Product Protection
Illegitimate products are a threat to patient safety. These products, also referred to as counterfeit or fake products, are made and sold in a manner that falsely represents their authenticity, origin or effectiveness. According to the FDA, counterfeit products "may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients."1 Unfortunately, the counterfeiting business continues to grow—including with illegitimate products that are mass-marketed and sold online—and create significant patient safety risks. To help keep patient safety and product protection at the forefront, we have a well-established product protection program.
Ensuring that patients continue to benefit from safe medicines requires innovative approaches to expose and outwit counterfeiters. This is why we have a sustained, long-term commitment to address this challenging problem. Our product protection strategy includes:
Securing the integrity of Lilly medicines through legitimate supply channels.
Deterring counterfeiters of Lilly medicines through targeted investigations, Internet monitoring and legal actions.
Partnering with government, non-government organizations and trade associations to strengthen, enact and enforce anti-counterfeiting laws and raise awareness.
Serial Numbers and Serialization
Every package of Lilly medicine (bottles or cartons) is identified with a unique serial number to help confirm the medicine a patient receives is legitimate. We record the serial numbers and electronically track the movement of every bottle or carton of medicine. This process, called "serialization," is a regulatory requirement in some countries. It allows a documented chain of custody to be further established by requiring wholesalers and pharmacies to record shipments and receipts of serialized products.
Serialization not only helps secure the legitimate supply chain but also offers other potential benefits, such as automated expiration date monitoring, recording the batch number of specific medicines in a patient's electronic medical records and other tools that offer value to patients and health care providers. Because of these benefits and more, we support serialization and have invested in our packaging operations, distribution centers, and IT infrastructure to support this initiative, which includes new technology deployments on more than 30 packaging lines around the world.
The Patient's Role in Obtaining Safe Medicines
Steps patients can take to help ensure they receive safe medicines:
Buy medicine through authorized channels—for instance, make an appointment with a physician to obtain a valid prescription and fill it at a reputable, licensed pharmacy.
Check the packaging and look for anything unusual, such as changes in the shape and color of the medicine, a foreign language and/or signs of mishandling.
Report any suspicious products (e.g., potentially counterfeit, adulterated, etc.) to the pharmacy, law enforcement, health care provider and/or the manufacturer. Save the medicine so that it can be tested.
Visit our counterfeit resource page for more information on counterfeit products and how to identify a genuine Lilly medicine.
If a U.S. patient or caregiver has questions or concerns about the safety of any of their Lilly medicines, they should call 1-800-LillyRx (1-800-545-5979).