Browsing by Author "Balevic, Stephen J"
Now showing 1 - 2 of 2
- Results Per Page
- Sort Options
Item Open Access Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease.(Early human development, 2022-07) Ericson, Jessica E; Benjamin, Daniel K; Boakye-Agyeman, Felix; Balevic, Stephen J; Cotten, C Michael; Adler-Shohet, Felice; Laughon, Matthew; Poindexter, Brenda; Harper, Barrie; Payne, Elizabeth H; Kaneshige, Kim; Smith, P Brian; Best Pharmaceuticals for Children Act - Pediatric Trials NetworkBackground
Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991.Aims
Determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir; examine the association between acyclovir dose and exposure with adverse events (AEs).Study design
We obtained demographic information and acyclovir dosing via medical records. Acyclovir exposure was calculated using an established pharmacokinetic model.Subjects
Infants <120 days of age with neonatal HSV discharged from four academic children's hospitals.Outcome measures
We identified clinical and laboratory adverse events (AEs).Results and conclusions
We identified 49 infants with neonatal HSV treated with acyclovir; 42 infants had complete 21-day dosing information. Median mean daily dose was 59 mg/kg/day. Clinical AEs were common among all gestational and postnatal age groups. Rash was the most common clinical AE (37 %). Mild laboratory AEs occurred in 2-37 % of infants. The median maximum doses (mg/kg/day) were higher among infants with hypokalemia, elevated blood urea nitrogen, and thrombocytosis. For all other laboratory AEs, the median maximum doses for infants without events were higher or equal to the median maximum dose of infants with the AE. The odds of experiencing any clinical or laboratory AE did not differ by predicted acyclovir exposure for either area under the curve (AUC) or maximum concentration (Cmax) (odds ratio [OR] = 1.00 [0.98, 1.03] and OR = 1.01 [0.93, 1.12], respectively). Although AEs were common with high-dose acyclovir exposure, severe AEs were rare. Acyclovir exposure was not associated with AEs.Item Open Access Increasing contraception use among women receiving teratogenic medications in a rheumatology clinic.(BMJ open quality, 2018-01) Sadun, Rebecca E; Wells, Melissa A; Balevic, Stephen J; Lackey, Victoria; Aldridge, Erica J; Holdgagte, Nicholas; Mohammad, Samya; Criscione-Schreiber, Lisa G; Clowse, Megan EB; Yanamadala, MamataTeratogenic medications are often prescribed to women of childbearing age with autoimmune diseases. Literature suggests that appropriate use of contraception among these women is low, potentially resulting in high-risk unintended pregnancies. Preliminary review in our clinic showed suboptimal documentation of women's contraceptive use. We therefore designed a quality improvement initiative to target three process measures: documentation of contraception usage and type, contraception counselling and provider action after counselling. We reviewed charts of rheumatology clinic female patients aged 18-45 over the course of 10 months; for those who were on teratogenic medications (methotrexate, leflunomide, mycophenolate and cyclophosphamide), we looked for evidence of documentation of contraception use. We executed multiple plan-do-study-act (PDSA) cycles to develop and evaluate interventions, which centred on interprofessional provider education, modification of electronic medical record (EMR) templates, periodic provider reminders, patient screening questionnaires and frequent feedback to providers on performance. Among eligible patients (n=181), the baseline rate of documentation of contraception type was 46%, the rate of counselling was 30% and interventions after counselling occurred in 33% of cases. Averaged intervention data demonstrated increased provider performance in all three domains: documentation of contraception type increased to 64%, counselling to 45% and provider action to 46%. Of the patients with documented contraceptives, 50% used highly effective, 27% used effective and 23% used ineffective contraception methods. During this project, one unintentional pregnancy occurred in a patient on methotrexate not on contraception. Our interventions improved three measures related to contraception counselling and documentation, but there remains a need for ongoing quality improvement efforts in our clinic. This high-risk population requires increased provider engagement to improve contraception compliance, coupled with system-wide EMR changes to increase sustainability.