Or. Admin. Code § 855-041-6840

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-041-6840 - Drug Distribution and Control from a Drug Room in a Hospital

(1) General. The director of pharmacy shall establish and implement written procedures for the safe and efficient distribution of pharmaceutical products. An annually updated copy of such procedures shall be available for inspection by the Board.

(2) Availability. A pharmacist providing pharmaceutical services to a hospital maintaining a drug room shall be engaged by the hospital and shall schedule on-premises visits on at least a weekly basis.

(3) Span of Control. The pharmacist's span of supervision shall extend to all areas of the hospital where drugs are stored. No less than every two months inspections of these areas shall be conducted and substantiated by records so as to verify at least proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the required emergency drug supply.

(4) Director's Absence. In the absence of the director of the pharmaceutical service, pharmaceutical services shall be directed by a designated pharmacist.

(5) Responsibility. The director of pharmacy shall be responsible for procedures for the safe and efficient distribution of, control of and accountability for drugs. Accordingly, the director shall be responsible for, at a minimum, the following:

(a) Procedures for preparation and sterilization of parenteral medications manufactured within the hospital;

(b) Procedures for admixture of parenteral products, including education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information. When the admixture of parenteral products is not accomplished under the direct supervision of a pharmacist, such preparation shall be limited to a practitioner or registered nurse;

(c) Manufacture and compounding of drugs;

(d) Procedures for establishment of specifications for procurement of all pharmaceutical materials, including drugs, chemicals and biologicals, subject to approval of the appropriate committee of the hospital;

(e) Procedures for participation in the development and revisions of a hospital formulary system;

(f) Procedures for filling and labeling all stock containers from which drugs are to be administered;

(g) Maintaining and making available a sufficient inventory of antidotes and other emergency drugs, as well as current antidote information, telephone numbers of poison control center(s) and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the hospital;

(h) Records of all transactions of the hospital relating to pharmaceutical services as may be required by state or federal law, and maintenance of accurate control over and accountability for all pharmaceutical materials. The procedures shall include the keeping of accurate and complete records of the receipt, withdrawal from stock and use or other disposal of all legend drugs stored in the drug room and all other locations in the hospital;

(i) Participation in those aspects of the hospital's patient care evaluation program which relate to pharmaceutical material utilization and effectiveness;

(j) Meeting all inspection and other requirements of the pharmacy and drug laws of this state and rules thereunder.

Or. Admin. Code § 855-041-6840

1PB 3-1979(Temp), f. & ef. 10-31-79; 1PB 2-1980, f. & ef. 4-3-80; Renumbered from 855-041-0140, BP 7-2012, f. & cert. ef. 12-17-12

Stat. Auth.: ORS 689

Stats. Implemented: