Cal. BPC § 4427.65 — California Code / Code bpc / Division 2 / Chapter 9 / Article 25 / Section 4427.65
Section 4427.65
Status: in_force

(a) In addition to the locations authorized in Section 4427.3, an automated unit dose system (AUDS) may also be located and operated in either of the following locations:

(1) A facility licensed by this state with the statutory authority to provide pharmaceutical services.

(2) Jail, youth detention facility, or other correctional facility where drugs are administered within the facility under the authority of the medical director.

(b) The pharmacy operating the AUDS shall develop and implement, and review annually, written policies and procedures pertaining to the device.

(c) The pharmacy shall operate the AUDS in compliance with the following requirements:

(1) Transaction information shall be made readily available in a written format for review and inspection by individuals authorized by law. These records shall be maintained in the facility for a minimum of three years.

(2) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs.

(3) (A)  The facility and 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.

(B) 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.

(4) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following:

(A) A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be retrieved only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber’s order and the patient’s profile for potential contraindications and adverse drug reactions.

(B) Drugs that a prescriber has ordered for a patient on an as-needed basis, if the utilization and retrieval of those drugs are subject to ongoing review by a pharmacist.

(C) Drugs designed by the patient care policy committee or pharmaceutical service committee of the facility as emergency drugs or acute onset drugs. These drugs may be retrieved from an automated drug delivery system pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 48 hours after retrieval under this paragraph, the case shall be reviewed by a pharmacist.

(5) When used to provide pharmacy services pursuant to Section 4017.3 and this article, the automated drug delivery system shall be subject to all of the following requirements:

(A) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages.

(B) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for administration to a patient. The pharmacist shall review the prescriber’s order and the patient’s profile for potential contraindications and adverse drug reactions.

(C) The pharmacy providing services to the facility pursuant to this article shall control access to the drugs stored in the automated drug delivery system.

(D) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.

(E) 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.

(F) 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. When the prescriber’s order requires a dosage variation of the same drug, licensed personnel shall have access to the drug ordered for that scheduled time of administration.

(G) Systems that allow licensed personnel to have access to multiple drugs and are not patient specific in their design, shall be allowed under this subdivision if those systems have electronic and mechanical safeguards in place to ensure that the drugs delivered to the patient are specific to that patient.

(6) 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:

(A) 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.

(B) 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.

(C) The facility, in conjunction with the pharmacy, 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.

(7) 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. A pharmacist shall conduct the review on a monthly basis, which 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.