(a) (1) For purposes of this section and Section 1261.5, an âautomated drug delivery systemâ 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. For purposes of this section, an automated drug delivery system shall include an automated unit dose system, as defined in subdivision (b) of Section 4017.3 of the Business and Professions Code. (2) For purposes of this section, âfacilityâ means a health facility licensed pursuant to subdivision (c), (d), (k), or (n) of Section 1250 that has an automated drug delivery system provided by a pharmacy. (3) For purposes of this section, âpharmacy servicesâ means the provision of both routine and emergency drugs and biologicals to meet the needs of the patient, as prescribed by a physician. (b) 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. (c) Individualized and specific access to automated drug delivery systems shall be limited to facility and contract personnel authorized by law to administer drugs. (d) (1) 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. (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. (e) When used as an emergency pharmaceutical supplies container, drugs removed from the automated drug delivery system shall be limited to the following: (1) 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 prescriberâs order and the patientâs profile for potential contraindications and adverse drug reactions. (2) 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. (3) 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. (f) When used to provide pharmacy services pursuant to Section 4017.3 of, and Article 25 (commencing with Section 4427) of Chapter 9 of Division 2 of, the Business and Professions Code, the automated drug delivery system shall be subject to all of the following requirements: (1) Drugs removed from the automated drug delivery system for administration to a patient shall be in properly labeled units of administration containers or packages. (2) 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 prescriberâs order and the patientâs profile for potential contraindications and adverse drug reactions. (3) The pharmacy providing services to the facility pursuant to Article 25 (commencin
‹ Prev All California sections Next ›
Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.