Template*
Medication Therapy Protocol (MTP)
*DISCLAIMER: This template is not intended to serve as a final version of a Medication
Therapy Protocol that fully complies with the provisions of 20 CSR 2220-6.080 in the State of
Missouri. St. Louis College of Pharmacy does not guarantee that any protocol developed as
part of a certificate program will be approvable by the Missouri State Board of Pharmacy.
St. Louis College of Pharmacy accepts no liability for the content of protocols developed on the
basis of this template, or for the consequences of any actions taken pursuant to them.
I.
Effective Dates of This Protocol
A. This Medication Therapy Protocol will commence on ____________________ (date)
and will expire one (1) year after the start/revision date.
B. The authorizing physician and the pharmacist will review the protocol at least
annually and will revise the protocol as necessary. Revisions will result in a new
protocol with a new start date.
C. This 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.
D. Other circumstances that will result in termination of this protocol:
II.
This 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.
III.
Pharmacist Access to Patient Medical Records to Facilitate Medication Therapy
Services
A. Modes of Access to Patient Medical Records
B. Methods of Ensuring HIPAA Compliance
C. Methods of Ensuring Privacy, Confidentiality, and Security of Protected Health
Information (PHI)
IV.
Authorizing Physician Access to Patient Records for Medication Therapy Services
Provided by the Pharmacist
V.
Initiating Medication Therapy Services in a Specific Patient
A. Prior to providing any medication therapy services in a patient, the pharmacist shall
receive a prescription order for a medication therapeutic plan from the authorizing
physician for a specific patient. This prescription order will authorize the pharmacist
to perform the services described in this medication therapy protocol.
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1.
2.
The prescription order for a medication therapeutic plan shall include the:
a. patient’s name, address, and date of birth;
b. date the prescription order for a medication therapeutic plan is issued;
c. clinical indication for the medication therapy services;
d. length of time for providing medication therapy services, if less than
one (1) year; and
e. authorizing physician’s name and address.
The prescription order for a medication therapeutic plan may be
transmitted orally, electronically, or in writing. Orally transmitted
prescription orders must include all of the information in VA1 above and
must be documented and maintained in the patient’s record.
B. The pharmacist shall review relevant prescription records, patient profiles, patient
medical records, or other medical information to determine the services to be
rendered.
VI.
Responsibilities of the Authorizing Physician
A. 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.
B. The practice location of the Authorizing Physician shall be no farther than fifty (50)
miles by road from the pharmacist identified in the written protocol. Note: the
addresses of the Authorizing Physician and the Pharmacist are on the signature
page of this protocol.
C. The 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.
VII.
Clinical Conditions, Diagnoses, and Diseases Covered by This Protocol
A. Clinical Conditions, Diagnoses, and Diseases
B. Types of Related Services Provided by the Pharmacist. NOTE: The Pharmacist
shall not delegate the responsibility of medication therapy services to another
person.
1.
2.
The Pharmacist is not permitted to diagnose any medical problem or
condition as part of this protocol or by the scope of practice for a
pharmacist defined by law in the State of Missouri.
Methods and Procedures
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3.
Assessing Patient-Specific Data and Issues
a. Interpreting, Monitoring, and Assessing Patient Test Results
VIII.
4.
Decision Criteria
5.
Plans
Drugs and/or Drug Categories Covered by This Protocol
A. Drugs and/or Drug Classes
B. Types of Related Services Provided by the Pharmacist. NOTE: The Pharmacist
shall not delegate the responsibility of medication therapy services to another
person.
1.
2.
The Pharmacist is not permitted to independently issue a prescription for
any drug, medication, or device as part of this protocol or by the scope of
practice for a pharmacist defined by law in the State of Missouri.
Methods and Procedures
a. Performing Medication Reconciliation
b. Performing Drug Utilization Review
c. Drug Therapy-Related Patient Assessment Procedures or Testing
(Including Laboratory Testing) to be Ordered or Performed by the
Pharmacist
3.
Assessing Patient-Specific Data and Issues
a. Assessment of Adverse Drug Reactions and Adverse Drug Events
b. Pharmacokinetic Assessments
c. Pharmacodynamic Assessments
4.
Decision Criteria
5.
Plans
a. Note: The 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.
b. Establishment of Therapeutic Goals for Medications
c. Establishment of Medication-Related Action Plans
a. Plans for Modifying Medications
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i. For the purposes of this protocol, 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 substitution.
ii. 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
iii. If the Pharmacist modifies medication therapy or a
device, the Pharmacist shall document such
modification appropriately in the patient record.
Pharmacists providing medication therapy services for
patients of a health care entity shall document the
initiation in a patient medical record that the health care
entity is required to maintain under state or federal law.
b. Plans for Monitoring Medications and Evaluating Treatment
Progress
d. Management of Adverse Drug Reactions and Adverse Drug Events
e. Formulating and Documenting Personal Medication Records
f.
Documenting Clinical Outcomes
g. Patient Education and Counseling
6.
7.
IX.
Description of any authority granted to the Pharmacist to administer any
drug or medication (list all medications/drugs)
Devices used by the Pharmacist
Procedures for Documenting Medication Therapy Decisions Made by the Pharmacist
A. Criteria and Plans for Timely Communication Between the Pharmacist and the
Authorizing Physician
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X.
1.
Types of Feedback from the Pharmacist to the Authorizing Physician
2.
Modes of Communication
3.
Frequency and Timeliness of Communications
4.
Reporting of Specific Therapeutic Decisions Made by the Pharmacist
Provisions and Courses of Action for Managing Emergency Situations
A. Management of Anaphylaxis
B. Management of Adverse Reactions and Adverse Events
C. Management of Needle Sticks
XI.
Notification Requirements
A. Within twenty-four (24) hours after learning of an anaphylactic or other adverse
medication reaction, adverse needle stick, or any 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, within twenty-four (24) hours after
any modification of therapy allowed in this protocol.
C. If the Pharmacist is providing medication therapy services for, or on behalf of, a
health care entity, as defined by rule, documentation of the notifications required by
the rules may be recorded in a patient medical record that is required to be
maintained by the health care entity pursuant to state or federal law.
D. 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.
E. All notifications referred to in this section shall be in writing, unless otherwise allowed
by the Authorizing Physician.
F. Authorized designees of the Authorizing Physician include:
XII.
Record Keeping
A. The 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
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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:
1.
The identification of the patient, including, name, birthdate, address, and
telephone number; and
2.
The date(s) of any patient visit or consultation, including the reason for any
such visit/consultation; and
3.
Any pertinent assessments, observations, or findings; and
4.
Any diagnostic testing recommended or performed; and
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; and
6.
Referrals to the Authorizing Physician; and
7.
Referrals for emergency care; and
8.
9.
Any contact with the authorizing physician concerning the patient’s
treatment or medication therapy services plan; and
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. The Pharmacist shall maintain all records 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. The Pharmacist shall maintain all records required by law at the
following address:
C. Authorizing Physician Record Retention. The Authorizing Physician shall maintain all
records 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. The Authorizing Physician shall
maintain all records required by law at the following address:
D. Production of Records. Records maintained at a pharmacy shall 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.
XIII.
Mechanism and Procedures for Modifications or Amendments to This Protocol
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A. Procedures for Allowing the Authorizing Physician to Override, Rescind, Modify, or
Otherwise Amend This Protocol
B. All modifications or amendments must be documented in writing. Such
modifications/amendments will be signed and dated by all parties involved in this
protocol prior to their implementation.
C. Either the Authorizing Physician or the Pharmacist may immediately rescind this
protocol, with or without cause, as long as the recession is documented in writing.
D. If any conflict arises regarding the professional judgment of the Pharmacist and
Authorizing Physician with regard to the subject of the medication therapy services,
the Authorizing Physician has ultimate authority.
XIV.
Provisions for Pharmacy Residents
A. If specifically authorized by this protocol, a pharmacy resident shall be authorized to
perform medication therapy services under this written protocol in lieu of an
individual protocol, if the resident:
1.
holds a certificate of medication therapeutic plan authority from the
Missouri State Board of Pharmacy; and
2.
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.
is providing medication therapy services under the direct supervision of the
Pharmacist covered under this protocol who holds a certificate of
medication therapeutic plan authority.
4.
The resident listed (signed and dated) on this protocol is providing
medication therapy services as part of his/her residency training.
Signatures of the Health Professionals
Note: If this protocol includes multiple Authorizing Physicians or 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 this
written protocol.
PHARMACIST—By signing below, I attest that I 1) hold a certificate of medication therapeutic
plan authority from the Missouri State Board of Pharmacy; 2) hold a current Missouri pharmacist
license that is not under discipline with the Missouri State Board of Pharmacy; and 3) have
entered into this written protocol with a Missouri licensed physician. This medication therapy
protocol complies with all provisions of 20 CSR 2220-6.080 and section 338.010, RSMo. The
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services in this protocol are within the scope of my practice and are in accordance with my
skills, education, training, and competence.
________________________________________________
Signature
_______________________
Date
________________________________________________
Printed Name
_______________________
License Number
Address of the Practice Location
Note: Additional names (with signatures, printed names, and license numbers) of Pharmacists,
including pharmacy residents, may be added here.
……………………………………………………………………………………………………………….
AUTHORIZING PHYSICIAN—By signing below, I attest that I am actively engaged in the
practice of medicine in the state of Missouri and I hold a current and unrestricted Missouri
physician license pursuant to Chapter 334, RSMo. I am in compliance with all pertinent and
related rules and regulations by the Missouri State Board of Registration for the Healing Arts
and this protocol is within the scope of my practice as the Authorizing Physician. I am
responsible for the oversight of the medication therapy services provided by the pharmacist that
are authorized by this protocol. I have considered 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.
________________________________________________
Signature
_______________________
Date
________________________________________________
Printed Name
_______________________
License Number
Address of the Practice Location
Note: Additional names (with signatures, printed names, and license numbers) of Authorizing
Physicians may be added here.
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