The devastating California wildfires have led to Governor Gavin Newsom declaring a state of emergency. This declaration has prompted the California State Board of Pharmacy (the “Board”) to implement immediate regulatory waivers and operational adjustments to address the unique challenges posed by this disaster. These actions ensure that healthcare providers and pharmacies can continue delivering essential services to affected residents while navigating emergency conditions. Pharmacies and providers should closely review these waivers and provisions, understand their implications and seek counsel to ensure compliance.
Emergency Provisions Under California Law
California law, under Business and Professions Code (“BPC”) Section 4062(a), allows pharmacists and licensed clinics to furnish dangerous drugs or devices in reasonable quantities without a prescription to protect public health and safety. Pharmacists are required to document key details, including the date, recipient’s name and address, and specifics of the medication or device provided, with the information communicated to the patient’s attending physician as soon as possible.
The Board, under its authority in BPC Section 4062(b), has issued waivers specifically in response to the current wildfire emergency. These waivers temporarily suspend certain requirements related to prescription forms, record-keeping, and labeling, enabling pharmacies to focus on urgent patient care without administrative delays.
Waiver for Mobile Pharmacies and Clinics
In response to the fires, the Board, under BPC Section 4062(c), has authorized the deployment of mobile pharmacies and clinics in the affected regions. These mobile units are crucial in maintaining access to medications and healthcare services in areas where infrastructure has been damaged or destroyed. The Board’s waiver permits these units to operate with flexibility, provided they:
- Maintain dispensing records as required under BPC Section 4062(a).
- Operate under the supervision of licensed pharmacists or professional directors.
- Implement appropriate security measures for drug storage.
- Cease operations within 48 hours of the state of emergency ends unless an extension is granted.
Additionally, for pharmacies that have been destroyed or severely damaged during the fires, the Board permits relocation under BPC Section 4062(e) without triggering ownership or location transfer requirements, provided that the management and ownership remain unchanged. However, pharmacies must notify the Board immediately upon securing a new location.
Remote Processing Waiver
To address staffing shortages and ensure uninterrupted service during the wildfires, the Board has issued a Remote Processing Waiver, expanding the provisions of BPC Section 4071.1(a). This waiver allows pharmacists, pharmacy technicians, and pharmacy interns to perform remote processing tasks, including interpreting, clarifying, and approving medication orders and prescriptions, even for controlled substances.
Pharmacies utilizing this waiver must implement secure policies to protect patient information and comply with record-keeping requirements. This waiver provides pharmacies the flexibility needed to sustain operations and meet patient needs during the ongoing emergency.
Staffing Ratio Waiver
The Board has temporarily waived staffing ratio requirements under BPC Section 4115(g)(1) and Title 16, CCR Section 1793.7, in response to the surge in prescription volume and limited staff availability due to the fires. This waiver permits pharmacies in affected counties to employ an additional pharmacy technician per supervising pharmacist, provided that the need is documented. Supervising pharmacists may decline additional technicians if patient care could be compromised, ensuring professional judgment is maintained.
Drug Delivery Waiver
To mitigate disruptions caused by the wildfires, the Board has waived certain provisions of BPC Section 4059.5(a) & (d), allowing manufacturers, wholesalers, or third-party logistics providers to deliver dangerous drugs and devices to alternate premises. Deliveries must meet the following conditions:
- Confirmation that the recipient is legally authorized to receive the delivery.
- Verification that the alternate premises have adequate security for up to 72 hours.
- Receipt by an authorized individual who signs for the delivery.
This waiver reflects the Board’s efforts to ensure that medications reach impacted areas without undue delay, while maintaining appropriate safeguards.
Dispensing Controlled Substances and Dangerous Drugs
Under California Health & Safety Code Section 11159.3, pharmacists may dispense controlled substances without adhering to standard prescription form requirements during emergencies. Prescriptions must include the notation “11159.3 exemption.” For Schedule II controlled substances, pharmacists may provide up to a seven-day supply, ensuring patients have access to critical medications while maintaining compliance.
Additionally, pharmacists may refill prescriptions for dangerous drugs or devices without prescriber authorization under BPC Section 4064, a measure that supports continuity of care during emergencies.
Record-Keeping and Compliance Requirements
Pharmacies and healthcare providers must ensure compliance with all documentation requirements, even under emergency waivers. All activities under the waivers must be properly logged, with annotations such as “dispensed pursuant to BPC 4062(b)” or “11159.3 exemption” to facilitate post-emergency audits.
Verification of patient eligibility for emergency services is crucial, particularly for emergency refills of controlled substances. Pharmacies must also maintain secure access to patient records to protect confidentiality during remote and mobile operations.
Additional Directives for Health Plans
The California Department of Managed Health Care (“DMHC”) has issued directives to health plans, requiring them to support members impacted by the wildfires. These measures include suspending prescription refill limitations, permitting out-of-network pharmacy use, and reducing barriers to accessing non-contracted providers. Pharmacies should stay updated on any communications they receive from the payors that may outline further guidelines for pharmacies to follow, in addition to those identified by the Board.
Legal Support for Disaster Response
Navigating the regulatory landscape during natural disasters requires strategic planning and compliance expertise. Frier Levitt is committed to supporting pharmacies and healthcare providers in California and nationwide. Our team provides tailored legal solutions to address the unique challenges of emergency scenarios, including managing waivers, PDMP reporting, and operational compliance.
For assistance with emergency preparedness and compliance, contact Frier Levitt today. Together, we can help you maintain the highest standards of care and operational integrity during these critical times.
