Rationale, Aims And Objective: Manual chart review is an effective but expensive method for adverse drug event (ADE) detection. Building an expert system capable of mimicking the human expert's decision pathway, to deduce the occurrence of an ADE, can improve efficiency and lower cost. As a first step to build such an expert system, this study explores pharmacist's decision-making processes for ADE detection.
Methods: Think-aloud procedures were used to elicit verbalizations as pharmacists read through ADE case scenarios. Two types of information were extracted, firstly pharmacists' decision-making strategies regarding ADEs and secondly information regarding pharmacists' unmet information needs for ADE detection. Verbal protocols were recorded and analysed qualitatively to extract ADE information signals. Inter-reviewer agreement for classification of ADE information signals was calculated using Cohen's kappa.
Results: We extracted a total of 110 information signals, of which 73% consisted of information that was interpreted by the pharmacists from the case scenario and only about half (53%, n = 32) of the information signals were considered relevant for the detection of the ADEs. Excellent reliability was demonstrated between the reviewers for classifying signals. Fifty information signals regarding unmet information needs were extracted and grouped into themes based on the type of missing information.
Conclusions: Pharmacists used a forward reasoning approach to make implicit deductions and validate hypotheses about possible ADEs. Verbal protocols also indicated that pharmacists' unmet information needs occurred frequently. Developing alerting systems that meet pharmacists' needs adequately will enhance their ability to reduce preventable ADEs, thus improving patient safety.
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http://dx.doi.org/10.1111/j.1365-2753.2008.00992.x | DOI Listing |
Microorganisms
January 2025
Department of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.
A comprehensive pharmacovigilance surveillance on antibacterials is lacking. This study aims to investigate safety signals of antibacterial-related adverse drug events (ADEs) with seriousness and to identify predictors of serious ADEs. This study investigated 52,503 antibacterial-induced ADEs reported to the Korea Adverse Event Reporting System Database from January 2013 to December 2022.
View Article and Find Full Text PDFFront Pharmacol
January 2025
Department of Cardiology, Affiliated Changshu Hospital of Nantong University, Changshu, China.
Objective: This study aims to analyze the adverse drug events (ADEs) associated with tolvaptan in the Food and Drug Administration Adverse Event Reporting System database from the fourth quarter of 2009 to the second quarter of 2024.
Methods: After standardizing the data, various signal detection techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were employed for analysis.
Results: Among the 7,486 ADE reports where tolvaptan was the primary suspected drug, a total of 196 preferred terms were identified, spanning 24 different system organ classes.
BMC Psychiatry
January 2025
Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical University, 149 Dalian Road, huichuan district, Zunyi, Guizhou, 563003, People's Republic of China.
Objective: Paliperidone palmitate is a second-generation antipsychotic that has undergone extensive investigation in clinical trials. However, real-world studies assessing its safety in large populations are lacking. As such, this study aimed to comprehensively evaluate real-world adverse drug events (ADEs) linked to paliperidone palmitate by employing data mining techniques on the U.
View Article and Find Full Text PDFClin Biochem
January 2025
Department of Gastrointestinal Surgery, Yongchuan Hospital of Chongqing Medical University, Yongchuan, Chongqing 402160, China. Electronic address:
Objective: To investigate the clinical significance of fecal Syndecan-2 (SDC2) gene methylation combined with blood tumor abnormal protein (TAP) detection for the diagnosis of colorectal cancer (CRC) and its precancerous lesions.
Methods: A retrospective study was conducted to collect patients diagnosed with CRC or colorectal adenoma (Ade) from March 2020 to March 2023, and healthy people (Nor) without any gastrointestinal diseases during the same period as the control group. All participants underwent the fecal SDC2 gene methylation test, blood TAP test and fecal occult blood test (FOBT).
FASEB J
January 2025
Department of Neurology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.
Aerobic exercise (AE) has been shown to offer significant benefits for Alzheimer's disease (AD), potentially influencing the gut microbiota. However, the impact of changes in intestinal flora in early Alzheimer's disease induced by aerobic exercise on metabolic pathways and metabolites is not well understood. In this study, 3-month-old APP/PS1 and C57BL/6 mice were divided into two groups each: a control group (ADC for APP/PS1 and WTC for C57BL/6) and an aerobic exercise group (ADE for APP/PS1 and WTE for C57BL/6).
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