Number Of Adverse Drug Events Research Articles

Drug Targets, Current and Future Therapeutics for the Treatment of Multi Drug Resistant Tuberculosis with their Clinical Applications: A Critical Review

Abstract: Multi drug-resistant or extensive drug resistance Mycobacterium tuberculosis poses numerous challenges for health care workers and for public health authorities. Treating multidrug resistant or extensive drug resistance tuberculosis continues to be a difficult task, as a longer regimen is associated with a higher number of adverse drug events and economic burden and has a significant negative effect on health care resources. Many trials and observational studies were conducted. Few studies are underway to develop the universal regimen and improve the outcomes related to multi or extensive drug resistance tuberculosis with a shorter regimen duration. The current review will discuss which drug inhibits what target, their synthesis, genetic aspects, repurposed drugs, novel drugs, and extensive trials for the treatment of multi or extensive drug resistance tuberculosis.

Identification, conservation, and expression of tiered pharmacogenes in zebrafish.

The number of adverse drug events in the United States is critically high, with annual rates exceeding 1 million cases over the last nine years. One cause of adverse drug events is the underlying genetic variation that can alter drug responses. Pharmacogenomics is a growing field that seeks to better understand the relationship between a patient’s genetics and drug efficacy. Currently, pharmacogenomics relies largely on human trials, as there is not a well-developed animal model for studying preventative measures and alternative treatments. Here, we analyzed pharmacogene expression at two developmental time points in zebrafish to demonstrate the potential of using this model organism for high-throughput pharmacogenomics research. We found that 76% of tiered human pharmacogenes have a zebrafish ortholog, and of these, many have highly conserved amino acid sequences. Additional gene ontology analysis was used to classify pharmacogenes and identify candidate pathways for future modeling in zebrafish. As precision medicine burgeons, adopting a high-throughput in vivo model such as the zebrafish could greatly increase our understanding of the molecular pathology underlying adverse drug events.

Clinical and Cost-Saving Effects of the Drug Utilization Review Modernization Project in Inpatient and Outpatient Settings in Korea.

Korea's national health insurance authority introduced a drug utilization review modernization pilot project in which health professionals provided follow-up services to monitor adverse drug events. We aimed to evaluate the effects of the project on clinical and economic outcomes. We conducted difference-in-differences analysis using National Health Insurance claims data from the Health Insurance Review and Assessment Service. We calculated the number of adverse drug events and allergic reactions as a clinical indicator and medical costs incurred to manage these events as an economic indicator. Absolute difference in each outcome measure was defined as the value after the project minus the value before the project. Difference-in-differences was defined as a difference in absolute differences between the intervention group and the control group. Overall, difference-in-differences were -43 and -826 for the number of drug-related adverse events and allergic reactions and -$198,700 and $53,318 for medical costs in the inpatient and outpatient settings, respectively. For outpatients, the monthly number of adverse drug events and allergic reactions has grown higher for the control group than for the intervention group after implementation of the pilot project. Implementation of the pilot project lowered the number of adverse drug events and allergic reactions in the inpatient and outpatient setting. The project also lowered medical costs incurred to manage these events in the inpatient setting only. Based on our findings, we recommend that the pilot project be expanded on a nationwide level at least in the inpatient setting.

The Sex-Specific Impact of the FORTA (Fit-fOR-The-Aged) List on Medication Quality and Clinical Endpoints in Older Hospitalized Patients: Secondary Analysis of a Randomized Controlled Trial.

BackgroundLittle is known about the sex-specific impact of drug optimization tools such as the Fit fOR The Aged (FORTA) list on drug use and relevant clinical endpoints in older people.ObjectiveWe aimed to detect gender differences of interventional effects on medication quality and related clinical effects in the VALFORTA trial.Patients and methodsA sex-specific analysis of data from 409 patients (147 men and 262 women, mean age 79.4 and 82.7 years, respectively) in acute geriatric care comparing the control and FORTA intervention groups was performed. Changes of the FORTA score (sum of over- and undertreatment errors per patient), the incidence of adverse drug events (ADEs) during hospitalization, and several clinically relevant endpoints [e.g., the Barthel index (BI)] were tested for equivalence at a 20% margin. “Success” or “failure” for the development of these clinical endpoints was defined and their frequencies compared by a risk reduction analysis.ResultsSex differences were insignificant for the reduction of the FORTA score, the improvement of BI, or over- and undertreatment errors (p > 0.05). In women only, the FORTA intervention significantly increased the number of patients without an ADE (p = 0.010). Statistical sex equivalence was found for the improvement of the FORTA scores, BI, and the number of prevented events (e.g., falls, confusion, or renal failure) (p < 0.05), but not for the improvement of specific mistreatments or over- and undertreatment scores under altered inclusion criteria (p > 0.05).ConclusionsBoth sexes benefit equally from the FORTA intervention regarding the amelioration of the quality of drug treatment as well as several clinically relevant outcomes. In addition, the positive impact of the FORTA intervention on the number of adverse drug events appears to be greater in women.Trial Registration NumberDRKS00000531.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40801-022-00292-9.

Adverse drug reactions amongst admitted advanced age Africans

Background: Medical therapy amongst advanced age adults sometimes have its inherent significant risks such as adverse drug reactions (ADRs) resulting from the drug itself or drug-drug interactions or interactions from other substances such as alcohol. Aim: The main aim of this study is to highlight ADRs noticed by the older adult while on admission either in the past or present with the goal of preventing them and improving treatment outcomes. Methods: A purposive cross-sectional sampling of 126 elderly patients that were admitted to the different wards of the hospital within a 3-month period was carried out of which 25 older adults who met the criteria of being able to recall ADRs in the past or during current admission were included in the study. Results: ADR was reported in a ratio of M: F ratio of 1:1.08 with a prevalence of 19.8% of the total older patients evaluated. Conclusion: Self-reported ADRs amongst these advanced age in-patients were high. The actual number of adverse drug events may be higher if they actually looked out for by the physicians or other health care workers. The use of screening tools by physicians and other prescribing health workers can help in curbing adverse drug events in older adults.

Adherence to Antibiotic Stewardship Program Associated with Shorter Course of Treatment and Fewer Adverse Events

Group Name: NorthShore University HealthSystemBackground: Prolonged antibiotic use has been attributed to an increased incidence of adverse drug events (ADEs). Cessation of unnecessary antibiotics would decrease length of treatment and may help prevent these adverse events. We evaluated whether an antibiotic stewardship intervention aimed at stopping unnecessary antibiotic usage would both shorten the duration of treatment and reduce ADEs. Methods: At NorthShore University HealthSystem, a 4-hospital, 832-bed system, we identified patients who were started on empiric antibiotics during a hospital admission between May 2, 2016, and June 30, 2018. Within 24 hours of antibiotic initiation, an infectious disease (ID) physician reviewed each patient chart. If the patient was unlikely to have a symptomatic bacterial infection, the ID physician left a note in the electronic medical record (EMR) recommending antibiotic cessation. Two physician reviewers retrospectively reviewed whether the treatment team accepted these recommendations and assessed potential ADEs for 30 days after the recommendation through inpatient and outpatient notes in the EMR. These ADEs were defined using previously published criteria. If the 2 reviewers disagreed on the presence of an ADE, an ID physician acted as the tie breaker. We compared the number of antibiotic days and the number of ADEs between cases in which the recommendations were followed and cases in which they were not. Results: We reviewed 168 cases: 78 (46.43%) followed recommendations and 90 (53.57%) did not. There were no significant differences in baseline patient characteristics between the 2 groups. There was a significant difference in total ADEs between the 2 groups: in 6 cases (7.69%) the recommendations were followed, and 21 (23.33%) they were not followed (P = .011). There was also a significant difference in antibiotic days between cases in which recommendations were followed (1.40 days) versus those in which they were not followed (1.99 days) (p &lt; 0.001). Conclusions: Antibiotic-associated adverse events can cause harm to patients and increase healthcare costs, particularly when used for patients who are unlikely to have a bacterial infection. An antibiotic stewardship program to identify patients in an EMR who are unlikely to benefit from antibiotic use can decrease the length of total antibiotic usage and help prevent adverse events.Funding: NoDisclosures: None

Impact of Beta-Lactam Allergies on Selection of Antimicrobials in an Inpatient Setting Among Veteran Population.

Beta-lactam antibiotics are among the most common and widely used antibiotics. However, reported allergy to this class of antibiotics is also common, leading to the use of alternative broad-spectrum antibiotics by healthcare providers. This has led to the emergence of various negative health outcomes. The purpose of the study is to investigate the impact of using alternative antibiotics secondary to a beta-lactam allergy among U.S. veterans who have otherwise multiple comorbidities. This retrospective observational analysis was conducted over a 5-year period (January 1, 2011 to December 31, 2016) at the Memphis Veterans Affairs Medical Center (VAMC). Admitted patients with a documented beta-lactam allergy were categorized to preferred or non-preferred status based on initial antibiotic therapy antibiotic, allergy history, published guidelines, and local antibiogram. Preferred therapy was defined as the optimal antibiotic treatment for a given indication based on patient allergy history, published Infectious Disease Society of America guidelines, and local antibiogram of Memphis VAMC. The therapy was classified as "non-preferred" if it did not satisfy the preferred therapy criteria. Non-preferred treatments were further assessed for appropriateness based on indication and patient-specific factors. Chi-square and Fisher's exact tests were conducted to find a difference in rates of negative sequelae among patients receiving preferred vs. non-preferred treatments and appropriate vs. inappropriate treatments. Of the 1806 admissions identified, data were collected on 95 unique patients with 147 different antibiotic regimens. There were 68 (52%) preferred treatment regimens and 64 (48%) non-preferred treatment regimens. Of the 64 non-preferred treatments, 43 (67%) were inappropriate. There was a statistically significant decrease in the number of adverse drug events and in the combined negative sequelae outcome among patients receiving preferred therapy vs. non-preferred therapy (2 vs. 12; P < .01 and 11 vs. 23; P < .01, respectively). The receipt of non-preferred antibiotic therapy among veterans with a recorded beta-lactam allergy may be associated with an increased risk of developing negative outcomes. Among military personnel, removing unnecessary beta-lactam allergies would improve readiness with optimal antibiotic choices and avoidance of unnecessary risks, expediting return to full duty.

Improving medication safety practice at a community hospital: a focus on bar code medication administration scanning and pain reassessment

IntroductionIn the USA over 30% of medication errors occur at the point of administration. Among non-surgical patients in US hospitals exposed to opioids, 0.6% experience a severe opioid-related adverse event....

Pharmacogenetics in primary care.

The use of pharmacogenetic information is becoming mainstream with insurance companies and others starting to pay for widescale implementation of this new technology starting with patients who have anxiety and depression. It has been introduced in response to the unpredictability of medication, the high number of adverse drug events, and lack of drug effectiveness. Greater than one-third of patients are identified as having one or more pharmacogenetic variants. Each pharmacogenetic variant may affect the metabolism of several medications used in primary care, in addition to the antidepressant and anti-anxiolytic medications. Pharmacogenetic information is evolving with major international working groups providing continuous updates. It is challenging to incorporate this new information along with all the other variables needed to identify safe and effective drug options within a normal consultation. Medication decision support software is one solution that can help address this.

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.

Efficacy and safety of interleukin-1 antagonists in rheumatoid arthritis: a systematic review and meta-analysis.

Rheumatoid arthritis patients have a high level of pro-inflammatory interleukin-1. Augmenting the blockade of interleukin-1 receptors by external interleukin-1 receptor antagonist modifies the progression of the disease. Therefore, the aim of this study was to evaluate the clinical efficacy and safety of interleukin-1 receptor antagonist (anakinra) in the treatment of rheumatoid arthritis. Clinical trials and extension studies that compared anakinra with placebo or other medications were included. Electronic bibliographic databases: PubMed, Scopus, and Web of Sciences were searched from inception to November 2017. The American College of Rheumatology 20% (ACR20) improvement was the primary efficacy outcome measure. Total number of adverse drug events, serious adverse drug events, total treatment withdrawals, and treatment-related withdrawals were safety outcome measures. Ten studies were included in this review. One study did not fulfil quantitative criteria and was assessed qualitatively. Six clinical trials and three extension studies were included in meta-analysis. Patients treated with anakinra are 42% more likely to have ACR20 response than patients without IL-1Ra (pooled RR 1.42; 95% CI 1.01, 2.00). Patients on 30-150mg anakinra have lower Health Assessment Questionnaire (HAQ) score than patients without IL-1Ra (SMD - 0.28; 95% CI - 0.53, - 0.03). The inflammatory marker erythrocyte sedimentation rate (ESR) was significantly lower among patients treated with 30-150mg anakinra (SMD - 0.44; 95% CI - 0.65, - 0.23). Patients on anakinra have a 34% more risk of treatment-related withdrawal than placebo. The other parameters were not found to be statistically significant. Anakinra has a significant improvement in ACR20, HAQ, and ESR. The ACR20 response is maintained after 48weeks of treatment. Anakinra shows higher episodes of treatment-related withdrawals than placebo.

Identifying the prevalence of adverse drug events associated with potentially inappropriate medications using the Screening Tool of Older Persons’ Prescriptions criteria

Objectives The study's primary objective was to determine the prevalence of adverse drug events (ADEs) that could be identified using the Screening Tool of Older Persons’ Prescriptions (STOPP) criteria. Secondary objectives included characterizing and identifying the prevalence of potentially inappropriate medications (PIMs) and ADEs in the study population, classifying each of the identified ADE using the Naranjo scale, and identifying the time required to use this tool in the clinical setting. Methods The STOPP criteria were used to identify PIMs in elderly patients’ charts with a documented ADE. Patients who were found to have at least one PIM were reviewed to determine whether the documented ADE could be attributed to the PIM. Key findings A total of 290 PIMs were identified across three points of care: admission, hospital stay and discharge. The most prevalent types of PIMs were proton pump inhibitors (21%), benzodiazepines (14.1%) and duplicate drug class (7.9%). The most common ADEs that could be attributed to a PIM were incontinence associated with alpha-blockers (37.5%) and constipation associated with calcium-channel blockers (14.6%). The median time required for chart review on admission, hospital stay and discharge was 2, 2, and 1 minute, respectively. Conclusions The study suggests a large number of patients are affected by PIMs and secondary ADEs. With the short time that is needed to review patients’ medications, the STOPP criteria may be beneficial in reducing the number of ADEs associated with PIMs.

Incidence and determinants of medication errors and adverse drug events among hospitalized children in West Ethiopia.

BackgroundMedication errors cause a large number of adverse drug events with negative patient health outcomes and are a major public-health burden contributing to 18.7–56 % of all adverse drug events among hospitalized patients. The aim of this study was to assess the incidence and determinants of medication errors and adverse drug events among hospitalized children.MethodsA prospective observational study was conducted among hospitalized children in the pediatrics ward of Nekemte Referral Hospital from February 24 to March 28, 2014. Data were collected by using checklist guided observation and review of medication order sheets, medication administration records, and other medical charts of the patients. To identify the independent predictors of medication errors and adverse drug events, backward logistic regression analysis was used. Statistical significance was considered at p-value <0.05.ResultsOut of 233 patients who were included in the study, 175 (75.1 %) of patients were exposed to medication errors. From the 1,115 medication orders reviewed, 513 (46.0 %) medication errors, 75 (6.7 %) potential adverse drug events and 17 (1.5 %) actual adverse drug events were identified. Of the 17 adverse drug events, eight (47.0 %) were preventable while nine (53.0 %) were not. Most medication errors were dosing errors (118; 23.0 %), followed by wrong drug (109; 21.2 %) and wrong time of administration (79; 15.4 %). On multivariable logistic regression analysis, length of hospital stay of ≥ 5 days (AOR = 4.2, 95 % CI = 1.7-10.4, p = 0.002), and number of medication of 4–6 (AOR = 4.9, 95 % CI = 2.3-10.3, p < 0.001) and number of medication of ≥7 (AOR = 10.4, 95 % CI = 3.0-35.9, p < 0.001) were independent predictors of medication errors; and length of hospital stay of ≥ 5 days (AOR = 3.5, 95 % CI = 1.2-10.1, p = 0.023) and number of disease conditions =2 (AOR = 4.6, 95 % CI = 1.4-15.1, p = 0.014) were independent predictors of adverse drug events.ConclusionMedication errors and adverse drug events are common on the pediatrics ward of Nekemte Referral Hospital. In particular, children with multiple medications and longer hospital stays, and those with co-morbidities and longer hospital stays, were at greater risk for medication errors and adverse drug events, respectively.

National Rules for Drug-Drug Interactions: Are They Appropriate for Tertiary Hospitals?

The application of appropriate rules for drug–drug interactions (DDIs) could substantially reduce the number of adverse drug events. However, current implementations of such rules in tertiary hospitals are problematic as physicians are receiving too many alerts, causing high override rates and alert fatigue. We investigated the potential impact of Korean national DDI rules in a drug utilization review program in terms of their severity coverage and the clinical efficiency of how physicians respond to them. Using lists of high-priority DDIs developed with the support of the U.S. government, we evaluated 706 contraindicated DDI pairs released in May 2015. We evaluated clinical log data from one tertiary hospital and prescription data from two other tertiary hospitals. The measured parameters were national DDI rule coverage for high-priority DDIs, alert override rate, and number of prescription pairs. The coverage rates of national DDI rules were 80% and 3.0% at the class and drug levels, respectively. The analysis of the system log data showed an overall override rate of 79.6%. Only 0.3% of all of the alerts (n = 66) were high-priority DDI rules. These showed a lower override rate of 51.5%, which was much lower than for the overall DDI rules. We also found 342 and 80 unmatched high-priority DDI pairs which were absent in national rules in inpatient orders from the other two hospitals. The national DDI rules are not complete in terms of their coverage of severe DDIs. They also lack clinical efficiency in tertiary settings, suggesting improved systematic approaches are needed.

Impact of pharmacist involvement in the transitional care of high-risk patients through medication reconciliation, medication education, and postdischarge call-backs (IPITCH Study).

Previous data suggest that direct pharmacist interaction with patients through medication reconciliation, discharge counseling, and postdischarge phone calls decreases the number of adverse drug events (ADEs) and plays an overall positive role in transitional care. Previous studies have evaluated pharmacist involvement in improving transitional care, but these studies did not include multiple postdischarge follow-up phone calls. The objectives of this study were to assess the impact of pharmacist involvement in transitions of care as measured by decreased medication errors (MEs) and ADEs, patients' knowledge related to communication about their medications as measured by improvement in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores, and 30-day all-cause inpatient readmissions and emergency department (ED) visits. This was a prospective, randomized, single-period longitudinal study that occurred from November 2012 through June 2013 at an urban, tertiary, academic medical center. Patients admitted to 2 designated internal medicine units on high-risk medications or with greater than 3 prescription medications upon discharge were included for randomization. The control group received the usual hospital standard of care. The study group received face-to-face medication reconciliation, a patient-specific pharmaceutical care plan, discharge counseling, and postdischarge phone calls on days 3, 14, and 30 to provide education and assess study endpoints. A total of 278 patients were included in the final analysis, with 141 in the control group and 137 in the study group. Fifty-five patients (39%) in the control arm experienced an inpatient readmission or ED visit within 30-days postdischarge compared to 34 patients (24.8%) in the study arm (P = 0.01). Eighteen patients (12.8%) in the control group experienced an ADEs or MEs compared to 11 patients (8%) in the study group (P > 0.05). The HCAHPS scores during the study period showed a 9% improvement for the assessed questionnaire domain (P > 0.05). This study demonstrated that pharmacist involvement in hospital discharge transitions of care had a positive impact on decreasing composite inpatient readmissions and ED visits. Statistically significant difference in medication-related events and HCAHPS scores were not observed. Patients with moderately complex medication regimens benefited from a continuity of care involving a pharmacy team during transitions in care.

Increasing the number of Adverse drug events by the use of an Adverse Drug Event Manager (ADEM)

increasing the number of Adverse drug events by the use of an Adverse Drug Event Manager (ADEM)

The renal effects of NSAIDs in dogs.

The quality of life for dogs with osteoarthritis can often be improved with nonsteroidal anti-inflammatory drugs (NSAIDs); however, the number of adverse drug events associated with NSAID use reported to the Federal Drug Administration Center for Veterinary Medicine is higher than that for any other companion animal drug. Of those events, adverse renal reactions are the second most reported. NSAIDs produce pharmacologic effects via inhibition of cyclooxygenase (COX), which decreases production of prostanoids. Prostaglandins are synthesized by both the COX-1 and COX-2 enzymes in the healthy kidney and influence renal blood flow, glomerular filtration rate, renin release, and Na excretion. There are important species differences in the renal expression of COX-1 and COX-2. For example, dogs have higher basal levels of COX-2 expression in the kidney compared with humans. In addition, in dogs with chronic kidney disease, an increase in COX-2 expression occurs and synthesis of prostaglandins shifts to the COX-2 pathway. For those reasons, NSAIDs that target COX-2 may be expected to adversely affect renal function in dogs, especially dogs with chronic kidney disease. The purpose of this review was to evaluate the literature to report the renal effects of NSAIDs in dogs.

SAFE Medication Management for Patients With Physical Impairments of Stroke, Part Two.

Part one of this series addressed impairments of stroke affecting motor skills. This second article focuses on the sensory impairments of stroke as they affect medication management: vision, hearing, memory and thinking, communication, and emotional disturbances. Each impairment is discussed, and possible interventions are proposed. Every patient is an individual and requires variable care plans. Interventions and strategies, such as tools for assessment, practice tips, and assistive devices, aid patients, families, and their caregivers in practicing safe medication management. Development of a comprehensive care plan will assist the patient to return as close to previous capabilities as possible. Patient outcomes and successes are variable. The rehabilitation nurse uses observation, skills, and experience to assess stroke patients' needs and develop strategies to assist the patient in managing their medications. Involving patient, family, and caregivers in the teaching of SAFE (Systematic, Accurate, Functional, Effective) medication management increases safety, decreases the number of adverse drug events, and prevents hospitalizations.

Comparative efficacy and safety of triple therapy (ramipril, telmisartan, hydrochlorothiazide) vs dual anti hypertensive therapy (ramipril or telmisartan, hydrochlorothiazide) in stage 2 hypertensive patients.

To evaluate the comparative efficacy and safety of ramipril 5mg plus hydrochlorothiazide 12.5mg (R + HCTZ), telmisartan 40mg plus hydrochlorothiazide12.5mg (T + HCTZ) and ramipril 2.5mg plus telmisartan 20mg plus hydrochlorothiazide12.5mg (R + T + HCTZ) in patients with stage 2 hypertension. A prospective, open label, randomized comparative study was conducted to study the comparative efficacy and safety of R+HCTZ (group 1), T+HCTZ (group 2)and R+T+TCTZ (group3) in 88 patients with stage 2 hypertension without co-morbid conditions. Echocardiography was done to assess left ventricular function. Patients were followed up to 24 weeks and any ADR occurring in this period was recorded. All the three treatment groups showed significant fall in both systolic and diastolic blood pressure compared to the baseline scores (p<0.0001). Intergroup comparison did not reveal any significant difference. Total number of adverse drug events reported were 15. Group III had higher percentage ADRs. Dry cough (8) was most common ADR. The echocardiography parameters did not change from baseline values with all three treatment regimens. All three medications were of equal efficacy in patients with stage 2 hypertension without co morbid conditions, failing to prove superiority over each other.

Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study.

BackgroundAdverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data.MethodsWe linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data.ResultsAmong 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0–11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%).ConclusionsAdverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.