2010 Highlight
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Pfizer become the first company to allow health care providers to directly contact its Medical Information Group via phone, and soon via e-mail, with questions about drugs from their smartphones using the Epocrates mHealth software.
Patient safety is our absolute first priority—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 and in use 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. These professionals deploy highly advanced technologies to provide the earliest possible signals of any change in the benefit/risk profile of a medicine.
Improving Adverse Event Reporting
The global adverse event reporting systems are key assets in providing an early warning that medicines may have unintended effects. However, these systems are only as good as the information put into them by patients and health care professionals. We are taking the lead in improving the quality of adverse event reporting. Our public U.S. Web site remains the only one among major biopharmaceutical companies that allows a direct link for patients to file adverse event reports with the U.S. FDA. In addition, we are collaborating with other innovators to make it possible for doctors to more easily report adverse events to the company and to the regulatory authorities using advanced electronic tools.
In addition, we recast our systems for processing adverse event reports internally, to help ensure complete compliance with FDA time lines and guidelines. We also introduced an integrated database, including legacy Wyeth products, late in 2010, that ensures all adverse event reporting is consistent.
Building Quality Into Clinical Trials
In 2010, Pfizer received two Warning Letters from the FDA, based on audits of company activities that took place primarily in mid-decade. These included findings of lapses in accurate reporting of clinical trial results.
In discussions with the FDA, the company committed to two courses of remedial action. First, the company introduced a series of corrective and preventive actions, reviewed and approved by the FDA, to deal directly with the issues uncovered in the Agency's audits. Concurrently, the company launched a top-to-bottom re-engineering of its clinical trial process to make sure that quality procedures were "built-in" at every step of the way. The Clinical Trial Excellence Project, as it is called, achieved its milestones in 2010 and is currently on track to complete in late 2011.
Protecting Consumers from Counterfeiting
We have taken a leadership position among pharmaceutical companies to protect consumers from the dangers posed by counterfeits, working closely with national authorities to fight the counterfeiting of our medicines. Since 2004 those efforts have prevented more than 65 million counterfeit dosages of Pfizer medicines from being dispensed to patients around the world.
The partnerships we have formed with enforcement authorities—which include training authorities from 94 countries and testing suspected Pfizer product at no cost—are the key to our success. As of December 31, 2010, we had confirmed the presence of counterfeits in 93 countries, including breaches of the legitimate supply chain in 47, a 15 percent increase from December 2009.
Communicating Safety Information
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 shows how a medicine's safety profile 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.
Once we bring a medicine to market, our research efforts do not end there. Additional risks and benefits can become apparent after an approved medicine is used by large numbers of patients. In many cases we conduct post-marketing clinical trials or take other approaches to analyze the "real-world" use of our medicines. Through our Web site, we provide information about our post-marketing study commitments and the results of the studies we implement.
Innovations in Patient Care and Safety
As a leader in biopharmaceutical research, we have great interest in new tools that help physicians and other health care professionals improve patient care and ensure patient safety. Mobile health (mHealth) platforms are a primary focus of our innovations in this area. For example, our collaboration with Epocrates—the world's most widely used mHealth software provider—facilitates improved real-time decision-making by providing health care professionals with detailed, up-to-date clinical information on 40 Pfizer products. The collaboration also includes a special "Contact Pfizer" feature through which physicians click a button to access the Pfizer Medical Information Group and obtain scientific answers to their product questions or to report an adverse event. The Epocrates application for iPhone, BlackBerry and other smart phones is used by about 1 million physicians, or nearly 40 percent of all U.S. physicians, who can turn to us quickly, for questions that may affect patient outcomes and safety.
Because our medicines and vaccines are mediated by doctors, our mHealth strategy has focused on physicians first. At the same time, we are exploring applications of mHealth in pharmaceutical clinical trials, as well as in providing consumers with more in the way of health care information and tools. We have engaged in a strategic partnership with Keas to explore the use of its novel technology platform to develop consumer-centric health and wellness solutions for consumers, patients and their providers, including Web-based personalized health care plans and tools to empower patients to make progress in their own health care.
