Opioids in America: 6 things to know about the evolution of an epidemic

The misuse of opiates — heroin, oxycodone, hydrocodone, codeine, morphine and fentanyl, among others — represents one of the leading causes of accidental death in the U.S.

Addiction rates have increased among most demographics during the past decade. Nearly 13,000 people in the U.S. died from heroin overdoses in 2015, a roughly 2,000-case increase from the previous year, according to the CDC. CDC officials said the number of opioid-related deaths in 2015 averaged more than 30,000 people, narrowly surpassing the total number of gun-related homicides that occurred during the same year.

Here are six things to know about the opioid epidemic.

1. Many Americans first encounter opioids as a treatment for severe pain. In 2000, the Joint Commission introduced pain management standards to help medical professionals effectively treat patients' pain. According to the 2000 report, pain was to be regarded as the "fifth vital sign" — a symptom clinicians should be aware of and aim to mitigate as much as possible. While the standards didn't explicitly advocate for opioid use, they acknowledged that opioids proved to be an effective treatment for chronic pain.

Over time, clinicians began to raise concern over medical professionals' increasing reliance on opioids for pain management. In 2004, the Joint Commission stripped the designation of pain as the fifth vital sign from its accreditation standards manual and issued new pain management standards in January that included the monitoring of opioid prescriptions and the promotion of nonpharmacologic pain treatment options.

In May 2016, the CDC released guidelines aimed to assist medical officials in prescribing opioids to treat chronic pain. The recommendations were based off of an updated 2014 systemic review of scientific evidence discussing the effectiveness and risk of opioid prescriptions, and a supplemental review of the benefits and harms, values and preferences and cost of such drugs. The agency also consulted with experts within the medical community and the public.

However, the proposed suggestions were met with criticism from a number of prominent national medical organizations. The American Medical Association said in a statement that though the organization was "largely supportive of the guidelines," the suggestions may have unintended consequences, such as encouraging "access and insurance coverage limitation for nonpharmacologic treatments" and expressed concern about "the potential side effects … strict dosage and duration limits [may have] on patients." The American Cancer Society Cancer Action Network took issue with the fact the guidelines failed to address opioid prescribing as it relates to cancer care, arguing cancer patients also "experience severe pain that limits their quality of life."

2. OxyContin. A recent working paper authored by researchers at the RAND Corp., and the Philadelphia-based University of Pennsylvania Wharton School of Business suggests the release of OxyContin directly coincided with, and potentially spurred, the increase in fatal heroin overdoses between 1999 and 2010.

The drug, released by Purdue Pharma during the mid-1990s, was designed to provide extended pain relief over the course of 12 hours. However, drug users discovered that crushing the pill before injecting or snorting it could allow them to bypass the time release mechanism. Following the drug's release, Purdue Pharma was met with a slew of criticism for failing to warn users of the drug's potential addictive qualities. In 2007, the drug manufacturer pled guilty to misleading consumers about OxyContin's addictive nature and was ordered to pay $600 million in fines.

In 2010, Purdue Pharma released a second version of the pill that was allegedly "harder to crush," according to The Washington Post. The reformulation became the first drug to receive the "abuse-deterrent" designation from the Food and Drug Administration because of its ability to "deter" abuse, even if it cannot fully prevent it. The researchers posit the spike in heroin deaths began "precisely the year following [the] reformulation [of OxyContin]." States with the highest initial rates of OxyContin abuse experienced the largest increases in heroin deaths, researchers said.

3. Fentanyl. In recent years, fentanyl — a synthetic opioid 50 times more powerful than morphine — has quickly become a leading contributor to the opioid epidemic. Though introduced to the medical industry in the 1960s, officials did not name the drug as a significant driver of the epidemic until 2013, a New York Times report suggests.

Health experts believe the drug's increasing prominence in the market stems from the ease with which fentanyl can be mixed with other opioids, such as heroin, to increase its potency. Lewis Nelson, MD, a medical toxicologist and emergency physician at NYU School of Medicine in New York City, told Forbes mere micrograms of fentanyl can mimic the effect that milligrams of other opioids induce. "This difference in fentanyl's potency is critical — it takes very little to have the same effect as other opioids. The reason so many are dying is because the dose is relatively uncontrolled with street fentanyl, and small excesses can lead to overdose," Dr. Nelson said.

According to a 2016 report released by the U.S. Drug Enforcement Agency, law enforcement agencies recovered 167 kilograms of illicit fentanyl across the nation in 2015. The report claimed illicit fentanyl is often manufactured in foreign countries and smuggled into the U.S.

Fentanyl can appear in several forms, including pressed into pills and sold as counterfeit oxycodone prescriptions. "You can't move. When you inject [fentanyl], it hits before you're even done giving the shot," a fentanyl user who chose to remain anonymous told The New York Times. "That's why so many people get caught with the needle still hanging out of their arm. It's bam! To your brain."

4. Medical industry's perspective. To curb the effects of the epidemic, some physicians argue prescriptions should be scaled back; others suggest the cost of untreated chronic pain is too high for patients to bear, necessitating the use of opioids. The discrepancy has created a "civil war" within the medical community as to how to address the issue.

A highly publicized example of the ongoing debate came in December 2015 after the New England Journal of Medicine published an article by Jane Ballantyne, MD, and Mark Sullivan, MD. The article proposed that physicians should aim to provide patients with strategies to cope with the pain rather than provide medication to decrease pain intensity. Some readers claimed the authors lacked compassion for patients and their needs, while others lauded their approach to reduce patients' dependency on medication.

Despite differing in their stance on when prescription opioids may be permissible to prescribe, there is a relative consensus among professionals that the medical community and lawmakers must step in to help those affected by the epidemic. Boston Medical Center is using a recently received $25 million donation to fund an opioid abuse treatment center. Legislators in California introduced a bill in March that would issue a one-cent-per-milligram surcharge on prescription opioids. The revenue from the tax would go toward funding drug addiction, treatment and rehabilitation programs across the state.

5. Naloxone. Naloxone, often referred to by the brand name Narcan, is a medication that works as an opioid antagonist by blocking opioid receptors in the brain from receiving stimulation. The drug is available in several forms, including as an auto-injectable and nasal spray. Hospitals and health systems have partnered with law enforcement and various health departments across the nation to teach and supply officials with the antidote to use in emergency situations. In April, New Mexico became the first state to mandate that law enforcement officers carry the drug with them when out in the field.

However, increasing reliance on the medication and an uptick in the number of opioid-related overdoses during the past several years has caused the price of naloxone to skyrocket. In 2005, the price of Hospira's generic version of the antidote rose from less than $1 per milliliter vial to more than $15 by 2014, according to a CNBC report. Similarly, the list price for two doses of Evzio, a naloxone auto-injector delivery device manufactured by Kaleo Pharma, rose nearly 550 percent to $3,750 since the product was first marketed in 2014, according to the report. The pricing trajectory has drawn comparisons to insulin injectors and Mylan's EpiPen, which continues to be the only FDA-approved delivery device available to treat patients experiencing anaphylactic shock.

6. State and federal government response. Despite campaigning on the platform that he will work to address the opioid epidemic sweeping the nation, President Donald Trump has yet to introduce federal legislation targeting the issue.

HHS Secretary Tom Price, MD, said previous legislation signed into effect under the Obama administration will provide $485 million in grants to combat the epidemic, and that the Trump administration will follow those grants with an additional "half a million [dollar] commitment" in 2018, according to Dr. Price. More than 20 federal lawmakers have also called on President Trump to allocate an additional $9.3 billion in federal funding to help halt the epidemic.

Some state governments, however, are instituting a different approach. Two counties in West Virginia have filed lawsuits against drug wholesalers and pharmaceutical retailers, as well as against multiple organizations within the pharmaceutical supply chain, to recoup finances the counties spent to address opioid abuse in their areas. The Cherokee Nation, similarly, filed a lawsuit against three leading pharmaceutical companies — AmerisourceBergen Drug Co., Cardinal Health and McKesson Corp. — as well as pharmacy retailers CVS, Walgreens and Wal-Mart, for allegedly flooding their community with highly addictive painkillers. Most recently, Ohio Attorney General Mike DeWine filed a lawsuit against the industry's largest drug manufacturers, accusing the companies of engaging in fraudulent and deceptive marketing practices and allegedly fueling opioid addiction in the state.

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