3 CCR 713-1.18 - RESPONSIBILITIES OF A PHYSICIAN WHO ENGAGES IN DRUG THERAPY MANAGEMENT WITH A COLORADO LICENSED PHARMACIST
A.
Basis: The general authority for promulgation of these
Rules by the Colorado Medical Board ("Board") is set forth in sections
12-20-204(1),
12-240-106(1)(a),
and 24-4-103, C.R.S.
B.
Purpose: The
Board has adopted these Rules to delineate the requirements and
responsibilities applicable to a licensed physician who enters into an
agreement with a Colorado licensed pharmacist to provide "drug therapy
management" by protocol as defined in these Rules. Colorado State Board of
Pharmacy Rule 17.00.00 ("Pharmaceutical Care, Drug Therapy Management and
Practice by Protocol") defines the requirements and responsibilities applicable
to a Colorado licensed pharmacist who enters into an agreement with a Colorado
licensed physician to provide "drug therapy management" by protocol.
C.
Definitions
1. "Active, unrestricted license" means a
license that is not currently subject to any practice restrictions, terms, or
conditions, including but not limited to terms of probation.
2. "Board" means the Colorado Medical Board
unless otherwise specified in these Rules.
3. "Drug therapy management" means the review
and evaluation of drug therapy regimens for patients undertaken by a pharmacist
in order to provide drug therapy, monitor progress and modify drug therapy.
Drug therapy management may only be undertaken pursuant to an initial diagnosis
made by a licensed physician, a valid order for the therapy, and a written
agreement, which delineates proper protocols to be used, and the type of
interaction that must occur between the pharmacist and the physician.
Therapeutic interchange programs in inpatient and group model integrated closed
HMO settings that are approved by medical staff committees are not considered
drug therapy management for purposes of these Rules. Drug therapy management
may include:
a. Collecting and reviewing
patient drug histories;
b.
Obtaining and checking vital signs;
c. Ordering and evaluating the results of
laboratory tests directly related to management of the drug therapy when
performed in compliance with the protocol ordered by the physician;
d. Modifying drug therapy when appropriate,
in compliance with the protocol ordered by the physician; and
e. Implementing the drug therapy plan agreed
upon between the physician and the pharmacist, using a protocol and managing
the therapy according to the protocol.
4. "Protocol" means a specific written plan
for a course of medical treatment for a certain disease state containing a
written set of specific directions created by the physician, groups of
physicians, hospital medical committee, or pharmacy and therapeutics
committee.
D.
Eligibility to Enter into a Drug Therapy Management
Agreement:
1. A physician may
engage in drug therapy management by protocol with a Colorado licensed
pharmacist only when the protocol used is within the scope of the physician's
current practice and are consistent with the physician's education, training
and experience.
2. Only a physician
with an active, unrestricted Colorado license may engage in a drug therapy
management agreement with a Colorado licensed pharmacist. Upon a showing of
good cause and written request, the Board may allow a physician with a
restricted license to engage in drug therapy management with a Colorado
licensed pharmacist. Consideration shall be given on a case by case basis. It
is anticipated that such waivers would be rare. The decision to grant such a
waiver shall be in the sole discretion of the Board.
3. A physician may engage in a drug therapy
management agreement only with a Colorado licensed pharmacist who has an
active, unrestricted license to practice pharmacy and who meets the
qualifications to provide drug therapy management as determined by the Colorado
State Board of Pharmacy and set forth in Pharmacy Board Rule
17.00.30.
E.
Protocol Requirements:
1. The protocol used by a physician and
pharmacist engaging in drug therapy management must follow the format of and
contain the elements required in Exhibit A, which is attached to these
Rules.
2. The protocol used by a
physician and pharmacist engaging in drug therapy management must demonstrate a
plan of treatment that constitutes evidence-based medicine. This means that the
plan of treatment must be guided by or based on current, objective, and
supported scientific evidence as published in scientific literature, rather
than anecdotal observations.
3. The
protocol shall be signed and dated by the authorizing physician or chairperson
of the authorizing group or committee. Upon request, the physician shall submit
the written protocols for drug therapy management to the Board for
review.
4. The protocol shall be
reviewed and revised as necessary by the physician, at least annually. The
protocol must also be revised in a timely fashion to reflect any changes in the
accepted standard of medical care. The protocol developed must allow for the
provision of patient care that meets generally accepted standards of medical
practice.
F.
Requirements for Written Agreements or General Authorization
Plans:
1. Physicians who wish to
engage in drug therapy management with Colorado licensed pharmacists in an
inpatient setting or in a group model integrated closed HMO setting must first
execute a general authorization plan. The general authorization plan must
identify those physicians and pharmacists who are authorized and who have
agreed to participate in drug therapy management in the specified practice
setting. The general authorization plans must define the responsibilities of
physicians and pharmacists engaging in drug therapy management in order to
assure compliance with generally accepted standards of medical practice and
with those items set forth in paragraph (D)(2) of these Rules.
2. A physician who wishes to engage in drug
therapy management by protocol with a Colorado licensed pharmacist in any other
setting must first execute a written agreement containing the following
information:
a. Pharmacist's name;
b. Physician's name;
c. Diagnoses relevant to the drug therapy to
be managed and other patient conditions relevant to maintenance of the
patient's health during drug therapy management;
d. Protocol to be employed;
e. Functions and activities the pharmacist
will perform, and restrictions or limitations on the pharmacist's
management;
f. Method, content and
frequency of reports to the physician;
g. Manner in which pharmacist's drug therapy
management will be monitored by the physician, including method and
frequency;
h. A specified time, not
to exceed twenty-four hours (excluding Saturdays, Sundays and State holidays),
within which the pharmacist must notify the physician or when applicable, the
covering physician, of any modifications of drug therapy;
i. A provision that allows the physician to
override any action taken by the pharmacist when the physician deems it to be
necessary;
j. An effective date of
the agreement and signatures of both parties;
k. A provision addressing how drug therapy
management will be handled when the patient has more than one physician
involved in evaluating or treating the medical condition which is the subject
of the agreement. All physicians who are actively involved in the management of
the relevant conditions shall be parties to the agreement.
l. A provision that the pharmacist agrees to
maintain liability insurance in the amount of at least $1,000,000 per
occurrence.
3. Any
general authorization plan or written agreement executed in accordance with
these Rules must allow any physician or pharmacist to withdraw from the general
authorization plan or written agreement within a period of time specified in
the agreement.
G.
Record Keeping and Retention of Records
1. A physician who engages in drug therapy
management by protocol with a Colorado licensed pharmacist must obtain copies
of the pharmacist's records for each patient in a timely manner and must review
such records.
2. The physician's
receipt and review of the records are important for the following reasons:
a. To assure that the drug therapy management
is in compliance with the protocol and with these Rules;
b. To assure that the physician's decision to
participate in drug therapy management is consistent with generally accepted
standards of medical practice;
c.
To assure that the patient's drug therapy management records are complete;
and
d. To assure that the physician
is providing overall care to the patient that meets generally accepted
standards of medical practice.
Notes
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