June 30, 2019
60 Minutes has consistently presented misleading, inaccurate accounts of pharmaceutical distributors’ role in the opioid abuse crisis. The latest episode perpetuates a number of myths around the opioid epidemic and does a disservice to any effort to truly understand and address its root causes — notably, the shift in medical practice to treat pain more aggressively and the role of illegal drugs in most overdose deaths.
To understand the country’s opioid abuse epidemic and the solutions needed to reduce diversion and misuse of prescription opioids, we need to separate fact from fiction.
The misuse and abuse of prescription opioids is a complex public health challenge that requires a collaborative and systemic response that engages all stakeholders.
Those bringing lawsuits would be better served addressing the root causes of the opioid abuse epidemic, rather than trying to redirect blame through litigation. As logistics experts, distributors do not manufacture, promote, prescribe or dispense opioids.
While the plaintiffs’ attorneys are irresponsibly focused on hypothetical litigation scenarios that will do little to fundamentally address our nation’s opioid epidemic, distributors continue to focus on both our essential role in providing supply chain partners and their patients with the medicines they need and also continue to work with key stakeholders to find solutions to prescription opioid abuse and misuse.
The Drug Enforcement Administration (DEA) as well as state regulatory entities (e.g. state boards of pharmacy) oversee and regulate the pharmaceutical supply chain. Each entity in the supply chain that handles these medicines, including prescribers, dispensers, manufacturers and distributors, is a registrant of the DEA and licensed by states.
Additionally, the DEA regulates the volume and supply of opioid controlled substances in the market.
Pharmaceutical distributors are required to report sales of Schedule II and III opioid-based medications to the DEA’s Automation of Reports and Consolidated Orders System (ARCOS). This system collects data around the flow of opioid controlled substances, from the point of manufacturing through commercial distribution to delivery to DEA- and state-licensed pharmacies, hospitals and other healthcare providers.
Distributors have submitted thousands of suspicious orders to the DEA and state boards of pharmacy. In addition to reporting every opioid distribution to DEA real time through ARCOS, if distributors identify certain suspicious ordering or prescribing patterns at any point, there is a reporting system in place to alert the DEA and state boards and report possible drug diversion or other illegal activity. For more information about suspicious order reporting, click here.
Distributors have developed integrated security and monitoring systems to ensure that the medicines they handle and transport are authentic and legitimate; safely secured throughout delivery to avoid tampering or diversion; and properly received by licensed pharmacies and healthcare providers across the country.
Through an extensive verification process, distributors can ensure that pharmacists and providers are licensed by state pharmacy boards and have completed mandatory registration with the DEA.
If distributors identify certain suspicious ordering or prescribing patterns at any point, there is a reporting system in place to alert the DEA and report possible drug diversion — and distributors have submitted thousands of suspicious orders to the DEA and state regulators.
60 Minutes and the plaintiffs’ lawyers suing distributors refer to the DEA’s ARCOS database but fail to report that distributors have historically not had access to the most critical information in the database — the amount of medicine a pharmacy or hospital receives from all distributors.
For years, HDA and its pharmaceutical distributor members have consistently asked for greater insight and transparency related to ARCOS data as a necessary step toward improving monitoring and coordination with DEA. Only recently has DEA, in step with the Department of Justice (DOJ), outlined new guidelines to make ARCOS data more accessible and transparent to distributors and other entities in the supply chain.
HDA and its pharmaceutical distributor members supported federal legislation to help strengthen and improve communication between the industry and DEA, as well as other state and federal regulators and law enforcement. This legislation, enacted into law in 2018, is designed to enhance data sharing and increase coordination between distributors and the DEA. The goal of Congress was to expand distributors’ access to critical information including DEA’s ARCOS database, helping individual companies have a better understanding of the full scope of the distributions received by licensed pharmacies and other healthcare facilities across the country.
This legislation also called for the establishment a centralized suspicious orders database, which will provide a more streamlined and uniform reporting mechanism for submitting suspicious order reports to the DEA. A comprehensive data management system that is operated by the DEA and accessible to DEA’s state and local partners will help 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 act on these new opportunities to collaborate with the DEA and state regulators, so that we can be even more effective in supporting law enforcement efforts. Additionally, we have put forward a number of policy solutions that will meaningfully address the public health crisis.
The reporting fails to account for the dramatic change in the practice of medicine that resulted in year-over-year increases in the number of opioid prescriptions written by doctors. The effect of that change in the practice of medicine was an increase in DEA’s annual quota for the production of opioids.
The DEA also sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids manufactured each year. During the height of the opioid epidemic, the DEA, in response to the change in the practice of medicine that resulted in increasing numbers of opioid prescriptions, approved year-over-year increases in opioid production. In fact, between 1993 and 2015, the DEA approved a 39-fold increase of oxycodone and a 12-fold increase of hydrocodone to meet what it believed were legitimate medical needs based on the year-over-year increases in the numbers of prescriptions doctors were writing for opioids.
Distributors support the DOJ’s calls to evaluate potential changes to the annual production quotas for opioids.
HDA and its members are committed to stopping opioid abuse and misuse before it occurs through investments in information technology and state-of-the-art monitoring tools to prevent diversion, initiatives to provide education and awareness to consumers, and practical policy solutions to address opioid abuse and misuse.
Distributors’ primary role is logistics, providing safe and timely delivery of prescription medicines. Distributors do not manufacture, prescribe or promote opioids to doctors or patients, nor are distributors in the position to police the practice of medicine. The ultimate responsibility and enforcement power in controlling the supply and demand of opioids in the market rests with the DEA.
Getting a medicine starts with a prescription, and distributors simply provide the logistics support to help make sure medicines prescribed by your healthcare provider gets to your hospital, pharmacy or other healthcare facility safely, securely and reliably.
Distributors continuously monitor, protect and enhance the security of the pharmaceutical supply chain to ensure medicines are properly and securely handled, stored and delivered.
As healthcare logistics experts, we deliver medications ordered by pharmacies based on prescriptions written by licensed physicians or healthcare providers. We review every order and only fulfill requests that come from licensed and approved pharmacists and providers. We also deploy state-of-the-art security procedures that ensure that every order is safely and securely delivered.
Healthcare distribution represents a high-volume, low-profit margin business. Pharmaceutical distributors work with large numbers of pharmaceutical manufacturers to safely, securely and reliably deliver their medicines to licensed pharmacies, hospitals or long-term care facilities.
The distributors’ role is important because it streamlines the pharmaceutical supply chain while also achieving cost savings for our nation’s healthcare system. Recent analysis from Berkeley Research Group (BRG) shows that HDA members move medicines from manufacturers to healthcare providers for less than one percent of the cost of brand medicines.
Plaintiff attorneys have attempted to draw a comparison between the opioid-related lawsuits and the litigation against the tobacco industry. The comparison is absurd on its face. Tobacco was an unregulated product with no redeeming quality from a health perspective. By contrast, opioids serve an important medical need and are used to treat patients suffering from a range of conditions, including cancer and post-surgical care. Furthermore, prescription opioids are approved by the Food and Drug Administration and are among the most heavily regulated products in the country, with overlapping layers of state and federal oversight.
Additionally, distributors play an important role in the pharmaceutical supply chain, delivering a wide variety of medicines to pharmacies and healthcare facilities and creating efficiencies for the healthcare system overall. If you were to bankrupt these companies as the plaintiffs suggested on 60 Minutes, then the entire healthcare system and ultimately patient care would be negatively affected.
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 nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.