Atypical antipsychotics and hyperglycemic emergencies: multicentre, retrospective cohort study of administrative data.

OBJECTIVE: To evaluate the relationship between initiation of atypical antipsychotic agents and the risk of hyperglycemic emergencies. METHOD: We conducted a multicentre retrospective cohort study using administrative health data from 7 Canadian provinces and the UK Clinical Practice Research Datalink. Hospitalizations for hyperglycemic emergencies (hyperglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic state) were compared between new users of risperidone (reference), and new users of olanzapine, other atypical antipsychotics, and typical antipsychotics. We used propensity scores with inverse probability of treatment weighting and proportional hazard models to estimate the site-specific hazard ratios of hyperglycemic emergencies in the year following drug initiation separately for adults under and over age 66 years. Site-level results were pooled using meta-analytic methods. RESULTS: Among 725,489 patients, 55% were aged 66+years; 5% of younger and 19% of older patients had pre-existing diabetes. Hyperglycemic emergencies were rare (1-2 per 1000 person years), but more frequent in patients with pre-existing diabetes (6-12 per 1000 person years). We did not find a significant difference in risk of hyperglycemic emergencies with initiation of olanzapine versus risperidone; however heterogeneity existed between sites. The risk of an event was significantly lower with other atypical (99% quetiapine) compared to risperidone use in older patients [adjusted hazard ratio, 95% confidence interval (CI): 0.69, 0.53-0.90]. CONCLUSIONS: Risk for hyperglycemic emergencies is low after initiation of antipsychotics, but patients with pre-existing diabetes may be at greater risk. The risk appeared lower with the use of quetiapine in older patients, but the clinical significance of the findings requires further study.

Comparative effectiveness of tiotropium and ipratropium in prevention of hospital readmission for COPD: a population-based cohort study.

BACKGROUND: In the treatment of chronic obstructive pulmonary disease (COPD), tiotropium bromide has a longer duration of action than ipratropium bromide; however, tiotropium bromide is a more expensive alternative treatment. At issue is whether tiotropium reduces the risk for hospital readmissions for COPD compared with ipratropium. OBJECTIVES: A population-based cohort study was conducted to assess whether tiotropium reduces the risk for hospital readmissions for COPD compared with ipratropium. METHODS: British Columbia (BC) linked provincial administrative health databases were used to identify new patients with COPD (aged ≥45 years) with a first hospital admission for COPD from 2003 to 2011. The study period was defined as the 30-day tiotropium or ipratropium treatment-initiation period after hospital discharge. Patients were followed up for ≤6 months from drug initiation to hospital readmission for COPD. In a subanalysis, the 2 treatment groups were matched on age, sex, and high-dimensional propensity scores derived from 200 empirically identified and predefined covariates. The risk for hospital readmission was estimated using multivariate Cox proportional hazards and logistic regression analyses. RESULTS: In total, 3723 patients with COPD were dispensed tiotropium (n = 992) or ipratropium (n = 2731) within 30 days from the index hospital admission for COPD. The mean age of these patients was 72.8 years, and 50.8% were women. Tiotropium-treated patients were more likely to be in a higher income category and were more likely to use a greater number of medications compared with ipratropium-treated patients. Among the subset of 1500 matched patients, 215 (14.3%) were readmitted to hospital within 6 months. There was no statistically significant group difference in hospital readmissions using either analytical approach (hazard ratio = 0.98 [95% CI, 0.72-1.34]; odds ratio = 0.97 [95% CI, 0.70-1.36]). CONCLUSIONS: In this select group of patients, neither tiotropium nor ipratropium was effective in significantly decreasing the risk for rehospitalization for COPD within 6 months.

Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov.

Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.

Development and validation of a predictive algorithm to identify adult asthmatics from medical services and pharmacy claims databases.

OBJECTIVE: To develop and validate the accuracy of a predictive model to identify adult asthmatics from administrative health care databases. STUDY SETTING: An existing electronic medical record project in Montreal, Quebec. STUDY DESIGN: One thousand four hundred and thirty-one patients with confirmed asthma status were identified from primary care physician's electronic medical record. DATA COLLECTION/EXTRACTION METHODS: Therapeutic indication of asthma in an electronic prescription and/or confirmed asthma from an automated problem list were used as the gold standard. Five groups of asthma-specific markers were identified from administrative health care databases to estimate the probability of the presence of asthma. Cross-validation evaluated the diagnostic ability of each predictive model using 50 percent of sample. PRINCIPAL FINDINGS: The best performance in discriminating between the patients with asthma and those without it included indicators from medical service and prescription claims databases. The best-fitting algorithm had a sensitivity of 70 percent, a specificity of 94 percent, and positive predictive value of 65 percent. The prescriptions claims-specific algorithm demonstrated a nearly equal performance to the model with medical services and prescription claims combined. CONCLUSIONS: Our algorithm using asthma-specific markers from administrative claims databases provided moderate sensitivity and high specificity.

A randomized trial of the effectiveness of on-demand versus computer-triggered drug decision support in primary care.

OBJECTIVES: Prescribing alerts generated by computerized drug decision support (CDDS) may prevent drug-related morbidity. However, the vast majority of alerts are ignored because of clinical irrelevance. The ability to customize commercial alert systems should improve physician acceptance because the physician can select the circumstances and types of drug alerts that are viewed. We tested the effectiveness of two approaches to medication alert customization to reduce prevalence of prescribing problems: on-physician-demand versus computer-triggered decision support. Physicians in each study condition were able to preset levels that triggered alerts. DESIGN: This was a cluster trial with 28 primary care physicians randomized to either automated or on-demand CDDS in the MOXXI drug management system for 3,449 of their patients seen over the next 6 months. MEASUREMENTS: The CDDS generated alerts for prescribing problems that could be customized by severity level. Prescribing problems included dosing errors, drug-drug, age, allergy, and disease interactions. Physicians randomized to on-demand activated the drug review when they considered it clinically relevant, whereas physicians randomized to computer-triggered decision support viewed all alerts for electronic prescriptions in accordance with the severity level they selected for both prevalent and incident problems. Data from administrative claims and MOXXI were used to measure the difference in the prevalence of prescribing problems at the end of follow-up. RESULTS: During follow-up, 50% of the physicians receiving computer-triggered alerts modified the alert threshold (n = 7), and 21% of the physicians in the alert-on-demand group modified the alert level (n = 3). In the on-demand group 4,445 prescribing problems were identified, 41 (0.9%) were seen by requested drug review, and in 31 problems (75.6%) the prescription was revised. In comparison, 668 (10.3%) of the 6,505 prescribing problems in the computer-triggered group were seen, and 81 (12.1%) were revised. The majority of alerts were ignored because the benefit was judged greater than the risk, the interaction was known, or the interaction was considered clinically not important (computer-triggered: 75.8% of 585 ignored alerts; on-demand: 90% of 10 ignored alerts). At the end of follow-up, there was a significant reduction in therapeutic duplication problems in the computer-triggered group (odds ratio 0.55; p = 0.02) but no difference in the overall prevalence of prescribing problems. CONCLUSION: Customization of computer-triggered alert systems is more useful in detecting and resolving prescribing problems than on-demand review, but neither approach was effective in reducing prescribing problems. New strategies are needed to maximize the use of drug decision support systems to reduce drug-related morbidity.

Evaluation of the use of an integrated drug information system by primary care physicians for vulnerable population.

OBJECTIVE: To investigate whether an electronic prescribing and integrated drug information system was more likely to be used by primary care physicians for patients of low socioeconomic (SES) patients. METHODS: Prospective 9 months follow-up study was conducted in Montreal, Canada from March to November 2003. The study included 28 primary care physicians and their 4096 respective patients with provincial drug insurance. Utilization rate was defined as the number of times the electronic medication history (EMH) and electronic prescribing system (E-rx) were accessed divided by the total number of medical visits made by those patients. System audit trails (utilization), provincial health insurance databases (visits) were used to measure system utilization rate. For each patient neighborhood-based measures of household income, derived from Statistics Canada, were used to measure socioeconomic status. RESULTS: The EMH was used 14.5 times per 100 visits. In comparison to high SES patients, there was a significant 70% increase (RR: 1.70; 95%CI: 1.15-2.47) in the EMH utilization for low SES patients. The electronic prescribing system was used 38.5 times per 100 visits and did not vary by patient SES. The EMH utilization rate for low SES patients with multiple emergency room (ER) visits was 2.4 times higher than for high SES patients with <1 ER visit (RR: 2.38; 95%CI: 1.36-4.14). The utilization rate for low SES patients, who took, at least six drugs per day, was four times higher compared to high SES patients with less complex drug management (RR: 4.00; 95%CI: 2.22-7.17). CONCLUSIONS: Primary care physicians were more likely to access electronic information on current drug use for patients of low SES taking multiple medications and with fragmented care.

The development and evaluation of an integrated electronic prescribing and drug management system for primary care.

OBJECTIVE: To develop and evaluate the acceptability and use of an integrated electronic prescribing and drug management system (MOXXI) for primary care physicians. DESIGN: A 20-month follow-up study of MOXXI (Medical Office of the XXIst Century) implementation in 28 primary care physicians and 13,515 consenting patients. MEASUREMENT: MOXXI was developed to enhance patient safety by integrating patient demographics, retrieving active drugs from pharmacy systems, generating an automated problem list, and providing electronic prescription, stop order, automated prescribing problem alerts, and compliance monitoring functions. Evaluation of technical performance, acceptability, and use was conducted using audit trails, questionnaires, standardized tasks, and information from comprehensive health insurance databases. RESULTS: Perceived improvements in continuity of care and professional autonomy were associated with physicians' expected use of MOXXI. Physician speed in using MOXXI improved substantially in the first three months; however, only the represcribing function was faster using MOXXI than by handwritten prescription. Physicians wrote electronic prescriptions in 36.9 per 100 visits and reviewed the patient's drug profile in 12.6 per 100 visits. Physicians rated printed prescriptions, the current drug list, and the represcribing function as the most beneficial aspects of the system. Physicians were more likely to use the drug profile for patients who used more medication, made more emergency department visits, had more prescribing physicians, and lower continuity of care. CONCLUSION: Primary care physicians believed an integrated electronic prescribing and drug management system would improve continuity of care, and they were more likely to use the system for patients with more complex, fragmented care.

Inappropriate prescribing practices: the challenge and opportunity for patient safety.

Adverse clinical events related to inappropriate prescribing practices are an important threat to patient safety. Avoidance of inappropriate prescribing in community settings, where the majority of prescriptions are written, offers a major area of opportunity to improve quality of care and outcomes. Electronic medication order entry systems, with automated clinical risk screening and online alerting capabilities, appear as particularly promising enabling tools in such settings. The Medical Office of the Twenty First Century (MOXXI-III) research group is currently utilizing such a system that integrates identification of dosing errors, adverse drug interactions, drug-disease and allergy contraindications and potential toxicity or contraindications based on patient age. This paper characterizes the spectrum of alerts in an urban community of care involving 28 physicians and 32 pharmacies. Over a consecutive nine-month period, alerts were generated in 29% of 22,419 prescriptions, resulting in revised prescriptions in 14% of the alert cases. Drug-disease contraindications were the most common driver of alerts, accounting for 41% of the total and resulting in revised prescriptions in 14% of cases. In contrast, potential dosing errors generated only 8% of all alerts, but resulted in revised prescriptions 23% of the time. Overall, online evidence-based screening and alerting around prescription of medications in a community setting demands confirmation in prescribers' clinical decision making in almost one-third of prescriptions and leads to changed decisions in up to one-quarter of some prescribing categories. Its ultimate determination of clinical relevance to patient safety may, however, have to await more detailed examination of physician response to alerts and patient outcomes as a primary measure of utility. Patient safety is an increasingly recognized challenge and opportunity for stakeholders in improving health care delivery. It involves many issues, including delayed diagnosis and treatment, as well as inappropriate undertreatment and overtreatment. The common denominators, however, are that care and outcomes could be better, and there is a role for patients, providers and policy makers in making improvements.

The impact of electronic health records on time efficiency of physicians and nurses: a systematic review.

A systematic review of the literature was performed to examine the impact of electronic health records (EHRs) on documentation time of physicians and nurses and to identify factors that may explain efficiency differences across studies. In total, 23 papers met our inclusion criteria; five were randomized controlled trials, six were posttest control studies, and 12 were one-group pretest-posttest designs. Most studies (58%) collected data using a time and motion methodology in comparison to work sampling (33%) and self-report/survey methods (8%). A weighted average approach was used to combine results from the studies. The use of bedside terminals and central station desktops saved nurses, respectively, 24.5% and 23.5% of their overall time spent documenting during a shift. Using bedside or point-of-care systems increased documentation time of physicians by 17.5%. In comparison, the use of central station desktops for computerized provider order entry (CPOE) was found to be inefficient, increasing the work time from 98.1% to 328.6% of physician's time per working shift (weighted average of CPOE-oriented studies, 238.4%). Studies that conducted their evaluation process relatively soon after implementation of the EHR tended to demonstrate a reduction in documentation time in comparison to the increases observed with those that had a longer time period between implementation and the evaluation process. This review highlighted that a goal of decreased documentation time in an EHR project is not likely to be realized. It also identified how the selection of bedside or central station desktop EHRs may influence documentation time for the two main user groups, physicians and nurses.

Non-participation bias in health services reseach using data from an integrated electronic prescribing project: the role of informed consent / Sego por falta de participación en la investigación de los servicios de salud al usar datos de un proyecto integrado de prescripción electrónica: el papel del consentimiento informado / Sesgo pela falta de participação na pesquisa dos serviços de saúde ao usar dados de um projeto integrado de prescrição eletrônica: o papel do consentimento informado

Electronic prescribing potentially reduces adverse outcomes and provides critical information for drug safety research but studies may be distorted by non-participation bias. 52,507 patients and 28 physicians were evaluated to determine characteristics associated with consent status in an electronic prescribing project. Physicians with less technology proficiency, seeing more patients, and having patients with higher fragmentation of care were less likely to obtain consent. Older patients with complex health status, higher income, and more visits to the study physician were more likely to consent. These systematic differences could result in significant non-participation bias for research conducted only with consenting patients.

La prescripción electrónica reduce, potencialmente, los resultados adversos. y proporciona información crítica para una investigación segura en drogas, pero los estudios pueden ser distorsionados por un sesgo por falta de participación. Se evaluó a 52.505 pacientes y a 28 médicos para determinar características asociadas con el estatus del consentimiento en un proyecto de prescripción electrónica. Los médicos con menor eficiencia tecnológica, con más cantidad de pacientes que, además, mostraban mayor fragmentación en su atención, presentaban menor opción de obtener consentimiento. Los pacientes de más edad, con estatus de salud complejo, mayor ingreso y con más visitas al médico a cargo, manifestaban mayor disposición a consentir. Estas diferencias sistemáticas podrían desembocar en un sesgo significativo por falta de participación en la investigación llevada a cabo sólo con pacientes con consentimiento.

A prescrição eletrônica reduz potencialmente os resultados adversos e proporciona informação crítica para uma pesquisa segura em drogas, porém os estudos podem ser destorcidos por um sesgo por falta de participação. Avaliou-se 52.505 pacientes e a 28 médicos para determinar características associadas com o estatus do consentimento num projeto de prescrição eletrônica. Os médicos com menor eficiência tecnológica, com mais quantidade de pacientes que os outros, mostravam maior fragmentação em sua atenção, apresentavam menos opção para conseguir o consentimento. Os pacientes mais idosos, com estudos de saúde maiôs complexos, maiores salários e com mais visitas ao médico, manifestavam maior disposição de consentir. Estas diferenças sistemáticas poderiam desembocar num erro significativo por falta de participação na pesquisa levada a cabo somente com pacientes que consentiram.