Drug Disposition and Drug-Drug Interaction Data in 2013 FDA New Drug Applications: A Systematic Review

2014 ◽  
Vol 42 (12) ◽  
pp. 1991-2001 ◽  
Author(s):  
Jingjing Yu ◽  
Tasha K. Ritchie ◽  
Aditi Mulgaonkar ◽  
Isabelle Ragueneau-Majlessi
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Disposition ◽  
Interaction Data ◽  
New Drug ◽  
Drug Drug Interaction

scholarly journals What Can Be Learned from Recent New Drug Applications? A Systematic Review of Drug Interaction Data for Drugs Approved by the US FDA in 2015

2016 ◽  
Vol 45 (1) ◽  
pp. 86-108 ◽  
Author(s):  
Jingjing Yu ◽  
Zhu Zhou ◽  
Katie H. Owens ◽  
Tasha K. Ritchie ◽  
Isabelle Ragueneau-Majlessi
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Interaction Data ◽  
New Drug ◽  
The Us ◽  
Us Fda

Drug-drug interaction software in clinical practice: a systematic review

2014 ◽  
Vol 71 (2) ◽  
pp. 131-142 ◽  
Author(s):  
Tina Roblek ◽  
Tomaz Vaupotic ◽  
Ales Mrhar ◽  
Mitja Lainscak
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Clinical Practice ◽  
Drug Drug Interaction

scholarly journals Appropriateness of Overridden Alerts in Computerized Physician Order Entry: Systematic Review (Preprint)

2019 ◽  
Author(s):  
Tahmina Nasrin Poly ◽  
Md.Mohaimenul Islam ◽  
Hsuan-Chia Yang ◽  
Yu-Chuan (Jack) Li
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Allergy ◽  
Adverse Drug Events ◽  
Clinical Decision ◽  
Drug Drug Interaction ◽  
Indispensable Tool ◽  
Physician Order Entry ◽  
Clear Information

BACKGROUND The clinical decision support system (CDSS) has become an indispensable tool for reducing medication errors and adverse drug events. However, numerous studies have reported that CDSS alerts are often overridden. The increase in override rates has raised questions about the appropriateness of CDSS application along with concerns about patient safety and quality of care. OBJECTIVE The aim of this study was to conduct a systematic review to examine the override rate, the reasons for the alert override at the time of prescribing, and evaluate the appropriateness of overrides. METHODS We searched electronic databases, including Google Scholar, PubMed, Embase, Scopus, and Web of Science, without language restrictions between January 1, 2000 and March 31, 2019. Two authors independently extracted data and crosschecked the extraction to avoid errors. The quality of the included studies was examined following Cochrane guidelines. RESULTS We included 23 articles in our systematic review. The range of average override alerts was 46.2%-96.2%. An average of 29.4%-100% of the overrides alerts were classified as appropriate, and the rate of appropriateness varied according to the alert type (drug-allergy interaction 63.4%-100%, drug-drug interaction 0%-95%, dose 43.9%-88.8%, geriatric 14.3%-57%, renal 27%-87.5%). The interrater reliability for the assessment of override alerts appropriateness was excellent (kappa=0.79-0.97). The most common reasons given for the override were “will monitor” and “patients have tolerated before.” CONCLUSIONS The findings of our study show that alert override rates are high, and certain categories of overrides such as drug-drug interaction, renal, and geriatric were classified as inappropriate. Nevertheless, large proportions of drug duplication, drug-allergy, and formulary alerts were appropriate, suggesting that these groups of alerts can be primary targets to revise and update the system for reducing alert fatigue. Future efforts should also focus on optimizing alert types, providing clear information, and explaining the rationale of the alert so that essential alerts are not inappropriately overridden.

scholarly journals The impact of CYP2D6 mediated drug-drug interaction: a systematic review on a combination of metoprolol and paroxetine/fluoxetine

2018 ◽  
Vol 84 (12) ◽  
pp. 2704-2715 ◽  
Author(s):  
Muh. Akbar Bahar ◽  
Jasper Kamp ◽  
Sander D. Borgsteede ◽  
Eelko Hak ◽  
Bob Wilffert
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Drug Interaction ◽  
The Impact

scholarly journals Appropriateness of Overridden Alerts in Computerized Physician Order Entry: Systematic Review

10.2196/15653 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e15653 ◽  
Author(s):  
Tahmina Nasrin Poly ◽  
Md.Mohaimenul Islam ◽  
Hsuan-Chia Yang ◽  
Yu-Chuan (Jack) Li
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Allergy ◽  
Adverse Drug Events ◽  
Clinical Decision ◽  
Drug Drug Interaction ◽  
Indispensable Tool ◽  
Physician Order Entry ◽  
Clear Information

Background The clinical decision support system (CDSS) has become an indispensable tool for reducing medication errors and adverse drug events. However, numerous studies have reported that CDSS alerts are often overridden. The increase in override rates has raised questions about the appropriateness of CDSS application along with concerns about patient safety and quality of care. Objective The aim of this study was to conduct a systematic review to examine the override rate, the reasons for the alert override at the time of prescribing, and evaluate the appropriateness of overrides. Methods We searched electronic databases, including Google Scholar, PubMed, Embase, Scopus, and Web of Science, without language restrictions between January 1, 2000 and March 31, 2019. Two authors independently extracted data and crosschecked the extraction to avoid errors. The quality of the included studies was examined following Cochrane guidelines. Results We included 23 articles in our systematic review. The range of average override alerts was 46.2%-96.2%. An average of 29.4%-100% of the overrides alerts were classified as appropriate, and the rate of appropriateness varied according to the alert type (drug-allergy interaction 63.4%-100%, drug-drug interaction 0%-95%, dose 43.9%-88.8%, geriatric 14.3%-57%, renal 27%-87.5%). The interrater reliability for the assessment of override alerts appropriateness was excellent (kappa=0.79-0.97). The most common reasons given for the override were “will monitor” and “patients have tolerated before.” Conclusions The findings of our study show that alert override rates are high, and certain categories of overrides such as drug-drug interaction, renal, and geriatric were classified as inappropriate. Nevertheless, large proportions of drug duplication, drug-allergy, and formulary alerts were appropriate, suggesting that these groups of alerts can be primary targets to revise and update the system for reducing alert fatigue. Future efforts should also focus on optimizing alert types, providing clear information, and explaining the rationale of the alert so that essential alerts are not inappropriately overridden.

scholarly journals Differential Impact of Nevirapine on Artemether-Lumefantrine Pharmacokinetics in Individuals Stratified by CYP2B6 c.516G>T Genotypes

2019 ◽  
Vol 64 (3) ◽  
Author(s):  
Sa’ad T. Abdullahi ◽  
Julius O. Soyinka ◽  
Adeniyi Olagunju ◽  
Rahman A. Bolarinwa ◽  
Olusola J. Olarewaju ◽  
...  
Keyword(s):  
Drug Interaction ◽  
Genetic Polymorphisms ◽  
Drug Disposition ◽  
Geometric Mean ◽  
Plasma Concentrations ◽  
Clinical Malaria ◽  
Pharmacokinetic Parameters ◽  
Drug Drug Interaction ◽  
The Impact ◽  
Hiv Negative

ABSTRACT There is an increased recognition of the need to identify and quantify the impact of genetic polymorphisms on drug-drug interactions. This study investigated the pharmacogenetics of the pharmacokinetic drug-drug interaction between nevirapine and artemether-lumefantrine in HIV-positive and HIV-negative adult Nigerian subjects. Thirty each of HIV-infected patients on nevirapine-based antiretroviral therapy and HIV-negative volunteers without clinical malaria, but with predetermined CYP2B6 c.516GG and TT genotypes, were administered a complete treatment dose of 3 days of artemether-lumefantrine. Rich pharmacokinetic sampling prior to and following the last dose was conducted, and the plasma concentrations of artemether/dihydroartemisinin and lumefantrine/desbutyl-lumefantrine were quantified using tandem mass spectrometry. Pharmacokinetic parameters of artemether-lumefantrine and its metabolites in HIV-infected patients on nevirapine were compared to those in the absence of nevirapine in HIV-negative volunteers. Overall, nevirapine reduced exposure to artemether and desbutyl-lumefantrine by 39 and 34%, respectively. These reductions were significantly greater in GG versus TT subjects for artemether (ratio of geometric mean [90% confidence interval]: 0.42 [0.29 to 0.61] versus 0.81 [0.51 to 1.28]) and for desbutyl-lumefantrine (0.56 [0.43 to 0.74] versus 0.75 [0.56 to 1.00]). On the contrary, it increased exposure to dihydroartemisinin and lumefantrine by 47 and 30%, respectively. These increases were significantly higher in TT versus GG subjects for dihydroartemisinin (1.67 [1.20 to 2.34] versus 1.25 [0.88 to 1.78]) and for lumefantrine (1.51 [1.20 to 1.90] versus 1.08 [0.82 to 1.42]). This study underscores the importance of incorporating pharmacogenetics into all drug-drug interaction studies with potential for genetic polymorphisms to influence drug disposition.

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