Two years ago, Congress approved bipartisan legislation to address the rapidly growing opioid epidemic. Yet today, that legislation — S.483: Ensuring Patient Access and Effective Drug Enforcement Act — is the subject of two upcoming media reports which mischaracterize the intent and outcome of the legislation.
For nearly a decade prior to President Barack Obama’s signing of S. 483, and as the opioid epidemic escalated, communication and collaboration between the DEA and its registrants (including distributors, manufacturers and pharmacists) was virtually non-existent.
Despite numerous industry requests for more clarity, the DEA did little to provide adequate guidance on the roles and responsibilities under the Controlled Substances Act. In 2015, the Government Accountability Office (GAO) published a report that highlighted many ways the DEA was not appropriately communicating its expectations to the industry, which posed risks for patient safety and health:
“For example, 36 of 55 distributors commented that more communication or information from, or interactions with, DEA would be helpful. DEA officials indicated that they do not believe there is a need for more registrant guidance or communication. Federal internal control standards call for adequate communication with stakeholders. Without more registrant awareness of DEA resources and adequate guidance and communication from DEA, registrants may not fully understand or meet their CSA roles and responsibilities.”
In response to the GAO report, a bipartisan group in Congress introduced the Ensuring Patient Access and Effective Drug Enforcement Act. Under the law:
- The DEA remains fully empowered to take quick action against a DEA registrant (i.e., prescribing physician, pharmacist, distributor, manufacturer) if there is “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur….”
- In circumstances where there is a lack of regulatory clarity around a DEA registrant’s roles and responsibilities, a corrective action plan provides a registrant 30 days to adequately address the DEA’s concerns.
- HHS is required to submit, by April 2017, a report to Congress on the opioid epidemic. To date, the report has not been developed.
Importantly, the bill had broad, bipartisan support from Democratic and Republican Congressional leaders, supply chain partners and patient groups. Notably, the Department of Justice and the DEA agreed to the legislative language.
Better coordination and collaboration between the DEA and its registrants is critical. Individual distributors are only aware of the product it ships and not what other distributors may be sending to the same location. Without more complete information from the DEA, each distributor operates in a silo. As the primary regulator of controlled substances, DEA not only sets the annual quotas based on “legitimate medical need” for the amount of opioids that can be manufactured each year (which increased significantly year over year until 2016), but is the only entity to know the full scope of opioids that are being distributed and dispensed across the country at any given time.
More Work to be Done
While the law provides a much-needed framework for a more effective and collaborative partnership between the DEA and its registrants, the Ensuring Patient Access and Effective Drug Enforcement Act only addresses a small part of the challenge that we face. To truly address the opioid epidemic, there is much more work to be done.
For example, there is broad recognition that addressing the overprescribing of opioids needs to be at the top of the list. Leading public health experts and researchers have consistently found that the prevalence of opioid abuse and misuse was tied to the overprescribing of opioids, particularly when it came to treatment of chronic pain and even some acute conditions, such as dental procedures. Leading providers, like Dr. Atul Gawande, point to changes in medical practices nearly twenty years ago when pain was dubbed “the fifth vital sign.”
Dr. Francis Collins, head of the National Institutes of Health, emphasized this point in a recent interview with the Washington Post. “…It was the medical profession, I'm sorry to say, in the late 1990s that greatly began to increase the prescription of opioids because of a sense that as long as somebody actually was in pain, they couldn't get addicted. Well, we found out that's absolutely wrong."
This was a pivotal moment that led to a shift in the way many doctors’ prescribed pain medication. With the benefit of hindsight, today’s medical community acknowledges that the medications that were liberally prescribed for decades carry significant addiction risk.
Treating pain is a complex, challenging health issue. Incomplete media reporting that ignores the real challenges and root causes of the opioid epidemic — and shifts blame to pharmaceutical distributors — are dangerous and irresponsible. The reality is that pharmaceutical distributors, as logistics experts, deliver ALL medicines, including controlled substances, to licensed pharmacists and healthcare providers. They do not manufacture, market, prescribe, or dispense medicines — including opioids. They also have no mechanism to drive the demand of opioids among patients. That’s why using our industry as a scapegoat for the opioid epidemic misrepresents how the supply chain actually works and is regulated.
Now is the time for urgent action to advance common-sense solutions to this crisis. As an industry, we are supportive of various initiatives by public health organizations to reduce clinically inappropriate opioid prescribing, increase disposal of unused medicine, and improve patient, pharmacist and physician education — and will do our part to contribute to those efforts.
For more information on our efforts to support and protect the public health, click here.
- HDA Statement on 60 Minutes/Washington Post Coverage on Distributors, Opioid Epidemic
- Fact Sheet: Correcting the Record: What The Washington Post Won’t Say About Distributors and Regulation of Controlled Substances in the Supply Chain
- Open Letter: A Crisis of Misinformation
ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 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.