Limiting Supply of Rx Opioids Fails to Achieve Goals

By Pat Anson, PNN Editor

Limiting initial prescriptions for opioid pain medication to 5-days’ supply did not reduce the rate at which patients in New Jersey transitioned to long-term opioid use, according to a new study at Rutgers University.

In 2017, New Jersey became one of the first states in the country to impose a mandatory 5-day limit on initial opioid prescriptions for acute pain. If a patient needed more, their doctor would have to write a new prescription, enroll them in a pain management program, and counsel them on the risks of opioid addiction.

At least 38 other states adopted similar laws, with the goal of reducing opioid diversion, misuse and overdose. Six years later, there is little evidence that New Jersey’s 5-day limit saved lives or accomplished any of its goals.

“This policy’s apparent failure to achieve its goals illustrates the extreme difficulty of solving healthcare problems by dictating physician behavior,” said senior author Stephen Crystal, PhD, director of the Rutgers Center for Health Services Research.

Crystal and his colleagues analyzed pharmacy data for over 130,000 New Jersey Medicaid patients who were prescribed opioids for the first time between 2014 to 2019. Their findings, recently published in the Journal of General Internal Medicine, show that new opioid prescriptions fell at a monthly rate of less than one percent (0.76%) after the 5-day limit was imposed, a decline that was about half the monthly rate (1.62%) prescriptions were falling before the limit took effect.

Doctors were writing fewer prescriptions for opioids in New Jersey and other states long before limits on the supply were even passed. Opioid prescriptions nationally are now at their lowest level in over 20 years.

“Opioid prescribing was already decreasing before this policy went into effect,” said lead author Peter Treitler, a research project manager at the Rutgers Institute for Health, Health Care Policy and Aging Research. “And so, by the time this New Jersey policy went into effect, it really didn’t change prescribing practices very much, at least in the New Jersey Medicaid population.”

An earlier study by the Rutgers research team found that medically treated overdoses in the Medicaid population tripled in New Jersey after the 5-day limit was imposed. Most of the overdoses involved illicit fentanyl and other street drugs, not prescription opioids.

Less than a third of New Jersey’s overdose survivors were even diagnosed with a chronic pain condition, suggesting the state’s focus on limiting pain medication was misdirected. Most people who overdose suffer from substance abuse disorder, depression or other mental health issues. And most overdoses involve illicit fentanyl and other street drugs, not prescribed medication.

In 2022, there were nearly 2,900 drug deaths in New Jersey – about 30% more than the number that overdosed in 2016, the year before the state’s 5-day limit became law.  

Diarrhea Drug Involved in Growing Number of Overdoses

By Pat Anson, PNN Editor

A little over a year ago, the Food and Drug Administration asked Johnson & Johnson and other drug makers to limit the number of anti-diarrhea pills they sell. FDA commissioner Scott Gottlieb, MD, said the “unprecedented and novel action” was needed because Imodium and other over-the-counter formulations of loperamide were being abused by opioid addicts.  

A few of us guffawed at the news as another example of government regulation gone amuck.

But it turns out there is cause for concern.

Researchers at Rutgers University have documented that overdoses of loperamide have been steadily increasing in number and severity, and have even resulted in some deaths.

Their study, published in the journal Clinical Toxicology, found a growing number of people addicted to opioids who are using loperamide to prevent or self-treat withdrawal symptoms. Some are even taking massive doses to get a high similar to heroin, fentanyl or oxycodone.

The New Jersey Poison Control Center has reported several fatalities or near-fatalities from loperamide in the past 12 months.

“When used appropriately, loperamide is a safe and effective treatment for diarrhea – but when misused in large doses, it is more toxic to the heart than other opioids which are classified under federal policy as controlled dangerous substances,” said senior author Diane Calello, MD, executive director of New Jersey Poison Control at Rutgers New Jersey Medical School.

“Overdose deaths occur not because patients stop breathing, as with other opioids, but due to irregular heartbeat and cardiac arrest.”

The researchers reviewed toxicology cases in a national poison control center database from 2011 to 2016, and found a 91 percent increase in loperamide overdoses during that time period.  In 2015 alone, there were 916 cases and two deaths.

Patients who misused loperamide were predominantly young Caucasian men and women. The majority used extremely high doses of loperamide, the equivalent of 50 to 100 two-milligram pills per day.

“Possible ways of restricting loperamide misuse include limiting the daily or monthly amount an individual could purchase, requiring retailers to keep personal information about customers, requiring photo identification for purchase and placing medication behind the counter,” Calello said. "Most importantly, consumers need to understand the very real danger of taking this medication in excessive doses."

Misuse of loperamide is concerning because it is readily available over-the-counter, undetectable in routine drug tests, and can be bought in large quantities online or in retail stores.

In 2017, the FDA added a warning label to loperamide products cautioning consumers not to ingest high doses. Some drug makers are now selling the anti-diarrhea pills in smaller packages and in blister packs that are harder to open.

Can Gabapentin Improve Your Sex Life?

By Pat Anson, PNN Editor

Over the years the nerve drug gabapentin (Neurontin) has been used to treat a cornucopia of chronic pain conditions, from fibromyalgia and diabetic neuropathy to hot flashes and shingles.

Gabapentin is so widely prescribed that a Pfizer executive once called the drug “the snake oil of the twentieth century” because researchers found it successful in treating just about everything they studied.

Add sexual function to the list.

In a small study, researchers at Rutgers University found that gabapentin improved sexual desire, arousal and satisfaction in 89 women with provoked vulvodynia, a chronic condition characterized by stinging, burning and itching at the entry to the vagina. Vulvar pain often occurs during intercourse, which leads to loss of interest in sex.

The improvements in desire, arousal and sexual satisfaction were small, but considered “statistically significant” in research parlance. Gabapentin did not improve lubrication or orgasm.

"Our theory was that reducing pelvic floor muscle pain might reduce vulvodynia pain overall and thus improve sexual function," said Gloria Bachmann, MD, director of the Women's Health Institute at Rutgers and lead author of the study published in the Journal of Obstetrics and Gynecology.

"We found that women with greater muscle pain responded better in terms of pain and improved arousal than those with less pain, which suggests that Gabapentin be considered for treatment in women who have significant muscle tightness and spasm in the pelvic region.”

Does this mean gabapentin is a female version of Viagra? Not necessarily, says Bachmann, who stressed that the study only focused on women with vulvodynia.

“We didn't research the question of gabapentin enhancing sexual function in all women,” Bachmann wrote in an email to PNN. “The decision to give gabapentin to a woman who reports chronic vulvar pain and sexual dysfunction would have to be made on an individual basis, depending on her medical history and the results of her physical and pelvic examination.

“From the data, it appears that women with increased muscle tenderness of the pelvic floor may be the group who benefit most from gabapentin.”

Sales of gabapentin have soared in recent years — not because it improves sexual satisfaction — but because it is seen as a safer pain reliever than opioid medication.

Patients prescribed gabapentin often complain of side effects such as mood swings, depression, dizziness, fatigue and drowsiness.  Drug abusers have also discovered that gabapentin can heighten the effects of heroin, cocaine and other illicit substances, and it is increasingly being abused.