BILL NUMBER: AB 2373 CHAPTERED 09/29/06 CHAPTER 775 FILED WITH SECRETARY OF STATE SEPTEMBER 29, 2006 APPROVED BY GOVERNOR SEPTEMBER 29, 2006 PASSED THE ASSEMBLY AUGUST 29, 2006 PASSED THE SENATE AUGUST 28, 2006 AMENDED IN SENATE AUGUST 22, 2006 AMENDED IN SENATE JUNE 19, 2006 AMENDED IN SENATE JUNE 12, 2006 AMENDED IN SENATE MAY 25, 2006 AMENDED IN ASSEMBLY APRIL 27, 2006 AMENDED IN ASSEMBLY APRIL 5, 2006 INTRODUCED BY Assembly Members Aghazarian and Plescia FEBRUARY 23, 2006 An act to amend Section 1261.6 of the Health and Safety Code, relating to health facilities. LEGISLATIVE COUNSEL'S DIGEST AB 2373, Aghazarian Automated drug delivery system. Existing law provides for skilled nursing and intermediate care facilities that use an automated drug delivery system to store and distribute drugs to accurately track the movement of drugs into and out of the system. This bill would include nursing facilities within the scope of that requirement. Under existing law, after the pharmacist reviews the prescriber's order, access by licensed personnel to the automated drug delivery system is limited to the drug as ordered by the prescriber and reviewed by the pharmacist and that is specific to the patient. This bill, until January 1, 2012, would permit access by licensed personnel to multiple drugs that are not patient specific only if the automated drug delivery system has both electronic and mechanical safeguards in place to ensure that only the drugs delivered to the patient are specific to that patient. The bill would require each facility using such an automated drug delivery system to notify the department in writing prior to utilization of the system, as provided. The bill would require the department, as part of its oversight of those facilities, to review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system. Existing law requires that a pharmacist stock an automated drug delivery system, unless the system utilizes removable pockets, drawers, or similar technology, in which case stocking may be done outside the facility and delivered to the facility under specified conditions. This bill would specify that this exception applies to the use of removable pockets, cards, drawers, or similar technology. Existing law exempts drugs dispensed from an automated drug delivery system that meets specified requirements from certain drug container labeling requirements if, among other things, those drugs are contained in unit dose packaging. This bill would include within the definition of unit dose packaging drugs packaged in blister pack cards. Existing law makes a violation of statutory requirements applicable to licensing of the above facilities a crime. By expanding the scope of the application of the above requirements to include nursing facilities that have an automated drug delivery system, this bill would change the definition of a crime, thereby imposing 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. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. 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. (2) For purposes of this section, "facility" means a health facility licensed pursuant to subdivision (c), (d), or (k), of Section 1250 that has an automated drug delivery system provided by a pharmacy. (3) For purposes of this section, "pharmacy services" 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 prescriber's order and the patient's 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 4119.1 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 prescriber's order and the patient's profile for potential contraindications and adverse drug reactions. (3) The pharmacy providing services to the facility pursuant to Section 4119.1 of the Business and Professions Code shall control access to the drugs stored in the automated drug delivery system. (4) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. (5) 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. (6) 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. (7) (A) 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. Each facility using such an automated drug system shall notify the department in writing prior to the utilization of the system. The notification submitted to the department pursuant to this paragraph shall include, but is not limited to, information regarding system design, personnel with system access, and policies and procedures covering staff training, storage, and security, and the facility's administration of these types of systems. (B) As part of its routine oversight of these facilities, the department shall review a facility's medication training, storage, and security, and its administration procedures related to its use of an automated drug delivery system to ensure that adequate staff training and safeguards are in place to make sure that the drugs delivered are appropriate for the patient. If the department determines that a facility is not in compliance with this section, the department may revoke its authorization to use automated drug delivery systems granted under subparagraph (A). (C) This paragraph shall remain in effect only until January 1, 2012, unless a later enacted statute is enacted on or before January 1, 2012, deletes or extends that date. (g) 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, or similar technology, 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, or drawers 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, or drawers are transported between the pharmacy and the facility in a secure tamper-evident container. (3) The facility, in conjunction with the pharmacy, has developed policies and procedures to ensure that the pockets, cards, or drawers are properly placed into the automated drug delivery system. (h) 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. (i) Drugs dispensed from an automated drug delivery system that meets the requirements of this section shall not be subject to the labeling requirements of Section 4076 of the Business and Professions Code or Section 111480 of this code if the drugs to be placed into the automated drug delivery system are in unit dose packaging or unit of use and if the information required by Section 4076 of the Business and Professions Code and Section 111480 of this code is readily available at the time of drug administration. For purposes of this section, unit dose packaging includes blister pack cards. 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.