Detection of adverse drug reactions through the minimum basic data set

Salmerón-García, Antonio; Barrera, J Cabeza; Pavón, María; Marquez, Eva; Miguel, Sol Cortés de; Vallejo-Rodríguez, Inmaculada; García, Susana Raya; Fernández, Emilia Casado

doi:10.1007/s11096-010-9372-2

Cited by 13 publications

(17 citation statements)

References 21 publications

(19 reference statements)

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“…There was an increase in the number of ADE from 11 007 in 2004 to 18 750 in 2013 (global rate 1.46%). In Europe, studies using administrative databases have shown that the rate of adverse drug reactions are between 0.8% - 1.83% [11, 13, 26]. The systematic review of Cano et al about the ADE in hospitals found that the proportion of patients with ADEs ranged from 2.15% to 19.2% in Europe [27].…”

Section: Discussionmentioning

confidence: 99%

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Adverse drug events—Analysis of a decade. A Portuguese case-study, from 2004 to 2013 using hospital database

2017

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PurposeThe goal of this study was to characterise adverse drug events (ADE), including both adverse drug reaction (ADR) and accidental poisoning by drugs (AP), considering age, gender, length of stay (LOS), number of deaths and year, during the period 2004–2013. Additionally distributions of the ten’s most frequent ADR and AP were characterized, considering age-group and gender.MethodsA retrospective descriptive nationwide study was conducted, based on the hospital discharges database in Portugal from 2004 to 2013, using ICD-9. Events were identified based on the following codes: from E930 to E949.9 and from E850 to E858.9.ResultsA total of 9 320 076 patients were discharged within this period, with 133 688 patients (1.46%) having at least one ADE, 4% of them related with AP. The mean age of these patients was 63.79 years (SD 21.31), 54.50% were female and the mean LOS was 14.05 days (SD 22.19). Patient with AP had a mean age of 41.06 years (SD 34.05), 54.70% were female and LOS was 7.15 days (SD 19.42). We have identified 10.691 deaths that represent 8.00% from the total of patients with an ADE. The patients above 65 years were more affected by ADR and children below 18 were more affected by AP.ConclusionIn the last decade an increasing trend of ADR were observed and an AP pattern relatively stable. Elderly people and children were the age groups most affected. Antibiotics (in ADR) and benzodiazepine-based tranquilizers (in AP) were the major problems. This is a huge, increasing and challenging problem. Further research, using individual and contextual risk factors should be developed to understand spatiotemporal variability, promoting tailored interventions, within and across countries.

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Section: Discussionmentioning

confidence: 99%

“…Previous studies have shown the rate of ADR in hospital inpatients ranging from 0.8% to 26.1% [7–11]. Also it was found that 1.8% to 12.8% of ADR can lead to hospitalization [12–15].…”

Section: Introductionmentioning

confidence: 99%

Adverse drug events—Analysis of a decade. A Portuguese case-study, from 2004 to 2013 using hospital database

2017

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“…Previous studies have shown the rate of ADR in hospital inpatients ranging from 0.8% to 26.1% [7–9, 36, 37]. Studies using administrative datasets have shown rates of ADR between 0.8% and 1.8% in Europe [26, 37, 38].…”

Section: Discussionmentioning

confidence: 99%

“…Studies using administrative datasets have shown rates of ADR between 0.8% and 1.8% in Europe [26, 37, 38]. The differences in the results observed can be due to differences in the accuracy of data reporting in the datasets used or to the definition of the ADR.…”

Section: Discussionmentioning

confidence: 99%

A decade of adverse drug events in Portuguese hospitals: space-time clustering and spatial variation in temporal trends

Scripcaru

Mateus

Nunes

2017

BMC Pharmacol Toxicol

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BackgroundThe aim of this study is to identify the distribution by municipalities of adverse drug events (ADE) in Portugal, including adverse drug reactions (ADR) and accidental poisoning by drugs (AP), on municipality/years ADE rate clustering. Also we identify areas with different trends in time.MethodsWe used a national dataset of public hospital discharges in Continental Portugal from 2004 to 2013. Events were identified based on codes: from E930 to E949.9 (ADR) and from E850 to E858.9 (AP). Space-time clustering and spatial variation in temporal trends methods were applied in three different time-periods: globally, by year and grouped in 2 classes (periods of 5 years).ResultsA total of 9,320,076 patients were discharged within this period, with 133,688 patients (1.46%) having at least one ADE, 4% of them related with AP. Critical space-time identified clusters (p < 0.001) were the municipalities from Lisbon metropolitan area and Centro region area. The global rate increased at a 7.8% mean annual percentage change, with high space-time heterogeneity and variation in time trends clusters (p < 0.001). For whole period, 2004–2013, all clusters presented increasing trends. However when analyzed by period of 5 years we identified two clusters with decreasing trends in time in 2004–2008.ConclusionThe impact of ADE is huge, with widely variations within country and in time, and represents an increasing challenge. Future research using individual and contextual risk factors are urgently needed to understand this spatiotemporal variability in order to promote local tailored and updated actions of prevention.

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“…Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality and contribute to a substantial burden on the public health system with significant financial costs. In Australia alone, it has been estimated that almost two million patients suffer an adverse drug event annually with 190 000 requiring hospitalisation . Spontaneous reporting systems (SRS) are an effective mechanism for detecting ADRs and form an essential part of post‐marketing drug surveillance .…”

Section: Introductionmentioning

confidence: 99%

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants

Wong

Saini

et al. 2015

Pharmacoepidemiol Drug Saf

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Detection of adverse drug reactions through the minimum basic data set

Cited by 13 publications

References 21 publications

Adverse drug events—Analysis of a decade. A Portuguese case-study, from 2004 to 2013 using hospital database

Adverse drug events—Analysis of a decade. A Portuguese case-study, from 2004 to 2013 using hospital database

A decade of adverse drug events in Portuguese hospitals: space-time clustering and spatial variation in temporal trends

Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants

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