U.S. House Passes Two Bills to Help Fight Opioid Abuse

The U.S. House of Representatives has unanimously passed two bills aimed at fighting opioid abuse and its harmful effects. One bill would reauthorize federal funding to states for prescription drug monitoring programs, while the other would create uniform standards for diagnosing and treating newborns exposed to opioids.

The prescription drug monitoring bill, called the National All Schedules Prescription Electronic Reporting Reauthorization Act (NASPER), would provide state funding to establish, implement and improve prescription drug monitoring programs, the Boston Herald reports. The programs are designed to help screen and treat people who are addicted to prescription opioids or at risk of becoming addicted, the article notes.

NASPER originally became law in 2005. It is administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). The reauthorization of NASPER would allow SAMHSA to provide grants to states for prescription drug monitoring programs, offering timely access to accurate prescription information.

The bill on diagnosing and treating newborns exposed to opioids, if passed by the Senate, would become the first federal measure to address the issue, according to the newspaper. The bill, called the Protecting Our Infants Act of 2015, is designed to reduce the problem of neonatal abstinence syndrome (NAS). Babies born with NAS undergo withdrawal from the addictive drugs their mothers took during pregnancy, such as oxycodone, morphine or hydrocodone. Symptoms can include seizures, fever, excessive crying, tremors, vomiting and diarrhea, she said. Withdrawal can take several weeks to a month.

“Right now there is no standard for treatment with NAS,” bill author Katherine Clark, U.S. Representative from Massachusetts, told the Herald. “This problem leads to long stays in the NICU and hundreds of millions in Medicaid dollars.”

In a news release, Clark noted, “Our nation‘s opioid crisis cuts across all boundaries, destroys lives, and has a devastating impact on hundreds of newborns every day.”

HHS Will Revise Regulations on Prescribing Buprenorphine for Opioid Addiction

The Department of Health and Human Services (HHS) will remove some obstacles that limit the ability of doctors to prescribe buprenorphine for patients who are addicted to heroin or prescription painkillers.

The Department of Health and Human Services (HHS) will remove some obstacles that limit the ability of doctors to prescribe buprenorphine for patients who are addicted to heroin or prescription painkillers, The Huffington Post reports.

Under current regulations, doctors who are certified to prescribe buprenorphine (sold as Suboxone) are allowed to write prescriptions for up to 30 patients initially. After one year, they can request authorization to prescribe up to a maximum of 100 patients. The HHS will develop revisions to the regulations “to provide a balance between expanding the supply of this important treatment, encouraging the use of evidence-based [medication-assisted treatment], and minimizing the risk of drug diversion,” the department said in a press release.

In areas hard hit by opioid addiction, doctors’ buprenorphine treatment slots can fill up quickly, the article notes. One recent study found buprenorphine treatment is unavailable in U.S. counties where more than 30 million people live.

Legislation proposed earlier this year by U.S. Senators Edward Markey of Massachusetts and Rand Paul of Kentucky would increase the first-year cap from 30 patients to 100, and would allow nurse practitioners and physician assistants to prescribe buprenorphine. After one year, physicians could seek to remove the cap entirely if they were certified as substance abuse treatment specialists, or if they went through an approved training.

Dr. Jeffrey Goldsmith, President of the American Society of Addiction Medicine, said in a statement that his organization “applauds the Administration for taking this step to expand access to evidence-based addiction treatment and close the gap between those who need treatment and those who receive it.”

Govt says Drugs to Treat Alcoholism don’t have to Lead to Sobriety

A regular bottle cap with a stop sign in red embossed on the top representing bandwidth cap or alcohol limits on an isolated background 

Drugmakers aiming to tackle alcoholism, a condition that affects 17 million Americans, may have a smoother path to market under a U.S. proposal to guide development of treatments.

Drugs to treat alcoholism can gain approval by proving patients using them no longer drink heavily, the Food and Drug Administration clarified Wednesday. The agency released draft guidelines for pharmaceutical companies wanting to develop alcoholism treatments that make clear that sobriety doesn’t have to be the main goal.

“The abstinence-based endpoints have often been considered an unattainable threshold in the clinical trial setting, and may be considered a hindrance to clinical development for drugs to treat alcoholism,” Eric Pahon, an FDA spokesman, said in an e-mail.

Clinical trials of the three drugs that are FDA-approved and sold for alcoholism focused on sobriety, and most required patients to be abstinent to start the studies, Pahon said. The National Institute on Alcohol Abuse and Alcoholism has said current medications are effective for some but that more treatments are needed for the broader population.

“While total abstinence from alcohol is desirable, reducing heavy drinking to within ‘low-risk’ daily limits presents an alternative goal in drug development so more treatments may be developed,” Pahon said.

Industry, researchers and addiction and recovery groups can comment on the proposal for 60 days.

Current Drugs

The drugs sold for alcoholism are: naltrexone, which limits the release of pleasure-inducing dopamine caused by alcohol; acamprosate, which can be used by those who have quit drinking to stay sober; and disulfiram, known as Antabuse, which creates unpleasant side effects in people who drink.

Alcoholism is identified as continued drinking despite physical and psychosocial consequences, according to the FDA proposal. Ultimately, an alcoholism drug should improve those consequences, which can be done through sobriety or a reduction in the use of alcohol, the agency said.

The NIAAA defines heavy drinking as a man consuming more than four standard drinks in a day or a woman taking more than three. A standard drink in the U.S. contains 14 grams of alcohol, which could be in the form of a shot of hard liquor, a 12-ounce bottle of beer or a 5-ounce glass of wine.

Selincro, made by H. Lundbeck A/S and Biotie Therapies Oyj, is the first and only drug approved in the European Union for reducing alcohol use, according to Bloomberg Intelligence analyst Grace Guo.

Arbaclofen from Reckitt Benckiser Group Plc and XenoPort Inc., TKM-ALDH2 from Tekmira Pharmaceuticals Corp. and Alnylam Pharmaceuticals Inc. and ADX71441 from Addex Therapeutics Ltd. are in early development to treat alcohol-use disorder, Guo said.

The NIAAA said in September it would start a clinical trial in the first half of this year on Santa Clara, California-based XenoPort’s restless-leg syndrome medicine Horizant as a treatment for alcohol use disorder.

Binge Drinking isn’t just for College Kids Anymore

Black line art illustration of a drunk man with a beverage.

The typical picture of a binge drinker may look as much like a middle-age man working long hours as it does a college fraternity boy partying late at night.
Doctors are increasingly focusing on that older population after years of placing a higher priority on experimenting adolescents and young alcoholics. Evidence is emerging that high-pressure jobs push millions of people toward binge drinking, and deaths from alcohol abuse escalate as people get older.
A new study from 14 countries published in the British Medical Journal found that people who work more than 48 hours a week are more likely to drink to excess — defined as 14 drinks a week for women and more than 21 for men. And the U.S. Centers for Disease Control and Prevention estimated in a report last week that six people die daily from alcohol poisoning, mainly those ages 35 to 65.
“Drinking is a fast and easy way to shake off work. That’s where the problem comes,” said Cassandra Okechukwu, an assistant professor at Harvard School of Public Health in Boston. “We have defined it and call it risky alcohol use. We aren’t paying as much attention to that as we pay to the definition of alcoholism. We need to pay more attention.”
Numerous studies show regular drinking, as long as it doesn’t turn into a binge, is healthy, especially for the heart. While red wine is generally touted for its health benefits, beer and liquor have also been shown to ward off various medical conditions. Doctors warn against starting to drink or consuming more for the potential health benefits, and point out that excessive consumption can lead to a raft of ailments ranging from cancer to sudden death.
Poisoning Deaths
The numbers on excessive drinking don’t make sense right away, and they puzzle researchers. Young people are still more likely to binge drink — defined as five or more drinks in a few hours for men and four or more for women. People 65 and older who binge drink do it more frequently than other age groups.
The people dying of alcohol poisoning, however, are middle-aged. Three in four are men, the CDC found.
In a 2012 survey by the agency, 71 percent of Americans said they’d had a drink in the past year, while about 56 percent had done so in the past month. There are a small and growing number of people who drink excessively at one sitting, and it’s not clear why, said George Koob, director of the National Institute on Alcohol Abuse and Alcoholism.
“We’re seeing a higher number of drinks per individual,” he said. “What’s growing is the intensity of drinking in a single bout. We are concerned about that. We haven’t figured out how to address it.”
Longer Hours
Working long hours may exacerbate the problem. The study in the BMJ found that people who worked 49 to 54 hours a week and 55 hours a week had an increased propensity of 13 percent and 12 percent, respectively, for risky drinking.
A glass of wine or a beer or two after the work is a common way to take the edge off after a tough day at the office. The problem is when it morphs into something more. For people who already drink, stress at work or home can lead to an even greater reliance on alcohol, said Sandra Brown, a psychology and psychiatry professor who’s vice chancellor for research at the University of California at San Diego.
“People develop tolerance when they drink regularly,” Brown said. “They don’t realize they are drinking more and put themselves in a more dangerous situation.”
Nationwide, alcohol is responsible for 88,000 deaths a year, making it the third-leading cause of preventable death in the U.S.
Liver, Pancreas
For people in their 30s, 40s and 50s, the effects of alcohol can linger much longer than just a nasty hangover. It taxes the liver and the pancreas, and can lead directly to depression.
The damage from drinking can accumulate over a lifetime, with new risk factors appearing in middle age, said Joseph Lee, a medical director at the Hazelden Betty Ford Foundation. And while most people who have trouble drinking show signs when they’re young, that’s not always the case, he said.
“Just because you went through your college frat days unscathed, it doesn’t mean you have a free pass for the rest of your life,” Lee said. “We see a lot of people who always had a risk for addiction that didn’t manifest until something happened, like a promotion to a high-pressure job, a divorce or a death in the family.”
For middle-aged drinkers, the beer pong and drinking games they played when they were younger can simply carry over as they age and try to hold onto their “adolescent joys,” Koob said. They need to realize their brains and bodies have changed, however, and can’t handle it the same.
“When you are young, the pleasurable effects of alcohol are more rewarding and the hangovers are less,” Koob said. “As you get older, there is a switch over where the hangovers become more excruciating and the pleasurable effects become less. That’s when the demons come rushing out of the bottle.”

CVS Will Sell Naloxone Without Prescription in 14 States

CVS announced it will add 12 states to its program to sell the opioid overdose antidote naloxone without a prescription, bringing the total to 14. The company already sells naloxone without a prescription in Massachusetts and Rhode Island.

“Over 44,000 people die from accidental drug overdoses every year in the United States and most of those deaths are from opioids, including controlled substance pain medication and illegal drugs such as heroin,” Tom Davis, Vice President of Pharmacy Professional Practices at CVS, said in a statement. “Naloxone is a safe and effective antidote to opioid overdoses and by providing access to this medication in our pharmacies without a prescription in more states, we can help save lives.”

The states included in Wednesday’s announcement are Arkansas, California, Minnesota, Mississippi, Montana, New Jersey, North Dakota, Pennsylvania, South Carolina, Tennessee, Utah and Wisconsin. Pharmacy boards in these states can make decisions about offering naloxone without a prescription.

“While all 7,800 CVS/pharmacy stores nationwide can continue to order and dispense naloxone when a prescription is presented, we support expanding naloxone availability without a prescription and are reviewing opportunities to do so in other states,” Davis said.

Use of naloxone kits resulted in almost 27,000 drug overdose reversals between 1996 and 2014, according to a government study published earlier this year. Providing naloxone kits to laypersons reduces overdose deaths, is safe, and is cost-effective, the researchers noted.

“U.S. and international health organizations recommend providing naloxone kits to laypersons who might witness an opioid overdose; to patients in substance use treatment programs; to persons leaving prison and jail; and as a component of responsible opioid prescribing,” the researchers wrote in the Morbidity and Mortality Weekly Report.

US Opioid Epidemic Fueled by Prescribing Practices

The United States is facing the worst “man-made epidemic” of opioid abuse in the history of modern medicine, and it is the direct result of poor research and outdated teaching practices, according to a leading pain expert.

“There’s been over 200,000 deaths from prescription opioids and many more hundreds of thousands of overdose admissions, and millions are addicted or dependent on prescription opioids, and while some patients don’t meet the classic definition of opioid use disorder, as many as 30% of patients who are sitting across from you in your office have opioid use disorder or are severely dependent,” Gary Franklin, MD, MPH, vice president of Physicians for Responsible Opioid Prescribing, said during a Webinar sponsored by the Centers for Disease Control and Prevention’s Clinician Outreach and Communication Activity (COCA).

“So this is an extremely serious epidemic, and while I know that taking care of these patients is not an easy thing to do, we need to reduce overdose deaths and admissions, and we have ways to reverse trends which we all need to embrace.”

The most important step toward reversing the epidemic of prescription opioid abuse is to stop prescribing opioids for the wrong indications.

Recent reports have consistently concluded that there are insufficient data on the long-term effectiveness of prescription opioids to support their use in the treatment of chronic pain, but there is clear evidence of a dose-dependent risk for serious harms.

The biggest triggers to the initiation and perpetuation of prescription opioid abuse comes from their use for the treatment of nonspecific musculoskeletal disorders, especially chronic low back pain, headaches, and disorders such as fibromyalgia.

Although there is no proven benefit for their use in these disorders, “people with these indications are on chronic opioids, and they have become disabled, and they are spilling over into social security and disability systems,” Dr Franklin said.

In recognition of this problem, the American Academy of Neurology and a number of states, including Washington, have produced guidelines that advise that in general, opioids should not be routinely used for the treatment of musculoskeletal conditions, headache, or fibromyalgia.

“Not only is there no evidence to support their use in these conditions, there is quite a bit of evidence against doing so, and these are probably the most routine patients we have who are on chronic opioids and who have become dependent and addicted to them in our country,” Dr Franklin said.

Indeed, in a 2008 study conducted by Dr Franklin and colleagues (Spine. 2008;33:199-204), results showed that 14% of workers who sustained a low back injury were disabled at 1 year and that receiving opioids for at least 7 days at a cumulative dose of 150 mg morphine equivalent dose (MED) doubled the risk of being on disability 1 year later, after adjusting for baseline reported pain, function, and injury severity.

Dosing Guidance

The issue of the MED and the risk for an overdose event, either hospitalization or death, is also extremely important in community efforts to reduce the risk for opioid-induced harm.

Recent evidence suggests that there is a dramatic increase in death when opioids are administered at a dose of 100 mg MED ― “but the risk of overdose is also two- to fivefold higher when that same opioid MED runs between 50 and 99 mg MED,” Dr Franklin said.

“So you need to be paying a lot more attention to lower doses of opioids and never go over 100 mg MED.”

This is particularly important for patients who are receiving a combination of an opioid and either a benzodiazepine or another sedative-hypnotic or muscle relaxants, all of which can dramatically add to the risk for opioid harm, even at lower doses of opioids, he added.

Dr Franklin also cautioned that the intermittent use of opioids does not spare patients from overdose and that in doses lower than 100 mg MED, many patients enrolled in Washington State’s Medicaid program have been admitted for opioid overdose even when they were not using opioids on a long-term basis.

Comprehensive guidelines from Washington State on prescribing opioids make it very clear that physicians must proceed with caution when initiating opioid therapy to improve function and pain in patients with chronic pain or when transitioning to the long-term use of opioids.

Before initiating treatment with any opioid, patients should be screened for current or past substance abuse as well as depression.

Clinically Meaningful Improvement

“When you are tracking pain and function, you also have to make sure there is clinically meaningful improvement in both pain and function,” said Dr Franklin.

In Washington State, a clinically meaningful improvement in pain and function means at least a 30% improvement in both.

Physicians also need to track pain and function at every visit so that they can better judge how well the opioid may be working — or not.

Sleep disturbances are common in patients with chronic pain, and physicians need to help patients with various measures to improve sleep hygiene or prescribe a tricyclic antidepressant, which will help with underlying depression as well sleep disturbances, he added.

There are also many nonpharmacologic alternatives to long-term opioid use that are strongly supported by evidence.

Graded exercise is well established as a good treatment modality for chronic pain, as are cognitive-behavioral therapy (CBT), mindfulness-based stress reduction techniques, and various forms of meditation and yoga.

If patients who are currently receiving opioids are scheduled for an elective operation, they should resume their preoperative dose of opioids 6 weeks after surgery.

If they are not receiving opioids at the time of the procedure, patients should be off all opioids within 6 weeks.

And if patients are not improving on opioid therapy, “the ongoing risk from continued treatment outweighs the benefit,” Dr Franklin said.

“And opioids in these patients should be tapered to zero.”

The new guidelines indicate that when tapering opioids, the dose should be reduced by 10% a week, with or without accompanying CBT, inpatient detoxification, or treatment in a pain clinic.

“These patients are losing their lives in our system, and we need to do everything possible to reverse this epidemic and saves lives,” Dr Franklin said.

“And I am glad to say our efforts are paying off, as we have seen a 30% sustained decline in death from overdose in Washington State and a dramatic decline in the proportion of injured workers on chronic opioids as well.”