Mo. Code Regs. tit. 20 § 2220-6.080

Current through Register Vol. 49, No. 24, December 16, 2024

Section 20 CSR 2220-6.080 - Medication Therapy Services By Protocol

PURPOSE: This rule establishes procedures for the provision of medication therapy services by protocol, as authorized by section 338.010, RSMo.

(1) Except as otherwise provided herein, a pharmacist who holds a certificate of medication therapeutic plan authority from the Missouri State Board of Pharmacy shall be authorized to provide medication therapy services in Missouri if the pharmacist-

(A) Holds a current Missouri pharmacist license that is not under discipline with the Missouri State Board of Pharmacy; and

(B) Has entered into a written protocol with a Missouri licensed physician that complies with the requirements of this rule.

(2) General Requirements. A pharmacist may provide medication therapy services only with current certification and as authorized by the protocol and the authorizing physician. A pharmacist providing medication therapy services pursuant to this rule shall comply with the following:

(A) Prior to providing medication therapy services, the pharmacist shall receive a prescription order for a medication therapeutic plan from the authorizing physician for a specific patient which authorizes the pharmacist to perform medication therapy services. Except as otherwise provided in subsection (2)(B) of this rule, the prescription order for a medication therapeutic plan shall be valid for no more than one (1) year and shall include:

1. The patient's name, address, and date of birth;

2. The date the prescription order for a medication therapeutic plan is issued;

3. The clinical indication for medication therapy services;

4. The length of time for providing medication therapy services, if less than one (1) year; and

5. The authorizing physician's name and address;

(B) A prescription order for a medication therapeutic plan may be transmitted orally, electronically, or in writing. If an oral prescription order for a medication therapeutic plan is issued, all information required under subsection (2)(A) of this rule shall be documented by the pharmacist and maintained in the patient's record in accordance with section (7) of this rule;

(C) The pharmacist shall review relevant prescription records, patient profiles, patient medical records, or other medical information to determine the services to be rendered; and

(D) In lieu of compliance with 20 CSR 2220-2.018, prescription orders for medication therapy services shall comply with the provisions of this rule, provided the pharmacist shall maintain the prescription order in the patient record required by section (7) of this rule and shall document any change or alteration made to the prescription ordered based on contact with the prescriber in the applicable patient record.

(3) Authorizing Physician Requirements.

(A) The authorizing physician shall be actively engaged in the practice of medicine in the state of Missouri and shall hold a current and unrestricted Missouri physician license pursuant to Chapter 334, RSMo.

(B) The authorizing physician shall be responsible for the oversight of the medication therapy services provided by the pharmacist that are authorized by protocol. The authorizing physician shall also consider the level of skill, education, training, and competence of the pharmacist and ensure that the activities authorized by the protocol are consistent with the pharmacist's level of skill, education, training, and competence.

(C) The written protocol shall be reviewed and signed by the pharmacist and the authorizing physician at least annually and revised as needed. The authorizing physician and pharmacist shall document the date of the annual review on the written protocol.

(D) The authorizing physician shall review the pharmacist's medication therapy service activities regularly, but not less than once every three (3) months. If the pharmacist is providing medication therapy services for, or on behalf of, a health care entity, the review requirements shall be satisfied if the pharmacist's work and services are reviewed every three (3) months by a clinical care committee, pharmacy and therapeutics committee, or a reviewing body/committee of the health care entity that includes a Missouri-licensed physician. The review required by this subsection may be accomplished in person or by electronic means.

(E) The practice location of the authorizing physician shall be no further than fifty (50) miles by road from the pharmacist identified in the written protocol.

(F) An authorizing physician shall notify the Missouri State Board of Registration for the Healing Arts of a written protocol for medication therapy services entered with a pharmacist at each renewal of the authorizing physician's license.

(4) Protocol Requirements.

(A) The medication therapy services performed by a pharmacist pursuant to the protocol shall be within the authorizing physician's scope of practice and within the skill, education, training, and competence of both the authorizing physician and the pharmacist.

(B) The written protocol between the authorizing physician and pharmacist shall, at a minimum, include the following:

1. The identity and signatures of the authorizing physician and pharmacist;

2. The effective dates of the protocol;

3. A statement of clinical conditions, diagnoses, diseases, and specific drugs, or drug categories included in the written protocol and the type of medication therapy services allowed in each case;

4. A statement of the methods, procedures, decision criteria, and plan the pharmacist is to follow when conducting medication therapy services;

5. Procedures for documenting medication therapy decisions made by the pharmacist and a plan for communication, feedback, and reporting to the authorizing physician concerning specific decisions made;

6. A mechanism and procedure that allows the authorizing physician to override, rescind, modify, or otherwise amend the protocol. All modifications or amendments to the protocol shall be documented in writing, signed, and dated by all involved parties prior to the implementation of such modification or amendment. The protocol may be immediately rescinded by the authorizing physician or the pharmacist with or without cause, provided the rescission is documented in writing. If any conflict arises regarding the professional judgment of the pharmacist and physician with regard to the subject of the medication therapy services, the physician has ultimate authority;

7. A statement that the pharmacist shall not delegate the responsibility of medication therapy services to another person;

8. A description of any authority granted to the pharmacist to administer any drug or medication including the identification of any such drug, medication, or device;

9. A description of drug therapy related patient assessment procedures or testing that may be ordered or performed by the pharmacist, including any authority to order or perform routine or other laboratory testing;

10. Provisions for allowing the pharmacist to access the patient's medical records for purposes of providing medication therapy services;

11. A provision for providing the authorizing physician access to patient records for medication therapy services provided by the pharmacist for patients of the authorizing physician;

12. Provisions establishing a course of action the pharmacist is authorized to follow to address emergency situations, including, but not limited to, anaphylactic or other adverse medication reactions, adverse needle sticks, or other adverse events;

13. Criteria for timely communication from the authorizing physician to the pharmacist and from the pharmacist to the authorizing physician, not inconsistent with the provisions of this rule;

14. The notification requirements required by section (5) of this rule; and

15. The method for reviewing the pharmacist's medication therapy work or services by the authorizing physician, as required by subsection (3)(D) of this rule.

(C) The written protocol shall include a description of medication therapy services the pharmacist is authorized to render or provide. Such services may include:

1. Assessing patient-specific data and issues;

2. Establishing medication therapeutic goals or medication related action plans for identified medical conditions and medication related concerns;

3. Assessing and addressing adverse reactions and adverse drug events;

4. Modifying and monitoring medication regimens;

5. Evaluating treatment progress;

6. Assessing and monitoring pharmacokinetic and pharmacodynamic changes in medication regimen reviews;

7. Medication reconciliation;

8. Drug utilization review;

9. Formulating and documenting personal medication records;

10. Documenting clinical outcomes;

11. Interpreting, monitoring, and assessing patient test results;

12. Initiation of drug therapy, as authorized by protocol; and

13. Patient education and counseling.

(D) The protocol required by this section shall be signed and dated by the authorizing physician and the pharmacist. If the protocol includes multiple authorizing physicians or participating pharmacists, a separate protocol shall not be required for each physician or pharmacist if all authorizing physicians and pharmacists have signed and dated a statement agreeing to be governed by the terms of the written protocol.

(E) Any revisions, modifications, or amendments to the protocol must be in writing. The authorizing physician shall promptly notify the pharmacist of any such revision, modification, or amendment and shall maintain documentation of the notification, including the date such notification was made. The authorizing physician may delegate the notification requirements of this subsection to an authorized designee, provided the physician shall be ultimately responsible for compliance with the notification requirements.

(F) A pharmacist shall not be authorized to adjust, change, or modify any controlled substance prescribed for a patient, except as authorized by state or federal law.

(G) The protocol shall be maintained by the authorizing physician and the pharmacist for a minimum of eight (8) years after termination of the protocol. The protocol may be maintained electronically.

(H) A protocol shall automatically and immediately terminate if the pharmacist ceases to maintain an active Missouri pharmacist license, the authorizing physician is deceased, or if the authorizing physician fails to maintain an active, unrestricted Missouri physician license.

(I) Pharmacy Residents. If specifically authorized by the protocol, a pharmacy resident shall be authorized to perform medication therapy services under the written protocol of a Missouri pharmacist in lieu of an individual protocol, if-

1. The resident holds a certificate of medication therapeutic plan authority from the Missouri State Board of Pharmacy;

2. The resident is enrolled in a residency training program accredited by the American Society of Health-System Pharmacists or a residency training program with a valid application for accreditation pending with the American Society of Health-System Pharmacists; and

3. The resident is providing medication therapy services under the supervision of a Missouri pharmacist certified by the Missouri State Board of Pharmacy to perform medication therapy services.

(J) The provisions of subsection (4)(I) shall only apply to medication therapy services provided by a pharmacist as part of his/her residency training.

(5) Notification Requirements. A pharmacist shall comply with the following notification requirements:

(A) Within twenty-four (24) hours after learning of an anaphylactic or other adverse medication reaction, adverse needle stick, or other adverse event experienced by a patient, the pharmacist shall notify the patient's authorizing physician or an authorized designee of the authorizing physician;

(B) The pharmacist shall notify the authorizing physician or an authorized designee of the authorizing physician in the written protocol of any modification of therapy, within twenty-four (24) hours, provided the protocol may include more stringent notification requirements;

(C) A pharmacist shall be deemed in compliance with the notification requirements of this rule if the pharmacist is providing medication therapy services for, or on behalf of, a health care entity, as defined by this rule, and documentation of the notifications required by this section is recorded in a patient medical record that is required to be maintained by the health care entity pursuant to state or federal law; and

(D) Notifications required by this section shall be in writing unless otherwise authorized by the authorizing physician.

(6) Modifying Drug Therapy.

(A) A pharmacist may be authorized by protocol to modify a patient's non-controlled substance medication therapy, subject to the following:

1. If the pharmacist modifies medication therapy and a medication or device is to be dispensed, the pharmacist shall create a prescription for the medication or device modified under the authorizing physician's name. Such prescription may be dispensed by a licensed pharmacy and shall be maintained in the prescription records of the dispensing pharmacy as provided by the rules of the Missouri State Board of Pharmacy; and

2. If the pharmacist modifies medication therapy or a device, the pharmacist shall document such modification according to section (7) of this rule. Pharmacists providing medication therapy services for patients of a health care entity shall be deemed in compliance with the provisions of this subsection if the modification is documented in a patient medical record that the health care entity is required to maintain under state or federal law.

(B) The pharmacist shall not modify any controlled substance prescription. A prescription from the authorizing physician shall be required to modify a controlled substance.

(C) For purposes of 20 CSR 2220-6.060, 20 CSR 2220-6.070, and 20 CSR 2220-6.080, modification of medication therapy shall include selecting a new, different, or additional medication or device, discontinuing a current medication or device, or selecting a new, different, or additional strength, dose, dosage form, dosage schedule, or route of administration for a current medication or device, and implementing such selection(s). Medication therapy services shall not include the sole act of dispensing a drug or device pursuant to a valid prescription for the product or generic substitutions made pursuant to section 338.056, RSMo.

(7) Record Keeping.

(A) A pharmacist shall document and maintain an adequate patient record of medication therapy services provided to each patient. The records may be maintained in electronic format provided the records are capable of being printed for review by the Missouri State Board of Registration for the Healing Arts and the Missouri State Board of Pharmacy. An adequate and complete patient record shall include documentation of the following:

1. The identification of the patient, including, name, birthdate, address, and telephone number;

2. The date(s) of any patient visit or consultation, including the reason for any such visit/consultation;

3. Any pertinent assessments, observations, or findings;

4. Any diagnostic testing recommended or performed;

5. The name of any medication or device modified and the strength, dose, dosage schedule, dosage form, and route of administration of any medication modified or administered;

6. Referrals to the authorizing physician;

7. Referrals for emergency care;

8. Any contact with the authorizing physician concerning the patient's treatment or medication therapy services plan;

9. Any informed consent for procedures, medications, or devices; and

10. Any consultation with any other treatment provider for the patient and the results of such consultation.

(B) Pharmacist Record Retention. Except as otherwise provided herein, records required to be maintained by a pharmacist pursuant to this rule shall be maintained securely and confidentially for a minimum of seven (7) years after termination of the protocol unless more stringent requirements are established for record keeping under state or federal law. All records required to be maintained by the pharmacist by this rule shall be maintained by the pharmacist at an address that shall be identified in the written protocol.

(C) Physician Record Retention. Except as otherwise provided herein, records required to be maintained by the authorizing physician pursuant to this rule shall be maintained securely and confidentially for a minimum of seven (7) years after termination of the protocol unless more stringent requirements are established for record keeping pursuant to state or federal law.

(8) Production of Records. Records maintained at a pharmacy must be produced during an inspection or investigation by the Missouri State Board of Pharmacy, Missouri State Board of Registration for the Healing Arts, or their authorized representatives, as requested by the respective board or the board's designee. Records not maintained at a pharmacy shall be produced within three (3) business days after a request from the Missouri State Board of Pharmacy, Missouri State Board of Registration for the Healing Arts, and/or its authorized representative. Failure to maintain or produce records as provided by this rule shall constitute grounds for discipline.

(9) Nothing in this rule shall be construed to permit medical diagnosis of any condition by a pharmacist or the independent issuing of a prescription by a pharmacist.

(10) A pharmacist shall not violate or practice in a manner inconsistent with the provisions of this rule or a written protocol. A pharmacist's failure to abide by the requirements of this rule or the provisions of a written protocol shall be subject to disciplinary action pursuant to the provisions of Chapter 338, RSMo.

(11) The requirements of this rule shall not apply to the administration of vaccines pursuant to protocol as governed by 20 CSR 2220-6.050 or the administration of medication by protocol as governed by 20 CSR 2220-6.040.

(12) The Missouri State Board of Registration for the Healing Arts and the Missouri State Board of Pharmacy separately retain the right and duty to discipline their respective licensees for violations of any state or federal statutes, rules, or regulations regardless of the licensee's participation in a protocol agreement.

(13) The provisions of 20 CSR 2220-6.060 to 20 CSR 2220-6.080 and 20 CSR 2150-5.026 to 20 CSR 2150-5.028 shall only be deemed applicable to persons or entities under the jurisdiction of the Missouri State Board of Pharmacy and the Missouri State Board of Registration for the Healing Arts, as established by Chapter 338, RSMo, and Chapter 334, RSMo.

20 CSR 2220-6.080

AUTHORITY: sections 338.010, 338.140.1., and 338.380, RSMo Supp. 2011.* Original rule filed Jan. 13, 2012, effective Aug. 30, 2012.

*Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011 ; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011 ; and 338.380, RSMo 2007.