Category: Federal Forum Posters
Purpose: New safety warnings were recently released for fluoroquinolone antibiotics. The July 2018 Food and Drug Administration (FDA) News Release strengthened side effect warnings for serious blood sugar disturbances and mental health risks and emphasized previous warnings regarding risk of tendon rupture, tendinitis, and peripheral neuropathy. Additionally, the FDA has determined fluoroquinolones should be last-line options for acute bacterial sinusitis, uncomplicated urinary tract infections, and acute bacterial exacerbation of chronic bronchitis, as risk usually outweighs benefit. The purpose of this research is to investigate the appropriateness of fluoroquinolone prescribing for outpatients receiving care at a VA medical center.
Methods: This study will be submitted to the Institutional Review Board for approval. Patients prescribed an outpatient oral fluoroquinolone over a six-month period will be identified using the electronic medical record database and 150 will be randomly selected; those who are less than 18 years of age, deceased, or pregnant at time of prescribing will be excluded. The following data will be collected: age, gender, drug, dose, duration, indication, empiric versus definitive therapy, culture sensitivities, prescriber, service, antimicrobial drug reactions and descriptions, QTc interval, diagnosis of myasthenia gravis and diabetes, history of transplant, serum creatinine, height, weight, and active prescription for the following at time of fluoroquinolone prescription: corticosteroid, sulfonylurea, other diabetes medication. Descriptive statistics will be utilized to analyze the data. Data will also be used in estimating creatinine clearance and assessing for reasonable alternative therapy options. The primary endpoint will be the percentage of patients who were prescribed a fluoroquinolone for acute bacterial sinusitis, uncomplicated urinary tract infections, or acute bacterial exacerbation of chronic bronchitis. Use of a fluoroquinolone for these indications will be considered appropriate if no relative contraindication exists and there are no reasonable alternative therapies. Data will be recorded without identifiers and maintained confidentially.
Shantel Ann Jones– Pharmacy Resident, Louis A. Johnson VAMC, Bridgeport, WV