A Computational Framework for Identifying Age Risks in Drug-Adverse Event Pairs

The identification of associations between drugs and adverse drug events (ADEs) is crucial for drug safety surveillance. An increasing number of studies have revealed that children and seniors are susceptible to ADEs at the population level. However, the comprehensive explorations of age risks in drug-ADE pairs are still limited. The FDA Adverse Event Reporting System (FAERS) provides individual case reports, which can be used for quantifying different age risks. In this study, we developed a statistical computational framework to detect age group of patients who are susceptible to some ADEs after taking specific drugs. We adopted different Chi-squared tests and conducted disproportionality analysis to detect drug-ADE pairs with age differences. We analyzed 4,580,113 drug-ADE pairs in FAERS (2004 to 2018Q3) and identified 2,523 pairs with the highest age risk. Furthermore, we conducted a case study on statin-induced ADE in children and youth. The code and results are available at https://github.com/Zhizhen-Zhao/Age-Risk-Identification

Safety Considerations for the Inpatient Medication-Use Process in Pediatric and Neonatal Patients

The delivery of safe and effective healthcare to pediatric and neonatal patients presents unique challenges to the medication-use system. The diversity of patients within this population and the consequences of ontogeny on pharmacokinetics and pharmacodynamics directly impact the safe use of medications in children and increase the risk of adverse drug events.1 This review will explore the medication-use system for hospitalized children and neonates, discuss vulnerabilities within this system, and provide examples of advancements made to improve the pediatric medication-use system.

Comparative Efficacy of Chinese Herbal Injections for Treating Severe Pneumonia: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Controlled Trials

Background: Severe pneumonia (SP) has a high mortality rate and is responsible for significant healthcare costs. Chinese herbal injections (CHIs) have been widely used in China as a novel and promising treatment option for SP. Therefore, this study assessed and ranked the effectiveness of CHIs to provide more sights for the selection of SP treatment.Method: Seven databases were searched from their inception up to April 1, 2021. The methodological quality of included study was evaluated by the Cochrane risk-of-bias tool. Then, a Bayesian network meta-analysis (NMA) was performed by OpenBUGS 3.2.3 and STATA 14.0 software. The surface under the cumulative ranking curve (SUCRA) probability values were applied to rank the examined treatments. A clustering analysis was utilized to compare the effect of CHIs between two different outcomes.Results: A total of 64 eligible randomized controlled trials (RCTs) involving 5,904 participants were identified for this analysis. Six CHIs including Xuebijing injection (XBJ), Tanreqing injection (TRQ), Reduning injection (RDN), Xiyanping injection (XYP), Shenfu injection (SF), and Shenmai injection (SM) were included. The results of the NMA showed that XBJ [odds ratio (OR) = 0.24, 95% credible interval (CI): 0.19, 0.30], TRQ (OR = 0.22, 95% CI: 0.12, 0.37), RDN (OR = 0.29, 95% CI: 0.04, 0.94), and SM (OR = 0.27, 95% CI: 0.08, 0.63) combined with conventional Western medicine (WM) improved the clinical effective rate more significantly than WM alone. Based on SUCRA values, TRQ + WM (SUCRA: 66.4%) ranked the highest in improving the clinical effective rate, second in four different outcomes, and third in only one. According to the cluster analysis, TRQ + WM exerted a positive effect on improving the efficacy of SP. As for safety, less than 30% (18 RCTs) of the included studies reported adverse drug reactions/adverse drug events (ADRs/ADEs), including 14 RCTs of XBJ, 3 RCTs of TRQ, and 1 RCT of RDN.Conclusion: In conclusion, the study found that the CHIs as co-adjuvant therapy could be beneficial for patients with SP. TRQ + WM showed an outstanding improvement in patients with SP considering both the clinical effective rate and other outcomes.Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021244587].

A Qualitative Analysis to Understand Perception about Medication-Related Problems among Older Minority Adults in a Historically Black Community

Older adults taking multiple chronic medications experience an increased risk of adverse drug events and other medication-related problems (MRP). Most current literature on medication management involves researcher-driven intervention, yet few studies investigate patients’ understanding of MRP in a diverse community setting. This report investigates patients’ perception of MRP and patient-centered strategies among a cohort of the older adult group in a historically Black urban community. The study design is qualitative using structured open-ended questions in a multidisciplinary patient-centered focus group. Patients (age 65 years or older) taking seven or more medications were recruited. The group comprises patients, caregivers, pharmacists, health educators, a physician, and a nurse. Recordings of the group discussion are transcribed verbatim and analyzed using thematic content analysis and categorized by codes developed from the social-ecological model. The group reports patient-provider relationships, previous experience, fear of side effects played important roles in medication adherence. There is an unmet need for medication management education and tools to organize complex medication lists from multiple providers. This study provides important insights into MRP experienced by minority older adults and provided researchers with potential strategies for future interventions.

Combining a Pharmacological Network Model with a Bayesian Signal Detection Algorithm to Improve the Detection of Adverse Drug Events

Introduction: Improving adverse drug event (ADE) detection is important for post-marketing drug safety surveillance. Existing statistical approaches can be further optimized owing to their high efficiency and low cost.Objective: The objective of this study was to evaluate the proposed approach for use in pharmacovigilance, the early detection of potential ADEs, and the improvement of drug safety.Methods: We developed a novel integrated approach, the Bayesian signal detection algorithm, based on the pharmacological network model (ICPNM) using the FDA Adverse Event Reporting System (FAERS) data published from 2004 to 2009 and from 2014 to 2019Q2, PubChem, and DrugBank database. First, we used a pharmacological network model to generate the probabilities for drug-ADE associations, which comprised the proper prior information component (IC). We then defined the probability of the propensity score adjustment based on a logistic regression model to control for the confounding bias. Finally, we chose the Side Effect Resource (SIDER) and the Observational Medical Outcomes Partnership (OMOP) data to evaluate the detection performance and robustness of the ICPNM compared with the statistical approaches [disproportionality analysis (DPA)] by using the area under the receiver operator characteristics curve (AUC) and Youden’s index.Results: Of the statistical approaches implemented, the ICPNM showed the best performance (AUC, 0.8291; Youden’s index, 0.5836). Meanwhile, the AUCs of the IC, EBGM, ROR, and PRR were 0.7343, 0.7231, 0.6828, and 0.6721, respectively.Conclusion: The proposed ICPNM combined the strengths of the pharmacological network model and the Bayesian signal detection algorithm and performed better in detecting true drug-ADE associations. It also detected newer ADE signals than a DPA and may be complementary to the existing statistical approaches.

Use of a Deprescribing Tool in an Interdisciplinary Primary-Care Patient-Aligned Care Team

Objective: To pilot the VIONE approach in a single Primary Care Patient Aligned Care Team (PACT). The authors aim for the Clinical Pharmacy Specialist (CPS) to perform 20 comprehensive medication reviews (CMRs) and the pilot PACT physician (PCP) to complete 200 VIONE discontinuations. Cost avoidance and CPS recommendations will also be analyzed. Polypharmacy is associated with increased risk of adverse drug events, falls, hospitalizations, and death. VIONE is a deprescribing tool that assists providers in identifying inappropriate medications. Design: Quality Improvement Setting: Single VA Health Care System (VAHCS) Participants: High-risk veterans in pilot PACT Interventions: The CPS educated the PCP regarding VIONE methodology and assisted with CMRs. When deprescribing was warranted, VIONE discontinuation reasons were selected in the Computerized Patient Record System (CPRS). Data were electronically stored in a national dashboard. Results: The authors identified 231 veterans at risk for polypharmacy-related adverse events. The PCP and CPS were able to reach 99 veterans and make 136 medication discontinuations between September 1, 2019, and March 1, 2020. The CPS performed 20 CMRs, resulting in 90 deprescribing recommendations. Thirty-eight CPS recommendations were accepted and contributed $18,835.95 to the sum annualized cost avoidance of $21,904.80. Conclusion: The VIONE methodology was successfully implemented in the pilot PACT. The utilization of the CPS was associated with an increased average number of medication discontinuations per veteran and contributed to cost avoidance.

Adverse drug reactions amongst admitted advanced age Africans

Background: Medical therapy amongst advanced age adults sometimes have its inherent significant risks such as adverse drug reactions (ADRs) resulting from the drug itself or drug-drug interactions or interactions from other substances such as alcohol. Aim: The main aim of this study is to highlight ADRs noticed by the older adult while on admission either in the past or present with the goal of preventing them and improving treatment outcomes. Methods: A purposive cross-sectional sampling of 126 elderly patients that were admitted to the different wards of the hospital within a 3-month period was carried out of which 25 older adults who met the criteria of being able to recall ADRs in the past or during current admission were included in the study. Results: ADR was reported in a ratio of M: F ratio of 1:1.08 with a prevalence of 19.8% of the total older patients evaluated. Conclusion: Self-reported ADRs amongst these advanced age in-patients were high. The actual number of adverse drug events may be higher if they actually looked out for by the physicians or other health care workers. The use of screening tools by physicians and other prescribing health workers can help in curbing adverse drug events in older adults.