Patient safety is absolutely integral to our success. It is 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 work to ensure safety in everything we do with patients. 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.
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.
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, for example, has piloted a virtual clinic and Internet pharmacy for our innovative medicine for erectile dysfunction, which is 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 virtual clinic specifically for this innovative medicine in Europe and adapt the model to other Pfizer product brands.
Patient Care and Safety Work Continue after Product Launch
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.
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.
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.