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Adverse Drug Reaction

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Maria Teresa Herdeiro – One of the best experts on this subject based on the ideXlab platform.

  • strategies to improve Adverse Drug Reaction reporting a critical and systematic review
    Drug Safety, 2013
    Co-Authors: Cristian Gonzalezgonzalez, Adolfo Figueiras, Elena Lopezgonzalez, Maria Teresa Herdeiro
    Abstract:

    Background Underreporting is the major limitation of a voluntary Adverse Drug Reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting.

  • influence of pharmacists attitudes on Adverse Drug Reaction reporting a case control study in portugal
    Drug Safety, 2006
    Co-Authors: Maria Teresa Herdeiro, Adolfo Figueiras, Jorge Polonia, Juan Jesus Gestalotero
    Abstract:

    Introduction: Pharmacists can play a fundamental role in Adverse Drug Reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists’ ADR reporting in northern Portugal.

  • physicians attitudes and Adverse Drug Reaction reporting a case control study in portugal
    Drug Safety, 2005
    Co-Authors: Adolfo Figueiras, Maria Teresa Herdeiro, Jorge Polonia, Juan Jesus Gestalotero
    Abstract:

    Objectives: Voluntary Adverse Drug Reaction (ADR) reporting is fundamental to medical Drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge-and attitude-related factors associated with ADR reporting by physicians in Northern Portugal.

Adolfo Figueiras – One of the best experts on this subject based on the ideXlab platform.

  • strategies to improve Adverse Drug Reaction reporting a critical and systematic review
    Drug Safety, 2013
    Co-Authors: Cristian Gonzalezgonzalez, Adolfo Figueiras, Elena Lopezgonzalez, Maria Teresa Herdeiro
    Abstract:

    Background Underreporting is the major limitation of a voluntary Adverse Drug Reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting.

  • influence of pharmacists attitudes on Adverse Drug Reaction reporting a case control study in portugal
    Drug Safety, 2006
    Co-Authors: Maria Teresa Herdeiro, Adolfo Figueiras, Jorge Polonia, Juan Jesus Gestalotero
    Abstract:

    Introduction: Pharmacists can play a fundamental role in Adverse Drug Reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists’ ADR reporting in northern Portugal.

  • physicians attitudes and Adverse Drug Reaction reporting a case control study in portugal
    Drug Safety, 2005
    Co-Authors: Adolfo Figueiras, Maria Teresa Herdeiro, Jorge Polonia, Juan Jesus Gestalotero
    Abstract:

    Objectives: Voluntary Adverse Drug Reaction (ADR) reporting is fundamental to medical Drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge-and attitude-related factors associated with ADR reporting by physicians in Northern Portugal.

Munir Pirmohamed – One of the best experts on this subject based on the ideXlab platform.

  • development of the liverpool Adverse Drug Reaction avoidability assessment tool
    PLOS ONE, 2017
    Co-Authors: Louise E Bracken, Munir Pirmohamed, Jamie J Kirkham, Anthony J Nunn, Rosalind L Smyth, M Peak, Janine Arnott, Mark A Turner
    Abstract:

    Aim To develop and test a new tool to assess the avoidability of Adverse Drug Reactions that is suitable for use in paediatrics but which is also applicable to a variety of other settings. Methods The study involved multiple phases. Preliminary work involved using the Hallas scale and a modification of the existing Hallas scale, to assess two different sets of Adverse Drug Reaction (ADR) case reports. Phase 1 defined, modified and refined a new tool using multidisciplinary teams. Phase 2 involved the assessment of 50 ADR case reports from a prospective study of paediatric inpatients by individual assessors. Phase 3 compared assessments with the new tool for individuals and groups in comparison to the ‘gold standard’ (the avoidability outcome set by a panel of senior investigators: an experienced clinical pharmacologist, paediatrician and pharmacist). Main Outcome Measures Inter-rater reliability (IRR), measure of disagreement and utilization of avoidability categories. Results Preliminary work—Pilot phase: results for the original Hallas cases were fair and pairwise kappa scores ranged from 0.21 to 0.36. Results for the modified Hallas cases were poor, pairwise kappa scores ranged from 0.06 to 0.16. Phase 1: on initial use of the new tool, agreement between the two multidisciplinary groups was found on 13/20 cases with a kappa score of 0.29 (95% CI -0.04 to 0.62). Phase 2: the assessment of 50 ADR case reports by six individual reviewers yielded pairwise kappa scores ranging from poor to good 0.12 to 0.75 and percentage exact agreement (%EA) ranged from 52–90%. Phase 3: Percentage exact agreement ranged from 35–70%. Overall, individuals had better agreement with the ‘gold standard’. Conclusion Avoidability assessment is feasible but needs careful attention to methods. The Liverpool ADR avoidability assessment tool showed mixed IRR. We have developed and validated a method for assessing the avoidability of ADRs that is transparent, more objective than previous methods and that can be used by individuals or groups.

  • development and inter rater reliability of the liverpool Adverse Drug Reaction causality assessment tool
    PLOS ONE, 2011
    Co-Authors: Ruairi M Gallagher, Jamie J Kirkham, Jennifer Mason, Kim A Bird, Paula R Williamson, Anthony J Nunn, Mark A Turner, Rosalind L Smyth, Munir Pirmohamed
    Abstract:

    Aim To develop and test a new Adverse Drug Reaction (ADR) causality assessment tool (CAT). Methods A comparison between seven assessors of a new CAT, formulated by an expert focus group, compared with the Naranjo CAT in 80 cases from a prospective observational study and 37 published ADR case reports (819 causality assessments in total). Main Outcome Measures Utilisation of causality categories, measure of disagreements, inter-rater reliability (IRR). Results The Liverpool ADR CAT, using 40 cases from an observational study, showed causality categories of 1 unlikely, 62 possible, 92 probable and 125 definite (1, 62, 92, 125) and ‘moderate’ IRR (kappa 0.48), compared to Naranjo (0, 100, 172, 8) with ‘moderate’ IRR (kappa 0.45). In a further 40 cases, the Liverpool tool (0, 66, 81, 133) showed ‘good’ IRR (kappa 0.6) while Naranjo (1, 90, 185, 4) remained ‘moderate’. Conclusion The Liverpool tool assigns the full range of causality categories and shows good IRR. Further assessment by different investigators in different settings is needed to fully assess the utility of this tool.

  • attitudes and knowledge of hospital pharmacists to Adverse Drug Reaction reporting
    British Journal of Clinical Pharmacology, 2001
    Co-Authors: Christopher F Green, David R Mottram, Philip H Rowe, Munir Pirmohamed
    Abstract:

    Aims  To investigate the attitudes of UK hospital pharmacists towards, and their understanding, of Adverse Drug Reaction (ADR) reporting. Methods  A postal questionnaire survey of 600 randomly selected hospital pharmacists was conducted. Results  The response rate was 53.7% (n = 322). A total of 217 Yellow Cards had been submitted to the CSM/MCA by 78 (25.6%) of those responding. Half of those responding felt that ADR reporting should be compulsory and over three-quarters felt it was a professional obligation. However, almost half were unclear as to what should be reported, while the time available in clinical practice and time taken to complete forms were deemed to be major deterrents to reporting. Pharmacists were not dissuaded from reporting by the need to consult a medical colleague or by the absence of a fee. Education and training had a significant influence on pharmacists’ participation in the Yellow Card Scheme. Conclusions  Pharmacists have a reasonable knowledge and are supportive of the Yellow Card spontaneous ADR reporting scheme. However, education and training will be important in maintaining and increasing ADR reports from pharmacists.

Juan Jesus Gestalotero – One of the best experts on this subject based on the ideXlab platform.

  • influence of pharmacists attitudes on Adverse Drug Reaction reporting a case control study in portugal
    Drug Safety, 2006
    Co-Authors: Maria Teresa Herdeiro, Adolfo Figueiras, Jorge Polonia, Juan Jesus Gestalotero
    Abstract:

    Introduction: Pharmacists can play a fundamental role in Adverse Drug Reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists’ ADR reporting in northern Portugal.

  • physicians attitudes and Adverse Drug Reaction reporting a case control study in portugal
    Drug Safety, 2005
    Co-Authors: Adolfo Figueiras, Maria Teresa Herdeiro, Jorge Polonia, Juan Jesus Gestalotero
    Abstract:

    Objectives: Voluntary Adverse Drug Reaction (ADR) reporting is fundamental to medical Drug safety surveillance; however, substantial under-reporting exists and is the main limitation of the system. This study sought to identify the knowledge-and attitude-related factors associated with ADR reporting by physicians in Northern Portugal.

Richard Hubbard – One of the best experts on this subject based on the ideXlab platform.

  • refining Adverse Drug Reaction signals by incorporating interaction variables identified using emergent pattern mining
    arXiv: Artificial Intelligence, 2016
    Co-Authors: Jenna Reps, Uwe Aickelin, Richard Hubbard
    Abstract:

    Purpose: To develop a framework for identifying and incorporating candidate confounding interaction terms into a regularised cox regression analysis to refine Adverse Drug Reaction signals obtained via longitudinal observational data. Methods: We considered six Drug families that are commonly associated with myocardial infarction in observational healthcare data, but where the causal relationship ground truth is known (Adverse Drug Reaction or not). We applied emergent pattern mining to find itemsets of Drugs and medical events that are associated with the development of myocardial infarction. These are the candidate confounding interaction terms. We then implemented a cohort studstudy design using regularised cox regression that incorporated and accounted for the candidate confounding interaction terms. Results The methodology was able to account for signals generated due to confounding and a cox regression with elastic net regularisation correctly ranked the Drug families known to be true Adverse Drug Reactions above those.

  • refining Adverse Drug Reaction signals by incorporating interaction variables identified using emergent pattern mining
    , 2015
    Co-Authors: Jenna Reps, Uwe Aickelin, Richard Hubbard
    Abstract:

    Purpose: To develop a framework for identifying and incorporating candidate confounding interaction terms into a regularised cox regression analysis to refine Adverse Drug Reaction signals obtained via longitudinal observational data.Methods: We considered six Drug families that are commonly associated with myocardial infarction in observational healthcare data, but where the causal relationship ground truth is known (Adverse Drug Reaction or not). We applied emergent pattern mining to find itemsets of Drugs and medical events that are associated with the development of myocardial infarction. These are the candidate confounding interaction terms. We then implemented a cohort studstudy design using regularised cox regression that incorporated and accounted for the candidate confounding interaction terms.Results: The methodology was able to account for signals generated due to confounding and a cox regression with elastic net regularisation correctly ranked the Drug families known to be true Adverse Drug Reactions above thosethat are not. This was not the case without the inclusion of the candidate confounding interaction terms, where confounding leads to a non-Adverse Drug Reaction being ranked highest.Conclusions: The methodology is efficient, can identify high-order confounding interactions and does not require expert input to specify outcome specific confounders, so it can be applied for any outcome of interest to quickly refine its signals. The proposed method shows excellent potential to overcome some forms of confounding and therefore reduce the false positive rate for signal analysis using longitudinal data.