Where Do We Go from Here?
Seeking Answers to End America’s Opioid Crisis
The opioid epidemic, like other epidemics of drug abuse before it, does not lend itself to simple solutions. In this case, given that many of the opioids that are abused are legal, approved therapies that are prescribed by physicians, the challenge of separating good from bad is even more complex.
According to the latest public data, a significant number of patients who are prescribed opioids for chronic pain misuse them. At the same time, millions of people who are suffering from severe pain rely on opioids to maintain some quality of life.
As healthcare logistics experts, distributors play an important role in delivering medicines — including vaccines, antibiotics, cancer medicines and chronic disease treatments — to licensed healthcare professionals for the patients they serve. While our members do not manufacture, promote, prescribe or dispense opioids, we do recognize that it will require a commitment from every entity in the supply chain to end this public health emergency.
In order to move forward with solutions that address the urgent needs of patients, the broader health system and law enforcement, we first need to understand how we, as a country, arrived at this point.
Nearly two decades ago, the medical community and patient advocates identified a serious gap in care management for those suffering from chronic and acute pain. As a result, the American Pain Society introduced the concept of “pain as the 5th vital sign” in 1996 — a move grounded in the belief that assessing pain should be as standard as checking the four vital signs — body temperature, heart rate, blood pressure and respiration rate. While well-intentioned, the declaration was based on the now discredited premise that subjective pain levels could be similarly measured. In reality, pain measurement is much more complicated.
In a recent interview, leading health researcher and doctor, Atul Gawande, noted that the push to be more comprehensive in treating pain ultimately left doctors with few options.
By 2001, The Joint Commission, which is largely responsible for the accreditation of hospitals and other healthcare organizations, reinforced the “5th vital sign” concept by calling for mandated pain assessments in clinical practice. By 2006, The Centers for Medicare & Medicaid Services (CMS), the nation’s largest health insurer, had introduced new patient satisfaction surveys for hospitals that asked consumers to rate their level of care and satisfaction related to pain management. The surveys, known as Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), were instrumental in determining Medicare payments to hospitals.
The collective impact was staggering.
In fact, recent government data estimate that close to 92 million people (38 percent of the U.S. population) used prescription opioids in 2014–2015.
As the demand for opioids and controlled substances increased, the Drug Enforcement Administration (DEA), the primary federal agency responsible for regulating controlled substances, was regularly approving an ever-growing supply of opioids in the market. As part of its regulatory oversight, the DEA is required to set the annual production ceiling for opioids based on legitimate medical need, determining the amount of opioids that can be manufactured and sold in the U.S. each year. From 2004 to 2013, during the height of the crisis, the DEA consistently approved increased production of opioids, effectively adding to the supply in the market. In fact, the head of the DEA’s Office of Diversion Control, Joe Rannazzisi, approved year-over-year increases in certain opioids, including a 200 percent increase in oxycodone production.
It is not hard to see how the complex factors driving the supply and demand of opioids in the market quickly escalated. The challenge, however, for those on the frontlines of the crisis — the providers, the pharmacists and even the regulators themselves — is that this was not the kind of public health crisis of the past. This was a crisis actively facilitated by their own attempts to do the right thing and treat pain.
In some cases, the problem became even more complex after a medicine was prescribed and dispensed. For example, most individuals who abuse pain medicines obtained the prescription drug from a friend or family member. This remains common today.
In addition, one of the persistent challenges that has plagued law enforcement and the medical community is the lack of complete data to effectively monitor patients who may be “doctor-shopping” for additional pain medicines for themselves or family members. Even while improvements in electronic health records and greater use of prescription drug monitoring programs at the state level have provided some support for early intervention efforts, there is still a long way to go in making these programs accessible and usable for those prescribing and dispensing medicines, including general practitioners, dentists and specialists.
As distributors, we have experienced these data gaps first hand. For example, distributors have no access to patient or prescription information. Our members are not medical professionals and cannot substitute their judgment for that of physicians. When it comes to monitoring the amount of opioids available to patients, that responsibility rests with the DEA — a regulatory role that deserves far greater scrutiny and attention.
The DEA is the only entity that has a window into the entire movement of the most addictive prescription drugs in the U.S., from manufacturer down to pharmacy and hospital. One of the tools that the DEA uses to monitor and track controlled substances is its own Automation of Reports and Consolidated Orders System, known as the ARCOS database. Each manufacturer and distributor reports its sales of certain controlled substances, including almost all opioids, to the DEA. The agency then captures every transaction in the ARCOS database.
Each individual distributor only knows what it ships to a particular customer — not what its competitors are shipping to the same customer. Although the ARCOS data provides DEA with a complete picture of the total ordering by pharmacies, DEA has not used its “bird’s eye view” via ARCOS to alert the supply chain to pharmacies who appear to be ordering excessive quantities of opioids from multiple distributors.
In addition, DEA failed to provide clear guidance to distributors and other DEA registrants about what constitutes a “suspicious order” as that term is used in DEA’s 1974 regulation. DEA has also failed to provide any guidance about what type of information should be reported to the agency. As a result, the DEA’s own suspicious order reporting requirements have not contributed to meaningful enforcement action by the agency.
In June 2015, the Government Accountability Office reported that, “DEA communication with and guidance for its registrants are essential to help ensure that registrants take actions that prevent abuse and diversion but do not unnecessarily diminish patients’ access to controlled substances for legitimate use because of their uncertainty about how to appropriately meet their [Controlled Substances Act] roles and responsibilities.”
Recognizing that the lack of clarity and rulemaking from the DEA was beginning to impact patient access to necessary treatments, Congress took a critical step to address this growing challenge.
In 2016, the Ensuring Patient Access and Effective Drug Enforcement Act (S. 483/Public Law 114-145) passed without dissent and with bipartisan support from Congress. The law, which was negotiated transparently with the Department of Justice (DOJ), the DEA and Congress, clarified the definition of “imminent danger” where no previous standard had existed. As part of S. 483, the DEA remains fully empowered to take immediate action against a registrant if there is “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.”
Today, distributors are working closely with enforcement officials and others across the supply chain to make sure that patients with legitimate pain needs can access treatment, while also preventing abuse, misuse and diversion before it begins. Our goal is full compliance with all regulations and full cooperation with the DEA to meet our shared objectives.
Despite the progress that has been made, there has been notable mischaracterizations about the intent of this law, and as a result, some policymakers are looking to overturn it altogether. To be clear — simply repealing the law will not serve patients well. However, if it is determined that there have been any unintended consequences that undermine the DEA’s ability to take legitimate actions to prevent prescription drug abuse, DEA and DOJ should bring forward suggested changes to Congress.
That is why we support a range of comprehensive actions that can be taken right now that would make a meaningful difference in the lives of millions of Americans. Importantly, public policy must balance dual considerations: stemming the tide of abuse, while preserving access to those who would needlessly suffer without pain medicines.
Our comprehensive solutions are all measures that have broad support by the public health community to achieve these goals starting with the following:
- Congress needs to fund addiction treatment. Too many patients are denied access to treatment, including medication assisted treatment.
- We need to enhance prescription drug monitoring programs that would allow pharmacists, providers, and distributors to identify and prevent system-wide abuses.
- As a health system, we should promote appropriate clinical guidelines on opioid prescribing. Doing so would prioritize patient safety and health while also addressing their specific pain needs.
- There needs to be greater use of e-prescribing for controlled substances. Increasing e-prescribing will cut down on instances of forged prescriptions and improve utilization monitoring.
- Now is the time to reduce barriers to coverage of alternative pain treatments. We need to make sure patients have options other than opioids for their care.
- It is also important that we are providing patients with resources regarding safe use of pain treatments and options for disposing unwanted medicines. Together, these steps will reduce the risk of opioids falling into the wrong hands.
Already, we have seen growing consensus around these key steps. The recent recommendations from the President’s Commission on Combating Drug Addiction and the Opioid Crisis, coupled with those of The National Academies of Sciences, Engineering, and Medicine released this summer, offer a thoughtful and comprehensive blueprint for making sure patients get the care they need, and, equally important, that the health system evolves to prevent prolonging this epidemic into the future.
For distributors, opioids are a small fraction of the medicines we distribute, but we are committed to help implement solutions to this multifaceted problem. Lawmakers, regulators and everyone in the healthcare system have the solutions — we cannot waste any more time in making them a reality.