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Partnering With Patients

Do you know how medicines are studied?

Healthcare providers, pharmaceutical companies, regulatory authorities (like the FDA) and patients work together to better understand and reduce risks of medicines. This extensive safety system is called Pharmacovigilance (PV). Pfizer has thousands of experts around the globe working to analyze and communicate the risks and benefits of our medicines both before and after they are approved for use. Patients also have an important role to play in reporting side effects they may experience.

Please view the infographic below to learn more about the role you play in maximizing patient safety.

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Helping Patients Use Their Medicines More Safely by Pfizer Health Care Professionals regulatory agencies pharmaceutical industry HELPING PATIENTS USE THEIRMEDICINES MORE SAFELY Understanding the roles of patients, healthcare providers, pharmaceutical companies, and regulatory authorities 1 You or a loved one will likely takemedicine at some point in life. 82% of U.S. adults take at least one medicine, including vitamins and supplements, in a given week 2 29% take five or more 3 As a patient, you want your medical treatment to: 4,5 Improve your health Be as safe as possible Safety is everyone’s first priority, butmedicines may still have side effects. Fortunately, there are many stepsin place to help protect those whotake medicines. BALANCING BENEFIT AND RISK 4,6 Regulatory agencies review data and approve a medicinewhen its benefits are greater than its risks. It takes studying thousands of possible new medicines by companies like Pfizer to get ONE through the drug development process and approved by regulatory authorities such as the FDA. 7 Pfizer’s medicines are available in over 150 countries around the world. Weemploy thousands of medicine safety specialists. These specialists work withregulatory authorities to understand and communicate the risks and benefitsof our medicines both before and after they are approved for patients. Companies like Pfizer and regulatory authorities like the Food and DrugAdministration (FDA) make every effort to understand: Who can benefitfrom a medicine How patients shoulduse that medicine What are the risks ofthe medicine The product information shows what companies and regulatory agencies learn about the medicine and helps healthcare providers and patients: 8 Understand the balance of thebenefits and risks of a medicine Choose the right treatment option PHARMACOVIGILANCE What is pharmacovigilance (PV)? 9,10 Pharmacovigilance is defined by the World Health Organization (WHO) as “thescience and activities relating to the detection, assessment, understanding andprevention of adverse effects or any other drug-related problem” PV INCLUDES AN EXTENSIVE SAFETY SYSTEM: Identifying and managing possiblesafety concerns associated withthe medicines we take Helping protect patients Drug companies, healthcare providers and regulators arealways monitoring for medicine safety, both before and after amedicine has been approved. Clinical trials often find common side effects of a medicine,but some effects can only be found when large numbers ofpeople are using the medicine after it is approved. Learn more about pharmacovigilance by clicking here. WHAT CAN YOU DO? YOU, the patient or caregiver, are an important part of this network. 10 Understand how to use your medicine more safely and its possible effects 1 Read the product information and any other trusted resourcesavailable to you Speak to your healthcare provider about your specific situation Wherever you live, you should tell your healthcare provider if you experience any side effect. You can also tell the drug company. If you are in the U.S., you can contact the FDA (MedWatch). 11,12 Realize you or a loved one might be the first to experience a side effect.Please be sure to report any side effects: Report side effects for Pfizer products by calling 1-800-438-1985. Contact the U.S. FDA directly ator call 1-800-FDA-1088. To report side effects outside the U.S., ask your healthcareprovider or local health authority for more information. A key piece of the pharmacovigilance process is YOUR OWN CAREFUL ATTENTION TO SIDE EFFECTS. 10 SOURCES 1 apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf 2 bu.edu/slone/files/2012/11/SloneSurveyReport2006.pdf 3 cdc.gov/medicationsafety/basics.html#ref1 4 fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf 5 who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf?ua=1 6 fda.gov/Drugs/ResourcesForYou/Consumers/ucm143558.htm 7 phrma.org/advocacy/research-development/clinical-trials 8 fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073107.pdf 9 who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ 10 apps.who.int/medicinedocs/documents/s19612en/s19612en.pdf 11 fda.gov/Safety/MedWatch/SafetyInformation/default.htm 12 accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home