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Fighting diversion

The Cardinal Health Suspicious Order Monitoring Program

The diversion of controlled substances has received considerable attention over the past year and is one of the top issues facing the pharmaceutical industry.
“Our nation is in the throes of an epidemic of controlled prescription drug abuse and addiction,” said Joseph A. Califano, Jr., chairman and president of The National Center on Addiction and Substance Abuse, and former U.S. Secretary of Health, Education and Welfare.
As an industry leader, Cardinal Health is committed to addressing the important challenge of diversion in a timely manner, starting with aggressively implementing new systems and procedures to enhance our controls and further guard against distribution to pharmacies engaged in diversion. These steps include:
  • Reviewing and auditing our controls that guard against distribution to pharmacies engaged in diversion;
  • Aggressively implementing enhancements to our controls, including a new Suspicious Order Monitoring process that flags and holds orders that warrant further inspection. We are working around the clock to refine this process and our systems;
  • Self-imposing restrictions on our handling of controlled substances when reviews reveal areas in our system that require additional focus;
  • Enhancing our training and education on regulatory requirements, and our role in preventing diversion with a better understanding our customers’ businesses;
  • Centralizing our Quality and Regulatory responsibilities and adding resources.

In February 2008, after a pilot period, Cardinal Health implemented an enhanced, centrally-administered Suspicious Order Monitoring Program, an automated program that monitors all controlled substance orders for all retail independent, Medicine Shoppe and Medicap pharmacy customers. Under this program, these customers are assigned a monthly threshold for each family of controlled substances, based on class of trade, size (small, medium or large) and historical purchases from Cardinal Health. If a customer attempts to place an order that would exceed its monthly threshold, the order is flagged and held for review by Cardinal Health’s Quality and Regulatory Affairs department. All subsequent orders by that customer for products in that controlled substance family will be held until the evaluation by the Quality and Regulatory Affairs team is complete.
“We believe our enhanced monitoring program for orders of controlled substances will become an important tool to combat this societal issue and enhance our compliance with regulatory requirements,” said Mark Hartman, Senior Vice President of Supply Chain Integrity.
In addition, we are improving our sales team’s knowledge of regulatory requirements and their ability to understand their customers’ business so they can help Cardinal Health prevent diversion. As part of this training, Cardinal Health’s sales consultants learn to look for “red flags” that could signal an illegitimate pharmacy engaged in diversion. These red flags include retail pharmacies with minimal or no front-end merchandise, pharmacies ordering a high percentage of controlled substances relative to non-controlled substances, and noticeable signs the pharmacy is using the Internet to solicit and fulfill orders of controlled substances. We also are training every Cardinal Health distribution and customer service center employee on diversion.