Pharmacovigilance is the process of collecting, monitoring, researching and evaluating information from health care providers and patients for the purposes of understanding and preventing drug-related problems.
- Lilly's pharmacovigilance system collects data throughout the lifecycle of each product. When important safety issues arise, Lilly issues updated communications to doctors, patients and health regulators.
- At the initiation of clinical trials, the safety profile of the product is developed from animal data (e.g., toxicology studies) and generalizations from drugs in the same pharmacological class. This information is provided to clinical trial investigators in the Investigator Brochure. From the first human dose and throughout the course of clinical trials, safety information is collected and reviewed by Lilly staff to provide the most-up-to-date information possible about the safety profile of Lilly products.
- At the time of marketing approval, safety data from the clinical trials and non-clinical studies are summarized in the approved labeling (i.e., the package insert for the product). Post-marketing studies may be conducted to continue to collect information about benefits and risks of the product.
- In addition, health care providers and patients spontaneously report adverse events as a result of their experiences. Each is reviewed and follow up contacts are initiated when additional information is needed.
- Data from post-marketing studies and spontaneous reports are reviewed periodically, and when new information suggests that there may be an important new safety issue emerging, Global Patient Safety conducts an evaluation. If analyses of the collective safety information indicate a change in the benefit/risk profile of the product, then Lilly's risk management programs are initiated.
- These risk management programs may include communications to patients in the form of updates to the package insert, letters to health care providers and/or patients, notification to regulators and further studies to evaluate safety concerns.
The Lilly 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. Accurate and up-to-date safety information is critical for health care providers and patient to best decide how and for whom a medical should be used. It is important for Lilly, regulators, health care 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.