Drug Safety Toolkit Introduction
The Connecting for Drug Safety Collaboration recognizes that there is significant interest in using electronic data sources with information to consider before deciding to implement such a program as well as to assess the benefits and risks of medications. The Connecting for Drug Safety Collaboration has created this Toolkit to provide anyone contemplating, designing, or implementing a drug safety surveillance program using electronic data sources with the guides, templates and tools for optimizing their efforts. The Collaboration welcomes you to our community, however we do ask that, in order to take advantage of the tools and involvement opportunities, you register to become a member of the community. It is free and your information will not be used for marketing.
We welcome your feedback on this Toolkit and the work it represents. Should you move forward with establishing a pharmacovigilance effort based on this toolkit, sharing your individual experiences for future iterations of this toolkit will help others. Please feel free to contact us using the information at the bottom of this page.
Toolkit Contents
The eHI Drug Safety Toolkit contains both online and downloadable components that are presented in the following sections:
- Getting Started - This section contains a Prescreening Questionnaire and an online Readiness Assessment that will help prospective Communities evaluate their readiness to develop drug safety surveillance programs using electronic data sources.
- Implementation - This section contains a Methodology Guide and a review of some of the key lessons learned in the process of developing the drug safety surveillance programs at the two Anchor Communities. More comprehensive treatments of these subjects are available for download for Communities that are ready to establish a program.
- Legal and Privacy - This section contains general legal guidance that covers all of the major legal issues involved in drug safety collaborations involving Health Information Exchanges (HIEs), health systems and pharmaceutical companies. It also includes template agreements related to establishing HIEs for drug safety.
- Engaging the Public - This section reviews the results of market research on the key messages that will help promote support for drug safety surveillance programs using electronic data sources.
- Additional Resources - Contains definitions of terms, literature references, and answers to frequently asked questions related to this Toolkit and the Connecting Communities for Drug Safety initiative.
- Downloads - Contains links to downloadable versions of the Toolkit components, associated templates, and other resources. These offline components are generally more comprehensive than what is available on the website.
You can access each section by clicking the sub-links in the navigation bar across the top of the page above or by clicking the bulleted links above.
How Was the Toolkit Developed?
This Toolkit was created by several organizations and the Collaboration itself. To date, outside of the Collaboration, three organizations have contributed to the content of the Toolkit - BearingPoint, Inc. (including the Readiness Assessment, Methodology Guide, Lessons Learned, Definitions, and overall Toolkit design) APCO Worldwide (market research on engaging the public), and Coppersmith Gordon Schermer & Brockelman, PLC (legal guidance on privacy and health information exchange). Much of this work drew from the experiences of the two Anchor Communities that participated in the Collaboration, Partners HealthCare System and the Regenstrief Institute; both organizations provided valuable input and feedback throughout the development of the Toolkit.
In its first iteration, the Toolkit was supported by Eli Lilly and Company, Johnson & Johnson, and Pfizer Inc. The Toolkit is an evolving resource, which gets better with the input of national, state and local leaders who contribute their expertise and experiences.
Contact us
We welcome your feedback and questions. Please send email to one of the following addresses:
General questions or comments:
drug.safety@ehealthinitiative.org
Questions or comments about the eHealth initiative in general, or to share your Community's experiences:
eHealth Initiative, Foundation for eHealth Initiative
818 Connecticut Avenue, N.W., Suite 500
Washington, D.C. 20006
Tel: 202-624-3270
Fax: 202-429-5553
Email: info@ehealthinitiative.org
Web: http://www.ehealthinitiative.org/
