History Of Adverse Drug Reactions Research Articles

Analysis of Risk Factors and Predictors of Success in Controlling Drop Out Pulmonary Tuberculosis: An Observational Study in Batang Regency, Indonesia

Introduction: Pulmonary tuberculosis (TB) remains a significant public health problem in Batang Regency, Indonesia. The high drop out (DO) rate of treatment is one of the main obstacles in controlling TB. This study aims to identify risk factors and predictors of DO for pulmonary TB treatment in Batang Regency. Methods: An analytical observational study with a cross-sectional design was conducted in 2023 involving 150 pulmonary TB patients who were recorded as having DO in the 2021-2022 period. Primary data was collected through interviews and secondary data from medical records. Bivariate analysis using the Chi-square test or Fisher's exact test, and multivariate analysis using logistic regression were performed to identify risk factors and predictors of DO. Results: Bivariate analysis showed that young age (<25 years) (OR = 3.21; 95% CI: 1.54-6.69), long distance of residence from health facilities (OR = 4.12; 95% CI: 1.98-8.57), and a history of adverse drug reactions (ESO) (OR = 5.63; 95% CI: 2.65-11.94) were significant risk factors for DO. Multivariate analysis confirmed that young age (aOR = 2.95; 95% CI: 1.35-6.43), long distance of residence (aOR = 3.88; 95% CI: 1.79-8.41), and history of ESO (aOR = 5.12; 95% CI: 2.38-11.01) were independent predictors of DO. Conclusion: Young age, long distance of residence from health facilities, and history of ESO are risk factors and independent predictors of DO for pulmonary TB treatment in Batang Regency. Interventions that target these factors, such as intensive education and counseling for young patients, increased access to health services, and optimal management of ESO, are needed to increase the success of TB control.

Prospective,multi-center,and large-scale hospital centralized monitoring of clinical safety of Reduning Injection in 100249 children cases

This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.076%, indicating a very rare ADR. The main symptoms of ADR were pruritus, diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsion, and chills. All ADR cases were reported for the first time, including three new ADR cases and 73 known ADR cases. The categories of ADR was general ADR. All ADR was mild in severity. There were more males than females in ADR patients. One patient had a history of ADR, and the drug causing ADR was buprofen. The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL. The dropping speed was 30 drops or less per min, and the solvent type was 5% glucose injection. The most common manifestation of ADR patients was pruritus, followed by diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsions, and chills. 72 patients(94.74% of ADR patients) discontinued the drug, and three patients(3.95% of ADR patients) were given oxygen inhalation. 47 cases(61.84% of ADR patients) were treated with medication, of which dexamethasone was the most used(24 cases, 46.15% of ADR patients). 76 ADR patients were cured or improved. ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM), TCM syndrome type is wind heat syndrome, and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection, ascorbic acid/vitamin C injection. This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.

The application of Global Trigger Tool in monitoring antineoplastic adverse drug events: a retrospective study.

This study aimed to establish an antineoplastic drugs trigger tool based on Global Trigger Tool (GTT), to examine the performance by detecting adverse drug events (ADEs) in patients with cancer in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of antineoplastic ADEs. Based on the triggers recommended by the GTT and those used in domestic and foreign studies and taking into account the scope of biochemical indexes in our hospital, some of them were adjusted. A total of 37 triggers were finally developed. Five hundred medical records of oncology patients discharged in our hospital from 1 June 2020 to 31 May 2021 were randomly selected according to the inclusion and exclusion criteria. These records were reviewed retrospectively by antineoplastic drugs trigger tool. The sensitivity and specificity of the triggers were analyzed, as well as the characteristics and risk factors for the occurrence of ADEs. Thirty-three of the 37 triggers had positive trigger, and the sensitivity rate was 91.8% (459/500). For the specificity, the positive predictive value of overall ADEs was 46.0% (715/1556), the detection rate of ADEs was 63.0% (315/500), the rate of ADEs per 100 admissions was 136.0 (95% CI, 124.1-147.9), and the rate of ADEs per 1,000 patient days was 208.33 (95% CI, 201.2-215.5). The top three antineoplastic drugs related to ADEs were antimetabolic drugs (29.1%), plant sources and derivatives (27.1%), and metal platinum drugs (26.3%). The hematologic system was most frequently involved (507 cases, 74.6%), followed by gastrointestinal system (89 cases, 13.1%). Multivariate logistic regression analysis showed that the number of combined drugs (OR = 1.14; 95% CI, 1.07-1.22; P < 0.001) and the previous history of adverse drug reaction (ADR) (OR = 0.38; 95% CI, 0.23-0.60; P < 0.001) were the risk factors for ADEs. The length of hospital stay (OR = 0.40; 95% CI, 0.14-1.12; P < 0.05) and the previous history of ADR (OR = 2.18; 95% CI, 1.07-4.45; P < 0.05) were the risk factors for serious adverse drug events (SAE). The established trigger tool could be used to monitor antineoplastic drugs adverse events in patients with tumor effectively but still needs to be optimized. This study may provide some references for further research in order to improve the rationality and safety of antineoplastic medications.

Risk factors for and characteristics of community- and hospital-acquired drug-induced acute kidney injuries.

Drugs constitute one of the leading causes of acute kidney injuries (AKIs) and can appear in community (CA‐AKI) or hospital (HA‐AKI) population. The objectives of the present study of a cohort of hospitalized patients with AKI were to describe the characteristics of drug‐induced AKIs and the patients' short‐term outcomes and assess risk factors for drug‐induced AKIs overall, CA‐AKIs, and HA‐AKIs. Based on a cohort of 1557 hospitalized patients suffering from AKIs based on PMSI extraction and chart review (IRA‐PMSI), drug‐induced AKIs were identified by applying the Naranjo adverse drug reaction (ADR) probability scale. Multivariate logistic regression was used to identify factors associated with CA‐AKIs and/or HA‐AKIs. When considering the 1557 patients who experienced an AKI, 445 (28.6%) of the injuries were drug‐induced (180 CA‐AKIs (40.4%) and 265 HA‐AKIs (59.6%)). Antibiotics, diuretics, and contrast agents were significantly more likely to be involved in HA‐AKIs, whereas antineoplastic, lipid‐lowering drugs, antidiabetics, and immunosuppressive were significantly more likely to be involved in CA‐AKIs. Female sex (odds ratio [OR] [95%CI] = 1.3 [1.04–1.67]), chronic kidney disease (CKD) (OR = 1.8 [1.40–2.67]), and a history of ADRs of any type (OR = 1.3 [1.05–1.73]) were significant risk factors for drug‐induced AKIs. CKD was a risk factor for both CA‐AKI and HA‐AKI. In view of the long‐term impact of AKI on the kidneys and the differences between our CA‐AKI and HA‐AKI subgroups, our present results are interesting for optimizing treatments, limiting the occurrence of CA‐ and HA‐AKIs and (ultimately) reducing healthcare costs.

Oral amoxicillin challenge for low-risk penicillin allergic patients.

Penicillin allergy is the most reported adverse drug reaction (ADR). Being labelled with 'penicillin allergy' is associated with suboptimal antibiotic therapy and poor patient outcomes. Most labelled with 'penicillin allergy' are at low risk of harm from penicillins and guidelines recommend testing for accurate diagnosis. Although skin testing is recommended to exclude immunoglobulin E (IgE)-mediated reactions, there is limited access in most settings. To evaluate oral amoxicillin challenge without prior skin testing for patients labelled with 'penicillin allergy' assessed as low risk during hospital admission. General Medical inpatients with a 'penicillin allergy' label were assessed. For those who had tolerated a penicillin since the index event, the ADR label was removed. Those assessed as 'low risk' were administered 250 mg amoxicillin orally without prior skin testing. The durability of de-labelling was subsequently assessed by review of clinical records. Of 224 patients with a history of a penicillin ADR, 162 (72%) were low risk. A further 12 were excluded and of the remaining 150, 56 (37%) had tolerated penicillins since their index reaction and were de-labelled without challenge, 15 (10%) with a non-allergic history were de-labelled. The remaining 79 were offered an oral amoxicillin challenge; 38 declined and 41 tolerated amoxicillin. Overall, 112 of the 224 (50%) patients had their ADR label removed. A careful ADR history enables de-labelling of many patients. An oral amoxicillin challenge without prior skin testing is safe and feasible for low-risk penicillin allergic patients while in hospital.

Risk Assessment Of Adverse Drug Reactions In Elderly Patients With Chronic Diseases

Introduction: The adverse drug reaction (ADR) is 4-7 times more common in elderly patients. That was also related to changes in pharmacokinetics and pharmacodynamics that triggered the emergence of Drug-Related Problems. Objective: The purpose of this study was to assess ADR in elderly patients with chronic diseases using the GerontoNET Score and the Screening Tool of Older People's Prescriptions (STOPP) criteria. Methods: The research design used a cross-sectional study which was analyzed descriptively. The sample consisted of 72 patients, aged more than 60 years, accompanied by chronic diseases, and hospitalized at Waluyo Jati Kraksaan Hospital. The exclusion criteria were patients referred to the Intensive Care Unit. Assessment to see the risk of ADR in elderly patients with chronic diseases using the GerontoNet Score while the wrong type of drug is given to elderly patients using the STOPP criteria. The variables contained in the GerontoNET Score are comorbid conditions ³4 (score= 1), heart failure (score= 1), liver disease (score = 1), the number of drugs such as: £5 (score= 0); 6-7 (score=1); ³8 (score=4), history of ADR (score=2), kidney failure (score=1). Results: The variable with the most ADR risk factors was the number of drugs ³8 drugs as many as 47 patients (65.3%) with GerontoNET score ³4 as much as 70.8%. The types of drugs included in the STOPP criteria are clopidogrel, Arixtra (fondaparinux), beta-blockers, NSAIDs, and furosemide. Conclusion: The risk factor for ADR was the number of drugs ³8 drugs.

Dose Dependent Antimicrobial Cellular Cytotoxicity-Implications for ex vivo Diagnostics.

Introduction:Ex vivo and in vitro diagnostics, such as interferon-γ (IFN-γ) release enzyme linked ImmunoSpot (ELISpot) and flow cytometry, are increasingly employed in the research and diagnostic setting for severe T-cell mediated hypersensitivity. Despite an increasing use of IFN-γ release ELISpot for drug causality assessment and utilization of a range of antimicrobial concentrations ex vivo, data regarding antimicrobial-associated cellular cytotoxicity and implications for assay performance remain scarcely described in the literature. Using the measurement of lactate dehydrogenase (LDH) and the 7-AAD cell viability staining, we aimed via an exploratory study, to determine the maximal antimicrobial concentrations required to preserve cell viability for commonly implicated antimicrobials in severe T-cell mediated hypersensitivity.Method: After an 18-h incubation of patient peripheral blood monocytes (PBMCs) and antimicrobials at varying drug concentrations, the cell cytotoxicity was measured in two ways. A colorimetric based assay that detects LDH activity and by flow cytometry using the 7-AAD cell viability staining. We used the PBMCs collected from three healthy control participants with no known history of adverse drug reaction and two patients with a rifampicin-associated drug reaction with eosinophilia and systemic symptoms (DRESS), confirmed on IFN-γ ELISpot assay. The PBMCs were stimulated for the investigated drugs at the previously published drug maximum concentration (Cmax), and concentrations 10- and 100-fold above.Results: In a human immunodeficiency virus (HIV) negative and a positive rifampicin-associated DRESS with positive ex vivo IFN-γ ELISpot assay, use of 10- and 100-fold Cmax drug concentrations decreased spot forming units/million cells by 32–100%, and this corresponded to cell cytotoxicity of more than 40 and 20% using an LDH assay and 7-AAD cell viability staining, respectively. The other antimicrobials (ceftriaxone, flucloxacillin, piperacillin/tazobactam, and isoniazid) tested in healthy controls showed similar dose-dependent increased cytotoxicity using the LDH assay, but cytotoxicity remained lower than 40% for all Cmax and 10-fold Cmax drug concentrations except flucloxacillin. All 100-fold Cmax concentrations resulted in cell death >40% (median 57%), except for isoniazid. 7-AAD cell viability staining also confirmed an increase in lymphocyte death in PBMCs incubated with 10-fold and 100-fold above Cmax for ceftriaxone, and flucloxacillin; however, piperacillin/tazobactam and isoniazid indicated no differences in percentages of viable lymphocytes across concentrations tested.Conclusion: The LDH cytotoxicity and 7-AAD cell viability staining techniques both demonstrate increased cell death corresponding to a loss in ELISpot sensitivity, with use of higher antimicrobial drug concentrations for ex vivo diagnostic IFN-γ ELISpot assays. For all the antimicrobials evaluated, the use of Cmax and 10-fold Cmax concentrations impacts cell viability and potentially affects ELISpot performance. These findings inform future approaches for ex vivo diagnostics such as IFN-γ release ELISpot.

Nurses' Knowledge, Attitudes, and Practice in Relation to Pharmacovigilance and Adverse Drug Reaction Reporting: A Systematic Review.

Aim To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated barriers from a nurse perspective. Methods A systematic review was conducted. Electronic databases including MEDLINE, Embase, Scopus, and Web of Knowledge from January 2010 to October 2020 were searched. Original observational studies that were written in English and which focused on nurses' knowledge, attitudes, practice, and perceived barriers regarding pharmacovigilance and ADR reporting in various healthcare settings were included. Results Twenty-three studies published in English from 2010 to 2020 were retrieved during the search process. Overall, in the knowledge domain, the median percentages of nurses who were aware of the definitions of ADRs were 74.1%, while only 26.3% were aware of the adverse drug reaction reporting form. In the attitude domain, 84.6% of nurses believed ADR reporting to be important for patient/medicine safety and 37.1% had a fear of legal liability following ADR reporting. Although 67.1% of nurses encountered ADRs during their professional life, only 21.2% had a history of ADR reporting. In addition, lack of knowledge/training (median: 47.1%) was identified as the most common barrier in ADR reporting from a nursing viewpoint. Conclusion Despite positive nurse attitudes, knowledge and practice in relation to pharmacovigilance activities and ADR reporting did not occur regularly or often. Improving nurses' knowledge through in-service training and degree-level education and addressing the main barriers of ADR reporting may help to achieve an improved level of reporting.

Dose Dependent Antimicrobial Cellular Cytotoxicity – Implications for ex vivo diagnostics

Introduction: Ex vivo and in vitro diagnostics, such as interferon-γ (IFN-γ) release enzyme linked ImmunoSpot (ELISpot) and flow cytometry, are increasingly employed in the research and diagnostic setting for severe T-cell mediated hypersensitivity. Despite an increasing use of IFN-γ release ELISpot for drug causality assessment and utilization of a range of antimicrobial concentrations ex vivo, data regarding antimicrobial-associated cellular cytotoxicity and implications for assay performance remain scarcely described in the literature. Using the measurement of lactate dehydrogenase (LDH) and the 7-AAD cell viability staining, we aimed via an exploratory study, to determine the maximal antimicrobial concentrations required to preserve cell viability for commonly implicated antimicrobials in severe T-cell mediated hypersensitivity. Method: After an 18-h incubation of patient peripheral blood monocytes (PBMCs) and antimicrobials at varying drug concentrations, the cell cytotoxicity was measured in two ways. A colorimetric based assay that detects LDH activity and by flow cytometry using the 7-AAD cell viability staining. We used the PBMCs collected from three healthy control participants with no known history of adverse drug reaction and two patients with a rifampicin-associated drug reaction with eosinophilia and systemic symptoms (DRESS), confirmed on IFN-γ ELISpot assay. The PBMCs were stimulated for the investigated drugs at the previously published drug maximum concentration (Cmax), and concentrations 10- and 100-fold above. Results: In a human immunodeficiency virus (HIV) negative and a positive rifampicin-associated DRESS with positive ex vivo IFN-γ ELISpot assay, use of 10- and 100-fold Cmax drug concentrations decreased spot forming units/million cells by 32-100%, and this corresponded to cell cytotoxicity of more than 40 and 20% using an LDH assay and 7-AAD cell viability staining, respectively. The other antimicrobials (ceftriaxone, flucloxacillin, piperacillin/tazobactam, and isoniazid) tested in healthy controls showed similar dose-dependent increased cytotoxicity using the LDH assay, but cytotoxicity remained lower than 40% for all Cmax and 10-fold Cmax drug concentrations except flucloxacillin. All 100-fold Cmax concentrations resulted in cell death >40% (median 57%), except for isoniazid. 7-AAD cell viability staining also confirmed an increase in lymphocyte death in PBMCs incubated with 10-fold and 100-fold above Cmax for ceftriaxone, and flucloxacillin; however, piperacillin/tazobactam and isoniazid indicated no differences in percentages of viable lymphocytes across concentrations tested. Conclusion: The LDH cytotoxicity and 7-AAD cell viability staining techniques both demonstrate increased cell death corresponding to a loss in ELISpot sensitivity, with use of higher antimicrobial drug concentrations for ex vivo diagnostic IFN-γ ELISpot assays. For all the antimicrobials evaluated, the use of Cmax and 10-fold Cmax concentrations impacts cell viability and potentially affects ELISpot performance. These findings inform future approaches for ex vivo diagnostics such as IFN-γ release ELISpot.

Identification of Risk Factors and Cross-Reactivity of Local Anesthetics Hypersensitivity: Analysis of 14-Years' Experience.

PurposeLocal anesthetics (LA) are widely used and adverse drug reactions (ADR) occur in 2.5–10%, but hypersensitivity reactions are rare (ranging between 0% and 4.3%). Risk is so overestimated causing too many allergy clinic referrals. There are limited and also conflicting results over the management of LA allergy. We aimed to find out who should be referred to an allergy clinic for a LA allergy testing, to define the subjects with an increased risk of LA allergy and to assess the need for testing for identifying alternative LA.Patients and MethodsWe performed a retrospective study of patients referred to our clinic for diagnostic workup of LA hypersensitivity from 2006 to 2020.ResultsIn our cohort of 398 patients, tests were positive in 14 (3.52%) of them. Personal history of ADR with LA was the only independent risk factor for positive test (RR=4.007, p=0.033). Presence of generalized cutaneous symptoms and hypotension during past reaction were independent predictors of positive test (RR=9.043, p=0.021 and RR=10.445, p=0.038, respectively). The negative predictive value of intradermal test at dilution of 1:100 for immediate-type reaction was high (97.56%). Also, we demonstrated cross-reactivity within the amide-group LAs and co-occurrence of immediate- and delayed-type reactions.ConclusionOnly patients with an LA-induced ADR should be referred to an allergy clinic. History of generalized cutaneous symptoms and/or hypotension during the reaction may define subjects with an increased risk of LA allergy. A stepwise test procedure may start with skin tests especially for these patients with increased risk factors. In presence of LA allergy, alternative LA should always be confirmed by performing a challenge test.

Development and validation of a clinical instrument to predict risk of an adverse drug reactions in hospitalized patients.

Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution's research ethics committee. In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure <79 mmHg, diabetes mellitus, serum urea ≥ 67 mg/dL, serum sodium ≥141 mmol/L, serum potassium ≥4.9 mmol/L, main diagnosis of neoplasia, prescription of ≥3 ATC class B drugs, prescription of ATC class R drugs, prescription of intravenous drugs and ≥ 6 oral drugs. In the validation sample, the ADR risk tool based on those variables showed sensitivity 61%, specificity 73% and area under the ROC curve 0.73. We report a clinical tool for ADR risk stratification in patients hospitalized in general wards based on 14 variables.

Quality of sleep among patients diagnosed with tuberculosis-a cross-sectional study.

Tuberculosis (TB)can affect sleep and can predispose patients to chronic diseases like diabetes mellitus. On the other hand, sleep deprivation and diabetes mellitus can worsen tuberculosis. The aim of this study was to assess sleep quality, to estimate the prevalence of poor sleepers and those at risk for restless legs syndrome (RLS) and to evaluate the knowledge and practices regarding sleep hygiene among patients diagnosed with TB. In a cross-sectional study, a semi-structured questionnaire was administered to patients diagnosed with TB in Bengaluru, India. The questionnaire was comprised ofsections including demography, knowledge and practice regarding sleep hygiene, the international restless leg study group consensus diagnostic criteria to diagnose RLS, the Pittsburgh sleep quality index, the Epworth sleepiness scale, and history of adverse drug reactions (ADRs). Of 206 participants enrolled, 125 men (61%),mean (SD) age was 41.0 (16.2) years, and 121 (59%) had pulmonary TB while the remaining 85 (41%) had extrapulmonary TB.The prevalence (95% confidence intervals) of poor quality sleeperswas 17% (12,23%), those with poor knowledge of sleep hygiene(< 6 marks)33% (27, 40%), those at risk for RLS 32% (26, 39%),and those with excessive daytime sleepiness (EDS) 12% (8, 17%). Prevalence of poor quality sleepers and those at risk for RLS are higher than normal population, thus making sleep quality assessment important in patients diagnosed with TB. Prevalence of those at risk for EDS was comparable to normal population.

18F-FDG-PET brain imaging may highlight brain metabolic alterations in dysautonomic syndrome after human papilloma virus vaccination.

The aim of this study was to evaluate brain glucose metabolism by means of [18F]-fluoro-deoxygluycose (F-FDG) PET in a group of patients presenting dysautonomic syndrome after human papilloma virus (HPV) immunization. Medical records of patients, referred to the 'Second Opinion Medical Consulting Network' Medical Centre (Modena, Italy) diagnosed with dysautonomic syndrome were searched. Inclusion criteria were presence in the medical history of adverse drug reactions following HPV vaccine; a Montreal Cognitive Assessment score <25 and good quality of a F-FDG-PET brain scan performed within 12 months from the diagnosis of dysautonomic syndrome. F-FDG-PET images of patients (HPV-group) were compared to a control group, matched for age and sex, using statistical parametric mapping (SPM). The F-FDG-PET study was available for five female patients. The SPM-group analysis revealed significant hypometabolism (P < 0.05 false discovery rate corrected) in the right superior and medial temporal gyrus (Brodmann areas 22, 21) and insula (Brodmann area 13). At a threshold of P < 0.001 (uncorrected), further hypometabolic regions were revealed in the right superior temporal gyrus (Brodmann area 42) and caudate head and in the left superior temporal gyrus (Brodmann area 22), frontal subcallosal gyrus (Brodmann area 47) and insula (Brodmann area 13). Relative hypermetabolism (P = 0.001) was revealed in the right premotor cortex (Brodmann area 6). This study revealed the possibility of altered brain glucose metabolism in subjects with dysautonomic syndrome post-immunization with HPV vaccine. These results could reinforce the hypothesis of a causal relationship between HPV vaccine, or some component included in the vaccine and the development of clinical manifestations.

Risk factors associated with the severity of adverse drug reactions by Xiyanping injection: A propensity score-matched analysis.

Xiyanping injection (XYP), extraction of Andrographis paniculate (Andrographis paniculata (Burm. f.) Nees, chuan xin lian), is a Chinese patent medicine approved to treat bronchitis in China. In 2017, safety incidents associated with treatment of XYP began to emerge throughout China. However, the risk factors of severity of adverse reactions by XYP remain uncertain. To determine risk factors for the severity of XYP-associated adverse drug reactions (ADRs). We analyzed a total of 26,317 cases of ADRs linked to the use of XYP injection in the China National Adverse Drug Reaction Monitoring Information System from 2004 to 2017. Data were analyzed with respect to age, gender, ethnicity, previous ADRs, family history of ADRs, dosage specification, medication frequency specification, body weight, route of administration, herb-drug interactions (ribavirin, cefatriaxone, penicillin sodium, ambroxol hydrochloride, clindamycin, cefoxitin sodium, azithromycin, ceftazidime, amoxicillin sodium and clavulanate potassium, levofloxacin, cefazolin sodium pentahydrate, acyclovir) by univariate analysis and multivariate analysis. Propensity score matching was used to compare severity of (general or serious) ADRs. We included 24,911 cases of general ADRs and 1406 cases of serious ADRs. Univariate analysis identified age (p​<​0.001), body weight (p​<​0.001), route of administration (p​=​0.008), co-administration of XYP with ribavirin (p​=​0.031) as risk factors of severity of ADRs. Multivariate analysis identified XYP​+​ribavirin combination (p​=​0.048) and age (p​<​0.001) as the independent risk factors. Upon propensity score matching, the variables were relatively balanced amongst the two groups of patients with general or severe ADRs, and the level of severity in patients who received treatment of XYP​+​ribavirin increased (p​=​0.020). Age and co-administration of ribavirin may be potential risk factors for the severity of XYP-associated ADRs. This reminds us to pay more attention to the safety of elderly medication. Minimizing the herb-drug-interaction effects of XYP and ribavirin is a viable treatment target for healthcare professionals in managing serious ADRs amongst patients receiving XYP injection.

Associations between the adverse drug reactions and the tuberculosis treatment dropout rates at the Cempaka Putih Islamic Hospital in Jakarta, Indonesia

Objective: Tuberculosis (TB) treatment is associated with various adverse drug reactions (ADRs). The aim of this study was to determine the associations between ADRs and the rate of TB treatment dropout among the patients at Cempaka Putih Islamic Hospital in Jakarta, Indonesia. Materials and Methods: A cross-sectional study was conducted based on the medical records of the TB patients treated at Lung Polyclinic of Cempaka Putih Islamic Hospital between January 2016 and December 2017. Results: Of 178 study participants, 80 had a history of ADR while the other 98 did not. There were statistically significant relationships between the rate of TB treatment dropout and the characteristics of patient, including the age (P = 0.022, prevalence ratio [PR] = 0.599, 95% confidence interval [CI] = 0.408–0.870) and ADR type (P = 0.001, PR = 5.333, 95% CI = 1.402–20.285). Furthermore, there were significant relationships between ADRs and comorbid disease (P = 0.000, PR = 1.871, 95% CI = 1.370–2.555). However, ADR treatment status based on the given guidelines does not have a statistically significant relationship with the rate of TB treatment dropout (P = 0.172, PR = 2.028, 95% CI = 0.582–7.071). Conclusion: The results of this study showed that age and ADR type significantly increased the prevalence of the rate of TB treatment dropout among our patient cohorts.

Knowledge, Attitudes, and Practice of Hospital Pharmacists Regarding Pharmacovigilance and Adverse Drug Reaction Reporting in Japan

Background: The importance of pharmacovigilance in Japan is gradually being recognized. However, Japanese pharmacists’ knowledge of and perspectives on pharmacovigilance have been examined only in some areas of Japan. Objective: The objective of this study was to clarify the knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting among hospital pharmacists in Japan. Setting: A questionnaire survey among Japanese hospital pharmacists. Method: The questionnaire was distributed to 48 028 pharmacists during a 3-month period between January and March 2017. Main Outcome Measure: The prevalence of hospital pharmacists who understood pharmacovigilance and the ADR reporting system. Results: Of the respondents (response rate; 9.9% = 4760/48 028), 21.9% were &lt;30 years of age, 27.3% were ≥50 years of age, and 46.7% were women. In response to the question “Have you ever heard of the term ‘pharmacovigilance’?,” 12.4%, 33.8%, and 47.4% answered “I understand what it is,” “I have heard of it, but I do not understand what it is,” and “I do not know what it is,” respectively. Pharmacists who understood the term “pharmacovigilance” were also more frequently acquainted with its associated terms and actions. And, 69.7% of respondents wished to acquire more information on pharmacovigilance and 50.9% did not have a personal history of ADR reporting. The most common reason for ADR nonreporting was “It was a well-known adverse drug reaction” (44.5%). Conclusions: Our results suggest that more aggressive promotion of pharmacovigilance and of the ADR reporting system among Japanese pharmacists is needed.

The effect of preparative solid food status on the occurrence of nausea, vomiting and aspiration symptoms in enhanced CT examination: prospective observational study.

To evaluate the correlation between preparative solid food status and the incidence of nausea, vomiting and aspiration symptoms in contrast-enhanced CT examination, and to provide direction for standardizing the preparative dietary policies. Patients who underwent routine enhanced CT examination at our hospital between June 2015 and June 2017 (110,836 cases) were enrolled and allocated into solid food fasting group (51,807 cases) and solid food non-fasting group (59,029 cases). Fluids ingestion was not restricted for any case. The differences in the incidence of nausea, vomiting and aspiration symptoms between the two groups of patients with various basic data were compared. The risk factors for the occurrence of nausea, vomiting and aspiration symptoms were analyzed. The total incidence of nausea and vomiting was extremely low (0.071%), and no aspiration developed. There was no significant difference in the incidence of nausea and vomiting between the two groups in all respects (p > 0.05). The incidence of nausea and vomiting in patients with an iodine adverse drug reaction (ADR) history was higher than those with other ADR history (p = 0.008) and those without ADR history (p = 0.001). The occurrence of nausea and vomiting has no correlation with the preparative solid food status. Unless compulsory in clinical needs and constraints and gastrointestinal examination, solid food fasting is not a must in other examinations. Particular attention should be paid to the patients with an iodine ADR history in an effort to prevent possible ADRs. The correlation between preparative solid food status and the incidence of nausea, vomiting and aspiration symptoms in contrast-enhanced CT examination were comprehensively analyzed in a large-scale population.

Mortality from adverse drug reaction-related hospitalizations in south-west Ethiopia: A cross-sectional study.

Adverse drug reactions (ADRs) are an important cause of mortality during medical care. To our knowledge, no Ethiopian studies have reported on mortality due to ADRs in patients presenting to hospital from the community setting. The aim of this study was to determine the mortality rate attributable to ADRs in patients presenting to hospital, identify drugs implicated in the ADR-related deaths and identify factors contributing to ADR-related mortality at Jimma University Specialised Hospital (JUSH), south-west Ethiopia METHODS: This cross-sectional study included 1001 patients aged ≥18years consecutively admitted to medical wards from May 2015 to August 2016. ADR-related mortality was determined through detailed review of medical records, laboratory tests and patient interviews followed by causality assessment by the Naranjo algorithm and expert consensus. Of 1001 patients, 15, 1.5% (95% confidence interval [CI]: 0.80%-2.30%) died with an ADR. The primary suspected causes of death were drug-induced hepatotoxicity (7, 43.8%) followed by acute kidney injury (4, 25.0%). Isoniazid (6, 33.3%), pyrazinamide (3, 16.7%), efavirenz (2, 11.1%) and tenofovir (2, 11.1%) were commonly implicated drugs. The majority of ADRs (14, 93.8%) were preventable. Unadjusted bivariate comparisons suggested patients who died with ADRs were more likely to have pre-existing liver disease (40.0% vs 7.0%; 95% confidence interval [CI]: 8.1%-57.8%), a history of ADRs (40% vs 1.4%; 95% CI: 13.8%-63.4%), a lower mean (±SD) body mass index (BMI, 17.6±2.1 vs 20.0±2.9kg/m2 ; 95% CI=0.9-3.9), exposure to antitubercular (46.7% vs 18.9%; 95% CI: 2.3%-53.1%) and antiretroviral (40.0% vs 7.7%; 95% CI: 7.5%-57.2%) therapies, and a higher mean number of medications (7.1±3.3 vs 3.8±2.1; 95% CI: 2.2-4.4) and Charlson Comorbidity Index (3.9±2.9 vs 1.6±1.8; 95% CI: 1.4-3.2) than surviving patients without ADRs. Fatal ADRs were common in patients presenting to hospital. The drugs implicated were mostly antitubercular and antiretroviral therapies, reflecting the high burden of HIV and tuberculosis in the study population. ADR-related deaths were significantly associated with poor nutritional status. The majority of ADR-related deaths were preventable, highlighting the need to develop a multidisciplinary approach to closely monitor patients who are prescribed antitubercular and antiretroviral therapies, particularly in patients with hepatic disease, a history of ADRs, who are malnourished and who are exposed to multiple medications.

Evaluation of Predisposing Factors Associated with Suspected Adverse Drug Reactions of Hospitalized Patients

: Objectives: To study the incidence and to evaluate the risk factors of suspected adverse drug reactions developed in the hospitalized patients of various departments and to assess the causality and severity of adverse drug reactions (ADRs). Methods: It was a retrospective-prospective study conducted in a tertiary care hospital for a period of two years two months, with a specific predefined criterion. A total of 254 subjects with ADRs were identified during the period of study for which 1:1 ratio of subjects with non-ADRs were taken. Subjects of all age groups and of either sex were enrolled. Risk factors included subjects’ age group, gender, polypharmacy, comorbidity, intercurrent diseases and concurrent interactive drugs. Statistical analysis used: Multiple logistic regression analysis was performed to find the association of risk factors with adverse drug reactions. Results: The incidence of suspected adverse drug reactions in hospitalized patients was13% (254/1952, 95%CI). Polypharmacy was the most significant predictor of adverse drug reactions (OR=55.952; 95%CI). Elderly population with multidrug therapy had developed the higher rate of ADRs. Cephalosporin’s 27.6%, fluoroquinolones 15.5%, penicillamines 12.1%, anti-hypertensive 8.7%, NSAIDs 8.3% were more frequently implicated. Risk factors for suspected ADRs were: age (more than 60 years) (OR=1.033: 95% CI), gender , comorbidity (OR=1.008; 95% CI), intercurrent diseases (OR=19.27; 95% CI). Conclusion: Polypharmacy, history of ADR, concurrent interactive drugs and inter current disease were the significant risk factors of adverse drug reactions. The elderly population was the vulnerable age group for ADRs. Multidrug therapy and comorbidity resulted in higher risk of ADRs in an older population. The Higher rate of suspected ADRs were probable and very less severe.Key words: Adverse drug reaction, Age, Comorbidity, Polypharmacy, Risk factor.

Polypharmacy in the oldest old (\u226580\xa0years of age) patients in China: a cross-sectional study

BackgroundThe oldest old generally have worse health and more comorbidities than the general population of older adults, and they are more likely to be exposed to polypharmacy. Reliable investigation of polypharmacy among the oldest old (≥80 years of age) in China are lacking. So this study aims to describe the polypharmacy status of oldest old patients ≥80 years of age and to assess the factors influencing medication compliance.MethodsThis was a cross-sectional study of 258 oldest old patients ≥ 80 years of age and hospitalized at a tertiary hospital in Beijing between December 1, 2014 and June 30, 2015. They completed three validated questionnaires to assess their pre-admission status (general demographics, medication knowledge, and medication adherence). Potentially inappropriate medications (PIM) use was evaluated by physicians.ResultsThe majority of the patients (55.4%) took < 10 types of drugs. The numbers of drugs taken ranged from 8 to 60 drugs (median of 22.9). Patients taking 11–20 drugs accounted for 46.1% of the patients. Subjects with a history of adverse drug reactions accounted for 40.3%. The proportion of PIMs was 27.1%. Compliance was only 32.6% among the oldest old patients with polypharmacy. Age and medication classes were independently negatively associated with compliance, and medication knowledge was independently positively associated with compliance.ConclusionOldest old patients (≥ 80 years of age) had a poor medication knowledge. Age, medication classes, and medication knowledge were independently associated with medication compliance.