Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting risks earlier.

PURPOSE: The purpose of this study was to evaluate how risk estimates generated from cumulative meta-analysis performs over time for drugs having their benefit/risk ratio re-evaluated due to safety issues and, additionally, assess whether results are consistent with regulatory authorities' conclusions. METHODS: Four major regulatory authorities were searched for their issued safety alerts supported by longitudinal, comparative studies (experimentals and/or observationals). The random-effects model was used to pooled odds ratios (OR) over time by including studies according to the year they first became available. RESULTS: Seventeen safety alerts were included in this study. In 2008, proton-pump inhibitors (PPIs) were associated with an increased risk for bone fractures [OR 1.25, 95 % confidence interval (CI) 1.00-1.55, P = 0.049); the US Food and Drug Association (FDA) issued a safety alert in 2010 and added warnings to the label. An increased risk for Clostridium-difficile-associated diarrhea was pooled for PPIs in 2004 (OR 1.89, 1.19-3.02, P = 0.007); US FDA issued a safety alert in 2012, adding warnings to the label. PPIs were associated with pneumonia in 2009 (OR 1.40, 1.06-1.85, P = 0.017); US FDA issued an alert in 2012 but concluded that the benefit/risk (B/R) ratio remains positive. Statins were associated with an increased risk for diabetes (OR 1.07, 1.01-1.15, P = 0.033) in 2008. The European Medicines Agency (EMA) issued an alert in 2012, including warnings to the label. The remaining cumulative meta-analyses did not estimate increased risks in advance of regulatory decisions. CONCLUSION: This study demonstrates that meta-analysis may help predict iatrogenic risks. However, between-study heterogeneity can considerably affect the estimated results, and therefore, this technique should not replace further assessments during BR ratio re-evaluations.

Análisis de las preferencias de los profesionales sanitarios respecto a la prescripción electrónica de tratamientos farmacológicos en pacientes hospitalizados / Health personnel assessment about medical order entry systems of pharmacologic treatments in hospitalized patients

Objetivo. Evaluar preferencias de profesionales sanitarios acerca de la prescripción electrónica (PE) sobre las condiciones de trabajo, riesgo de errores de medicación y utilidad de ventajas aportadas por este sistema. Material y métodos. Estudio transversal mediante entrevista a una muestra de usuarios de PE en un hospital terciario. El cuestionario se estructuró en 3 categorías para valorar: su repercusión en la carga de trabajo, en el riesgo de errores de medicación y sus ventajas teóricas, inconvenientes y sugerencias. Resultados. Participaron 76 profesionales (58 médicos, 9 farmacéuticos y 9 DUE). Sobre su repercusión en la rutina lo mejor valorado fue la reducción de la carga de trabajo y el tiempo empleado (bueno o muy bueno para el 85,5%; IC 95%: 75,5-92,5). Opinaron que la reducción de errores se debía principalmente a soportes de ayuda predefinidos. Las ventajas mejor valoradas fueron: legibilidad y alertas (las consideraron positivamente un 98,7% [IC 95%: 92,9-99,9] y 97,4% [IC 95%:90,81-99,68]). Estimaron como principales inconvenientes los tecnológicos: excesiva dependencia, falta de equipos y fallos informáticos, así como la falta de continuidad farmacoterapéutica entre las distintas unidades de hospitalización durante el ingreso. La necesidad de unificación entre aplicaciones informáticas del hospital fue la sugerencia de mejora más repetida. Conclusión. Los profesionales sanitarios manifestaron un alto grado de satisfacción sobre la PE, a la que consideraron eficaz y segura. Como principal inconveniente destacaron la dependencia de la tecnología y falta de infraestructura. También opinaron que sería deseable una mayor integración entre las distintas aplicaciones informáticas (AU)

Objective: to evaluate health personnel perceptions about medical order entry systems concerning the effect on workflow, medication errors risk and assessment of its potential advantages. Material and methods: A cross-section opinion interview was conducted in a tertiary care hospital. Questionnaire consisted of three sections: perception of its effect on workflow, influence on medication error risk and assessment of potential advantages. We also asked them to assess drawbacks and provide suggestions about this prescription system. Results: 76 health professionals were interviewed (58 physicians, 9 pharmacists and 9 nurses). They were satisfied mainly due to decrease the workload (85.5%; IC 95%: 75.58-92.55). They thought that the main characteristics that contribute to reduce medication errors are clinical decision supports related to predefined aspects which the program provided by default. Among potential benefits of medical order entry systems, legibility and warnings triggered by the program (98.7%; IC 95%: 92.90-99.97 and 97,4%; IC 95%: 90.81-99.68 respectively) were the most valuable. High technology dependence, IT failures and lack of infrastructure and medication therapy discontinuities at times of transition between different hospitals’ units were the main drawbacks considered. The most repeated suggestion was related to the improvement of links between other health informatics applications used in the hospital. Conclusion: health personnel were highly satisfied with the CPOE system, which is considered to be effective and safe. Technology dependence and IT failures were the main disadvantages reported. According to them, a greater coordination and unification of all software applications available in the hospital would be desirable (AU)

Meaningful use: notes from the journey.

After debate, speculation, and anxiety throughout the industry, the first physicians and hospitals have embarked on stage 1 of the meaningful use program. So far... so good.

Balancing act: Can CMIOs and CIOs make physician documentation work for everyone?

Physician documentation in the patient record has long served multiple purposes, from core clinician-to-clinician communication, to billing requirements, to data analysis tasks. Now with the advancing progress of the meaningful use process under the federal Health Information Technology for Economic and Clinical Health (HITECH) Act, even more elements are being added to the demands on M.D. documentation. What kinds of strategies are the leaders of pioneering organizations coming up with that might serve as models for their peers across the industry?

Clinical Tech Trends 2010. Tech Trend: CPOE.

UNLABELLED: THE LANDSCAPE: It's not just the push to obtain federal funding under the ARRA-HITECH legislation that's driving a burst of CPOE implementation of late; it's the realization on the part of CIOs and other organizational leaders that CPOE really is foundational for progress in improving care quality and efficiency. THE FUTURE: The image of CPOE is rapidly being transformed. Clinician leaders and CIOs see the technology as a vital tool in eliminating unnecessary and problematic variation in care, and in spurring data analysis for quality and patient safety improvement going forward. The challenge, as many hundreds of hospitals move towards CPOE in order to qualify for meaningful use under ARRA-HITECH: can they all implement successfully?

[Guidelines for the order process of medical laboratory tests]. / Outils pour l'élaboration et la gestion des formulaires de demande d'examens de biologie médicale.

This document presents the requirements enumerated in the ISO 15189 standard to make reliable the formulation of a medical laboratory test order. The contents and the filling conditions of the request laboratory tests form are described, to clarify the interest of the information required. The purpose is to help to construct a specific formulation allowing the adequate realization of the laboratory tests but also to collect the needed clinical information essential to allow a relevant interpretation of the results with a goal of improvement of patient care. We present also the main forms required for special laboratory tests, particularly concerning the human genome. Finally, the criteria to be reviewed at the entry of the laboratory (contract review) during the request acceptation before its registration are enumerated.

A mandate in Mass. Massachusetts wants CPOE in place by 2012. Will CIOs be willing and able to comply?

A new state law in Massachusetts will require hospitals and community health centers to adopt CPOE systems by 2012, and EHRs by 2015. CIOs--particularly those at community hospitals--face many significant challenges in meeting the CPOE and EHR deadlines. According to a study by MassTech and the New England Health Care Institute, CPOE systems can offer a full return on investment in just over two years. There is a critical need for hospitals to invest in nursing documentation and wireless infrastructure and have a stable network in place.

Procurement of prescriber support systems.

Supporting the process of medication selection and electronic management of prescriptions is a high priority issue in the eHealth strategies of many countries today. Procuring such systems can be quite difficult, especially if one should encourage suppliers from different countries to participate. The new ISO Technical Report 22,790 provides a new approach to facilitate this process by giving an international basis for specifying the functional characteristics desired. The paper describes the content of the report and discusses the procurement process in the light of the European public procurement directive and patient safety.

Medicare program; standards for e-prescribing under Medicare Part D and identification of backward compatible version of adopted standard for e-prescribing and the Medicare prescription drug program (version 8.1). Final rule.

This final rule adopts uniform standards for medication history, formulary and benefits, and fill status notification (RxFill) for the Medicare Part D electronic prescribing (e-prescribing) drug program as required by section 1860D-4(e)(4)(D) of the Social Security Act (the Act). In addition, we are adopting the National Provider Identifier (NPI) as a standard for identifying health care providers in e-prescribing transactions. It also finalizes the June 23, 2006 interim final rule with comment period that identified the National Council for Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 8.1 ("NCPDP SCRIPT 8.1") as a backward compatible update of the NCPDP SCRIPT 5.0 ("NCPDP SCRIPT 5.0"), until April 1, 2009. This final rule also retires NCPDP SCRIPT 5.0 and adopts the newer version, NCPDP SCRIPT 8.1, as the adopted standard. Finally, except as otherwise set forth herein, we are implementing our compliance date of 1 year after the publication of these final uniform standards. This is the second set in a continuing process of issuing e-prescribing final standards for the Medicare Part D program,