Chapter 480-33 OUTPATIENT CLINIC PHARMACIES
For purposes of these Rules and Regulations, the following
definitions apply:
| (1) |
Outpatient
Clinic. An outpatient clinic shall be defined as a health care facility or
location, other than a medical practitioner's office, providing outpatient
treatment or case such as, but not limited to, an outpatient surgery center,
outpatient urgent care center, infusion treatment center, or ambulatory care
center.
| (b) |
Outpatient Clinic Pharmacy. An
outpatient clinic pharmacy shall be defined as that part of an outpatient
clinic health care facility engaged in the practice of pharmacy. |
| (c) |
Outpatient Clinic Pharmacy License. An
outpatient clinic pharmacy license shall be defined as a pharmacy license
issued by the Georgia State Board of Pharmacy to Clinic pharmacies, pursuant to
the provisions of O.C.G.A. Title 26, Chapter 4, whereas the licensee shall be
subject to special outpatient clinic pharmacy regulations as set forth herein,
but exempt from other certain regulations and requirements. |
| (d) |
Outpatient. An outpatient shall be
defined as an ambulatory patient who comes to an outpatient clinic to receive
health care services related to the objectives of the outpatient clinic and
departs within 24 hours. |
| (e) |
Standard Ward Inventory. The pharmacist-in-charge of the outpatient clinic
pharmacy or his/her pharmacist designee may, in the best interest of the
patients served, establish one or more lists of the kind and quantity of drugs
to be kept at one or more locations at all times within the outpatient clinic
and such stocks of drugs shall be known as standard ward inventory. The use of
standard ward inventory shall be minimized. A copy of the list of items on
standard ward inventory must be kept by the pharmacist-in-charge or his/her
pharmacist designee. |
| (f) |
Outpatient
Prescription. An outpatient prescription shall be defined as a prescription
drug order prescribed by a medical practitioner engaged in the practice of that
clinic and prescribed for services received in that clinic in conjunction with
health care services related to the objectives of that clinic. |
|
| (1) |
All outpatient clinic pharmacies shall
renew biennially by June 30th of each odd numbered year with the Georgia State
Board of Pharmacy. Certificates of registration shall be issued to outpatient
clinic pharmacies which meet the requirements for licensure and which comply
with Chapter 480-33 of the Rules of the Georgia State Board of
Pharmacy. |
| (2) |
Minimum Required
Information for Licensure. The Board requires the following information from
each outpatient clinic pharmacy as part of the initial licensing procedure and
as part of each renewal of such license. The name, complete street address for
the business (i.e., geographic location), and telephone number of the
applicant/ licensee. All trade or business names used by the
applicant/licensee. Address, telephone numbers, and the name(s) of the clinic
administrator;
| (a) |
The type of ownership or
operation (i.e., partnership, corporation, or sole proprietorship);
and |
| (b) |
The name(s) of the owner
and/or operator of the applicant/licensee, including:
| 1. |
If a sole proprietorship, the complete
name of the proprietor; |
| 2. |
If a
partnership, the complete name of each partner, and the name of the
partnership; |
| 3. |
If a corporation,
the name and title of each corporate officer and director, the corporate name
and the state of incorporation, and the name of the parent company, if any.
| (i) |
Where operations are conducted at more
than one location by a single outpatient clinic pharmacy, each such location
shall be licensed by the Board. |
| (ii) |
Applications for Licensure.
| (I) |
Registration of an outpatient clinic
pharmacy shall be considered filed with the Board when an application is
received by the Board, a fee paid, and a report from the Director of the
Georgia Drugs and Narcotics Agency (GDNA) certifying that the applicant
possesses the necessary qualifications for a license. |
| (II) |
Application fees shall not be
refundable. |
| (III) |
Licenses shall
become null and void upon the sale, transfer or change of mode of operation or
location of the business. |
| (IV) |
Licenses are renewed for two year periods and expire on June 30th of each odd
numbered year and may be renewed upon the payment of the required fee for each
place of business and the filing of an application for renewal. If the
application for renewal is not filed with the Board and the fee paid before
September 1st, of each odd numbered year, the license shall lapse and may not
be renewed. An application for reinstatement shall be required. Reinstatement
shall be at the sole discretion of the Board. |
| (V) |
Changes in any information in this
section shall be submitted to the Board prior to such change. |
|
| (iii) |
Minimum Qualifications.
| (I) |
To obtain an outpatient clinic pharmacy
license, the outpatient clinic pharmacy must employ a
pharmacist-in-charge. |
| (II) |
The
Board shall consider the following factors in determining eligibility for
licensure for each person(s) in charge of the facility when considering an
application for an outpatient clinic pharmacy license:
| I. |
Any convictions of the applicant under any
Federal, State, or local laws relating to drugs, wholesale or retail drug
distribution, or distribution of controlled substances; |
| II. |
Any felony convictions of the applicant
under any Federal, State, or local laws; |
| III. |
The furnishing by the applicant of false
or fraudulent material or information in any application; |
| IV. |
Suspension or revocation of Federal,
State, or local government of any pharmacist, pharmacy or other healthcare
license currently or previously held by the applicant; |
| V. |
Failure to comply with any licensing
requirements under a previously held license, if any; |
| VI. |
Failure to comply with any requirements to
maintain and/or make available to the state licensing authority or to Federal,
State, or local law enforcement officials, any records required to be
maintained by outpatient clinic pharmacies; |
| VII. |
Other factors or qualifications the Board
considers relevant to and consistent with the public's health and safety;
and |
| VIII. |
The Board reserves the
right to deny a license to an applicant if it determines that the granting of
such a license would not be in the best interest of the
public. |
|
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|
|
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| (3) |
An outpatient clinic pharmacy registered
with the Board shall not be authorized to dispense refills on prescription drug
orders. |
| (4) |
Nothing in these
regulations shall be construed to prohibit an outpatient clinic from applying
for a retail pharmacy license as provided for in O.C.G.A. §§ 26-4-110 and Rule
480-6-.01. Any retail pharmacy located
in an outpatient clinic holding a retail pharmacy license, shall comply with
all the laws, rules and regulations applicable to such licensed retail
pharmacy. |
| (5) |
Nothing herein shall
be construed to interfere with a practitioner of the healing arts practicing as
authorized by law. |
The Personnel shall be as follows:
| (a) |
Pharmacist-in-charge. Each outpatient
clinic pharmacy shall be directed by a pharmacist, hereinafter referred to as
the pharmacist- in-charge, who is licensed to engage in the practice of
pharmacy in this State, and who is knowledgeable in and thoroughly familiar
with the specialize functions of outpatient clinic pharmacies. The
pharmacist-in-charge shall be responsible for all activities of the outpatient
clinic pharmacy, and for meeting the requirements of the Georgia Pharmacy Laws
and Rules and Regulations of the Georgia State Board of Pharmacy. The
pharmacist-in-charge shall be employed on a full-time or part-time basis
consistent with the needs and objections of the outpatient clinic. |
| (b) |
Supportive personnel. The
pharmacist-in-charge of an outpatient clinic pharmacy shall be assisted by a
sufficient number of additional pharmacists and non-licensed personnel, in
ratios consistent with state law and Board Rules as may be required to operate
such pharmacy competently, safely, and to meet the needs of the patients of the
clinic facility.
| 1. |
The pharmacist-in-charge
shall insure that non-licensed personnel shall be adequately trained. The
pharmacist-in-charge shall develop and implement written policies and
procedures to specify the duties to be performed by such non-licensed
personnel. These policies and procedures shall, at a minimum, specify that
non-licensed personnel are personally and directly supervised by a licensed
pharmacist and that non-licensed personnel are not assigned duties which may be
performed only by licensed pharmacists. |
| 2. |
Secretarial and clerical personnel shall
be provided as required to assist with record-keeping, report submission, and
other administrative duties, provided such personnel do not perform any
dispensing duties. |
| 3. |
Supervision.
All of the activities and operations of each outpatient clinic pharmacy shall
be personally and directly supervised by the pharmacist-in-charge or his/her
pharmacist designee. All functions and activities of non-licensed personnel
shall be personally and directly supervised by an adequate number of licensed
pharmacists to insure that all such functions and activities are performed
competently, safely, and without risk of harm to patients. Personal supervision
can only be accomplished by the physical presence of a licensed pharmacist in
the clinic pharmacy. |
|
The following regulations shall be followed in the absence of a
pharmacist:
| (a) |
General. When a
licensed pharmacist is not physically present in the clinic pharmacy, written
policies and procedures shall be prepared in advance by the
pharmacist-in-charge for the provision of drugs to the medical staff and other
authorized licensed personnel of the clinic by use of after hours cabinets or
containers and/or by access to the pharmacy. |
| (b) |
After hours cabinets or containers.
Access to drugs, in the absence of a licensed pharmacist, shall be by locked
cabinet(s) or other enclosure(s) or container(s) constructed and located
outside of the pharmacy area to which only specifically authorized licensed
clinic personnel as indicated by written policies and procedures may obtain
access by key or combination, and which is sufficiently secure to deny access
to unauthorized persons. The pharmacist-in-charge shall, in conjunction with
the appropriate committee of the outpatient clinic facility, develop inventory
listings of those drugs to be included in such cabinet(s), enclosure(s) or
container(s) and shall insure that:
| 1. |
Such
drugs available are properly labeled, with drug name, strength, lot number and
expiration date; |
| 2. |
Only
pre-packaged drugs are available therein, in amounts sufficient for immediate
therapeutic requirements; |
| 3. |
Whenever access to such cabinet(s), enclosure(s) or container(s) shall have
been gained, written practitioner's orders and proof of use for controlled
substances are provided; |
| 4. |
All
drugs therein are inventoried no less than once per week. A system of
accountability must exist for all drugs contained therein; and |
| 5. |
Written policies and procedures are
established to implement the requirements of this subsection. |
|
| (c) |
Access to pharmacy. Whenever
any drug is not available from standard ward inventories or after hours
cabinet(s), container(s) or enclosure(s) and such drug is required to treat the
immediate needs of a patient whose health would otherwise be jeopardized, such
drug may be obtained from the pharmacy pursuant to the practitioner's order and
the requirements of this subsection. One licensed health care professional as
designated in the policies and procedures may have access to the pharmacy and
may remove drugs therefrom. Such licensed health care professional shall be
designated in writing by the pharmacist-in-charge of the outpatient clinic
pharmacy and shall, prior to being permitted to obtain access to the pharmacy,
receive thorough education and training in the proper methods of access,
removal of drugs, and records and procedures required. Such education and
training shall be given by the pharmacist-in-charge who shall require, at a
minimum, the following records and procedures:
| 1. |
Removal of any drug from the pharmacy by
an authorized licensed health care professional must be recorded on a suitable
form showing name of drug, strength, amount, date, time and signature of the
designated licensed health care professional; |
| 2. |
The container from which the drug is
removed shall be placed conspicuously in the pharmacy to be promptly reviewed
and inspected by a pharmacist. |
|
| (d) |
Emergency kits. Drugs may be provided for
use by authorized health care personnel by emergency kits, provided such kits
meet the following requirements:
| 1. |
Emergency
kit drugs defined. Emergency kit drugs are those drugs which may be required to
meet the immediate therapeutic needs of patients and which are not available
from any other authorized source within the clinic in sufficient time to
prevent risk of harm to patients; |
| 2. |
Drugs included. The pharmacist-in-charge
and the medical staff of the clinic shall jointly determine the drugs, by
identity and quantity, to be included in emergency kits; |
| 3. |
Storage. Emergency kits shall be locked
and stored in limited access areas to prevent unauthorized access, and to
insure a proper environment for preservation of the drugs within
them; |
| 4. |
Labeling - exterior. The
exterior of emergency kits shall be labeled so as to clearly and unmistakably
indicate that it is an emergency drug kit and is for use in emergencies only.
In addition, a listing of the drugs contained therein, including name,
strength, quantity, and expiration date of the contents shall be attached.
Nothing in this section shall prohibit another method of accomplishing the
intent of this section, provided such method is approved by the Board, the GDNA
or one of their agents; |
| 5. |
Labeling
- interior. All drugs contained in emergency kits shall be labeled in
accordance with such State and Federal Laws and Regulations which pertain
thereto; and shall also be labeled with such other and further information as
may be required by the medical staff of the clinic to prevent misunderstanding
or risk of harm to the patients; |
| 6. |
Removal of drugs. Drugs shall be removed from emergency kits only pursuant to a
valid prescription drug order of an authorized prescribing practitioner, by
authorized clinic personnel, or by a pharmacist of the clinic
facility; |
| 7. |
Notification. Whenever
an emergency kit is opened, the pharmacy shall be notified; and the pharmacy
shall replace or re-stock and re-seal the kit within a reasonable time so as to
prevent risk of harm to patients. In the event the kit is opened in an
unauthorized manner, the pharmacy and other appropriate personnel of the
facility shall be notified; |
| 8. |
Inspections. Each emergency kit shall be opened and its contents inspected by
the pharmacy at least once every ninety (90) days. Upon completion of
inspection, the emergency kit shall be resealed. |
| 9. |
Procedures. The pharmacist-in-charge
shall, in conjunction with the medical staff of the clinic, develop and
implement written policies and procedures to insure compliance with the
provisions of this subsection. |
|
| (e) |
Authoritative, current antidote
information as well as the telephone number of the regional poison control
information center shall be posted or readily available in areas outside the
pharmacy where these drugs are stored or patients are being cared
for. |
| (1) |
Area. An outpatient clinic pharmacy shall
have within the clinic which it serves, sufficient floor space allocated to it
to insure that drugs are prepared in sanitary, well-lighted and enclosed
places, and which meet the other requirements of this section and the Georgia
Pharmacy Laws. The outpatient clinic pharmacy space requirements shall be a
minimum of 150 square feet. Such space shall include all areas which are
assigned and under the direct control of the pharmacist-in-charge. |
| (2) |
Minimum Equipment. No outpatient clinic
pharmacy licensed in accordance with Title 26, Chapter 4 of the Official Code
of Georgia Annotated shall engage in the practice of filing, compounding or
dispensing prescription drugs unless it shall possess the following items:
| (a) |
Copies of and/or electronic access to
current reference materials appropriate to the individual pharmacy practice.
These reference materials shall be authoritative on at least the topics of drug
interactions; patient counseling; compounding and pharmaceutical calculations;
and generic substitution. |
| (b) |
The
telephone number of a poison control center. This number shall be conspicuously
posted within the pharmacy and at other locations within the clinic
facility. |
| (c) |
Current copies of or
computer or electronic access to the following:
| 1. |
The Georgia Pharmacy Practice Act,
O.C.G.A. Title 26, Chapter 4; |
| 2. |
The Georgia Controlled Substances Act/Dangerous Drug Act, O.C.G.A. Title 16,
Chapter 13; |
| 3. |
Official Rules of
the Georgia State Board of Pharmacy. |
|
| (d) |
Equipment (appliances):
| 1. |
Refrigerator in operating condition and a
thermometer; and |
| 2. |
Sink in
working condition with both hot and cold running water. |
|
| (e) |
Weighing and labeling:
| 1. |
Class A Balance, Class I or II Electronic
Balance, or as approved by the Board; |
| 2. |
Assortment of weights: metric and
apothecary; |
| 3. |
Appropriate
prescription labels consistent with the requirements of the Georgia Drug and
Cosmetic Act, O.C.G.A. Title 26, Chapter 3; and |
| 4. |
Appropriate auxiliary labels that should
be used in the pharmacist's professional judgment. |
|
| (f) |
Other equipment;
| 1. |
Graduates of assorted sizes; |
| 2. |
Two mortars and pestles of assorted
sizes; |
| 4. |
One oral solid counting tray; |
| 5. |
Ointment slab, tile or ointment paper
pad; |
| 6. |
Typewriter, word processor
or computer with label printer; and |
| 7. |
Any other equipment necessary for a
specialized practice setting where such a specialized practice takes
place. |
|
| (g) |
Adequate
supply of drugs most commonly prescribed. |
| (h) |
Assorted sizes and types of appropriate
dispensing containers. |
|
| (3) |
Variances.
| (a) |
The pharmacist-in-charge in an outpatient
clinic facility may submit to the Georgia State Board of Pharmacy a typed
request for a variance to these provisions relating to minimum equipment
requirements. The reasons for the request for the variance must be included in
the submitted request. A variance may be granted by the Board only when, in the
judgment of the Board, there are sound reasons for doing so that relate to the
necessary or efficient delivery of health care. After consideration by the
Board, the requester will be notified of the Board's decision in
writing. |
| (b) |
If approved, said
letter(s) will serve as the proof of the Board's approval for the variances
indicated in the letter, and must be posted next to the facility's inspection
report. |
|
| (4) |
The
compounding, admixture, and quality control of large volume parenterals is the
responsibility of a pharmacist and shall be prepared under a laminar flow hood
within the pharmacy. Other licensed healthcare professionals who are authorized
by law to prepare or administer large volume parenterals must have special
training to do so. These functions of compounding shall be done primarily by
the pharmacy department with exceptions allowed for specialty-care areas,
emergency situations, and during unattended hours of the pharmacy department.
The pharmacist-in-charge shall be responsible for providing written guidelines
and for approving the procedure to assure that all pharmaceutical requirements
are met when any part of the above functions (preparing, sterilizing and
labeling parenteral medications and solutions) is performed within the clinic
by other licensed healthcare professionals who are authorized by law to prepare
parenteral medications and solutions. |
| (5) |
Storage. All drugs shall be stored in
designated areas within the clinic pharmacy 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 health care professionals are not present. |
| (6) |
Controlled drug storage for Schedule II
drugs. An enclosed controlled room or space with limited access capable of
showing forced entry is preferable. However, a safe or metal cabinet that can
be locked and that is permanently affixed to the structure is
acceptable. |
| (7) |
Unattended areas.
Whenever any area of a clinic pharmacy is not under the personal and direct
supervision of authorized personnel, such areas shall be locked. |
| (8) |
Security. All areas occupied by a clinic
pharmacy shall be capable of being locked by key or combination, so as to
prevent access by unauthorized personnel by force. The director of pharmacy
shall designate in writing, the name and specific area, of persons who shall
have access to particular areas within the pharmacy. These areas shall meet the
security requirements of Federal and State Laws and Regulations. Only those
persons so authorized shall be permitted to enter these areas. |
| (1) |
General. A drug distribution system is
the entirety of that mechanism by which a prescription drug order is executed,
from the time the practitioner transmits the order either orally, in writing,
or electronically to an authorized health professional to the time the ordered
drug is administered to the patient or delivered to the patient for
self-administration. |
| (2) |
Responsibility. The pharmacist-in-charge shall be responsible for the safe and
efficient distribution, control, and accountability for drugs, including IV
solutions and irrigation solutions. The other professional staff of the clinic
shall cooperate with the pharmacist-in-charge in meeting this responsibility
and in ordering, administering, and accounting for the pharmaceutical materials
so as to achieve this purpose. The pharmacist-in-charge shall establish written
procedures for the distribution of medications including standard ward
inventory, emergency kits, etc. to achieve this goal.
| (a) |
The drugs must be identified up to the
point of administration; |
| (b) |
The
pharmacy must receive a direct, electronic (only for drugs to be administered
on site) or mechanical copy of a practitioner's order before the first dose of
medication is dispensed except as defined by the clinic stat order
policy; |
| (c) |
Records of all
transactions of the clinic pharmacy as may be required by law, and as may be
necessary to maintain accurate control over and accountability for all
pharmaceutical materials within the scope of the clinic practice. Nothing in
this section shall prohibit the use of computerized records, where such records
meet all other requirements of the law. If an outpatient clinic pharmacy elects
to dispense prescription medications other than outpatient prescriptions as
defined herein, the pharmacy must meet all applicable State and Federal Laws
and regulations and must also obtain a retail pharmacy permit; and |
| (d) |
Participation in those aspects of the
clinic patient care evaluation program which relate to pharmaceutical material
utilization and effectiveness. |
|
| (3) |
Labeling.
| (a) |
For use inside the clinic, all drugs
dispensed by a 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. |
| (b) |
Drugs added to
parenteral admixtures. Wherever any drugs are added to parenteral admixtures,
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 person preparing the
admixture. |
|
| (4) |
Discontinued drugs. The pharmacist-in-charge 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 drugs.
| (a) |
Proof
of use of controlled drugs on standard ward inventory and/or those issued for a
specific patient. Proof of use of controlled substances and such other drugs as
may be specified by the appropriate committee of the clinic, shall be submitted
to the pharmacy, on forms provided by the pharmacy. Proof of use forms shall
specify at a minimum:
| 1. |
Drug name, strength,
and dosage form; |
| 3. |
Name of prescriber. This shall include, at
a minimum, the given and last name; |
| 4. |
Given and last name of patient; |
| 5. |
Date and time of administration to
patient; |
| 6. |
Signature of individual
administering, which shall include at a minimum, the initial, last name and
title; |
| 7. |
Documentation by two
signature verifications of destruction of all unused portions; |
| 8. |
Proof of receipt of medications that bears
identifying serial numbers; and |
| 9. |
Date medication was issued and the date that the proof of use form was
returned. |
|
| (b) |
Anesthesia, surgical, diagnostic and treatment departments that obtain
controlled drugs from the clinic pharmacy must show accountability of the
controlled drugs by proof of use as defined above. |
| (c) |
Use of computer hard copy is permitted
where such copy meets all other requirements of the law. |
| (d) |
Any outpatient clinic pharmacy licensed
by the Georgia State Board of Pharmacy in which controlled substances are
administered to patients, may make on-premises destruction of small quantities
of controlled substances prepared for parenteral and oral administration
provided:
| 1. |
The controlled substance is the
remainder of a single-dose unit; and |
| 2. |
The single-dosage unit from which the
ordered dose was prepared is the nearest possible size to the dose
ordered. |
|
| (e) |
Perpetual
inventory of Schedule II substances shall be required and accountability of
said drugs shall be by a proof of use form. |
| (f) |
Recall. The pharmacist-in-charge 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. |
| (g) |
Suspected
adverse drug reactions. All suspected adverse drug reactions shall be reported
immediately to the ordering practitioner, the pharmacy, and to the appropriate
committee of the clinic. An appropriate entry on the patient's record shall
also be made. |
| (h) |
Records and
reports. The pharmacist-in-charge 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 agents. These shall include, at a minimum, the
following:
| 1. |
Patient profile, chart or other
appropriate record; |
| 2. |
Proof of use
forms for controlled substances; |
| 3. |
Reports of suspected adverse drug reactions; |
| 4. |
Inventories of night cabinets, cabinets or
enclosures; emergency drug kits; and standard ward inventories; |
| 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 the rules and
regulations of the Georgia State Board of Pharmacy. |
|
| (i) |
Standard Ward Inventory. The outpatient
clinic pharmacy may distribute drugs within a clinic for the purpose of
establishing and/ or maintaining a standard ward inventory. Such drugs may be
supplied only upon a signed requisition from an authorized licensed health care
professional of said clinic or by an inventory replacement system. These drugs
may be administered only pursuant to a practitioner's order and shall be
documented in the patient's record. A record of drugs administered to patients
in ancillary areas such as surgical suite, treatment rooms, anesthesiology and
diagnostic areas will become a part of the patient's record and shall be
retrievable by the pharmacy. A survey of usage trends of each standard ward
inventory shall be made monthly. Such records shall be maintained for a period
of two years. |
| (j) |
Security of
controlled substances. Controlled drugs that are maintained as authorized
standard ward inventory in patient care/ treatment areas outside the pharmacy
shall be stored in secured cabinets or areas that provide a double lock
system. |
|
Drugs shall be administered only upon the orders of those
members of the medical staff who have been granted staff privileges. Drugs
shall be administered by authorized licensed personnel in accordance with
policies and procedures specified by the appropriate committee of the facility,
under applicable laws and rules and regulations, and by usual and customary
standards of good medical practice.
The pharmacist-in-charge shall establish procedures relating to
medications brought into the clinic. Such drugs shall not be administered
unless they can be precisely identified. Administration shall be pursuant to an
authorized practitioner's prescription drug order only. If such medications are
not to be administered, the medication shall be returned to an adult member of
the patient's immediate family or stored by the pharmacy and returned to the
patient at the time of his/her departure from the clinic. Nothing in this
section shall prohibit another method of accomplishing the intent of this
section provided such method is approved by an agent of the Georgia State Board
of Pharmacy. These medications shall not be maintained in any of the ancillary
areas of the clinic.
Investigational drugs shall be properly labeled.
Investigational drugs shall be dispensed and administered by the pharmacist in
accordance with an approved protocol that includes any requirements for a
patient's appropriate informed consent. Nurses may administer such drugs only
after they have been educated by the practitioner or the pharmacist. A central
unit shall be maintained by the pharmacy wherein essential information
regarding such drugs may be obtained. Investigational drugs in use shall be
properly stored, distributed, and controlled maintaining the confidentiality of
patient-medical staff information. The pharmacist-in-charge shall be
responsible for policies and procedures concerning the use of investigational
drugs.
| (1) |
Monthly. The
pharmacist-in-charge shall no less than once per month, personally or by
qualified designee, inspect all matters within his/her jurisdiction and
responsibility and make appropriate written records of such inspections. Such
inspections shall, at a minimum, verify that:
| (a) |
Drugs are dispensed only by licensed
pharmacists; |
| (b) |
Pharmacy personnel
are properly directed and supervised; |
| (c) |
Drugs for external use are stored
separately and apart from drugs for oral internal use or injection; |
| (d) |
Drugs requiring special storage
conditions to insure their stability are properly stored; |
| (e) |
No outdated drugs are stocked in the
outpatient clinic pharmacy or the facility it serves; |
| (f) |
Distribution and administration of
controlled substances are properly and adequately documented and reported by
both pharmacy and medical personnel; |
| (g) |
Standard Ward Inventory. Verification of
standard ward inventory lists and accountability, including such updating if
applicable are maintained; |
| (h) |
All
necessary and required security and storage standards are met; |
| (i) |
Metric-apothecary weight and measure
conversion tables and charts and compatibility charts are available; |
| (j) |
All policies and procedures of the
director of pharmacy and of appropriate committees of the clinic relevant to
the pharmacy are being followed; |
| (k) |
All discontinued and out-dated
medications are returned to the pharmacy for proper disposition; and |
| (l) |
Disinfectants and other similar supplies
intended for external use are stored separately and apart from drugs for oral
internal use or for parenteral injection. |
|
| (2) |
Board Inspection. The agents of the
Georgia Drugs and Narcotics Agency (GDNA) will conduct inspections on behalf of
the Georgia State Board of Pharmacy. Such inspections shall be conducted no
less than once every two years and cover all aspects of the management and
operation of all outpatient clinic pharmacies in this State to verify
compliance with the law, these rules and regulations of the Georgia State Board
of Pharmacy, and such other standards as may be appropriate to insure that the
health, safety, and welfare of patients of the clinic serviced by the pharmacy
are protected. A written report shall be filed with the GDNA, the pharmacist-
in-charge, and the clinic administrator. Any discrepancies or deficiencies
noted shall be corrected within a reasonable time. Written notice of such
corrections or a plan of action to correct deficiencies shall be filed with the
Georgia State Board of Pharmacy and GDNA within thirty (30) days after receipt
of the inspection report.
| (a) |
Every
registrant should ensure that all controlled substances and/or dangerous drugs
are purchased from and returned to firms currently licensed by the Georgia
State Board of Pharmacy. This requirement shall be met by obtaining and
maintaining a copy of each such firm's current Georgia Board permit. |
|
