength, and quantity dispensed;
(e) Directions for use, which may be placed on the container label or on a Medication Administration Record available and consulted at the time of the administration of each dose, provided, however, that both methods may be utilized inside a single facility;
(f) Name of physician prescribing;
(g) Required precautionary information regarding controlled substances;
(h) Such other and further accessory cautionary information as may be required or desirable for proper use and absolute safety to the patient; and
(i) Expiration date.
(3) If a unit dose drug distribution system is utilized, the above information shall be readily available on the patient medication profile. A drug distribution system in a long term care facility may be regarded as a unit dose drug distribution system if:
(a) The pharmacist maintains medication profiles on each patient and refers to these files each time a medication is filled;
(b) Doses of solid oral medications dispensed are pharmacy-prepared or manufacturer-prepared in individually packaged and sealed doses which are identifiable and properly labeled to include, at a minimum:
1. Brand and/or generic name of the drug;
2. Strength;
3. Lot number; and
4. Expiration date.
(c) Doses of medication for individual patients are placed into individual patient containers, bins, compartments, or drawers and whenever possible, are subdivided by dose and administration time and not to exceed a 72-hour supply. Drug distribution systems which exceed a 72-hour supply must follow labeling requirements of 480-24-.04(2).
(4) Partial filling of Schedule II drugs will be allowed but limited to 60 days only.
(5) Drugs added to parenteral, enteral, or irrigation solutions. Whenever any drugs are added to such solutions, whether within or outside the direct and personal supervision of a registered pharmacist, 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 the person so adding.
(6) Prescription drug orders.
(a) Drugs may be dispensed or administered only upon orders of an authorized prescriber. For schedule II drugs refer to the Georgia Controlled Substances Act, Code Section 16-13-41, and Chapter 480-22 of the Board rules and regulations. For other drugs orders may be received by the pharmacy by fax or delivery of:
1. A direct copy of a prescription drug order;
2. Obtaining a signed prescription drug order from the prescriber; or
3. A verbal or telephone order from an authorized prescriber or duly authorized agent.
(b) The consultant pharmacist will verify orders as required by current state and federal laws, rules and regulations.
(c) For purposes of recordkeeping under this chapter, all original prescriptions, those hard copies written by a practitioner, telephoned to the pharmacist by a practitioner and reduced to writing, or sent via facsimile machine or other electronic means must be retained as a permanent record for two years in the retail pharmacy and must be filed by the usually consecutively serial numbered prescription file or by patient name or by any other means that assures a complete, retrievable and accurate record. Any refill information subsequently authorized by a practitioner must be maintained in the manner required by O.C.G.A. § 26-4-80(3).
(7) Emergency kits. Emergency kits may be placed in licensed nursing homes by the pharmacy of the consultant or vendor pharmacist provided the following guidelines are met:
(a) A record of the drugs to be kept in an emergency drug kit be kept in the nursing home and the provider pharmacy;
(b) Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a new prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within 72 hours of the drug being taken from the kit.
(c) Emergency drug kits shall be stored in limited access areas and sealed to prevent unauthorized access and to insure a proper environment for preservation of the drugs therein. The provider pharmacy shall develop a method to readily determine if an emergency drug kit has been accessed without authorization;
(d) An emergency drug kit must be inventoried at least once a month by a pharmacist from the provider pharmacy and sign a card attached to the kit indicating the date it was inspected. The provider pharmacy must maintain an adequate record of such inspections.
(e) Special Agents of the GDNA shall have the authority to check emergency drug kits as well as the records in the provider pharmacy to determine that drugs and records are accurate and the emergency drug kit is being properly used;
(f) The provider pharmacy must apply on an individual basis to the Board, in care of the GDNA Director, for approval to place an emergency drug kit in each individual nursing home and a copy of this approval will be kept on file in both the nursing home and the provider pharmacy. Upon recommendation by the GDNA Director, the Board may revoke the approval for an emergency drug kit in any nursing home where abuse or misuse of drugs from the emergency drug kit is used for any purpose other than emergency purposes;
(g) The Board shall have the authority to approve on an individual basis the drugs and the amounts of each individual drug allowed to be kept in an emergency drug kit. Any change in the drugs and amounts kept in a kit must be submitted in writing to the GDNA Director who shall make recommendations to the Board. After Board approval, a copy of this approval will be maintained in the GDNA provider pharmacy file and by the nursing home. Any emergency drug kit approval becomes null and void once the approved pharmacy ceases to provide that kit.
(h) Each solid oral dosage form placed in an emergency drug kit must be individually labeled with the name and strength of the drug, lot number, expiration date, and other appropriate cautionary information; and
(i) The exterior of an emergency drug kit shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit and is for "EMERGENCY USE ONLY", and the label shall be physically signed and dated by the pharmacist who sealed the kit. In addition, a listing of the drugs contained therein, including the name, address, and telephone number(s) of the provider pharmacy shall be attached to both the exterior and the interior of an emergency drug kit.
(8) Accountability of scheduled drugs and other specified drugs.
(a) Proof of use. Proof of use of Schedule II, III, IV and V controlled substances and such other drugs as may be specified by the appropriate committee of the facility, shall be upon proof of use forms which shall specify at a minimum:
1. Name and strength of the drug;
2. Dose and route of administration for the drug;
3. Name of ordering prescriber;
4. Name of patient;
5. Date and time of administration to patient;
6. Signature and title of individual administering, the medication; and 7. Documentation of destruction of all unused portions of single doses shall include signature verifications of two licensed authorized personnel.
(b) Container requirement. Any medication that has to be counted and accounted for with proof of use forms must be dispensed in a container that allows verification of individual doses. Containers for solid oral doses must allow identification of individual doses and individual accountability.
(9) Medications brought by patients. When patients bring drugs into the facility, such drugs shall be sent to the vendor pharmacist who shall handle these drugs in accordance with guidelines established by the appropriate committee within the facility.

Rule 480-24-.05 Duties of Consultant Pharmacist

(1) A pharmacist serving as a consultant to a facility must contract with the facility in writing for those services. Notification must also be made to the Board in writing when a pharmacist becomes a consultant to a facility. The pharmacist must also notify the Board when the consultant services are terminated with a facility. When providing contracted services the consultant pharmacist is held to the same professional standards for a licensed pharmacist as set forth in state law and by the rules and regulations of the Board.
(2) The pharmacist, through the appropriate committee within the facility, shall establish policies and procedures for safe and effective drug therapy, distribution, use, and control. At a minimum, the pharmacist shall:
(a) Make periodic inspections, which shall occur at least every 30 days, of drugs and medication records kept within the facility. A written report of inspection shall be maintained at the facility; and,
(b) Remove for proper disposal any drugs or narcotics which are in a deteriorated condition, expired, discontinued for use, or the patient for whom they are ordered is no longer a patient These drugs shall be the responsibility of the vendor pharmacy.

Rule 480-24-.06 Destruction of Drugs

(1) The following methods of destruction of non-controlled substances are approved by the Board for medications dispensed to patients residing in long term care facilities (nursing home or skilled nursing facility) or other facility where a consultant pharmacist's services are required under state or federal regulations:
(a) When non-controlled drugs are expired, discontinued from use or the patient for whom they were ordered is no longer a patient, the drugs shall be immediately removed from the active stock and inventoried by two people who shall be licensed either as a pharmacists, a nurses, or a licensed practical nurses. The completed inventory record shall be signed and dated by these two individuals. The original inventory record 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:
1. Placed in a secure storage area at the facility separated from medications with active orders. The drugs can be destroyed at the facility by the consultant pharmacist and another pharmacist, nurse, or licensed practical nurse 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 record for two years. This record shall include at a minimum the date, time, personnel involved with the destruction and the method of destruction; or
2. Removed from the facility and kept by the consultant pharmacist until they are returned to the vendor pharmacist for destruction. The consultant pharmacist shall make a receipt for the drugs removed, and the original receipt to be kept by the facility and a copy of the receipt kept by the pharmacist. The receipt shall reflect: the date the drugs were removed from the facility, the name of the person removing the drugs, the name and address of the pharmacy to which the drugs have been removed. Both the receipt and its copy must be maintained for two years. Before any drugs can be removed for destruction, their inventory must be verified by at least one pharmacist and one other licensed health care practitioner. Once taken to the vendor pharmacy, the drugs must be stored in a secure, location, separate from active inventory, within the pharmacy. When the drugs are destroyed, a record of the manner of disposal of the drugs must be maintained by the vendor pharmacy for two years. The disposal record shall include at a minimum, whether:
(i) The drugs are destroyed at the pharmacy, and
(I) Manner of destruction;
(II) Date and time of destruction;
(III) Names of at least one pharmacist and one other licensed health care practitioner witnessing the destruction; or
(2) The drugs for destruction are removed from the pharmacy by transfer to a reverse distributor with a current permit issued by the Board; and
(I) The date and time the drugs were taken from the pharmacy;
(II) The name, Board permit number, address, and telephone number of the reverse distributor removing the drugs;
(III) The name and signature of the responsible person representing the reverse distributor physically removing the drugs;
(IV) The name and signature of the pharmacist transferring the drugs to the reverse distributor.
(2) The following methods of on-site destruction of controlled substances are approved by the Board:
(a) When controlled drugs are expired, discontinued from use or the patient for whom they are ordered is no longer a patient, the medication shall be removed from the active stock immediately and inventoried and verified by two people who shall be licensed either as a pharmacist, a nurse, or a licensed practical nurse. The completed inventory record shall be signed and dated by those two individuals. An inventory form will be established by the pharmacist, which must include the following data:
1. Date of discontinuance or inventory date;
2. Name of patient;
3. Name of issuing pharmacy;
4. Identifying serial numbers of the prescriptions;
5. Name and strength of drug; and
6. Quantities of drugs in containers when inventoried.
(b) After being removed from active stock, controlled substances to be destroyed must be placed in a secure cabinet or area as identified by the consultant or vendor pharmacist.
(c) On-site destruction can be as follows:
1. The consultant or vendor pharmacist will notify the GDNA as to the date and time the destruction will take place at least two weeks prior to destruction at the facility. (Please note that the consultant may set up a specific schedule of destruction - an example would be the first Tuesday in each month at 10:00 a.m.)
2. Three licensed professionals or law enforcement officers, one of whom must be a pharmacist, must witness the destruction of these drugs.
3. Destruction must take place within the facility.
4. Inventory of final destruction must be taken in duplicate, one copy shall be retained by the facility, and one copy shall be retained by the consultant pharmacist. 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 reconciled, accounted for, and destroyed at _______________(location) on _________(date) at ________o'clock."

___________________(Signature)

___________________(Signature)

___________________(Signature)

5. The Board and/or the GDNA, or the DEA, may prohibit any consultant pharmacist or facility from utilizing this method.
(3) Methods of off site destruction as follows:
(a) When controlled substances are expired, discontinued from use or the patient for whom they are ordered is no longer a patient, the medication shall be removed from the active stock immediately and inventoried and verified by two people who shall be licensed either as a pharmacist, a nurse, or a licensed practical nurse. The completed inventory record shall be signed and dated by those two individuals. An inventory form will be established by the pharmacist, which must include the following data:
1. Date of discontinuance or inventory date;
2. Full name of patient;
3. Name of issuing pharmacy;
4. Identifying serial numbers of the prescriptions;
5. Name and strength of drug; and
6. Quantities of drugs in containers when inventoried.
(b) After being removed from active stock, controlled substances to be destroyed must be placed in a secure cabinet or area as identified by the consultant or vendor pharmacist.
(c) The drugs, along with a copy of the permanent record, can then be transferred to the vendor pharmacy by the consultant pharmacist to hold for disposal by a Board licensed reverse drug distributor or by a GDNA Agent. The consultant pharmacist shall make a receipt for the drugs removed, and the original receipt is to be kept by the facility and a copy of the receipt kept by the consultant pharmacist, both for two years. The receipt shall reflect at a minimum:
1. The date the drugs were removed from the facility;
2. The name and signature of the consultant pharmacist removing the drugs;
3. The name and signature of the Director of Nursing witnessing the drug removal;
4. The name and address of the pharmacy to which the drugs are being removed.
(d) Once received by the pharmacy, the drugs for disposal must be stored in a secure location within the pharmacy. When disposal of the drugs takes place, a record of the disposal will be maintained by the pharmacy for two years. The type of disposal record shall be, either:
1. On a separate receipt showing the drugs for destruction were removed from the pharmacy by transfer to a Board licensed reverse distributor, showing:
(i) The date and time the drugs were taken from the pharmacy;
(ii) The name, address, telephone number and Board permit number of the reverse distribution firm taking possession of the drug;
(iii) The name and signature of the responsible person representing the reverse distributor firm and physically removing the drugs;
(iv) The name and signature of the pharmacy representative transferring possession of the drugs; and
(v) A copy of the permanent drug inventory destruction record from the facility; or
2. On the permanent record showing the drugs were destroyed by a GDNA Agent with:
(i) The signature of the GDNA Agent;
(ii) The signature of the pharmacy manager as listed on the pharmacy license; and
(iii) The date and time of the drug destruction.

Rule 480-24-.07 Hospice Emergency Drug Kits

Emergency Drug Kits may be placed in licensed hospices by the pharmacy of the consultant or vendor pharmacist provided the following guidelines are met:

(1) A record of the drugs to be kept in an emergency drug kit to be kept in the hospice and the provider pharmacy;
(2) Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a new prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within 72 hours of the drug being taken from the kit.
(3) Emergency drug kits shall be stored in limited access areas and sealed to prevent unauthorized access and to insure a proper environment for preservation of the drugs therein. The provider pharmacy shall develop a method to readily determine if an emergency drug kit has been accessed without authorization;
(4) An emergency drug kit must be inventoried once a month by a pharmacist from the provider pharmacy and sign a card attached to the kit indicating the date it was inspected. The provider pharmacy must maintain an adequate record of such inspections.
(5) Special Agents of the GDNA shall have the authority to check emergency drug kits as well as the records in the provider pharmacy to determine that drugs and records are accurate and the emergency drug kit is being properly used;
(6) The provider pharmacy must apply on an individual basis to the Board, in care of the GDNA Director, for approval to place an emergency drug kit in each individual hospice and a copy of this approval will be kept on file in both the hospice and the provider pharmacy. Upon recommendation by the GDNA Director, the Board may revoke the approval for an emergency drug kit in any hospice where abuse or misuse of drugs from the emergency drug kit is used for any purpose other than emergency purposes;
(7) The Board shall have the authority to approve on an individual basis the drugs and the amounts of each individual drug allowed to be kept in an emergency drug kit. Any change in the drugs and amounts kept in a kit must be submitted in writing to the GDNA Director who shall make recommendations to the Board. After Board approval, a copy of this approval will be maintained in the GDNA provider pharmacy file and by the nursing home. Any emergency drug kit approval becomes null and void once the approved pharmacy ceases to provide that kit.
(8) Each solid oral dosage form placed in an emergency drug kit must be individually labeled with the name and strength of the drug, lot number, expiration date, and other appropriate cautionary information; and
(9) The exterior of an emergency drug kit shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit and is for "EMERGENCY USE ONLY", and the label shall be physically signed and dated by the pharmacist who sealed the kit. In addition, a listing of the drugs contained therein, including the name, address, and telephone number(s) of the provider pharmacy shall be attached to both the exterior and the interior of an emergency drug kit.

Rule 480-24-.08 Crisis Stabilization Unit (CSU) Emergency Drug Kits

Emergency drug kits may be placed in licensed Crisis Stabilization Units (CSU) by the pharmacy of the consultant or vendor pharmacist provided the following conditions are met:

(1) A record of the drugs to be kept in an emergency drug kit must be kept in the CSU and the provider pharmacy;
(2) Drugs shall not be accessed for use from the emergency drug kit in an emergency situation without a prescription drug order from a licensed practitioner. A valid, signed prescription drug order for any such drug must be issued to the vendor pharmacy, supplying the emergency drug kit, within 72 hours of the drug being taken from the kit;
(a) Whenever an emergency drug kit is accessed and a drug is removed, personnel shall immediately reseal the kit with a tamper-proof, serial-numbered seal, with the seal serial number to be recorded in a log along with the name of the person removing the drug and resealing the kit and date the kit was opened;
(3) Emergency drug kits shall be stored in limited access areas and sealed to prevent unauthorized access and to insure a proper environment for preservation of the drugs therein. The provider pharmacy shall develop a method to readily determine if an emergency drug kit has been accessed without authorization;
(4) An emergency drug kit must be inventoried once a month by a pharmacist from the provider pharmacy and sign a card attached to the kit indicating the date it was inspected. The provider pharmacy must maintain an adequate record of such inspections;
(5) Special Agents of the GDNA shall have the authority to check emergency drug kits as well as the records in the provider pharmacy to determine that drugs and records are accurate and the emergency drug kit is being properly used;
(6) The provider pharmacy must apply on an individual basis to the Board, in care of the GDNA Director, for approval to place an emergency drug kit in each individual CSU and a copy of this approval will be kept on file in both the CSU and the provider pharmacy. Upon recommendation by the GDNA Director, the Board may revoke the approval for an emergency drug kit in any CSU where abuse or misuse of drugs from the emergency drug kit is noted;
(7) The Board shall have the authority to approve on an individual basis the drugs and the amounts of each individual drug allowed to be kept in an emergency drug kit. Any change in the drugs and amounts kept in a kit must be submitted in writing to the GDNA Director who shall make recommendations to the Board. After Board approval, a copy of this approval will be maintained in the GDNA provider pharmacy file and by the CSU. Any emergency drug kit approval becomes null and void once the approved pharmacy ceases to provide that kit;
(8) Each solid oral dosage form placed in an emergency drug kit must be individually labeled with the name and strength of the drug, lot number, expiration date, and other appropriate cautionary information; and
(9) The exterior of an emergency drug kit shall be labeled so as to clearly and unmistakably indicate that it is an emergency drug kit and is for "EMERGENCY USE ONLY", and the label shall be physically signed and dated by the pharmacist who sealed the kit. In addition, a listing of the drugs contained therein, including the name, address, and telephone number(s) of the provider pharmacy shall be attached to both the exterior and the interior of an emergency drug kit.