An Expiration Date for Pharmacogenetic Test Results and Prescribing Guidance?
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ABSTRACT:
SUBMITTER: Hernandez-Martinez V
PROVIDER: S-EPMC10585451 | biostudies-literature | 2023 Jul
REPOSITORIES: biostudies-literature
Publications
An Expiration Date for Pharmacogenetic Test Results and Prescribing Guidance?
Hernandez-Martinez Viviana V Duconge Jorge J Ruaño Gualberto G
The journal of applied laboratory medicine 20230701 4
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Project description:AimTo determine the projected impact of a multigene pharmacogenetic (PGx) test on medication prescribing.Materials & methodsA retrospective analysis was conducted with 122 cardiac catheterization laboratory patients undergoing angiography for eligibility of potential PGx-guided interventions that could have occurred if multigene PGx information was pre-emptively available at the time of the procedure. Medication data and presence of actionable at-risk genotypes were used to determine eligibility of a PGx intervention.Results20% of the study population (n = 24) would have qualified for at least one PGx-based medication intervention per US FDA or Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines within 6 months of their cardiac catheterization procedure. Commonly encountered gene-drug pairs for these interventions included: CYP2C19 for clopidogrel and antidepressants, CYP2D6 for antidepressants and codeine, SLCO1B1 for simvastatin, and VKORC1/CYP2C9 for warfarin.ConclusionPre-emptive use of a multigene PGx test in the cardiac catheterization laboratory offers potential to reduce adverse medication outcomes.
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Project description:(1) Background: The "obesity paradox" refers to a protective effect of higher body mass index (BMI) on mortality in acute infectious disease patients. However, the long-term impact of this paradox remains uncertain. (2) Methods: A retrospective study of patients diagnosed with community-acquired acute infectious diseases at Shamir Medical Center, Israel (2010-2020) was conducted. Patients were grouped by BMI: underweight, normal weight, overweight, and obesity classes I-III. Short- and long-term mortality rates were compared across these groups. (3) Results: Of the 25,226 patients, diverse demographics and comorbidities were observed across BMI categories. Short-term (90-day) and long-term (one-year) mortality rates were notably higher in underweight and normal-weight groups compared to others. Specifically, 90-day mortality was 22% and 13.2% for underweight and normal weight respectively, versus 7-9% for others (p < 0.001). Multivariate time series analysis revealed underweight individuals had a significantly higher 5-year mortality risk (HR 1.41 (95% CI 1.27-1.58, p < 0.001)), while overweight and obese categories had a reduced risk (overweight-HR 0.76 (95% CI 0.72-0.80, p < 0.001), obesity class I-HR 0.71 (95% CI 0.66-0.76, p < 0.001), obesity class II-HR 0.77 (95% CI 0.70-0.85, p < 0.001), and obesity class III-HR 0.79 (95% CI 0.67-0.92, p = 0.003)). (4) Conclusions: In this comprehensive study, obesity was independently associated with decreased short- and long-term mortality. These unexpected results prompt further exploration of this counterintuitive phenomenon.
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Project description:When minimally processed vegetables reach their expiration date, expose an increased microbial load. This includes mainly spoilage microorganisms but also foodborne pathogens, thus affecting the quality and safety of highly consumed ready-to-eat salads. A total of 144 ready-to-eat salads from the Cypriot market were analyzed in an attempt to determine the effects of the expiration date on the microbial load and plant metabolic variables of the salads. Possible correlations between them were also investigated for the first time. Furthermore, the impacts of the season (winter, summer), salad producing companies and type of salad and/or their interactions with the tested parameters were investigated. Results revealed that the microbial load (mainly spoilage microorganisms, such as Pseudomonas spp., yeasts and molds) increased towards the end of the shelf life. The microbial load was differentiated among the five salad producers and/or the salad types, highlighting the importance of a common and safe sanitation-processing chain in the preparation of ready-to-eat salads. Summer was the season in which Escherichia coli counts were found to be higher for plain lettuce, while Staphylococcus spp. was increased numbers for the lettuce+endive/radicchio, lettuce+rocket and lettuce+chives type of salads. Additionally, an increased Staphylococcus spp. was observed for plain rocket salads in winter. All samples examined were found negative for Salmonella enterica and Listeria monocytogenes. Moreover, carbon dioxide production and damage indexes (hydrogen peroxide and lipid peroxidation) increased on expiration date on both winter and summer seasons, indicating plant tissue stress at the end of shelf life. These findings indicate that the expiration date and relevant shelf life of processed vegetables are important parameters to be considered when postharvest management is applied to these products, ensuring safety and quality.
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Project description:IntroductionReporting and sharing pharmacogenetic test results across clinical laboratories and electronic health records is a crucial step toward the implementation of clinical pharmacogenetics, but allele function and phenotype terms are not standardized. Our goal was to develop terms that can be broadly applied to characterize pharmacogenetic allele function and inferred phenotypes.Materials and methodsTerms currently used by genetic testing laboratories and in the literature were identified. The Clinical Pharmacogenetics Implementation Consortium (CPIC) used the Delphi method to obtain a consensus and agree on uniform terms among pharmacogenetic experts.ResultsExperts with diverse involvement in at least one area of pharmacogenetics (clinicians, researchers, genetic testing laboratorians, pharmacogenetics implementers, and clinical informaticians; n = 58) participated. After completion of five surveys, a consensus (>70%) was reached with 90% of experts agreeing to the final sets of pharmacogenetic terms.DiscussionThe proposed standardized pharmacogenetic terms will improve the understanding and interpretation of pharmacogenetic tests and reduce confusion by maintaining consistent nomenclature. These standard terms can also facilitate pharmacogenetic data sharing across diverse electronic health care record systems with clinical decision support.Genet Med 19 2, 215-223.
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Project description:Although major advancements have been made in the therapeutics for people with cystic fibrosis (PwCF), many still require the use of multiple medications to manage acute exacerbations of disease and maintain health. Iterative trial and error processes of pharmacotherapeutic management can be optimized by assessing and incorporating pharmacogenetics. For 82 PwCF, we reviewed 2 years of medication use and response history and interrogated metabolizer status for common pharmacogenes, revealing 3336 medication exposure events (MEEs) to 286 unique medications. As expected, the more frequent MEEs were those commonly used to treat cystic fibrosis (CF), such as antibiotics and respiratory medications. Antibiotics also comprised 56.7% of the undesirable drug responses. The impact of gene variants on drug responses was assessed using Pharmacogenomics Knowledgebase (PharmGKB) and Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. Thirty-three (11.5%) medications have strong evidence of genetic influence on response as evidenced by gene-based dosing guidelines. 110 (38.5%) unique medications had at least one association with a very important pharmacogene, whereas 143 (50%) were associated with at least one clinical or variant annotation. Over 97% of participants had at least one actionable genotype. Eleven (13.4%) patients with an actionable genotype, taking the impacted medication, had an undesirable drug response described in the CPIC guidelines that could potentially have been mitigated with a priori knowledge of the genotype. PwCF take many medications for disease management, with frequent dose changes to elicit a desired clinical effect. As CF care evolves, implementing pharmacogenetics testing can improve efficiency and safety of prescribing practices using precision selection and dosing at medication initiation.
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Project description:The accrual and analysis of genomic sequencing data have identified specific genetic variants that are associated with major depressive disorder. Moreover, substantial investigations have been devoted to identifying gene-drug interactions that affect the response to antidepressant medications by modulating their pharmacokinetic or pharmacodynamic properties. Despite these advances, individual responses to antidepressants, as well as the unpredictability of adverse side effects, leave clinicians with an imprecise prescribing strategy that often relies on trial and error. These limitations have spawned several combinatorial pharmacogenetic testing products that are marketed to physicians. Typically, combinatorial pharmacogenetic decision support tools use algorithms to integrate multiple genetic variants and assemble the results into an easily interpretable report to guide prescribing of antidepressants and other psychotropic medications. The authors review the evidence base for several combinatorial pharmacogenetic decision support tools whose potential utility has been evaluated in clinical settings. They find that, at present, there are insufficient data to support the widespread use of combinatorial pharmacogenetic testing in clinical practice, although there are clinical situations in which the technology may be informative, particularly in predicting side effects.
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Project description:Intravenous (IV) fluid prescribing is a common occurrence in inpatient settings; it has been repeatedly demonstrated that high levels of mortality and morbidity are associated with inappropriate IV fluid prescribing. IV fluid prescriptions are often completed by the most junior and inexperienced members of the clinical team. In recognition of the issues surrounding IV fluid prescribing and in an effort to combat the issues surrounding current practice, the National Institute for Health and Care Excellence (NICE) published guidance in December 2013 - 'Intravenous fluid therapy in adults in hospital (CG174)'. At our hospital the approach to IV fluid prescribing amongst junior doctors was highly variable with poor awareness of the NICE guidance. We defined necessary components for the documentation of IV fluid prescriptions based upon the NICE guidance. Our initial data showed that these components were infrequently documented, with prescriptions often having no indication for IV fluid, no 24 hour plan / review, no documentation of patient weight or request for further weights, and no current or requested fluid balance charts. Lanyard cards emphasising the necessary components of an appropriate IV fluid prescription along with a copy of the NICE fluid prescribing algorithm were distributed to junior doctors on the acute admissions units. Following the introduction of the lanyard cards there was a significant increase in the documentation of the defined prescription components. Significant increases in the documentation of indication for IV fluid and patient weight, which are essential components of accurate fluid prescription, were demonstrated on both medical and surgical admissions units. Subsequently, as a result of improved documentation and consideration given to fluid prescriptions, we were able to increase the percentage of maintenance IV fluid prescriptions that conformed to NICE guidelines. As an endpoint to this intervention all new Foundation Year 1 doctors at our hospital were issued with IV fluid prescribing lanyard cards at Trust induction; the authors believe that this intervention will lead to a unified approach and a sustained improvement in IV fluid prescribing practices and prescription documentation at this hospital site.
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Project description:A risk-based approach was used to develop guidance to be followed by food business operators (FBOs) when deciding on food information relating to storage conditions and/or time limits for consumption after opening a food package and thawing of frozen foods. After opening the package, contamination may occur, introducing new pathogens into the food and the intrinsic (e.g. pH and aw), extrinsic (e.g. temperature and gas atmosphere) and implicit (e.g. interactions with competing background microbiota) factors may change, affecting microbiological food safety. Setting a time limit for consumption after opening the package (secondary shelf-life) is complex in view of the many influencing factors and information gaps. A decision tree (DT) was developed to assist FBOs in deciding whether the time limit for consumption after opening, due to safety reasons, is potentially shorter than the initial 'best before' or 'use by' date of the product in its unopened package. For products where opening the package leads to a change of the type of pathogenic microorganisms present in the food and/or factors increasing their growth compared to the unopened product, a shorter time limit for consumption after opening would be appropriate. Freezing prevents the growth of pathogens, however, most pathogenic microorganisms may survive frozen storage, recover during thawing and then grow and/or produce toxins in the food, if conditions are favourable. Moreover, additional contamination may occur from hands, contact surfaces or contamination from other foods and utensils. Good practices for thawing should, from a food safety point of view, minimise growth of and contamination by pathogens between the food being thawed and other foods and/or contact surfaces, especially when removing the food from the package during thawing. Best practices for thawing foods are presented to support FBOs.
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