Patient safety
What we’re doing to help keep patients safe
Safety data collection
Safety information is collected to monitor and maintain the safety profile of all Lilly medicine. The laws governing the development, manufacturing and marketing of products (drugs or devices) require collection of adverse events.
We collect adverse event reports, which can be reported here , from all over the world and enter the information into a common electronic database to further evaluate the safety and risks of our medicines.
We also monitor the impact of our medicines, including reports of:
- Outcomes of use of a product during pregnancy (maternal and paternal exposure) and breastfeeding
- Lack of drug effect
- Overdose, abuse and misuse
- Medication error
- Suspected transmission of infectious agents
- Potential adverse events associated with product complaints
Healthcare professionals play a crucial role in adverse event collection and the continuous evaluation of a product's safety profile through:
- Reporting adverse events to regulatory agencies including Health Canada or the manufacturer of the product
- Providing basic information related to the adverse event, such as reporter, patient, adverse event and drug
- Including any relevant information in the reports that might enable a thorough evaluation of the adverse event
- Providing additional information when contacted by the regulatory authority or the manufacturer.
Signal management
Safety information is collected to monitor and maintain the safety profile of all Lilly medicine. The laws governing the development, manufacturing and marketing of products (drugs or devices) require collection of adverse events.
We collect adverse event reports, which can be reported here , from all over the world and enter the information into a common electronic database to further evaluate the safety and risks of our medicines.
We also monitor the impact of our medicines, including reports of:
- Outcomes of use of a product during pregnancy (maternal and paternal exposure) and breastfeeding
- Lack of drug effect
- Overdose, abuse and misuse
- Medication error
- Suspected transmission of infectious agents
- Potential adverse events associated with product complaints
Healthcare professionals play a crucial role in adverse event collection and the continuous evaluation of a product's safety profile through:
- Reporting adverse events to regulatory agencies including Health Canada or the manufacturer of the product
- Providing basic information related to the adverse event, such as reporter, patient, adverse event and drug
- Including any relevant information in the reports that might enable a thorough evaluation of the adverse event
- Providing additional information when contacted by the regulatory authority or the manufacturer.
Risk management activities
For each new medicine we launch, we document the important known and potential risks and how these risks will be further evaluated in a Risk Management Plan. In addition, the Risk Management Plan outlines the risk minimization activities that will be implemented to optimize the drug's benefit-risk profile and increase patient safety. This document is regularly reviewed and updated as additional safety data becomes available.
Regulatory reporting
Regulatory authorities worldwide, including Health Canada, monitor the benefit-risk balance of marketed medicines, in accordance with each country's local or regional laws and regulations.
Based on these activities, regulatory authorities may take actions such as requesting that drug companies update the information in the product's label or conduct additional risk assessment or minimization activities. This may include additional research to evaluate a safety risk or communications to health care providers/consumers to bring attention to and emphasize the new information included in the updated product label. In some instances, regulatory authorities may decide to directly communicate with the public.
By law, we are required to report safety information to regulatory authorities according to specific timelines. Following approval, we continue to inform health authorities on the safety of our products through the submission of expedited individual case safety reports, periodic aggregate safety reports, clinical study reports, and other relevant communication on safety issues in a timely manner consistent with applicable regulations.
We are also required to promptly communicate with regulatory authorities when we become aware of any new safety information that might influence the evaluation of a product's benefits and risks.
Communicating to health care providers and patients
We communicate safety findings for our medicines to regulators, patients and/or health care providers—whether favorable or unfavorable to our product. We attempt to provide information appropriate to each audience in an accurate, objective and balanced manner, in order for physicians and patients to make more informed decisions about Lilly medicines.
When safety surveillance activities lead to a change in the benefit-risk balance of a product, this change is communicated to health care providers and/or patients through the following:
- Updates to the Investigator Brochure and/or informed consent document for clinical trials
- Revision of labeling (package insert) for marketed products
- Providing safety information to physicians via Dear Health Care Professional Letters; to consumers via Patient Package Inserts and Medication Guides; or to the public via press releases
It is important for Lilly, regulators, health care providers and patients to work together to ensure that everyone participates in reporting any adverse event that might be attributed to a medicine.