Editorial: Reducing the Harm of Medication-Recent Trends in Pharmacovigilance.
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ABSTRACT:
SUBMITTER: Ramirez E
PROVIDER: S-EPMC9469192 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
Publications
Editorial: Reducing the Harm of Medication-Recent Trends in Pharmacovigilance.
Ramírez Elena E González-Munoz Miguel M Kulkarni Chanda C de Abajo Francisco J FJ
Frontiers in pharmacology 20220830
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Project description:IntroductionDespite rising concerns regarding the safety of anti-obesity medications, there is a lack of comprehensive pharmacovigilance investigations utilising real-world data. We aimed to characterise the prevalence and seriousness of adverse drug events (ADEs) related to anti-obesity medications and to identify predictors associated with increased risk of serious adverse events (SAE), thereby conveying evidence on drug safety.MethodsWe conducted a cross-sectional analysis on ADE cases spontaneously reported to the Korea Adverse Event Reporting System Database (KIDS-KD). ADE reports pertaining to anti-obesity medications prescribed for overweight, obesity (International Classification of Disease, 10th revision (ICD-10) code E66) and abnormal weight gain (ICD-10 code E63.5) were included in the analysis. We performed a disproportionality to detect the association of the system organ class-based ADEs with their seriousness an individual's sex by estimating reporting odds ratios (RORs) and their 95% confidence intervals (CIs). We performed logistic regression to investigate factors that are substantially associated with increased SAE risks by estimating odds ratio (OR) and their 95% CIs.ResultsThe most common causative anti-obesity medication was phentermine, followed by liraglutide. ADEs associated with psychiatric disorders (ROR = 1.734; 95% CI = 1.111-2.707), liver and biliary system disorders (ROR = 22.948; 95% CI = 6.613-70.635), cardiovascular disorders (ROR = 5.707; 95% CI = 1.965-16.574), and respiratory disorders (ROR = 4.567; 95% CI = 1.774-11.762) were more likely to be serious events. Additionally, men are more likely to experience ADEs related gastrointestinal disorders (ROR = 1.411) and less likely to have heart and rhythm disorders (ROR = 0.507). The risk of SAE incidences was positively correlated with being male (OR = 2.196; 95% CI = 1.296-3.721), dual or triple combination of anti-obesity medications (OR = 3.258; 95% CI = 1.633-6.501 and OR = 8.226; 95% CI = 3.046-22.218, respectively), and concomitant administration of fluoxetine (OR = 5.236; 95% CI = 2.218-12.365).ConclusionsSeriousness of anti-obesity medication-related ADEs differs among system-organ class, while sex-related differences in ADE profiles are also present. The predictors substantially increasing risk of SAE incidences include being male, having a higher number of concomitant medications (including multiple combination of anti-obesity medications), and concurrent use of fluoxetine. Nonetheless, further pharmacovigilance investigation and monitoring are needed to enhance awareness on ADEs induced by anti-obesity medications.
| S-EPMC10471157 | biostudies-literature
Project description:In response to concerns regarding overprescribing of psychotropic medication in children/adolescents, this study examined trends in psychotropic medication use in Ireland by age group and gender. A retrospective, repeated, cross-sectional study of the Irish pharmacy claims database was conducted. Yearly prevalence of children/adolescents receiving dispensed psychotropic medications was analysed from January 2017 to December 2021 and compared across years, age groups (5-15 years, and stratified as 5-11 and 12-15 years) and gender. Yearly prevalence was defined as the mean number of patients in receipt of medication per month per 1000 eligible population during a given calendar year. Negative binomial regression was used to examine the association of year, age group and gender on prevalence. Prevalence ratios (PRs) per year (average change in prevalence between each year) were presented with 95% confidence intervals (CIs). The prevalence of included psychotropic medications dispensed in the 5-15 years group increased from 6.41 (95% CI: 6.22, 6.59) in 2017 to 8.46 (95% CI: 8.26, 8.68) in 2021 per 1000 eligible population (32% increase). The PR per year (adjusting for age category and gender) was 1.07 (95% CI: 1.035, 1.107; p < 0.001). An increasing trend over time was also observed for all individual drug classes. These findings suggest increased use of psychotropic medication in children/adolescents from 2017 to 2021. However, despite increased prevalence over time, comparison with the literature shows that psychotropic medication use in Ireland remains lower than international comparators.
| S-EPMC11909023 | biostudies-literature
Project description:ObjectiveTo conduct a systematic review and meta-analysis to assess: 1) changes in medication error rates and associated patient harm following electronic medication system (EMS) implementation; and 2) evidence of system-related medication errors facilitated by the use of an EMS.Materials and methodsWe searched Medline, Scopus, Embase, and CINAHL for studies published between January 2005 and March 2019, comparing medication errors rates with or without assessments of related harm (actual or potential) before and after EMS implementation. EMS was defined as a computer-based system enabling the prescribing, supply, and/or administration of medicines. Study quality was assessed.ResultsThere was substantial heterogeneity in outcomes of the 18 included studies. Only 2 were strong quality. Meta-analysis of 5 studies reporting change in actual harm post-EMS showed no reduced risk (RR: 1.22, 95% CI: 0.18-8.38, P = .8) and meta-analysis of 3 studies reporting change in administration errors found a significant reduction in error rates (RR: 0.77, 95% CI: 0.72-0.83, P = .004). Of 10 studies of prescribing error rates, 9 reported a reduction but variable denominators precluded meta-analysis. Twelve studies provided specific examples of system-related medication errors; 5 quantified their occurrence.Discussion and conclusionDespite the wide-scale adoption of EMS in hospitals around the world, the quality of evidence about their effectiveness in medication error and associated harm reduction is variable. Some confidence can be placed in the ability of systems to reduce prescribing error rates. However, much is still unknown about mechanisms which may be most effective in improving medication safety and design features which facilitate new error risks.
| S-EPMC7810459 | biostudies-literature
Project description: Not available
| S-EPMC10808739 | biostudies-literature
Project description:Recent economic and health policy changes may have affected the ability of chronically ill patients to afford their medications. We assessed changes in cost-related nonadherence to medication (CRN) before and after the implementation of Medicare Part D in 2006.We used data from the National Health Interview Survey, an annual, population-based survey of community-dwelling, noninstitutionalized US adults, to estimate CRN in 8,673 stroke survivors aged 45 years or older, representing 4.8 million survivors, for the years 1999 to 2010. The main outcome measure was CRN, defined as self-reported inability to afford prescribed medication within the past 12 months.During the period 1999 to 2010, 11.4% of stroke survivors, approximately 543,000 individuals, reported CRN. From 1999 to 2010, CRN more than doubled among stroke survivors aged 45 to 64 years (from 12.7 to 26.5%; ptrend = 0.01). CRN remained stable among those aged 65 years or older (from 3.8 to 7.0%; ptrend = 0.21). From 1999-2005 to 2006-2010, CRN among uninsured stroke survivors aged 45 to 64 years increased from 43.1 to 57.1% (p = 0.03). Among stroke survivors aged 65 years or older with Medicare coverage, CRN was higher among Medicare Part D participants than those without the drug benefit (7.9 vs 4.8%; p = 0.02). After adjustment for sociodemographic and clinical factors, CRN was similar among Medicare Part D enrollees and nonenrollees.From 1999 to 2010, CRN increased significantly among stroke survivors younger than 65 years, particularly among those without health insurance. There was no evidence that Medicare Part D decreased CRN among stroke survivors with Medicare.
| S-EPMC3677727 | biostudies-literature
Project description:Classifying harm associated with a medication error can be time consuming and labour intensive and limited studies undertake this step. There is no standardised process, and few studies that report harm assessment provide adequate methods to allow for study replication. Studies typically mention that a clinical review panel classified patient harm and provide a reference to a classification tool. Moreover, in many studies it is unclear whether potential or actual harm was classified as studies refer only to 'error severity'. The tools used to categorise the severity of patient harm vary widely across studies and few have been assessed for inter-rater reliability and criterion validity. In this paper, we describe the systematic process we undertook to synthesise the defining elements and strengths, while mitigating the limitations, of existing harm classification tools to derive the Harm Associated with Medication Error Classification (HAMEC). This new tool provides a harm classification for use across clinical and research settings. The provision of an explicit process for its application and guiding category descriptors are designed to reduce the risk of misclassification and produce results that are comparable across studies. As the World Health Organisation embarks on its international safety challenge of reducing medication-related harm by 50%, accompanying methodological advances are required to measure progress.
| S-EPMC6647434 | biostudies-literature
Project description: Not available
| S-EPMC9350505 | biostudies-literature
Project description:ObjectiveTo describe the trends in suicide and emergency department (ED) visits for self-harm in youth by immigration status and immigrant characteristics.DesignPopulation-based longitudinal cohort study from 1996 to 2012 using linked health and administrative datasets.SettingOntario, Canada.ParticipantsYouth 10 to 24 years, living in Ontario, Canada.ExposureThe main exposure was immigrant status (recent immigrant (RI) versus long-term residents (LTR)). Secondary exposures included region of birth, duration or residence, and refugee status.Main outcome measureTrends over time in suicide and ED self-harm were modelled within consecutive 3-year time periods. Rate ratios were estimated using Poisson regression models.Results2.5 to 2.9 million individuals were included per cohort period. LTR suicide rates ranged from 7.4 to 9.4/100 000 male person-years versus 2.2-3.4/100 000 females. RI's suicide rates were 2.7-7.2/100,000 male versus 1.9-2.7/100 000 female person-years. Suicide rates were lower among RI compared with LTR (adjusted relative rate (aRR)=0.70, 95% CI=0.57 to 0.85) with different mechanisms of suicide. No significant time trend in suicide rates was observed (p=0.40). ED self-harm rates for LTR and RI were highest in females (2.6-3.4/1000 LTR females versus 1.1-1.5/1000 males, 1.2-1.8/1000 RI females versus 0.4-0.6/1000 males). RI had lower rates of self-harm compared with LTR (aRR=0.60, 95% CI=0.56 to 0.65). Stratum-specific rates showed a steeper decline per period in RI compared with LTR (RI: aRR=0.85, 95% CI=0.81 to 0.89; LTR: aRR=0.91, 95% CI=0.90 to 0.93). Observed trends were not universal across region of origin and by refugee status.InterpretationSuicide rates have been stable and ED self-harm rates are declining over time among RI youth. These trends by important subgroups should continue to be monitored to allow for early identification of subpopulations of immigrant youth in need of targeted and culturally appropriate public health interventions.
| S-EPMC5589002 | biostudies-literature
Project description:BackgroundSystematic exclusion of pregnant people from interventional clinical trials has created a public health emergency for millions of patients through a dearth of robust safety data for common drugs.MethodsWe harnessed an enterprise collection of 2.8 M electronic health records (EHRs) from routine care, leveraging data linkages between mothers and their babies to detect drug safety signals in this population at full scale. Our mixed-methods signal detection approach stimulates new hypotheses for post-marketing surveillance agnostically of both drugs and diseases-by identifying 1,054 drugs historically prescribed to pregnant patients; developing a quantitative, medication history-wide association study; and integrating a qualitative evidence synthesis platform using expert clinician review for integration of biomedical specificity-to test the effects of maternal exposure to diverse drugs on the incidence of neurodevelopmental defects in their children.ResultsWe replicated known teratogenic risks and existing knowledge on drug structure-related teratogenicity; we also highlight 5 common drug classes for which we believe this work warrants updated assessment of their safety.ConclusionHere, we present roots of an agile framework to guide enhanced medication regulations, as well as the ontological and analytical limitations that currently restrict the integration of real-world data into drug safety management during pregnancy. This research is not a replacement for inclusion of pregnant people in prospective clinical studies, but it presents a tractable team science approach to evaluating the utility of EHRs for new regulatory review programs-towards improving the delicate equipoise of accuracy and ethics in assessing drug safety in pregnancy.
| S-EPMC9481638 | biostudies-literature
Project description: Not available
| S-EPMC9531153 | biostudies-literature