Health Law Highlights

California Enacts First-in-Nation Pharmacy Medication Error Reporting Law

From Husch Blackwell, by Kevin Khachatryan:

On October 8, 2023, the California Governor signed Assembly Bill 1286 (AB 1286), a comprehensive pharmacy bill aimed at enhancing patient safety. The bill’s key mandate is a new requirement for community pharmacies to report outpatient medication errors to the California Board of Pharmacy. The legislation also includes several other provisions that regulate the practice of pharmacy in California.

The bill was enacted in response to a 2021 survey by the California Board of Pharmacy, which revealed significant staffing issues contributing to medication errors. The survey found that 91% of retail pharmacists reported inadequate staffing for safe patient care, 83% lacked sufficient time for safe patient consultation, and 78% had insufficient time to conduct proper health screenings before administering immunizations. This led to the establishment of a Medication Error Reduction and Task Force Ad Hoc Committee and the sponsorship of AB 1286.

AB 1286 also introduces several other changes, including amendments which govern staffing decisions in pharmacies and the responsibilities of the Pharmacist-in-Charge (PIC). The law now requires chain community pharmacies to be staffed at all times with at least one clerk or pharmacy technician dedicated to pharmacy-related services, subject to certain conditions. The bill also expands the list of actions that constitute unprofessional conduct and authorizes specially trained pharmacy technicians to prepare and administer certain vaccines and medications.

Health Law Highlights

New California Law Imposes Significant Data Management Requirements for Sensitive Health Data

From Troutman Pepper, by Brent Hoard, Emma Trivax, and Erin Whaley:

  • Effective January 1, AB 352 introduces significant changes to the management and sharing of sensitive health information in California, particularly related to reproductive health services. The bill amends the existing [[Reproductive Privacy Act and the Confidentiality of Medical Information Act (CMIA)]] and several other statutes.
  • Enhanced Security Measures: By July 1, businesses that electronically store or maintain certain medical information must implement enhanced security measures, including limiting user access, preventing sharing of medical information outside of California, segregating certain medical information, and disabling access to segregated information from outside California.
  • Prohibition on Cooperation With Out-of-State Inquiries: Health care providers and related entities are prohibited from cooperating with out-of-state or federal inquiries that would identify an individual seeking or obtaining an abortion or abortion-related services, unless authorized under existing law provisions.
  • Prohibition on Disclosure of Medical Information: Entities are prohibited from knowingly disclosing information that would identify an individual related to an abortion to any individual or entity from another state, unless authorized under specific conditions. A grace period until January 31, 2026, is provided for entities working diligently and in good faith to comply with the prohibition.
  • Exclusion From Automatic Data Sharing: The bill excludes the exchange of health information related to abortion and abortion-related services from automatic sharing on the California Health and Human Services Data Exchange Framework. Entities should assess their compliance, undertake a data inventory, develop technical controls, revise procedures for individual rights requests, and incorporate these changes into training sessions.