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SB-528 Pharmacy: automated drug delivery systems.(2017-2018)

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Date Published: 06/12/2017 09:00 PM
SB528:v96#DOCUMENT

Amended  IN  Assembly  June 12, 2017
Amended  IN  Senate  April 20, 2017
Amended  IN  Senate  March 28, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill No. 528


Introduced by Senator Stone

February 16, 2017


An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


SB 528, as amended, Stone. 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 clinic’s 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 pharmacist’s 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.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:

4119.11.
 (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a “covered entity” under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:
(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350).

(1)

(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients.

(2)

(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.

(3)

(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.

(4)

(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.

(5)

(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.

(6)

(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.
(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.
(b) For purposes of this section, an “automated drug delivery system” has the same meaning as in subdivision (a) of Section 4105.5.
(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.
(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.
(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.
(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.
(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.
(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescriber’s order and the patient’s profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.
(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.
(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.

(j)After the pharmacist reviews the prescriber’s order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.

(k)

(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:
(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.
(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.
(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.

(l)

(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.

(m)

(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.

SEC. 2.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.