Use of the Electronic Health Record for Monitoring Adverse Drug Reactions.

PURPOSE OF REVIEW: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality. The electronic health record (EHR) provides an opportunity to monitor ADRs, mainly through the utilization of drug allergy data and pharmacogenomics. This review article explores the current use of the EHR for ADR monitoring and highlights areas that require improvement. RECENT FINDINGS: Recent research has identified several issues with using EHR for ADR monitoring. These include the lack of standardization between EHR systems, specificity in data entry options, incomplete and inaccurate documentation, and alert fatigue. These issues can limit the effectiveness of ADR monitoring and compromise patient safety. The EHR has great potential for monitoring ADR but needs significant updates to improve patient safety and optimize care. Future research should concentrate on developing standardized documentation and clinical decision support systems within EHRs. Healthcare professionals should also be educated on the significance of accurate and complete ADR monitoring.

EVG/COBI/FTC/TAF Bioequivalence Comparing Whole Tablets with Tablets Dissolved in Tap Water.

Medication adherence can be challenging for persons with difficulty swallowing tablets. We investigated the bioequivalence of a dissolved tablet when compared with that of a whole tablet of the fixed-dose combination elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir (TFV) alafenamide fumarate (TAF). A within-subject fixed-order two-period open-label study was conducted in 12 HIV-negative research participants after obtaining informed consent. Participants took a single dose each of the whole tablet and dissolved tablet under direct observation, separated by a 14-day washout period. The dissolved tablet was prepared by adding one whole EVG/COBI/FTC/TAF tablet to 120 mL tap water and stirring. Both dosage types were taken with a standardized meal. Plasma samples were obtained for 72 h postdose. Plasma EVG, FTC, TAF, and TFV were analyzed with liquid chromatographic-tandem mass spectrometric methods. Peak plasma concentration (Cmax) and the area under the concentration-time curve extrapolated to infinity (AUC0-∞) were estimated using WinNonlin software (v.8.3). The primary outcome was bioequivalence consistent with FDA guidance using the 90% confidence interval or the geometric mean ratio. Of 12 participants, 7 were black (58%) and 5 were white (42%), 4 were women (33%), 8 were men (67%), and the mean age was 43.6 years (23-54). There were no complaints about taste with the dissolved tablet. Bioequivalence was established only for FTC. EVG Cmax and AUC0-∞ were higher by 18% and 12%, respectively, when taking the dissolved compared with the whole tablet. TAF AUC0-∞ and Cmax were both 8% lower, whereas TFV Cmax and AUC0-∞ were 8% and 5% lower, respectively, when taken after dissolution. EVG/COBI/FTC/TAF dissolved rapidly in water and had no unpleasant taste. Increases in EVG and decreases in TAF and TFV concentrations were observed when taking dissolved EVG/COBI/FTC/TAF. These changes were judged to be clinically insignificant. Dissolving EVG/COBI/FTC/TAF in water may be suitable for those with pill swallowing challenges. The trial was registered on (//clinicaltrials.gov NCT03717129).

Direct antiviral agents (DAAs) and their use in pregnant women with hepatitis C (HCV).

INTRODUCTION: Direct-Acting Antiviral Agents (DAAs) provide safer, efficacious, tolerable, and curative therapy for women with hepatitis C. Their preferred safety and efficacy profile make them potential therapies for the elimination of perinatal transmission of hepatitis C virus (HCV). However, DAAs are not currently recommended for use during pregnancy due to limited pharmacokinetic and safety data. AREAS COVERED: This review covers the different DAA drug combinations, the available data on their pharmacodynamic and pharmacokinetic properties, how the physiology in pregnancy can potentially affect DAA drug disposition, known drug-drug interactions with DAAs, and available and planned epidemiological and pharmacokinetic studies on DAA use during pregnancy. Although no large randomized clinical trials or prospective cohort studies involving DAAs have been completed in pregnancy, the currently available studies demonstrate no significant changes in pharmacokinetics, and no major safety concerns in women with hepatitis C. EXPERT OPINION: Initial pharmacokinetic and safety data suggest that DAAs have high efficacy and a low risk of adverse events during pregnancy. As more pharmacokinetic and epidemiologic data become available, DAAs could become a preferred option for treating HCV during pregnancy and elimination of perinatal transmission of hepatitis C virus.