Alabama Administrative Code
Title 540 - ALABAMA BOARD OF MEDICAL EXAMINERS
Chapter 540-X-26 - COLLABORATIVE PHARMACY PRACTICE
Section 540-X-26-.04 - Collaborative Drug Therapy Management Agreement: Required Terms
Universal Citation: AL Admin Code R 540-X-26-.04
Current through Register Vol. 42, No. 11, August 30, 2024
(1) Each Agreement shall contain the following elements, at a minimum:
(a) Names and Titles of Collaborating
Providers. The Agreement must contain identification of the Collaborating
Pharmacist, the Collaborating Physician, Covering Physician(s), and Covering
Pharmacist(s) who are parties ("collaborating providers") to the Agreement. The
Agreement shall state the procedure to be followed to indicate changes in the
collaborating providers participating in the Agreement. Unless expressly stated
in the Agreement, changes to the list of collaborating providers bound by the
Agreement shall not automatically void the Agreement. Signatures may be
handwritten, electronic, or any other method authorized by the Board of
Pharmacy and the Board of Medical Examiners.
(b) Authorized Care and Services. The
Agreement must contain an "Authorized Care and Services" section defining the
nature and scope of patient care services and activities, including screening,
prevention, assessment, management, and care, authorized or restricted, to be
provided by the Collaborating Pharmacist pursuant to approved Protocol(s) under
the Agreement. All care and services to be provided shall be within the routine
scope of practice and services delivered by the Collaborating Physician;
provided, however, that the authorized care and services may not be broader in
scope than the permissible functions and activities authorized under the
Collaborating Pharmacist's license, training, experience, and Board of
Pharmacy's laws, rules, policies, and procedures. All care and services
provided, with the exception of immunizations, opioid antagonists, and acute,
uncomplicated illness or injury, must be pursuant to a diagnosis appropriately
made and documented by the Collaborating Physician. An Agreement which includes
a Protocol authorizing the Collaborating Pharmacist to modify or discontinue
drug therapy must include specific authorization in the authorized care and
services portion of the Agreement and must contain a Formulary that may be
modified or discontinued by the Collaborating Pharmacist under the terms of the
Agreement.
(c) Documentation and
Communication.
1. The Collaborating Physician
shall be responsible for documenting the communication in the patient medical
record maintained by the Collaborating Physician. The Collaborating Physician
shall, within 24 hours, communicate to the Collaborating Pharmacist any changes
initiated to a patient's drug therapy that is subject to an Agreement; a
written, telephonic, or electronic prescription which contains specific dosage
information may satisfy this requirement. The collaborating pharmacist shall,
within 24 hours, communicate to the collaborating physician and any
physician(s) designated by the patient any changes to a patient's drug therapy
and/or individual patient care services as set out in the Agreement. The
Agreement shall describe the methods for documenting the patient medical record
by the Collaborating Pharmacist and the Collaborating Physician, for
documentation of services performed pursuant to the Agreement, and for
communication and feedback between the Collaborating Pharmacist and the
Collaborating Physician. All such records shall be maintained by the
Collaborating Physician for a period of not less than six (6) years from the
date of the last patient contact, or if the patient is a minor, the record
shall be maintained for a period of not less than eight (8) years from the date
of the last patient contact. All such records shall be maintained by the
Collaborating Pharmacist within the employing pharmacy for a period of not less
than two (2) years from the date of the last patient contact.
2. A pharmacist performing testing or
screening for and treatment of acute, uncomplicated illness or injury
conditions shall also:
(i) Provide each
patient with written information to advise the patient to seek follow-up care
from either a physician with whom the patient has a pre-existing relationship,
or, if no pre-existing relationship exists, to seek follow-up care from the
collaborating physician.
(ii)
Provide the patient with a consent form allowing any changes to a patient's
drug therapy and/or individual patient care services as set out in the
Agreement to be provided to the collaborating physician and the physician with
whom the patient has a pre-existing relationship.
(d) Override Clause. A provision
must be included in the Agreement providing for the Collaborating Physician to
override the actions taken by the Collaborating Pharmacist specific to services
provided under the Agreement. This provision must state how such overrides
shall be documented and communicated to the Collaborating Pharmacist and the
patient in a timely manner, as defined in the Agreement.
(e) Expiration, Modification, and
Termination. The effective date of the Agreement shall be stated in the
Agreement. Each Agreement must contain a term or expiration date upon which the
Agreement will expire if not renewed; however, in any event, all Agreements
must be reviewed, updated where applicable, and renewed by December 31 at least
every two (2) years as evidenced by signatures of the parties. Every Agreement
must contain a provision stating the process for modification or termination of
the Agreement by any of the parties. An Agreement may be amended upon mutual
approval by the Collaborating Physician and Collaborating Pharmacist who have
been duly authorized to execute, modify, or change the Agreement. Such
amendments shall include, at a minimum, a description of the desired change and
the effective date of the change. Any amendment executed shall not
automatically void the terms and conditions of the existing Agreement unless
expressly stated. Amendments to the authorized care and services which
establish substantive additions or reductions to the scope of patient care
services provided under the Agreement, including new therapeutic classes of
drugs added to the authorized Formulary, must be provided to the Board of
Pharmacy and Board of Medical Examiners no later than ten (10) days from the
date the amendment is signed by the parties.
(f) Automatic Exclusions. Agreements must
have a provision that identifies any terms under which a provider will be
automatically excluded from participation in the Agreement, which shall
include, but are not limited to: death; the suspension, surrender, revocation,
or retirement of license; loss or restriction of prescriptive authority; the
suspension, surrender, or revocation of a Drug Enforcement Administration
registration or Alabama Controlled Substances Certificate; or exclusion from
any federally-funded health programs.
(g) Quality Assurance. The Collaborating
Physician and Collaborating Pharmacist shall engage in a quality assurance
review of the care provided for patients pursuant to the Agreement on a
quarterly basis. Quality Assurance shall include, and the Agreement shall
provide for, a quarterly review by the Collaborating Physician of a meaningful
sample of patient records. A "meaningful sample" shall consist of:
1. Not less than twenty-five percent (25%) of
the patients treated pursuant to the Agreement for the first two years of the
Agreement;
2. Not less than ten
percent (10%) of the patients treated pursuant to the Agreement after the
Agreement has been in effect for two years; and
3. All adverse outcomes of the patients
treated pursuant to the Agreement.
The quality assurance review shall be properly documented, retained by the participating parties of the Agreement, and available for review by representatives of the Board of Medical Examiners for at least five (5) years and the Board of Pharmacy for at least two (2) years.
(h) All Agreements
shall require the Collaborating Pharmacist to use an area for in-person or
other approved consultations with patients that ensures the confidentiality of
the communication and complies with the requirements and standards set forth by
the Board of Pharmacy in Ala. Admin. Code r.
680-X-2-.27.
(i) Notice. All Agreements shall include a
provision stating which party or parties shall bear the costs and
responsibility of promptly notifying affected individuals in the event that an
Agreement expires or is terminated. All Agreements shall specify when patients
served by an Agreement are to be notified of changes to the Agreement. Any
provision of the Agreement notwithstanding, the patients served by an Agreement
shall be promptly notified when a Collaborating Physician or Collaborating
Pharmacist departs from or is terminated from an Agreement, and said notice
shall include the Collaborating Physician's or Collaborating Pharmacist's
contact information as well as instructions for how patients may obtain copies
of their records or have them forwarded to the physician or pharmacist of their
choice.
(2) Agreements that include the testing or screening for and treatment of acute, uncomplicated illness or injury shall also include:
(a)
Patient selection criteria, which shall include the physician's instructions
for obtaining relevant patient medical history for the purpose of identifying
disqualifying health conditions, adverse reactions, and contraindications to
the approved course of treatment.
(b) Treatment protocols, which shall include
the physician's instructions for the treatment of acute, uncomplicated illness
or injury based on the patient's age, symptoms, and test results, including
negative results.
(c) Any other
requirements as established by the Board of Pharmacy and Board of Medical
Examiners.
Author: Alabama Board of Medical Examiners
Statutory Authority: Code of Ala. 1975, § 34-24-53; Act 2019-368 (Code of Ala. 1975, § 34-23-77).
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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