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. In addition to reporting controlled substances transactions to DEA on a regular basis, we have invested significant amounts of time and financial resources into our Controlled Substance Monitoring Program (CSMP).
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. 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 more than 70 team members in Regulatory Affairs CSMP with over 290 years of cumulative DEA and DOJ law enforcement experience. McKesson team members also include pharmacists and state and local government investigators, as well as experienced professionals from the retail pharmacy industry, pharmaceutical manufacturing and data analytics. Our CSMP team is among the strongest in the industry.
- Thorough customer due diligence and ongoing oversight: McKesson performs comprehensive analyses on prospective pharmacy customers before agreeing to supply prescription medications. This rigorous process includes the gathering of specific pharmacy information and the validation of both state and federal regulatory licensure. McKesson monitors its customers’ orders of controlled substances for potential diversion 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 what is known as the customer’s threshold that limits the quantity of controlled substances a customer may order within a specified period. The system makes ongoing refinements by analyzing various data points including customer-specific information, business trends and other relevant information.
- Regular ARCOS reporting: McKesson reports controlled substances transactions to the DEA via the DEA's automated ARCOS drug reporting system. This database allows the DEA to monitor the flow of controlled substances from the point of manufacture through commercial distribution channels to the point of sale or pharmaceutical distribution at the dispensing/retail level—hospitals, retail pharmacies, practitioners, mid-level practitioners and teaching institutions.
- Tightly controlled physical supply chain: Controlled substances are locked, monitored and stored in two DEA-regulated spaces. Schedule 2 substances go 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 packaged 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. In addition to providing its customers with literature on how to identify the warning signs of prescription opioid abuse and diversion, McKesson conducts informational meetings at medical trade shows and pharmacy association meetings to emphasize the importance of preventing diversion. Similarly, McKesson educates its own employees on the company’s regulatory obligations, including CSMP-specific training sessions at annual sales meetings.
- Ongoing state and federal collaboration efforts: McKesson is an active participant in state and federal legislative efforts around controlled substances. The company also strongly supports the Center for Disease Control’s clinical guidelines and calls for additional formal medical education on the risks of opioid use as important ways to curb clinically inappropriate prescribing, doctor-shopping and diversion.