Or. Admin. Code § 855-041-6530 - Robotic Distribution Systems

(1) A robotic drug distribution system used in a central pharmacy must be in a secure area under the control of the PIC and must be connected with the system that contains the patient's drug profile.

(2) The pharmacy must maintain the following documentation for each system:

(a) Details of the equipment including manufacturer's name, model and serial number;

(b) A description of how the system is used;

(c) Policies and procedures that include:

(A) Quality assurance performed at least quarterly including a requirement that a pharmacist visually verifies the accuracy of the electronic or bar code labeling using an audit procedure that includes random sampling;

(B) Procedures for training personnel in safe system operation, security, accuracy, patient confidentiality, access and downtime procedures.

(3) All distribution records must be recorded electronically and retained for 3 years or as approved by the Board. Records must include:

(a) Identity of robotic drug distribution system accessed;

(b) Type of transaction;

(c) Date and time of transaction;

(d) Name, strength, dosage form, and quantity of the drug accessed;

(e) Identity of the patient for whom the drug was ordered;

(f) Any other information the PIC may deem necessary.

(4) Only a pharmacy technician, certified pharmacy technician, intern, pharmacist or a person designated by the PIC may have access to the system.

(5) Only a pharmacy technician, certified pharmacy technician, intern or pharmacist may stock drugs in the system.

(6) All drugs in the system must be packaged and labeled in accordance with state and federal laws and regulations.

(7) Controlled Substances:

(a) Controlled substances must be handled in accordance with all applicable state and federal laws and regulations;

(b) Schedule III, IV and V drugs may be stocked in a robotic drug distribution system provided there is adequate security to limit access to those personnel designated by the PIC;

(c) Schedule II drugs may not be stocked in any robotic drug distribution system.

(8) Drugs prepared by a robotic system must be packaged and separated by patient or as approved by hospital protocol, prior to distribution for administration.

Notes

Or. Admin. Code § 855-041-6530

BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155 & 689.508