Under-Reporting of Adverse Drug Reactions

Hazell, Lorna; Shakir, Saad

doi:10.2165/00002018-200629050-00003

Cited by 1,482 publications

(1,208 citation statements)

References 51 publications

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“…Under-reporting of ADRs is a worldwide phenomenon and this has been established from previous studies [14,15,19,20]. The determinants of under-reporting, from our study, include lack of knowledge of the forms for reporting, ignorance of the rules and procedure for reporting, and not being sure of the type of reactions to be reported.…”

Section: Discussionmentioning

confidence: 53%

Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Healthcare Workers in a Tertiary Centre in Northern Nigeria

Fadare¹,

Enwere²,

Afolabi³

et al. 2011

Trop. J. Pharm Res

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Section: Discussionmentioning

confidence: 53%

Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Healthcare Workers in a Tertiary Centre in Northern Nigeria

Fadare¹,

Enwere²,

Afolabi³

et al. 2011

Trop. J. Pharm Res

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“…of underreporting or errors associated with spontaneous reporting ( 37,38 ). Another strength is the usefulness of simple clinical and easily available laboratory prognostic markers including prothrombin time in predicting mortality in patients with non-acetaminophen hepatotoxicity as depicted in models in Table 5 and Figure 3 .…”

Section: Livermentioning

confidence: 99%

Single-Center Experience With Drug-Induced Liver Injury From India: Causes, Outcome, Prognosis, and Predictors of Mortality

Devarbhavi

Dierkhising

Kremers

et al. 2010

American Journal of Gastroenterology

208

190

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Although drug-induced liver injury (DILI) is rare, it may result in signifi cant morbidity or death. The causes and outcome vary according to regions, with acetaminophen and complementary medicines common in the West and the Far East, respectively. This study evaluates the causes, outcomes, predictors, and models for 90-day mortality from DILI from India. METHODS:Consecutive patients with DILI from 1997 to 2008 based on International Consensus Criteria from a medical college hospital setting were studied. RESULTS:Of the 313 patients, 58 % were males. Leading causes were a combination of four anti-tuberculous drugs (ATDs) (58 % ), anti-epileptics ( SUPPLEMENTARY MATERIAL is linked to the online version of the paper at

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“…A recent large meta-analysis of 37 studies, using a wide variety of surveillance methods, concluded that on average only about 5% of ADRs are being reported. 22 Thus, true UK statistics of AZA-related ADRs may be up to 20-fold higher than those reported to the UK Medicines Control Agency.…”

Section: Methodsmentioning

confidence: 96%

Improving pharmacovigilance in Europe: TPMT genotyping and phenotyping in the UK and Spain

et al. 2009

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Thiopurine S-methyltransferase (TPMT) is the rate-limiting step in the conversion of thiopurine drugs including azathioprine (AZA) to inactive metabolites. Heritable deficiency of TPMT activity increases risk for adverse events, most notably, myelosuppression leading to leukopenia and neutropenic sepsis. The reported European Commission study was undertaken to identify current evidence for the clinical utility of testing for TPMT status and extent of uptake, by either genotyping or phenotyping, in the clinical setting. Data presented here for the UK and Spain indicate that there has been a considerable increase in the uptake of TPMT testing in recent years. There are some data that support routine TPMT testing before AZA prescribing for reducing AZA-related adverse events. Key data include evidence in favor of TPMT testing in addition to the current practice of routine monitoring for reducing the number of AZA-related episodes of myelosuppression, averting deaths from neutropenic sepsis and improving health-related quality of life. Further data are needed for determining the cost-effectiveness of routine TPMT testing.

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Under-Reporting of Adverse Drug Reactions

Cited by 1,482 publications

References 51 publications

Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Healthcare Workers in a Tertiary Centre in Northern Nigeria

Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Healthcare Workers in a Tertiary Centre in Northern Nigeria

Single-Center Experience With Drug-Induced Liver Injury From India: Causes, Outcome, Prognosis, and Predictors of Mortality

Improving pharmacovigilance in Europe: TPMT genotyping and phenotyping in the UK and Spain

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