Life-saving methadone medication is hard to get. Is it harder in Ohio, Kentucky?
Terry DeMio- A Cincinnati methadone patient calls methadone clinic rules 'a system of rewards and punishment.'
- A nonprofit's survey shows Kentucky and Ohio are among states restricting methadone more than the federal government does even as overdose deaths surge.
- Kentucky is considering changing methadone clinic rules to improve access and experience for patients.
- Ohio officials say their rules incorporate flexibilities for patients and doctors so that individuals have the best care but one medical director says the state micromanages treatment decisions..
- Ohio has more than doubled its opioid treatment programs since the overdose epidemic started.
What if medication for your life-threatening health condition was available but only under conditions? Things like traveling to a particular clinic to get it rather than having a 30-day prescription filled at a pharmacy and taking it home. Urinating in front of someone every so often for a lab test, and more.
It happens a lot in the United States, including in Ohio and Kentucky, for people who take methadone for opioid use disorder. It happens even though the medication is approved by the U.S. Food and Drug Administration and despite overdose deaths climbing nationwide, with more than 100,000 people dying in 2021.
"Federal regulations limit the availability of methadone at a time when there is a great need to boost access to this effective treatment,” says the Pew Charitable Trust's Substance Use Prevention and Treatment Initiative. The trust is a nonprofit, nongovernmental, nonpartisan group, and one of its arms recommends solutions based in evidence to prevent overdose and treat substance use disorders.
Add to that more state conditions. Pew found in a recently released survey that nearly all states – including Ohio and Kentucky – have more rules than the federal government requires for opioid treatment programs. They aren't always based on evidence and they limit access to care or worsen patients' experience, the organization says.
National survey:Explore how individual states regulate opiod treatment programs
"When state opioid treatment program rules make it harder for facilities to open or for people to remain in care, that decreases access to life-saving medication," said Frances McGaffey, lead researcher for Pew's substance use prevention and treatment initiative, in an interview with The Enquirer. "Pew conducted this research to shine a light on the information that state policymakers need, to examine rules in their state and make changes to improve care – which can ultimately save lives.”
The director of Ohio's Department of Mental Health and Addiction Services says the Ohio regulations are flexible in many cases and have become more so in recent years. Department director Lori Criss said it's often up to a methadone clinic's medical staff, along with the patient, to decide how an individual patient is best served in a way that ensures their safety and health.
Not everyone agrees.
Ask Molly B. True, a Cincinnati resident who's on the board of directors of Harm Reduction Ohio and has been a methadone patient in Ohio and Kentucky on and off for years.
“It’s a reward and punishment system," she said, "and it’s so broken."
What extra rules does Ohio have for methadone dispensing?
Only clinics certified by the federal Substance Abuse and Mental Health Services Administration may dispense methadone in the United States. They can dispense other FDA-approved medications, but the others can be prescribed in doctors' offices and after they're induced. Methadone, like other medications for opioid use disorder, is considered one part of treatment, the administration says, with counseling another.
A lot of Ohio's treatment program rules do fall in line with the federal regulations, but Pew found several restrictions that it says can make it hard for patients to get their prescribed methadone.
Among the extra rules:
- Ohio is among 26 states that require more drug tests per year (12) than the eight that are mandated federally.
- It's among 10 states that require observed collection of urine samples for drug testing.
- It's among 48 states that allow discharge from a methadone program for things the federal government doesn’t require, including missing counseling sessions or using drugs.
- Along with seven states, Ohio has zoning restrictions that do not allow a methadone program to be located near any public or private school or child care provider.
- Finally, Ohio does not require opioid treatment programs to have extended hours, such as early or late on weekdays.
"What if I got a shift job?" True asked. "Someone who works a day shift, how are they going to go to a clinic? It opens at 5:30? OK, now add children into that."
Ohio has boosted access to treatment by more than doubling opioid treatment clinics since 2016 to 114 opioid treatment programs. Sixty-eight of these offer methadone and buprenorphine (a medication that can be prescribed to patients for up to 30 tablets per month, and after the person is adjusted to taking it, can be taken at home). The other 43 offer buprenorphine only.
What's going on with urine screenings?
But there are reasons, some that may seem simple, that people aren't comfortable getting their medication at a clinic.
"I can't pee in front of anyone," True said. She has a letter from her primary care physician that exempts her from monitored urine screening. "It causes a lot of trauma for me," she explained. "But I'm fortunate enough to have a doctor who knows my entire situation."
Not everyone does.
Dr. Roberto Soria, chief medical officer and interim CEO at the Crossroads Center, limits observed screenings as much as possible at the methadone clinic he oversees in Corryville.
"I agree they are degrading, and in some patients with sex abuse history, possibly traumatic. We have other measures to help us ascertain the validity of a drug sample, which are helpful."
Soria said the clinic bases the number of urine screenings for drugs on each patient's needs rather than any quota. At Crossroads, he said, 16 is the usual number per year, partly because the clinic has a lot of pregnant patients, who need more frequent screening.
About 5% of urine screenings start with observation at the Crossroads Center, usually because of prior signs of tampering or other specific reasons. Some patients prefer saliva tests, Soria said, and that's OK too.
Getting take-home medication is easier in Ohio now, but not easy enough, addiction specialist says
During the early COVID-19 pandemic lockdowns, Ohio came up with a method that allowed more methadone patients to take home their medications. It was a model that the Substance Abuse and Mental Health Services Administration praised, and now, the state has adopted the same, loosened, rules to take-home medications for patients, Criss pointed out. She said the actual decision-making about take-home medication is between the medical provider and the patient, and treating individuals as just that is the key to providing the best care.
Soria appreciates the changes, but he said it's still not as fluid a process to get people take-home methadone as it could be.
"We still have to ask for permission to the state for certain extra take-home (medications) and even medical variances," Soria said. "The confusing part is that the persons making decisions are not medical providers and the people asking for the variance are medical providers. This list can go on and on but it basically comes down to the state micromanaging OTP (opioid treatment program) medical directors (or) programs."
"This is a significant barrier to treatment," he said.
And while the Substance Abuse and Mental Health Services Administration is reinforcing its take-home policies, the American Society of Addiction Medicine says patients should be able to get methadone at pharmacies, under guidance or rules of the administration.
Pew's substance use initiative also criticizes the concept at some clinics of ending medication treatment because someone uses drugs while in treatment. Why? Because opioid use disorder is a chronic condition. Beyond that, kicking people out of treatment for drug use isn't a concept based in evidence. Instead, longer treatment retention is associated with better outcomes. One reason: If someone doesn't get the medication to block cravings and withdrawal, they are more likely to use another opioid, overdose and die.
At Crossroads, Soria said, patients are rarely dropped from treatment because of ongoing drug use. "And that fact is well known among our patients."
"My philosophy is that we are not here to 'play cop,' and eventually their using behavior will become obvious," Soria said. "I hammer home to all my staff that our patients are all motivated at one level or another and that it is up to us to work with that motivation."
For True, methadone is a harm-reduction tool. She hasn't stopped using opioids, but methadone treatment has helped her dramatically cut back. The problem for her, True said, is that fentanyl stays in the body so long as norfentanyl (a non-euphoria-producing substance that's made in the breakdown of fentanyl) that it's hard to get a clear drug screen.
And if she doesn't get a negative drug screen, "I can't get take-homes." So every day, she drives or gets a ride to a clinic.
Among the positive things Ohio does, according to Pew, is allow "guest dosing." That means people who are from other clinics and traveling in Ohio may drop in an Ohio clinic and get their medication. True guest-doses at clinics out of Ohio when she travels.
As for extended hours, some clinics provide them. Both Criss and Soria said that a struggle with providing added hours is that it's hard to find people who want to work during those times, especially since the pandemic started.
Kentucky has extra methadone-dispensing rules and is working on potential changes
Kentucky has its own host of extra rules, some of which aren't based in evidence, Pew's survey shows.
One thing Pew criticized was that Kentucky's programs include a goal of having the patient stop medication for opioid use disorder at some point.
That flies in the face of evidence-based treatment. "There is no scientific consensus that long-term use of (medication for opioid use disorder) is harmful," Pew stated. "In fact, long-term treatment can lead to better outcomes in employment, health and criminal justice involvement."
There are several other rules in Kentucky that Pew said do not fall in line with evidence, or add on to federal rules, slapping barriers up against people who need methadone treatment.
But the commonwealth reached out to Pew's substance use disorder prevention and treatment group in 2021 and collaborated on policy changes.
The changes they came up with are under consideration now, and Pew's group sent a letter in support of them. They include decreasing the number of required drug screens for patients and removing counseling requirements that aren't specific to an individual. They don't allow discharging a patient for having a positive drug screen, and they expand take-home dosing, "so that (patients) are more likely to stay in treatment and receive lifesaving medication," Pew's letter says.
The commonwealth is currently reviewing all the public comments about the proposed new rules, said spokeswoman Susan Dunlap.
Is methadone safe? What about people selling their doses?
Methadone treatment has always been tough to get, with access limited by strict federal guidelines since the 1970s.
"Now, our research has found exactly how difficult it can be for patients to get methadone and stay in treatment, and patients have been saying that for years," McGaffey said.
But the medication is safe and effective when used as prescribed for opioid use disorder, research shows. It fills opioid receptors in the brain, which helps prevent painful withdrawal symptoms from stopping opioid use, and curbs cravings for drugs such as heroin and fentanyl. It does basically what other opioids do, but it acts slowly, and it doesn't provide the euphoria that other opioids do, experts say. It can help patients get to and stay in recovery.
As for diversion – people taking their doses out of the clinic and selling them to others – the National Institute on Drug Abuse says that most data suggest that most of the time, methadone that's misused is taken to control withdrawal symptoms, not to get high.
"Many of states’ current regulations are based on an approach developed during the ‘war on drugs’ in the 1970s, which focused on reducing crime and diversion rather than treating addiction like a public health problem," said Pew's McGaffey. "That’s why we tend to see tight restrictions – rather than a patient-centered, evidence-based approach.
"Fortunately, with all the knowledge and data we have now," McGaffey said, "states have a prime opportunity to update their methadone policies with an evidence-backed approach that’s much overdue.”
As a methadone clinic medical director, Soria said he advocates for his patients' needs and tries to remove barriers to treatment. He added, however, that a patient's stability is a factor in what's decided.
“'First do no harm' goes hand-in-hand with 'allowing no harm,' which is my approach to treating my patients," Soria said.
True says that whatever flexibilities have been built into the system, and whatever number of treatment programs have been added in states, she has a bottom-line concern, as a harm-reduction advocate, for people who get methadone treatment:
"No other medication in the United States is restricted like this."