SB 528: Pharmacy: automated drug delivery systems.

(1)Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law The Pharmacy Law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.

This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.

This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the delivery of drugs from the system. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated drug delivery system within the covered entity and developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.

(2)Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.