Pharmacy.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law authorizes the board to appoint an executive officer to exercise the powers and perform the duties delegated by the board. A violation of the Pharmacy Law is a crime. (1) Existing law requires every pharmacy to designate a pharmacist-in-charge who is responsible for a pharmacy's compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. This bill would authorize a pharmacist-in-charge to make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist's ability to practice competently and safely. The bill would authorize a pharmacist on duty, if the pharmacist-in-charge is not available, to adjust staffing according to workload if needed. The bill would require a pharmacist-in-charge or pharmacist on duty to immediately notify store management of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. The bill would require store management to take immediate and reasonable steps to address and resolve those conditions, and, if those conditions are not resolved within 24 hours, would require the pharmacist-in-charge or pharmacist on duty to ensure the board is notified. The bill would require the executive officer, upon a reasonable belief that conditions within a pharmacy exist that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff, to issue a cease and desist order, as specified. The bill would make a failure to comply with the cease and desist order unprofessional conduct for a pharmacy corporation. (2) Existing law, with specified exceptions, prohibits a community pharmacy from requiring a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located, is made available to assist the pharmacist at all times. This bill would require a chain community pharmacy to be staffed at all times with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services. The bill would prohibit the board from taking action against a pharmacy for a violation of this requirement if specified conditions apply, including if the pharmacist on duty waives the requirement in writing during specified hours based on workload needs. The bill would require, if staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, that scheduled closures for lunch time for all pharmacy staff be established and publicly posted and included on the outgoing telephone message. The bill would require a licensed community pharmacy, as defined, to report all medication errors to an entity approved by the board and to maintain records, as prescribed. The bill would deem these reports confidential and not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act, except that the board would be authorized to publish certain deidentified information compiled from the data in the reports in accordance with specified requirements. (3) Existing law authorizes a pharmacy technician to perform prescribed nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist who is responsible for the duties performed under their supervision by a technician. Existing law prohibits a pharmacy with only one pharmacist from having more than one pharmacy technician performing these tasks. This bill would additionally authorize a pharmacy technician under the direct supervision and control of a pharmacist to prepare and administer influenza and COVID-19 vaccines via injection or intranasally, prepare and administer epinephrine, perform specimen collection for specified tests, receive prescription transfers, and accept clarification on prescriptions under prescribed conditions. The bill would prohibit a pharmacy with only one pharmacist from having more than one pharmacy technician performing these additionally authorized tasks and specify that if a pharmacy technician is performing these additionally authorized tasks, a second pharmacy technician is required to be assisting a pharmacist with performing the nondiscretionary tasks currently authorized under existing law. (4) Existing law establishes specific provisions for the licensure of clinics, including requiring a clinic that makes an application for a license to show evidence that the professional director is responsible for the safe, orderly, and lawful provision of pharmacy services. Existing law requires a consulting pharmacist be retained to approve the clinic's policies and procedures in conjunction with the professional director and the administrator and to visit the clinic regularly and at least quarterly. Existing law requires the consulting pharmacist to certify in writing quarterly that the clinic is, or is not, operating in compliance with existing law governing clinics. This bill would require a consulting pharmacist, before July 1 of every odd-numbered year, to complete a Surgical Clinic Self-Assessment Form as determined by the board as a means to promote compliance through self-examination and education, as specified, including a requirement that the professional director of the clinic and consulting pharmacist make a prescribed certification signed under penalty of perjury, kept on file in the clinic for 3 years, and made available to the board or its designee, upon request. The bill would require, as part of the renewal process for a clinic license, that the consulting pharmacist certify compliance with the quarterly inspections and provide the most recent self-assessment form. By expanding the crime of perjury, this bill would impose a state-mandated local program. (5) Existing law requires the board to take action against any holder of a license who is guilty of unprofessional conduct or whose license has been issued by mistake. Existing law establishes a list of specified actions that constitute unprofessional conduct. This bill would expand the list of specified actions that constitute unprofessional conduct to include actions or conduct that would subvert the efforts of a pharmacist to comply with laws and regulations, or exercise professional judgment, including creating or allowing conditions that may interfere with a pharmacist's ability to practice with competency and safety or creating or allowing an environment that may jeopardize patient care; actions or conduct that would subvert the efforts of a pharmacist-in-charge to comply with laws and regulations, exercise professional judgment, or make determinations about adequate staffing levels to safely fill prescriptions of the pharmacy or provide other patient care services in a safe and competent manner; actions or conduct that would subvert the efforts of a pharmacist intern or a pharmacy technician to comply with laws or regulations; or establishing policies and procedures related to time guarantees to fill prescriptions within a specified time unless those guarantees are required by law or to meet contractual requirements. (6) Existing law authorizes the board to issue a cease and desist order for operating any facility under existing law that requires licensure or for practicing any activity under existing law that requires licensure without obtaining that licensure. This bill would authorize the board to assess administrative fines and issue orders of abatement to any unlicensed entity who engages in any action that requires licensure under the jurisdiction of the board, not to exceed $5,000 for each occurrence pursuant to a citation issued by the board. (7) By imposing new requirements under the Pharmacy Law, the violation of which would be a crime, this bill would impose as state-mandated local program. (8) Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest. This bill would make legislative findings to that effect. (9) 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.