Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting

Miguel, Ana; Azevedo, Luís Filipe; Lopes, Fernando; Costa‐Pereira, Altamiro

doi:10.1002/pds.3348

Cited by 36 publications

(31 citation statements)

References 17 publications

(22 reference statements)

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“…Nevertheless, we believed that the detection rate in our study may still under-estimated due to under-recognition and under-reporting of ADRs in routine hospital activity. However, when compared with the spontaneous report, our study confirmed that administrative database yields higher detection rate of ADRs than spontaneous report 9 . In this study, about 286 % increase in incidence of ADR-related hospital admission was detected when using administrative database (2.74 %), as compared to spontaneous report (0.71%).…”

Section: Discussionsupporting

confidence: 75%

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Detection of adverse drug reaction (ADR)-related hospital admissions: A pilot study using administrative database for ADR monitoring in Thailand

Siltharm¹,

Pattanaprateep²,

Pongcharoensuk³

et al. 2017

Pharm Sci Asia

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Section: Discussionsupporting

confidence: 75%

“…Pharm Sci Asia 2017; 44 (3), [142][143][144][145][146][147][148][149][150][151][152][153] rates for ADRs than analysis of database and spontaneous reporting [6][7][8][9] . Nevertheless, medical chart review and intensive monitoring require high resource and technical intensive.…”

Section: Original Articlementioning

confidence: 99%

Detection of adverse drug reaction (ADR)-related hospital admissions: A pilot study using administrative database for ADR monitoring in Thailand

Siltharm¹,

Pattanaprateep²,

Pongcharoensuk³

et al. 2017

Pharm Sci Asia

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“…Pharmacovigilance centres play a major role in the postmarketing monitoring of drug safety, which, in many countries, is based on spontaneous (or voluntary) reporting [7]. Clinical observations, from both patients and healthcare professionals, serve as a starting point for reporting suspected ADRs.…”

Section: Introductionmentioning

confidence: 99%

“…Clinical observations, from both patients and healthcare professionals, serve as a starting point for reporting suspected ADRs. Most reported suspected ADRs are reported by health professionals, but also by patients [7], which means that health professionals should have sufficient knowledge, adequate abilities, and a positive attitude to evaluating and reporting possible ADRs encountered in daily practice. They are encouraged, and in some countries legally obliged, to report serious and unknown ADRs to the competent authority [8, 9].…”

Section: Introductionmentioning

confidence: 99%

“…They are encouraged, and in some countries legally obliged, to report serious and unknown ADRs to the competent authority [8, 9]. Although ADR reporting is a professional responsibility, the rate of underreporting is high and this hinders optimal ADR monitoring [7, 10, 11]. Previous studies have identified multiple factors as underlying the low level of ADR reporting: indifference, lack of motivation, lack of knowledge, negative attitudes, misconceptions, and difficulty in accessing forms [11].…”

Section: Introductionmentioning

confidence: 99%

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Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study

et al. 2017

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IntroductionPharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme.MethodsIn this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized feedback letter to the reporter, as well as a summary for the European Medicines Agency (EMA) and World Health Organization (WHO) pharmacovigilance databases. This student assessment was then verified and evaluated by staff from The Netherlands Pharmacovigilance Centre Lareb (Lareb), using an e-questionnaire. Student attitudes, intentions, skills, and knowledge of ADR reporting were evaluated using the e-questionnaire, before and after participation in the programme.ResultsFrom May 2014 to January 2015, a total of 43 students assessed 100 different ADR reports selected by Lareb staff (n = 3). Student assessments were rated as useful (93%), scientifically substantiated (90%), accurate (92%), and complete (92%), and, on average, did not cost Lareb staff extra time. Medical students were positive about ADR reporting, and their awareness of ADR reporting increased significantly following participation in the programme (p < 0.05). After participation in the programme, the students intended to report serious ADRs in their future practice, and their knowledge of pharmacovigilance and ADR reporting showed they had a high overall level of pharmacological understanding.ConclusionThe student-run pharmacovigilance programme is a win–win venture. It offers students a valuable ‘pharmacovigilance experience’, creates awareness in future doctors, and has the potential to increase pharmacovigilance skills and knowledge.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0502-1) contains supplementary material, which is available to authorized users.

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Development and Validation of Algorithms for the Detection of Statin Myopathy Signals From Electronic Medical Records

Chan

Tham

Tan

et al. 2017

Clin Pharma and Therapeutics

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The purpose of this study was to develop and validate sensitive algorithms to detect hospitalized statin-induced myopathy (SIM) cases from electronic medical records (EMRs). We developed four algorithms on a training set of 31,211 patient records from a large tertiary hospital. We determined the performance of these algorithms against manually curated records. The best algorithm used a combination of elevated creatine kinase (>4× the upper limit of normal (ULN)), discharge summary, diagnosis, and absence of statin in discharge medications. This algorithm achieved a positive predictive value of 52-71% and a sensitivity of 72-78% on two validation sets of >30,000 records each. Using this algorithm, the incidence of SIM was estimated at 0.18%. This algorithm captured three times more rhabdomyolysis cases than spontaneous reports (95% vs. 30% of manually curated gold standard cases). Our results show the potential power of utilizing data and text mining of EMRs to enhance pharmacovigilance activities.

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Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting

Abstract: Although not frequently used, the detection of ADRs through databases is a relatively less expensive, fast and effective methodology that can improve current pharmacovigilance systems.

Cited by 36 publications

References 17 publications

Detection of adverse drug reaction (ADR)-related hospital admissions: A pilot study using administrative database for ADR monitoring in Thailand

Detection of adverse drug reaction (ADR)-related hospital admissions: A pilot study using administrative database for ADR monitoring in Thailand

Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study

Development and Validation of Algorithms for the Detection of Statin Myopathy Signals From Electronic Medical Records

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