Dataset Information

Risk Factors Related to Serious Adverse Drug Reactions Reported through Electronic Submission during Hospitalization in Elderly Patients.

ABSTRACT:

Background

Many studies have assessed the risk factors for adverse drug reactions (ADRs) in elderly patients. However, most of these studies have focused on risk factors for ADRs, not serious ADRs (s-ADRs). s-ADRs are commonly found in hospitalized patients. s-ADRs warrant imminent but thorough investigations, given their critical impact on patient health. Therefore, this retrospective study aimed to assess the associated risk factors for s-ADRs in elderly hospitalized patients.

Methods

In-patients aged >65 years having ADRs during hospitalization at a university hospital in Korea between 2010 and 2012 were included. Medical professionals spontaneously reported ADRs using an electronic submission system at the study hospital. Further, all descriptions of ADRs were characterized and categorized through the screening of electronic medical records. We compared the characteristics of patients having s-ADRs with those of patients not having s-ADRs.

Results

There were 353 cases of ADRs, 67 of which were s-ADRs. Patients taking more than eight concomitant drugs showed the highest odds ratio (OR, 11.99; 95% confidence interval [CI], 3.42-42.03). The ratio of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) was also significantly related to s-ADRs (OR, 2.78; 95% CI, 1.33-5.81). The use of antibiotics (OR, 2.39; 95% CI, 1.13-5.02) and antineoplastics (OR, 4.17; 95% CI, 1.09-15.94) were significant risk factors.

Conclusion

Our findings highlight the importance of polypharmacy. Liver function tests (AST/ALT ratio) must be monitored carefully within high-risk groups for ADRs.

SUBMITTER: Won SH

PROVIDER: S-EPMC8943238 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Risk Factors Related to Serious Adverse Drug Reactions Reported through Electronic Submission during Hospitalization in Elderly Patients.

Won Seon-Hye SH Suh Sang-Yeon SY Yim Eunji E Ahn Hong-Yup HY

Korean journal of family medicine 20220317 2

<h4>Background</h4>Many studies have assessed the risk factors for adverse drug reactions (ADRs) in elderly patients. However, most of these studies have focused on risk factors for ADRs, not serious ADRs (s-ADRs). s-ADRs are commonly found in hospitalized patients. s-ADRs warrant imminent but thorough investigations, given their critical impact on patient health. Therefore, this retrospective study aimed to assess the associated risk factors for s-ADRs in elderly hospitalized patients.<h4>Metho ...[more]

PMID: 35320898

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Project description:Serious Adverse Drug Reactions (ADRs) can cause a longer stay, which can result in fatal outcomes. Understanding the prognostic factors for the serious ADRs play a vital role in developing appropriate serious ADR prevention strategies. This study aimed to analyze nationwide database in Thailand to identify predisposing factors associated with the serious ADRs, explore drug exposure, distribution of serious ADRs, types of ADRs, and classify the determinants of serious ADR due to anti-infective in Thailand. The national database of anti-infective-induced ADRs from January 2012 to December 2021 in Thailand's 77 provinces, Thai Vigibase at the Health Product Vigilance Center (HPVC), was considered. After pre-processing, frequencies and percentages were used to investigate the distribution of ADR seriousness. To determine the significance of the independent variables on the seriousness of anti-infective-induced ADRs, logistic regression and the Classification and Regression Tree (CART) model were performed. A p-value < 0.05 was considered statistically significant. A total of 82,333 ADR cases, of which 20,692 were serious ADRs (25.13%). Serious ADRs is statistically associated with region, gender, ethnicity, age, type of patient, history of drug allergy, chronic disease and dose frequency (p-value < 0.001). The most commonly reported serious ADRs were in the South region of Thailand (OR = 1.92, 95% CI = 1.88-1.97), followed by the North region (OR = 1.68, 95% CI = 1.64-1.71) of Thailand. Gender and history of drug allergy were also statistically associated with the seriousness of ADRs (p-value = 0.001). Reported ADRs revealed that patients were males (OR = 1.11, 95% CI = 1.11-1.13) and those with a prior history of drug allergy (OR = 1.22, 95% CI = 1.20-1.24) were more likely to experience serious ADRs. The risk of having an ADR reported as serious was significantly higher in patients aged 60 and over (OR = 1.42, 95% CI = 1.39-1.46) and patients aged 40-59 years (OR = 1.34, 95% CI = 1.31-1.37) compared to patients aged 0-19 years. IPD patients most commonly associated with serious ADRs. The results of this study will enable healthcare professionals to use caution when prescribing to those groups. Furthermore, developing a reporting system to reduce serious ADR evidence, such as software with electronic prescribing databases or applications that enable efficient detection of ADRs in high-risk groups, was critical in order to closely monitor and improve patient safety.

Project description:BackgroundLack of adequate detail compromises analysis of reported suspected adverse drug reactions (ADRs). We investigated how comprehensively Ugandan healthcare professionals (HCPs) described their most recent previous-month suspected ADR, and determined the characteristics of HCPs who provided comprehensive ADR descriptions. We also identified rare, serious, and unanticipated suspected ADR descriptions with medication safety-alerting potential.MethodsDuring 2012/13, this survey was conducted in purposively selected Ugandan health facilities (public/private) including the national referral and six regional referral hospitals representative of all regions. District hospitals, health centres II to IV, and private health facilities in the catchment areas of the regional referral hospitals were conveniently selected. Healthcare professionals involved in prescribing, transcribing, dispensing, and administration of medications were approached and invited to self-complete a questionnaire on ADR reporting. Two-thirds of issued questionnaires (1,345/2,000) were returned.ResultsNinety per cent (241/268) of HCPs who suspected ADRs in the previous month provided information on five higher-level descriptors as follows: body site (206), drug class (203), route of administration (127), patient age (133), and ADR severity (128). Comprehensiveness (explicit provision of at least four higher-level descriptors) was achieved by at least two-fifths (46%, 124/268) of HCPs. Received descriptions were more likely to be comprehensive from HCPs in private health facilities, regions other than central, and those not involved in teaching medical students. Overall, 106 serious and 51 rare previous-month suspected ADRs were described. The commonest serious and rare ADR was Stevens-Johnson syndrome (SJS); mostly associated with oral nevirapine or cotrimoxazole, but haemoptysis after diclofenac analgesia and paralysis after quinine injection were also described.ConclusionSurveyed Ugandan HCPs who had suspected at least one ADR in the previous month competently provided comprehensive ADR descriptions: more, indeed, than are received per annum nationally. Properly analyzed, and with local feed-back, voluntary ADR reports by HCPs could be an essential alerting tool for identifying rare and serious suspected ADRs in Uganda.

Project description:BackgroundAdverse drug reactions (ADRs) are the major cause of medication-related hospital admissions in older patients living in the community. This study aimed to develop and validate a score to predict ADR-related hospitalization in people aged ≥65 years.MethodsADR-related hospitalization and its risk factors were determined using a prospective, cross-sectional study in patients aged ≥65 years admitted to two hospitals. A predictive model was developed in the derivation cohort (n = 768) and the model was applied in the validation cohort (n = 240). ADR-related hospital admission was determined through expert consensus from comprehensive reviews of medical records and patient interviews. The causality and preventability of the ADR were assessed based on the Naranjo algorithm and modified Schumock and Thornton criteria, respectively.ResultsIn the derivation sample (mean [±SD] age, 80.1±7.7 years), 115 (15%) patients were admitted due to a definite or probable ADR; 92.2% of these admissions were deemed preventable. The number of antihypertensives was the strongest predictor of an ADR followed by presence of dementia, renal failure, drug changes in the preceding 3 months and use of anticholinergic medications; these variables were used to derive the ADR prediction score. The predictive ability of the score, assessed from calculation of the area under the receiver operator characteristic (ROC) curve, was 0.70 (95% confidence interval (CI) 0.65-0.75). In the validation sample (mean [±SD] age, 79.6±7.6 years), 30 (12.5%) patients' admissions were related to definite or probable ADRs; 80% of these admissions were deemed preventable. The area under the ROC curve in this sample was 0.67 (95% CI 0.56-0.78).ConclusionsThis study proposes a practical and simple tool to identify elderly patients who are at an increased risk of preventable ADR-related hospital admission. Further refinement and testing of this tool is necessary to implement the score in clinical practice.

Project description:ImportanceSerious cutaneous adverse drug reactions (cADRs) are potentially life-threatening drug hypersensitivity reactions involving the skin and internal organs. Antibiotics are a recognized cause of these reactions, but no studies have compared relative risks across antibiotic classes.ObjectivesTo explore the risk of serious cADRs associated with commonly prescribed oral antibiotics, and to characterize outcomes of patients hospitalized for them.Design, setting, and participantsNested case-control study using population-based linked administrative datasets among adults aged 66 years or older who received at least 1 oral antibiotic between 2002 and 2022 in Ontario, Canada. Cases were those who had an emergency department (ED) visit or hospitalization for serious cADRs within 60 days of the prescription, and each case was matched with up to 4 controls who did not.ExposureVarious classes of oral antibiotics.Main outcomes and measuresConditional logistic regression estimate of the association between different classes of oral antibiotics and serious cADRs, using macrolides as the reference group.ResultsDuring the 20-year study period, we identified 21 758 older adults (median age, 75 years; 64.1% female) who had an ED visit or hospitalization for serious cADRs following antibiotic therapy and 87 025 matched controls who did not. In the primary analysis, sulfonamide antibiotics (adjusted odds ratio [aOR], 2.9; 95% CI, 2.7-3.1) and cephalosporins (aOR, 2.6; 95% CI, 2.5-2.8) were most strongly associated with serious cADRs relative to macrolides. Additional associations were evident with nitrofurantoin (aOR, 2.2; 95% CI, 2.1-2.4), penicillins (aOR, 1.4; 95% CI, 1.3-1.5), and fluoroquinolones (aOR, 1.3; 95% CI, 1.2-1.4). The crude rate of ED visits or hospitalization for cADRs was highest for cephalosporins (4.92 per 1000 prescriptions; 95% CI, 4.86-4.99) and sulfonamide antibiotics (3.22 per 1000 prescriptions; 95% CI, 3.15-3.28). Among the 2852 case patients hospitalized for cADRs, the median length of stay was 6 days (IQR, 3-13 days), 9.6% required transfer to a critical care unit, and 5.3% died in the hospital.Conclusion and relevanceCommonly prescribed oral antibiotics are associated with an increased risk of serious cADRs compared with macrolides, with sulfonamides and cephalosporins carrying the highest risk. Prescribers should preferentially use lower-risk antibiotics when clinically appropriate.

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Project description:Background:The Protecting Canadians from Unsafe Drugs Act will eventually require institutions to report all serious adverse drug reactions (ADRs), although the proposed regulations do not yet define what will need to be reported and by whom. Knowledge about the occurrence of serious ADRs in the hospital setting is needed to optimize the effectiveness of reporting and to determine the potential implications of mandatory reporting. Objectives:To quantify and characterize suspected serious ADRs in patients admitted to a general medicine service, to assess the likelihood of causality, and to determine inter-rater agreement for identification of ADRs and assessment of their likelihood. Methods:This prospective observational study involved 60 consecutive patients admitted to a general medicine service at a tertiary care teaching centre starting on March 28, 2016. The primary outcome was the number of serious ADRs, defined by Health Canada as ADRs that result in hospital admission, congenital malformation, persistent or significant disability or incapacity, or death; that are life-threatening; or that require significant intervention to prevent one of these outcomes. Medical records were reviewed independently by pairs of pharmacists for serious ADRs, and the likelihood of causality was assessed using the World Health Organization-Uppsala Monitoring Centre system. Inter-rater agreement was calculated using the kappa score, and disagreements were resolved by discussion and consensus. Results:Twenty-three serious ADRs occurred in the sample of 60 patients. The proportion of patients experiencing a serious ADR that contributed to the original hospital admission was 19/60 (32%, 95% confidence interval [CI] 20%-43%), and 4 patients (7%, 95% CI 0%-13%) experienced a serious ADR during their hospital stay. Inter-rater agreement for occurrence of serious ADRs was moderate (kappa 0.58, 95% CI 0.35-0.76). Conclusion:Reportable serious ADRs were common among patients admitted to a general medicine service. Canadian hospitals would face difficulties reporting all serious ADRs because of the frequency of their occurrence and the subjectivity of their identification.

Dataset Information

Risk Factors Related to Serious Adverse Drug Reactions Reported through Electronic Submission during Hospitalization in Elderly Patients.

Background

Methods

Results

Conclusion

Publications

Risk Factors Related to Serious Adverse Drug Reactions Reported through Electronic Submission during Hospitalization in Elderly Patients.

Similar Datasets

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