How We Work to Ensure People Can Safely Access Our Medicines When They Need Them
Genentech is committed to patient safety, to protecting the integrity of our medicines as they move through the supply chain, and to ensuring patients and healthcare professionals are able to access our medicines when they need them.
Medicines that are counterfeit, adulterated, diverted from approved supply chains, illegally imported, or stolen pose a significant risk to the safety of patients. Genentech employs several strategies to combat these global threats to public health.
We are committed to giving patients and healthcare professionals the information they need to safely access our medicines. It is vital that we all work together to recognize and avoid illegitimate medicines.
Why illegitimate medicines are a threat
Counterfeit, adulterated, diverted, illegally imported, and stolen medicines are neither safe nor effective. Analysis of seized counterfeit medicines has shown that they may contain too much or too little of the active ingredients, or none at all. They may even contain harmful chemicals.
Even authentic medicines that are removed from the legitimate supply chain may harm patients. These diverted, illegally imported, and in some cases stolen, medicines may not be stored or handled properly. They could be contaminated or damaged.
The safety and effectiveness of such medicines cannot be ensured.
What we're doing to help protect patient safety
Roche and Genentech employ several strategies to help ensure the integrity of our medicines as they move through the supply chain and protect patients from illegitimate medicines.
- We regularly assess our distribution networks to ensure each of our medicines is distributed through the most appropriate channel
- We work closely with suppliers and customers to secure our distribution channels
- We have built systems that allow us to imprint a unique serial number on every unit of medicine sold in the United States
- We use special packaging and printing techniques so illegitimate medicines are harder to make and easier to detect
- We closely monitor the Internet and social media channels to identify suspicious product sources
- We partner with governments to help protect patients from illegitimate medicines
- We provide patients and healthcare professionals with information to help ensure they can safely access our medicines
Our approach to distributing our medicines
As part of our commitment to patient safety and to ensuring patients and healthcare professionals have access to our medicines when they need them, we regularly assess our distribution models. We work with our authorized distributors to ensure we are using the most appropriate distribution channels for each of our medicines based on their unique characteristics.
Since many of our medicines have complex and lengthy manufacturing processes and require special storage and handling, we work to ensure our distribution models:
- Facilitate appropriate storage and handling to reduce the likelihood of product degradation
- Support our overall anti-counterfeiting efforts
- Help prevent disruption to patient access or treatment by appropriately managing supply
Identifying and tracking our medicines through the supply chain
In compliance with the Drug Quality and Security Act, Genentech has built systems that will allow us to imprint a unique serial number on every unit of medicine sold in the United States.
With these systems, distributors, pharmacies and healthcare providers can verify that they are receiving genuine product. In addition, they are able to track where the medicine has been and confirm it has been handled only by authorized parties within the legitimate supply chain.
How to help protect patients
What you can do as a healthcare professional:
- Always purchase medicines from legitimate distributors that are licensed to operate within the United States. Many of our medicines require special storage and handling, so they are only available from specific authorized distributors. View Genentech's Authorized Distributor Directory
- Be wary of new or unfamiliar distributors that offer deep discounts
- Familiarize yourself with the medications you prescribe or dispense to patients, paying specific attention to the presence of altered or unsealed containers or changes in the packaging of the medicine. Medicines where the labeling is not in English and those which lack a National Drug Code (NDC) number are likely to be counterfeits or illegal imports
- Bring any differences in the physical appearance or taste of the medicine, or unexpected side effects experienced by the patient to the attention of the FDA (1-800-FDA-1088) and Genentech (1-888-835-2555)
- Be aware that even authentic medicines that are approved for use in other countries may harm patients. These illegally imported medicines may not have been stored or handled properly. They could be contaminated or damaged
What you can instruct your patients to do:
- Familiarize themselves with the medications they use, paying specific attention to the presence of altered or unsealed containers or changes in the packaging of the product
- Bring any differences in the physical appearance or taste of the medicine, or any unexpected side effects to the attention of their Healthcare Provider and the FDA (1-800-FDA-1088)
- Always purchase medicines from legitimate pharmacies that are licensed to operate within the United States
- When purchasing medicine online, visit FDA.gov/BeSafeRx or call 1-888-463-6332 to make sure they are using a safe, legal online pharmacy
How we're partnering with government
Where possible, we support local, state and federal government efforts aimed at combating illegitimate medicines.
- We work with government and law enforcement to develop stronger laws and improve enforcement
- We support efforts to help government agencies identify and prosecute sources of counterfeit and illegally imported medicines
- We conduct visual and chemical analysis to help identify counterfeit, adulterated, and unapproved medicines
If there is a concern about authenticity or integrity of one of our medicines, we will inform health authorities and assist law enforcement agencies to evaluate the situation and determine appropriate next steps.