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Quality And Characteristics Of Voluntary Reporting Of Adverse Drug Reactions By Health-care Professionals

Posted on:2010-03-18Degree:MasterType:Thesis
Country:ChinaCandidate:J W ShenFull Text:PDF
GTID:2144360275492197Subject:Pharmacy
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Objective:To examine the quality of voluntary reporting of adverse drug reactions (ADRs) by three health-care professionals,as well as the charctaristics with which they detect or report the ADRs in clinical.Methods:Reports submitted by doctors,pharmacists and nurses from Shanghai ADR database from 2006 to 2008 were imported to ACCESS and analyzed with SPSS and data-mining method to learn the characteristics of the ADR reports from different health-care professionals.Results:The portion of ADR reports from doctors is 65.14%,higher than those from pharmacists(26.71%) and nurses(8.14%).More than 99%of ADR reports achieved documentation grade 3 according to the documentation grading scheme developed by WHO and National Adverse Drug Reaction Monitoring Center of China.The portions of new and serious ADRs in reports from nurses are higher than those from other healthcare professionals,resulting as 5.85%in 2006,12.28%in 2007,and 11.93%in 2008,respectively.Some fundamental information is ignored in the reports,such as medical records(loss rate>10%) or the correspondence(loss rate>5%).Reporting in time from all healthcare professionals are reduced during 2006 to 2008.Among them,the proportion of delayed reporting over 3 months from pharmacists is higher than those from doctors and nurses,presented as 3.75%, 6.99%and 9.30%,respectively.The causality assessments from nurses are moderately consistent with those from the local ADR monitoring center,and are 41.50%,70.45%,and 55.42%,respectively,in three years.On recognizing or detecting the ADR,Physicians are often aroused by the reactions with significant characteristics of drug-induced,more involved laboratory diagnostic tests or lower background frequency(ROR=1.217,95%CI:1.176-1.26;ROR=1.279,95%CI: 1.145-1.428;ROR=1.383,95%CI:1.335-1.433),pharmacists are more concerned about the expanding pharmacologic actions(ROR=1.37.95%CI:1.319-1.422),whereas nurses pay more attention to ADRs often occur in a suggestive time relationship with drug exposure(ROR=1.586,95%CI:1.468-1.700).Conclusion:ADR reports have their own professional characteristics.ADR reports by different medical professions are diverse in levels due to the professional backgrounds and views in the process of the identification and recognition of ADRs. We should estimate appropriately the data from the voluntary reporting system,and use the data carefully and scientifically.To improve the efficiency of ADR monitoring,we should encourage all health-care professionals for their contribution and afford them continuing training and education programs.
Keywords/Search Tags:adverse drug reaction, adverse drug reaction monitoring, data mining, drug safety, pharmacovigilance, voluntary reporting system
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