Pharmacovigilance Methods

Improvement of patient safety has been important in healthcare for the last several years^{10, 11}. As awareness of the issues with patient safety has grown, the demand by stakeholder groups for safer care for their constituencies has taken the form of new regulations for future reimbursement, improved standards for accreditation and requirements for new technologies which can meet the new goals. One area of patient safety in particular - pharmacovigilance⁸ - is looking for dramatic improvements in methods, practice, and technologies. There is growing public concern with health risks posed by approved drugs, after several high profile drug safety issues¹⁰. All stakeholders, inlcuding the FDA, the pharmaceutical industry, consumer organizations, Congress, professional societies, health care entities--agree on the need to improve the system, and this has spawned a concerted effort to get better information about who is at risk for which medications⁹ and one of the important means to do this will be a better use of electronic healthcare data.

The Collaborative has as its goal the creation of network of communities to serve as a prototype early-stage sentinel system for the identification and testing of drug safety signals. The hope is that by creating a viable network model that allows individual communities or aggregates of communities to add their value to the network and maintain to a large degree their independence we can create a functioning drug safety network that can grow and evolve over time as we establish more sophisticated methods of analysis and more closely integrated sets of data. One of the most important things we can do in the beginning of this effort is to establish a shared understanding about the problem and shared commitment to possible solutions to the problem.

The Collaboration represents a unique partnership between pharmaceutical companies and academic community healthcare centers. Partners HealthCare System and Regenstrief Institute represent academic medical providers, research, and informatics organizations. eHealth Initiative concentrates on multiple stakeholders in healthcare that are serving their communities and constituents. We all have an overall concern for safety and improving healthcare, but the individual focus of each group can be very different. There is a need to understand several topics, specifically have an understanding of pharmacovigilance; therefore, the links below are provided for additional pharmacovigilance background.

To get started, additional information:

U.S. Food and Drug Administration. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. April 2005. www.fda.gov/Cder/Guidance/6359OCC.htm
U.S. Food and Drug Administration. Guidance for Industry E2E Pharmacovigilance Planning. April 2005. http://www.fda.gov/CBER/gdlns/ichpvp.htm
Guidelines for Good Pharmacoepidemiology, International Society for Pharmacoepidemiology, 2004. www.pharmacoepi.org/resources/guidelines_08027.cfm.
Rodriguez EM, Staffa JA, Graham DJ, 2001, The role of databases in drug postmarketing surveillance, Pharmacoepidemiology and Drug Safety, 10:407-10.
World Health Organization. Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products.” www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/index.html.
Stephens' Detection of New Adverse Drug Reactions Fifth Edition edited by John Talbot and ; Patrick Waller. 2004, John Wiley and Sons, Ltd.
Pharmacoepidemiology Fourth Edition, Brian L Strom (Ed), October 2005.
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications to identify identifying new information about hazards associated with medicines and prevent harm to patients.
http://www.fda.gov/oc/initiatives/advance/reports/report0508.html
http://www.iom.edu/?id=37339
http://jama.ama-assn.org/cgi/content/short/297/17/1917