Preventability analysis of adverse drug reactions detected in two internal medicine departments in Romania

Farcaş, Andreea; Bucşa, Camelia; Sinpetrean, Aura; Leucuţa, Daniel; Mogoşan, Cristina; Dumitraşcu, Dan L.; Achimaș, Andrei; Bojiţă, Marius

doi:10.1007/s11739-012-0843-4

Cited by 9 publications

(7 citation statements)

References 29 publications

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“…However, the data from a study showed lower preventability for ADRs (12%) compared with our finding (Dequito et al, 2011). As described in previous studies, insufficient monitoring, inappropriate dosing, and DDIs were the most frequent factors involved in ADR preventability (Farcas et al, 2014;Al Damen and Basheti, 2019). Incriminated drugs were withdrawn in 94.29% of the reports, which is in line with a previous study in a psychiatric department of a tertiary care teaching hospital in India (Patel et al, 2015).…”

Section: Discussionsupporting

confidence: 91%

“…Severe ADRs, as major concerns for public health, are a contributing factor of hospitalizations and morbidity (Rottenkolber et al, 2011;Marques et al, 2014). The analysis indicated a preventability rate of 53.97% among ADRs, comparable with the results of studies conducted in Romania and Jordan showing that 41% and 44.7% of ADRs were preventable, respectively (Farcas et al, 2014;Al Damen and Basheti, 2019). However, the data from a study showed lower preventability for ADRs (12%) compared with our finding (Dequito et al, 2011).…”

Section: Discussionsupporting

confidence: 79%

“…A systematic review showed that cardiovascular medicines were commonly associated with preventable drug-related admissions (Howard et al, 2007). In another study, cardiovascular agents were identified as the second most frequently responsible drugs linked to preventable ADRs (Farcas et al, 2014). Frontiers in Pharmacology frontiersin.org…”

Section: Discussionmentioning

confidence: 99%

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Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

et al. 2022

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Introduction: Adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact on mortality, morbidity, and healthcare costs. Drug–drug interactions (DDIs) are an important contributor to ADRs. Most of the studies focused only on potential DDIs (pDDIs), while the detailed data are limited regarding the ADRs associated with actual DDIs.Methods: This retrospective study evaluated ADRs reported between 2011 and 2020 in a tertiary hospital. The causality and severity of ADRs were evaluated through the Naranjo Algorithm and Hartwig’s scale, respectively. Preventability classification was based on the modified Schoumock and Thornton scale. For ADRs with at least two suspected drugs, pDDIs were identified according to the Lexi-Interact. We further checked whether the ADR description in the reports corresponded to the clinical consequences of the pDDIs.Results: A total of 1,803 ADRs were reported, of which 36.77% ADRs were classified as mild, 43.26% as moderate, and 19.97% as severe. The assessment of causality showed that the distributions of definite, probable, and possible categories were 0.33%, 58.68%, and 40.99%, respectively. A total of 53.97% of ADRs were identified as preventable ADRs, while 46.03% were recognized as unpreventable. The severity of ADRs was significantly correlated with age, the number of suspected drugs and preventability. Antimicrobial agents were the most common implicated pharmacological group, and the most frequently affected system was the gastrointestinal system. Considering individual drugs, aspirin was the most frequently reported drug. Among 573 ADRs with at least two suspected drugs, 105 ADRs were caused by actual DDIs, of which only 59 and 6 ADRs were caused by actual DDIs in category D and X, respectively. The most frequent drugs involved in actual DDIs of category D were aspirin and heparin, with the majority of ADRs being gastrointestinal bleeding.Conclusion: This study analyzed the pattern of ADRs in detail and obtained clinical evidence about ADRs associated with actual DDIs. These findings may be useful to compare patterns between different centers and to design preventive strategies for ADRs. Continuous education and training should be provided for physicians regarding the knowledge and recognition of ADRs associated with DDIs.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 79%

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Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

et al. 2022

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“…The focus in nine (11%) of the studies was on paediatric care units, with three of these studies being situated in neonatal intensive care units [42][43][44]. Seven (9%) studies involved elderly patient care units, six of which were specialised care units for geriatric patients aged above 65 years [35,[45][46][47][48][49].…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Preventable medication harm across health care settings: a systematic review and meta-analysis

Hodkinson

Tyler

Ashcroft

et al. 2020

BMC Med

106

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Background Mitigating or reducing the risk of medication harm is a global policy priority. But evidence reflecting preventable medication harm in medical care and the factors that derive this harm remain unknown. Therefore, we aimed to quantify the prevalence, severity and type of preventable medication harm across medical care settings. Methods We performed a systematic review and meta-analysis of observational studies to compare the prevalence of preventable medication harm. Searches were carried out in Medline, Cochrane library, CINAHL, Embase and PsycINFO from 2000 to 27 January 2020. Data extraction and critical appraisal was undertaken by two independent reviewers. Random-effects meta-analysis was employed followed by univariable and multivariable meta-regression. Heterogeneity was quantified using the I2 statistic, and publication bias was evaluated. PROSPERO: CRD42020164156. Results Of the 7780 articles, 81 studies involving 285,687 patients were included. The pooled prevalence for preventable medication harm was 3% (95% confidence interval (CI) 2 to 4%, I2 = 99%) and for overall medication harm was 9% (95% CI 7 to 11%, I2 = 99.5%) of all patient incidence records. The highest rates of preventable medication harm were seen in elderly patient care settings (11%, 95% 7 to 15%, n = 7), intensive care (7%, 4 to 12%, n = 6), highly specialised or surgical care (6%, 3 to 11%, n = 13) and emergency medicine (5%, 2 to 12%, n = 12). The proportion of mild preventable medication harm was 39% (28 to 51%, n = 20, I2 = 96.4%), moderate preventable harm 40% (31 to 49%, n = 22, I2 = 93.6%) and clinically severe or life-threatening preventable harm 26% (15 to 37%, n = 28, I2 = 97%). The source of the highest prevalence rates of preventable harm were at the prescribing (58%, 42 to 73%, n = 9, I2 = 94%) and monitoring (47%, 21 to 73%, n = 8, I2 = 99%) stages of medication use. Preventable harm was greatest in medicines affecting the ‘central nervous system’ and ‘cardiovascular system’. Conclusions This is the largest meta-analysis to assess preventable medication harm. We conclude that around one in 30 patients are exposed to preventable medication harm in medical care, and more than a quarter of this harm is considered severe or life-threatening. Our results support the World Health Organisation’s push for the detection and mitigation of medication-related harm as being a top priority, whilst highlighting other key potential targets for remedial intervention that should be a priority focus for future research.

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“…Drug-drug interactions (DDIs) with serious adverse consequences for patients at intensive care unit (ICU) occur with high prevalence of 5.3% and are responsible for almost 15.5% of all adverse drug reactions in that patient population (1). In principle, DDIs are all preventable if potential for their occurrence is noticed on time (2). There are numerous softwares providing for rapid, bed-side discovery of clinically relevant potential DDIs, which were already validated in practice, and demonstrated significant sensitivity and specificity.…”

Section: Introductionmentioning

confidence: 99%

Predictors of potential drug-drug interactions in patients at intensive care unit

Iličković¹,

Orlandić-Čejović²,

Tanasković³

et al. 2019

Acta fac medic Naissensis

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Drug-drug interactions (DDIs) with serious adverse consequences for patients at intensive care unit (ICU) occur with the prevalence of 5.3%. The aim of our study was to reveal the risk factors for potential DDIs among the ICU patients. This retrospective cohort analysis took place in the ICU of the Clinical Center Podgorica, Montenegro, between June 1, 2017 and September 30, 2018. The study was conducted as a chart review of the ICU patients (n = 99) who spent ≥ 2 days in the ICU. The main outcome measure was the number of DDIs per patient. Ninety-four percent of patients had at least one potential DDI, while 20% of patients had at least one potential DDI which required a change of therapy. The number of potential DDIs per patient according to the Medscape was 6.6 ± 9.1 and 3.8 ± 4.9 according to the Epocrates. A higher number of drugs (or therapeutic groups) prescribed per patient increased the number of potential DDIs, including those which required a change of therapy. The patients who were prescribed antiarrhythmics, anticoagulants or two antiplatelet drugs experienced more DDIs than patients without these therapeutic groups, while delirium, dementia and drug allergy were protective factors. The main limitation of our study was its uni-centerdness, which allowed for certain degree of bias. Routine screening of the ICU patients with high number of prescribed drugs who receive antiarrhythmics, anticoagulants or double antiplatelet therapy for potential DDIs may prevent a great deal of DDIs with potentially deleterious effects.

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Preventability analysis of adverse drug reactions detected in two internal medicine departments in Romania

Cited by 9 publications

References 29 publications

Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

Adverse drug reactions and correlations with drug–drug interactions: A retrospective study of reports from 2011 to 2020

Preventable medication harm across health care settings: a systematic review and meta-analysis

Predictors of potential drug-drug interactions in patients at intensive care unit

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