Survivability of hospitalized chronic kidney disease (CKD) patients with moderate to severe estimated glomerular filtration rate (eGFR) after experiencing adverse drug reactions (ADRs) in a public healthcare center: a retrospective 3 year study
Abstract:BackgroundAccurate identification and routine preventive practices are crucial steps in lessening the incidence of medications and patients related adverse drug reactions (ADRs).MethodsThree years retrospective study was conducted among chronic kidney disease (CKD) patients at multi-wards in a tertiary healthcare center. Data collected included demographic characteristics, physical examination results, comorbid conditions, laboratory tests and medications taken. Only medication prescribed during the hospital s… Show more
“…Our findings are difficult to compare with those of other studies, which differ from ours in several ways. Most of them assessed ADR incidence at hospital admission (1)(2)(3)5,(7)(8)(9)(10)13) or during hospitalization, (1,(11)(12)(13)23) and used highly heterogeneous study settings, definitions of ADRs, and methods for ascertaining ADRs (spontaneous report, intensive chart review, or both). In this study, we evaluated ADR incidence in nephrology outpatients, with and without hospitalization; they were identified from an extensive review of medical records, hospitalization reports, and participant interviews.…”
Section: Discussionmentioning
confidence: 99%
“…The concept of ADR has evolved over time and today includes any harmful and unwanted reaction to a drug, occurring at doses normally used in humans, or resulting from drug misuse or error, or from accidental or willful overdose. (6) Most available studies have focused on ADR-related hospitalizations (with the ADR either the cause of admission (2,3,5,(7)(8)(9)(10) or occurring during hospitalization, (11,12) or both (1,13,14)); very few have examined ADRs in outpatient settings. 4Although clinicians recognize ADRs as a major problem in CKD patients, few studies have investigated the incidence of and factors associated with ADRs in this population.…”
Background and objectivesLittle is known about the burden of adverse drug reactions in CKD. We estimated the incidence of overall and serious adverse drug reactions and assessed the probability of causation, preventability, and factors associated with adverse drug reactions in patients seen by nephrologists.Design, setting, participants, & measurementsThe Chronic Kidney Disease-Renal Epidemiology and Information Network cohort included 3033 outpatients (65% men) with CKD and eGFR<60 ml/min per 1.73 m2, with follow-up for 2 years. Adverse drug reactions were identified from hospitalization reports, medical records, and participant interviews and finally assessed for causality, preventability, and immediate therapeutic management by experts in pharmacology.ResultsMedian (interquartile range) age was 69 (60–76) years old; 55% had eGFR≥30 ml/min per 1.73 m2, and 45% had eGFR<30 ml/min per 1.73 m2. Participants were prescribed a median (range) of eight (five to ten) drugs. Over 2 years, 536 patients had 751 adverse drug reactions, 150 (in 125 participants) classified as serious, for rates of 14.4 (95% confidence interval, 12.6 to 16.5) and 2.7 (95% confidence interval, 1.7 to 4.3) per 100 person-years, respectively. Among the serious adverse drug reactions, 32% were considered preventable or potentially preventable; 16 caused death, directly or indirectly. Renin-angiotensin system inhibitors (15%), antithrombotic agents (14%), and diuretics (10%) were the drugs to which the most adverse drug reactions were imputed, but antithrombotic agents caused 34% of serious adverse drug reactions. The drug was discontinued in 71% of cases, at least temporarily. Adjusted hazard ratios for serious adverse drug reaction were significantly higher in patients with eGFR<30 versus ≥30 ml/min per 1.73 m2 (1.8; 95% confidence interval, 1.3 to 2.6), in those prescribed more than ten versus less than five medications (2.4; 95% confidence interval, 1.1 to 5.2), or in those with poor versus good adherence (1.6; 95% confidence interval, 1.4 to 2.4).ConclusionsAdverse drug reactions are common and sometimes serious in patients with CKD. Many serious adverse drug reactions may be preventable. Some specific pharmacologic classes, particularly antithrombotic agents, are at risk of serious adverse drug reactions.Clinical Trial registry name and registration numberChronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN), NCT03381950
“…Our findings are difficult to compare with those of other studies, which differ from ours in several ways. Most of them assessed ADR incidence at hospital admission (1)(2)(3)5,(7)(8)(9)(10)13) or during hospitalization, (1,(11)(12)(13)23) and used highly heterogeneous study settings, definitions of ADRs, and methods for ascertaining ADRs (spontaneous report, intensive chart review, or both). In this study, we evaluated ADR incidence in nephrology outpatients, with and without hospitalization; they were identified from an extensive review of medical records, hospitalization reports, and participant interviews.…”
Section: Discussionmentioning
confidence: 99%
“…The concept of ADR has evolved over time and today includes any harmful and unwanted reaction to a drug, occurring at doses normally used in humans, or resulting from drug misuse or error, or from accidental or willful overdose. (6) Most available studies have focused on ADR-related hospitalizations (with the ADR either the cause of admission (2,3,5,(7)(8)(9)(10) or occurring during hospitalization, (11,12) or both (1,13,14)); very few have examined ADRs in outpatient settings. 4Although clinicians recognize ADRs as a major problem in CKD patients, few studies have investigated the incidence of and factors associated with ADRs in this population.…”
Background and objectivesLittle is known about the burden of adverse drug reactions in CKD. We estimated the incidence of overall and serious adverse drug reactions and assessed the probability of causation, preventability, and factors associated with adverse drug reactions in patients seen by nephrologists.Design, setting, participants, & measurementsThe Chronic Kidney Disease-Renal Epidemiology and Information Network cohort included 3033 outpatients (65% men) with CKD and eGFR<60 ml/min per 1.73 m2, with follow-up for 2 years. Adverse drug reactions were identified from hospitalization reports, medical records, and participant interviews and finally assessed for causality, preventability, and immediate therapeutic management by experts in pharmacology.ResultsMedian (interquartile range) age was 69 (60–76) years old; 55% had eGFR≥30 ml/min per 1.73 m2, and 45% had eGFR<30 ml/min per 1.73 m2. Participants were prescribed a median (range) of eight (five to ten) drugs. Over 2 years, 536 patients had 751 adverse drug reactions, 150 (in 125 participants) classified as serious, for rates of 14.4 (95% confidence interval, 12.6 to 16.5) and 2.7 (95% confidence interval, 1.7 to 4.3) per 100 person-years, respectively. Among the serious adverse drug reactions, 32% were considered preventable or potentially preventable; 16 caused death, directly or indirectly. Renin-angiotensin system inhibitors (15%), antithrombotic agents (14%), and diuretics (10%) were the drugs to which the most adverse drug reactions were imputed, but antithrombotic agents caused 34% of serious adverse drug reactions. The drug was discontinued in 71% of cases, at least temporarily. Adjusted hazard ratios for serious adverse drug reaction were significantly higher in patients with eGFR<30 versus ≥30 ml/min per 1.73 m2 (1.8; 95% confidence interval, 1.3 to 2.6), in those prescribed more than ten versus less than five medications (2.4; 95% confidence interval, 1.1 to 5.2), or in those with poor versus good adherence (1.6; 95% confidence interval, 1.4 to 2.4).ConclusionsAdverse drug reactions are common and sometimes serious in patients with CKD. Many serious adverse drug reactions may be preventable. Some specific pharmacologic classes, particularly antithrombotic agents, are at risk of serious adverse drug reactions.Clinical Trial registry name and registration numberChronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN), NCT03381950
“…Additionally, highest number of ADRs were reported from Hospital Pulau Pinang from 2014 till 2016 [11, 13] which corresponds to the duration of this study. Some of the methods outlined in this manuscript overlap with our earlier published research article [22].…”
Section: Methodsmentioning
confidence: 99%
“…Data were collected retrospectively from the medical records using a standardized form for each patient. Information gathered included (a) demographic characteristics (b) results of physical examination (c) existing comorbid conditions (d) laboratory tests results (e) medication types (f) date start and end of ADRs and (g) information of ADRs causative drugs [22]. Fig.…”
Section: Methodsmentioning
confidence: 99%
“…ADRs reporting forms were filled up by the ward pharmacist when an adverse drug reaction (ADR) was detected. Approximately 1–2 pharmacists will be routinely placed in a ward for each shift to monitor ADRs and to assist in other clinical functions during the duration of this study [22].…”
Background
Chronic kidney disease (CKD) is a significant health burden that increases the risk of adverse events. Currently, there is no validated models to predict risk of mortality among CKD patients experienced adverse drug reactions (ADRs) during hospitalization. This study aimed to develop a mortality risk prediction model among hospitalized CKD patients whom experienced ADRs.
Methods
Patients data with CKD stages 3–5 admitted at various wards were included in the model development. The data collected included demographic characteristics, comorbid conditions, laboratory tests and types of medicines taken. Sequential series of logistic regression models using mortality as the dependent variable were developed. Bootstrapping method was used to evaluate the model’s internal validation. Variables odd ratio (OR) of the best model were used to calculate the predictive capacity of the risk scores using the area under the curve (AUC).
Results
The best prediction model included comorbidities heart disease, dyslipidaemia and electrolyte imbalance; psychotic agents; creatinine kinase; number of total medication use; and conservative management (Hosmer and Lemeshow test =0.643). Model performance was relatively modest (R square = 0.399) and AUC which determines the risk score’s ability to predict mortality associated with ADRs was 0.789 (95% CI, 0.700–0.878). Creatinine kinase, followed by psychotic agents and electrolyte disorder, was most strongly associated with mortality after ADRs during hospitalization. This model correctly predicts 71.4% of all mortality pertaining to ADRs (sensitivity) and with specificity of 77.3%.
Conclusion
Mortality prediction model among hospitalized stages 3 to 5 CKD patients experienced ADR was developed in this study. This prediction model adds new knowledge to the healthcare system despite its modest performance coupled with its high sensitivity and specificity. This tool is clinically useful and effective in identifying potential CKD patients at high risk of ADR-related mortality during hospitalization using routinely performed clinical data.
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