What We’re Doing to Help Keep Patients Safe
When you're on a mission to make life better, patient safety will always be a priority. Our goal is to ensure that the benefits and risks of our medications are continuously monitored and well-understood by regulators, health care providers and patients, beginning with the discovery of a potential new medicine and continuing as long as it is available to patients.
Pharmacovigilance
Lilly's Global Patient Safety organization, consisting of more than 300 physicians, pharmacists, nurses and other health care professionals, is dedicated to the collection, monitoring, evaluation and reporting of safety information through the science of pharmacovigilance. Pharmacovigilance is the process of collecting, monitoring, researching and evaluating information from health care providers and patients to understand and prevent drug-related problems. Well before a medicine is approved by regulatory authorities and reaches people, it is rigorously assessed through carefully designed clinical trials to better understand its benefits and risks. The results of these studies are shared with regulators, such as the Food and Drug Administration (FDA) in the United States, so they can conduct their own assessment before approving the drug for wider use. We take a comprehensive and rigorous approach to pharmacovigilance designed to maintain and evaluate the product's benefit-risk profile. When important safety issues arise, we communicate them to doctors, patients and regulatory agencies. Monitoring a medicine's benefits and risks happens through various avenues. The following approaches outline our commitment to patient safety and regulatory reporting.
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 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
Off-label use
Overdose, abuse and misuse
Medication error
Suspected transmission of infectious agents
Potential adverse events associated with product complaints
Health care providers 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 (FDA) 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
The goal of the signal management process is to identify, evaluate and communicate drug safety risks as early as possible. Signal management consists of the following components: signal detection, signal prioritization, signal evaluation, risk evaluation and risk minimization (including risk communication).
A safety "signal" is a report or reports of an event with an unknown causal relationship to treatment that is recognized as worthy of further exploration and continued surveillance. Safety signals are evaluated to determine if they represent a drug-related risk, and if so, to better understand the seriousness and frequency of the risk. Safety surveillance leads to the detection and analysis of potential risk factors whose confirmation helps prevent or mitigate risk in the whole or special population.
We actively search for safety signals from numerous relevant sources of safety data by using both qualitative and quantitative methodologies. Once a signal has been detected, it is evaluated to assess the possibility of a causal association between the product and the adverse event. Safety signals are assessed and evaluated by safety teams, using all relevant sources of safety data, based on clinical and medical factors such as the potential public health impact and the strength of the signal.
Risk Management Activities
Risk management is the continuous process of identifying, characterizing and minimizing a medicine’s risks to maximize safe use by health care providers, patients and caregivers.
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.
Read more about Benefit-Risk Balance.
Regulatory Reporting
We routinely communicate safety information to regulatory authorities as a part of our expedited and periodic reporting and risk management activities.
Regulatory authorities worldwide, including the FDA, 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.