§ 4427.6. — 4427.6. (Added by Stats. 2018, Ch. 666, Sec. 9.)

California § 4427.6.

• Jurisdiction: California
• Code BPC: Business and Professions Code - BPC
• Div. 2.: DIVISION 2. HEALING ARTS
• Ch. 9.: CHAPTER 9. Pharmacy
• Art. 25.: ARTICLE 25. Automated Drug Delivery System

Text

In addition to any other requirements imposed by this article, an APDS shall additionally meet the following requirements:
(a)
The pharmacy shall develop and implement, and review annually, written policies and procedures pertaining to the APDS, including all of the following:
(1)
Maintaining the security of the APDS and the dangerous drugs and dangerous devices within that APDS.
(2)
Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the APDS and for which patients.
(3)
Ensuring that patients are aware that
consultation with a pharmacist is available for any prescription medication, including for those delivered via the APDS.
(4)
Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the APDS at the location where the APDS is placed pursuant to subdivision (b) of Section 4427.3, regarding maintenance and filing procedures for the APDS.
(5)
Orienting participating patients on the use of the APDS, notifying patients when expected prescription medications are not available in the APDS, and ensuring that patient use of the APDS does not interfere with delivery of drugs and devices.
(6)
Ensuring delivery of drugs and devices to patients expecting to receive them from the APDS in the event the APDS is disabled or malfunctions.
(b)
The APDS shall only be used for patients who have signed a written consent form demonstrating their informed consent to receive prescribed drugs and devices from an APDS, and whose use of the APDS meets inclusion criteria established pursuant to subdivision (a).
(c)
The APDS shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.
(d)
A pharmacist licensed by the board shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.
(e)
Drugs shall be dispensed from the APDS only upon authorization by a licensed pharmacist after the pharmacist has reviewed the prescription and the
patient’s profile for potential contraindications and adverse drug reactions.
(f)
All prescribed drugs and devices dispensed to a patient from an APDS for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.
(g)
The APDS shall include a notice, prominently posted on the APDS, providing the name, address, and phone number of the pharmacy that holds the ADDS license for that APDS.
(h)
The labels on all drugs and devices dispensed by the APDS shall comply with Section 4076 and with Section 1707.5 of Title 16 of the California Code of Regulations.
(i)
Any incident involving the APDS where a complaint, error, or omission has occurred shall be
reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125.
(j)
An APDS may be located and operated in a medical office or other location where patients are regularly seen for purposes of diagnosis and treatment, and the APDS is only used to dispense dangerous drugs and dangerous devices to patients of the practice.
(k)
The board shall not issue a pharmacy more than 15 ADDS licenses for APDS units. Consistent with Section 4001.1, the board, by regulation, may reduce the number of ADDS licenses a pharmacy may be issued for APDS units.
(
l
)
The pharmacy holding the ADDS license for an APDS shall maintain the policies and procedures developed pursuant to subdivision (a) for three years after the last date of use of that APDS.

Legislative History

Added by Stats. 2018, Ch. 666, Sec. 9. (SB 1447) Effective January 1, 2019. Operative July 1, 2019, pursuant to Section 4427.8.