• medication safety
• paediatrics

• Humans
• Medication Errors/statistics & numerical data
• Medication Errors/prevention & control
• Child
• Retrospective Studies
• Hospitals, Pediatric/standards
• Inpatients
• Child, Preschool
• Infant

• 1094878 National Health and Medical Research Council
• 1174021 NHMRC Leadership Investigator Grant
• 1143941 NHMRC Early Career Fellowship

• case report
• drug administration error
• intrathecal digoxin
• medical error
• medication error in pregnancy

• Acute myocardial infarction
• Adverse drug events
• Adverse drug reactions
• Medication harm
• Rehospitalisation

• Aged
• Cross-Sectional Studies
• Frail Elderly
• Frailty/epidemiology
• Geriatric Assessment/methods
• Humans
• Observational Studies as Topic
• Polypharmacy
• Retrospective Studies

• PA Research Foundation Grant 2020
• The University of Queensland

• benchmarking
• medication error
• palliative care service

• adverse drug event
• dementia
• fall
• nursing home
• polypharmacy
• psychotropic drugs

• Accidental Falls
• Aged, 80 and over
• Humans
• Japan/epidemiology
• Nursing Homes
• Psychotropic Drugs/adverse effects
• Retrospective Studies

• cardiovascular disease
• frailty
• hypertension
• medication-related harm
• older people
• polypharmacy

• health & safety
• health economics
• health policy

• Cost-Benefit Analysis
• Hospitals
• Humans
• Income
• Surveys and Questionnaires
• United Kingdom

• European Union

• Academic Medical Centers/standards
• Anesthesia/standards
• Documentation/standards
• Electronic Health Records/standards
• Hospital Information Systems/standards
• Humans
• Pain Management/standards
• Quality Assurance, Health Care/standards
• Quality Improvement/standards

• Anti-Bacterial Agents/adverse effects
• Drug Hypersensitivity/diagnosis
• Drug Hypersensitivity/epidemiology
• Drug Hypersensitivity/etiology
• Drug-Related Side Effects and Adverse Reactions
• Humans

• K01 AI125631 NIAID NIH HHS

• Drug-Related Side Effects and Adverse Reactions
• Humans
• Inpatients
• Medication Errors
• Patient Safety
• Psychiatry
• United States

• R01 MH086722 NIMH NIH HHS

• Adult
• Hospitalization
• Hospitals
• Humans
• Medication Errors/prevention & control
• Medication Reconciliation
• Pharmacists

• STOPP/START
• adverse drug reactions
• drug/medical use evaluation
• geriatrics
• medication therapy management
• older adult

• clinical governance
• drug overdose
• inpatients
• medication error
• patient safety
• risk management

• Child
• Hospitals, Teaching
• Humans
• Medication Errors
• Retrospective Studies
• Risk Management
• United Kingdom/epidemiology

To assess the appropriateness of medication-related clinical decision support (CDS) alerts associated with renal insufficiency and the potential/actual harm from overriding the alerts.

Override rate frequency was recorded for all inpatients who had a renal CDS alert trigger between 05/2017 and 04/2018. Two random samples of 300 for each of 2 types of medication-related CDS alerts associated with renal insufficiency—“dose change” and “avoid medication”—were evaluated by 2 independent reviewers using predetermined criteria for appropriateness of alert trigger, appropriateness of override, and patient harm.

We identified 37 100 “dose change” and 5095 “avoid medication” alerts in the population evaluated, and 100% of each were overridden. Dose change triggers were classified as 12.5% appropriate and overrides of these alerts classified as 90.5% appropriate. Avoid medication triggers were classified as 29.6% appropriate and overrides 76.5% appropriate. We identified 5 adverse drug events, and, of these, 4 of the 5 were due to inappropriately overridden alerts.

Alerts were nearly always presented inappropriately and were all overridden during the 1-year period studied. Alert fatigue resulting from receiving too many poor-quality alerts may result in failure to recognize errors that could lead to patient harm. Although medication-related CDS alerts associated with renal insufficiency had previously been found to be the most clinically beneficial alerts in a legacy system, in this system they were ineffective. These findings underscore the need for improvements in alert design, implementation, and monitoring of alert performance to make alerts more patient-specific and clinically appropriate.

• alert fatigue
• medical informatics
• medication safety
• patient safety
• quality of care

• diseases
• health care
• medical research
• risk factors

• Adult
• Aged
• Aged, 80 and over
• Disease Management
• Drug-Related Side Effects and Adverse Reactions/epidemiology
• Drug-Related Side Effects and Adverse Reactions/etiology
• Ethiopia/epidemiology
• Female
• Hospitalization
• Humans
• Incidence
• Male
• Middle Aged
• Prospective Studies
• Public Health Surveillance
• ROC Curve
• Risk Factors
• Tertiary Care Centers

• Claims data
• EU(7)-PIM list
• Elderly
• PRISCUS list
• Potentially inappropriate medication

• Adolescent
• Adult
• Child
• Decision Support Techniques
• Female
• Ghana
• Health Facilities/statistics & numerical data
• Humans
• Maternal Health Services/organization & administration
• Maternal Health Services/statistics & numerical data
• Middle Aged
• Non-Randomized Controlled Trials as Topic
• Patient Satisfaction/statistics & numerical data
• Pregnancy
• Primary Health Care/methods
• Primary Health Care/statistics & numerical data
• Quality of Health Care
• Young Adult

• QUALMAT Study was funded by the European Union

There is a limited number of studies assessing the epidemiology of Adverse Drug Events (ADEs) in the outpatient setting, especially those that do not result in healthcare use. The primary objective of this study was to assess the prevalence and determinants of self-reported ADEs among Lebanese outpatients. It was a cross-sectional observational study performed among Lebanese outpatients visiting community pharmacies across Lebanon. A questionnaire was designed to elicit patients’ relevant information. The association between categorical variables were evaluated using Pearson χ² test or Fisher's exact test. Binary logistic regression was performed to identify factors that affect the experience of self-reported ADEs. The study comprised 3148 patients. Around 37% of patients reported experiencing an ADE in the previous year. When ADEs occur, 70.5% of the respondents reported informing their physicians. Increasing number of medications per patient, use of injectable medication, and inquiring about potential drug-drug interactions were associated with higher experience of ADEs (p = 0.049; p = 0.003; and p = 0.009 respectively). Patients who received hospital discharge counseling reported experiencing less ADEs (p = 0.002). Our study showed prevalence of ADEs among Lebanese outpatients especially patients with polypharmacy, and highlighted the need to educate patients about the importance of reporting ADEs to their physicians.

• Clinical decision support system
• Medication
• Patient outcomes
• Significant factors
• Systematic review

Adverse drug events (ADEs) are a burden to the healthcare system. Preventable ADEs, which was ADEs due to medication errors, could be reduced if medication errors can be prevent or ameliorate.

We investigated the burden of preventable ADEs on the length of hospital stay (LOS) and costs, and estimated the national burden of preventable ADEs in pediatric inpatients in Japan.

We analyzed data from the Japan Adverse Drug Events (JADE) study on pediatric patients and estimated the incidence of preventable ADEs and associated extended LOS. Costs attributable to extended LOS by preventable ADEs were calculated using a national statistics database and we calculated the effect of preventable ADEs on national cost excess.

We included 907 patients with 7377 patient-days. Among them, 31 patients (3.4%) experienced preventable ADEs during hospitalization. Preventable ADEs significantly increased the LOS by 14.1 days, adjusting for gender, age, ward, resident physician, surgery during hospitalization, cancer, and severe malformation at birth. The individual cost due to the extended LOS of 14.1 days was estimated as USD 8258. We calculated the annual extra expense for preventable ADEs in Japan as USD 329 676 760. Sensitivity analyses, considering the incidence of preventable ADEs and the length of hospital stay, showed that the expected range of annual extra expense for preventable ADEs in Japan is between USD 141 468 968 and 588 450 708.

Preventable ADEs caused longer hospitalization and considerable extra healthcare costs in pediatric inpatients. Our results would encourage further efforts to prevent and ameliorate preventable ADEs.

• Cost
• Japanese pediatric inpatients
• length of hospital stay
• preventable ADEs
• quality of healthcare

• clinical decision support
• electronic health records
• machine learning
• medication alert systems
• patient safety

• adverse drug events
• antipsychotic polypharmacy
• epidemiology
• psychiatry
• patient safety

Background  Medication dose adjustment is crucial for patients with renal dysfunction (RD). The assessment of renal function is generally mandatory; however, the renal function may change during the hospital stay and the manual assessment is sometimes challenging.

Objective  We developed the clinical decision support system (CDSS) that provided a recommended dose based on automated calculated renal function.

Methods  We conducted a prospective cohort study in a single teaching hospital in Japan. All hospitalized patients were included except for obstetrics/gynecology and pediatric wards between September 2013 and February 2015. The CDSS was implemented on December 2013. Renal and hepatic dysfunction (HD) were defined as changes in the estimated glomerular filtration rate (eGFR) and alanine aminotransferase or alkaline phosphatase levels based on these measurements during hospital stay. These measurements were obtained before (phase I), after (phase II), and 1 year after (phase III) the CDSS implementation.

Results  We included 6,767 patients (phase I: 2,205; phase II: 2,279; phase III: 2,283). The patients' characteristics were similar among phases. Changes in eGFR were similar among phases, but the incidence of RD increased in phase III (phase I: 228 [10.3%]; phase II: 260 [11.4%]; phase III: 296 [13.0%], p  = 0.02). However, the differences in incidences of RD were not statistically significant after adjusting for eGFR at baseline and age. The incidences of HD were also similar among phases (phase I: 175 [13.2%]; phase II: 171 [12.9%]; phase III: 167 [12.2%], p  = 0.72).

Conclusion  The CDSS implementation did not affect the incidence of renal and HD and changes in renal and hepatic function among hospitalized patients. The effectiveness of the CDSS with renal-guided doses should be investigated with respect to other endpoints.

Introduction: Medication error is unintentional and can be reduced by reducing the risk factors. Patients suffering from chronic diseases are at an increased risk of medication errors.

Objective: This work aims to assess the risk factors associated with medication errors among patients suffering from chronic disorders in hospitals of South Punjab, Pakistan.

Methodology: Multiple logistic regression analysis was used to assess the impact of different risk factors on the prevalence of medication errors in patients suffering from chronic diseases.

Results: A greater risk for the occurrence of medication errors was associated with age ≥60 years (odds ratio, OR = 1.9; 95% CI = 1.3–3.1; p = 0.001), overburdened healthcare system (OR = 2.2; 95% CI = 1.64–3.56; p < 0.000), number of prescribed drugs ≥5 (OR = 1.74; 95% CI = 1.02–2.64; p < 0.000), comorbidities (OR = 2.6; 95% CI = 1.72–3.6; p = 0.003), Charlson comorbidity index (OR = 1.31; 95% CI = 0.49–1.84; p = 0.004), and multiple prescribers to one patient (OR = 1.12; 95% CI = 0.64–1.76; p = 0.001).

Conclusion: Older age, overburdened healthcare system, number of prescribed drugs, comorbidities, Charlson comorbidity index, and multiple prescribers to one patient are significant risk factors for the occurrence of medication errors.

• chronic diseases
• drug-drug interactions
• inappropriate prescribing
• medication errors
• risk factors

• Adverse drug event
• Contributing factor
• Incidence rate
• Independent predictor
• Patient safety
• Prospective observational study

Potential additive effects of polypharmacy are rarely considered in adverse events of geriatric patients living in long-term care facilities. Our aim, therefore, was to identify adverse events in this setting and to assess plausible concomitant drug causes.

A cross-sectional observational study was performed in three facilities as follows: (i) adverse event identification: we structurally identified adverse events using nurses’ interviews and chart review. (ii) Analysis of the concomitantly administered drugs per patient was performed in two ways: (ii.a) a review of summary of product characteristics for listed adverse drug reactions to identify possible causing drugs and (ii.b) a causality assessment according to Naranjo algorithm.

(i) We found 424 adverse events with a median of 4 per patient (range 1–14) in 103 of the 104 enrolled patients (99%). (ii.a) We identified a median of 3 drugs (range 0–11) with actually occurring adverse events listed as an adverse drug reaction in the summary of product characteristics. (ii.b) Causality was classified in 198 (46.9%) of adverse events as “doubtful,” in 218 (51.2%) as “possible,” in 7 (1.7%) as “probable,” and in 1 (0.2%) adverse event as a “definitive” cause of the administered drugs. In 340 (80.2%) of all identified adverse events several drugs simultaneously reached the highest respective Naranjo score.

Patients in long-term facilities frequently suffer from many adverse events. Concomitantly administered drugs have to be frequently considered as plausible causes for adverse events. These additive effects of drugs should be more focused in patient care and research.

• Adverse drug reactions
• Aged
• Naranjo algorithm
• Nursing homes
• Side effects

• adverse drug events
• central nervous system depressant drug
• epidemiology
• patient safety
• pediatric inpatient

Medication errors have been identified as the most common preventable cause of adverse events. The lack of granularity in medication error terminology has led pharmacovigilance experts to rely on information in individual case safety reports’ (ICSRs) codes and narratives for signal detection, which is both time consuming and labour intensive. Thus, there is a need for complementary methods for the detection of medication errors from ICSRs. The aim of this study is to evaluate the utility of two natural language processing text mining methods as complementary tools to the traditional approach followed by pharmacovigilance experts for medication error signal detection.

The safety surveillance advisor (SSA) method, I2E text mining and University of Copenhagen Center for Protein Research (CPR) text mining, were evaluated for their ability to extract cases containing a type of medication error where patients extracted insulin from a prefilled pen or cartridge by a syringe. A total of 154,209 ICSRs were retrieved from Novo Nordisk’s safety database from January 1987 to February 2018. Each method was evaluated by recall (sensitivity) and precision (positive predictive value).

We manually annotated 2533 ICSRs to investigate whether these contained the sought medication error. All these ICSRs were then analysed using the three methods. The recall was 90.4, 88.1 and 78.5% for the CPR text mining, the SSA method and the I2E text mining, respectively. Precision was low for all three methods ranging from 3.4% for the SSA method to 1.9 and 1.6% for the CPR and I2E text mining methods, respectively.

Text mining methods can, with advantage, be used for the detection of complex signals relying on information found in unstructured text (e.g., ICSR narratives) as standardised and both less labour-intensive and time-consuming methods compared to traditional pharmacovigilance methods. The employment of text mining in pharmacovigilance need not be limited to the surveillance of potential medication errors but can be used for the ongoing regulatory requests, e.g., obligations in risk management plans and may thus be utilised broadly for signal detection and ongoing surveillance activities.

• Individual case reports
• Medication errors
• Natural language processing
• Pharmacovigilance
• Precision
• Recall
• Signal detection
• Text mining

Supplemental digital content is available in the text.

There have been epidemiological studies of adverse events (AEs) among general patients but those of patients cared by cardiologist are not well scrutinized. We investigated the occurrence of AEs and medical errors (MEs) among adult patients with cardiology in Japan.

• Community care
• Community health nurses
• High-risk medication
• Home care nurse
• Medication care

• Community Health Services/standards
• Humans
• Qualitative Research

• R1 side-chain
• R2 side-chain
• anaphylactic shock
• cefepime
• ceftriaxone
• immunohistochemistry
• liability
• medical malpractice

Classifying harm associated with a medication error can be time consuming and labour intensive and limited studies undertake this step. There is no standardised process, and few studies that report harm assessment provide adequate methods to allow for study replication. Studies typically mention that a clinical review panel classified patient harm and provide a reference to a classification tool. Moreover, in many studies it is unclear whether potential or actual harm was classified as studies refer only to ‘error severity’. The tools used to categorise the severity of patient harm vary widely across studies and few have been assessed for inter-rater reliability and criterion validity. In this paper, we describe the systematic process we undertook to synthesise the defining elements and strengths, while mitigating the limitations, of existing harm classification tools to derive the Harm Associated with Medication Error Classification (HAMEC). This new tool provides a harm classification for use across clinical and research settings. The provision of an explicit process for its application and guiding category descriptors are designed to reduce the risk of misclassification and produce results that are comparable across studies. As the World Health Organisation embarks on its international safety challenge of reducing medication-related harm by 50%, accompanying methodological advances are required to measure progress.

• medication error
• medication safety
• patient safety
• pharmaceutical care
• tertiary care

• children
• drug-related problems
• hospitalized pediatric patients
• risk factors

• attitudes
• health knowledge
• medication therapy management
• older adult
• patient participation
• patient safety
• practice
• qualitative research
• quality improvement

• adverse drug events
• brown bag
• medication reconciliation
• pharmacy
• pharmacy clinical services

• Nationwide Readmission Database
• United States
• adverse drug events
• readmission

• Event reporting
• Machine learning
• Medication events
• Patient safety

• JADE study
• Naranjo Algorithm
• adverse drug reactions
• categorization
• daily practice
• modification
• patient safety
• pharmacovigilance
• sensitivity
• specificity

• Adverse drug event
• Drug related problem
• Gulf Cooperation Council
• Medication error
• Medication safety

• Adverse drug events
• Adverse drug reactions
• Drug-related problems
• Medication errors
• Medication harm

• adverse drug reactions
• elderly
• medication errors
• medication safety
• patient safety

This study aimed to compare the use of trigger tools and non-targeted chart review as methods for the detection of adverse drug events in an intensive care unit considering the health system of a developing country.

Patients were divided in groups that were submitted to different methods (trigger tool and non-targeted chart review) for adverse drug event detection. Medical records were retrospectively reviewed, and adverse drug events detected during the data collection were analyzed by a multidisciplinary team and classified according to their causality, predictability, severity and damage level.

The search for adverse events performed by trigger tools and non-targeted chart review allowed the identification of similar numbers of events (61.09 and 64.04 ADE/1000 patient-days, respectively), types of event and related drugs. In both groups, the most frequently detected adverse events were related to metabolic, gastrointestinal, cardiovascular and hematological systems. These organic systems matched the drugs most associated with adverse event occurrence: anti-infectives, antithrombotics and insulins. Events identified by non-targeted chart review presented higher causality relationships and were considered less severe than those observed by trigger tool use (p < 0.05).

The similar performance between these methods supports trigger tool applicability in the ICU routine, as this methodology requires less time to retrieve information from the medical records.

• Adverse drug events
• Chart review
• Intensive care units
• Patient safety
• Trigger tool

• Feedback
• League tables
• P-chart
• Prescribers
• Prescribing errors
• Prescription review
• Primary care
• Statistical process control chart

• Ambulatory Care
• Drug Prescriptions/standards
• Feedback
• Humans
• Malaysia
• Medication Errors/prevention & control
• Practice Patterns, Physicians'
• Primary Health Care

• National Institutes of Health (Ministry of Health Malaysia)

Polypharmacy is increasingly common in older adults, placing them at risk of medication‐related harm (MRH). Patients are particularly vulnerable to problems with their medications in the period following hospital discharge due to medication changes and poor information transfer between hospital and primary care. The aim of the present study was to investigate the incidence, severity, preventability and cost of MRH in older adults in England postdischarge.

An observational, multicentre, prospective cohort study recruited 1280 older adults (median age 82 years) from five teaching hospitals in Southern England, UK. Participants were followed up for 8 weeks by senior pharmacists, using three data sources (hospital readmission review, participant telephone interview and primary care records), to identify MRH and associated health service utilization.

Overall, 413 participants (37%) experienced MRH (556 MRH events per 1000 discharges), of which 336 (81%) cases were serious and 214 (52%) potentially preventable. Four participants experienced fatal MRH. The most common MRH events were gastrointestinal (n = 158, 25%) or neurological (n = 111, 18%). The medicine classes associated with the highest risk of MRH were opiates, antibiotics and benzodiazepines. A total of 328 (79%) participants with MRH sought healthcare over the 8‐week follow‐up. The incidence of MRH‐associated hospital readmission was 78 per 1000 discharges. Postdischarge MRH in older adults is estimated to cost the National Health Service £396 million annually, of which £243 million is potentially preventable.

MRH is common in older adults following hospital discharge, and results in substantial use of healthcare resources.

• health economics
• health service use
• hospital discharge
• medication harm
• older adults
• pharmacoepidemiology