Pharmacy Policy Updates, March 2024
California Enacts Law With Patient Safety Provisions
As of January 1, 2024, California has enacted Assembly Bill (AB) 1286, the Stop Dangerous Pharmacies Act, which has several new provisions intended to improve patient safety. These provisions focus on medication error reporting, minimum staffing provisions, and staffing decisions, among others.1 According to a press release, the new law is the first in the nation to establish medication error reporting requirements to protect workers and patients.2
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AB 1286 establishes that a chain community pharmacy must be staffed at all times during normal business hours (defined as 8 am to 7 pm) with at least 1 clerk or pharmacy technician who is fully dedicated to performing pharmacy-related services. Exceptions include when the on-duty pharmacist waives the requirement in writing based on workload needs, when the pharmacy is open beyond the defined business hours, and if the pharmacy’s prescription volume per day is less than 75 prescriptions based on the average daily prescription volume for the past calendar year.1
Furthermore, AB 1286 establishes expanded duties for pharmacy technicians, including preparing and administering influenza and COVID-19 vaccines, preparing and administering epinephrine, performing specimen collection for tests waived under Clinical Laboratory Improvement Amendments, receiving prescription transfers, and accepting clarification on prescriptions. The law does establish conditions that must be met for these activities, including, importantly, that the duties are performed under the direct supervision and control of a pharmacist.1
In addition, AB 1286 addresses steps that pharmacy staff can take if they are concerned that the working conditions in their pharmacy are harmful. Effective January 1, 2024, the pharmacist in charge or on duty is required 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. Such conditions include, but are not limited to, workplace safety and health hazards, sustained temperatures that could impact drug stability, and vermin infestation that poses a risk for drug safety or efficacy.1
e-Prescribing Expands Nationwide
e-prescribing is a widespread practice, and the legal landscape for this process is developing rapidly. The practice is known to decrease medication errors, increase efficiency, reduce forged prescriptions, and simplify prescription transfers and cancellations.
According to the National Association of Boards of Pharmacy (NABP), 35 states require e-prescribing in some form. Several states—California, Delaware, Florida, Iowa, Michigan, Minnesota, and New York—mandate e-prescribing for all prescriptions, including controlled substances. More commonly, states require e-prescriptions only for all controlled substances, although some only require e-prescribing for certain types of controlled substances.
There are some questions surrounding the use of e-prescribing, namely concerns about security and privacy, lack of interoperability, and high costs for implementation and maintenance of the systems. Despite these concerns, however, laws enhancing the use of e-prescribing are almost certain to continue expanding, according to the NABP.
New Jersey Establishes Program for Anonymous Distribution of Opioid Antidotes
As part of statewide and national efforts to address opioid overdose–related deaths, New Jersey has approved a pilot program to allow opioid antidotes to be dispensed at no cost to anonymous recipients at pharmacies that have obtained standing orders from the commissioner of health or a licensed physician.
Previous pilot programs only authorized opioid antidote dispensing for a few days, whereas this program will permit patients to obtain free naloxone at any time. All FDA-approved naloxone 4-mg nasal spray products are covered, and only 1 package containing 2 doses of naloxone is covered per dispensing.
At the time of dispensing, pharmacists are required to provide the recipient with opioid overdose response and prevention information, ask whether they are older than 14 years, and advise them that the antidote should not be administered to anyone with known allergies to the ingredients.
After dispensing the product to an individual patient, the pharmacy will be reimbursed through the New Jersey FamilyCare/Medicaid system, regardless of the patient’s Medicaid eligibility. The program is limited to individual patients, but organizations such as first responder programs have access to a different program.
References
California Enacts Bill With Patient Safety Provisions
1. Frequently asked questions: Assembly Bill 1286 Haney, Chapter 470, Statutes of 2023). California State Board of Pharmacy. December 21, 2023. Accessed February 12, 2024. https://www.pharmacy.ca.gov/publications/ab1286_faqs.pdf
2. Stop Dangerous Pharmacies Act is signed into California Law. News release. Assemblymember Matt Haney: District 17. October 9, 2023. Accessed February 12, 2024. https://a17.asmdc.org/press-releases/20231009-stop-dangerous-pharmacies-act-signed-california-law
e-Prescribing Expands Nationwide
Revolutionizing health care: the evolving path of e-prescriptions. National Association of Boards of Pharmacy. January 31, 2024. Accessed February 12, 2024. https://nabp.pharmacy/news/blog/revolutionizing-health-care-the-evolving-path-of-e-prescriptions/
New Jersey Establishes Program for Anonymous Distribution of Opioid Antidotes
Pilot program to distribute opioid antidotes anonymously to individual patients. New Jersey Division of Consumer Affairs. Accessed February 12, 2024. https://www.njconsumeraffairs.gov/Documents/Naloxone-Pilot-Program-Agreement.pdf
