Connecting Communities for Drug Safety Collaboration

Resources and Tools

The eHI Connecting Communities for Drug Safety Collaboration will develop several useful tools and resources designed to help national, state and local leaders improve drug safety efforts by leveraging health information technology.? The following tools and resources will be developed as part of the project, to stimulate and advance efforts in the field related to drug safety:

• A literature review on surveillance methodologies, including those related to the three use cases;
• Technical ?lessons learned? reports which will offer general guidance on utilizing electronic clinical health information to support pharmacovigilance;
• Technical guides to support technical requirements and specifications for using electronic clinical data from a wide range of clinical and administrative health information technology systems, to support pharmacovigilance for the three use cases;
• Legal guidance document to assist national, state and local leaders navigate the laws, regulations and rules regarding the use of electronic health information for safety surveillance;
• Model legal agreements for health information exchange initiatives and hospitals, that can be used by those interested in launching drug safety surveillance efforts;
• Model legal agreements that can be used by health information exchange initiatives as they work with stakeholders in their own communities to mobilize health information;?
• Communications strategies, key messages, and communications materials that can be used by national, state and local leaders to communicate the importance of drug safety and the use of electronic clinical information to support surveillance efforts;
• Final report which highlights lessons learned, results achieved, and mechanisms to carry this work forward.

These tools and resources will be posted in this section of the website, as they are completed.

The following highlights key resources and reading materials related to the use of electronic health information for population health uses, such as pharmacovigilance.

Policies and Principles for Using Electronic Health Care Information for Improving Population Health

• American Health Information Community, Population Health Workgroup, Visioning Matrix, 2006. http://www.hhs.gov/healthit/ahic/materials/meeting10/bio/Visioning_Matrix.doc
• AHRQ Conference on Data Collection and Reporting. Collecting and Reporting Data for Performance Measurement: Moving Toward Alignment. November 8-9, 2006
• AMIA: Toward a National Framework for the Secondary Use of Health Data, Safran et al, September 2006.
  http://www.amia.org/inside/initiatives/healthdata/finalpapertoward[...].pdf
• AMIA: Background Materials for AMIA June 14-15, 2007 Secondary Data Conference,
  http://www.amia.org/inside/initiatives/healthdata/2007/index.asp
• AQA Data Sharing and Aggregation Principles for Performance Measurement and Reporting, January 2006.
  http://www.aqaalliance.org/files/DataAggPrinciples-May06.doc
• AQA Principles for Health Information Technology and Measurement Aggregation, April 2006.
  http://www.aqaalliance.org/files/PrinciplesforHITandMeasAgg-May06.doc
• de Brantes, Emery, Overhage, Glaser, Marchibroda, The Potential of HIEs as Infomedaries. Journal of Healthcare Information Management, Vol. 21, No. 1.
  http://www.ehealthinitiative.org/assets/documents/Winter07JHIMArticle[...].PDF
• eHealth Initiative Blueprint: From Consensus to Common Action, Improving Population Health Principles, Strategies and Actions, http://www.ehealthinitiative.org/blueprint/key_elements/population_health.asp, October 10, 2007.
• eHealth Initiative, Connecting Communities Toolkit, 2006.
  http://toolkit.ehealthinitiative.org
• Markle Foundation, Connecting for Health, Response to Federal Request for Information on Data Stewardship,
  http://www.connectingforhealth.org/resources/cfh_ahrq_aqa_rfi_073007.pdf
• National Committee on Vital and Health Statistics. Report to the Secretary of the U.S. Department of Health and Human Services on Enhanced Protections for Uses of Health Data: A Stewardship Framework for ?Secondary Uses? of Electronically Collected and Transmitted Health Data. Pre-decisional Document for Discussion Only, http://www.ncvhs.hhs.gov/071031lt.pdf, October 21, 2007.?

Pharmacovigilance and Adverse Event Reporting

• Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.  U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). March 2005. http://www.fda.gov/Cder/guidance/6359OCC.htm
• The Clinical Impact of Adverse Event Reporting. U.S. Food and Drug Administration http://www.fda.gov/medwatch/articles/medcont/postrep.htm
• ?Spontaneous Reporting System Modeling for the Evaluation of Automatic Signal Generation Methods in Pharmacovigilance? in  Statistics for Industry and Technology (Advances in Statistical Methods for the Health Sciences.  Pages 75-92.  Birkh?user Boston. 2007.
• Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance ? lack of vigilance, lack of trust. JAMA 2004;292:2647-50.
• The International Society of Pharmacovigilance (ISoP).  http://www.isoponline.org.

Health Information Exchange

• eHealth Initiative. Improving the Quality of Healthcare through Health Information Exchange: Selected Findings from eHealth Initiative?s Third Annual Survey of Health Information Exchange Activities at the State, Regional and Local Levels. Washington, D.C.: eHealth Initiative; September 2006.
  http://toolkits.ehealthinitiative.org/assets/Documents/eHI2006HIESurvey[...].pdf
• Markle Foundation, Connecting for Health Common Framework, http://www.connectingforhealth.org/commonframework
• Development of State Level Health Information Exchange Initiatives ? AHIMA. http://www.staterhio.org.
• eHealth Initiative Blueprint: Building Consensus for Common Action, http://www.ehealthinitiative.org/blueprint.