Naltrexone Shortage Disrupts Addiction Treatment

By Pat Anson, PNN Editor

An inexpensive drug used to manage chronic pain and treat substance use disorders has joined the growing list of medications that are in short supply in the United States.

The Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) both recently added naltrexone tablets to their drug shortage lists. It’s not clear what caused the shortage, but the ASHP says “there is insufficient supply for usual ordering.”  

Naltrexone is FDA-approved to treat both alcohol and opioid use disorder, and is also used off-label in low doses to treat some chronic pain conditions.

In 50mg doses, naltrexone blocks opioid receptors in the brain and reduces cravings for opiates or alcohol. But in smaller doses of 5mg or less, patients have found low-dose naltrexone (LDN) to be an effective pain reliever for interstitial cystitis, Ehlers-Danlos syndrome, fibromyalgia, and other painful conditions.

LDN advocates believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller. Because it is an opioid antagonist, naltrexone should not be taken with opioid medication.

So far, the shortage only affects 50mg naltrexone tablets. Pain patients usually obtain LDN by prescription from compounding pharmacies, which make the low dose versions in-house.

Several drug makers are reporting short supplies of 50mg tablets, including Accord Healthcare, Major, Elite Laboratories, SpecGx, Sun Pharma, Tagi Pharma, and Avet Pharmaceuticals. The companies didn’t provide the ASHP with a reason for the shortage, but said the tablets are on back order and would be released when they become available.    

The naltrexone shortage comes at an inopportune time, as more people abused alcohol and other substances during the pandemic and sought treatment. The drug that helps them stay sober is now hard to get.

"People are coming in with more cravings," Dr. Aviva Zohar, an addiction medicine provider, told Philly Voice. "Even the feeling of, 'I don't know when my medicine is coming in,' is a huge struggle. It's horrific (and) causing a lot of stress.”

To make up for the shortage, some providers are giving patients Vivitrol, an injectable, extended-release formulation of naltrexone taken once a month. A single Vivitrol injection costs about $1,700, while a month’s supply of 50mg naltrexone tablets costs about $48.

The cheap price of naltrexone may be responsible for the shortage. Most drugs in short supply are low-cost generics with slim profit margins. Some manufacturers have reduced or stopped making generics because they’re not worth the cost of production or the risk of litigation.   

Three generic opioids commonly taken for pain — immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets — have been on the ASHP shortage list for nearly a year, with no end in sight.

Illicit Drug Use by Teens Fell Significantly in 2021

By Pat Anson, PNN Editor

Substance abuse by U.S. teenagers declined significantly this year, according to the results of a new national survey that found the use of prescription opioids by adolescents fell to the lowest level in nearly two decades.

Illicit drug use by 10th graders fell by nearly 12 percent in 2021, and by about 5% for eighth and 12th graders. The findings represent the largest one-year decline in illicit drug use by teens since the Monitoring the Future survey began in 1975.

The study by University of Michigan researchers found that teenagers reported increased feelings of boredom, anxiety, depression and loneliness in 2021 – no doubt fueled by pandemic-related fears and isolation. But unlike their adult counterparts, young people overall did not increase their use of marijuana, alcohol and other drugs.

“We have never seen such dramatic decreases in drug use among teens in just a one-year period. These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” Nora Volkow, MD, Director of the National Institute on Drug Abuse, said in a statement.

“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts.”

The Monitoring the Future survey is given annually to students in eighth, 10th and 12th grades, who self-report their drug use behaviors and attitudes. The results from this year’s survey were collected from February through June 2021. Over 32,000 students enrolled in 319 public and private schools in the U.S. participated, with some taking the survey at home and others while at school.

The percentage of students who reported using any illicit drug other than marijuana within the past year decreased significantly. Among 12th graders, for example, 7.2% reported using an illicit drug in 2021, compared to 11.4% in 2020.

Decreases were also reported in the use of alcohol by 12th graders (46.5% in 2021 vs. 55.3% in 2020) and in marijuana (30.5% in 2021 vs. 35.2% in 2020).

Significant declines in use were also reported by students in 2021 for a wide range of drugs, including cocaine, heroin, hallucinogens, cigarettes and nonmedical use of amphetamines, tranquilizers, and prescription opioids.

The decline in drug use by teens is not a one-year fluke and is part of a long running trend. For example, the use of Vicodin by 12th graders has fallen by nearly 92 percent since its peak in 2003. The use of OxyContin has declined by 83% since its peak in 2005.   

MONITORING THE FUTURE SURVEY

“In addition to looking at these significant one-year declines in substance use among young people, the real benefit of the Monitoring the Future survey is our unique ability to track changes over time, and over the course of history,” said Richard Miech, PhD, who led the Monitoring the Future study at the University of Michigan. “We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people.”

Not all the news is good. The researchers found that adolescents who suffered severe stress, anxiety or depression due to the pandemic, experienced financial hardship, or whose parents used drugs were most likely to use drugs themselves.

Other studies have found that adults who regularly use recreational drugs increased their drug usage during the pandemic. A new study of alcohol sales in 16 U.S. states found a major increase in wine and liquor sales in the first few months of the pandemic, by as much as 20 to 40 percent in some states.

Another recent study found that opioid prescribing briefly increased in the early stages of the pandemic, as patients postponed corrective procedures and it became harder to obtain non-opioid therapies for pain such as massage and physical therapy. Opioid prescribing returned to previous levels after a few months.   

The CDC announced last month that the U.S. has seen over 100,000 drug deaths in the 12-month period ending in May, 2021. The record-high spike in overdoses is thought to be primarily a result of pandemic lockdowns and the continuing spread of illicit fentanyl.   

Study Finds Low Risk of Rx Opioid Abuse Among Young People

By Pat Anson, PNN Editor

The stories are heartbreaking. A young man gets a prescription for opioid pain medication and quickly becomes addicted.

“I lost everything. I had to leave school, and stop playing sports in college. I started to watch my life slip away. These drugs are addictive. One prescription can be all it takes to lose everything,” says Mike.

A mother loses her son to an overdose.

“My son… was 20 years old when he was prescribed opioids,” says Ann Marie. “It took him five days to get addicted.”

These are some of the real-life stories being told in a CDC awareness campaign that warns against the use of prescription opioids. “It only takes a little to lose a lot,” is the theme in a series of CDC videos, billboards and online ads.

The stories are sad, but the widespread belief that adolescents and young adults can quickly become addicted to prescription opioids is not accurate for the vast majority of young people, according to a large new study published in JAMA Pediatrics.

Researchers at Indiana University looked at a database of over 77,000 young people in Sweden between the ages of 13 and 29 who were prescribed opioids for the first time. They were compared to a control group that was given non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief. Both groups had no previous signs of substance abuse.

Only 4.6% of those prescribed an opioid developed a substance use disorder or other substance-related issue, such as an overdose or criminal conviction within five years of being prescribed.  That compared to 2.4% of those in the control group.

"By using several rigorous research designs, we found that there was not a huge difference -- in fact, the difference was smaller than some previous research has found,” said Patrick Quinn, PhD, an assistant professor at the IU School of Public Health-Bloomington. “But the study still shows that even a first opioid prescription may lead to some risk."

Interestingly, young people given oxycodone were at no greater risk of developing a substance abuse problem than those given “weaker” opioids such as codeine or tramadol.

Quinn says further research is needed to determine how much substance abuse risk is caused by opioid medication alone and how much is related to other issues, such as mental health, genetics and environmental factors.

"We need to have a good understanding of what those risks might be in order for patients and doctors to make informed decisions," said Quinn. "Our findings highlight the importance of screening for substance use disorders and other mental health conditions among patients with pain, including those receiving opioid therapy."

A 2018 study of young people given opioids after their wisdom teeth were removed also found the risk of long-term use low. The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist.