New California Law Affects Pharmacy Operations, Staffing Ratios, And Much More

On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and pharmacist fatigue by creating first of its kind requirements. The new provisions will be effective on January 1, 2024. Given recent attention nationwide directed towards pharmacist workload issues, it will be interesting to see if other states adopt any of these provisions or if other Boards will consider some or all of these requirements too extreme.

The law gives the pharmacist in charge (“PIC”) the power to make staffing decisions to ensure that enough staff are present “to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely.” If a PIC is not present, the law allows any pharmacist on duty to make staffing decisions. Taken to the extreme, a pharmacist could decide that seven technicians are necessary to support a shift at a small community pharmacy, regardless of standard metrics for coverage, and as noted below, the Board could find it to be “unprofessional conduct” if the owner determines that this coverage is inappropriate and takes action to reduce staffing. Pharmacists are also required to notify store management immediately of any conditions that pose an immediate risk of harm to patients, personnel, or pharmacy staff such as safety and health hazards, and temperature issues. Store management has 24 hours to take reasonable steps to resolve the issues before the pharmacist must notify the Board of Pharmacy. The Board may then issue an order to cease and desist pharmacy operations affected by the condition until they are resolved.

Additionally, chain community pharmacies must always be staffed with at least one clerk or pharmacy technician who is fully dedicated to performing pharmacy services. However, this does not apply beyond regular business hours or to pharmacies with a prescription volume of less than 75 prescriptions per day on average. The exception for pharmacies with smaller volumes does not apply, however, if the pharmacist is expected to provide immunizations and CLIA-waived tests. Due to the increased role pharmacists play with immunizations, this means that the exception for smaller volume pharmacies would rarely apply, except that the bill does allow the pharmacist on duty to waive this requirement based on workload need.

The bill also codifies a technician’s ability to administer flu and COVID-19 vaccines, and also allows them to prepare and administer epinephrine, collect specimens for CLIA-waived tests, receive prescription transfers, and accept prescription clarifications. Only certified technicians can perform these tasks, and only if the pharmacy has another technician that is assisting the pharmacist with prescription processing tasks.

Pharmacies will also be required to report all medication errors to the Board either directly or through a third party such as a patient safety organization within 14 days of discovering the error. The law defines medication error as “any variation from a prescription drug not authorized by the prescriber.”¹ The data reported will be confidential, but the board may publish a deidentified summary of the data.

Finally, the bill makes it “unprofessional conduct” to take any actions to subvert compliance with these provisions and prohibits establishing policies and procedures related to time guarantees to fill prescriptions within a specified time unless those guarantees are required by law or contract.

While this law poses significant changes to current pharmacy practices, the Board of Pharmacy has yet to provide any additional guidance. Quarles will continue to monitor updates on this topic. If you have any questions, please contact your local attorney or:

• Susan Trujillo: (602) 229-5318 / susan.trujillo@quarles.com
• Andrea Seach: (602) 229-5200 / andrea.seach@quarles.com
  
  
  

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¹To be codified at Business & Professions Code § 4113.1(d)