Increased Take Home Doses for Patients at Opioid Treatment Programs: What’s the Risk?

Digital art downloaded from ETSY – by Ukranian artist Julia

The pandemic led to loosening of regulations on take home medications for patients being treated at opioid treatment programs, dosing on either methadone or buprenorphine. As I blogged about in my 12/1/21 post, SAMHSA has proposed guidelines for continuing extended take homes. Now there’s more evidence to support benefits of this approach.

Last week there was an article in the Journal of the American Medical Association (March 1, 2022, pp. 791-886), by Gomes et al., outlining results of the looser restrictions.

The authors concluded, after examining the study data, that increased take home dose schedules were associated with significantly lower rates of patients dropping out of treatment, without any increase of opioid-related overdoses, during the six months of follow up.

This is great news and supports the current popular viewpoint that more take home doses for patients at opioid treatment programs (OTPs) can be given without a reduction in safety.

This study was done in Ontario, Canada. Of course, I was concerned that Canadian take home schedules were already different from the U.S., but the authors say that both countries have similar take home schedules pre-pandemic. However, in Canada, patients can get some doses from pharmacies as well as OTPs. Treatment in Canada tends to be less centralized in the U.S

This study was large, including a total of over twenty-one thousand patients enrolled in opioid use disorder treatment programs.

The study divided these patients into four groups, depending on the number of take-home doses they were receiving pre-pandemic. Group one consisted of patients who dosed on methadone with no more than one take home dose per week. Similarly, Group Two dosed with buprenorphine/naloxone with no more than one take home per week. Group Three patients dosed with methadone and had up to a week of take-home doses just before COVID hit, and Group Four dosed on buprenorphine/naloxone and got five or six take homes per week pre-COVID.

To be included in the study, every subject had to have had at least one physician visit between 3/22/2020 and 4/21/2020.

Then the study divided each of the four groups of patients into “exposed” or “non-exposed” based on whether they received extra take home doses. For example, in the first group of patients, dosing daily on methadone, some of these patients received up to a week of take-home doses and some remained daily dosers, depending on decisions made by their physicians. For the patients in groups 3 and 4, which were made up of patients getting 5 or 6 take homes per week, they were either “exposed” to approximately two weeks’ of take homes or they were “non-exposed” to the extra take homes and remained on weekly schedules.

The study wanted to see if the patients who received the extra take homes in the four groups had worse outcomes than the ones who didn’t get the extra take homes. The primary outcomes that were observed were fatal or non-fatal opioid overdoses, interruption in treatment for opioid use disorder, and discontinuation of treatment. The interruption of treatment was defined as a gap in treatment of 5 to 14 days, and termination was defined as a gap of more than 14 days.

The study subjects were followed for 180 days.

The data is surprising and supports the use of more take home doses for patients.

 In group one, the group of patients dosing daily on methadone, the patients who were given extra take home doses had significantly lower risk of opioid overdose. They were also less likely to have an interruption or termination of their methadone treatment than the patients who remained on daily dosing schedule.

So…getting extra take home doses decreased the risk of having an opioid overdose. I would not have expected this. I wasn’t surprised that those patients were less likely to have disruption of treatment.

Buprenorphine/naloxone patients who were dosed daily prior to COVID but received extra take homes with the new guidelines were not significantly more likely to have opioid overdose. They  were less likely to have interrupted or terminated treatment, compared to those patients who remained at daily dosing.

Similarly, when they looked at groups 3 and 4, composed of patients already getting a week of take-home medication, the patients who were “exposed” to two weeks of take homes were less likely to have interruption of treatment.

Why were these results so good? Was it because the physicians were exceptionally wise when they decided which patients were safe to get extra take homes and who weren’t? That might be one explanation, and the explanation that would made me happy, but I can’t tell that from the data.

I looked at the article to see if there were specific factors that were associated with extra take home. I looked to see if some factors were associated with NOT getting extra take homes. The article says physicians making the decisions did have guidance from a document from the Canadian Centre for Addiction and Mental Health: “COVID 19 Opioid Agonist Treatment Guidance.” It discouraged advanced take homes for patients with recent overdose, unstable psychiatric illness, or use of illicit substances in ways that were considered high risk. This article says that it appears physicians used this guidance when deciding about take-home status. Patients who didn’t get advanced take homes tended to have higher rates of mental illness and medical problems related to alcohol use disorders

The authors say their study should be interpreted with caution, since there are some factors that may not have been captured by this clinical data. They say that the decision to allow more take homes was affected by complex characteristics that could confound the outcome of the study. They also say that overdoses may have been under-counted if they occurred out in the community and if the victims weren’t transferred to a hospital.

Even with its possible limitations, this study presents good news about the extra methadone doses and buprenorphine/naloxone doses that were given in Canada during the first months of COVID. More patients were maintained in treatment with no increase in overdoses. This study’s conclusions are supported by other articles in scientific literature that support the safety of extending take home doses for patients on both methadone and buprenorphine/naloxone. (Amram et al., 2021; Levander et al., 2021.

I do wish there was additional information about the physicians’ decision- making process regarding extra take home doses.