Lilly's Commitment to Patient Safety,
Why Safety Matters?
The safety of patients using Lilly medicines is our highest priority.
Beginning with the discovery of a potential new drug and for as long as it is available to patients, our goal at Lilly is to ensure that the benefits and risks of a medication are continuously monitored and well-understood by regulators, doctors and patients.
Lilly maintains a system of collection and reporting of adverse events (AE) throughout the lifecycle of each marketed product. This system is designed to continually maintain and evaluate the product's benefit/risk profile. When important safety issues arise, Lilly communicates them to doctors, patients and regulatory agencies.
At Lilly a dedicated team of physicians, pharmacists, nurses, and other healthcare providers, are responsible for the collection, monitoring, evaluation, and reporting of safety information.
Physician’s role in reporting of Adverse Events (AEs)
Why Report Adverse Events (AEs)?
- Regulatory agencies and pharmaceutical manufacturers use a risk assessment and decision making process to preserve patient safety.
- Once a product is on the market, it is still important to report adverse events. This helps ensure that we have the best information available to make decisions about benefit and risk for a specific patient. It is important for physicians to try and collect all available information when an adverse event is first reported.
- Lilly requests physician to report all adverse events, both non-serious and serious events, regardless of severity or outcome so that we can ensure that we provide the Physician the best understanding that we have about the risk profile of our medications.
- Lilly, the regulatory agencies, and your patients rely on you to voluntarily report adverse events so that patients can be better served.
The patient’s role in reporting Adverse Events (AEs):
Personal responsibility: Following your physician’s treatment recommendations is the first and most important step in the path for a better health.
Immediately report events: If you are not responding well to the medication or are having an abnormal reaction, immediately contact your treating physician and update him/her. You may have other dosage options or other medication options that your physician would like you to try.
If you suffer an abnormal reaction as a result of using a medication, contact your doctor immediately.
Safety From Discovery to Market Approval and Beyond
- Well before a medicine is approved by regulatory authorities and reaches patients, it is rigorously assessed through carefully designed clinical trials to better understand its benefits and risks.
- However even after thorough research in clinical trials, Lilly continues to carefully monitor for new safety findings, so safety evaluation does not stop when a medication reaches the market.
- In fact, the monitoring increases - through collection of information from ongoing clinical studies spontaneous adverse event reports voluntarily reported directly by the physicians or the patients using the medication.
- All Safety Information is assessed and we share new findings and reports with regulators and in some cases with physicians, in order to appropriately manage risks associated with the use of our medicines.
- We also work diligently to combat drug counterfeiting, which poses serious health threats to patients.