About McKesson’s Controlled Substance Monitoring Program
McKesson is 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 McKesson's anti-diversion efforts.
Our 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 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: McKesson’s CSMP team is comprised of approximately 90 individuals and includes former DOJ lawyers, DEA special agents and diversion investigators, experts from the retail pharmacy industry and the field of data analytics, state health care agency and drug task force investigators and several pharmacists.
- Thorough customer due diligence and ongoing oversight: McKesson performs detailed analysis on prospective pharmacy customers before agreeing to supply them with controlled substances, including validating both state and federal regulatory licensure. McKesson also monitors its customers’ orders of controlled substances throughout the customer relationship.
- Advanced customer purchasing analysis: Using complex and dynamic algorithms, McKesson has 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: McKesson reports 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: McKesson has been proactive in educating its customers about the importance of compliance with DEA and state agency regulations. Similarly, McKesson educates its own employees on the company’s regulatory obligations, including CSMP-specific training sessions.