Bill Text: CA SB1447 | 2017-2018 | Regular Session | Amended
Bill Title: Pharmacy: automated drug delivery systems.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2018-09-21 - Chaptered by Secretary of State. Chapter 666, Statutes of 2018. [SB1447 Detail]
Download: California-2017-SB1447-Amended.html
Amended
IN
Assembly
August 23, 2018 |
Amended
IN
Assembly
August 20, 2018 |
Amended
IN
Assembly
July 03, 2018 |
Amended
IN
Assembly
June 20, 2018 |
Amended
IN
Senate
April 17, 2018 |
Senate Bill | No. 1447 |
Introduced by Senator Hernandez |
February 16, 2018 |
LEGISLATIVE COUNSEL'S DIGEST
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
The people of the State of California do enact as follows:
SECTION 1.
Section 4008 of the Business and Professions Code is amended to read:4008.
(a) Except as provided by Section 159.5, the board may employ legal counsel and inspectors of pharmacy. The inspectors, whether the inspectors are employed by the board or the department’s Division of Investigation, may inspect during business hours all pharmacies, wholesalers, dispensaries, stores, or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.(g)This section shall remain in effect only until July 1, 2019, and as of that date is repealed.
SEC. 2.
Section 4008 is added to the Business and Professions Code, to read:4008.
(a) Except as provided by Section 159.5, the board may employ legal counsel and inspectors of pharmacy. The inspectors, whether the inspectors are employed by the board or the department’s Division of Investigation, may inspect during business hours all pharmacies, wholesalers, dispensaries, stores, or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.SEC. 3.
Section 4017.3 is added to the Business and Professions Code, to read:4017.3.
(a) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.(a)Notwithstanding any provision of this chapter, a prescriber may dispense a dangerous drug, including a controlled substance, to an emergency room patient if all of the following apply:
(1)The hospital pharmacy is closed and there is no pharmacist available in the hospital.
(2)The dangerous drug is acquired by the hospital pharmacy.
(3)The dispensing information is recorded and provided to the pharmacy when the pharmacy reopens.
(4)The hospital pharmacy
retains the dispensing information and, if the drug is a schedule II, schedule III, or schedule IV controlled substance, reports the dispensing information to the Department of Justice pursuant to Section 11165 of the Health and Safety Code.
(5)The prescriber determines that it is in the best interest of the patient that a particular drug regimen be immediately commenced or continued, and the prescriber reasonably believes that a pharmacy located outside the hospital is not available and accessible at the time of dispensing to the patient.
(6)The quantity of drugs dispensed to any patient pursuant to this section are limited to that amount necessary to maintain uninterrupted therapy during the period when pharmacy services outside the hospital are not readily available or
accessible, but shall not exceed a 72-hour supply.
(7)The prescriber shall ensure that the label on the drug contains all the information required by Section 4076 and Section 1707.5 of Title 16 of the California Code of Regulations.
(b)(1)A hospital emergency room may use an APDS, as defined in subdivision (c) of Section 4017.3, to dispense, at a maximum, a 72-hour supply of a dangerous drug or dangerous device to an emergency room patient. The APDS shall conform to the requirements in Article 25 (commencing with Section 4427) and shall use a standardized label that provides directions for use and relevant warnings. The standardized label shall be approved by the hospital pharmacy and shall conform to the requirements of paragraph (7) of subdivision
(a).
(2)When dangerous drugs and dangerous devices are provided from the APDS, the prescriber shall enter the patient’s name on the standardized label, hand the dangerous drug or dangerous device to the patient, and counsel the patient on the use of the dangerous drug or dangerous device. The prescriber shall record the dangerous drug or dangerous device and the quantity dispensed in the patient’s medical record and in the dispensing records of the APDS. A pharmacist designated by the hospital may provide patient consultation through telephone or electronic communication in place of the prescriber.
(3)Controlled substances dispensed from an APDS shall be reported to the Controlled Substance Utilization Review and Evaluation System (CURES) Prescription Drug Monitoring Program
database within one business day.
(4)The hospital emergency room shall provide the patient with information on how to reach a pharmacist who, after the patient leaves the hospital, is available to respond to patient inquires through telephone or electronic communication.
(c)The prescriber shall be responsible for any error or omission related to the drugs dispensed.
SEC. 5.SEC. 4.
Section 4105.5 of the Business and Professions Code is amended to read:4105.5.
(a) For purposes of this section, an “automated drug delivery system” has the same meaning as that term is defined in paragraph (1) of subdivision (a) of Section 1261.6 of the Health and Safety Code.(f)This section shall remain in effect only until
July 1, 2019, and as of that date is repealed.
SEC. 6.SEC. 5.
Section 4119.1 of the Business and Professions Code is amended to read:4119.1.
(a) A pharmacy may provide pharmacy services to a health facility licensed pursuant to subdivision (c), (d), or both, of Section 1250 of the Health and Safety Code, through the use of an automated drug delivery system that need not be located at the same location as the pharmacy.(f)This section shall remain in effect only until July 1, 2019, and as of that date is repealed.
SEC. 7.SEC. 6.
Section 4186 of the Business and Professions Code is amended to read:4186.
(a) Automated drug delivery systems, as defined in subdivision (h), may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic 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 drugs. All policies and procedures shall be maintained at the location where the automated drug system is being used.(i)This section shall remain in effect only until July 1, 2019, and as of that date is repealed.
SEC. 8.SEC. 7.
Section 4186 is added to the Business and Professions Code, to read:4186.
(a) Automated drug delivery systems, as defined in Section 4017.3, may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic 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 drugs. All policies and procedures shall be maintained at the location where the automated drug system is being used.SEC. 9.SEC. 8.
Section 4400 of the Business and Professions Code is amended to read:4400.
The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:SEC. 10.SEC. 9.
Article 25 (commencing with Section 4427) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:Article 25. Automated Drug Delivery System
4427.
As used in this article, “drugs” or “dangerous drugs” shall have the same meaning as “dangerous drug” as provided in Section 4022 and “devices” or “dangerous devices” shall have the same meaning as “dangerous device” as provided in Section 4022.4427.4427.1.
An ADDS shall not be installed or operated in California unless it meets the requirements of this article.4427.1.4427.2.
(a) An ADDS installed, leased, owned, or operated in California shall be licensed by the board.4427.2.4427.3.
(a) An ADDS shall be placed and operated inside an enclosed building, with a premises address, at a location approved by the board.4427.3.4427.4.
(a) The ADDS shall be owned or leased by the pharmacy holding the license for the ADDS.4427.4.4427.5.
Prior to installation, and annually thereafter, the pharmacy holding the ADDS license shall provide training on the operation and use of the ADDS to pharmacy personnel and to personnel using the ADDS at the location where the ADDS is placed pursuant to subdivision (b) of Section4427.5.4427.6.
In addition to any other requirements imposed by this article, an APDS shall additionally meet the following requirements:(m)An APDS may be located, operated, and used to dispense, at a maximum, a 72-hour supply of a dangerous drug or dangerous device to a patient of a hospital emergency room that complies with Section 4068.
4427.6.4427.7.
(a) A pharmacy holding an ADDS license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the ADDS. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the ADDS shall be included in the self-assessment.4427.7.4427.8.
(a) This article shall become operative on July 1, 2019.SEC. 11.SEC. 10.
Section 1261.6 of the Health and Safety Code is amended to read:1261.6.
(a) (1) For purposes of this section and Section 1261.5, an “automated drug delivery system” means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An automated drug delivery system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.(j)This section shall remain in effect only until July 1, 2019, and as of that date is repealed.