Pharmacists Effectively Administered Passive Immunizations Too

During the recent pandemic, the U.S. government authorized the expansion of the scope of pharmacy practice. An often-mentioned success story is the number of COVID-19 vaccinations administrated by pharmacists to senior citizens.

A second, less-known success was the safe and effective delivery of monoclonal antibodies (mAbs) in a community pharmacy.

To highlight this achievement, a retrospective, observational study was published by the Journal of the American Pharmacists Association on January 7, 2023, which concluded community pharmacists could administer mAbs safely and effectively in an outpatient setting with low adverse events.

Of the 93 patients included in this study, adverse effects were reported in 4.3% of patients at mAbs administration and 9.7% at follow-up.

The study authors, Tyler S. Dougherty, PharmD, BCACP, Jimmy McBride, Carol L. Barnett, and Wendy M. Gabriel, wrote, 'pharmacists should continue to evaluate potential clinical service offerings in pharmacist to increase patient healthcare access and demonstrate their value in the healthcare system.'

'A Call to Action is needed to permanently expand federal and state pharmacy practice regulations to maintain the valuable public health services provided by pharmacists during the recent pandemic.'

Another significant opportunity may present itself this summer.

The U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application on March 6, 2023, for LEQEMBI™, a humanized immunoglobulin gamma 1 mAbs for the treatment of Alzheimer's disease (AD). 

The LEQEMBI application has been granted by the FDA Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.

If approved, treatment with LEQEMBI could be initiated in qualifying patients with mild cognitive impairment or mild dementia stage of the disease.

According to the Alzheimer's Association's Alzheimer's Disease Facts and Figures, an estimated 6.5 million Americans aged 65 and older are living with dementia due to AD.

The recommended dosage of LEQEMBI is 10 mg/kg administered as an intravenous infusion that takes about one hour, once every two weeks. 

If the demand for this innovative therapy surpasses traditional delivery models, pharmacies may be called into service again since most people live within a few miles of a community pharmacy.

Immunity to a disease is achieved through the presence of antibodies to that disease in a person's system, says the U.S. Centers for Disease Control and Prevention (CDC).

When mAbs are administered, people are given antibodies to a disease (passive immunity) rather than producing them through their immune system following vaccination or infection.

The CDC says the significant advantage of passive immunity is that protection is immediate, whereas active immunity (vaccination) takes time to develop. 

Either way, if an immune person comes into contact with that disease in the future, their immune system will recognize it and immediately fight it.