3 CCR 713-1-A - PROTOCOL TO BE DEVELOPED AND USED FOR DRUG THERAPY MANAGEMENT BY A PHYSICIAN AND PHARMACIST OR GROUPS OF PHYSICIANS AND PHARMACISTS
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.
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.