Abstract
Background: Adverse drug reactions (ADRs) are a major cause of hospital admissions, prolonged hospital stays, morbidity, and drug-related mortality. In this study, we sought to identify the most frequently reported medications and associated side effects in adolescent-aged patients in an effort to prioritize clinical pharmacology consultation efforts for hospitals seeking to improve patient safety. Methods: Quarterly reported data were obtained from the United States Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2014 and ending in the third quarter of 2017. We then used the GeneCards database to map the pharmacogenomic biomarkers associated with the most reported FAERS drugs. Data homogenization and statistics analysis were all conducted in R for statistical programming. Results: We identified risperidone (10.64%) as the compound with the most reported ADRs from all reported cases. Males represented 90.1% of reported risperidone cases with gynecomastia being the most reported ADR. Ibuprofen OR=188 (95% CI, 105.0000 – 335.000) and quetiapine fumarate OR=116 (95% CI, 48.4000 – 278.000) were associated with the highest odds of completed suicide in teenagers. Ondansetron hydrochloride OR=7.12 (95% CI, 1.59 – 31.9) resulted in the highest odds of pneumothorax. Lastly, olanzapine (8.96%) represented the compound with the most reported drug-drug interactions cases, while valproic acid OR=221 (95% CI, 93.9000 – 522.000) was associated with the highest odds of drug-drug interactions. Conclusion: Despite any data limitations, physicians prescribing risperidone in males should be aware of the high rates of adverse drug events and an alternative psychotropic should be considered in male patients. Further, patients with a history of pneumothorax or genetically predisposed to pneumothorax should be considered for an alternative antiemetic to ondansetron hydrochloride, due to increased odds associated with the drug and adverse event.
Highlights
When considering the aims of precision medicine, which has the underlying theme of maximizing therapeutic efficacy while minimizing adverse drug reactions, all physician and surgeon specialists provide an integral part in achieving the overall goal of this national endeavor (Manolio, 2016; Rasmussen-Torvik et al, 2014; Weinshilboum & Wang, 2017)
If nothing is done, national implementation of precision medicine remains a challenge, due to not having enough trained medical doctors who focus on implementing pharmacogenomics into patient care and contribute to pharmacogenomics education (McCauley et al, 2017; Rosenman et al, 2017). With this information as a background, the primary aim of this article is to determine the most frequently reported drugs and associated adverse drug reactions that are found within the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) that will aid in prioritizing efforts for clinical pharmacology consultation services
Data The United States Food and Drug Administration’s (FDA) Adverse Events Reporting System (FAERS) quarterly reports were downloaded, with dates ranging from the third quarter of 2014 to the third quarter of 2017
Summary
When considering the aims of precision medicine, which has the underlying theme of maximizing therapeutic efficacy while minimizing adverse drug reactions, all physician and surgeon specialists provide an integral part in achieving the overall goal of this national endeavor (Manolio, 2016; Rasmussen-Torvik et al, 2014; Weinshilboum & Wang, 2017). When implementing hospital-based clinical pharmacology consultation units, aside from the established drug-gene guidelines, what is a reasonable approach for hospital pharmacologists to prioritize medications that are associated with the most reported adverse drug reactions that will improve hospital safety outcomes? An approach that systematically addresses the top medications associated with the most reported adverse drug events, leading to a prioritization method for hospital pharmacologists to improve medication safety, is lacking (Davies et al, 2009; Shepherd et al, 2012). Patients with a history of pneumothorax or genetically predisposed to pneumothorax should be considered for an alternative antiemetic to ondansetron hydrochloride, due to increased odds associated with the drug and adverse event
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