DEFINITION
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 a physician, groups of physicians, hospital
medical committee, or pharmacy and therapeutics committee.
ELEMENTS
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 Section (C) of these Rules.
In addition, a protocol created for drug therapy management
by physicians working with pharmacists should adopt the following
format:
1. Disease state being
addressed.
2. Target audience (a
department and/or all physicians participating or an individual physician if
applicable).
3. Setting for
application (a department, clinic, office, pharmacy).
4. 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).
5. Summary of who will do what (what the
physician will do, what the pharmacist will do). For example, in a cardiac risk
service protocol, the clinical pharmacy specialist, working with the primary
care physician or cardiologist may adjust medication doses as needed to achieve
defined therapeutic goals within the constraints agreed upon for treatment.
He/she may also be asked to contact the prescriber with medication change
recommendations, or order necessary tests.
6. Indicate how patients may get referred
into this disease state program (for example, from an internist, family
physician or cardiologist).
7.
Indicate the enrollment criteria for this disease state (for example, a history
of myocardial infarction, percutaneous transluminal angioplasty or stent
placement, etc.).
8. 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.
9. 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, directions for interpreting such
tests, 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.
10. 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 paragraph 9 of
this Exhibit A for those states. Specify any mitigating factors that may apply
to the therapy.
11. 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.
12. 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.
13. 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.
14. Indicate the reporting required by the
pharmacist and the physician.
15.
Indicate the references to the evidence based article(s) that support the
protocol being used.
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. For example, in a large hospital setting, chiefs of
service will most likely be the signing party. In a small hospital, the chief
medical officer might be the signer. In a retail setting, the physician
involved, or the physician who represents the group, if the agreement is with a
group, should be the signer. In a pharmacy, the pharmacy manager and the
pharmacist conducting the therapy should sign. In any event, the individual
signing the agreement will be held responsible for the therapy. DTM may not be
delegated by physicians to office staff, unless it is staff with prescriptive
authority, and only after the physician has made a diagnosis and referred the
patient to therapy.
