Ethical and Safe Products
Product Safety

Bristol Myers Squibb is committed to providing products and services that meet or exceed customer expectations and regulatory requirements and deliver superior value and quality. We monitor and evaluate safety data associated with our marketed medicines and our investigational drugs in clinical trials. To ensure we meet our worldwide safety reporting requirements, employees must promptly report any potential or actual adverse events or other events associated with our products when they become aware of them. Adverse or other events include any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

We embed technology and systems to sense and protect our brands from counterfeiting, tampering, theft or diversion. In addition, employees are required to promptly report possible instances by notifying Corporate Security and Quality and Compliance representatives and business unit senior management within 24 hours.

SASB - HC-BP-260a.1

Supply Chain Digitization (previously known as Global Serialization) ensures that Bristol Myers Squibb is compliant with “track and trace” regulations. “Serialization” simply requires adding a serial number to data already on a medicine’s packaging. Doing so enables each saleable unit of a product to be tracked throughout the entire supply chain. All Bristol Myers Squibb medicines in serialized markets are now required to have a unique identifier in the packaging.

We start the serialization process with a unique 2D data matrix being placed on a carton. As the product moves through the supply chain, this code is scanned by wholesalers, distributors and dispensers to confirm that the product is legitimate.

The second part of pharma serialization involves the exchange of this serialized data between nodes in the supply chain in accordance with specific and various market regulations. The ability to encode more information on packaging (including unit-level identification), combined with experience in exchanging data with internal and external partners, offers valuable new capabilities for us. Nearly all of our internal and external packaging lines are serialization capable.

Moving forward, we will focus on improving supply chain visibility and delivering innovation in the customer experience. By 2023, the U.S. is expected to have a system that will allow the gathering of transactional data across the supply chain for each unique identifier, establishing full end-to-end visibility in the event a suspect product is detected. These capabilities, originally developed to meet government regulations aimed at protecting patient safety, may be leveraged for a customer-specific experience and delivery of patient-specific medicines.

SASB - HC-BP-250a.4

All takeback of BMS medications from patients is managed by the Pharmaceutical Product Stewardship Work Group (PPSWG), a membership association founded in 2014 to organize and facilitate cooperative efforts among pharmaceutical producers to address the disposal of unwanted, unused or expired medicines from households. The PPSWG coordinates these efforts through the MED-Project, a stewardship organization that implements and operates mandated household unwanted medicine and sharps takeback programs. Due to regulations, pharmaceutical products are not sorted after collection, making it difficult for Bristol Myers Squibb to calculate the amount of unused BMS product collected from U.S. patients. Learn more in BMS’ household-generated sharps management plan.

We also collaborate with numerous organizations on facilitating takeback in our industry, including educational initiatives, myoldmeds.com and medsdisposal.eu, which work to improve awareness of existing pharmaceutical disposal options. These websites create an easy way for patients to identify a location near them to dispose of unwanted, unused or expired medicines from their households and highlight the importance of patients following the instructions provided with medicines, including labeling information and medication guides, as well as how to securely store and dispose of unwanted, unused or expired medicines.

SASB - HC-BP-260a.2

We take counterfeit medicines very seriously and do all we can to build safety into our medicines and into the supply chain. We evaluate potential risks across the value chain and apply scientific and technical controls to try to reduce the ability to produce counterfeits, but also to enhance our ability to detect counterfeits. This requires that we work with multiple global authorities, including the U.S. Department of Homeland Security and Customs and Border Protection, to share information and collaborate on the detection and removal of counterfeits and unsafe medicines from the market.

We also have robust drug safety and surveillance programs and support global reporting of any suspected counterfeits. Interwoven into the reporting or detection programs are time-bound processes that initiate product recall and subsequent testing as appropriate and in concert with the regulatory authorities.

Learn more:
Our position on key issues

Partnerships to advance product safety
We partner with a wide variety of organizations to further product safety globally
and across our supply chain, including:

Buying Prescription Medicine Online: A Consumer Safety Guide Cargo Theft Counterfeit Drugs and Travel Learn About Counterfeit Drugs Around the Globe Pharmaceutical Supply Chain Initiative The Partnership for Safe Medicines The Pharmaceutical Security Institute USFDA: Counterfeit Medicine USFDA: Drug Supply Chain Integrity

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Ethical and Safe Products Product Safety

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Ethical and Safe Products
Product Safety