Mich. Admin. Code R. 338.589 - Professional responsibility; patient counseling; "caregiver" defined

Rule 89.

(1) A pharmacist has a professional responsibility for the strength, quality, purity, and the labeling of all drugs and devices dispensed under a prescription. In discharging this responsibility, a pharmacist shall utilize only those drugs and devices that are obtained from manufacturers and wholesale distributors licensed under section 17748 of the code, MCL 333.17748, or from other lawful channels of distribution.

(2) A pharmacist shall not fill a prescription order if, in the pharmacist's professional judgment, any of the following provisions apply:

(a) The prescription appears to be improperly written.

(b) The prescription is susceptible to more than 1 interpretation.

(c) The pharmacist has reason to believe that the prescription could cause harm to the patient.

(d) The pharmacist has reason to believe that the prescription may be used for other than legitimate medical purposes.

(3) A prescription drug must be dispensed only when the pharmacy is open and under the personal charge of a pharmacist.

(4) To encourage intended, positive patient outcomes, a pharmacist shall communicate to the patient, or the patient's caregiver, necessary and appropriate information regarding safe and effective medication use when a prescription is dispensed. As used in this subrule, "caregiver" means the parent, guardian, or other individual who has assumed responsibility for providing a patient's care. All of the following provisions apply to communicating medication safety and effectiveness information:

(a) The information must be communicated orally and in person, except when the patient or patient's caregiver is not at the pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed or electronic/digital material designed to help the patient use the medication safely and effectively satisfies the requirements of this subrule.

(b) The information must be provided with each prescription for a drug not previously prescribed for the patient.

(c) If the pharmacist determines it appropriate, the information must be provided with prescription refills.

(d) The information must be provided if requested by the patient or patient's caregiver or agent for any prescription dispensed by the pharmacy. This subrule does not require that a pharmacist provide consultation if a patient or a patient's caregiver refuses consultation. This subrule does not apply to prescriptions dispensed for administration to a patient while the patient is in a medical institution.

(5) Pharmacist delegation of acts, tasks, or functions must comply with section 16215 of the code, MCL 333.16215, and be under the personal charge of the delegating pharmacist, except as provided in section 17742b of the code, MCL 333.17742b, R 338.486, and R 338.3665(c). A pharmacist that delegates acts, tasks, or functions to a licensed or unlicensed individual shall do all of the following:

(a) Determine the knowledge and skill required to safely and competently complete the specific act, task, or function to be delegated.

(b) Before delegating an act, task, or function, determine whether the delegate has the necessary knowledge and skills to safely and competently complete the act, task, or function.

(c) Provide written procedures or protocols, or both, to be followed by the delegatee in the performance of the delegated act, task, or function.

(d) Supervise and evaluate the performance of the delegatee.

(e) Provide remediation of the performance of the delegatee, if indicated.

(6) A delegating pharmacist bears the ultimate responsibility for the performance of delegated acts, tasks, and functions performed by the delegatee within the scope of the delegation.

(7) A pharmacist may remotely access a pharmacy database as well as any other necessary databases that are routinely accessed to perform their functions. In accessing any database, a pharmacist shall provide adequate security to protect the confidentiality and integrity of a patient's protected health information.

Notes

Mich. Admin. Code R. 338.589

2020 AACS; 2024 MR 5, Eff. 2/29/2024