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      Barriers to reporting of adverse drugs reactions: a cross sectional study among community pharmacists in United Kingdom

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          Abstract

          Background:

          Adverse Drug Reactions (ADRs) are a major public health problem. Prompt reporting of suspected ADRs is fundamental in the post-marketing surveillance of medicines and helps in ensuring medicine safety. However, fewer ADRs are reported in general and in particular by community pharmacists. There is limited knowledge about the factors which are preventing community pharmacists in the UK from reporting an ADR.

          Objectives:

          To identify the barriers to ADR reporting among community pharmacists practicing in the UK.

          Methods:

          A cross sectional study using a 25-items questionnaire (both online and paper based) including 10 barriers to ADR reporting was conducted from 1st April 2012 to September 2012. Community pharmacists practicing in the West Midlands, UK, were approached for the participation in this study. Chi-Square and regression were applied to identify covariates for the barriers to ADR reporting. A significant value of 0.05 was assigned for analysis.

          Results:

          Of the 230 invited community pharmacists, 138 pharmacists responded (response rate 60%). The median age of respondents was 31 years. All pharmacists reported that they would report both serious and mild ADRs from drugs with black triangle among children as well as adults. About 95% (n=131) of the pharmacists were familiar with the paper based ADR reporting system. Store-based pharmacists were more likely to be more confident about which ADRs to report [0.680, 95% Confidence Interval 0.43-3.59]. Lack of time 46.4% (n=64), and pharmacists perception that ADR is not serious enough to report (65.2%; n=90) were identified as barriers to ADR reporting. Majority 63.0% (n=87) of the pharmacists identified training and information about what to report and access to Information Technology (IT) (For example access to internet connection) 61.6% (n=85) as facilitators to ADR reporting process.

          Conclusion:

          Lack of time and ADRs considered not serious enough by pharmacists to report were barriers to ADR reporting. Further training and education about the types of ADRs to be reported can help to improve the reporting of ADRs.

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          Most cited references36

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          Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies.

          To determine the prevalence of hospital admissions associated with ADRs and examine differences in prevalence rates between population groups and methods of ADR detection. Studies were identified through electronic searches of Cumulative Index to Nursing and Allied Health Literature, EMBASE, and MEDLINE to August 2007. There were no language restrictions. A systematic review was conducted of prospective observational studies that used the World Health Organization ADR definition. Subgroup analysis examined the influence of patient age groups and methods of ADR detection on reported ADR admission rates. All statistical analyses were performed using STATA v 9.0. Twenty-five studies were identified including 106,586 patients who were hospitalized; 2143 of these patients had experienced ADRs. The prevalence rates of ADRs ranged from 0.16% to 15.7%, with an overall median of 5.3% (interquartile range [IQR] 2.7-9.0%). Median ADR prevalence rates varied between age groups; for children, the ADR admission rate was 4.1% (IQR 0.16-5.3%), while the corresponding rates for adults and elderly patients were 6.3% (IQR 3.9-9.0%) and 10.7% (IQR 9.6-13.3%), respectively. ADR rates also varied depending on the methods of ADR detection employed in the different studies. Studies that employed multiple ADR detection methods, such as medical record review and patient interview, reported higher ADR admission rates compared with studies that used medical record review alone. Anti-infective drugs were most often associated with ADR admissions in children; cardiovascular drugs were most often associated with ADR admissions in adults and elderly patients. Approximately 5.3% of hospital admissions were associated with ADRs. Higher rates were found in elderly patients who are likely to be receiving multiple medications for long-term illnesses. The methods used to detect ADRs are also likely to explain much of the variation in the reported ADR prevalence rates between different studies.
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            Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies.

            To establish the percentage hospital admission related to adverse drug reactions (ADRs) from the data available in the literature. Literature search in the Medline database, meta-analysis. From the literature it is revealed that a considerable part of all hospital admissions are related to adverse drug reactions. However, these data are not homogenous, i.e. larger studies display a lower percentage of ADR related hospital admission, while smaller studies display a higher percentage. Subgroup analysis showed that for elderly people the odds of being hospitalised by ADR related problems is 4 times higher than for younger ones (16.6% vs. 4.1%). A considerable part of these hospitalisations can be prevented. Subgroup analysis revealed that in the elderly up to 88% of the ADR related hospitalisations are preventable; for the non-elderly this is only 24%. Comparatively more elderly people are hospitalised than younger ones. Combining these findings, twice as much elderly people are hospitalised by ADR related problems than non-elderly, while preventability of ADR related hospitalisation might yield 7 times more people in the elderly than in the non-elderly. The estimation of the costs of ADR related hospitalisations in the Health Care system in The Netherlands is discussed. Many elderly people are hospitalised by ADR related problems; an important part of these hospitalisations can be avoided.
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              WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems

              Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed.
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                Author and article information

                Contributors
                Journal
                Pharm Pract (Granada)
                Pharm Pract (Granada)
                Pharmacy Practice
                Centro de Investigaciones y Publicaciones Farmaceuticas
                1885-642X
                1886-3655
                Jul-Sep 2017
                08 August 2017
                : 15
                : 3
                : 931
                Affiliations
                Warwick Medical School, Gibbet Hill campus, University of Warwick . Coventry (United Kingdom). E.Cheema.1@ 123456warwick.ac.uk
                College of pharmacy, Umm-ul-Qura University . Makkah (Saudi Arabia). amhaseeb@ 123456uqu.edu.sa
                School of Pharmacy, Malaysia Campus, Monash University . Selangor (Malaysia). tahir.pks@ 123456gmail.com
                Warwick Medical School, Gibbet Hill campus, University of Warwick . Coventry (United Kingdom). p.a.sutcliffe@ 123456warwick.ac.uk
                Fellowship of Postgraduate Medicine . London (United Kingdom). drjsinger@ 123456gmail.com
                Author information
                http://orcid.org/0000-0002-8538-7392
                http://orcid.org/0000-0003-2455-5054
                http://orcid.org/0000-0003-0081-1957
                http://orcid.org/0000-0003-4198-4678
                http://orcid.org/0000-0001-8870-3584
                Article
                pharmpract-15-931
                10.18549/PharmPract.2017.03.931
                5597805
                28943977
                97e23792-9100-4ccf-b15a-f4fce6a31364
                Copyright: © Pharmacy Practice

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY-NC-ND 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 01 February 2017
                : 24 July 2017
                Categories
                Original Research

                adverse drug reaction reporting systems,professional practice,attitude of health personnel,pharmacies,pharmacists,surveys and questionnaires,regression analysis,united kingdom

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