Our Commitment to Patient Safety

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.?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. 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.?

Safety Data Collection?

Safety information is collected in order to monitor and maintain the safety profile of all Lilly products. The laws governing the development, manufacturing?and marketing of products (drugs or devices) requires?collection of adverse events.?

Lilly collects?adverse event reports?from all over the world and enters the information into a common electronic database to further evaluate the safety and risks of our products.?

Lilly also monitors the impact of our products, 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).?

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. 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.?

Lilly actively searches 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?medicinal?product's risks?to?maximize?safe use by?Health Care Providers,?patients and caregivers.?

For each new medicinal product?Lilly documents,?in a Risk?Management Plan,?the important?known and important potential?risks and?the way in which these risks will be further evaluated. In addition, the Risk Management Plan outlines the risk minimization activities that will be implemented to?optimize the benefit risk profile of the drug and?increase patient safety.?This?document?is regularly reviewed and updated as additional safety data become 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 drugs, 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 drug'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 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, Lilly is required to report safety information to regulatory authorities according to specific timelines. Following approval,?Lilly?continues 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.?

Lilly is also required to promptly communicate with regulatory authorities when Lilly becomes 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

Lilly communicates safety findings to regulators, patients and/or health care providers - whether favorable or unfavorable to a Lilly product. Lilly attempts 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 products.?

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 all participate in the reporting of any adverse event that might be attributed to a medication.

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