105 CMR, § 140.344

Current through Register 1537, December 20, 2024
Section 140.344 - Pharmacy and Therapeutics Committee

Each clinic that maintains and operates a clinic pharmacy shall establish a pharmacy and therapeutics committee composed of members of the medical staff, the pharmacy director, the clinic administrator or his or her representative, members of the nursing staff and other personnel as appropriate to the services the clinic provides.

(A) The committee shall serve as an advisory group to the medical staff and pharmacy director on matters concerning drugs used in the clinic. The committee shall review all reports of medication errors and adverse drug reactions. The committee shall meet at least quarterly and shall keep minutes of its meetings.
(B) The committee shall develop written policies for safe and effective drug therapy, distribution, control and use. The clinic shall adopt policies developed and recommended by the committee, including at least:
(1) a therapeutic guide and recommended drug list for use in the clinic, which shall be reviewed not less than once a year;
(2) standards concerning the use and control of investigational drugs and drug research programs;
(3) procedures for access to drugs for use by the clinic when the pharmacy is closed, and a list of persons who are allowed such access;
(4) methods to ensure appropriateness of continuing drug therapy;
(5) procedures for reporting and preventing medication errors and reporting adverse drug reactions;
(6) methods to ensure compliance with M.G.L. c. 112, § 12D, and 105 CMR 720.000: List of Interchangeable Drug Products, 105 CMR 721.000: Standards for Prescription Format and Security in Massachusetts and 105 CMR 722.000: Dispensing Procedures for Clinic and Hospital Pharmacies;
(7) a drug recall procedure that can be readily implemented; and
(8) systems for the control and accountability of all drugs including, but not limited to, procedures for reporting theft, loss or suspected tampering of any controlled substance, in accordance with 105 CMR 700.005(D). Such policies must ensure compliance with up to date standards for product quality, security and record keeping systems.

105 CMR, § 140.344

Amended by Mass Register Issue 1443, eff. 5/14/2021.