Or. Admin. R. 855-041-6200

Current through Register Vol. 63, No. 9, September 1, 2024

Section 855-041-6200 - Chief Pharmacy Officer and Pharmacist in Charge

(1) The CPO must specify the respective responsibilities of the CPO and the PIC if separate individuals hold these positions.

(2) In addition to the duties listed in this rule, the PIC has the responsibilities listed in OAR 855-115-0210.

(3) The CPO must establish policies and procedures that include:

(a) Procedures for general distribution of drugs throughout the hospital;

(b) A procedure for review and revision of the policies and procedures not less than every three years;

(c) Procedures for the supervision of pharmacy services including storage, distribution, control and accountability for drugs including controlled drugs;

(d) Procedures to ensure that all areas of the hospital where drugs are stored are inspected not less than every two months to verify proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the emergency drug supplies;

(e) Policies and procedures that govern the preparation, verification and sterilization of parenteral drugs compounded within the hospital. Procedures must comply with OARs 855-045-0200 through 855-045-0270 and these rules;

(f) Procedures for administration of drugs, including self-administration;

(g) Procedures for labeling drugs;

(h) Policies and procedures that govern the filling and labeling of containers from which drugs are to be administered;

(i) Procedures for a Quality Assurance program to ensure that there is a planned, ongoing and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services, and for identifying and resolving problems. Such monitoring and evaluation must be accomplished through ongoing collection of information and periodic assessment of the collected information;

(j) Emergency drug distribution;

(k) Procedures for procurement of all drugs subject to approval of the appropriate committee of the hospital;

(l) Procedures to ensure that discontinued, outdated, adulterated or misbranded drugs are returned to the pharmacy for proper disposition, or that the PIC makes proper disposition or disposal of such drugs at the storage site;

(m) A recall procedure that can be quickly activated to assure the CPO and pharmacy staff, and the medical staff that all drugs included in the recall have been returned to the pharmacy for proper disposition;

(n) Policies and procedures for the use of investigational drugs;

(o) Procedures to be followed in the absence of the pharmacist.

(4) The CPO must:

(a) Participate in the development and revisions of a hospital formulary;

(b) Maintain an emergency and disaster plan for pharmacy services, and participate in the facility's emergency and disaster plan;

(c) Ensure that records of all transactions of the hospital pharmacy that are required by state and federal laws and regulations are maintained, and maintain accurate control and accountability for all pharmaceutical materials;

(d) Participate in the hospital's Quality Assurance program related to drugs;

(e) Comply with all inspection and other requirements of the pharmacy in accordance with all applicable state and federal laws and regulations.

Or. Admin. R. 855-041-6200

BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 29-2024, minor correction filed 04/10/2024, effective 4/10/2024

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155