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Chapter 480-35 PHARMACIST MODIFICATION OF DRUG THERAPY

Rule 480-35-.01 Definitions

(1) Board. Board means the Georgia State Board of Pharmacy.
(2) Drug Therapy Modification. Drug Therapy Modification means the adjustment of dosages, dosage schedules, and/or medications by a pharmacist under authority delegated and supervised by a physician. Such medications need not be pharmaceutically or therapeutically equivalent to the initial prescription issued to the patient by the prescribing physician.
(3) Pharmacist. Pharmacist means a person holding a current license to practice pharmacy in the State of Georgia.
(4) Physician. Physician means a person holding a current license to practice medicine in the State of Georgia.
(5) Supervision by a Physician. Supervision by a physician means the pharmacist has a means available to communicate with the physician for consultation, assistance, and direction in regards to drug therapy modification.

Rule 480-35-.02 Pharmacist Certification

(1) A pharmacist may apply to the Board for a certification which will allow the pharmacist to enter into a protocol or agreement with a physician for drug therapy modification. Each application shall be reviewed by the Board for completeness and authenticity before certification can be issued. Such application shall include, but is not limited to:
(a) Completion of an application form approved by the Board to include at a minimum:
(i) Name, home address, telephone number, and email address (if applicable);
(ii) Georgia pharmacist license number, including any previous sanctions by the Board or any other actions by a licensing or criminal authority; and
(iii) Current place of practice setting, including name, address, and telephone number and place where the protocol and patient records will be maintained.
(b) Submission of an application fee approved by the Board;
(c) Submission of evidence of completion of a course of study, approved by the Board, related to drug therapy modification; and
(d) Submission of evidence of 0.3 continuing education units (CEUs) or 3.0 contact hours in courses related to drug therapy modification. Such CEUs must be obtained during the 12 months prior to submitting the application.
(2) The Board will review the completed application. If the pharmacist has a current license in good standing, the completed course of study is approved, and the continuing education hours are acceptable, the Board may issue a certification, renewable on an annual basis.
(3) A certification authorizing drug therapy modification must be renewed by December 31st of each year. A certification authorizing drug therapy modification not renewed by December 31st shall expire.
(4) In order to renew a certification, a pharmacist must apply to the Board on an application form approved by the Board, submit a renewal fee, and submit evidence of 0.3 CEUs or 3 contact hours in continuing education courses obtained annually and approved by the Board or the Accreditation Council for Pharmacy Education (ACPE).
(5) The current certification must be posted with the pharmacist's license.

Rule 480-35-.03 Continuing Education

In order to renew a certification under this chapter, the continuing education must:

(1) Be from a provider approved by the Board pursuant to Rule 480-3-.03 or a provider approved by ACPE.
(2) Have been taken and credit received for the continuing education during the 12 months preceding the application for renewal.
(3) Have been from a live program at least 1.0 contact hour (0.1 CEU) in length.
(4) Have been on the topic of the therapy area in which the Pharmacist seeks to make drug therapy modifications.

Rule 480-35-.04 Requirements for a Protocol

(1) A physician may delegate authority to a pharmacist certified under this chapter to modify drug therapy through a protocol for a patient under the physician's direct medical care and supervision. The protocol shall meet the applicable requirements for the issuance of prescriptions provided in O.C.G.A. Section 16-13-41 or 16-13-74, which ever is applicable.
(2) A protocol shall be in writing and must contain the following:
(a) The printed name and signature of the physician, along with the license number issued to the physician by the Georgia Composite Board of Medical Examiners;
(b) The printed name and signature of the pharmacist, along with the license number issued to the pharmacist by the Board;
(c) The date the protocol was established, and the date the protocol becomes effective;
(d) The length of time the protocol shall be in effect;
(e) The identity of each patient covered by the protocol, and a mechanism to inform the patient the physician has authorized the pharmacist to modify the patient's drug therapy pursuant to this protocol, including information as to how the patient may opt out of the protocol;
(f) The physician's diagnosis of condition or disease state for each patient identified in the protocol, along with a listing of the initial drug therapy prescribed by the physician for each patient;
(g) A description of the parameters and responsibilities for drug therapy modification;
(h) Description of the monitoring required by the pharmacist and physician for each patient identified in the protocol;
(i) The procedures the pharmacist must follow when modifying drug therapy including, but not limited to, the method and frequency of notification to the physician of any drug therapy modification;
(j) For each patient's drug therapy modification, the identification of types and categories of medications allowed to be utilized, and the maximum/minimum dosage levels within each type and category of medication; and
(k) Identification of the documentation required by the pharmacist when drug therapy has been modified, including, but not limited to, a record of any problems or complications encountered, a list of recommendations, and a list of all drug modifications.
(3) No protocol can be longer than two (2) years. Protocols shall terminate immediately when the pharmacist's or physician's license and/or certificate has lapsed, been revoked, or has not been renewed.

Rule 480-35-.05 Recordkeeping

(1) Each pharmacist certified for drug therapy modification, who enters into a drug therapy modification protocol with a physician, shall establish and maintain a separate record system which shall include, but not limited to, the following:
(a) A patient medical record for each patient named in the protocol;
(b) Documentation of any action taken regarding drug therapy, including counseling of the patient in regard to the new medication;
(c) Documentation of any prescription drug order initiated by the pharmacist on behalf of the physician pursuant to the protocol;
(d) Documentation of any test results supporting drug therapy modification;
(e) Documentation of any notification to the physician regarding drug therapy modification;
(f) Documentation of any problems or adverse effects encountered due to the initial drug order or any drug therapy modification; and
(g) Other pertinent patient information;
(2) All such patient records must be maintained for a period of ten (10) years following the date the protocol is terminated;
(3) Nothing in this rule shall prohibit a pharmacist who is practicing outside a licensed pharmacy from documenting the patient information required in this rule in the patient's medical record established by the physician, clinic, or other medical facility, and such documentation shall meet the requirements of this rule.
(4) All patient records required by this rule must be available for inspection and copying by the Georgia Drugs and Narcotics Agency upon request.

Rule 480-35-.06 Financial Remuneration for Professional Services

Nothing in this rule shall be construed to prohibit the pharmacist from being remunerated for the professional services rendered.

Rule 480-35-.07 Authority to Initiate Modification of Drug Therapy

Nothing in this chapter shall be construed to limit or restrict the authority of a pharmacist to substitute a drug as provided in O.C.G.A. Section 26-4-81.

Rule 480-35-.08 Exception

Nothing in this chapter shall be construed to limit hospital pharmacists from participating in medication therapy management by protocol or other legal authority established or approved by a member of the hospital medical staff for the care and treatment of hospital patients.