The Global Patient Safety (GPS) organization is a team of over 300 individuals, including physicians, pharmacists, nurses and other drug safety professionals. The process we use, called pharmacovigilance, is designed to continuously evaluate a drug's safety profile through analysis of information that is collected from around the world. When a safety finding is identified, the GPS team works with regulatory authorities to inform healthcare providers and patients. This information is communicated through changes to the medication's package insert, patient information guide; and occasionally through letters sent directly to healthcare providers or other means. Additional studies, when necessary, are conducted to further assess and understand the safety profile of the medication.
Accurate and up-to-date safety information is critical for healthcare providers and patients to best decide how and for whom a medication should be used. It is important for Lilly, regulators, healthcare providers and patients to work together to ensure that all participate in the reporting of any adverse event that might be attributed to a medication.