DEA Rules and Enforcement/
Suspicious Orders Monitoring

HDMA’s Position:
HDMA supports “suspicious orders” monitoring and reporting as an important component of addressing the serious issue of misuse and diversion of controlled substances. HDMA recognizes that increased abuse and diversion of controlled substances threaten patient safety and the security of the healthcare supply chain. Distributors – along with manufacturers, pharmacies and healthcare practitioners – share a mission and responsibility to continuously monitor, protect and enhance processes and practices to reduce diversion of controlled substances.

HDMA proactively developed the HDMA Industry Compliance Guidelines: Reporting Suspicious Orders and Preventing Diversion of Controlled Substances to support distributors’ ongoing commitment to the safe and efficient distribution of all prescription medicines, including controlled substances. These Industry Compliance Guidelines (ICG) are consistent with, and further extend, distributors’ track record of supporting and implementing initiatives to improve the safety, security and integrity of the healthcare supply chain.

Issue:
The U.S. healthcare supply chain is one of the most secure and sophisticated in the world, routinely enabling the safe and efficient delivery of medicines. At the center of this supply chain, distributors are uniquely positioned to perform due diligence to help support the security of the controlled substances they deliver to their customers. This can help ensure that those who purchase controlled substances from distributors intend to dispense them for legally acceptable purposes.

Additional Information:
HDMA has met with and received constructive feedback from the Drug Enforcement Administration (DEA) on the ICG. DEA has issued a letter to HDMA commending the industry on its effort, noting that “…companies that implement processes and procedures that effectively accomplish these objectives will do much to ensure that vital controlled substances are not diverted to illegitimate uses.” HDMA and its members will continue to take a leadership role in addressing this important issue.

For more information, refer to: http://www.healthcaredistribution.org/gov_affairs/pdf_controlled/20081113_icg.pdf and
http://www.healthcaredistribution.org/gov_affairs/pdf_controlled/20081113_dealetteronicg.pdf

The Healthcare Distribution Management Association (HDMA) is the national association representing primary healthcare distributors, the vital link between the nation’s pharmaceutical manufacturers and healthcare providers. Each business day, HDMA member companies ensure that nearly nine million prescription medicines and healthcare products are delivered safely and efficiently to nearly 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. HDMA and its members work daily to provide value and achieve cost savings, an estimated $42 billion each year to our nation’s healthcare system.