Pfizer 2011 Annual Review | Pfizer: the world's largest research-based pharmaceutical company
Patient Safety

Patient Safety

Patient safety is a core value and our absolute first priority—from the moment a compound is cleared for clinical trials, to its approval by regulators for use by patients, through its manufacture and distribution, and for as long as it is for sale and in use anywhere in the world.

We begin with the understanding that every medication, from aspirin to the most complex cancer therapy, carries both risks and benefits. We use our science to quantify those risks and benefits, and our medical knowledge to communicate with doctors and patients, so that the best treatment decisions can be made.

Thousands of Pfizer colleagues in specialized groups are devoted to drug safety, risk management, quality assurance, data collection and analysis, global security, medical communication and regulatory compliance. These professionals focus intently on the safe, effective and appropriate use of our medicines, vaccines and other products, and have the authority and resources to make sure that patient interests trump all others. Pfizer invests heavily in highly sophisticated technologies and processes to provide possible signals of any change in the benefit/risk profile of a medicine, including new approaches centered on "real world" experience outside clinical development.

Part of patient safety is ensuring consistent supply of needed medicines. In 2011, Pfizer stepped in to cover drug shortages caused by others in the industry. Read more

Protecting Patients From Counterfeit and Substandard Medicines

Medicines are reasonably easy to counterfeit. Pfizer has taken a leadership position among pharmaceutical companies to protect patients, working in close coordination with many national authorities and multinational coalitions to fight the counterfeiting of medicines. Since 2004, these efforts have prevented more than 65 million counterfeit dosages of Pfizer medicines from being dispensed to patients around the world, and led to the confiscation of enough active pharmaceutical ingredients to manufacture 68 million more. Our partnerships with enforcement authorities—which include training authorities from 94 countries and a standing offer to test suspected Pfizer products at no cost—are key to our progress. As of December 31, 2011, we had confirmed the presence of Pfizer drug counterfeits in 93 countries, including breaches of the legitimate supply chain in 47 of them.

We are also experimenting with direct-to-consumer models that greatly reduce even the possibility of counterfeiting. Pfizer Israel has piloted a virtual clinic and Internet pharmacy for Viagra, the world's most counterfeited drug. In addition to removing barriers to treatment, the virtual clinic is designed to thwart counterfeiting by giving patients a trusted online alternative source for the medicine. As a result of the pilot program's success, there are now plans to launch the Viagra virtual clinic in Europe and adapt the model to other Pfizer brands.

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, including mobile health platforms. For example, our collaboration with Epocrates—the leading mHealth software provider, used by 1 million physicians in the U.S.—improves real-time decision-making by providing health care professionals with detailed, up-to-date clinical information on Pfizer products, as well as one-click access to doctors working for Pfizer.

Another leadership area for Pfizer is adverse event reporting. These systems, commonly used by governments around the world, are integral to the early warning system on unexpected drug safety issues, by allowing doctors and patients to report their experiences with a medicine directly to regulators. These experiences are then recorded by the regulating agency and forwarded to the manufacturer for mandated investigation and closure. We have sought to improve the quality of adverse event reporting to make it easier for doctors and patients to report adverse events and to get a bigger picture from each report. Re-engineering of the adverse event management system inside the company, in 2011, led to better, faster, adverse event reports, at rates consistently above the already-high industry standards. In addition, our public U.S. website remains the only major biopharmaceutical company website that allows a direct link for patients to file adverse event reports with the FDA.

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. Pfizer's External Medical Communications team has hundreds of medical professionals literally at the beck and call of doctors around the world to discuss how our medicines are properly prescribed, and to answer questions about the risk and benefit profile. In 2011, this team answered more than 800,000 inquiries from prescribers, and that number is expected to jump to more than 1 million inquiries in the year to come.

The Pfizer Medicine Safety Education website 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.

Our research and development of a medicine does not end with its launch. Additional benefits and, sometimes, new risks 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 while protecting the privacy of patients. Through our website, we provide information about our post-marketing study commitments and the results of the studies we implement. Overall, Pfizer is building on a heritage of patient safety to help make certain that doctors and patients have the information needed to drive the best possible patient outcomes. We know the risks of medicines are very real and must be respected, and we are committed to being best in class when it comes to using the newest technologies to discover and evaluate safety signals.