United States: The US Department of Health and Human Services (HHS) is making important updates to regulate Opioid Treatment Programs or OTP, accredited and certified programs providing medication like methadone or buprenorphine to people with opioid use disorder, happening for the first time in a decade.  

It has opened doors for the people being treated to take medicines or their methadone medications or even can now schedule telehealth appointments in ways they hadn’t always been able to do before.  

The previously mentioned programs are the only existing certified programs in the US through which people can have access to methadone treatment. In this, opioid use disorder is being treated by decreasing cravings and withdrawal and ultimately blocking or lessening the effects of opioids.  

These new rulings to update the OTP regulations are seen as the latest action in the series of actions that the Biden-Harris administration has taken recently to curb the nation’s ongoing overdose epidemic.  

More about the rules under process  

The final rule is scheduled to be published on Friday and is likely to update the OTP regulations.  

More updates in the rule include expanding eligibility for patients to take home doses of their methadone treatment, allowing nurse practitioners and physician assistants to order medications, and allowing patients to start treatment via telehealth.  

HHS Secretary Xavier Becerra said the updates are made to “meet people where they are” and make treatments more accessible.  

According to Rachel Pryor, counselor to the secretary, “If you are trying to take care of your family, get a new job, maybe go back to school and stay in recovery, being able to access treatment via telemedicine, that’s just a basic thing that makes a difference in somebody’s life to help them stay well,” CNN Health reported.  

She further added, “Being able to take home doses of methadone so that you don’t have to go back and forth to a methadone clinic every single day, that helps you keep your job and get your life back,” and, “We’re just trying to help people keep their lives together.”  

While recalling an account of meeting with four young people, Becerra said he had a firsthand experience of how fast one’s life could go out of control.  

He met with them through the drug abuse prevention organization CADCA, which had been suffering from the nation’s current substance abuse crisis.  

Why are updates the need of the hour?  

According to Pryor, rules and regulations were relaxed for using telemedicine for the treatment of opioid use disorders during the COVID-19 pandemic, and the updates in the OTP regulations will make these telemedicine options permanent.  

HHS assistant secretary for mental health and substance use and leader of the Substance Abuse and Mental Health Services Administration or SAMHSA, Delphin-Rittmon said, “This final rule represents a historic modernization of OTP regulations to help connect more Americans with effective treatment for opioid use disorders,” CNN Health reported.  

She further added, “While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible,” and “In short, this update will help those most in need.”  

Moreover, as per Dr. Noa Krawczyk, an assistant professor in the Department of Population Health at the NYU Grossman School of Medicine and a member of the Center for Opioid Epidemiology and Policy, who is not involved with HHS, among the ongoing issues for people in the United States, inaccessibility to medications for opioid use disorder has been one of them.  

To address that, in the latest efforts, officials have expanded access to treatment, which is “great,” as per Krawczyk; however, still, more work is yet to be done to ensure that both harm reduction tools and medications are accessible for those who need them the most.  

For example, all US counties do not have an Opioid Treatment Program, and these geographic disparities affect access, she said.  

As per CNN Health reports, she further added, “Historically, how medications for opioid use disorder have been regulated has made them very difficult to proliferate. For example, methadone, which is the most evidence-based treatment that we’ve had since the ’70s, is very restricted. In the US, you can only get it through an Opioid Treatment Program right now, a special clinic that has very distinct licensing and which is not available in most counties,” CNN Health reported.  

She continued stating, “There’s a lot of stigma against these medications,” and “People have a negative notion around methadone. They think that if you’re on one of these medications, you’re replacing one drug for another, which is a very big myth, since they’re extremely effective and help people achieve a lot of different goals, including staying alive.”  

More tests for “very scary” drugs are possible now  

On Thursday, HSS made an announcement that a certain portion of federal grant funds would be utilized to purchase test strips for xylazine, which is an animal sedative commonly termed tranq.  

After this, the local health departments, first responders, or health systems, which are the grant recipients, would be able to use the funding to purchase xylazine test strips as tools to help prevent overdose and other drug-related harms.  

Capt. Christopher Jones, director of the Center for Substance Abuse Prevention at SAMHSA, said, “We want communities to be able to have resources to purchase these test strips so that individuals will know what’s going on in their drug supply,” CNN Health reported.  

Moreover, Pryor added, “In 2021, we made it clear that fentanyl test strips were an allowable use for these grantees. What we are making public is that xylazine test strips are also an allowable use for these grantees,” and “Xylazine is a very scary thing that is out there today on the streets with fentanyl.”  

Fentanyl is said to be a powerful synthetic opioid that is about 100 times more powerful than morphine and 50 times more potent than heroin. Moreover, Xylazine is not an opioid but a sedative that’s commonly used in veterinary medicine.  

Test strips to detect the presence of fentanyl within recreational drugs are commonly used, and xylazine test strips are also becoming more popular.  

As per the experts, when xylazine is added to fentanyl products or other drugs, it could increase the risk of an overdose.  

Krawczyk said, “Xylazine because it adds a sedative effect, it adds to what the opioids already do in terms of slowing down breathing and having a risk for an overdose. It can lengthen or strengthen that effect, so it is more dangerous,” CNN Health reports.  

He further added This is definitely an emerging issue that we need to learn and do much more about in terms of trying to get test strips out and educate people about how to address xylazine in the drug supply and medically.”  

The White House has stated that fentanyl laced with xylazine is an emerging threat The US is facing.  

Visual Representation for opioid

As per the US Centers for Disease Control and Prevention (CDC) report, among 21 jurisdictions, the monthly overdose of fentanyl overdose deaths where xylazine was detected climbed from about 3% of deaths in January 2019 to nearly 11% in June 2022 in an almost four-fold rise.  

As per CDC’s National Center for Health Statistics, within a 12-month period ending in August, more than 112,000 people died from a drug overdose.  

Becerra stated, “Drug overdoses reach every corner of our society, taking lives and causing immeasurable pain to families and communities. That’s exactly why President Biden made it a key priority of his Unity Agenda. We have made important progress, but there is still a lot of work to do,” CNN Health reported.  

However, this week’s update by HHS through SAMHSA also included a toolkit on how to prevent and respond to overdoses.  

Also, the latest version of the Overdose Prevention and Response Toolkit has appendices for specific audiences, which also include people who use drugs, people who take prescription opioids, first responders, and health care practitioners.  

According to Jones, “When we’re looking at over 110,000 overdose deaths, we have to pull all the levers that we have to drive down overdoses, and medication treatment for opioid use disorder is one of the strongest evidence-based practices we have,” and “We know it can reduce the risk for dying by 50%. And so this rule is modernizing how we provide medication treatment in Opioid Treatment Programs so that more people can get access.” 


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