Tag: addiction treatment

New Dosage Strength Of Opioid Addiction Drug Approved By FDA

The FDA commissioner noted that the approval will expand access for patients and reduce drug development costs.

The U.S. Food and Drug Administration (FDA) approved a new dosage strength for a maintenance drug for the treatment of opioid addiction.

Cassipa, which is a sublingual (applied under the tongue) film that combines the opioid treatment drug buprenorphine and the opioid overdose reversal drug naloxone, will now be available in a 16 milligrams/4 milligrams dosage, and according to FDA Commissioner Scott Gottlieb, should be used in conjunction with counseling and therapy.

The new dosage strength is approved by the FDA in both brand name and generic versions, and in various strengths.

The approval underscores the agency’s emphasis on greater development of and access to medication-assisted treatment (MAT) for substance use disorder. The full range of MAT is a key element of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, and was the focus of guidelines issued to drug manufacturers for evaluating the effectiveness of new or existing MAT products.

In a statement issued in April 2018, Gottlieb described the FDA-approved MAT drugs—methadone, buprenorphine and naltrexone—as “safe and effective in combination with counseling and psychosocial support to stabilize brain chemistry [and] reduce or block the euphoric effects of opioids.”

The FDA has also cited statistics from the Substance Abuse and Mental Health Services Administration (SAMHSA), which found that patients using MAT for opioid dependency have reduced their chance of overdose death by half.

In addition to its suggested efficacy for opioid use disorder, Gottlieb noted that newer treatment options like the increased dosage strength for Cassipa will not only “broaden access for patients,” but may also “reduce drug development costs, so products may be offered at a lower price to patients” via the agency’s “streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine.”

This approach is the abbreviated 505(b)(2) pathway under the Federal Food, Drug and Cosmetic Act, which allows manufacturers to use the FDA’s findings regarding the safety of their product to grant approval.

The FDA is advising that Cassipa should be used in conjunction with a complete treatment plan that includes counseling and other support, and should only be used after the patient is introduced to the drug and stabilized up to a dose of 16 mg of buprenorphine using another marketed product. Additionally, Cassipa can only be prescribed by Drug Addiction Treatment Act-certified prescribers.

View the original article at thefix.com

17 September 2018
Senate Considers Opioid Crisis Bill, But Critics Say It Isn’t Enough

“A little drama for little substance,” said one addiction advocate familiar with the bill.

The Senate is preparing to pass a bill to address the opioid epidemic, but critics say that the legislation skirts around the most important — and contentious — issues that could help change the way that opioid addiction is handled.

“A little drama for little substance,” one addiction advocate familiar with the bill told STAT News.

The bill addresses treatment and prevention, according to a copy reviewed by STAT. There are provisions that will better equip law enforcement to detect fentanyl being shipped in the mail system and that will help develop a have a better disposal system for unused opioids, in order to reduce the amount of opioids on the street. In addition, there are provisions to expand treatment by easing access to medication-assisted treatment with buprenorphine, training doctors to screen for substance use disorder and increasing access to treatment via telemedicine.

However, treatment advocates say that the bill will do little to affect how treatment is delivered because it does not take enough bold steps to change the status quo.

“Overdose rates continue to rise, and our response is still falling short given the mammoth size of the problem,” said Andrew Kessler, the founder of Slingshot Solutions, a behavioral health consulting group. “We are in the early phases of our response to this epidemic, and I can only hope that this bill is the first of many we can pass.”

One big change that has a chance of passing is repealing the IMD exclusion, which prevents treatment centers with more than 16 beds from receiving Medicaid payments.

An opioid response bill passed in June repealed the exclusion, but only for treatment for opioid and cocaine addiction.

Despite the fact that the current Senate bill doesn’t mention the exclusion, Ohio Senator Rob Portman said that he is hopeful a repeal will be included in the final bill. He said that leadership has agreed on the repeal, but could not gather enough votes.

“We’ve worked out an agreement that I think most leadership on both sides agree with, but we weren’t able to get the signoff from everybody,” Portman said.

The Senate bill also includes a call for the development of best practices in disclosing a patient’s history with substance abuse. The House bill would allow a history of addiction treatment to be disclosed without a patient’s expressed permission, but Senate lawmakers are concerned that this could lead to breaches of privacy and stigma.

With the coming November election, many lawmakers are hesitant to vote on anything controversial, meaning that the bill may languish. However, some Senators are pushing to make sure it gets a vote this month.

“As soon as both parties agree, we can have a roll call vote next week. When we do that, it’ll get virtually unanimous support, and then we’ll work with the House and put the bills together,” said Sen. Lamar Alexander (R-Tenn.), who has spearheaded the bill.

View the original article at thefix.com

6 September 2018
Inside California's Massive Addiction Treatment Overhaul

Medi-Cal recipients will now have expanded access to addiction treatment.

The California Health Care Foundation released a report on August 3 this year outlining the state’s new approach for residents using Medi-Cal and seeking substance abuse treatment options.

California is the first state in the United States to use the new health care system structure, in a five-year pilot program authorized by the federal Centers for Medicare and Medicaid Services.

Medi-Cal is California’s low-income health insurance, and previously covered very few addiction treatment services. In addition, patients had no database to explore what treatment plan would be best for their needs.

A new system, called Drug Medi-Cal Organized Delivery, ensures that counties who participate can offer many more services to people struggling with addiction, as well as coordinate, manage and evaluate quality of care in those services.

A huge leap forward is the increase in payment to treatment providers, allowing more access to various types of treatment. In California there are over 10 million people using Medi-Cal health insurance.

“It’s been an enormous change,” William Harris, assistant regional manager of Riverside County’s substance abuse treatment program, told California Health Report. “We’re operating under an entirely new paradigm and are able to expand services and be more inclusive and better meet the needs of the population of our county.”

Nineteen California counties have adopted the program with 21 more scheduled to do so in upcoming months. These counties represent 97% of the state’s Medi-Cal population.

The California Health Care Foundation study looked at the four 2017 adopters of the new Medi-Cal system, including Riverside, Los Angeles, Marin and Santa Clara counties. Co-author Molly Brassil told California Health Report that the Medi-Cal program report was a way to access the strengths and weaknesses of the system.

“This report sort of tells the story to other counties that, yes, (the implementation) is not without challenges and it isn’t easy, but it’s doable,” she affirmed. “I was taken aback by how positive all the counties were given the tremendous lift it is for all of them.”

The newly offered services have induced a flood of user demand. In Riverside there was a large volume of calls after launching a hotline to screen members for substance use disorders and refer them for possible treatment. Since the inception of the program in 2017, Riverside has had to triple its staff to meet growing demand.

The new system takes current research and implements it into their model, by treating substance use disorder like any other medical illness.

Brassil noted to California Health Report that the goal is for substance abuse screening and treatment to become a mainstream part of all health care.

The Medi-Cal program is working, and Brassil would like to see it put in place for good. “We’ve heard from folks overall that this is the right thing to do. It’s hard, but that doesn’t mean it’s not worth doing.”

View the original article at thefix.com

31 August 2018
How Racism Brought About Acupuncture For Addiction Treatment In The US

Community leaders in the Bronx in the ’70s were wary of using methadone to treat addiction so they opted to take a holistic approach.

A distrust in the profit-driven pharmaceutical establishment formed the roots of acupuncture for addiction treatment in the United States, according to a report in The Atlantic.

According to writer Olga Khazan, it all began with community activists in the Bronx. During the 1970s, the northernmost New York City borough faced a daunting drug problem with few resources to fight it.

Community activists the Young Lords and the Black Panthers, and their supporters, rallied for the creation of an in-patient drug treatment program at Lincoln Hospital, and won.

About 200 people were in line at the opening of Lincoln Detox, but according to Khazan, the community, including detox staffers, were not convinced that methadone was the answer to the Bronx’s drug problem.

As Samuel Roberts, professor of history and sociomedical sciences at Columbia University, explained, this sentiment was rooted in a distrust for the establishment disseminating the pharmaceutical drug. “Methadone was highly regulated—it’s run by white doctors, in white coats, in white hospitals,” Roberts told Khazan.

This fueled a growing interest in acupuncture—a staple of Traditional Chinese Medicine that involves inserting thin needles at strategic points to balance the body’s flow of energy—because it did not require medication and facilitated the idea of community members treating one another.

Some traveled to Montreal to receive training in practicing acupuncture, which they would bring back to Lincoln Detox. (Tupac’s stepfather Mutulu Shakur was among these people. He’d later found his own organization, the Black Acupuncture Advisory Association of North America.)

Lincoln Detox would later drop methadone altogether, opting instead to offer acupuncture treatment and other holistic treatment instead.

Bob Duggan, who founded Penn North, a recovery center in Baltimore, learned about acupuncture for addiction recovery from Lincoln Detox, and brought it to Baltimore. Daily acupuncture is a mandatory part of the center’s recovery program.

There are currently more than 600 recovery programs in the United States that use acupuncture, according to the National Acupuncture Detoxification Association (NADA).

While there’s no clear consensus among the research community in the efficacy of acupuncture for addiction recovery, Sara Bursac, executive director of NADA, says the practice is effective as part of a multi-faceted program that includes counseling and 12-step meetings.

View the original article at thefix.com

10 August 2018
Alaska Congressman Shares Story of Granddaughter's Addiction

During a public forum, US Rep Don Young revealed that his 27-year-old granddaughter battles addiction and has relapsed three times.

U.S. Representative Don Young (R-Alaska) gave voice to the emotional toll taken on family and friends of individuals with substance dependency when he spoke about his granddaughter’s struggle for sobriety at a public forum on August 1, 2018.

Speaking at an event on Alaska Native issues in Juneau, Young—who has a history of blunt and occasionally inflammatory statements on various social and political topics—spoke movingly about the sadness and frustration he has experienced while trying to help his granddaughter. He also noted that expanded access to treatment facilities is a requirement to assist those who hope to break the cycle of dependency.

Young, who at 85 is the longest currently serving member of the House of Representatives, visited the Juneau forum as part of an extended stay in southeast Alaska during the House’s August recess. He was queried on a variety of subjects by members of the audience, including increased funding for the Indian Child Welfare Act and the National Rifle Association, which he supported.

The focus turned to drug and alcohol dependency when Juneau resident Logan Henkins spoke about his battle with substance abuse, from which he said that he had been sober for 60 days. Young told the assembled audience that he was personally acquainted with the struggle through his 27-year-old granddaughter, whom he said had relapsed three times.

“The challenge we have is when she goes to rehab,” said Young. “Where does she go when she gets out?” He noted that his granddaughter will experience weeks of sobriety before “she falls back to those that she ran with before. That is what drives me crazy,” he said.

Young opined that stronger punishment of drug dealers, whom he told the audience were “killing your kids,” would offer a solution, but also said that access to treatment is crucial for helping individuals like his granddaughter. “Support forces, halfway houses, some place you can stay away… we ought to have that,” he stated.

Young, who is seeking re-election this year, also touched on substance dependency when he was asked to support Savanna’s Act, a bill that would increase support for tribal governments to investigate missing and murdered Native American women. Young, who said that he would consider the legislation, added that the reason for these incidents is “mostly” related to drugs and alcohol, and added that tribal leaders needed to address the issue within their own ranks.

“We have a responsibility within our own tribes,” he said. This prompted a response from Richard Peterson, president of the Central Council of Tlingit and Haida Indian Tribes of Alaska, who said, “We’re in this together, and we have to remember that. I remind you, congressman, sovereignty doesn’t mean that we’re alone.”

View the original article at thefix.com

10 August 2018
Sober Cleveland Police Officer Gives Back To Local Recovery Community

After a lengthy battle with alcoholism, a Cleveland detective got sober and inspired those around him to change their lives.

Today, Cleveland police detective Chris Gibbons puts the bad guys in jail cells, but in 1992 he was on the other side of the law, sitting in a jail cell soaking wet and shivering after being brought in for public intoxication. After seven years of battling alcoholism, Gibbons had hit rock bottom.

“How did the son of a policeman end up here?” Gibbons said to News 5 Cleveland.

After that night, Gibbons was determined to turn his life around. He became a police officer just like his father and grandfather had been. And he inspired his sister, Erin Becker, to start her own path to sobriety.

“Most of my struggle was internal,” Becker said. “I just got to a point of hopelessness.”

Gibbons has been sober for 26 years and Becker has been in recovery for 17 years. Now, the siblings run a sober house together, helping women start their lives in recovery. Becker co-founded the Edna House, which has grown over the years, helping woman with limited means get sober.

“It started with three women. Now we have 40 women,” Becker said. “The women that come in, they see that the people that are here helping them, the staff, the woman that runs the program, we’re all in recovery. That catches their attention. Nothing is asked of them here. When they come to Edna and the only thing that is asked is, ‘Do you have a willingness to work on your own recovery?’ They know something is different.”

Gibbons is on the board of directors for Edna House and volunteers with men’s recovery programs though the area. He enjoys seeing the transformation of the 300 women who have graduated from Edna House.

“They’re almost unrecognizable when they’re done. They look so much better. They feel so much better,” Gibbons said. “You can actually see the happiness and the glow on their face whereas when they came in they were totally broken.”

In addition, Gibbons serves on the Cleveland Police Department’s Employee Assistance Unit, which helps officers navigate traumatic and stressful situations.

“It gives you a little credibility,” Gibbons said. “When I approach an officer or someone in the community who is struggling with it, I can say I’ve been there and I have a good life today because of my decision not to drink.”

Gibbons has prompted other law enforcement officials to become involved in the recovery community and sponsor events. Some of the people in recovery have even followed Gibbons’ footsteps and started a law enforcement career.

“Several dispatchers who actually went through this house are sober to this day because of their involvement here,” Becker said.

View the original article at thefix.com

3 August 2018
Overdose Risks During Pregnancy Examined In New Study

The study revealed the need for better addiction recovery support for pregnant women with substance use disorder.

A new study has found that the risk of overdose drops in pregnant women but increases after giving birth.

The study, published in the journal Obstetrics & Gynecology, looked at women giving birth in Massachusetts. In doing so, researchers found a greater number of women with opioid use disorder than had been found in other states.

Researchers also discovered that during pregnancy, opioid overdose events went down, the third trimester resulting in the lowest amount. However, after birth, that number rose and became especially high from 6 to 12 months after delivery.

“Our findings suggest we need to develop extended and long-term services to support women and families impacted by substance use disorder,” said Davida Schiff, a pediatrician at MassGeneral Hospital for Children and the lead author of the paper, according to Science Daily. “We need additional research to determine the best ways to improve retention in treatment and adherence to medication therapy after delivery, and we need to enhance our medical and public health infrastructure to provide support to women in achieving long-term recovery.”

In many states, opioid overdoses have been “major contributors to pregnancy-associated deaths.” In pregnant women, estimates of opioid use disorder range from .4 to .8%, and up to 2% in all women that fall into the reproductive age category.

Pregnancy can drive a woman to seek treatment, Science Daily notes. Often, such treatment includes therapy and potentially medications like methadone or buprenorphine.

Researchers chose to study a Department of Public Health dataset, which included nearly 178,000 deliveries of an infant 20 or more gestational weeks to Massachusetts women between Jan. 1, 2012 and Sept. 30, 2014. Of those, 4,154 women were found to have likelihood of opioid use disorder within a year before giving birth.

Additionally, of the women in the dataset, 184 experienced what researchers refer to as an opioid overdose event in the year preceding or following delivery. Such an event means the woman faced admission to a heath care facility for an overdose or death as a result of an overdose.

Those who experienced an overdose event were “more likely to be younger, single, unemployed, less educated and less likely to have received adequate prenatal care,” Science Daily reported. They were more likely “to have evidence of homelessness or a diagnosis of anxiety or depression.”

Co-author and Massachusetts Commissioner of Public Health Monica Bhare says that this research is vital in gaining a bigger picture of who is most at risk.

“These findings help expand the lens from which we view the epidemic and allow us to tailor our policies and programs in ways that will increase opportunities for treatment and recovery for these women and their children,” she said.

View the original article at thefix.com

21 July 2018
Kids, Parents & Grandparents All Face Strain Of Opioid Crisis

One expert estimates that for every child in foster care due to a parent’s addiction there are 18 to 20 children who have been informally taken in by family members.

When parents are living with opioid addiction—or even trying to establish their lives in recovery—it can take a toll on the whole family, from kids to grandparents, as roles are redefined.

Donna Butts, the executive director of Generations United, a Washington, D.C.-based organization, has seen how families have coped with drug epidemics fueled by cocaine or meth. This time, she told CBS News, feels different.

“With the opioid epidemic, it seems so much more severe and, in some ways, more hopeless,” she said. “Which is why I think the grandparents and other relatives that are stepping forward are playing such a critical role because the hope is with the children.”

Oftentimes family members will step up to care for the children of people who are addicted without going through the formal foster care system, making it difficult to get an estimate on how many families have been rearranged because opioid addiction.

The foster care statistics themselves are overwhelming; Butts estimates that for every child in foster care because of a parent’s addiction there are 18 to 20 children who have been informally taken in by family members.

This has financial implications for the family member taking responsibility for the children, usually the grandparents. Twenty percent of grandparents raising grandchildren are living in poverty, and 40% are older than 60, which often means they are retired or semi-retired and living on a fixed income.

In addition, many children have been exposed to trauma, and their grandparents have been through their own traumatic experiences in seeing their child battle addiction.

“What they really need is to understand the impact of trauma on the children and try to help support them as they deal with that. Also, they need to have access to trauma-informed services, the services that can really help them to overcome what they’ve experienced,” Butts said.

However, she noted that having stable grandparents can really help children overcome the harms of having a parent battling addiction.

Even for parents who are working to get clean, keeping custody of the children can be challenging.

Jillian Broomstein, of New Hampshire, was in a methadone program when her son was born. Because the baby tested positive for opioids, he was taken by the Division for Children, Youth and Families. Broomstein had just one year to be off opioids and in a stable housing situation, or she would risk losing custody permanently, according to WGBH.

“I cannot stress enough that 12 months is a really short window for somebody who’s in early recovery,” says Courtney Tanner, who runs a New Hampshire recovery home where pregnant women and new moms can live with their babies while getting sober.

Situations like Broomstein’s are too common, she said.

“Here in New Hampshire what I have seen is a mom can be enrolled in this program and compliant in treatment and they are giving birth to a child and that child is still being removed and put into foster care.”

However, given the right resources, people in recovery are able to be reunited with their children.

“We see a lot of that,” said Dr. Frank Kunkel, the president and chief medical officer of Accessible Recovery Services. “We see a lot of people that spin out of control. They’re involved with the judicial system and all that. And we see grandma have the kids for a while. Then they’ll get back on track with things legally, and they’ll get on our medications, and they’ll get in seeing their therapist, and they’ll turn their life around. We see that every day.”

View the original article at thefix.com

10 July 2018
Too Often, Insurers Cover Opioids But Not Addiction Treatment Meds

“Buprenorphine and methadone are incredibly effective medications… So I really do think it’s a stigma issue.”

As is the case for many people battling opioid addiction, Mandy’s dependency started at home. She was prescribed an opioid for back pain, and her insurance company gladly covered the cost of the pills.

However, after Mandy became dependent on opioids and was prescribed buprenorphine to help with her rehabilitation program, her insurer stepped back, unwilling to pay.

“It makes me want to go out and use [drugs],” Mandy said when she spoke to Vox. The 29-year-old who lives in the Chicago area asked that only her first name be used. “It’s way easier to get opiates or heroin… It’s so much easier than dealing with this bullshit.”

Many Americans who had no problem getting their insurance companies to pay for addictive opioid pain pills have found that getting insurers to cover treatment—particularly medication-assisted treatment (MAT) that relies on pharmaceuticals like buprenorphine—is an uphill battle despite the fact that the drugs have been proven effective.

“Buprenorphine and methadone are incredibly effective medications,” said Tami Mark, a health economist at RTI International, a non-profit that conducts policy research. “If you had any other drug with their kind of effect size, it would be immediately covered… So I really do think it’s a stigma issue.”

For people in early recovery, like Mandy, refusals to cover medications or delays in getting prescriptions approved can be deadly.

“The risk of relapse is incredibly high,” said Sara Ballare-Jones, a social work case manager at the University of Kansas Health System. She often has patients wait three days to get their medications approved because they require prior authorization from the insurance companies.

In Mandy’s case her claim was denied, leaving her to pay out of pocket for buprenorphine, which costs nearly $3,000 each year. The 29-year-old said that is a huge amount to have to pay while also handling daily expenses like student loans and rent.

“I’m feeling all these old issues and all this shit, and then it’s just more bullshit,” she said. “I’m just trying to reenter society… It’s really hard.”

It’s also incredibly frustrating for Mandy, who knows firsthand how easy it is to get insurers to cover opioids. “I never paid a dime for my opioids. Those were always covered,” she said. “But I’m paying all this money for the treatment.”

Mandy’s doctor, Dennis Brightwell, said that he usually sees issues with private insurance companies. While Medicaid is required to cover most medication-assisted treatments, most private insurers balk at covering them, putting vulnerable patients in an awkward position.

“If you send a commercial patient to the pharmacy, you don’t know until they get there how it’s going to go,” Brightwell said. “Sometimes it’s not such a problem. Sometimes it’s a prior authorization that is pretty straightforward. Sometimes it’s very difficult to get them to approve it. And there’s not an easy way to find out upfront what medications they approve.”

View the original article at thefix.com

7 July 2018
"American Greed" Tackles Crackdown On Recovery Industry Fraud

The latest episode of the CNBC series examines the case of notorious sober home operator Kenny Chatman who was convicted of health care fraud and human trafficking.

By now you’ve likely heard of the Kenny Chatman story. He is perhaps the most nefarious of all sober living home operators, who used his business to sabotage clients’ recovery so he could continue collecting insurance payments, even using it as a front for prostitution.

His high-profile case shed a harsh light on fraud and the lack of regulation in the recovery industry, and spurred several reforms since.

“Kenny Chatman saw an opportunity, saw a chance to make a lot of money, and didn’t care who he hurt to make that happen,” assistant U.S. attorney Maria Villafana said on American Greed, the CNBC series which featured Chatman’s story on Monday, July 2.

Chatman’s South Florida facilities encouraged, rather than prohibited, drug use to perpetuate the cycle of “treatment” and keep millions of dollars’ worth of insurance payments coming in.

Last May, Chatman was sentenced to 27 years in prison after pleading guilty to health care fraud, money laundering, and human trafficking. His case led to 50 arrests and the shutdown of about 200 facilities.

The recovery industry is “really not a comprehensive system” that lacks a standard for treating substance use disorders, said Mark Mishek, president and CEO of the Hazelden Betty Ford Foundation. Insurers and regulators tend to focus on the short term, which is a big problem for people seeking recovery.

“It’s a disease that needs to be managed over a person’s lifetime. So, the system we have today, for example, may provide insurance coverage for a short residential stay or for an outpatient program,” said Mishek. “That’s not enough. Patients and their families need to be involved in recovery for many, many weeks if not months and years in order to get well.”

Last July, Florida enacted a law that established tighter rules and penalties on sober living homes that scam clients and falsely advertise their services. It also mandates background checks for any owners, directors, and clinical supervisors at treatment centers.

And last month, the U.S. House of Representatives passed legislation that would increase coverage for the treatment of substance use disorder under Medicaid, and would expand the use of medication like methadone for treating substance use disorder.

View the original article at thefix.com

3 July 2018