In October 2018, the SUPPORT for Patients and Communities Act was signed into law. This bipartisan legislation offered a comprehensive response to the prescription opioid abuse epidemic — its enactment marked a significant step towards advancing meaningful solutions to address this public health crisis.
HDA strongly supported the law. Specifically, the Alliance backed two key provisions to enhance the monitoring of controlled substances in the healthcare supply chain, while fostering greater coordination, information sharing and communication between the Drug Enforcement Administration (DEA) and healthcare stakeholders.
One year since the SUPPORT Act was enacted, it is important to review what the law set out to accomplish, understand the implementation and operational challenges that regulators and the industry are working through and explore how it has changed the way industry stakeholders interact.
Suspicious Order Reporting
One critical aspect of the SUPPORT Act was facilitating the development of a centralized database for suspicious orders reporting.
The DEA has taken the first steps to establish this system, with the goal of providing distributors and other industry partners the ability to more seamlessly report suspicious orders and equipping stakeholders with new tools to analyze supply chain data. The SUPPORT Act sought to advance this effort by providing a more streamlined and uniform process for submitting suspicious order reports and facilitating information sharing between federal and state regulators. Specifically, the law requires that the DEA prepare and make available information regarding suspicious orders in a state within a reasonable period after obtaining the information.
A comprehensive data management system that is operated by DEA, along with the data the agency is required to share with state and local partners, helps federal and state entities identify trends that indicate that a pharmacy or other dispenser should no longer be permitted to handle controlled substances.
Our industry is eager to continue our collaboration with DEA and state regulators so that we can be even more effective in supporting law enforcement efforts.
ARCOS Database Access
The SUPPORT Act also broadened distributor access to critical information in the DEA’s Automation of Reports and Consolidated Orders System (ARCOS), a cornerstone of HDA’s policy recommendations.
Increasing distributor access to the ARCOS database allows distributors to consider a customer’s orders in the context of their overall ARCOS-reportable shipments. While distributors are required to report all sales of Schedule I and II substances, as well as all Schedule III narcotic substances, DEA officials were previously prohibited from disclosing this information to other entities.
Broadening access to this additional information allows distributors to:
- Indicate the specific drugs that distributors should watch most carefully;
- Detect new trends and patterns; and,
- Help assess orders placed by individual practitioners, which are less frequent and harder to analyze than retail pharmacies or large healthcare entities.
The industry is eager to continue working with the DEA to make the ARCOS system more dynamic by making registrant reporting more frequent and expanding the scope of ARCOS-reportable drugs to all controlled substances. Further, HDA has flagged operational challenges that registrants have encountered with the current database, including the ability for more than one employee to access the database at any particular time.
While the SUPPORT Act represented tremendous strides in supporting coordination and collaboration between stakeholders across the healthcare industry to address the prescription opioid abuse epidemic, there is always more work to be done.
As Congress and regulators consider additional reforms to improve the collective response to the opioid crisis, HDA urges DEA to address the operational challenges related to SUPPORT Act implementation, finalize additional guidance on suspicious order reporting and to address the influx of substances, such as illegal fentanyl, that are now increasingly the cause of the epidemic.
HDA and our distributor members continue to advocate for Practical Solutions to Address Opioid Abuse and Misuse. Our industry is committed to mitigating prescription opioid abuse and misuse before it begins through investments in information technology and state-of-the-art monitoring tools to prevent diversion and initiatives to provide education and awareness to consumers. This includes HDA’s role as the founding member of Allied Against Opioid Abuse, a national education and awareness coalition working to address the prescription opioid abuse crisis in a meaningful way by educating patients about the rights, risks and responsibilities associated with opioid medicines.
Learn more about pharmaceutical distributors’ efforts to combat prescription drug abuse through the HDA website.
ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.