Related Articles

Adverse event-related costs for systemic metastatic breast cancer treatment among female Medicaid beneficiaries.

J Med Econ. 2016 Nov;19(11):1027-1033

Authors: Irwin DE, Masaquel A, Johnston S, Barnett B

Abstract
OBJECTIVE: This retrospective study compared the real-world incidence and costs of systemic treatment-related adverse events (AEs) in patients with metastatic breast cancer in a Medicaid population.
METHODS: Insurance claims data for adult women who received biologic or chemotherapy (± hormonal therapy) for metastatic breast cancer between 2006-2013 were extracted from the Truven Health MarketScan(®) Multi-State Medicaid database. Incidence of AEs (per 100 person years) and average monthly AE-related healthcare costs (per-patient-per-month) during each line of therapy (first or later lines) were estimated. The association between AEs and total all-cause healthcare costs was estimated using multivariable regression.
RESULTS: A total of 729 metastatic breast cancer patients were analyzed. Hematological (202.3 per 100 person years) and constitutional AEs (289.6 per 100 person years) were the most common class of AEs reported. Unadjusted per-patient-per-month AE-related expenditure by class were highest for hematological AEs ($1524), followed by gastrointestinal ($839) and constitutional AEs ($795), with anemia ($942), nausea/vomiting ($699), and leukopenia/neutropenia ($550) having incurred the highest total AE-related costs. Adjusted total all-cause monthly costs increased with the number of AEs ($19,701 for >7 AEs, $16,264 for 4 - 6 AEs, and $13,731 for 1 - 3 AEs) compared to no AEs ($5908) (all p < 0.01).
CONCLUSIONS: Among metastatic breast cancer patients treated with systemic therapy in a Medicaid population, AEs were associated with significant increases in costs, which increased with the number of AEs experienced. Therapies associated with a lower incidence of AEs may reduce cost burden and improve patient outcomes.

PMID: 27206801 [PubMed - indexed for MEDLINE]

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Clinical pharmacists' opportunities to reduce inappropriate prescription of QT-prolonging medications: calls to action.

Int J Pharm Pract. 2017 Apr;25(2):176-179

Authors: Dhanani TC, Mantovani EH, Turner JR

Abstract
All biologically active agents carry the potential to lead to adverse reactions in certain individuals, including serious cardiac adverse reactions. Since 2005, there has been an international regulatory landscape governing the investigation of a new drug's propensity to lead to the polymorphic ventricular tachycardia Torsades de Pointes (Torsades), a rare but potentially fatal occurrence. When a regulatory agency considers it appropriate, warning information is placed in a medicine's patient information leaflet (label) concerning drug-induced QT interval prolongation, a phenomenon associated with Torsades. In busy hospital settings, however, prescribers, including cardiologists, make injudicious prescribing decisions that put patients at risk. The science of cardiac safety, including the clinical trials that generate the information about QT prolongation in patient information leaflets, is frequently not part of the curriculum at Schools of Pharmacy. Given that medication-induced cardiotoxicity is extremely serious, we advocate that schools integrate the science of cardiac safety into existing therapeutics/therapeutic medication monitoring courses. Given their expert knowledge of pharmacology, pharmacists working as part of a hospital's clinical team would then be even better placed to review prescribing decisions concerning medications that prolong the QT interval, and alert prescribers in cases where reassessing their decisions seems prudent. National pharmacy societies or other pertinent professional societies could create practice guidelines to support graduates once employed as clinical pharmacists. Clinical pharmacists are well placed to be influential arbiters of safer prescribing decisions. Cardiac safety education during their pharmacy training and practice guideline support from professional societies during their careers can optimize this role.

PMID: 27677250 [PubMed - indexed for MEDLINE]

Related Articles

The economic burden of common adverse events associated with metastatic colorectal cancer treatment in the United States.

J Med Econ. 2017 Jan;20(1):54-62

Authors: Latremouille-Viau D, Chang J, Guerin A, Shi S, Wang E, Yu J, Ngai C

Abstract
AIMS: Adverse events (AEs) associated with treatments for metastatic colorectal cancer (mCRC) may compromise the course of treatment, impact quality-of-life, and increase healthcare resource utilization. This study assessed the direct healthcare costs of common AEs among mCRC patients in the US.
METHODS: Adult mCRC patients treated with chemotherapy or targeted therapies were identified from administrative claims databases (2009-2014). Up to the first three mCRC treatment episodes per patient were considered and categorized as with or without the AE system/organ category during the episode. Total healthcare costs (2014 USD) were measured by treatment episode and reported on a monthly basis. Treatment episodes with the AE category were matched by treatment type and line of treatment to those without the AE category. Adjusted total cost differences were estimated by comparing costs during treatment episodes with vs without the AE category using multivariate regression models; p-values were estimated with bootstrap.
RESULTS: A total of 4158 patients with ≥1 mCRC treatment episode were included (mean age = 59 years; 58% male; 60% with liver and 14% with lung metastases; 2,261 [54%] with a second and 1,115 [27%] with a third episode). On average, two treatment episodes were observed per patient with an average length of 166 days per episode. Adjusted monthly total cost difference by AE category included hematologic ($1,480), respiratory ($1,253), endocrine/metabolic ($1,213), central nervous system (CNS; $1,136), and cardiovascular ($1,036; all p < .05).
LIMITATIONS: Claims do not include information on the cause of AEs, and potentially less severe AEs may not have been reported by the physician when billing the medical service. This study aimed to assess the association between costs and AEs and not the causation of AEs by treatment.
CONCLUSIONS: The most costly AEs among mCRC patients were hematologic, followed by respiratory, endocrine/metabolic, CNS, and cardiovascular.

PMID: 27603498 [PubMed - indexed for MEDLINE]

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How much information about the benefits of medicines is included in patient leaflets in the European Union? - A survey.

Int J Pharm Pract. 2017 Apr;25(2):147-158

Authors: Dickinson R, Raynor DK, Knapp P, MacDonald J

Abstract
INTRODUCTION: Patient information leaflets (PILs) are required with all licensed medicines throughout the European Union (EU) and they must include information about all side effects and their likelihood. This has led to criticism of a lack of balance, with little information included about potential benefits. Recent European Medicines Agency guidance proposed the inclusion of benefit information, and this study examined the current prevalence and type of such information in PILs in the EU.
METHODS: A survey and content analysis of the English translation of PILs in the EUwas carried out. Random quota sampling was used on the most frequently dispensed (n = 50) and newly licensed medicines (n = 50) in 2011/2. Leaflets were searched for benefit information meeting predefined criteria, and data synthesised and categorised into 10 categories.
RESULTS: Eighty-five (85%) leaflets described how the medicine works, with 45 providing information about the rationale for treatment (more commonly for newly licensed (32/50) than most commonly dispensed medicines (13/50; P < 0.001). Nearly half (47) did not describe whether the medicine was curative, symptomatic or preventative. The terms used to communicate uncertainty were imprecise (such as 'may help'). None communicated numerical benefit information.
CONCLUSION: Current PILs do not appropriately communicate information about benefit. At the basic level, around a half did not include information about treatment rationale or whether the treatment was to treat symptoms, curative or preventative. However, for true informed decision making, patients need quantitative information about benefits and none of the leaflets provided this.

PMID: 27405658 [PubMed - indexed for MEDLINE]

Funding Opportunity RFA-ES-17-006 from the NIH Guide for Grants and Contracts. The funding opportunity announcement (FOA) will support development and pilot testing of assays, such as DNA repair capacity or mutation detection, that will facilitate the wider use of genome integrity investigation in epidemiological and population studies.

Funding Opportunity RFA-NS-17-024 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NeuroNEXT sites and potential new sites to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies for neurological disorders, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials.

Notice NOT-GM-17-010 from the NIH Guide for Grants and Contracts

Notice NOT-EY-17-007 from the NIH Guide for Grants and Contracts

Notice NOT-HL-17-523 from the NIH Guide for Grants and Contracts

Notice NOT-HL-17-522 from the NIH Guide for Grants and Contracts

Notice NOT-OD-17-086 from the NIH Guide for Grants and Contracts

Notice NOT-MH-17-035 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-AG-18-012 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites applications to design and implement research infrastructure that will enable the monitoring of cognitive abilities and age, state, context, or health condition-related changes in cognitive abilities on mobile devices. This effort will include the development (or support for development) of apps on the Android and iOS platforms, the validation of tests and items to be used on the two leading smartphone platforms in age groups ranging from 20 to 85, and the norming of successfully validated measures to nationally representative U.S. population samples that will also receive gold standard measures, including the NIH Toolbox for Assessment of Behavioral and Neurological Function. A goal of this project is to also support data collection efforts from participants enrolled in projects awarded through this FOA as well as other NIH-funded studies though FY2022, and enable the widespread sharing of both the collected data and the test instruments.

Funding Opportunity RFA-AR-18-001 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to publicize a competition for Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRCs). These Centers promote collaborative basic, translational and clinical research and provide important resources that can be used by the national muscular dystrophy research communities. The Centers also provide an outstanding environment for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Center investigators are expected to participate in important community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities.

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Related Articles

Phenotypic and genomic survey on organic acid utilization profile of Pseudomonas mendocina strain S5.2, a vineyard soil isolate.

AMB Express. 2017 Dec;7(1):138

Authors: Chong TM, Chen JW, See-Too WS, Yu CY, Ang GY, Lim YL, Yin WF, Grandclément C, Faure D, Dessaux Y, Chan KG

Abstract
Root exudates are chemical compounds that are released from living plant roots and provide significant energy, carbon, nitrogen and phosphorus sources for microbes inhabiting the rhizosphere. The exudates shape the microflora associated with the plant, as well as influences the plant health and productivity. Therefore, a better understanding of the trophic link that is established between the plant and the associated bacteria is necessary. In this study, a comprehensive survey on the utilization of grapevine and rootstock related organic acids were conducted on a vineyard soil isolate which is Pseudomonas mendocina strain S5.2. Phenotype microarray analysis has demonstrated that this strain can utilize several organic acids including lactic acid, succinic acid, malic acid, citric acid and fumaric acid as sole growth substrates. Complete genome analysis using single molecule real-time technology revealed that the genome consists of a 5,120,146 bp circular chromosome and a 252,328 bp megaplasmid. A series of genetic determinants associated with the carbon utilization signature of the strain were subsequently identified in the chromosome. Of note, the coexistence of genes encoding several iron-sulfur cluster independent isoenzymes in the genome indicated the importance of these enzymes in the events of iron deficiency. Synteny and comparative analysis have also unraveled the unique features of D-lactate dehydrogenase of strain S5.2 in the study. Collective information of this work has provided insights on the metabolic role of this strain in vineyard soil rhizosphere.

PMID: 28655216 [PubMed]

CodeMapper: semiautomatic coding of case definitions. A contribution from the ADVANCE project.

Pharmacoepidemiol Drug Saf. 2017 Jun 28;:

Authors: Becker BFH, Avillach P, Romio S, van Mulligen EM, Weibel D, Sturkenboom MCJM, Kors JA, ADVANCE consortium

Abstract
BACKGROUND: Assessment of drug and vaccine effects by combining information from different healthcare databases in the European Union requires extensive efforts in the harmonization of codes as different vocabularies are being used across countries. In this paper, we present a web application called CodeMapper, which assists in the mapping of case definitions to codes from different vocabularies, while keeping a transparent record of the complete mapping process.
METHODS: CodeMapper builds upon coding vocabularies contained in the Metathesaurus of the Unified Medical Language System. The mapping approach consists of three phases. First, medical concepts are automatically identified in a free-text case definition. Second, the user revises the set of medical concepts by adding or removing concepts, or expanding them to related concepts that are more general or more specific. Finally, the selected concepts are projected to codes from the targeted coding vocabularies. We evaluated the application by comparing codes that were automatically generated from case definitions by applying CodeMapper's concept identification and successive concept expansion, with reference codes that were manually created in a previous epidemiological study.
RESULTS: Automated concept identification alone had a sensitivity of 0.246 and positive predictive value (PPV) of 0.420 for reproducing the reference codes. Three successive steps of concept expansion increased sensitivity to 0.953 and PPV to 0.616.
CONCLUSIONS: Automatic concept identification in the case definition alone was insufficient to reproduce the reference codes, but CodeMapper's operations for concept expansion provide an effective, efficient, and transparent way for reproducing the reference codes.

PMID: 28657162 [PubMed - as supplied by publisher]

Assessment of acquired mucociliary clearance defects using micro-optical coherence tomography.

Int Forum Allergy Rhinol. 2017 Jun 28;:

Authors: Tipirneni KE, Grayson JW, Zhang S, Cho DY, Skinner DF, Lim DJ, Mackey C, Tearney GJ, Rowe SM, Woodworth BA

Abstract
BACKGROUND: Dehydration of airway surface liquid (ASL) disrupts normal mucociliary clearance (MCC) in sinonasal epithelium, which may lead to chronic rhinosinusitis (CRS). Abnormal chloride (Cl(-) ) transport is one such mechanism that contributes to this disorder and can be acquired secondary to environmental perturbations, such as hypoxia at the tissue surface. The objective of this study was to assess the technological feasibility of the novel micro-optical coherence tomography (μOCT) imaging technique for investigating acquired MCC defects in cultured human sinonasal epithelial (HSNE) cells.
METHODS: Primary HSNE cell cultures were subjected to a 1% oxygen environment for 12 hours to induce acquired cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction. Ion transport characteristics were assessed with pharmacologic manipulation in Ussing chambers. ASL, periciliary fluid (PCL), and ciliary beat frequency (CBF) were evaluated using μOCT.
RESULTS: Amiloride-sensitive transport (ΔISC ) was greater in cultures exposed to hypoxia (hypoxia: -13.2 ± 0.6 μA/cm(2) ; control: -6.5 ± 0.1 μA/cm(2) ; p < 0.01), whereas CFTR-mediated anion transport was significantly diminished (hypoxia: 28.6 ± 0.3 μA/cm(2) ; control: 36.2 ± 1.6 μA/cm(2) ; p < 0.01), consistent with acquired CFTR dysfunction and sodium hyperabsorption. Hypoxia diminished all markers of airway surface function microanatomy as observed with μOCT, including ASL (hypoxia: 5.0 ± 0.4 μm; control: 9.0 ± 0.9 μm; p < 0.01) and PCL depth (hypoxia: 2.5 ± 0.1 μm; control: 4.8 ± 0.3 μm; p < 0.01), and CBF (hypoxia: 8.7 ± 0.3 Hz; control: 10.2 ± 0.3 Hz; p < 0.01).
CONCLUSION: Hypoxia-induced defects in epithelial anion transport in HSNE led to predictable effects on markers of MCC measured with novel μOCT imaging. This imaging method represents a technological leap forward and is feasible for assessing acquired defects impacting the airway surface.

PMID: 28658531 [PubMed - as supplied by publisher]

Chasing Zero: Increasing Infection Control Compliance on an Inpatient Cystic Fibrosis Unit.

J Nurs Care Qual. 2017 Jun 23;:

Authors: Johnson S, McNeal M, Mermis J, Polineni D, Burger S

Abstract
Patients with cystic fibrosis have increased risk of pulmonary infections, and reducing spread of microorganisms is critical. To improve hospital-staff adherence to infection control guidelines, we implemented brightly colored Safe Zone floor decals, staff compliance contracts, and an infection control in-service video. Audits of staff adherence conducted pre and postintervention demonstrated an increased and sustainable improvement among each group (P < .05). These effective measures may be implemented to improve infection control compliance elsewhere.

PMID: 28658183 [PubMed - as supplied by publisher]

Adeno-Associated Virus (AAV) gene therapy for cystic fibrosis: current barriers and recent developments.

Expert Opin Biol Ther. 2017 Jun 28;:

Authors: Guggino WB, Cebotaru L

Abstract
INTRODUCTION: Since the cystic fibrosis (CF) gene was discovered in 1989, researchers have worked to develop a gene therapy. One of the most promising and enduring vectors is the AAV, which has been shown to be safe. In particular, several clinical trials have been conducted with AAV serotype 2. All of them detected viral genomes, but identification of mRNA transduction was not consistent; clinical outcomes in Phase II studies were also inconsistent. The lack of a positive outcome has been attributed to a less-than-efficient viral infection by AAV2, a weak transgene promoter and the host immune response to the vector. Areas Covered: Herein, the authors focus on AAV gene therapy for CF, evaluating past experience with this approach and identifying ways forward, based on the progress that has already been made in identifying and overcoming the limitations of AAV gene therapy. Expert opinion: Such progress makes it clear that this is an opportune time to push forward toward the development of a gene therapy for CF. Drugs to treat the basic defect in CF represent a remarkable advance but cannot treat a significant cohort of patients with rare mutations. Thus, there is a critical need to develop a gene therapy for those individuals.

PMID: 28657358 [PubMed - as supplied by publisher]