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

Current through Register Vol. 42, No. 9, June 28, 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.