First ever indictment against Chinese manufacturers of opioids

The Justice Department recently took unprecedented steps to combat the opioid crisis in the United States by filing indictments against Chinese manufacturers of fentanyl and other opioid substances. The department has labeled these manufacturers as Consolidate Priority Organization Targets (CPOTS), which it believes are the “most significant drug trafficking threats in the world,” because they have elements of the most productive money laundering and drug trafficking organizations.

The investigations of the Chinese manufacturers revealed a new and disturbing facet of the opioid crisis in America—fentanyl and fentanyl analogues are coming into the United States in numerous ways, including highly pure shipments of fentanyl from factories in China directly to U.S. customers who purchase it on the Internet. Unwary or inexperienced users often have no idea that they are ingesting fentanyl until it is too late. The Centers for Disease Control estimates that over 20,000 Americans were killed by fentanyl and fentanyl analogues in 2016, and the number is rising at an exponential rate.

The indictments, filed against two Chinese nationalists and a handful of American citizens which are alleged to have conspired with the nationalists, claimed that the nationals operated chemical plants and labs in China and sold fentanyl to United States citizens via the internet. The indictment against one manufacturer further alleged that the chemical structure of the drugs had been modified in order to evade prosecution. If convicted, the nationalists could face prison time and significant monetary penalties.

CDC urges providers to consider risks of opioid treatments

Although opioid prescriptions declined for five years since a peak in 2010, the Centers for Disease Control and Prevention (CDC) found that the highest-prescribing counties dispensed six times more opioids per resident in 2015. The CDC urges providers to consider evidence-based guidance for opioid prescriptions and weigh the risks and benefits of such treatment with patients.

Demographics

According to the CDC’s Vital Signs report, a breakdown of the number of opioids prescribed per person in 2015 by county revealed considerable variation, with clusters of high-rate counties located in various places across the country. The CDC believes that the variation reveals inconsistencies among providers who prescribe opioids. Counties with higher prescribing tended to have small cities or large towns, more white residents, more dentists and primary care providers, a higher rate of uninsurance or unemployment, and more people with a chronic condition like diabetes or arthritis, or a disability.

Issues

The CDC identified three specific issues with high prescribing that pose risks for patients. In 2015, there were enough opioids prescribed to keep every American constantly medicated for three weeks. This level of prescription may indicate that providers need to consider more non-opioid treatment options, such as physical therapy and other medications, and only use opioids when the benefits are most likely to outweigh the risks.

Even for those on low doses, taking an opioid for more than three months increases a patient’s risk of addiction 15 fold. When treating acute pain, opioids should only be prescribed for the expected duration of severe pain. In addition, a dose of 50 morphine milligram equivalents (MMEs) or more per day doubles a patient’s risk of overdose death. The CDC believes that the average daily MME per prescription remains too high.

Resources

The CDC recommends continuously balancing risks and benefits throughout opioid treatment, from the starting prescription through dosage increases. The agency’s Guideline for Prescribing Opioids for Chronic Pain outlines when a provider should initiate or continue opioids for chronic pain, treatment options, and risks and harms of opioid use.

Trump administration disperses $485M in opioid fight

The Trump Administration announced $485 million in grants to assist states with combating opioid addiction. The funding is the first part in two rounds of opioid-focused state grants provided for by the 21st Century Cures Act (Cures Act) (P.L. 114-255). The funds will be administered by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The funding will be received by all 50 states, the District of Columbia, American Samoa, Micronesia, Northern Marianas, Palau, Puerto Rico, and the Virgin Islands. The allocation of the $485 million was determined according to need. The largest grants were awarded to states with the highest rates of overdose deaths and unmet need for opioid addiction treatment. Some of the highest awarded states include: California ($44,749,771), Florida ($27,150,403), Ohio ($26,060,502), Pennsylvania ($26,507,559), and Texas ($27,362,357).

In a letter to governors, HHS Secretary Price called the opioid crisis alarming, noting that “opioids were responsible for over 33,000 deaths in 2015.” He also admonished governors that “we cannot continue to lose our nation’s citizens to addiction.” Price cautioned that “while I am releasing the funding for the first year immediately, my intention for the second year is to develop funding allocations and policies that are the most clinically sound, effective and efficient.”

Highlight on Massachusetts: Seeing the opioid crisis differently

Massachusetts, like many states, has an opioid epidemic. The number of individuals experiencing opioid-related overdose and death in Massachusetts was four-times higher in 2015 than it was in 2000. The crisis isn’t new, but state health officials have taken a new step to raise awareness and disseminate information concerning the epidemic. State health officials released an interactive website designed to display information graphically so that it will have a more profound impact.

Chapter 55

As part of an effort to combat the epidemic, Chapter 55 of the Acts of 2015 was signed into law—a piece of state legislation that permitted an analysis of government datasets to achieve better understanding of the opioid crisis. The Massachusetts Department of Public Health (DPH) led the data analysis, which culminated in a report: The Chapter 55 Report. The report identified a number of trends as well as analyzed key factors impacting the crisis, including: costs, growth of addiction, prescriptions, illegal drugs, and demographics.

Crisis

The crisis in Massachusetts is above the national average, due in part to a sharp rise in opioid-related deaths in the last two years. For example, 2014 was the first year since 1999 that the fatal overdose rate in Massachusetts was more than double the national average. Additionally, while, in 2000, about one third of admissions to substance abuse treatment centers were opioid-related, by 2015, opioid-related issues accounted for more than half of admissions. A similar pattern was documented by the Health Policy Commission in terms of emergency department visits and hospitalizations.

Deaths

The website offers novel displays of opioid-related death data, including state maps that demonstrate by county across three blocks of time—2001 to 2005, 2006 to 2010, and 2011 to 2015—the number of individuals, per 100,000 people, who died as the result of opioids. By scrolling over a county, the maps demonstrate the five-year death rate for that county and the death rate per 100,000 people. Some counties have undergone massive increases in their opioid-related death rate. For example, from 2001 to 2005, Eastham County had a five-year death count of zero and a death rate per 100,000 people of zero. In stark contrast, from 2011 to 2015, Eastham County had a five-year death count of nine and a death rate per 100,000 people of 36.3.

Heroin

Another set of maps demonstrates the percentage of patients in treatment who listed heroin as their primary substance of abuse. The four separate maps correspond to the frequency of that designation, by county, in 2000, 2005, 2010, and 2015. In 2000, only about 20 counties were identified as having over 46 percent  of substance abuse treatment patients indicating heroin as their primary substance of abuse—a designation shown as green on the map. The 2000 map is merely speckled with green. By 2015, however, the map is almost entirely green, with the majority of counties marked as having over 46 percent of patients indicating heroin as their primary substance of abuse.

Transition

The website also uses graphics to display the trends related to the transition between prescriptions and illegal opioids.  The graphics demonstrate, based upon specific drugs—heroin, fentanyl, prescription opioids, methadone—the likelihood that an individual had a legal opioid one, three, or six months before death.  For example, in Massachusetts, between 2013 and 2014, 867 individuals who died of an opioid-related overdose had a positive toxicology screen for heroin. Sixty-five percent of those individuals had a legal opioid prescription between 2011 and 2014.

Conclusion

The website offers information about addressing substance abuse and gives examples of steps that can still be taken to expand treatment options, tailor treatment and prevention efforts, and develop post-incarceration treatment plans. The Massachusetts DPH aims to continue to use data as a tool to obtain insight and solutions for the problem.  If nothing else, the agency’s graphic depiction of the Chapter 55 Report is successful in that it is a stark and dramatic way to say: something is wrong.