Counterfeit medicines are a threat to patient safety. Counterfeit drugs may include products:
Without active ingredients,
With incorrect quantities of active ingredients,
Correct quantities of active ingredients but with fake packaging,
With high levels of impurities and contaminants,
That are illegal copies of an original product
Counterfeit drugs have caused serious injury – and even death – around the globe. Dangerous, toxic ingredients have been found in counterfeit medications. People who take these drugs may ingest arsenic, boric acid, brick dust, cement powder, chalk dust, floor polish, leaded road paint, nickel, shoe polish and talcum powder.
Unfortunately, the counterfeiting business is growing. Global criminal networks product and distribute counterfeits in all major therapeutic areas, in all major geographies, and in more than 100 countries. Counterfeit drug sales generated an estimated $200 billion in illicit profits in one year alone.
The Internet contributes to the problem, creating an anonymous, global marketplace for the counterfeit drug trade. Nearly 96% of online drug sellers are not legitimate. And 62% of medicines purchased online are fake or substandard. Additionally, per a recent study, 31% of newly reviewed websites offered controlled substances such as opioids, and nearly 100% offered products without a valid prescription. Further, 94% offered drugs that were not FDA approved.
The vast majority of online pharmacy websites do not require a valid prescription to sell a medicine; others issue an on-the-spot “prescription” after patients answer a simple questionnaire. This setting provides the perfect haven for counterfeiters to sell illegitimate medicines.
Any pharmacy that says it orders or ships prescription products from a foreign country is operating illegally. These pharmacies are not operating under appropriate regulatory oversight, and therefore, no authority can guarantee the authenticity of the medication they sell.
No single entity can stop counterfeiting. That's why Lilly is partnering with global government regulatory and law enforcement agencies, other pharmaceutical companies and other parties who want to ensure that patients receive only genuine medicines that are made, distributed and sold by reputable manufacturers and pharmacies that care as much as we do about patient safety. Each of us plays an important role in the fight against counterfeit medicines.
Patient’s Role in Anti-Counterfeiting
Buying through established channels – for instance, obtaining a prescription from an in-person meeting with a physician and filling it at a reputable pharmacy – is the first step to help ensure patients obtain safe products.
Patients should check the packaging and look for any changes in the shape and color of the medicine.
If patients suspect a counterfeit or tampered product, they should report it to their pharmacy, health care provider and the manufacturer. Patients should also save the medicine so that it can be tested. If you have additional questions or concerns about the safety of any of their Lilly medicines, please call 1-800-LillyRx.
Lilly’s Role in Anti-Counterfeiting
Ensuring that patients can continue to benefit from safe medicines requires innovative approaches to expose and outwit counterfeiters. Lilly has made a sustained, long-term commitment to address this challenging problem. Our efforts include:
Securing the integrity of Lilly products through the legitimate supply channels.
Deterring major counterfeiters of Lilly products 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.
Patient safety is the driving force behind Lilly’s global anti-counterfeiting efforts. Lilly is deeply engaged in efforts to combat counterfeiters. We are a founder and board member of the Alliance for Safe Online Pharmacies (ASOP), a broad coalition of stakeholders with an interest in protecting patient safety and ensuring patients have access to safe and legitimate online pharmacies.
Lilly worked collaboratively with European stakeholders (pharmacists, wholesalers and parallel distributors) on the successful implementation of the Falsified Medicines Directive to help ensure counterfeit medicines cannot be dispensed to patients through legitimate supply chain channels in the European Union.
In the U.S., Lilly actively advocated for the Drug Quality and Security Act, federal legislation that established a uniform federal standard for coding, serializing and tracking pharmaceutical products.
Lilly also supported the National Association of Boards of Pharmacy (NABP) as it launched the “.pharmacy” top-level domain name as a home for safe and legal online pharmacies.
In addition, Lilly supports law enforcement in the criminal prosecution of counterfeiters around the world, through gathering evidence, testing samples, testifying in court and filing civil actions.
To stop counterfeit medicines, we must combine the efforts of governments, patient organizations, medical networks, manufacturers (brand owners) and others. We will succeed in stopping this threat only if we act together – and act globally.
Government’s Role in Anti-Counterfeiting
Lilly is partnering with governments, non-government organizations and trade associations to strengthen, enact and enforce anti-counterfeiting laws, and to raise awareness of this important public health issue. Lilly encourages organizations and governmental regulatory agencies to speak up about the counterfeit drug threats they encounter. Lilly also is joining forces with non-governmental organizations such as the Alliance for Safe Online Pharmacies, International Federation of Pharmaceutical Manufacturers and Associations, Pharmaceutical Research and Manufacturers of America , European Federation of Pharmaceutical Industries and Associations and others to alert patients, health care providers and government officials about alarming global trends in counterfeit medicine distribution. Increasing awareness is critical to combating the growing technological sophistication and capabilities of today’s counterfeiters.
Serialization is the unique identification of individual packs (cartons or bottles) of medications. As each batch of finished product is packaged, a globally unique code is assigned and physically marked on the packaging in the form of a two-dimensional code known as a datamatrix. At the conclusion of the packaging order, the serial numbers are electronically linked to the product’s batch number in Lilly’s global SAP environment.
To track and trace the movement of individual packs, serial numbers can be recorded and electronically linked to outbound deliveries to customers. This is a regulatory requirement in some countries, where a documented chain of custody is 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 offers other potential benefits. These include automated checking of expiry dates, a way to record 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.
Lilly had made a considerable investment in its 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. Additionally, Lilly is working closely with other organizations and regulatory bodies to advocate for unified serialization standards globally. These efforts will help ensure that doctors, pharmacists and patients can be confident in the medicines they prescribe, dispense and receive.