3 CCR 716-1.22 - RULES AND REGULATIONS CONCERNING RESPONSIBILITIES OF ADVANCED PRACTICE REGISTERED NURSES WITH PRESCRIPTIVE AUTHORITY WHO ENGAGE IN DRUG THERAPY MANAGEMENT WITH A COLORADO LICENSED PHARMACIST
A.
BASIS: The authority for the promulgation of these rules and
regulations by the State Board of Nursing ("Board") is set forth in sections
12-20-204(1),
12-255-107(1)(j),
and 12-255-112 of the Colorado Revised
Statutes (C.R.S.).
B.
PURPOSE: The Board has adopted these Rules to authorize advanced
practice registered nurses with prescriptive authority to participate with
qualified pharmacists in drug therapy management, in conjunction and consistent
with the Colorado State Board of Pharmacy; and to delineate the requirements
and responsibilities applicable to an advanced practice registered nurse with
prescriptive authority who enters into an agreement with a Colorado licensed
pharmacist to provide "drug therapy management" by protocol as defined in these
Rules. The Colorado State Board of Pharmacy Rule 6.00.00 ("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 prescriber to provide "drug therapy
management" by protocol.
C.
DEFINITIONS:
For the purposes of Rule 1.24, the following terms have the indicated meaning:
1. "Active,
unrestricted license" means a license that is not currently subject to any
practice restrictions, encumbrances, terms, or conditions including, but not
limited to terms of probation.
2.
"Board" means the State Board of Nursing unless otherwise specified in these
Rules.
3. "Drug therapy management"
or "DTM" 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 an advanced practice registered nurse
with full prescriptive authority (RXN), 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 RXN.
a. Drug therapy management may include:
(1) Collecting and reviewing patient drug
histories;
(2) Obtaining and
checking vital signs;
(3) 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 RXN;
(4) Modifying drug therapy
when appropriate, in compliance with the protocol ordered by the RXN;
and
(5) Implementing the drug
therapy plan agreed upon between the RXN 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 treatment for a certain disease state containing a
written set of specific directions created by the RXN.
5. "RXN" means, for purposes of Rule 1.24, an
advanced practice registered nurse with an active, unrestricted license having
full prescriptive authority in Colorado.
D.
ELIGIBILITY TO ENTER INTO A DRUG
THERAPY MANAGEMENT AGREEMENT:
1. An
RXN may engage in drug therapy management by protocol with a Colorado licensed
pharmacist only when the protocol used is within the scope of the RXN's current
practice and is consistent with the RXN's role and population focus.
2. Only an RXN with an active, unrestricted
license as defined herein and having full prescriptive authority in Colorado
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 an RXN with a restricted or an encumbered license to engage in drug
therapy management with a Colorado licensed pharmacist. Consideration may 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. An RXN 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 6.00.30.
E.
PROTOCOL
REQUIREMENTS:
1. The protocol used by
an RXN and pharmacist engaging in drug therapy management must follow the
format of and contain the elements required by Section (H) of Rule
1.24.
2. The protocol used by an
RXN and pharmacist engaging in drug therapy management must demonstrate a plan
of treatment that constitutes evidence-based practice. 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 RXN. Upon request, the
RXN 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 RXN, and at least annually. The
protocol must also be revised in a timely fashion to reflect any changes in the
accepted standard of care.
5. The
protocol developed must allow for the provision of patient care that meets
generally accepted standards of practice.
F.
REQUIREMENTS FOR WRITTEN AGREEMENTS
OR GENERAL AUTHORIZATION PLANS:
1. If
applicable, RXNs 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 RXNs, other prescribing healthcare
providers, 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 the RXNs, the
other prescribing healthcare providers, and pharmacists engaging in drug
therapy management in order to assure compliance with generally accepted
standards of practice and with those items set forth in Section (F)(2) of Rule
1.24.
2. An RXN 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 and license number;
b. RXN's name and RXN identifier
number;
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 RXN;
g.
Manner in which pharmacist's drug therapy management will be monitored by the
RXN, 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 RXN or when applicable, a covering RXN or
covering physician, of any modifications of drug therapy;
i. Within seventy-two hours following
notification by the pharmacist, the RXN must review and document acceptance or
rejection of the drug therapy modification;
j. A provision that allows the RXN to
override any action taken by the pharmacist when the RXN deems it to be
necessary;
k. An effective date of
the agreement and signatures of both parties;
l. A provision addressing how drug therapy
management will be handled when the patient has more than one prescribing
healthcare provider involved in evaluating or treating the medical condition
which is the subject of the agreement. All prescribing healthcare providers who
are actively involved in the management of the relevant conditions shall be
parties to the agreement; and
m. 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 RXN, other
prescribing healthcare provider, 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. An RXN 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 RXN'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 RXN's decision to
participate in drug therapy management is consistent with generally accepted
standards of practice;
c. to assure
that the patient's drug therapy management records are complete; and
d. to assure that the RXN is providing
overall care to the patient that meets generally accepted standards of
practice.
H.
ELEMENTS TO BE INCLUDED IN THE PROTOCOL DEVELOPED AND USED FOR DRUG
THERAPY MANAGEMENT BY AN RXN AND PHARMACISTS
1. For the purposes of drug therapy
management (DTM), the protocol must contain all of the information required by
Board of Pharmacy Rule 6, 3 CCR 719-1, and Sections (E) and (H) of Rule
1.24.
2. In addition, a protocol
created for drug therapy management by an RXN working with pharmacists should
adopt the following format:
a. Disease state
being addressed.
b. Setting for
application of DTM.
c. Goal of the
use of the protocol for the disease state (limit the degradation, maintain the
status, and/or improve the condition of patients with the disease
state).
d. Summary of who will do
what within the respective scopes of practice (what the RXN will do, what the
pharmacist will do).
e. Indicate
how patients may get referred into this disease state program (for example,
from an RXN practicing within their role and population focus, internist,
family physician or cardiologist).
f. Indicate the enrollment criteria for this
disease state (for example, a history of myocardial infarction, percutaneous
transluminal angioplasty or stent placement, etc.).
g. Indicate any other disease states that may
be present and the appropriate attention to those states during treatment for
this disease state. If there are any implications for this treatment, specify
how those implications will be handled.
h. Specify the nature and scope of the
therapy to be undertaken, the specific directions for each drug to be used, the
specified dosage regimen, forms or route of administration, directions for
implementing and monitoring the therapy, identification of appropriate tests
that may be requested and for what purposes, delineating critical test values
and specific parameters for dosage modification. If a laboratory monitoring
protocol is not individually developed, indicate the clinical parameters of
laboratory monitoring for the disease state for each protocol. The specificity
required above may be portrayed via an algorithm or similar matrix if the
disease state lends itself to such definition.
i. Specify other interventions necessary for
therapy (for example, lipid lowering therapy, aspirin therapy or
non-pharmacologic treatment necessary such as diet, physical activity, alcohol
use, tobacco cessation, etc.). Indicate whether or not those interventions are
within the DTM agreement, and if so, repeat the information in Section
(H)(2)(h) of Rule 1.24 for those states. Specify any mitigating factors that
may apply to the therapy.
j.
Specify clinical exclusions or aggravating factors. That is, if there are known
situations where a patient should not participate in DTM or whose participation
should be limited in some way. Specify how this will be addressed.
k. Indicate specific directions for
responding to acute allergic or other adverse reactions to therapy and the
method whereby patient safety will be preserved and safeguarded in such a
situation.
l. Indicate tracking
mechanisms to be used to ensure timeliness of therapy and patient visits, and
the method of follow-up if the patient does not make visits; specify method of
quality assurance checks on this.
m. Indicate the reporting required by the
pharmacist and the RXN.
n. Indicate
the references to the evidence based article(s) that support the protocol being
used.
3. Signatures.
Persons responsible for drug therapy management must sign the protocol, to
indicate that they have read them and understand the scope of their
responsibilities. In any event, the RXN, pharmacist, and all prescribing
healthcare providers who are actively involved in the DTM shall be held
responsible for the therapy. DTM may not be delegated by the RXN, unless it is
to and within a prescribing healthcare provider's scope of practice, and only
after the RXN has made a diagnosis and referred the patient to therapy.
Adopted: October 27, 2015
Effective: December 30, 2015
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.