Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.97-007 - Regulation 63 - Drug Therapy Management by a Pharmacist Under Written Protocol of a Physician
Universal Citation: AR Admin Rules 070.00.97-007
Current through Register Vol. 49, No. 2, February 2024
REGULATION 63
DRUG THERAPY MANAGEMENT BY A PHARMACIST UNDER WRITTEN PROTOCOL OF A PHYSICIAN
The purpose of this regulation is to provide standards for the maintenance of records of a pharmacist engaged in the provision of drug therapy management as authorized in § 17-92-101(14) and § 17-92-205(a).
(A) DEFINITIONS: The following words and
terms, when used in this regulation, shall have the following meanings, unless
the context clearly indicates otherwise:
(1)
ACT - The Arkansas Pharmacy Practice Act
(2) BOARD - The Arkansas State Board of
Pharmacy
(3) CONFIDENTIAL RECORD -
any health-related record maintained by a pharmacy or pharmacist-such as a
patient medication record, prescription drug order, or medication
order.
(4) DRUG THERAPY MANAGEMENT
-The performance of specific acts of drug therapy management delegated to a
pharmacist for an individual patient by an authorized practitioner through
written protocol. (Drug therapy management shall not include the selection of
drug products not prescribed by the practitioner, unless the drug product is
named in the practitioner initiated protocol.)
(5) WRITTEN PROTOCOL - A practitioner's
order, standing medical order, standing delegation order, or other order or
protocol as defined by rule of the Arkansas State Medical Board under the
Medical Practice Act.
(a) A written protocol
must contain at a minimum the following:
(i) a
statement identifying the individual practitioner authorized to prescribe drugs
and responsible for the delegation of drug therapy management;
(ii) a statement identifying the individual
pharmacist authorized to dispense drugs and to engage in drug therapy
management delegated by the practitioner;
(iii) a statement identifying the types of
drug therapy management decisions that the pharmacist is authorized to make
which shall include:
(I) A statement of the
ailments or diseases involved, drugs, and types of drug therapy management
authorized; and
(II) A specific
statement of the procedures, decision criteria, or plan the pharmacist shall
follow when exercising drug therapy management authority;
(iv) A statement of the activities the
pharmacist shall follow in the course of exercising drug therapy management
authority, including the method for documenting decisions made and a plan for
communication or feedback to the authorizing physician concerning specific
decisions made Documentation shall be recorded within a reasonable time of each
intervention and may be performed on the patient medication record patient
medical chart, or in a separate log book; and
(v) A statement that describes appropriate
mechanisms and time schedule for the pharmacist to report to the physician
monitoring the pharmacist's exercise of delegated drug therapy management and
the resuits of the drug therapy management.
(B) A standard protocol may be
used, or the attending practitioner may develop a drug therapy management
protocol for the individual patient. If a standard protocol is used, the
practitioner shall record, what deviations if any, from the standard protocol
are ordered for that patient.
(C)
Maintenance of records:
(1) Every patient
record required to be kept under this regulation shall be kept by the
pharmacist and be available, for at least two years from the date of such
record, for inspecting and copying by the Board or its representative and to
other authorized local, state, or federal law enforcement or regulatory
agencies.
(2) Patient records may
be maintained in an alternative data retention system, such as a data
processing system or direct imaging system provided:
(a) The records maintained in the alternative
system contain all of the information required on a manual record;
and
(b) The data processing system
is capable of producing a hard copy of the record upon the request of the
Board, its representative, or other authorized local, state, or federal law
enforcement or regulatory agencies.
(D) Written protocol:
(1) A copy of the written protocol and any
patient-specific deviations from the protocol shall be maintained by the
pharmacist and available for inspection by a Board Inspector upon
request.
(2) Written protocols,
including standard protocols, any patient specific deviations from a standard
protocol, and any individual patient protocol, shall be reviewed by the
practitioner and pharmacist at least annually and revised, if necessary. Such
review shall be documented in the pharmacist's records. Documentation of all
services provided to the patient, by the pharmacist, shall be reviewed by the
physician on the schedule established in the protocol.
(3) Any protocol from a practitioner shall be
maintained in the pharmacy and available for inspection by a Board Inspector
upon request.
(E)
Confidentiality:
(1) A pharmacist shall
provide adequate security to prevent indiscriminate or unauthorized access to
confidential records. If confidential health information is not transmitted
directly between a pharmacy and a practitioner, but is transmitted through a
data communication device, the confidential health information may not be
accessed or maintained by the operator of the data communication device unless
specifically authorized to obtain the confidential information by this
regulation.
(2) Confidential
records are privileged and may be released only to:
(a) the patient or the patient's
agent;
(b) practitioners and other
pharmacists when, in the pharmacist's professional judgment
(c) other persons, the Board, or other state
or federal agencies authorized by law to receive such information;
(d) a law enforcement agency engaged in
investigation of suspected violations of the Controlled Substances Act;
or
(e) a person employed by any
state agency which licenses a practitioner as defined in the Act if such person
is engaged in the performance of the person's official duties.
(3) This regulation shall not
affect or alter the provisions relating to the confidentiality of the
physician-patient communication as specified in the Medical Practice
Act.
Disclaimer: These regulations may not be the most recent version. Arkansas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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