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7/25/2016 12:00 AM

A research team that studied the benefits of patient navigation services with or without financial incentives for hospitalized individuals with HIV and substance use disorders are warning against too gloomy an interpretation of the results. While the two active treatments did not significantly decrease viral suppression rates at 12 months compared with usual care, results at 6 months (as the study’s interventions were concluding) were more encouraging.

A research team that studied the benefits of patient navigation services with or without financial incentives for hospitalized individuals with HIV and substance use disorders are warning against too gloomy an interpretation of the results. While the two active treatments did not significantly decrease viral suppression rates at 12 months compared with usual care, results at 6 months (as the study’s interventions were concluding) were more encouraging.

Therefore, the researchers are emphasizing that the takeaway from this study of a seriously ill population should not be one of “incentives don’t work,” but rather that “we can do more,” in the words of study lead author Lisa R. Metsch, Ph.D.

“At the end of the intervention protocol, there is a significant difference,” Metsch, who chairs the Department of Sociomedical Sciences at Columbia University’s Mailman School of Public Health, told ADAW. “Those who received the intervention with incentives were more likely to be virally suppressed.”

In total, the study findings that were published in the July 12 JAMA illustrate a great deal about the importance of comprehensive services for a population with such great and diverse needs that it often is not even included in research study samples. As pointed out to ADAW by Maxine Stitzer, Ph.D., the Johns Hopkins University Department of Psychiatry professor who designed the study’s contingency management protocol, sustained and effective care for this population would prove to be costly — not so much in the cost of patient incentives, but in securing the care navigators needed to help engage patients in both HIV and substance use care.

Study parameters

The study selected patients from 11 hospitals with high numbers of HIV patients and a high prevalence of substance use problems in the HIV population, from 11 major metropolitan areas scattered across the country. The 801 patients were randomized to one of three treatment conditions: 6 months of patient navigation services to help connect them with HIV and substance use treatment services; the same 6 months of navigation along with patient financial incentives to achieve a number of health behaviors, and usual care, which mainly involved standard referral to services in the community.

Metsch described the overall study population as “individuals out of HIV care, not engaged in the system, in the hospital, very sick, with untreated substance use.”

The patient navigators, who received 24 hours of initial training for the task, used a strengths-based case management approach and employed motivational interviewing techniques. They helped patients address any logistical challenges to receiving ongoing care, and they maintained a hands-on strategy by accompanying patients to their first substance use disorder and HIV treatment appointments.

The cash incentives in the study, Stitzer explained, departed from what has been used in most research that ties them to one particular desired behavior. The incentives in this study were designed to provide ongoing positive reinforcement, and were used in an attempt to achieve seven different outcomes, from attending treatment appointments to providing negative drug test specimens to having an active prescription for antiretroviral therapy. Those receiving incentives were eligible to earn a maximum of $1,160 over the 6-month intervention period.

”This is the right population for this kind of an [intensive] intervention,” said Stitzer.

The researchers assessed both HIV and substance use outcomes, with the primary outcome of HIV viral suppression at 12 months. At 6 months, as the interventions ended, 46.2 percent of the group receiving navigation with incentives was virally suppressed, compared with 35.2 percent of the group receiving usual care. But at 12 months, the viral suppression rates were much closer: 38.6 percent in the navigation with incentives group and 34.1 percent in the usual-care group (the 12-month rate for the navigation-only group was 35.7 percent).

Both Metsch and Stitzer acknowledged that substance use outcomes were generally disappointing, with no significant differences among the groups in drug-screen results, self-reported drug use or severity at 6 or 12 months. Moreover, engagement rates in professional substance use services were low across the board, with the highest being just 30.6 percent in the navigation with incentives group.

Yet they added that the 6-month results in viral suppression rates offer some cause for optimism. Stitzer added with regard to research on interventions in general, “The world keeps hoping that we’ll have permanent effects of interventions. But that doesn’t tend to happen. The interventions tend to be effective when they are in place.”

Improving engagement

Metsch said that with linkages to substance use treatment being less successful than hoped for in this study, she concludes that if the research were to be designed over again, “We’d try to start the substance use services directly in the hospital setting.”

She cited other factors that also should be accounted for in interpreting the results related to substance use. “We were limited by treatment availability in a particular area,” Metsch said. Many patients were primary stimulant users, complicating the task of identifying ideal treatment options, she said.

Also, outcomes in Southern study sites were worse than elsewhere, the researchers reported. Atlanta, Miami and Birmingham, Ala., were among the study sites.

Stitzer says the 6-month outcomes on viral suppression should have care providers taking heart and seeking to make their services as attractive as possible to the types of high-need patients treated in this study.

Bottom Line…

Use of patient navigation services with financial incentives did not result in 12-month improvement in HIV viral suppression rates among HIV patients with substance use disorders, but encouraging results at 6 months might offer reason for optimism.

7/25/2016 12:00 AM

Forty-six governors have signed on to a remarkable agreement to fight the opioid epidemic with prevention and treatment, including treatment with medications and harm reduction measures such as access to naloxone. The National Governors Association released the “Compact to Fight Opioid Addiction” on July 13.

Forty-six governors have signed on to a remarkable agreement to fight the opioid epidemic with prevention and treatment, including treatment with medications and harm reduction measures such as access to naloxone. The National Governors Association (NGA) released the “Compact to Fight Opioid Addiction” on July 13.

“Bringing governors together around core strategies to end the opioid epidemic adds momentum behind state efforts and sends a clear signal to opioid prescribers and others whose leadership is critical to saving lives,” said Massachusetts Gov. Charlie Baker, chair of the NGA Health and Human Services Committee. “Massachusetts is proud to bring our plans to the table for other states as we work collaboratively to find meaningful solutions to this public health crisis.”

The compact came about as a result of a resolution passed at the NGA’s winter meeting, which focused on opioid prescribing guidelines and the need for collective guidelines (see ADAW, Feb. 29).

There are some controversial provisions. For example, the compact calls for opioid prescribers and dispensers — which includes opioid treatment programs (OTPs) — to input information about their patients into prescription drug monitoring programs (PDMPs). Federal confidentiality law does not allow this without patient consent, and OTPs have been told by the federal government not to do it (see ADAW, Oct. 24, 2011). However, the state attorneys general have asked the federal government to make an exception for OTPs.

The compact was released at the start of the NGA summer meeting, which kicked off with a session on opioid abuse in which Health and Human Services Secretary Sylvia Mathews Burwell participated.

Below is the compact:

Taking steps to reduce inappropriate opioid prescribing, which may include:

  • Partnering with health care providers to develop or update evidence-based opioid prescribing guidelines, which may be informed by CDC’s guideline, and consider prescription limits with exceptions for certain patients and circumstances;
  • Requiring that physicians, osteopaths, nurse practitioners, physician assistants, dentists, veterinarians and all other opioid prescribers receive education on pain management, opioid prescribing and addiction throughout their training and careers;
  • Integrating data from state prescription drug monitoring programs (PDMPs) into electronic health records and requiring PDMP use by opioid prescribers and dispensers; and
  • Reducing payment and administrative barriers in Medicaid and other health plans to promote comprehensive pain management that includes alternatives to opioid painkillers.

Leading efforts to change the nation’s understanding of opioids and addiction, which may include:

  • Developing a communications strategy through the governor’s office to raise awareness about the risks of abuse associated with opioid use and reduce the stigma of addiction;
  • Establishing social media campaigns and integrating education into schools, athletic programs and other community-based settings to raise awareness about opioid abuse and addiction among youth and other at-risk groups; and
  • Partnering with professional associations to improve understanding of the disease of addiction among health care providers and law enforcement.

Taking actions to ensure a pathway to recovery for individuals with addiction, which may include:

  • Reducing payment and administrative barriers in Medicaid and other health plans to promote access to a range of treatment options, including well-supervised medication-assisted treatment and comprehensive recovery services;
  • Pursuing overdose prevention and harm reduction strategies, such as Good Samaritan laws and standing orders to increase access to and use of naloxone; and
  • Implementing and strengthening programs that provide addiction treatment as an alternative for non-violent individuals charged with low-level drug-related crimes.

NASADAD collaboration

The National Association of State Alcohol and Drug Abuse Directors (NASADAD) works closely with the NGA. NASADAD Executive Director Rob Morrison told ADAW the NGA has been “fully engaged” with NASADAD on opioid issues, and connects with NASADAD members to find out more about what they do. Of particular interest to other governors: the hub-and-spoke system of methadone clinics and buprenorphine prescribers developed in Vermont by SSA Barbara Cimaglio and Gov. Howard Shumlin.

“A lot of work goes into these summits,” said Morrison of the NGA meetings. The compact “was the culmination of a decent amount of work in which governors’ offices, their staff and leadership are talking about what their state is doing,” he told ADAW last week. Morrison added that the work done on the compact will be “very beneficial” for incoming governors after the elections in November. Ultimately, the compact shows the importance of NASADAD to the NGA on substance use disorder issues, and on the trust that governors have in the association.

At the 2017 winter meeting in Washington, D.C., the NGA will report on specific steps governors have taken to meet their commitments and build on existing efforts.

Among those not signing on to the compact: Gov. Paul LePage of Maine and Gov. Rick Scott of Florida. For the compact, and the full list of signatories, go to http://www.nga.org/cms/Compact-to-Fight-Opioid-Addiction.

7/25/2016 12:00 AM

There have been increasing reports of deaths in jails due to opioid withdrawal — deaths that could have been easily prevented by appropriate medical care. ADAW talked to medical experts this week about what’s going wrong with these tragic cases.

There have been increasing reports of deaths in jails due to opioid withdrawal — deaths that could have been easily prevented by appropriate medical care. ADAW talked to medical experts this week about what’s going wrong with these tragic cases.

Opioid withdrawal is often viewed as relatively benign compared to withdrawal from benzodiazepines or alcohol, which can be accompanied by fatal seizures. However, there is a clear standard of care for opioid withdrawal, which has symptoms that can range from mild to severe, with vomiting and diarrhea so intense and prolonged that dehydration and death can result.

The federal Bureau of Prisons has a clear protocol on opioid withdrawal, but this applies only to federal prisons. The deaths are taking place mainly in local jails. There are no standards for opioid withdrawal in jails.

“The level of care is probably better” in federal prisons, said Kevin Fiscella, M.D., M.P.H., liaison from the American Society of Addiction Medicine (ASAM) to the National Commission on Correctional Health Care, which is currently revising its opioid withdrawal position statement. Fiscella, who is a professor at the University of Rochester Medical Center in Rochester, N.Y., said management of opioids within corrections is a particular interest of his.

Everyone we talked to said that maintenance treatment with methadone or buprenorphine should be considered instead of management of withdrawal. However, in reality, many jails and prisons simply do not provide access to agonist medications, in which case withdrawal should be treated the way it is in hospitals providing detoxification, they agreed.

“Part of the problem is that there’s a misconception that people don’t die from untreated opioid withdrawal,” said Fiscella. “In fairness, this is something we’ve all been taught in medical school.” Otherwise healthy people fare better with untreated withdrawal, but people who are incarcerated are often not healthy, he said. “About once a month we hear about someone who is incarcerated in opioid withdrawal and dies during that period,” he said. Direct causes are dehydration due to vomiting and diarrhea with accompanying electrolyte imbalance. Another cause is aspiration pneumonia, when vomit gets into the lungs. “These deaths have clearly happened — cases have gone to the coroner and been documented,” said Fiscella. But he added that there may be many more cases that aren’t reported. “These direct causes are the ones we know about, but the estimate of one a month may be just the tip of the iceberg,” he said.

It’s also hard for jail staff to diagnose withdrawal, said Fiscella. “When someone is in acute withdrawal, it’s hard to tell what their problem is,” he said. “They hurt everywhere, they’re throwing up and they have diarrhea, and their blood pressure is going up.”

An even more pernicious problem is the mindset of many custodial staff who believe that inmates, when they say they are in withdrawal and need medication, are faking and just want drugs. “Custodial staff have become accustomed to lying; they are very suspicious of inmates, and essentially assume that anything an inmate says is a lie,” said Fiscella. But custodial staff should not be deciding whether an inmate needs medication or not, he said. “In a well-run jail, you should have health care staff who are making these decisions; you should not be relying on custodial staff on a routine basis to tell you that someone is sick,” he said.

Detox isn’t treatment

Opioid withdrawal should be managed the same way regardless of the setting in which it is taking place — corrections or medical — said Geetha Subramaniam, M.D., deputy director of the Center for Clinical Trials Network at the National Institute on Drug Abuse. “It is inhumane to have someone suffer through opioid withdrawal,” she said. Acute withdrawal usually lasts five to seven days, and symptoms include sniffles, runny nose, goose bumps, shivering, sweating, muscle cramping, diarrhea, yawning, blood pressure and pulse lability, and vomiting, she said. “But there’s no test to show that someone is in withdrawal, and it may just look like a bad case of the flu,” she said.

Treatment for opioid withdrawal is more than providing methadone or buprenorphine, added Subramaniam. “It is a whole supportive system,” she said. “You have to give other medications to reverse stomach cramping, nausea and diarrhea,” she said. In addition, they need to have treatment, because they will be at high risk for relapse when they are released, she said. “At no time should detoxification be considered treatment — it is just the management of a certain period,” she said. “Medications won’t magically control the desire to seek drugs.”

Jail realities

Even if opioid withdrawal isn’t life-threatening, not treating it is “inhumane,” said Jeanette M. Tetrault, M.D., associate professor of medicine and director of the addiction medicine fellowship program at the Yale University School of Medicine. And severe withdrawal, with prolonged vomiting and diarrhea, is “messy — why would they want that mess?” she asked.

“The problem is that it’s not medical people making the decisions; it’s based on the warden’s own biases,” said Tetrault of withdrawal management in jails. “But I think they know enough that an acute withdrawal process could progress to something life-threatening.”

But jails are places where safety and security are the primary goals, not medical care, said Tetrault. “There’s a lot of movement of people in and out of jails,” she told ADAW. Even obtaining medications for chronic conditions like high blood pressure is difficult in jail.

“Most jails are small jails, and the only health care they have is a nurse who comes in occasionally,” said Pamela F. Rodriguez, president and CEO of TASC (Treatment Alternatives for Safe Communities). “Medication is just not done in many jails — it’s an issue of security, and they don’t have the resources to verify medications.” This is not true in a big city jail like Chicago’s, where there is access to medical care, Rodriguez told us. But in most jails, they do little screening for any health problem except for mental health, to monitor for suicide.

What can be done

NIDA’s Subramaniam said the responsibility to provide adequate care to inmates going through withdrawal is with the corrections departments. “I would put the burden on the criminal justice system,” she told ADAW. “They should have a good rationale for not continuing maintenance treatment, and at the least they should be covering opioid withdrawal.”

Several years ago, Fiscella wrote a study on the national standards in jails, and found that it was rare for any jail to use an opioid agonist to treat withdrawal, which is the standard of care. About half of the jails used clonidine, which is not recommended due to the risk of hypotension, and can also result in a rebound reaction, said Fiscella. Currently, only a handful of jails use methadone or buprenorphine to treat opioid withdrawal, which is the standard of care and is used routinely in detoxification in treatment programs and hospitals.

There are three main barriers to treating opioid withdrawal in jail, said Fiscella: the mindset, staffing and costs, and concerns about diversion. The fourth is a rule by the Drug Enforcement Administration that methadone can’t be given by jails for more than three days, said Fiscella, noting that methadone is much less expensive than buprenorphine.

Ultimately, there will be lawsuits, with evidence that jails are not abiding by medical standards and caused deaths, said Fiscella. “Courts will be looking at constitutional challenges because of inhumane care, and this will make a difference to the big vendors” of correctional health care services, he said.

In the meantime, jail systems need to recognize that when someone is admitted in opioid withdrawal, it is an opportunity for treatment, preferably with medication.

For the federal Bureau of Prisons guideline for withdrawal, go to https://www.bop.gov/resources/pdfs/detoxification.pdf.

For the ASAM practice guideline, go to http://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf?sfvrsn=24.

Bottom Line…

Deaths due to withdrawing from opioids in jails could be prevented by standard medical care, but bias against inmates is a barrier to care.

From the Field
4/11/2016 12:00 AM

On February 9, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a proposed rule that made changes to the Confidentiality of Alcohol and Drug Abuse Patient regulations (42 CFR Part 2). The purported goal was to modernize regulations that had not been updated since 1987. After more than 40 years, it is unquestionably time to modernize these outdated rules while still maintaining privacy (especially as it relates to law enforcement, employers, divorce attorneys or others seeking to use the information against the patient).

In addition to having broader coverage for treatment of substance use and mental health disorders, in large part due to the Affordable Care Act and the Mental Health Parity and Addiction Equity Act (MHPAEA), we now utilize patient-centered medical homes that integrate patient care and quality measures that require follow-up after hospitalization and care coordination. Today integrated and coordinated care is expected as the new norm for delivering best-practice, whole-person care. Additionally, we have electronic health records and stringent federal privacy and security regulations that were not in place when 42 CFR Part 2 (referred to as “Part 2”) was enacted. The Part 2 regulations were appropriate for a different time. The regulations now hinder safe, effective, high-quality substance use treatment. The proposed rule makes many steps in the right direction, yet it still leaves barriers to coordinated, integrated health care for some people seeking treatment for substance use disorders.

Part 2 is the federal regulation governing the confidentiality of specified drug and alcohol treatment and prevention records. These regulations limit the use and disclosure of patients’ substance use medical records from certain substance use treatment programs. The Part 2 regulations were originally authorized by the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 and the Drug Abuse Prevention, Treatment, and Rehabilitation Act of 1972. These laws were consolidated in 1992 by the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act (PL 102-321). Based on these laws, Part 2 sets out protections against unauthorized disclosure of substance use records as a way to encourage people to seek treatment. The regulations were established to assure people with substance use problems that their information would not be shared without their very specific consent, other than under several circumscribed conditions detailed in the regulations.

Patient privacy is important, and it needs to be balanced with providing access to the same standard of care afforded to individuals with a medical illness. After all, isn’t this why we fought so hard for the MHPAEA? Doctors ask for a list of your medications, your allergies, your medical conditions and your previous surgeries for a reason: to ensure individualized quality health care without injury or harm to their patients. Don’t individuals with a substance use disorder deserve the same protections? Shouldn’t a doctor prescribing pain medications know whether or not his or her patient is being treated for an opioid addiction? Shouldn’t a primary care provider know that his or her patient has cirrhosis of the liver?

The proposed rule applies to federally assisted programs. These outdated standards do not apply to patients with substance use disorders seeking care outside of these programs. People being treated in non–Part 2 programs have their records protected in the same way medical and mental health records are protected, by the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) regulations. Hopefully, SAMHSA will truly modernize Part 2 in the final rule and ensure that a treating provider has all of the necessary patient records to properly treat his or her patient and allow for the sharing of patient information for services like care coordination without a signed authorization. If the final Part 2 rule mirrors HIPAA, for treatment, payment and health care operations, patients will have privacy protections, quality care and the benefits of whole-person integrated care. This can be accomplished while maintaining the Part 2 prohibitions on sharing information with law enforcement and for other non-treatment-related purposes that might inhibit people from accessing care.

To quote the Centers for Medicare & Medicaid Services when they announced their initiative supporting improving connectivity for behavioral health and Medicaid providers, “doctors and other clinicians need access to the right information at the right time in a manner they can use to make decisions that impact their patient’s health.”

In Case You Haven’t Heard
4/11/2016 12:00 AM

Is West Virginia looking at yet another barrier to treatment with methadone or buprenorphine? According to a “treatment fee” proposal by U.S. Sen. Joe Manchin, a tax on prescription opioids could be used to fund treatment. The government currently charges no tax, he said. His proposal would be one penny per milligram for every milligram purchased. However, this proposal might backfire if it ever comes to pass, unless it exempts methadone and buprenorphine, both opioids, and both used in SUD treatment.

Coming Up
4/11/2016 12:00 AM
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  • Meet the Editor

    Alison Knopf
    Editor

    Alison Knopf is a professional journalist who began covering the addiction field in 1984 as founding editor of Substance Abuse Report. She has been the editor of Alcoholism & Drug Abuse Weekly since 2005.
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