Chapter 480-21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES
For the purpose of these rules and regulations, the following
definitions apply:
| (a) |
Retail Pharmacy
Providing Home Health Care Services. A retail pharmacy providing home health
care services is defined as a licensed retail pharmacy that routinely prepares
and dispenses compounded, sterile parenteral products to outpatients. |
| (b) |
Outpatient. An outpatient is defined as a
patient in the home environment or an institutionalized patient that is
receiving compounded, sterile parenteral products from a pharmacy outside the
institution. |
| (c) |
Compounded,
Sterile Parenteral Products. Compounded, sterile parenteral products are
defined as those parenteral drug products that require preparation by the
pharmacist and which must be sterile, stable, and effective when dispensed for
patient use. |
All retail pharmacies providing home health care services must
have a current retail pharmacy permit. Therefore, they must comply with all
retail pharmacy laws and regulations as well as the special regulations
contained in these rules.
| (1) |
Pharmacist-in-Charge. The pharmacist-in-charge at each retail pharmacy
providing home health care services shall be knowledgeable in the specialized
functions of preparing and dispensing compounded, sterile parenteral products,
including the principles of aseptic technique and quality assurance. This
knowledge is may be obtained through residency training programs, continuing
education programs, or experience in an IV admixture facility. The
pharmacist-in-charge shall be responsible for the purchasing, storage,
compounding, repackaging, dispensing, and distribution of all drugs and
pharmaceuticals. The pharmacist-in-charge shall also be responsible for the
development and continuing review of all policies and procedures, training
manuals, and the quality assurance programs. The pharmacist-in-charge may be
assisted by additional pharmacists adequately trained in this area of
practice. |
| (2) |
Supportive Personnel.
The pharmacist-in-charge may be assisted by supportive personnel. These
personnel shall have specialized training in this field, and shall work under
the direct supervision of a licensed pharmacist. The training provided to these
personnel shall be described in writing in a training manual. The duties and
responsibilities of these personnel must be consistent with their training and
experience. |
| (3) |
Secretarial
Personnel. Secretarial and clerical support shall be provided as required to
assist with record keeping and other administrative duties. |
| (4) |
Staffing. A licensed pharmacist shall be
accessible at all times at each such licensed facility to respond to patients'
and other health professionals questions and needs. |
The physical requirements are:
| (a) |
Space. Each retail pharmacy providing
home health care services shall have a designated area for preparing
compounded, sterile parenteral products. This area shall be physically separate
from other areas and should be designed to avoid unnecessary traffic and
airflow disturbances. The minimum space shall be 150 square feet. It shall be
used only for the preparation of specialty products. It shall be of sufficient
size to accommodate a laminar airflow hood and to provide for the proper
storage of drugs and supplies under appropriate conditions of temperature,
light, moisture, sanitation, ventilation, and security. |
| (b) |
Equipment.
| 1. |
Laminar Airflow Hood; or Class 100 Clean
Room; |
| 2. |
Infusion Pumps, if
appropriate; |
| 3. |
Sink, in working
condition, with hot and cold running water, which is convenient to the
compounding area for the purpose of hand scrubs prior to compounding; |
| 4. |
Equipment for light/dark field
examination; |
| 5. |
Appropriate
disposal containers for used needles, syringes, etc., and if applicable,
cytotoxic waste from the preparation of chemotherapy agents; |
| 6. |
A Class II, vertical flow biological
safety cabinet, if chemotherapy agents are routinely prepared; |
| 7. |
Refrigerator/Freezer with a thermometer
and in working condition. |
|
| (c) |
Supplies.
| 1. |
Disposable needles, syringes and other
supplies needed for aseptic admixture; |
| 2. |
Disinfectant cleaning solutions; |
| 3. |
Handwashing agent with bactericidal
action; |
| 4. |
Disposable, lint free
paper towels; |
| 5. |
Appropriate
filters and filtration equipment; |
| 6. |
Disposable masks and sterile, disposable
gloves; |
| 7. |
Gowns, if chemotherapy
agents are routinely prepared; |
| 8. |
An oncology drug spill kit, if chemotherapy agents are routinely
prepared. |
|
| (d) |
References. In addition to references required of a retail pharmacy, current
edition of an established reference on IV stability and incompatibility, such
as, HANDBOOK ON INJECTABLE DRUGS, or KING'S GUIDE TO PARENTERAL
ADMIXTURES. |
| (e) |
Variances.
| 1. |
The pharmacist-in-charge may submit to the
Georgia State Board of Pharmacy a written request for a variance to these
provisions relating to minimum equipment requirements. Stated reasons for
application for variances must be included in the submitted request. A variance
shall be granted by the Board only when, in the judgement 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 requestor will
be notified in writing of the Board's decision. |
| 2. |
If approved, said letter(s) will serve as
the proof of the Board's approval for variances indicted in the letter, and
must be posted next to the inspection report. |
|
Regulations are:
| (a) |
General. A drug distribution system is the entirety of that mechanism by which
a physician's prescription drug order is executed, from the time the drug is
ordered and received in the pharmacy, to the time the prescribed drug is
dispensed to the patient. |
| (b) |
Purchasing. All drugs and pharmaceutical products purchased and dispensed by a
retail pharmacy providing home health care services shall meet national
standards of quality (USP-NF standards) and shall be clearly and accurately
labeled by the manufacturer or distributor as to contents. |
| (c) |
Policy and Procedure Manual. A policy and
procedure manual shall be prepared and maintained at each retail pharmacy
providing home health care services and be available for inspection by agents
of the Georgia Drugs and Narcotics Agency. The policy and procedure manual
shall set forth in detail the objectives and operational guidelines of the
pharmacy. The manual shall be reviewed and revised at a minimum on an annual
basis. A copy shall be provided to the Board of Pharmacy when applying for a
permit or engaging in this specialized area of practice. |
| (d) |
Prescription Drug Order. The pharmacist
or pharmacy intern/extern acting under the direct supervision of a licensed
pharmacist must receive a written or verbal prescription drug order from a
physician before dispensing any compounded, sterile parenteral product or other
drug. Prescriptions drug orders may be filed by patient, assigned consecutive
numbers, or any other system that assures a complete, retrievable and accurate
record. A new prescription drug order is required every six (6) months if the
physician does not specify a course of therapy. These prescriptions drug orders
shall, at a minimum, contain the following:
| 2. |
Patient
address for a controlled substance; |
| 3. |
Drug name, strength, and dispensing
quantity; |
| 4. |
Patient directions for
use; |
| 6. |
Prescriber's signature; |
| 7. |
Prescriber's address and drug enforcement
administration identification code, if applicable; |
|
| (e) |
Patient Profile. A pharmacy generated
patient profile that may be separate from the prescription file must be
maintained for each patient. The patient profile shall be maintained under the
control of the pharmacist-in-charge for a period of two years after the last
dispensing activity. The patient profile shall contain, at a minimum:
| 5. |
Compounded, sterile parenteral products
dispensed; |
| 7. |
Drug content and
quantity; |
| 9. |
Prescription serial
number; |
| 10. |
Identification of
dispensing pharmacist(s); |
| 11. |
Other
drugs patient is receiving; |
| 12. |
Patient's drug sensitivities and allergies to drugs and foods; |
| 13. |
Primary diagnosis of the
patient. |
|
| (f) |
Labeling.
Each compounded, sterile parenteral product dispensed to outpatients shall be
labeled with the following information with a permanent, non-removable label:
| 1. |
Name, address, and telephone number of the
retail pharmacy providing home health care services; |
| 2. |
Date and identifying prescription
number; |
| 4. |
Name of each drug (brand
or generic), strength, and amount; |
| 5. |
Directions for use to the patient,
including infusion rate; |
| 7. |
Required
precautionary information regarding controlled substances; |
| 8. |
Date and time of compounding; |
| 9. |
Expiration date and expiration time of the
product; and |
| 10. |
Identity of
pharmacist compounding and dispensing the product. |
|
| (g) |
Records and Reports. The
pharmacist-in-charge shall maintain appropriate records and reports as are
required to ensure patient's health, safety, and welfare. Such records shall be
readily available, maintained for two years, and subject to inspections by the
Board of Pharmacy or its agents. These records shall include, as a minimum, the
following:
| 3. |
Inventories of the pharmacy; |
| 4. |
Biennial controlled substances
inventories; |
| 5. |
Policy and
procedures manual; |
| 7. |
Policies and procedures
for cytotoxic waste, if applicable; |
| 8. |
Such other records and reports as may be
required by law and rules and regulations of the Board of Pharmacy. |
| 9. |
Delivery Service. The pharmacist-in-charge
is responsible for the environmental control of all products shipped or
delivered, and must ensure that all drug products are shipped in compliance
with O.C.G.A. 26-4-60(a)(11). Therefore, any compounded, sterile parenteral
product that is frozen, or requires refrigeration, must be shipped or delivered
to a patient in appropriate coolers and stored appropriately in the patient's
home. |
|
The following additional requirements are necessary for those
retail pharmacies providing home health care services that routinely prepare
chemotherapy agents to insure the protection of the personnel involved:
| (a) |
All chemotherapy agents should be
compounded in a vertical flow, Class II, biological safety cabinet. If
possible, other products should not be compounded in this cabinet. |
| (b) |
Protective apparel shall be worn by
personnel compounding chemotherapy drugs. This shall include disposable masks,
gloves, and gowns with tight cuffs. |
| (c) |
Proper aseptic and safety techniques
shall be used by personnel compounding chemotherapy agents. This shall include,
at a minimum, utilizing syringes and sets with luer-lock fittings, and wrapping
alcohol swabs around needle and neck of vials when withdrawing cytotoxic
solutions from a vial. |
| (d) |
Appropriate disposal procedures for cytotoxic waste must be developed that
comply with applicable state and federal regulations. |
| (e) |
Written policies and procedures for
handling both major and minor spills of cytotoxic agents must be
developed. |
| (f) |
Prepared doses of
chemotherapy must be dispensed and shipped or delivered in a manner to minimize
the risk of accidental rupture of the primary container. |
| (1) |
Primary Provider. There shall be a
designated practitioner responsible for the patient's medical care. There shall
be a clear understanding between the practitioner, the patient, and the
pharmacist of the responsibilities of each in the areas of the delivery of
care, the monitoring of the patient, and the reimbursement for services. The
responsibilities of each person shall be documented in the patient's
profile. |
| (2) |
Patient Counseling A
pharmacist shall provide to the patient or patient's care-giver any information
required for the use of the drugs, supplies and equipment being dispensed. The
pharmacist must document the patient's counseling in the pharmacy's patient
profile. |
| (3) |
Pharmacist-Patient
Relationship. It is imperative that a pharmacist-patient relationship be
established and maintained throughout the patient's course of therapy. The
patient should be contacted by the pharmacist at least quarterly. This contact
shall be documented in the patient's profile. |
| (4) |
Patient Monitoring. The pharmacist should
have access to clinical and laboratory data concerning each patient and should
monitor each patient's response to his drug therapy. Any unexpected or untoward
response should be reported to the prescribing physician. In the absence of the
pharmacist monitoring, it shall be documented in the patient's profile, which
health care provider has assumed this responsibility. |
There shall be a documented, ongoing quality control program
that monitors personnel performance, equipment, and facilities. The end product
shall be examined on a sampling basis as determined by the pharmacist-in-charge
to assure that it meets required specifications.
| (a) |
Hood Certification. All laminar flow
hoods shall be certified by Federal Standard 209B for operational efficiency at
least every 12 months. Appropriate records shall be maintained. |
| (b) |
Prefilters. Prefilters for the clean air
source shall be replaced on a regular basis and these activities shall be
documented. |
| (c) |
End Product
Sampling. There shall be written documentation that the end product has been
tested on a sampling basis for microbial contamination. |
| (d) |
Bulk Compounding. If bulk compounding of
parenteral solutions is performed utilizing nonsterile chemicals, extensive end
product testing must be documented prior to the release of the product from
quarantine. This process must include testing for sterility and
pyrogens. |
| (e) |
Expiration Dates. If
the product is assigned a lengthy expiration date (anything exceeding 10 days)
there must be in-house data or data in the literature to assure the sterility
and stability of the product at the time it is used by the patient. |
| (f) |
Quality Control Audits. There shall be
documentation of quality assurance audits at regular, planned
intervals. |
