Patient safety is the first priority at Pfizer—from the moment a compound is cleared for clinical trials, to its approval by regulators for marketing, through its manufacture and distribution, and for as long as it is for sale anywhere in the world. Thousands of Pfizer colleagues in specialized groups devoted to safety, risk management, quality assurance, data collection and analysis, global security, medical communication, and regulatory compliance focus intently on the safe, effective and appropriate use of our medicines, vaccines and other products.
We are among the innovators in improving patient safety. One area of great interest is improving the quality and speed of adverse event reporting. In 2009 we began a collaboration with Brigham and Women's Hospital, Partners Healthcare, the Clinical Data Exchange Consortium, and CRIX International to improve the timeliness and quality of data in adverse event reporting. In the group's pilot study, physicians used electronic health record technology to report adverse events directly to the U.S. Food and Drug Administration. Preliminary results show that these reports were more complete and more timely, often filed from the point of care. We are now working to expand the pilot to other health systems and to include devices as well.
We empower patients, their caregivers and the public with up-to-date, meaningful information—trying to make certain that people can understand clearly the benefits, risks and proper use of our medicines. The Pfizer Medicine Safety Education Web site (www.pfizer.com/medicinesafety) helps people understand more about how a medicine's safety is determined, monitored and communicated. This highly interactive site has had more than 100,000 unique visitors since its launch in late 2008. It includes a direct link to MedWatch, the FDA's Safety Information and Adverse Event reporting program.
We added two major sections to our medicine safety education site in 2009. One section—"Understanding Safety Updates"—explains the communication tolls regulators use to explain their actions in response to emerging safety information. In addition, we added an interactive, graphic teaching tool to help people visiting the site understand more about risk by using three major safety studies related to a medicine that's been around for more than a century—aspirin.
Clinical trials are designed to test the safety and efficacy of medicines before they are registered with regulators, who will decide if they should be made available to patients. However, additional risks, as well as benefits, can become apparent after a medicine is approved and used by larger numbers of patients. Thus, our responsibility for the safety of a medicine continues after we have introduced it and extends as long as it is offered for sale anywhere in the world. We have committed substantial resources to inform patients and providers about the safety, efficacy and appropriate use of our medicines. In many cases this means committing ourselves to conduct post-marketing clinical trials or taking other approaches to analyze the "real-world" use of our medicines. Through www.pfizer.com, we provide information about our post-marketing study commitments and the results of the studies we execute.
According to the World Health Organization's Fact Sheet on Counterfeit Medicines, "Counterfeit medicines are found everywhere in the world. They range from random mixtures of harmful toxic substances to inactive, ineffective preparations. Some contain a declared, active ingredient and look so similar to the genuine product that they deceive health professionals as well as patients. But in every case, the source of a counterfeit medicine is unknown and its content unreliable. Counterfeit medicines are always illegal. They can result in treatment failure or even death. Eliminating them is a considerable public health challenge."
Pfizer works closely with national authorities to fight the theft or counterfeiting of medicines and provides anti-counterfeiting training to enforcement agencies. Since the program's inception in 1998, training has been provided to authorities from 86 countries. We also continue to serve national law enforcement agencies by testing products they submit to us, free of charge.
This interactive educational section on www.pfizer.com helps patients, health care providers, public health professionals and caregivers to learn more about medicine safety.Go to the Site
Pfizer employs more than 2,000 medicine safety specialists around the world who are dedicated to the safe, effective and appropriate use of our medicines.Go to the Site