To protect the safety of patients, regulatory agencies and pharmaceutical manufacturers assess the safety of products (i.e., pre- and post-marketed medications) on an ongoing basis. This process depends on the reporting of adverse events to identify and minimize potential risks, including extremely rare events that would not have been identified in clinical trials. Often, infrequent side effects can be observed only after a medication has been approved and used across a large, diverse patient population for an extended period of time.
As required by law, we collect adverse-event reports from all over the world—from sources including healthcare providers, patients, medical literature, and regulatory agencies—as part of our continuous monitoring and evaluation of all Lilly products. We continually assess safety information, and we share new findings and emerging concerns openly with regulators and healthcare providers 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.
When safety-surveillance activities lead to a change in the benefit/risk balance of a product, we communicate these changes to healthcare providers and patients through:
- Updates to the investigator brochure and/or informed-consent document for clinical trials,
- The revision of labeling (package inserts) for marketed products, and
- The provision of safety information to physicians via letter, to consumers via patient package inserts and medication guides, and to the public via publications, press releases, and other means.
EDUCATING PATIENTS ABOUT THE BENEFIT/RISK BALANCE OF PHARMACEUTICALS
When a regulatory agency approves a medicine, it has concluded that, for the overall public, the medication’s benefits outweigh its risks for the conditions outlined in the product label. Still, accurate and up-to-date safety information is critical for healthcare providers and patients to best decide how and for whom a medication should be used. Lilly’s role in risk management centers on helping healthcare providers make informed decisions about how and when a medicine should be used, how to monitor the patient for potential adverse events, and how to communicate to the patient about proper use of the medication.
In January 2010, Lilly launched our Patient Safety website to educate key external stakeholders (including patients and doctors) about the role that the pharmaceutical industry and the FDA play in ensuring medicines are safe and effective.