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