Legal Briefs: New CA Regulations, Florida Law Expands Pharmacists’ Scope of Practice, and More

Ann Latner, JD, discusses three legal cases including a new California regulation, a court that says a pharmacy cannot be held liable for medical malpractice, and a Florida law that expands pharmacists’ scope of practice.

CA Adds Regulations to “No Pharmacist Left Alone” Law

In 2018, California passed SB1442–the “No Pharmacist Left Alone” bill–to address concerns about inadequate staffing in community pharmacies. Specifically, there were concerns that pharmacists working alone in community pharmacies had to perform other, non-pharmacy, duties, such as taking out trash, manning cash registers, and cleaning pharmacy bathroom. The legislation was passed to address concerns that inadequate community pharmacy staffing impairs the professional judgment and ability of pharmacists to do their jobs, and also endangers the public because it leaves licensed pharmacists with insufficient time to perform their functions safely and lawfully. The Bill prohibited a community pharmacy from requiring a pharmacist to work unless the pharmacy makes another employee available to assist the pharmacist at all times. (There are exceptions for hospital pharmacies, governmental pharmacies, independent pharmacies (four locations or less), and pharmacies that do not fill controlled substances prescriptions.) Effective September 15, 2020, the “No Pharmacist Left Alone” legislation was updated to regulate who can serve as the pharmacist assistant when the pharmacist is the only employee in the pharmacy. According to the newly updated regulations, the pharmacist assistant must be identified/named to the pharmacist, must be able to perform the same duties that non-licensed pharmacy personnel can perform, must be qualified to have access to controlled substances (ie: background check), and must be able to assist the pharmacist within five minutes of being asked. In addition, the new requirements specify that pharmacies must develop, adopt, and maintain written policies and procedures to identify the designated pharmacist assistant, train the pharmacist assistant, and outline the process for the pharmacist to request assistance and document response time. The regulations require that all of the pharmacy's impacted employees read and sign a copy of the policies and procedures.

Court Holds Pharmacy Cannot be Held Liable for Medical Malpractice

A Michigan appeals court reiterated that, as a matter of law, a pharmacy cannot be held liable for medical malpractice when it affirmed the dismissal of a lawsuit against a pharmacy. The pharmacy (as well as a physician and medical center) were sued by the estate of a man who died from the combined effects of methadone and Valium. The patient had been prescribed both the methadone and Valium by his treating physician and had taken the prescriptions to the pharmacy, where they were properly filled by the pharmacist. Shortly thereafter, the patient was found dead in his home. An autopsy identified the cause of death as intoxication by the combined effects of the two drugs. The patient’s family sued the doctor, the pharmacy and the medical center for medical malpractice. The pharmacy moved for summary judgment, claiming that pharmacies are not licensed healthcare professionals and thus are not subject to medical malpractice claims, and can only be liable for simple negligence, which did not happen in this case. The lower court granted the dismissal of the claim, and the patient’s family appealed.

On appeal, the court noted that the patient’s family conceded that pharmacies cannot be directly liable for medical malpractice. Instead, the patient’s family argued that even though a medical malpractice claim can’t be filed against a pharmacy, the pharmacy can still be vicariously liable for the individual pharmacist’s actions.  However, the court found that the pharmacist did nothing wrong. The prescriptions were filled correctly, and the drug combination only had a “potential danger” of side effects. The court found no negligence in the pharmacist’s duty to the patient. And the court refused to hold that the pharmacist should have screened for possible drug interactions and intervened where serious harm could have occurred. The pharmacist filled a legitimate prescription correctly, and thus there was no valid claim, held the court.

Florida Law Expands Pharmacists’ Scope of Practice

Florida recently enacted amendments to the state’s scope of practice rules making it easier for pharmacists to provide drug therapy services, testing, and treatment for minor health conditions. The legislation accomplishes this by requiring collaborative pharmacy practice agreements with licensed Florida physicians. The collaborative agreements allow pharmacists to initiate, modify, or discontinue drug therapy for: arthritis, asthma, chronic obstructive pulmonary disease, type 2 diabetes, HIV/AIDS, obesity, and other chronic condition adopted by the Florida Board of Pharmacy and the Board of Medicine/Osteopathic Medicine. Pharmacists must hold a PharmD degree or have practiced for five years as a licensed pharmacist to participate, and must complete a 20-hour initial course, and an 8-hour continuing education program.

The new legislation also allows pharmacists, pursuant to a written protocol with a Florida-licensed supervising physician, to test, screen for, and treat the following minor conditions: influenza, streptococcus, lice, skin conditions such as ringworm and athlete’s foot, and minor infections. As with the collaborative practice agreements, the written protocols must include certain terms and conditions and be appropriate to the pharmacists training.

Ann W. Latner, JD, is a freelance writer and attorney based in New York. She was formerly Director of Periodicals at the American Pharmacists Association.