[Evaluation of a self-administration of medication practice in a rehabilitation unit]. / Évaluation d'une pratique d'auto-administration médicamenteuse mise en place dans un service de rééducation.

OBJECTIVES: Self-administration consists in the administration of medications by the patient himself during his hospitalization. The order of October 10, 2022 (Arrêté du 10 octobre 2022 modifiant l'arrêté du 6 avril 2011) modified the April 6, 2011 regulation to allow and regulate self-administration practices in hospital units. This evolution opens new perspectives for patient autonomy. The objective of this study is, firstly, to evaluate the rate of medication errors from patients under self-administration and secondly, to evaluate the satisfaction of patients and caregivers. MATERIAL AND METHODS: Eligible patients were recruited from a locomotor and polyvalent rehabilitation unit. After verification of eligibility, explanation given to the patient about the hospital self-administration of medication procedure and signature of the compliance agreement, patients started self-administration. Medication errors were reported during seven days. Evaluations of patient and staff satisfaction were also carried out. RESULTS: Of the 83 patients admitted to the care service, 32 were able to experiment self-administered medication procedure during their hospitalization. To assess the safety of this practice, 1235 drug intakes were analyzed. Ninety-four administration errors were noted: 98% of them concerned analgesic drugs. All of these errors were omissions and none of them were rated as serious. The 20 patients questioned were all satisfied with self-administration. The 14 carers interviewed were satisfied with this change in practice. CONCLUSION: The medication self-administration process set up in the rehabilitation unit did not lead to serious medication errors. Patients and caregivers reported being satisfied with this new hospital practice.

No benefit of systematic hemodialysis catheter blood cultures for the early detection of catheter-related bloodstream infection
.

BACKGROUND: The use of a catheter for hemodialysis is associated with a 5-fold increased risk of septicemia. Early detection of catheter-related bloodstrean infection (CRBSI) may decrease morbidity and mortality, but the benefits of systematic blood cultures have not been demonstrated. MATERIALS AND METHODS: We retrospectively studied the blood culture results of patients who had been dialyzed with a tunneled jugular catheter for more than 1 month in a dialysis unit from January to December 2015. Systematic monthly catheter blood cultures were taken from the heparin lock solutions in the arterial and venous branches, at the beginning or end of the session. CRBSI was assessed using patient symptoms (fever, chills, hemodynamic instability) and positive catheter blood cultures. RESULTS: 75 patients were included. We analyzed the results of 577 systematic catheter blood cultures. 27 (5%) were positive, including 23 from patients who did not develop CRBSI in the following month. For the latter, there was a predominance of coagulase-negative staphylococci. Only four patients with positive catheter blood cultures went on to develop CRBSI in the following month. The sensitivity and specificity of these monthly blood cultures to detect CRBSI in the following month were 0.44 and 0.95, respectively. The positive and negative predictive values of the test were 0.14 and 0.99, respectively. CONCLUSION: In this study, systematic catheter blood cultures did not predict the occurrence of CRBSI. The sensitivity of these tests could be improved by increasing the sampling frequency. A cost-benefit analysis of such measures should be performed.

Case-crossover study to examine the change in postpartum risk of pulmonary embolism over time.

BACKGROUND: Although the current guidelines recommend anticoagulation up until 6 weeks after delivery in women at high risk of venous thromboembolism (VTE), the risk of VTE may extend beyond 6 weeks. Our objective was to estimate the risk of a pulmonary embolism in successive 2-week intervals during the postpartum period. METHODS: In a population-based, case-crossover study, we analyzed the French national inpatient database from 2007 to 2013 (n = 5,517,680 singleton deliveries). Using ICD-10 codes, we identified women who were diagnosed with a postpartum pulmonary embolism between July 1st, 2008, and December 31st, 2013. Deliveries were identified during a case "period" immediately before the pulmonary embolism, and five different control periods one year before the pulmonary embolism. Using conditional logistic regression, Odds ratios (ORs) and 95% confidential intervals (CIs) were estimated for ten successive 2-week intervals that preceded the diagnosis of pulmonary embolism. RESULTS: We identified 167,103 cases with a pulmonary embolism during the inclusion period. After delivery, the risk of pulmonary embolism declined progressively over time, with an OR [95%CI] of 17.2 [14.0-21.3] in postpartum weeks 1 to 2 and 1.9 [1.4-2.7] in postpartum weeks 11 to 12. The OR [95%CI] in postpartum weeks 13 to 14 was 1.4 [0.9-2.0], and the OR did not fall significantly after postpartum week 14. CONCLUSIONS: Our findings indicate that women are at risk of a pulmonary embolism up to 12 weeks after delivery. The shape of the risk curve suggests that the risk decreases exponentially over time. Future research is needed to establish whether the duration of postpartum anticoagulation should be extended beyond 6 weeks.

The risks of pulmonary embolism and upper gastrointestinal bleeding beyond 35days after total hip replacement for coxarthrosis among middle-aged patients: A cross-over cohort.

Prophylactic anticoagulation is recommended up to 35days after total hip replacement (THR). Although several observational studies have assessed the incidence of thrombotic events or bleeding events after THR, the corresponding measures of association have never been studied concomitantly. Here, we evaluated the duration of the elevated risks (relative to the baseline risk) of both venous thromboembolic events and bleeding events after THR for coxarthrosis among middle-aged patients. This was a population-based, cross-over cohort study of data extracted from the French national inpatient database between 2007 and 2013. We included middle-aged patients (aged 45 to 69) having undergone THR for coxarthrosis. We compared the numbers of pulmonary embolisms (PEs) (respectively upper gastrointestinal bleedings (UGIBs)) following the THR with the numbers occurring during three unexposed periods one year later. This enabled us to estimate the odds ratio (OR) [95% confidence interval (CI)] for each of six successive 35-day intervals. The study included 108,099 patients. The ORs for PE were respectively 12.4 (95% CI, 8.6-17.8) (absolute risk difference rate per 100,000 (ARD/100,000)=130) and 5.0 (95% CI, 3.4-7.4) (ARD/100,000=52) for the first two 35-day intervals, and the risk was close to 1 thereafter. The risk of UGIB fell quickly, with an OR of 6.5 (95% CI, 4.6-9.1) (ARD/100,000=83) and 0.8 (95% CI, 0.4-1.6) for the first two 35-day intervals, respectively. The majority of UGIBs occurred during the inpatient stay for THR. Among middle-aged patients, the risk of a PE remains elevated beyond 35days after THR for coxarthrosis, whereas the risk of a UGIB remains elevated for the first 35days only.

Three-Dimensional Measurement of the Uterus on Magnetic Resonance Images: Development and Performance Analysis of an Automated Deep-Learning Tool.

Uterus measurements are useful for assessing both the treatment and follow-ups of gynaecological patients. The aim of our study was to develop a deep learning (DL) tool for fully automated measurement of the three-dimensional size of the uterus on magnetic resonance imaging (MRI). In this single-centre retrospective study, 900 cases were included to train, validate, and test a VGG-16/VGG-11 convolutional neural network (CNN). The ground truth was manual measurement. The performance of the model was evaluated using the objective key point similarity (OKS), the mean difference in millimetres, and coefficient of determination R2. The OKS of our model was 0.92 (validation) and 0.96 (test). The average deviation and R2 coefficient between the AI measurements and the manual ones were, respectively, 3.9 mm and 0.93 for two-point length, 3.7 mm and 0.94 for three-point length, 2.6 mm and 0.93 for width, 4.2 mm and 0.75 for thickness. The inter-radiologist variability was 1.4 mm. A three-dimensional automated measurement was obtained in 1.6 s. In conclusion, our model was able to locate the uterus on MRIs and place measurement points on it to obtain its three-dimensional measurement with a very good correlation compared to manual measurements.

Comparison of the validity, perceived usefulness, and usability of I-MeDeSA and TEMAS, two tools to evaluate alert system usability.

OBJECTIVE: Two tools are currently available in the literature to evaluate the usability of medication alert systems, the instrument for evaluating human factors principles in medication-related decision support alerts (I-MeDeSA) and the tool for evaluating medication alerting systems (TEMAS). This study aimed to compare their convergent validity, perceived usability, usefulness, strengths, and weaknesses, as well as users' preferences. METHOD: To evaluate convergent validity, two experts mapped TEMAS' items against I-MeDeSA's items with respect to the usability dimensions they target. To assess perceived usability, usefulness, strengths, and weaknesses of both tools, staff with expertise in their medication alerting system were asked to use French versions of the TEMAS and I-MeDeSA. After the use of each tool, participants were asked to complete the System Usability Scale (SUS) and answer questions about the understandability and usefulness of each tool. Finally, participants were asked to name their preferred tool. Numeric scores were statistically compared. Free-text responses were analyzed using an inductive approach. RESULTS: Forty-five participants from 10 hospitals took part in the study. In terms of convergent validity, I-MeDeSA focuses more on the usability of the graphical user interface while TEMAS considers a wider range of usability principles. Both tools have a fair level of perceived usability (I-MeDeSA' SUS score = 61.85 and TEMAS' SUS score = 62.87), but results highlight that revisions are necessary to both tools to improve their usability. Participants found TEMAS more useful than I-MeDeSA (t = -3.63, p =.005) and had a clear preference for TEMAS to identify problems in formative evaluation (39 of 45; 0.867, p <.001) and to compare the usability of alert systems during the procurement process (36 of 45; 0.8, p <.001). CONCLUSIONS: The TEMAS is perceived as more useful and is preferred by participants. The I-MeDeSA seems more relevant for quick evaluations that focus on the graphical user interface. The TEMAS seems to be more suitable for in-depth usability evaluations of alert systems. Even if both tools are perceived to be equally usable, they suffer from wording, instructional, and organizational problems that hinder their use. The results of this study will be used to improve the design of I-MeDeSA and TEMAS.

Physicians' perceptions on the usefulness of contextual information for prioritizing and presenting alerts in Computerized Physician Order Entry systems.

BACKGROUND: One possible approach towards avoiding alert overload and alert fatigue in Computerized Physician Order Entry (CPOE) systems is to tailor their drug safety alerts to the context of the clinical situation. Our objective was to identify the perceptions of physicians on the usefulness of clinical context information for prioritizing and presenting drug safety alerts. METHODS: We performed a questionnaire survey, inquiring CPOE-using physicians from four hospitals in four European countries to estimate the usefulness of 20 possible context factors. RESULTS: The 223 participants identified the 'severity of the effect' and the 'clinical status of the patient' as the most useful context factors. Further important factors are the 'complexity of the case' and the 'risk factors of the patient'. CONCLUSIONS: Our findings confirm the results of a prior, comparable survey inquiring CPOE researchers. Further research should focus on implementing these context factors in CPOE systems and on subsequently evaluating their impact.

Escitalopram-induced hepatitis: A case report.

BACKGROUND: The antidepressant escitalopram is widely prescribed for the treatment of depression. It is generally well-tolerated, and cholestasis is not mentioned in its summary of product characteristics (SmPC). We present a case of cholestatic and cytolysis liver injury due to escitalopram and a VigiBase® study. CASE SUMMARY: A 68-year-old man was admitted to our emergency unit due to clinical jaundice associated with hepatitis, pruritus and dark urine. We tested the patient for the most common etiologies of jaundice, including hemolysis, viral hepatitis, cirrhosis, carcinoma, cholangitis, cholelithiasis and intrahepatic or extrahepatic obstruction. The etiological study was negative, and an adverse drug reaction was the sole possible explanation. The patient was receiving treatment with escitalopram. Two days after its withdrawal, pruritus was resolved. Ten days after withdrawal, clinical jaundice disappeared. It took a month and three weeks after withdrawal for the patient to have normalized liver function tests. To our knowledge, this is the first reported case of cholestasis where treatment with escitalopram was the only possible cause, with a highly probable causality. In addition, we determined whether escitalopram is associated with hepatotoxicity and cholestasis by performing a disproportionality analysis. All cases of hepatobiliary disorders induced by escitalopram and reported in the World Health Organization pharmacovigilance database (VigiBase®) were analyzed to characterize this toxicity. We found that patients treated with escitalopram had an increased risk of hepatitis [odds ratio (OR) = 1.938(1.186-3.166)] and cholestasis [OR = 1.866(1.279-2.724)] [OR (95% confidence interval)]. The median duration between the introduction of escitalopram and the occurrence of acute hepatitis and/or cholestasis was ten days +/- seven days. CONCLUSION: Although extremely rare, this case report, the review of the literature and the pharmacovigilance update confirm that escitalopram can cause drug-induced hepatotoxicity and cholestasis, generally within a week after initiation. Thus, escitalopram should be withdrawn immediately if an iatrogenic cause cannot be excluded. If its responsibility is ascertained, escitalopram should be consequently contraindicated. In addition, serotoninergic antidepressants in patients with non-severe depression are ineffective and harmful. Finally, the SmPC of escitalopram should be updated to alert for this risk and give clear clinical guidelines.

The ADE scorecards: a tool for adverse drug event detection in electronic health records.

Although several methods exist for Adverse Drug events (ADE) detection due to past hospitalizations, a tool that could display those ADEs to the physicians does not exist yet. This article presents the ADE Scorecards, a Web tool that enables to screen past hospitalizations extracted from Electronic Health Records (EHR), using a set of ADE detection rules, presently rules discovered by data mining. The tool enables the physicians to (1) get contextualized statistics about the ADEs that happen in their medical department, (2) see the rules that are useful in their department, i.e. the rules that could have enabled to prevent those ADEs and (3) review in detail the ADE cases, through a comprehensive interface displaying the diagnoses, procedures, lab results, administered drugs and anonymized records. The article shows a demonstration of the tool through a use case.

Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.

BACKGROUND: Direct oral anticoagulants (DOACs) are currently recommended as first-line or (after vitamin K antagonists) second-line therapy for preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation. In patients aged 80 years and over, however, the fear of DOAC-associated bleeding and the complexity of DOAC dosing regimes may prompt physicians to prescribe inappropriate dose levels. OBJECTIVE: The objective of this study was to determine compliance with French and European guidelines of doses of three DOACs (apixaban, dabigatran and rivaroxaban) prescribed to patients aged over 80 years in an indication of non-valvular atrial fibrillation, and to identify factors associated with poor compliance. METHODS: We performed a retrospective single-centre study of patients aged over 80 years routinely treated with a DOAC (apixaban, dabigatran or rivaroxaban) for non-valvular atrial fibrillation at Valenciennes General Hospital (Valenciennes, France) between 1 January, 2016 and 31 December, 2017. We determined compliance with French and European guidelines of DOAC doses as a function of each patient's clinical and laboratory parameters, and thus classified the regime as being appropriately dosed, overdosed or underdosed. RESULTS: A total of 703 patients (371 taking apixaban, 92 taking dabigatran and 240 taking rivaroxaban) were included in the study. We found that 274 patients (39%) had been prescribed an inappropriate DOAC regime, with underdosing in 241 cases (34%) and overdosing in 33 cases (5%). Underdosing mainly concerned the two most widely prescribed DOACs, i.e. apixaban (39% of all apixaban prescriptions were underdosed) and rivaroxaban (40%). Concomitant treatment with an antidepressant was associated with underdosing of rivaroxaban or apixaban (p = 0.0339). In contrast, initial management in a neurology department was associated with appropriate dosing (p = 0.000146) for both these DOACs. CONCLUSIONS: Among patients with non-valvular atrial fibrillation aged 80 years and over, about 40% of DOAC prescriptions feature inappropriate dose levels. It might be possible to reduce inappropriate dosing by raising awareness among hospital-based and private-practice prescribers, providing prescription support tools for DOACs, and performing medication reconciliations and reviews at hospital and in private practice.

Evaluation of a Computer Application for Retrospective Detection of Vitamin K Antagonist Treatment Imbalance.

OBJECTIVE: Management of vitamin K antagonists (VKAs) is difficult, and overdoses can have dramatic hemorrhagic consequences. The adverse drug event (ADE) scorecards is a tool intended for the detection and description of adverse drug reaction/ADE developed during a European computerized medical data processing project. It is used in a quality assurance process. Our objective was to evaluate the performance of the ADE scorecards in the detection of the contributing factors for VKA overdoses, among the cases where a VKA overdose is observed. METHODS: Twenty-eight rules allow the detection of VKA treatment overdose related to drug or a clinical situation. They were applied on 14,748 electronic medical records from a community hospital. Among 582 records including a VKA prescription, 59 cases of VKA overdoses (international normalized ratio ≥ 5) during the hospital stay have been identified. The ADE scorecards detected 49 of them. We evaluated the positive predictive value and sensitivity of these rules, by an expert review of the cases. RESULTS: The expert review confirmed the contribution of a detected risk factor to the VKA overdose in 11 cases. Therefore, the precision of the rules is 22.4%. The sensitivity is 84.6%. The risk factors were mainly infection and amiodarone introduction. The 4 cases of clinical injury related to a drug were properly designated by the rules. CONCLUSIONS: Our study shows the great potential of the ADE scorecards for detecting cofactors of VKA overdoses and gives an argument to include complex rules in the knowledge bases used for the detection and identification of ADEs in large medical databases.

Inappropriate anticholinergic drugs prescriptions in older patients: analysing a hospital database.

Background Although many anticholinergics are inappropriate in older patients, the prescription of these drugs in a hospital setting has not been extensively studied. Objective To describe prescriptions of anticholinergic drugs in terms of frequency, at risk situations and constipation in hospitalized, older adults. Setting Using a database from a French general hospital (period 2009-2013), we extracted information on 14,090 hospital stays by patients aged 75 and over. Methods Anticholinergic drug prescriptions were automatically detected, with a focus on prescriptions in three well-known at-risk situations: falls, dementia, and benign prostatic hyperplasia. Cases of constipation that might have been causally related to the administration of anticholinergic drugs were screened for and reviewed. Main outcome measure Prescriptions with a high associated risk of anticholinergic related adverse reactions. Results Administration of an anticholinergic drug was detected in 1412 (10.0%) of the hospital stays by older patients. At-risk situations were identified in 413 (36.5%) of these stays: 137 (9.7%) for falls, 243 (17.2%) for dementia, and 114 (8.1%) for benign prostatic hyperplasia; 78 (18.9%) of these 413 stays featured a combination of two or three at-risk situations. Cases of constipation induced by anticholinergic drug administration were identified in 188 (13.3%) patient stays by using validated adjudication rules for adverse drug reactions: 85 and 103 cases were respectively evaluated as "possible" or "probable" adverse drug reactions. Conclusions Anticholinergic drugs prescription was found in 10.0% of hospitalized, older patients. More than one third of these prescriptions occurred in at-risk situations and more than one in ten prescriptions induced constipation.

Explicit definitions of potentially inappropriate prescriptions of antibiotics in older patients: a compilation derived from a systematic review.

Potentially inappropriate prescriptions (PIPs) of antibiotics (antibiotic-PIPs) are generally detected by applying implicit definitions based on expert opinion. Explicit definitions are less frequently used, even though this approach would enable the automated detection of antibiotic-PIPs in electronic health records. Here, explicit definitions of antibiotic-PIPs used in studies of older adults were systematically reviewed. The MEDLINE®, Scopus® and Web of ScienceTM core collection databases were searched with a combination of three terms and their synonyms: 'potentially inappropriate prescription' AND 'antibiotic treatment' AND 'older patients'. Following standardised selection of publications, explicit definitions of antibiotic-PIPs were extracted and were classified into infectious diseases domains and subdomains. A total of 600 search queries identified 4270 records, 93 of which were selected for review. A total of 160 mentions of antibiotic-PIPs were found, corresponding to 62 distinct definitions in 19 infectious diseases domains. Nearly one-half of the definitions were related to upper respiratory tract infections (n = 11 definitions; 17.7%), lower respiratory tract infections (n = 8; 12.9%) and drug-drug interactions (n = 11; 17.7%). Almost 75% of definitions (n = 46) were mentioned in a single study only. Only three definitions concerned critically important antibiotics such as third-generation cephalosporins and fluoroquinolones. This systematic review identified 62 explicit definitions of antibiotic-PIPs. Most of the definitions were not found in more than one study and they varied in the degree of precision. We advocate the implementation of an expert consensus on explicit definitions of antibiotic-PIPs that correspond to today's challenges in public health.

Underuse of Oral Anticoagulants and Inappropriate Prescription of Antiplatelet Therapy in Older Inpatients with Atrial Fibrillation.

BACKGROUND: Several studies have shown that the prescription of antiplatelet therapy (APT) is associated with an increased risk of oral anticoagulant (OAC) underuse in patients aged 75 years and over with atrial fibrillation (AF). An associated atheromatous disease may be the underlying reason for APT prescription. The objective of the study was to determine whether the association between underuse of OAC and APT prescription was explained by the presence of an atheromatous disease. METHODS AND RESULTS: We performed a retrospective, observational, single-centre study between 2009 and 2013 based on administrative data. Patients aged 75 years and over with non-valvular AF were identified in a database of 72,090 hospital stays. Prescriptions of anti-thrombotic medications and their association with the presence of atheromatous disease were evaluated by the mean of a logistic regression. A total of 2034 hospital stays were included (mean age 84.3 ± 5.2 years). The overall prevalence of known atheromatous disease was 25.9%. OAC underuse was observed in 58.5% of the stays. In multivariable analysis, the prescription of an APT was associated with an increased risk of OAC underuse [odds ratio (OR) 6.85; 95% confidence interval (CI) 5.50-8.58], independently of the presence of a concomitant known atheromatous disease (OR 0.78; 95% CI 0.60-1.01). Among the 692 stays with APT monotherapy (34.0%), 232 (33.5%) displayed an atheromatous disease. CONCLUSIONS: The underuse of OAC is associated with the prescription of APT in older patients with AF, regardless of the presence or absence of known atheromatous disease. Our results suggest that APT is often inappropriately prescribed instead of OAC.

IT-CARES: an interactive tool for case-crossover analyses of electronic medical records for patient safety.

BACKGROUND: The significant risk of adverse events following medical procedures supports a clinical epidemiological approach based on the analyses of collections of electronic medical records. Data analytical tools might help clinical epidemiologists develop more appropriate case-crossover designs for monitoring patient safety. OBJECTIVE: To develop and assess the methodological quality of an interactive tool for use by clinical epidemiologists to systematically design case-crossover analyses of large electronic medical records databases. MATERIAL AND METHODS: We developed IT-CARES, an analytical tool implementing case-crossover design, to explore the association between exposures and outcomes. The exposures and outcomes are defined by clinical epidemiologists via lists of codes entered via a user interface screen. We tested IT-CARES on data from the French national inpatient stay database, which documents diagnoses and medical procedures for 170 million inpatient stays between 2007 and 2013. We compared the results of our analysis with reference data from the literature on thromboembolic risk after delivery and bleeding risk after total hip replacement. RESULTS: IT-CARES provides a user interface with 3 columns: (i) the outcome criteria in the left-hand column, (ii) the exposure criteria in the right-hand column, and (iii) the estimated risk (odds ratios, presented in both graphical and tabular formats) in the middle column. The estimated odds ratios were consistent with the reference literature data. DISCUSSION: IT-CARES may enhance patient safety by facilitating clinical epidemiological studies of adverse events following medical procedures. The tool's usability must be evaluated and improved in further research.

Evaluation of compliance with recommendations of prevention of thromboembolism in atrial fibrillation in the elderly, by data reuse of electronic health records.

Under-prescription of anticoagulants in the elderly with atrial fibrillation (AF) has been described in several studies, showing that only 15 to 44% of them receive anticoagulants. However, the European Society of Cardiology recommendations state that anticoagulants should be systematically prescribed. In case of refusal of the treatment by the patient, a platelet aggregation inhibitor should be prescribed in monotherapy or bitherapy according to the HAS-BLED bleeding risk score. In all the cases the patient should receive an antithrombotic treatment. In this work we observe the adequacy of prescription practices to the recommendations for AF in the elderly by data reuse on a monocentric observational retrospective cohort. Data of a 222 beds French community hospital were extracted for the year 2013. The patients aged over 75 years and presenting AF were selected. The HAS-BLED score was calculated and the consistency of the prescriptions with the recommendations of the European Society of Cardiology was verified. Then the compliance rate to the recommendations was calculated. The rules detected 433 patients with AF and aged over 75 years. From those patients, 45% received an anticoagulant, 32.1% received platelet aggregation inhibitors and 22.9% did not receive any antithrombotic treatment. When a platelet aggregation inhibitor was prescribed the recommendation for bitherapy was not followed in 97% of the cases. The compliance rate to the recommendations was 47.8%. This work highlights a major problem of quality of the prescriptions in the hospital field and shows how data reuse can help describing this type of issues.

Supervised analysis of drug prescription sequences.

Hospitals have at their disposal large databases that may be considered for reuse. The objective of this work is to evaluate the impact of a drug on a specific laboratory result by analyzing these data. This analysis first involves building a record of temporal patterns, including medical context, of drug prescriptions. Changes in outcome due to these patterns of drug prescription are assessed using short phases of the inpatient stay compared to monotonous changes in the laboratory result. To illustrate this technique, we investigated potassium chloride supplementation and its impact on kalemia. This method enables us to assess the impact of a drug (in its frequent context of prescription) on a laboratory result. This kind of analysis could play a role in post-marketing studies.

Routine use of the "ADE scorecards", an application for automated ADE detection in a general hospital.

Retrospective detection of Adverse Drug Events (ADEs) is challenging, notably because ADEs result from complex interactions between many factors. Data mining techniques have recently emerged in the field of automated retrospective ADE detection. The "ADE Scorecards" are a research application based on data-mining that has been built in the framework of the PSIP European Project, and potentially enables automated ADE retrospective detection. The objective of this paper is to evaluate the use of the ADE Scorecards in a real-life healthcare situation. For that purpose, the ADE Scorecards have been implemented in a French general hospital and have been used by the physicians and pharmacists for three years (corresponding to 73,000 inpatient stays). According to the results, 2% of the analyzed inpatient stays have a potential ADE with hyperkalemia, and 1% of them have a potential ADE with vitamin K antagonist overdose. In practice, the application, which was first designed to be a standalone web-based application for the physicians, has been used as a part of a more global quality improvement approach led by the pharmacists.

Evaluation of a computerized tool allowing retrospective detection of potential vitamin K antagonist overdoses in complex contexts.

Management of vitamin K antagonists (VKA) is difficult, and overdoses can have dramatic hemorrhagic consequences. These works form part of a European computerized medical data processing project, which aims to develop IT tools for describing adverse drug events (ADEs). Materials and methods A tool enabling retrospective research of potential ADE cases was developed, using complex ADE detection rules taking into account chronological parameters: the ADE scorecards. The rules were applied on 14,748 medical records from a community hospital. We evaluated the predictive positive value of the rules related to INR elevation by an expert review of the detected cases. The severity of the clinical consequences was evaluated. Results 49 cases were detected, among which 11 cases were ADEs. The predictive positive value of the rules is 22.44%, mostly related to antibiotics and amiodarone introduction. The four cases of clinical damage related to a drug were properly designated by the rules. Discussion - Conclusion Our study shows the great potential of developing complex rules for the identification of adverse drug events in large medical databases.