Related Articles

Optimistic bias, advertising skepticism, and consumer intentions for seeking information about the health risks of prescription medicine.

Health Mark Q. 2017 Apr-Jun;34(2):81-96

Authors: Park JS, Ahn HA, Haley EJ

Abstract
Based on a survey of prescription drug users (N = 408), this study revealed that: (a) the frequency of consumers' personal experience of prescription medicine adverse reactions negatively related to the extent of their optimistic bias about the chances of such events, (b) consumers' perceived personal control over adverse reactions positively related to optimistic bias, and (c) optimistic bias related more negatively to intentions to seek risk information when consumer skepticism toward direct-to-consumer advertising was high. When skepticism was low to average, optimistic bias did not inhibit such intentions. Implications and recommendations for the practice of direct-to-consumer advertising are provided.

PMID: 28590885 [PubMed - indexed for MEDLINE]

Related Articles

Potential drug-drug interactions in pediatric patients admitted to intensive care unit of Khyber Teaching Hospital, Peshawar, Pakistan: A cross-sectional study.

J Crit Care. 2017 Aug;40:243-250

Authors: Ismail M, Aziz S, Noor S, Haider I, Shams F, Haq I, Khadim F, Khan Q, Khan F, Asif M

Abstract
PURPOSE: To investigate frequencies, levels, clinical relevance and predictors of potential drug-drug interactions (pDDIs) in pediatric intensive care unit (PICU).
METHODS: Case notes of 411 patients were reviewed for pDDIs through Micromedex. Frequencies, levels and clinical relevance of pDDIs were reported. Logistic regression was applied to calculate the odds-ratios for predictors of pDDIs.
RESULTS: We recorded pDDIs in 59.4% patients. Major-pDDIs were found in 34.5% patients. Total 990 pDDIs were identified, of which, 37.8% were of moderate-severity and 30.6% of major-severity. Patient's case notes of top-ten pDDIs showed presence of signs/symptoms such as fever, jaundice, vomiting, anorexia, tachycardia, drowsiness, & lethargy; and abnormalities in labs such as total leukocytes count, blood urea nitrogen, alanine aminotransferase, & potassium-level. Odds of exposure to major-pDDIs were significantly higher in patients aged 6-12years (p=0.008); hospital stay of ≥7days (p=0.05); and ≥11 prescribed medicines (p<0.001).
CONCLUSION: Substantial numbers of patients in PICU are exposed to pDDIs. Major-pDDIs are of particular concern. Timely identification of pDDIs, preferably with computerized source, is crucial point for their management. Monitoring of clinically relevant parameters and identification of various predictors are needed to minimize or prevent the associated negative consequences of pDDIs.

PMID: 28458171 [PubMed - indexed for MEDLINE]

Related Articles

Pediatric Off-Label and Unlicensed Drug Use and Its Implications.

Curr Clin Pharmacol. 2017;12(1):18-25

Authors: Gore R, Chugh PK, Tripathi CD, Lhamo Y, Gautam S

Abstract
BACKGROUND: Worldwide, in the absence of standard pediatric prescribing information, clinicians often use medicines in children in a dosage form or for an indication that has not been approved for use. Inadequate clinical trials increase exposure to drugs that lack safety-efficacy data in pediatric population. Hence, off-label and unlicensed drug use must be regarded as a patient safety-issue that is known to be associated with increased risks of adverse drug reactions apart from under- or overdosing due to lack of pharmacokinetic data. This review aims to give an overview of the worldwide reported rates of off-label and unlicensed drug use in different patient populations in pediatric settings, with a brief summary of the related adverse drug reactions (ADRs) and a discussion of the existing regulatory provisions and possible solutions for ensuring safe use of medicines in children.
METHOD: Literature searches were conducted and we included studies that evaluated unlicensed or off-label drug use in various pediatric patient populations. The definition of off-label drug use and unlicensed drug varied between different studies.
RESULTS: Fourteen studies from different countries were included in the review and were grouped as: studies conducted in the patients admitted in neonatal intensive care units, in pediatric wards, in hospitalized children and in pediatric outpatient settings. The number of patients studied ranged from 34 in neonatal intensive care units to 355 409 hospitalized children. Many studies reported high rates of off-label (9% to 78.7%) and unlicensed (0.3% to 35%) drug use in different pediatric patient settings.
CONCLUSION: Given the prevalence of unlicensed and off-label drug use, the cooperation of various stakeholders including health professionals, pediatric population and their parents/caregivers, regulatory authorities, and the pharmaceutical industry is integral to instituting individual measures to avoid exposing children to unnecessary risks and avoid depriving them of potentially effective pharmacotherapy. Initiatives to encourage clinical trials for licensing drug use in children by providing market exclusivity and patent extension could aid in bridging the gap between approval and contemporary drug prescribing practices. Enforcement of legislations in the drug development process and subsequent pharmacovigilance could improve the quality of information and accountability of pharmaceutical industry to support and facilitate drug research in children.

PMID: 28322168 [PubMed - indexed for MEDLINE]

Related Articles

Cytochrome 2B6 polymorphism and efavirenz-induced central nervous system symptoms : a substudy of the ANRS ALIZE trial.

HIV Med. 2017 Sep;18(8):537-545

Authors: Gallien S, Journot V, Loriot MA, Sauvageon H, Morlat P, Reynes J, Reliquet V, Chêne G, Molina JM, ANRS 099 ALIZE trial study group

Abstract
OBJECTIVES: Single nucleotide polymorphisms in the cytochrome P450 (CYP) 2B6 gene have been associated with high interindividual variation in efavirenz pharmacokinetics. However, clinical data on the relationship of CYP2B6 polymorphisms with the occurrence of efavirenz-induced central nervous system (CNS) symptoms are limited.
METHODS: We analysed four polymorphisms in the CYP2B6 (516 G>T), CYP3A5 (6986 A>G) and ATP-binding cassette, sub-family B, member 1 (ABCB1) (2677 G>T/A and 3435 C>T) genes in HIV-infected adults virologically suppressed on a protease inhibitor-based regimen who switched to a regimen containing emtricitabine, didanosine and efavirenz in the setting of the ANRS ALIZE trial. Kaplan-Meier methods and Cox regression analysis were used to investigate their association with efavirenz plasma levels and CNS events up to 48 months after switching.
RESULTS: In total, 191 patients with a median age of 41 years, who were 87% male and 85% Caucasian, were enrolled in the study. Variant allelic frequencies were 0.49, 0.93, 0.59 and 0.63 for CYP2B6 516, CYP3A5 392, ABCB1 2677 and ABCB1 3435, respectively. The median efavirenz plasma concentration (MEPC) was 2.2 mg/L [interquartile range (IQR) 1.7-2.8 mg/L] and was significantly higher in patients with the deficient CYP2B6 516T. Overall, 242 CNS events were reported in 104 individuals (54%). No correlation was found between MEPC and CNS events. The occurrence of a first CNS event was lower in patients with the CYP2B6 516 G/G genotype vs. CYP2B6 516 T genotypes [50% (IQR: 40-60%) vs. 66% (IQR: 56-75%), respectively; P = 0.02]. In an adjusted Cox regression model, there was a tendency towards a higher risk of a first CNS event among carriers of the variant CYP2B6 516 T allele (relative risk 1.4 [95% CI, 0.99-2.1]; P?=?.06), compared with noncarriers.
CONCLUSIONS: The deficient CYP2B6 516 T allele is associated with higher efavirenz plasma drug levels and more frequent CNS-related symptoms.

PMID: 28145050 [PubMed - indexed for MEDLINE]

Related Articles

Health care professionals knowledge and perception of pharmacovigilance in a tertiary care teaching hospital in Amman, Jordan.

J Eval Clin Pract. 2017 Jun;23(3):608-613

Authors: Abu Hammour K, El-Dahiyat F, Abu Farha R

Abstract
RATIONALE, AIMS, AND OBJECTIVES: Underreporting of adverse drug reactions (ADRs) by health care professionals is a common inherent health problem encountered in many countries. This could be explained by the lack of awareness and knowledge about the guidelines to follow to identify and report ADRs. Thus, this study aimed to evaluate the awareness, knowledge, and perceptions among medical doctors and nurses regarding their role as ADRs reporters in Jordan.
METHODS: A cross-sectional study was conducted between September 2015 to January 2016 at the Jordan University Hospital in Amman. During the study period, a total of 670 validated questionnaires were distributed to medical doctors and nurses in different departments.
RESULTS: Most of health care professionals were not aware of the concept of pharmacovigilance. Medical doctors showed a better overall knowledge compared with nurses (P < .05). Interestingly, despite the low level of awareness, the majority of respondents believed in the necessity of reporting ADRs.
CONCLUSION: Although there is a low level of awareness among health care professionals regarding pharmacovigilance, there is strong agreement among them about the necessity of reporting ADRs and attending educational sessions about pharmacovigilance which will help them to improve the quality of services they provide.

PMID: 28090715 [PubMed - indexed for MEDLINE]

Related Articles

Impact of a Pharmacy-Cardiology Collaborative Practice on Dofetilide Safety Monitoring.

Ann Pharmacother. 2017 Jan;51(1):39-43

Authors: Quffa LH, Panna M, Kaufmann MR, McKillop M, Dietrich NM, Franck AJ

Abstract
BACKGROUND: Limited studies have been published examining dofetilide's postmarketing use and its recommended monitoring.
OBJECTIVE: To evaluate the impact of a collaborative pharmacy-cardiology antiarrhythmic drug (AAD) monitoring program on dofetilide monitoring.
METHODS: This retrospective cohort study was performed to assess if a novel monitoring program improved compliance with dofetilide-specific monitoring parameters based on the Food and Drug Administration's Risk Evaluation and Mitigation Strategy.
RESULTS: A total of 30 patients were included in the analysis. The monitoring parameters evaluated included electrocardiogram, serum potassium, serum magnesium, and kidney function. The primary outcome evaluated was the composite of these dofetilide monitoring parameters obtained in each cohort. In the standard cohort, 245 of 352 (69.6%) monitoring parameters were completed versus 134 of 136 (98.5%) in the intervention group ( P < 0.05).
CONCLUSION: A collaborative pharmacy-cardiology AAD monitoring program was associated with a significant improvement in dofetilide monitoring. This improvement could potentially translate into enhanced patient safety outcomes, such as prevention of adverse drug reactions and decreased hospitalizations.

PMID: 27630191 [PubMed - indexed for MEDLINE]

16 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

"Rare Diseases"[Mesh] OR "orphan disease"

These pubmed results were generated on 2018/04/03

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

37 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

"systems biology"

These pubmed results were generated on 2018/04/03

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Notice NOT-NS-18-054 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-RM-18-006 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites applications from the Program Directors/Principal Investigators of the current Building Infrastructure Leading to Diversity (BUILD) awards. BUILD is part of the Enhancing the Diversity of the NIH-Funded Workforce Program, also known as the Diversity Program Consortium (DPC), consists of three integrated initiatives: BUILD, the National Research Mentoring Network (NRMN) and the Coordination and Evaluation Center (CEC). The purpose of the funding is to allow BUILD sites to continue to implement and evaluate the multi-pronged student, faculty, and institutional interventions to enhance diversity in the NIH biomedical research workforce. In preparation for the second phase of the BUILD initiative, the applicants are expected to provide plans to transition into sustainable models for enhancing diversity in the biomedical research fields at their institutions. Applicants are also expected to develop an effective training, mentoring, or research capacity building intervention that will be disseminated to other institutions to increase the national impact of the initiative.

Funding Opportunity RFA-DK-18-005 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from integrative teams and individual investigators for projects to determine the mechanisms underlying the contribution of these risk-associated genes and their variants for T1D. The purpose is to accelerate the discovery of function of the causal genes and variants that influence the risk for disease.

Notice NOT-DE-18-016 from the NIH Guide for Grants and Contracts

Notice NOT-DA-18-010 from the NIH Guide for Grants and Contracts

Notice NOT-DE-18-014 from the NIH Guide for Grants and Contracts

Notice NOT-CA-18-061 from the NIH Guide for Grants and Contracts

Notice NOT-HL-18-614 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-18-735 from the NIH Guide for Grants and Contracts. This opportunity supports research opportunities that will advance our understanding of, and the implementation of, the use of genomic information about an individual to inform clinical care, and the health outcomes of that clinical use.

Funding Opportunity PAR-18-736 from the NIH Guide for Grants and Contracts. This opportunity supports research opportunities that will advance our understanding of, and the implementation of, the use of genomic information about an individual to inform clinical care, and the health outcomes of that clinical use.

Funding Opportunity PAR-18-737 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications for Silvio O. Conte Centers for Basic Neuroscience or Translational Mental Health Research. The institute seeks teams of researchers working at different levels of analysis and employing integrative, novel, and creative experimental approaches to address high-risk, high-impact questions in basic neuroscience research, or in translational research with the primary objectives of: (a) advancing the state of the science in basic brain and behavior research that will uncover and dissect the underlying mechanisms that will ultimately provide the foundation for understanding mental disorders; (b) supporting the integration and translation of basic and clinical neuroscience research on severe mental illnesses; and/or (c) advancing our understanding of the neurobehavioral developmental mechanisms and trajectories of psychopathology that begin in childhood and adolescence. The Conte Centers program is intended to support interdisciplinary basic neuroscience or translational research demonstrating an extraordinary level of synergy, integration, and potential for advancing the state of the field. This program is intended only for projects that could not be achieved using other, more standard grant mechanisms. The Conte Centers program also provides an opportunity to establish interdisciplinary basic neuroscience or translational research experiences for students and post doctorates.

Principles and applications of pharmacometrics in drug evaluation in children.

Therapie. 2018 Feb 16;:

Authors: Leroux S, Elie V, Zhao W, Magreault S, Jacqz-Aigrain E

Abstract
Drug evaluation in children is difficult for many well-identified reasons and many drugs are still used off-label. Innovative approaches are particularly adapted to the paediatric and neonatal populations, as clinical trials are difficult to conduct, need adapted designs in order to define the optimal dosage regimen in many diseases and therapeutic areas. Population approaches to define pharmacokinetics and pharmacokinetic/pharmacodynamics are now more currently used to define dosing regimens, adapted to the different paediatric and neonatal age groups, that allow to increase efficacy and reduce toxicity, by taking into account factors explaining variability in drug response. Such approaches are presented and the evaluation of vancomycin in neonates is detailed as different steps allowed validation of the optimal strategy to administer vancomycin in neonates.

PMID: 29605146 [PubMed - as supplied by publisher]