European Medicines Agency - News and press release archive - European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

19/04/2011
European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

On 15 April 2011, the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation with a broad cross-section of participants including industry, patient and healthcare professional representatives and national medicines regulatory authorities.

This was the first in a series of stakeholder meetings taking place during 2011 and 2012, when the Agency aims to raise awareness of the requirements of the new legislation and promote the exchange of ideas, concerns and opinions.

During this first meeting, immediate feedback from stakeholders was received mainly in relation to the Agency's and Member States' technical contribution to draft European Commission implementing measures. Close co-ordination and co-operation with stakeholders will maximise the opportunities for a successful and efficient adoption of new requirements, which come into legal force in July 2012.

The discussions during the day highlighted several key aspects of the new legislation including:
.changes to inspections and pharmacovigilance systems including the introduction of
Pharmacovigilance System Master Files;
.use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;
.minimum requirements for monitoring data in EudraVigilance;
.changes to Periodic Safety Update Reports (PSURs);
.format and content of risk management plans;
.new measures for transparency and communication including the creation of websites to highlight safety issues with medicines and the introduction of a public hearing process.

All presentations from the stakeholder forum have been published.

A second stakeholder forum will be held on 17 June 2011. Participants will include representation from similar groups to those present at the first meeting, and will be invited by the Agency as appropriate once agenda topics for the day have been finalised.

The new pharmacovigilance legislation, which amends existing legislation, was adopted in the European Union in December 2010. The legislation aims to save lives by strengthening the European-wide system for monitoring the safety of medicines. The new legislation forms part of a three-piece ‘pharmaceutical package’ and amends existing pharmacovigilance legislation contained in Directive 2001/83/EC and Regulation (EC) No.|726/2004|. The remaining parts concerning falsified medicines and information to patients have not yet been adopted by the European Parliament and the European Council.

European Medicines Agency - News and press release archive - European Medicines Agency holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

European Medicines Agency - News and press release archive - European Medicines Agency addresses development of new antibacterials

European Medicines Agency addresses development of new antibacterials

26/04/2011
European Medicines Agency addresses development of new antibacterials

The European Medicines Agency has published a report summarising the discussions at its workshop on antibacterials, held in London in February 2011.

The workshop covered issues including how new medicines to treat infections with bacteria resistant to many other antibiotics should be evaluated and how studies should be designed. The workshop also looked at how antibiotics against various specific types of infection should be tested, including pneumonia, complicated infections of the skin and soft tissue, bronchitis, sinusitis and blood infection.

The workshop brought together academics, regulators and representatives of the pharmaceutical industry, to discuss the ongoing revision of the Agency's guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. This guideline, which was released for public consultation between March and August 2010, aims to provide guidance to companies developing antibacterial medicines, covering how they should carry out studies to test these medicines' benefits and risks.

The views expressed in the report are the personal views of the experts who participated.
The Agency's official position will be reflected in the revised version of the guideline, which it expects to adopt by the end of June 2011.

European Medicines Agency - News and press release archive - European Medicines Agency addresses development of new antibacterials

SALUD EQUITATIVA: DIRECTORIO DE DOCUMENTOS EDITADOS EN ABRIL 2011 [*]

sábado 30 de abril de 2011
SALUD EQUITATIVA: DIRECTORIO DE DOCUMENTOS EDITADOS EN ABRIL 2011 [*]

SALUD EQUITATIVA - GESTIÓN EN SALUD PÚBLICA

SALUD EQUITATIVA
GESTIÓN EN SALUD PÚBLICA


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CIENCIAS DE LA HERENCIA

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CIENCIAS MÉDICAS NEWS

Consultas acumuladas desde enero 2009 a la fecha: 164.595
Consultas totales conjuntas (todos los blogs: 3): 1.560.245
Páginas consultadas desde el inicio de los blogs (3): > 9,5 millones

Discriminadas como sigue:
1. ESPAÑA: 45.755 [27,8%]
2. ARGENTINA: 37.971 [23,1%]
3. MÉXICO: 19.263 [11,7%]
4. COLOMBIA: 10.929 [ 6,6%]
5. ESTADOS UNIDOS DE NORTEAMÉRICA: 9.509 [ 5,8%]
6. PERÚ: 9.509 [ 5,7%]
7. VENEZUELA: 6.237 [ 3,8%]
8. CHILE: 5.412 [ 3,3%]
9. ECUADOR: 2.901 [ 1,8%]
10. BOLIVIA: 1.949 [ 1,2%]
11. LOS DEMÁS: 15.352 [ 9,3%]
Total de consultas: 164.595 [100%]

Documentos del mes de ABRIL 2011: 654
Documentos acumulados en 2011: 2.536
Documentos editados desde el inicio del blog (2008): 8.995


MUESTRA ESTADÍSTICA de un día: (al 30 de abril de 2011)
Páginas vistas por países (según estadísticas blogger):
España 2.029
Alemania 942
Estados Unidos 728
Argentina 703
México 305
Colombia 296
Perú 243
Chile 152
Reino Unido 97
Rusia 87


Archivo del blog
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Osteoporosis treatment following hip fracture: how... [South Med J. 2010] - PubMed result

South Med J. 2010 Oct;103(10):977-81.
Osteoporosis treatment following hip fracture: how rates vary by service.
Gregory PC, Lam D, Howell P.
SourceDepartment of Physical Medicine and Rehabilitation, The University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.


Abstract
OBJECTIVES: Osteoporosis is a prevalent condition among older people. It is often undiagnosed until patients suffer fragility fractures. Previous studies have shown low rates of initiating osteoporosis treatment during the acute hip fracture hospitalization. It is not clear if this varies by the treating service. We compared the rates of instituting osteoporosis treatment during the acute hospitalization for fragility hip fractures.

METHODS: Rates of initiating treatment among previously untreated patients were compared between the orthopedic, medicine, and rehabilitation services using retrospective cross-sectional chart review at an academic medical center. Between January 2005 and August 2008, 191 patients admitted with a fragility hip fracture survived to be discharged from the hospital.

RESULTS: There were 67 (35%) patients who were started on some form of osteoporosis treatment during their acute hospital stay. Factors statistically associated with starting treatment included having a discharge diagnosis of osteoporosis (P < 0.0001) and treating service (P < 0.0001). Orthopedics was the least likely of the 3 treating services to initiate treatment, while medicine was the most likely. CONCLUSIONS: Overall rates of osteoporosis treatment initiation were low at 35% of the 191 patients' records surveyed. Efforts to increase adherence during the acute hospital stay should be explored. A promising intervention includes instituting an osteoporosis consultative service to improve the likelihood of starting osteoporosis treatment post fragility fracture. Comment in South Med J. 2010 Oct;103(10):971-2. PMID:20818315[PubMed - indexed for MEDLINE] Osteoporosis treatment following hip fracture: how... [South Med J. 2010] - PubMed result

The influence of school-based natural mentoring re... [Health Educ Res. 2010] - PubMed result

Health Educ Res. 2010 Oct;25(5):892-902. Epub 2010 Jul 30.
The influence of school-based natural mentoring relationships on school attachment and subsequent adolescent risk behaviors.
Black DS, Grenard JL, Sussman S, Rohrbach LA.
SourceInstitute for Health Promotion and Disease Prevention Research, Keck School of Medicine, University of Southern California, Alhambra, CA 91803, USA. davidbla@usc.edu


Abstract
A relatively new area of research suggests that naturally occurring mentoring relationships may influence the development of adolescents by protecting against risk behaviors. Few studies have explored how these relationships function to reduce risk behavior among youth, especially in the school context. Based on previous research and theory, we proposed and tested a mediation model, which hypothesized that school attachment mediated the longitudinal association between school-based natural mentoring relationships and risk behaviors, including eight indicators of substance use and violence. Students (N = 3320) from 65 high schools across eight states completed a self-report questionnaire at baseline and 1-year follow-up. The sample was comprised of youth with an average age of 14.8 years and an almost equal percentage of females (53%) and males from various ethnic backgrounds. Tests for mediation were conducted in Mplus using path analysis with full information maximum likelihood procedures and models adjusted for demographic covariates and baseline level of the dependent variable. Results suggested that natural mentoring relationships had a protective indirect influence on all eight risk behaviors through its positive association on the school attachment mediator. Implications are discussed for strengthening the association between school-based natural mentoring and school attachment to prevent risk behaviors among youth.

PMID:20675354[PubMed - indexed for MEDLINE] PMCID: PMC2936556[Available on 2011/10/1]
The influence of school-based natural mentoring re... [Health Educ Res. 2010] - PubMed result

Safe practice of population-focused nursing care: ... [Nurs Outlook. 2010 Sep-Oct] - PubMed result

Nurs Outlook. 2010 Sep-Oct;58(5):226-32.
Safe practice of population-focused nursing care: Development of a public health nursing concept.
Issel LM, Bekemeier B.
SourceUniversity of Illinios at Chicago, School of Public Health, 1603 W. Taylor Street (MC 923), Chicago, IL 60612, USA. issel@uic.edu
Abstract
Patient safety, a cornerstone of quality nursing care in most healthcare organizations, has not received attention in the specialty of public health nursing, owing to the conceptual challenges of applying this individual level concept to populations. Public health nurses (PHNs), by definition, provide population-focused care. Safe practice of population-focused nursing care involves preventing errors that would affect the health of entire populations and communities. The purpose of this article is to conceptually develop the public health nursing concept of safe practice of population-focused care and calls for related research. Key literature on patient safety is reviewed. Concepts applying to population-focused care are organized based on Donabedian's Framework. Structural, operational and system failures and process errors of omission and commission can occur at the population level of practice and potentially influence outcomes for population-patients. Practice, research and policy implications are discussed. Safe PHN population-focused practice deserves attention.

Copyright © 2010. Published by Mosby, Inc.

PMID:20934077[PubMed - indexed for MEDLINE]
Safe practice of population-focused nursing care: ... [Nurs Outlook. 2010 Sep-Oct] - PubMed result

Making inpatient medication reconciliation patient... [J Hosp Med. 2010] - PubMed result

J Hosp Med. 2010 Oct;5(8):477-85.
Making inpatient medication reconciliation patient centered, clinically relevant and implementable: a consensus statement on key principles and necessary first steps.
Greenwald JL, Halasyamani L, Greene J, LaCivita C, Stucky E, Benjamin B, Reid W, Griffin FA, Vaida AJ, Williams MV.
SourceDepartment of Medicine, Inpatient Clinician Educator Service, Harvard Medical School, Boston, Massachusetts, USA. jlgreenwald@partners.org


Abstract
Medication errors and adverse events caused by them are common during and after a hospitalization. The impact of these events on patient welfare and the financial burden, both to the patient and the healthcare system, are significant. In 2005, The Joint Commission put forth medication reconciliation as National Patient Safety Goal (NPSG) No. 8 in an effort to minimize adverse events caused during these types of care transitions. However, the meaningful and systematic implementation of medication reconciliation, as expressed through NPSG No. 8, proved to be extraordinarily difficult for healthcare institutions around the country. Given the importance of accurate and complete medication reconciliation for patient safety occurring across the continuum of care, the Society of Hospital Medicine convened a stakeholder conference in 2009 to begin to identify and address: (1) barriers to implementation; (2) opportunities to identify best practices surrounding medication reconciliation; (3) the role of partnerships among traditional healthcare sites and nonclinical and other community-based organizations; and (4) metrics for measuring the processes involved in medication reconciliation and their impact on preventing harm to patients. The focus of the conference was oriented toward medication reconciliation for a hospitalized patient population; however, many of the themes and concepts derived would also apply to other care settings. This paper highlights the key domains needing to be addressed and suggests first steps toward doing so. An overarching principle derived at the conference is that medication reconciliation should not be viewed as an accreditation function. It must, first and foremost, be recognized as an important element of patient safety. From this principle, the participants identified ten key areas requiring further attention in order to move medication reconciliation toward this focus. 1 There is need for a uniformly acceptable and accepted definition of what constitutes a medication and what processes are encompassed by reconciliation. Clarifying these terms is critical to ensuring more uniform impact of medication reconciliation. 2 The varying roles of the multidisciplinary participants in the reconciliation process must be clearly defined. These role definitions should include those of the patient and family/caregiver and must occur locally, taking into account the need for flexibility in design given the varying structures and resources at healthcare sites. 3 Measures of the reconciliation processes must be clinically meaningful (i.e., of defined benefit to the patient) and derived through consultation with stakeholder groups. Those measures to be reported for national benchmarking and accreditation should be limited in number and clinically meaningful. 4 While a comprehensive reconciliation system is needed across the continuum of care, a phased approach to implementation, allowing it to start slowly and be tailored to local organizational structures and work flows, will increase the chances of successful organizational uptake. 5 Developing mechanisms for prospectively and proactively identifying patients at risk for medication-related adverse events and failed reconciliation is needed. Such an alert system would help maintain vigilance toward these patient safety issues and help focus additional resources on high risk patients. 6 Given the diversity in medication reconciliation practices, research aimed at identifying effective processes is important and should be funded with national resources. Funding should include varying sites of care (e.g., urban and rural, academic and nonacademic, etc.). 7 Strategies for medication reconciliation-both successes and key lessons learned from unsuccessful efforts-should be widely disseminated. 8 A personal health record that is integrated and easily transferable between sites of care is needed to facilitate successful medication reconciliation. 9 Partnerships between healthcare organizations and community-based organizations create opportunities to reinforce medication safety principles outside the traditional clinician-patient relationship. Leveraging the influence of these organizations and other social networking platforms may augment population-based understanding of their importance and role in medication safety. 10 Aligning healthcare payment structures with medication safety goals is critical to ensure allocation of adequate resources to design and implement effective medication reconciliation processes. Medication reconciliation is complex and made more complicated by the disjointed nature of the American healthcare system. Addressing these ten points with an overarching goal of focusing on patient safety rather than accreditation should result in improvements in medication reconciliation and the health of patients.

Comment on
Jt Comm J Qual Patient Saf. 2010 Nov;36(11):504-13, 481.
PMID:20945473[PubMed - indexed for MEDLINE]

Making inpatient medication reconciliation patient... [J Hosp Med. 2010] - PubMed result

Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Ann Fam Med. 2010 Sep-Oct;8(5):433-9.
Ethics of health research in communities: perspectives from the southwestern United States.
Williams RL, Willging CE, Quintero G, Kalishman S, Sussman AL, Freeman WL; RIOS Net Members.
SourceDepartment of Family and Community Medicine, University of New Mexico, Albuquerque, New Mexico 87131, USA. rlwilliams@salud.unm.edu


Abstract
PURPOSE: The increasing attention paid to community-based research highlights the question of whether human research protections focused on the individual are adequate to safeguard communities. We conducted a study to explore how community members perceive low-risk health research, the adequacy of human research protection processes, and the ethical conduct of community-based research.

METHODS: Eighteen focus groups were conducted among rural and urban Hispanic and Native American communities in New Mexico using a semistructured guide. Group transcriptions were analyzed using iterative readings and coding, with review of the analytic summary by group members.

RESULTS: Although participants recognized the value of health research, many also identified several adverse effects of research in their communities, including social (community and individual labeling, stigmatization, and discrimination) and economic (community job losses, increased insurance rates, and loss of community income). A lack of community beneficence was emphasized by participants who spoke of researchers who fail to communicate results adequately or assist with follow-through. Many group members did not believe current human research and data privacy processes were adequate to protect or assist communities.

CONCLUSIONS: Ethical review of community-based health research should apply the Belmont principles to communities. Researchers should adopt additional approaches to community-based research by engaging communities as active partners throughout the research process, focusing on community priorities, and taking extra precautions to assure individual and community privacy. Plans for meaningful dissemination of results to communities should be part of the research design.

PMID:20843885[PubMed - indexed for MEDLINE] PMCID: PMC2939419
Free PMC Article
Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Variation in hospital mortality rates for patients... [Am J Cardiol. 2010] - PubMed result

Am J Cardiol. 2010 Oct 15;106(8):1108-12.
Variation in hospital mortality rates for patients with acute myocardial infarction.
Bradley EH, Herrin J, Curry L, Cherlin EJ, Wang Y, Webster TR, Drye EE, Normand SL, Krumholz HM.
SourceSection of Health Policy and Administration, Yale School of Public Health, New Haven, Connecticut, USA. Elizabeth.bradley@yale.edu


Abstract
Hospitals vary by twofold in their hospital-specific 30-day risk-stratified mortality rates (RSMRs) for Medicare beneficiaries with acute myocardial infarction (AMI). However, we lack a comprehensive investigation of hospital characteristics associated with 30-day RSMRs and the degree to which the variation in 30-day RSMRs is accounted for by these characteristics, including the socioeconomic status (SES) profile of hospital patient populations. We conducted a cross-sectional national study of hospitals with ≥15 AMI discharges from July 1, 2005 to June 20, 2008. We estimated a multivariable weighted regression using Medicare claims data for hospital-specific 30-day RSMRs, American Hospital Association Survey of Hospitals for hospital characteristics, and the United States Census data reported by Neilsen Claritas, Inc., for zip-code level estimates of SES status. Analysis included 2,908 hospitals with 513,202 AMI discharges. Mean hospital 30-day RSMR was 16.5% (SD 1.7 percentage points). Our multivariable model explained 17.1% of the variation in hospital-specific 30-day RSMRs. Teaching status, number of hospital beds, AMI volume, cardiac facilities available, urban/rural location, geographic region, ownership type, and SES profile of patients were significantly (p < 0.05) associated with 30-day RSMRs. In conclusion, substantial variation in hospital outcomes for patients with AMI remains unexplained by measurements of hospital characteristics including SES patient profile. Copyright © 2010 Elsevier Inc. All rights reserved. PMID:20920648[PubMed - indexed for MEDLINE] Variation in hospital mortality rates for patients... [Am J Cardiol. 2010] - PubMed result

Research Activities, April 2011: Chronic Disease: Diet and medication adherence can reduce cardiovascular disease for patients with type 2 diabetes

Chronic Disease
Diet and medication adherence can reduce cardiovascular disease for patients with type 2 diabetes

Cardiovascular disease (CVD) is a serious but preventable complication of type 2 diabetes. Managing the numerous risk factors responsible for CVD in people with diabetes is an ongoing challenge for primary care clinicians. A new study found that the mean 10-year risk of CVD in this group was 16.2 percent. Yet nearly one-third of this total risk was attributable to factors such as high cholesterol, hypertension, and smoking, which can be modified with diet, exercise, smoking cessation, and medication adherence. For example, patients who reported good management of their diets and adherence to prescribed medication regimens lowered their mean risk of any cardiovascular event, such as a stroke or heart attack, by 44 and 39 percent, respectively.

The researchers examined the prevalence of CVD risk factors (elevated glycated hemoglobin or HbA1c levels, hypertension, high cholesterol, and smoking status), the attributable risk owing to these factors, and the association between attributable risk of CVD and diet, exercise, and medication adherence. The study population consisted of 313 patients with CVD who were being treated at 20 primary health care clinics in South Texas.

The primary driver of modifiable risk reduction was HbA1c levels (an indicator of blood-glucose control), accounting for nearly two-thirds of the decrease in attributable risk. The next biggest contributors were lipid levels and smoking status. The researchers conclude that high-quality diabetes care requires targeting modifiable patient factors strongly associated with CVD risk, including self-management behavior such as diet and medication adherence. This study was supported by the Agency for Healthcare Research and Quality (HS13008).

See "Cardiovascular disease in type 2 diabetes," by John Zeber, Ph.D., and Michael L. Parchman, M.D., in Canadian Family Physician 56, pp. e302-e307, 2010.


Research Activities, April 2011: Chronic Disease: Diet and medication adherence can reduce cardiovascular disease for patients with type 2 diabetes

AHRQ’s Effective Health Care Program Continuing Education Modules Are Available: Comparative Effectiveness Research on Premixed Insulin Analogues for Type 2 Diabetes: Discussing Applications to Clinical Practice | AHRQ Continuing Education

AHRQ’s Effective Health Care Program Continuing Education Modules Are Available

AHRQ has recently released three new continuing medical education/continuing education (CME/CE) modules based on comparative effectiveness research reviews from its Effective Health Care Program. These modules are free of charge:

* Comparative Effectiveness Research on Premixed Insulin Analogues for Type 2 Diabetes: Discussing Applications to Clinical Practice (accredited CME/CE for Physicians, Physician Assistants, Nurse Practitioners, Pharmacists, Nurses, Case Managers, Medical Assistants, Dieticians, Certified Health Education Specialists)

OPEN HERE PLEASE:
Comparative Effectiveness Research on Premixed Insulin Analogues for Type 2 Diabetes: Discussing Applications to Clinical Practice | AHRQ Continuing Education



** AHRQ's Comparative Effectivenss Research on Lipid-Modifying Therapies (accredited CME/CE for Physicians, Physician Assistants, Nurse Practitioners, Pharmacists, Nurses, Case Managers, Dieticians)

open here please:
AHRQ's Comparative Effectiveness Research on Lipid-Modifying Therapies | AHRQ Continuing Education



*** Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults with Type 2 Diabetes (accredited CME/CE for Physicians, Pharmacists, Nurses, Case Managers)

open here please:
Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults with Type 2 Diabetes | AHRQ Continuing Education

International Learning on Increasing the Value and Effectiveness of Primary Care Conference (I LIVE PC)

Conference on International Lessons in Primary Care Video Is Available

AHRQ hosted a small conference on international lessons in primary care system design and development. Leading thinkers, researchers, and implementers from Australia, Canada, Denmark, the Netherlands, New Zealand, and the United Kingdom joined a delegation from the United States led by Kevin Grumbach, Paul Grundy, and Kavita Patel to discuss models of care, system and community infrastructure, quality and safety, process of health system change and sustainability, and financing and incentives. The goal of the meeting was to propose a policy roadmap for the United States to revitalize its primary care system. The videos of the conference presentations and group discussions are available until April 30, 2012, on the AHRQ Web site. Later this year, AHRQ will publish a summary of the conference and individual papers from each of the seven participating delegations.

open here please:
International Learning on Increasing the Value and Effectiveness of Primary Care Conference (I LIVE PC)

Update: Third Symposium on Comparative Effectiveness Research Methods, June 6-7, 2011 | AHRQ Effective Health Care Program

Web Broadcast of Third Symposium on Patient-Centered Outcomes Research Methods Set for June 6-7

The AHRQ Effective Health Care Program, through its DEcIDE Research Network, is sponsoring a third invitational symposium on research methods entitled, “Methods for Developing and Analyzing Clinically Rich Data for Patient-Centered Outcomes Research”. This 2-day symposium will be held on June 6 and 7 at the AHRQ Conference Center. To expand access to the symposium proceedings, AHRQ will provide a live broadcast of the authors’ slides and audio presentations via the internet. If you are interested in viewing this broadcast select for more information and register. The symposium is a follow-up to the 2006 and 2009 AHRQ conferences on Methods in Comparative Effectiveness and Safety Research; papers presented at past conferences were published in the journal Medical Care. (Download these published papers or order free reprints by sending an e-mail to AHRQpubs@ahrq.hhs.gov pub#OM07-0085 and #OM10-0067.) The 2011 conference will focus on original research and the methodological insight or advances that arise from the conduct of the research. In addition, the symposium aims to provide a forum for scholarly deliberation of new and emerging research methods by scientists working in different disciplines and across settings. The symposium will feature presentations by authors whose abstracts were selected through a blinded peer-review process. In addition to the scientific presentations, keynote speeches will be given by John Concato, M.D., Yale School of Medicine and Louis Jacques, M.D., Director of Coverage & Analysis at the Centers for Medicare and Medicaid Services. For questions regarding the event, please contact Scott Smith at Scott.Smith@ahrq.hhs.gov.

Register:
Update: Third Symposium on Comparative Effectiveness Research Methods, June 6-7, 2011 | AHRQ Effective Health Care Program


Comparative Effectiveness and Safety: Emerging Methods - Executive Summary | AHRQ Effective Health Care Program
Comparative Effectiveness and Safety: Emerging Methods - Executive Summary | AHRQ Effective Health Care Program

Register for Webcast on TalkingQuality

Register for Webcast on TalkingQuality

AHRQ is sponsoring a free Webcast on TalkingQuality on May 11 at 2:00 p.m. – 3:00 p.m. EDT. TalkingQuality is a comprehensive resource and guide for organizations that produce and disseminate reports to consumers on the quality of care provided by health care organizations (e.g., hospitals, health plans, medical groups, and nursing homes) and individual physicians. The Webcast titled, “Who Are You Talking to? New Insights into the Audience for Consumer Reports on Health Care Quality,” will inform on ways to identify and explore the characteristics of people who seek health care quality information. The Webcast features Patrick McCabe, a partner at Getting Your Message Right (GYMR) Public Relations in Washington, DC, and Jeff Rabkin, President of Wowza in Minneapolis, MN. Select for more information and to register: https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=303617&sessionid=1&key=930BB38F453A573E87795E31F06D7D56&partnerref=ahrqnews&sourcepage=register.

Hospital Survey on Patient Safety Culture: 2011 User Comparative Database Report

Hospital Survey on Patient Safety Culture
2011 User Comparative Database Report

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Based on data from 1,032 U.S. hospitals, the Hospital Survey on Patient Safety Culture: 2011 User Comparative Database Report provides initial results that hospitals can use to compare their patient safety culture to other U.S. hospitals. In addition, the 2011 report presents results showing change over time for 512 hospitals that submitted data more than once. The report consists of a narrative description of the findings and four appendixes, presenting data by hospital characteristics and respondent characteristics for the database hospitals overall and separately for the 512 trending hospitals.

Select to download print version (Part 1 [http://www.ahrq.gov/qual/hospsurvey11/hospsurv111.pdf], PDF File, 1.7 MB; Parts 2 and 3 [http://www.ahrq.gov/qual/hospsurvey11/hospsurv1123.pdf], PDF File, 1.6 MB). PDF Help.


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The Agency for Healthcare Research and Quality (AHRQ) released the Hospital Survey on Patient Safety Culture [Surveys on Patient Safety Culture], a tool to help hospitals evaluate how well they had established a culture of safety in their institutions, in 2004. A database was also needed so hospitals and units in hospitals could determine how well they were doing in establishing a culture of safety in comparison to other similar hospitals or hospital units.

The Hospital Survey on Patient Safety Culture: 2011 User Comparative Database Report meets that need. Based on data provided voluntarily by 1,032 U.S. hospitals, the Report provides results that hospitals can use as one basis for comparison in their efforts to establish, improve, and maintain a culture of patient safety in their institutions.

The main report presents statistics (averages, standard deviations, minimum and maximum scores and percentiles) on the patient safety culture areas or composites assessed in the survey as well as the survey items.

Appendixes A and B present breakouts of the data by hospital characteristics (bed size, teaching status, ownership and control, region) and respondent characteristics (hospital work area/unit, staff position, interaction with patients). Appendixes C and D show trends over time for the 512 hospitals that administered the survey and submitted data more than once. The average percent positive scores are shown for the composites and items, broken down by hospital characteristics (bed size, teaching status, ownership and control) and respondent characteristics (hospital work area/unit, staff position, interaction with patients).

Another round of voluntary data collection is planned to update the database with results from additional hospitals. Select for Hospital Comparative Database Submission Information [Hospital Comparative Database Submission Information].

Contents
Executive Summary
Purpose and Use of This Report
Chapter 1. Introduction
Chapter 2. Survey Administration Statistics
Chapter 3. Characteristics of Participating Hospitals
Chapter 4. Characteristics of Respondents
Chapter 5. Overall Results
Chapter 6. Comparing Your Results
Chapter 7. Trending: Comparing Results Over Time
Chapter 8. What's Next? Action Planning for Improvement
References
Notes: Description of Data Cleaning and Calculations
List of Tables
List of Charts

Appendixes A and B—Overall Results by Hospital and Respondent Characteristics
Appendix A: Overall Results by Hospital Characteristics
Appendix B: Overall Results by Respondent Characteristics

Appendix C and D—Trending Results by Hospital and Respondent Characteristics
Appendix C: Trending Results by Hospital Characteristics
Appendix D: Trending Results by Respondent Characteristics

Managed and prepared by: Westat, Rockville, MD under Contract No. HHSA 290200710024C.

Joann Sorra, Ph.D.
Theresa Famolaro, M.P.S.
Naomi Dyer, Ph.D.
Kabir Khanna, M.A.
Dawn Nelson

The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report.

This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without specific permission of copyright holders.

AHRQ Publication No. 11-0030
Current as of April 2011


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Internet Citation:

Sorra J, Famolaro T, Dyer N, et al. Hospital Survey on Patient Safety Culture: 2011 User Comparative Database Report. AHRQ Publication No. 11-0030, April 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/hospsurvey11/

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Hospital Survey on Patient Safety Culture: 2011 User Comparative Database Report

Today's Topics In Health Disparities: HHS' Action Plan to Reduce Health Disparities - Kaiser Family Foundation

AHRQ Director Participates in Kaiser Family Foundation Webcast on Health Disparities

AHRQ Director Carolyn M. Clancy, M.D. participated in a live, interactive Webcast on issues relating to health and health care disparities in the United States hosted by the Kaiser Family Foundation. The examined the new Department of Health and Human Services’ Action Plan to Reduce Racial and Ethnic Health Disparities. In addition to Dr. Clancy, expert panelists on the Today's Topics in Health Disparities Webcast were Garth Graham, M.D., M.P.H., Deputy Assistant Secretary for Minority Health, and Herbert Smitherman, Jr., M.D., M.P.H., Assistant Dean of Community and Urban Health, and Associate Professor of Internal Medicine, Wayne State University School of Medicine, and President and CEO, Health Centers Detroit Foundation, Inc. The program addressed the contents of the strategy and its timeline for implementation as well as its implications for providers. The panelists also discussed how the new strategy relates to other recently released HHS strategies including the National Strategy for Quality Improvement in Health Care, the National Prevention and Health Promotion Strategy, the Healthy People 2020 initiative and the National HIV/AIDS Strategy for the United States. Panelists also considered what the strategy’s role as it relates to health reform implementation


http://www.kff.org/minorityhealth/todaystopics_hhs_042111.cfm

Today's Topics In Health Disparities: HHS' Action Plan to Reduce Health Disparities
On Monday, April 25, 2011 Today's Topics in Health Disparities webcast examined the new Department of Health and Human Services’ Action Plan to Reduce Racial and Ethnic Health Disparities.

The program addressed the contents of the strategy and its timeline for implementation as well as its implications for providers. The panelists also discussed how the new strategy relates to other recently released HHS strategies including the National Strategy for Quality Improvement in Health Care, the National Prevention and Health Promotion Strategy, the Healthy People 2020 initiative and the National HIV/AIDS Strategy for the United States. Panelists also considered what the strategy’s role as it relates to health reform implementation.

Today's Topics In Health Disparities: HHS' Action Plan to Reduce Health Disparities - Kaiser Family Foundation

Fundamentación de la bioética : Who is a real bioethicist? ||| bioetica & debat-Artículos

Fundamentación de la bioética : Who is a real bioethicist?
Enviado por Biblio on 22/3/2011 9:45:07
by Michael Cook
Bioedge 18 March 2011
http://www.bioedge.org/index.php/bioethics/bioethics_article/9452/
Stanford Medical Magazine, Spring 2011


Should you have recognised credentials to practice as a clinical bioethicist? According to an article in the Stanford Medical Magazine, there is interest in setting up a clinical ethics certification process. The American Society for Bioethics and Humanities is currently working on defining the core competencies which will be needed for hospitals which offer clinical bioethics consultations. “In some hospitals, there may not be an individual who possesses the full skill set, but there should be a committee or group that collectively has all of the skills,” says David Magnus, director of Stanford’s Center for Biomedical Ethics.

However, leading figures in bioethics have serious reservations – because no one quite knows what bioethics is. “Certification in medicine itself is a very complex and expensive business,” says Albert Jonsen, one of the early bioethicists and author of The Birth of Bioethics,. “I think the world of bioethics may be too small to support that at the present time. And given the diversity of theoretical and practical approaches, it’s hard to figure out how to give a standard examination.”

In the United States between 2,000 and 6,000 people “do” bioethics in some fashion. But the field is bedevilled by uncertainty about its foundations.

“Bioethics is a field that is always evolving because it exists in relation to newly emerging moral questions in society,” says Stanford bioethicist Laura Roberts. “The field itself struggles — we are always trying to make sense of things and to understand and resolve complex issues in ways that rely on more than mere intuition.”

This extends to the curricula in university courses in bioethics, as well. There is no agreement on how much philosophy, law, theology, sociology, anthropology or other disciplines should be included.

Enforcing accreditation would be possible if the Joint Commission, the body which accredits all hospitals, demanded it. At the moment it stipulates that hospitals should have the ability to provide clinical ethics consultations, but hasn’t specified the level of expertise. And at the moment, it has no plans to do so. ~ Stanford Medical Magazine, Spring 2011

bioetica & debat-Artículos