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8/9/2016 12:00 AM

This is exclusive breaking news from Alcoholism & Drug Abuse Weekly.

Starting September 5, there will be a new structure in the Substance Abuse and Mental Health Services Administration (SAMHSA) focusing on medicine and medications, ADAW has learned. SAMHSA will add a chief medical officer (CMO) within its new Office of Policy, Planning, and Innovation (OPPI). The CMO will head up all clinical activities at the agency and will be assisted in OPPI by another medical officer who specializes in substance use disorders (that position is still to be filled). There will also be a nurse practitioner in the OPPI assisting the CMO.

SAMHSA’s Center for Substance Abuse Treatment (CSAT) already has a medical director: Melinda Campopiano, M.D. The Center for Mental Health Services will also be getting a medical director. Mitra Ahadpour, M.D., is the director of CSAT’s Division of Pharmacologic Therapies.

Anita Smith Everett, M.D.

SAMHSA’s new CMO, Anita Smith Everett, M.D., is an associate professor of psychiatry at Johns Hopkins. ADAW interviewed Everett today for this exclusive report on her new appointment. Sitting in on the interview were CSAT Director Kimberly Johnson, Ph.D., and OPPI Director Monica Feit, Ph.D.

“I don’t think you can practice modern psychiatry without having a lot of experience with the broad issue of drug use,” Everett told ADAW. As the administrator of a community health center at Johns Hopkins, she has extensive experience with clinical treatment and program administration. Baltimore’s opioid problems are significant, she said, adding that it’s now unusual to have anyone come into the center who hasn’t had a relative who died as a result of an opioid overdose.

However, alcohol is a problem as well, she said. Johnson agreed. “I know that opioids have gotten a lot of press, but numbers-wise there are many more people with alcohol use disorders than opioid use disorders,” she said. “So most of our programs do treat alcohol.”

Medications

SAMHSA is going to encourage the use of medications, not only in the treatment of opioid use disorders, but for alcohol use disorders as well, said Johnson. “That’s why we’re premiering the new structure for SAMHSA in terms of having a chief medical officer,” she said. “We need to increase our attention to how medication can treat people.” And Everett had particular praise for Vivitrol, because it bypasses the medication “adherence” problem that some patients have, she said.

With the election coming up, many people wonder what will happen at SAMHSA. “This structure is going to be put in place regardless of what happens in the fall,” said Feit. “This is a structure that’s important to SAMHSA — to provide the structure that we need. Having clinical expertise front and center is critical.”

Asked for her best recollection of helping a patient recover, Everett cited a patient she treated for alcoholism. “This was in the old days of a 28-day residential program,” she said. “In my office I keep in a frame an envelope I got back from that patient, who wrote ‘Thank you’ on the back,” she said. “I keep that in my office as a source of inspiration for me.”

8/8/2016 12:00 AM

When the Food and Drug Administration (FDA) approved Probuphine, a six-month buprenorphine implant, this spring, there were strict indications (see ADAW, June 6). Now, the sponsor, Braeburn Pharmaceuticals, has moved forward into commercialization, starting with the process of training physicians in surgically placing the implant. The FDA, in its approval, required that such training be done by Braeburn.

When the Food and Drug Administration (FDA) approved Probuphine, a six-month buprenorphine implant, this spring, there were strict indications (see ADAW, June 6). Now, the sponsor, Braeburn Pharmaceuticals, has moved forward into commercialization, starting with the process of training physicians in surgically placing the implant. The FDA, in its approval, required that such training be done by Braeburn.

This leaves two main groups of Probuphine providers — prescribers and inserters, or surgeons. However, there is probably going to be an overlap, if prescribers — who are likely to be addiction experts — learn minor surgery, and if surgeons decide to treat addiction.

The National Institute on Drug Abuse (NIDA), which developed buprenorphine-naloxone for the treatment of opioid use disorders, supported the use of Probuphine in an editorial published July 19 in The Journal of the American Medical Association (JAMA). In the editorial, NIDA Director Nora Volkow, M.D., and Deputy Director Wilson Compton, M.D., point to research by Richard N. Rosenthal, M.D., and colleagues, published in JAMA the same day, showing that the implant is effective at achieving long-term opioid abstinence for stable patients already on low doses of oral buprenorphine.

In Rosenthal’s double-blind double-dummy study, 86 percent of patients receiving implants were abstinent from opioids for six months, compared to 72 percent of patients on sublingual buprenorphine. The long-term implant could make treatment more accessible to new populations who were previously difficult to reach, including those in the criminal justice system and rural areas, according to the NIDA editorial.

Rosenthal, who is medical director of addiction psychiatry at the Mount Sinai Institute of Mental Health in New York City, receives funding from Braeburn. The study published in JAMA and praised by NIDA was also funded by Braeburn.

Nonsurgeons doing surgery

The JAMA study described the implant as a “10- to 15-minute in-office procedure” in which “4 subdermal implants were inserted one at a time through a single 2.5- to 3-mm incision in the inner upper arm using an applicator designed for the implants.” The patient received a local anesthetic first. “The incision was closed with steri-strips, and a pressure bandage was applied for 24 hours,” according to the study.

“Nonsurgeons have been trained and are doing well with the procedure,” said Behshad Sheldon, executive director, president and CEO of Braeburn Pharmaceuticals. “Patients have been implanted by nonsurgeons and are doing well.” As of last week, 2,342 physicians have been certified to provide Probuphine, she said.

“Physicians are supposed to behave within their scope of practice,” said Rosenthal, who does not think the procedure is that complicated. “There are psychiatrists who are much more hands-on primary care–type people,” he told ADAW. “If they have the skill set, they can do minor office surgery.”

However, it’s also possible for a psychiatrist to refer patients to a hospital or surgeon for the procedure, said Rosenthal. “You need to have a relationship with someone who has gone through the training,” he said. Performing the procedure the way Braeburn — and the FDA — want it done “increases the efficacy and lowers the adverse effects,” he said.

For the most recent study, Rosenthal himself did not do the insertion, although he wanted to. He couldn’t because of the double-blind double-dummy nature of the study — the active implant and the placebo looked a little different, and he knew it. However, he found an obstetrician-gynecologist who was comfortable with the procedure, having done Norplant insertions, who did the insertions for his study.

Prescriber gets trained

Prescribers don’t have to be trained in insertion, but H. Westley Clark, M.D., a psychiatrist who was formerly director of the federal Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, wanted the training, and so he signed up. He doesn’t think most prescribers, who are addiction physicians or primary care physicians who do not do minor surgery, will be inserters, but said the training was “interesting.”

The company provides the insertion kit and the removal kit for about $30, but the insertion process itself is “labor-intensive,” said Clark. “I got to practice palpating, cutting, inserting and suturing on proxy material,” he told ADAW. “A great experience for a psychiatrist who doesn’t cut. Fortunately, I won’t have to do this in real life.”

However, many addiction doctors also are primary care physicians of some kind, “so minor surgical procedures fall within their bailiwick,” said Clark. In addition, some addiction physicians are surgeons and have the skills to perform the insertion, he said.

Adverse effects

Obviously, patients don’t want to have someone cutting, inserting and suturing who isn’t qualified, and Braeburn only requires that one minor surgery have been performed in the last three months. “If there is a problem, it would be the physician who does not have sufficient skills with minor surgery and who overestimates his or her skills after the basic training offered by Braeburn,” said Clark. “This would include any physician who misrepresents prior experiences.”

Qualifying procedures, according to Braeburn, are “those performed under local anesthesia using aseptic technique, and include, at a minimum, making skin incisions, or placing sutures.”

Physicians who undertake this procedure do assume the risks of any such procedure, noted Clark, including local migration of the implants, protrusion and expulsion, infections and nerve damage.

The FDA required Risk Evaluation and Mitigation Strategies both on implantation and after implantation. The Braeburn insertion training is part of that, although Rosenthal doesn’t understand why trained surgeons need to go through specialized training. “They’re being overly cautious,” Rosenthal said of the FDA. “My opinion is after a couple of years, in which there are no bad outcomes, they’ll back up a little bit. Anybody with decent office-based skills should be able to do this readily.”

Adverse events related to the insertion that were found in the first study were eliminated in the second, said Rosenthal. “We did simple things like changing the retraction and applying a 24-hour pressure bandage,” he said.

Counseling, too

The study was conducted on patients who had been on stable doses of 8 milligrams or less a day of buprenorphine, over a course of three months. These are very stable patients. That dosage represents 25 percent of buprenorphine prescriptions, said Rosenthal, noting that this shows that the Probuphine implant is meant for a specific subset of patients, he said. “Unlike people who are often in these studies, who are on the street, these subjects were referred from physician practices, were more highly educated, more likely to be employed,” he said.

Why would people need to get the implant if they are doing well on the oral dose? According to Rosenthal, patients who are “likely to forget” to take their pill are ideal, giving as examples “people who might travel a lot, or have ADD.”

However, Rosenthal said buprenorphine — either in implant form or oral — is not by itself a cure. “Until I see evidence to the contrary, you still need to learn how to move forward without using opioids as your primary coping mechanism,” he said. “As far as I’m concerned, most people need psychosocial therapies.”

“Counseling and drug testing are part of an overall treatment plan that is defined by each treating physician,” said Sheldon of Braeburn.

Even so, Braeburn itself is leaving the treatment up to the physician. While oral buprenorphine was approved by clinical trials that did utilize counseling, Probuphine was approved based on treating already stable patients. And there is always the fact that physicians are free to treat off-label — in other words, inserting more than four rods. Braeburn, however, does not encourage off-label use and does encourage counseling.

According to NIDA, future research is needed to determine whether the implant improves treatment adherence over time.

Bottom Line…

The Probuphine implant requires both prescribers and inserters, but there needs to be coordination, and in some cases, the provider may do both.

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.

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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