McKesson’s Controlled Substance Monitoring Program

We are committed to maintaining — and continuously enhancing — strong programs designed to detect and prevent opioid diversion within the pharmaceutical supply chain. As part of the 2022 comprehensive opioid settlement, McKesson, along with distributors Cardinal Health and Cencora, agreed to fund the creation of a data clearinghouse, which will be used to collect and analyze data from distributors, and potentially other parties such as retail pharmacies. Access to information from the clearinghouse will serve to strengthen and enhance our anti-diversion efforts.

Our controlled substance monitoring program (CSMP) uses sophisticated algorithms designed to monitor for suspicious orders, block the shipment of controlled substances to pharmacies when certain thresholds are reached and report those blocked orders to the U.S. Drug Enforcement Administration (DEA) and state agencies as required. We are proud of our CSMP and are dedicated to ongoing enhancements. Some highlights of our CSMP include:

• Experienced CSMP team: Our CSMP team is comprised of approximately 90 individuals and includes former U.S. Department of Justice (DOJ) lawyers, DEA special agents and diversion investigators, experts from the retail pharmacy industry and the field of data analytics, state healthcare agency and drug task force investigators, and several pharmacists.
• Thorough customer due diligence and ongoing oversight: We perform detailed analysis on prospective pharmacy customers before agreeing to supply them with controlled substances, including validating both state and federal regulatory licensure. We also monitor our customers’ orders of controlled substances throughout the customer relationship.
• Advanced customer purchasing analysis: Using complex and dynamic algorithms, we have developed a robust system to help identify suspicious orders for controlled substances. This system establishes limits on the quantity of controlled substances drug types a customer may order within a specified period.
• Regular ARCOS reporting: We report controlled substances transactions of required drug types to the DEA via the DEA's automated ARCOS drug reporting system. This database allows the DEA to monitor the flow of these controlled substances from the point of manufacture through commercial distribution channels to the point of sale.
• Tightly controlled physical supply chain: Controlled substances are stored in two DEA-regulated spaces in our distribution centers. Schedule 2 substances are maintained in a high-security vault and inventory checks of controlled substances are conducted frequently. Formal background checks are given to all employees who handle all controlled substances. Controlled substances are packed under stringent security procedures and shipped using various security measures.
• Regular customer education: We have been proactive in educating customers about the importance of compliance with DEA and state agency regulations. Similarly, we educate our own employees on the company’s regulatory obligations, including CSMP-specific training sessions.