Chapter 480-31 PATIENT COUNSELING
Purpose: The purpose of the regulations issued in this part is
to comply with the requirements of the Omnibus Budget Reconciliation Act of
1990 and to enhance the public health and welfare by providing that pharmacists
shall offer consultation to patients regarding their medications and various
conditions which could affect or be affected by the use of those
medications.
| (a) |
Patient Records.
| 1. |
A patient record system shall be
maintained by all pharmacies for patients for whom Prescription Drug Orders are
dispensed. For purposes of the regulations under this part,"Prescription Drug
Order" is defined to mean the lawful order of a Practitioner for a Drug or
Device for a specific patient. The patient record system shall provide for the
immediate retrieval of information necessary for the Dispensing Pharmacist to
identify previously dispensed drugs at the time a prescription drug order is
presented for dispensing. The Pharmacist or his designee shall make a
reasonable effort to obtain, record, and maintain the following information:
| (i) |
full name of the patient for whom the
Drug is intended. |
| (ii) |
address and
telephone number of the patient; |
|
| 2. |
The Pharmacist shall make a reasonable
effort to obtain from the patient or the patient's agent and shall record any
known allergies, drug reactions, idiosyncrasies, and chronic conditions or
disease states of the patient and the identity of any other Drugs, including
over-the-counter Drugs, or devices currently being used by the patient which
may relate to Prospective Drug Review unless the patient or the patient's agent
refuses such information. The Pharmacist shall make a reasonable effort to
obtain, record, and maintain the following information:
| (i) |
A list of all Prescription Drug Orders
obtained by the patient at the Pharmacy where the Prescription Drug Order is
being filled within the preceding two years, showing prescription number, name
and strength of the Drug, the quantity and date dispensed, the name of the
Practitioner; and |
| (ii) |
comments
from the Pharmacist relevant to the individual's drug therapy, including any
other information peculiar to the specific patient or Drug. |
|
| 3. |
A patient record shall be
maintained for a period of not less than two years from the date of the last
entry in the profile record. This record may be a hard copy or a computerized
form. |
|
| (b) |
Prospective
Drug Review.
| 1. |
A pharmacist shall review the
patient record and each Prescription presented for Dispensing for purposes of
promoting therapeutic appropriateness by identifying:
| (i) |
over-utilization or
under-utilization; |
| (ii) |
therapeutic
duplications; |
| (iii) |
drug-disease
contraindications; |
| (iv) |
Drug-Drug
interactions; |
| (v) |
incorrect Drug
dosage or duration of Drug treatment; |
| (vi) |
Drug-allergy interactions; |
| (vii) |
clinical abuse/misuse. |
|
| 2. |
Upon recognizing any of the
above, the Pharmacist shall take appropriate steps to avoid or resolve the
problem which shall, if necessary, include consultation with the
Practitioner. |
|
| (c) |
Patient Counseling.
| 1. |
Upon receipt of a
Prescription Drug Order and following a review of the patient's record, the
dispensing Pharmacist shall personally offer to discuss matters which will
enhance or optimize drug therapy with each patient or caregiver of such
patient. Such discussion shall be in person, whenever practicable, or by
telephone and shall include appropriate elements of patient counseling, based
on the professional judgment of the pharmacist. Such elements may include but
are not limited to the following:
| (i) |
the name
and description of the Drug; |
| (ii) |
the dosage form, dose, route of Administration, and duration of drug
therapy; |
| (iii) |
intended use of the
Drug and expected action; |
| (iv) |
special directions and precautions for preparation, Administration, and use by
the patient; |
| (v) |
common severe side
or adverse effects or interactions and therapeutic contraindications that may
be encountered, including their avoidance, and the action required if they
occur; |
| (vi) |
techniques for
self-monitoring drug therapy; |
| (viii) |
prescription
refill information; |
| (ix) |
action to
be taken in the event of a missed dose; and |
| (x) |
Pharmacist comments relevant to the
individual's Drug therapy, including any other information peculiar to the
specific patient or Drug. |
|
| 2. |
Additional forms of patient information
shall be used to supplement Patient Counseling when appropriate. |
| 3. |
Patient Counseling, as described above and
defined in the Act, shall not be required for:
| (i) |
in-patients of a hospital or institution
where other licensed health care professionals are authorized to administer the
drug(s). |
| (ii) |
inmates of
correctional institutions where pharmacy services are provided by the Georgia
Department of Corrections or by county or municipal political subdivisions
either directly or by a subcontractor of the above; or |
| (iii) |
patients receiving drugs from the
Georgia Department of Human Resources Division of Public Health; provided
however, that pharmacists who provide medications to patients in accordance
with Section 43-34-26.1 of the Official Code of Georgia Annotated shall include
in all dispensing procedures a written process whereby the patient or the
caregiver of such patient is provided with the information contained in Chapter
480-31 of the Rules of the Georgia State Board of Pharmacy. |
| (iv) |
refills of prescription drug orders for
which, in the professional judgment of the Pharmacist, appropriate counseling
has taken place or has been declined. The need for counseling on refills
resides in the professional judgment of the dispensing Pharmacist. |
|
| 4. |
A Pharmacist shall not be
required to counsel a patient or caregiver when the patient or caregiver
refuses such consultation. |
| 5. |
These
rules will become effective January 1, 1993. |
|
| (d) |
Nothing in these rules shall be
interpreted so as to prohibit the pharmacist from being remunerated for said
professional services. |
