Occurrence Of Adverse Drug Events Research Articles

Exploiting complex medical data with interpretable deep learning for adverse drug event prediction.

A variety of deep learning architectures have been developed for the goal of predictive modelling and knowledge extraction from medical records. Several models have placed strong emphasis on temporal attention mechanisms and decay factors as a means to include highly temporally relevant information regarding the recency of medical event occurrence while facilitating medical code-level interpretability. In this study we utilise such models with a large Electronic Patient Record (EPR) data set consisting of diagnoses, medication, and clinical text data for the purpose of adverse drug event (ADE) prediction. The first contribution of this work is an empirical evaluation of two state-of-the-art medical-code based models in terms of objective performance metrics for ADE prediction on diagnosis and medication data. Secondly, as an extension of previous work, we augment an interpretable deep learning architecture to permit numerical risk and clinical text features and demonstrate how this approach yields improved predictive performance compared to the other baselines. Finally, we assess the importance of attention mechanisms in regards to their usefulness for medical code-level and text-level interpretability, which may facilitate novel insights pertaining to the nature of ADE occurrence within the health care domain.

Safety Profile of Warfarin versus Dabigatran in Adult Patients with Non-valvular Atrial Fibrillation – A Prospective Cohort Study

Abstract: Context: Atrial fibrillation is the most commonly encountered sustained cardiac arrhythmia associated with extensive cardiovascular morbidity and mortality. Warfarin is the most recommended drug therapy for the prevention of thromboembolic events or stroke in patients with atrial fibrillation. Due to availability of newer drugs like dabigatran, the need for frequent PT/INR monitoring and bleeding risk has reduced drastically. Although, studies are lacking regarding its safety profile and therapeutic use in clinical practice. Aim: The main objective of the present study was to assess the safety profile of warfarin versus dabigatran in patients with non-valvular atrial fibrillation. Materials and Methods: This was a prospective cohort study carried out for a period of nine months. All adult patients, who were prescribed with either warfarin or dabigatran in non-valvular atrial fibrillation were included in the study. Patients were monitored initially for occurrence of adverse drug events and subsequently during their follow-up visits at 3 and 6 months. Reported ADEs were analyzed for various clinical characteristics and causality, severity and preventability using standard assessment scales. Results: A total of 75 patients (35 in warfarin and 40 in dabigatran cohort) were recruited. Out of 75, 38 patients experienced 70 ADEs (31 in warfarin and 39 in dabigatran cohort) which accounted for an overall incidence of 51%. Elevated coagulation profile (20%) followed by chest discomfort (10%), thrombocytopenia (7.14%), abdominal pain (7.14%), anemia (10%), gastritis (5.71%) and hematemesis (5.71%) were the most common reported ADEs among others. Dabigatran (55.71%) was associated with higher number but less severe ADEs as compared to warfarin (44.28%). Majority of ADEs were found to be probable (53%) in nature, moderate (57%) in severity, predictable (71%) and not preventable (40%). Conclusion: Dabigatran being a costly alternative appears to be safer than warfarin. Key words: Adverse drug events, Anticoagulants, Dabigatran, Non-valvular atrial fibrillation, Safety profile, Warfarin.

Analysis of adverse reactions risk signal of Xinyuan Capsules based on national ADR monitoring spontaneous reporting system

In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.

Ocular adverse events in drug sensitive TB patients on daily fixed dose combination anti-TB drugs: A record review study from Kerala, India

BackgroundGovernment of India's Revised National TB Control Programme (RNTCP) has begun implementing daily fixed dose combination (FDC) anti-TB treatment regimen for drug sensitive TB patients in which ethambutol is given for six months. Prolonged ethambutol use is known to cause ocular adverse drug events (ADE). ObjectivesTo assess the magnitude of ocular ADEs in adult drug sensitive TB patients initiated on daily FDCs and to describe the demographic and clinical profile of patients with ocular ADEs. MethodsWe conducted a retrospective cohort study involving review of RNTCP records of all adult (age >14 years) drug sensitive TB patients initiated on daily FDCs between1st January 2018 and 31st July 2018 in Thiruvananthapuram district, Kerala State, India. Results714 patients were initiated on daily FDCs during the study period. It was unknown whether all patients had undergone assessment for ocular ADEs. However, of these 714 patients, 8 patients (1.1%) were documented to have had ocular ADEs. Seven of these 8 patients had received ethambutol more than 15 mg/kg body weight and had developed ocular symptoms (decreased/blurring of vision) 3 months after TB treatment initiation. Ethambutol was stopped in all these 8 patients. In 5 patients it was recorded that ocular ADEs had resolved following stoppage of ethambutol and in the remaining it was unknown. ConclusionThe study confirms the occurrence of ocular ADEs among drug sensitive TB patients on daily FDCs and recommends strengthening of systems for assessing, documenting and managing ocular ADE.

Use of trigger tool to identify Adverse Drugs Events in dogs.

The highlight of the shortcomings in the regulation and surveillance of veterinary drugs in Brazil is the absence of a system to report adverse drug events (ADEs). The aim of this study was evaluate the use of triggers in dogs to detect ADEs by estimating the prevalence of ADE and identifying the possible triggers. We screened medical records for ADEs and degree of harm caused by an ADE, using known triggers, with the Global Trigger Tool: translated, adapted and validated for use in animal health. The triggers comprised two-fold increase in blood urea nitrogen or serum creatinine levels compared to baseline, administration of vitamin K, administration of diphenhydramine or promethazine, excessive sedation or hypotension, administration of an antiemetic, abrupt cessation of medication, or others. The association between the occurrence of ADEs and variables, such as age, race, duration of hospitalization, polypharmacy, and clinical outcome was evaluated. A total of 148 medical records were analyzed. The trigger tools identified the known triggers 109 times in 68 medical records. Additionally, 14 ADEs were identified; the prevalence of ADEs was 9.5%. Positive predictive values of the triggers were 12.8%, and “vitamin K administration” had the best performance. The duration of hospitalization (p-value = 0.030) and polypharmacy (p-value < 0.001) were associated with the occurrence of ADEs. Approximately 46% of the hospitalized dogs presented with at least one trigger. One out of five hospitalized dogs suffered from temporary harm due to an ADE. The duration of hospitalization and polypharmacy were found to be risk factors for ADEs in dogs.

An Intelligent m-Healthcare System for Improving the Service Quality in Domestic Care Industry

Abstract Due to declining fertility rate and increasing life expectancy, population aging has become a growing problem in Hong Kong. Domestic elderly service providers and public health institutions have been suffering from a shortage of experienced staff for elderly healthcare, which has led to a drop in both the quality and efficiency of the local elderly service. With the rising popularity of mobile applications and the betterment of machine vision technology, this paper describes the design of an Intelligent m-Healthcare System (ImHS) for relieving the manpower pressure on local elderly service providers by lowering the technical threshold and simplifying staff training process. Face recognition technology is applied to identify the elderly by searching and tracing the elderly medical record through the FaceAPI service. In addition, the proposed ImHS provides the immediate insight into healthcare knowledge for users, which lowers the occurrence of Adverse Drug Event (ADE) and shortens the duration of pill distribution process. By conducting a case study in a local elderly home, the proposed system allowed the nursing staff to better allocate healthcare resources and to improve the operation effectiveness and efficiency.

In-hospital adverse drug events: analysis of trend in Portuguese public hospitals.

The objectives of this study were to analyze in-hospital adverse drug events (ADEs) in Portuguese public hospitals, and their association with mortality and the duration of hospitalization. We analyzed an administrative database containing the registration of all hospitalizations occurring in Portuguese public hospitals in 2013-2015. ADEs were identified using the codes E850-858.9 and E930-949.9 from ICD-9-CM. We identified all episodes with registration of in-hospital ADE and we compared them with a random sample of an equal number of episodes with no events recorded. A total of 3,041,443 cases were analyzed, 60,521 presented at least one ADE from which 17,213 occurred in hospital context. The most frequent drug classes associated with ADE were the antineoplastics/immunosuppressant drugs, antibiotics and steroids. Patient characteristics associated with a greater occurrence of in-hospital ADEs (all with p < 0.001) were medical admissions (OR = 1.29), the diagnosis - myeloid leukaemia (OR = 18.63), nephrotic syndrome (OR = 15.75), pneumonia (OR = 1.33) -, a higher number of secondary diagnoses (OR = 1.27), and increased duration of hospital stay (OR = 1.06). Hospitalizations with records of in-hospital ADEs presented a significantly higher mortality (9.6% vs. 4.5) and duration of hospitalization (22.6 vs. 6.4 days). ADEs were shown to be directly associated with an increase in the duration of hospital stay of 8.18 days. This study adds some interesting insights related to the most frequent drug classes and patient characteristics that can influence the frequency of ADEs in Portuguese public hospitals and also the burden of injury resulting from them.

Clinical Importance of Drug Adherence during Tyrosine Kinase Inhibitor Therapy for Chronic Myelogenous Leukemia in Chronic Phase

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm constituting approximately 15% of newly diagnosed leukemia in adult patients. Development of tyrosine kinase inhibitors (TKIs) have dramatically improved outcomes in patients with chronic CML in chronic phase. However, adverse drug events (ADEs) associated with TKI therapy have influenced drug adherence, resulting in adverse clinical outcomes and a decline in the quality of life (QoL). In this study, we carried out a unique questionnaire survey to evaluate ADEs, which comprised 14 adverse events. We compared drug adherence rates between patients using imatinib and those who switched from imatinib to nilotinib, a second-generation TKI. Following the switch, the total number of ADEs decreased considerably in most cases. Simultaneously, better QoL was observed in the nilotinib group than in the imatinib group. Drug adherence was measured using Morisky’s 9-item Medication Adherence Scale (MMAS). MMAS increased significantly after switching to nilotinib in all cases. Drug adherence is a critical factor for achieving molecular response in patients with CML. In fact, our results showed a strong inverse correlation between clinical outcome (international scale (IS)) and adherence (MMAS), with a stronger tendency in the nilotinib group than in the imatinib group. In conclusion, low occurrence of ADEs induced a high level of QoL and a good clinical response with second-generation TKI nilotinib treatment.

Inappropriate prescribing defined by STOPP and START criteria and its association with adverse drug events among hospitalized older patients: A multicentre, prospective study.

ObjectivesTo provide baseline information on inappropriate prescribing (IP), and to evaluate whether potentially inappropriate medications (PIMs), as defined by STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions) criteria, were associated with preventable adverse drug events (ADEs) and/or hospitalization.MethodsWe prospectively studied older patients (n = 301) admitted to three urban, public-funded hospitals. We scrutinized their medical records and used STOPP-START (Screening Tool to Alert Prescribers to Right Treatment) criteria to determine PIM and potential prescribing omissions (PPO) respectively- together these constitute IP. Prescriptions with PIM(s) were subjected to a pharmacist medication review, aimed at detecting cases of ADE(s). The vetted cases were further assessed by an expert consensus panel to ascertain: i) causality between the ADE and hospitalization, using, the World Health Organization Uppsala Monitoring Centre criteria, and, ii) whether the ADEs were avoidable (using Hallas criteria). Finally, percentages of PIM-associated ADEs that were both preventable and linked to hospitalization were calculated.ResultsIP prevalence was 58.5% (n = 176). A majority (49.5%, n = 150) had moderate to severe degree of comorbidities (Charlson Comorbidity Index score ≥ 3). Median age was 72 years. Median number of medications was 6 and 30.9% (n = 93) had ≥8 medications. PIM prevalence was 34.9% (117 PIMs, n = 105) and PPO 37.9% (191 PPOs, n = 114). Most PIMs and PPOs involved overuse of aspirin and underuse of both antiplatelets and statins respectively. With every increase in the number of medications prescribed, the likelihood of PIM occurrence increased by 20%, i.e.1.2 fold (OR 1.20, 95% CI: 1.1–1.3). Among the 105 patients with PIMs, 33 ADEs (n = 33); 31 ADEs (n = 31) considered “causal” or “contributory” to hospitalization; 27 ADEs (n = 27) deemed “avoidable” or “potentially avoidable”; and 25 PIM-associated ADEs, preventable, and that induced hospitalization (n = 25), were identified: these equated to prevalence of 31.4%, 29.5%, 25.7%, and 23.8% respectively. The most common ADEs were masked hypoglycemia and gastrointestinal bleed. With every additional PIM prescribed, the odds for ADE occurrence increased by 12 folds (OR 11.8, 95% CI 5.20–25.3).ConclusionThe majority of the older patients who were admitted to secondary care for acute illnesses were potentially exposed to IP. Approximately a quarter of the patients were prescribed with PIMs, which were plausibly linked with preventable ADEs that directly caused or contributed to hospitalization.

Association of Adverse Drug Events with Broad-spectrum Antibiotic Use in Hospitalized Patients: A Single-center Study.

Objective The importance of antimicrobial stewardship is increasingly highlighted in this age of antimicrobial resistance. A better comprehension of adverse drug events (ADEs) can promote the appropriate use of antibiotics. We aimed to quantify the incidence of ADEs associated with broad-spectrum systemic antibiotics in a hospital setting. Methods We conducted a six-month prospective, observational study at Osaka University Hospital to describe the incidence of ADEs in patients hospitalized in general wards undergoing treatment with broad-spectrum antibiotics [carbapenems, piperacillin/tazobactam (PIPC/TAZ), and anti-methicillin-resistant Staphylococcus aureus agents]. The occurrence of ADE was defined as any cardiac, gastrointestinal, hepatobiliary, renal, neurologic, hematologic, dermatologic, or musculoskeletal manifestation after 48 hours or more of systemic antibiotic therapy. Results The 3 most frequently prescribed antibiotics were PIPC/TAZ (242 cases), meropenem (181 cases), and vancomycin (92 cases). Of 689 patients, 118 (17.1%) experienced ADEs, including gastrointestinal (6.4%), hepatobiliary (4.2%), dermatologic (2.5%), and renal (2.3%) manifestations. Patients treated with PIPC/TAZ, meropenem, doripenem, vancomycin, daptomycin, and teicoplanin developed ADEs at rates of 20.7%, 16.0%, 15.4%, 19.6%, 11.8%, and 10.9%, respectively. Conclusion Our study provides a quantitative value for the incidence of ADEs associated with broad-spectrum antibiotics in clinical practice. To optimize patient safety, clinicians need to be aware of the risks associated with antibiotic administration.

Adverse events following the use of immune checkpoint inhibitors: An analysis of the WHO VigiAccess database.

e13118 Background: Immune checkpoint inhibitors (ICIs), especially ipilimumab (ipi) and nivolumab (nivo), have received approvals from the U.S. Food and Drug Administration for the treatment of multiple tumor types. These medications have shown great promise in the treatment of several malignancies but are associated with immune-related adverse events. This study was undertaken to better understand the patterns of adverse events following different ICIs. Methods: We used the World Health Organization (WHO) Vigiaccess Database, the largest adverse events reporting database, to identify, summarize, and report adverse drug events (AE) attributed to ipi and nivo. The database contains reports for ipi beginning in 2008 and for nivo beginning in 2012. We manually extracted the data from the database and conducted Chi-square tests to examine the difference in occurrence of AEs in various organ systems between patients receiving ipi and nivo. The five most common organ systems affected by AE associated with ipi and nivo were identified. Results: AEs were reported in 15,504 ipi users and 21,306 nivo users. Ipi users reported significantly higher AEs in gastrointestinal system compared to nivo users (p &lt; 0.0001). Conversely, nivo users reported significantly higher AEs in respiratory disorders (p &lt; 0.0001), skin and subcutaneous tissue organ systems (p = 0.0001), and neoplasms benign, malignant and unspecified (p &lt; 0.0001) compared to ipi users. Conclusions: To our knowledge this is the largest study on reported AEs following ipi and nivo. The patterns of treatment-related AEs differed significantly for these two immune checkpoint inhibitor therapies. Further studies are required to guide treatment selection.[Table: see text]

Medication administration safety assessment tool: Construction and validation.

To build and validate the Patient Safety Assessment in Medication Administration (ASPAM - Avaliação da Segurança do Paciente na Administração de Medicamentos) tool. Methodological study in which the construction, Content Validation Index (CVI), construct validation (factorial analysis) and reliability were performed in terms of homogeneity (Cronbach's Alpha). The ASPAM reached CVI of 0.77 for simplicity, 0.76 for clarity and 0.93 for relevance. The exploratory factorial analysis was adequate for the tool (Kaiser-Meyer-Olkim of 0.66 and Bartlett's sphericity with p <0.001). The Cronbach's Alpha end of the scale with 28 items was 0.85. The ASPAM tool was valid and reliable for the identification of risk-generating conditions for the occurrence of Adverse Drug Events.

Evaluation of Rationality of Geriatric Patients' Prescription Based On Beers Criteria in a Tertiary Care Hospital in India.

AIM:Irrational prescribing for geriatric patients has become an important public health problem worldwide. Because India is one of the most populated countries having a great proportion of old people in the world, studies on the prevalence of inappropriate prescriptions can be very beneficial to increase the knowledge of health care providers and to reduce the occurrence of adverse drug events among this population.METHODS:A group of 482 inpatients above 64 years old were enrolled in a prospective study. Chart review method was used. The data were collected from patients’ prescription and medicine charts. Each prescription was checked individually for the inappropriate drug by using the AGS 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Suggestions were given to the physicians for inappropriate medications.RESULTS:The prevalence of potentially inappropriate medication is found to be 11.66% (n = 56). Out of 56 inappropriate medications, the most frequently inappropriate medication is Digoxin (25%) followed by Sprinolactone 19.64%. This study founds age, some medication, length of stay and number of diagnosis as predictors for getting a PIM. Feedback of the physicians varies based on the suggestions.CONCLUSION:This study concludes that the prevalence of PIMs among geriatrics patients of ≥ 65 years old is 11.66%. Some predictors have been identified for getting a PIM. This study shows that physicians’ feedback is dependent on the suggestions being given.

Economic Outcomes Associated with Safety Interventions by a Pharmacist-Adjudicated Prior Authorization Consult Service.

The establishment of a formulary management system ensures that health care professionals work together in an integrated patient care process to promote clinically sound, safe, and cost-effective medication therapy. Pharmacists have a foundational role within this system. A pharmacist-adjudicated prior authorization drug request (PADR) consult service has the potential to optimize drug therapy by decreasing medication misuse, minimizing adverse drug events (ADEs), and preventing medication errors. To (a) determine cost avoidance associated with pharmacist-adjudicated PADR safety interventions within the Durham Veterans Affairs Health Care System and (b) evaluate cost savings associated with pharmacist-adjudicated PADRs not approved due to a safety intervention, evaluate cost avoidance and direct cost savings based on clinical specialty of pharmacist adjudicating PADR, and characterize severity of avoided ADEs. Pharmacist-adjudicated PADRs not approved between July 1, 2016, and June 30, 2017, because of safety interventions were retrospectively reviewed. Cost avoidance was determined by multiplying the probability of ADE occurrence in the absence of PADR safety intervention by the estimated cost avoided based on the type of intervention. Direct cost savings was calculated by totaling the cost of requested medications not approved for each PADR and subtracting the cost of recommended alternative therapies and cost of pharmacist PADR review. All potential ADEs avoided were reviewed by a panel of 3 clinical pharmacists to validate ADE classification and ADE probability and severity scores. Descriptive statistics were used for all analyses. Of the 910 PADRs that were not approved during the study period, 96 met inclusion criteria. Pharmacist-adjudicated PADR safety interventions resulted in a total cost avoidance of $24,485.34 (mean = $255.06) and a direct cost savings of $288,695.63 (mean = $3,007.25). The practice settings of anticoagulation and infectious diseases PADRs resulted in the largest contribution to cost avoidance and direct cost savings, respectively. Prevented ADEs were classified as major for 64.6% of the PADRs. Pharmacist-adjudicated PADR safety reviews resulted in substantial economic benefit and prevention of major ADEs. This analysis supports the pharmacist's role in a formulary management system to optimize medication therapy. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for profit sectors. The authors have nothing to disclose.

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients

ObjectiveTo describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. MethodsThe validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back‐translation from Brazilian Portuguese to English. ResultsThe translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value. ConclusionThe research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.

Understanding adverse drug-related emergency department visits: development of a conceptual model through a systematic review.

Background:The burden of adverse drug event (ADE)-related emergency department (ED) visits is increasing despite several preventive measures. The objective of this paper was to develop and validate a conceptual model for a better understanding of ADE-related ED visits and to guide the design and implementation of effective interventions.Methods:The development of the model involved a systematic review of the literature using PubMed and Embase databases. Studies reporting the risk factors associated with ADE-related ED visits were included. The methodological qualities of the included studies were assessed using the Mixed Methods Appraisal Tool (MMAT). The model was mapped and validated using face and content validity by an expert panel. Deficiencies and targeted interventions were identified, and steps for the design and implementation were recommended.Results:The literature search generated 1361 articles, of which 38 were included in the review; 41 risk factors associated with ADE-related ED visits were identified. All factors were mapped, and the model was validated through face and content validity. The model consisted of six concepts related to sociodemographic factors, clinical factors, ADE-related to ED visits, ADE while in the ED, outcomes, and consequences. Interventions could be targeted at the factors identified in each concept to prevent ADE-related ED burden.Conclusion:A conceptual model to guide the successful design and implementation of strategies to prevent ADE-related ED visits and the occurrence of ADE at ED was developed. Clinicians should take these factors into consideration to prevent untoward events, especially when treating high-risk patients.

Effect of baseline renal and hepatic function on the incidence of adverse drug events: the Japan Adverse Drug Events study

Background The impact of renal and hepatic dysfunction on the morbidity and mortality of inpatients with adverse drug events (ADEs) is uncertain in daily clinical practice. The objective of this study was to investigate the effect of renal and hepatic function on ADEs and inpatients' morbidity and mortality. Methods The Japan Adverse Drug Events (JADE) study was a prospective cohort study carried out at three tertiary-care teaching hospitals in Japan. Participants were consecutive inpatients (n=3459) aged 15 years or older. We evaluated the effect of renal and hepatic function on the occurrence of ADEs, and assessed how they affected length of hospital stay (LOS) and in-hospital mortality. We used the estimated glomerular filtration rate to quantify renal function and categorized patients into three groups (normal, ≥60 mL/min/1.73 mm; moderate, ≥30 and <60 mL/min/1.73 mm; severe, <30 mL/min/1.73 mm). We defined patients as having hepatic dysfunction when at least one data point (total bilirubin, aspartate aminotransferase, alanine aminotransferase, or gamma glutamyltransferase) was beyond a cutoff value. Results We analyzed the laboratory data of 2508 patients. There was a significant difference in the occurrence of ADEs among the three GFR categories (normal, 20%; moderate, 26%; severe, 22%; p=0.02). More ADEs occurred in patients with hepatic dysfunction (25% vs. 20%, p=0.01). LOS was significantly longer in those with ADEs stratified either by renal or by hepatic dysfunction (p<0.0001). ADEs were independently associated with in-hospital mortality, adjusting for renal and hepatic function (p<0.0001). Conclusions Inpatients' organ dysfunction increased ADEs, and ADEs were associated with both LOS and in-hospital mortality independently, irrespective of renal and hepatic function.

Clinical, Economic, and Organizational Impact of the Clinical Pharmacist in an Orthopedic and Trauma Surgery Department.

The aim of this study was to evaluate the clinical, economic, and organizational impact of clinical pharmacist services added to an adult orthopedic and trauma surgery unit in a university hospital. This was a prospective, observational study performed from January to February 2017. All pharmacists' interventions were documented, and their clinical, economic, and organizational impact and the probability of adverse drug events (ADEs) were assessed using the clinical, economic and organizational scale three-dimensional scale. An expert panel composed of three clinical pharmacists, one surgeon and one anesthetist classified the pharmacist intervention. The potential clinical impact was determined through a consensus by the expert panel. Cost avoidance was calculated for serious ADEs with a major impact by avoiding an additional cost of €4912 per event and taking into account the probability of ADE occurrence. The pharmacists performed 1014 interventions for 28 days with a 95.3% acceptance rate by prescribers. Thirty-nine interventions were rated to have a major clinical impact (3.8%). The organizational impact was estimated favorable for 856 (84.4%) pharmacist interventions. Cost avoidance was estimated at €24,364, and the indirect costs benefit was estimated at €11,864 during the study. The cost-benefit ratio of the clinical pharmacist intervention was €1.94 in savings for every €1 invested. Clinical pharmacist services in an orthopedic and trauma surgery department have the potential to improve patient outcomes and avoid healthcare costs. Furthermore, the presence of a pharmacist in surgical units allows for communication between the unit and the pharmacy, which produces better fluidity and improves the quality of care.

Study of proportion and pattern of adverse drug events among patients coming to health centers in urban and rural areas

Background: Adverse drug events (ADE) are rated as the fifth leading cause of death among all diseases. Approximately 5-8% of all hospitalization worldwide is due to ADE. The present study was conducted with the aim of analyzing the pattern of Adverse Drug events in patients coming to urban and rural health care centres, their manifestations and severity.Methods: The study type useful in this study was cross sectional study. This method is helpful to find the exact duration of occurrence of ADE after administration of drug and to know what kind of adverse event patient is suffering from.Results: There are many studies done in peripheral health care centres regarding ADE in India. In our study, out of 250 patients, 125 were from urban and 125 were from rural. Among the 125 patients from urban 3.2% (4 cases) adverse drug events- reported. Among the 125 patients from rural 4% (5 cases)adverse drug events- reported.Conclusions: This study provides a baseline idea about the knowledge and perception toward ADEs among patients visiting an outpatient department at urban and rural hospital in India. Respondents were unaware about the process of reporting ADEs, reporting by the consumers, and the possible benefits to them by doing so. There is a strong need to do the work to make consumers aware about the same. Educational interventions are needed to improve awareness among patients regarding importance of ADE reporting.

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients

ObjectiveTo describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. MethodsThe validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back-translation from Brazilian Portuguese to English. ResultsThe translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value. ConclusionThe research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.