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9/12/2016 12:00 AM

The federal Centers for Disease Control and Prevention in interviews last week with ADAW continued to state that there is no causal connection between the successes in reducing prescribing of prescription opioids and the increase in overdoses with illicit opioids. If there were, some think the federal policies could be implicated, because they had reduced access to prescription opioids — which indeed were responsible for causing overdoses and addiction. However, the increase in heroin and illicit fentanyl overdoses is seen by many local law enforcement and public health officials to be an unintended consequence of the limits on the supply. The main route to reducing misuse of prescription opioids has been prescription drug monitoring programs, which allow doctors to track what other controlled substances a patient has been prescribed or dispensed.

The federal Centers for Disease Control and Prevention (CDC) in interviews last week with ADAW continued to state that there is no causal connection between the successes in reducing prescribing of prescription opioids and the increase in overdoses with illicit opioids. If there were, some think the federal policies could be implicated, because they had reduced access to prescription opioids — which indeed were responsible for causing overdoses and addiction. However, the increase in heroin and illicit fentanyl overdoses is seen by many local law enforcement and public health officials to be an unintended consequence of the limits on the supply. The main route to reducing misuse of prescription opioids has been prescription drug monitoring programs (PDMPs), which allow doctors to track what other controlled substances a patient has been prescribed or dispensed.

The PDMPs and other prescriber education initiatives have had a chilling effect on the prescribing of opioid analgesics, resulting in fewer of them being available on the street due to diversion.

Last month, the Surgeon General took another step in reducing physician prescribing, warning doctors about overdoses and referring to the CDC’s guide, which also warns about prescribing of opioids (see ADAW, March 28; December 21, 2015).

The CDC denies that the crackdown on prescription opioids, including the shutting down of “pill mills,” has sent people with opioid use disorders into the street to buy illicit fentanyl and heroin, and instead sticks to its main prevention goal of reducing prescription opioids.

“For the majority of heroin users, their first opioid was a prescription opioid,” said Rita Noonan, Ph.D., chief of the health systems and trauma systems branch in the CDC’s Division of Unintentional Injury Prevention. This is why focusing on prescription opioids makes sense “in the long term.”

Noonan also said that geographic areas where opioid prescribing is at high levels are targeted by drug dealers.

She cited a forthcoming study to be published in Health Affairs next month showing that states with pill mill laws and PDMPs were the same states where there was a significant decrease in opioid prescribing. From there, the CDC tried to see if there was also a decrease, or an increase, in heroin death rates, she said.

PDMPs, naloxone and treatment

The federal government has laid out a three-point response to the opioid overdose problem: (1) prescriber education, (2) naloxone provision and (3) treatment with methadone, buprenorphine or naloxone. If a patient is getting prescription opioids and is dependent on them, or is misusing them, or is doctor-shopping, or all three, that person is probably going to end up without refills. He or she will be in withdrawal and need treatment, or will seek out other drugs such as heroin or illicit opioids on the street.

We asked Noonan what the CDC is recommending physicians do about getting treatment for their patients who seem to need it. “We don’t officially work in treatment provision,” she said. “We have told our state grantees to make linkages to treatment, but we don’t fund treatment.” She said that the Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency that is responsible for treatment. President Obama “wanted to spend a lot of money to expand treatment,” she said, referring to the $1 billion proposed by the White House for the FY 2017 budget. She also suggested that the Federally Qualified Health Centers under the Health Resources and Services Administration are also participating in treatment initiatives.

“Scientifically speaking, given the research that we’ve done, there’s no relationship” between the efforts to reduce prescribing of opioids and the increases in heroin and illicit fentanyl overdoses, Noonan said. “Additional research can be done — I don’t want to speculate,” she said. “But what we have right now is evidence that suggests that these policies have had the intended effect, and that they have reduced overdose deaths.”

In fact, almost a year ago the CDC did issue an RFA for research on this subject. From the RFA: “The purpose of this research is twofold: to investigate the patterns of prescription opioid pain reliever (OPR) use and misuse and transitions from OPR misuse to heroin use (Priority # 1); and whether OPR prescribing is a risk factor for heroin overdose, and if policies and strategies aimed at curbing inappropriate prescribing are associated with increased or decreased risk for heroin overdose (Priority # 2). Applicants are expected to submit one application to address either the first or second research priority.” For the RFA, go to http://www.grants.gov/custom/viewOppDetails.jsp?oppId=280151.

Lack of evidence

Still, the main message from the White House has steadfastly been that there is no evidence that people, unable to get prescription opioids from whatever source (doctor, street dealer), are switching to heroin or other illicit opioids, despite anecdotal evidence that this is taking place. A New England Journal of Medicine article from the National Institute on Drug Abuse, the CDC and the Food and Drug Administration in January stated there was no evidence linking the successful crackdown on prescription opioids and increases in heroin (see ADAW, Jan. 18). The main issue is lack of evidence.

“The absence of data is not truth, but a silence that requires rigorous scientific inquiry,” Traci Green, Ph.D., a Brown University researcher on drug abuse epidemiology whose work has been funded by the CDC, told ADAW last spring. “I hope that whatever is found, we are willing to listen objectively to the data and decide on a policy path that is based on evidence.”

Green thought that the NIDA-CDC-FDA article was “premature.” There is “no reason to think that supply crackdowns” would not create unintended consequences, she said. “If we can learn from the past, then maybe we can try to improve the safety of the supply and drug use, reduce the harms of drug use through sensible harm minimization strategies, and quit with incarceration and purely enforcement (supply) based approaches as our sole focus,” she said.

She was particularly concerned about fentanyl, because exposure in the case of a tainted supply is more likely to be fatal than nonfatal, she said. Green is an expert in “counterfeit” prescription pills (see ADAW, June 6).

Four years ago, there was already evidence of a correlation between prescription opioid decreases and heroin increases: in 2012, the National Survey and Drug Use on Health found a heroin increase was correlated with a prescription opioid abuse decrease (see ADAW, Sept. 16, 2013).

Meanwhile, overdoses are going up, with the CDC itself issuing these reports. Last December, the CDC reported that heroin and illicit fentanyl overdoses were increasing (see ADAW, Jan. 11).

A CDC Vital Signs report from Florida in 2014 showed that heroin overdoses were increasing, while prescription opioid overdoses were decreasing (see ADAW, July 14, 2015).

Last year, the CDC’s Leonard J. Paulozzi, M.D., told ADAW that by preventing the initiation of prescription opioid use, there would be fewer heroin overdoses in the future (see ADAW, May 4, 2015). The rationale is that most heroin users say they first took prescription opioids. He admitted, however, that for some people, prevention is too late — they need treatment. “If you have a large cohort of people who are already physiologically dependent on heroin or prescription opioids, those people aren’t going to go away,” he told ADAW then. “They’re going to seek drugs, and they will need to get into treatment. But if we can stop feeding that pool now, it will help.”

Treatment not tracked by the CDC

The CDC has $70 million for funding to states to implement prevention strategies. The next step is to obtain data from those states to better track prescribing practices, morbidity outcomes and mortality outcomes, said Puja Seth, Ph.D., lead for the CDC’s prescription drug overdose epidemiology and surveillance team. The CDC will not track whether patients are referred to treatment, she said. “Treatment is more SAMHSA’s responsibility,” she said. “We want to know whether prescribers are checking the PDMPs before they prescribe.”

Seth added that it’s not possible to have patient-level data regarding who goes to treatment. “We do get some patient-level data on the PDMP form, and we have patient-level data around prescribing practices,” she said. “We can tell if a patient is doctor-shopping.” But the CDC can’t tell which patients are referred to treatment, or whether any physician is actually referring patients to treatment.

Bottom Line…

The increasing overdoses caused by heroin and illicit fentanyl, and the curbing of prescription opioid availability, are not related, the CDC says, abiding still by its main goals, which are to educate prescribers and encourage PDMPs.

8/29/2016 12:00 AM

Whether students misuse prescription stimulants because they are self-medicating attention-deficit hyperactivity disorder (ADHD) or because they have a substance use disorder (SUD) has been a question for years. A recent study, however, has shed light on the controversy, showing that half of these students actually have an SUD. In fact, the students who misuse these medications prefer immediate-release to extended-release stimulants, and use them repeatedly, not just once or twice, indicating addiction.

Whether students misuse prescription stimulants because they are self-medicating attention-deficit hyperactivity disorder (ADHD) or because they have a substance use disorder (SUD) has been a question for years. A recent study, however, has shed light on the controversy, showing that half of these students actually have an SUD. In fact, the students who misuse these medications prefer immediate-release to extended-release stimulants, and use them repeatedly, not just once or twice, indicating addiction.

Nonmedical use of stimulants is misuse, and in the college setting, where students may be misusing these medications in order to stay up late and study, it turns out that most, compared to controls, actually have psychiatric disorders, including ADHD.

The study, “Nonmedical Stimulant Use in College Students: Association with Attention-Deficit/Hyperactivity Disorder and Other Disorders,” was published in the July issue of the Journal of Clinical Psychiatry. Lead author Timothy E. Wilens, M.D., told ADAW that self-medication does exist. “I believe that a group are self-medicating their ADHD,” said Wilens, noting that the risk for ADHD was twice as great for misusers as for controls. He noted that in analyses he and his colleagues will be presenting at the American Academy of Child and Adolescent Psychiatry meeting in October, there was also “higher risk for clinical and neuropsychologically derived executive function deficits in misusers relative to controls.” But the data also support other research in which high rates of SUDs are found in stimulant misusers, said Wilens, who is chief of the Division of Child and Adolescent Psychiatry and co-director of the Center for Addiction Medicine at Massachusetts General Hospital.

Background

Up to 8 percent of college students are estimated to have ADHD, and stimulant medications are among the first-line treatments for this disorder in adolescents and young adults. However, there are few studies specifically evaluating ADHD and other diagnoses in college students misusing stimulants. To examine the gaps in research, this study looked at a heterogeneous sample of college students, focusing on ADHD and psychiatric and substance use disorders, the type of stimulants misused and the context of the misuse.

The researchers hypothesized that the stimulant misusers, compared to controls, would have higher rates of ADHD symptoms, or an actual ADHD diagnosis; that the rates of SUDs would be higher in stimulant misusers than in controls; and that stimulant misusers would have higher rates of other psychopathology than controls. In addition, they hypothesized that there would be a greater use of immediate-release compared to extended-release stimulants.

Study details

The researchers recruited 100 college students who misused stimulants but were not receiving them pursuant to a diagnosis of ADHD, and 200 controls who were not being treated with stimulants and had never misused them but for whom a prior diagnosis of ADHD was not exclusionary. Stimulants included those with Food and Drug Administration indications for ADHD: amphetamine (dextroamphetamine, lisdexamfetamine, immediate- and extended-release mixed amphetamine salts and immediate- and extended-release methylphenidate) but did not include modafinil, armodafinil, methamphetamine or other stimulants (such as cocaine and 3,4-methylenedioxymethamphetamine).

Assessments were made using DSM-IV-based interviews by raters with training and supervision from the senior investigator. Raters and reviewers were blinded to status.

Results

The final sample included 100 misusers and 198 controls (two were dropped because it turned out they had possibly misused stimulants). Misusers were more likely to have ADHD (27 percent vs. 16 percent) and conduct disorder (10 percent vs. 3 percent).

Stimulant misusers were 2.9 times more likely than controls to have an SUD, and 5.4 times more likely to report a combined alcohol and drug use disorder.

Implications

The study partially supported the researchers’ hypotheses that misusers are at higher risk for ADHD and/or multiple SUDs. These misusers were also more likely to have a poorer quality of life related to controls.

Standard survey studies use a very different method of quantifying ADHD than the structured diagnostic interviews used for this study. Still, the results are consistent with survey studies, which also suggest a high rate of self-medication of ADHD.

“Some misusers may be driven to use stimulants in an effort to achieve better grades, increase productivity, and self-treat their threshold or subthreshold ADHD, which are motivations not typically associated with the abuse of alcohol or other drugs,” the researchers wrote. They speculated, however, that SUDs themselves can result in academic problems, which result in stimulant misuse to improve already failing performance.

The researchers in this study, however, did not suggest that stimulant misusers are all self-medicating for ADHD. Nearly half of stimulant misusers have an SUD, most commonly involving alcohol or marijuana, followed by prescription stimulant misuse. Previous research has found that the onset of an SUD precedes stimulant misuse. This study found that nonmedical use of stimulants may be associated with a separate SUD that necessitates referral to treatment. The researchers go on to suggest that stimulant use disorders may be unique among SUDs, because “the behaviors and causalities may be entirely unrelated” to other SUDs. “Regardless, given the high rates of substance use disorder in our groups, college students who misuse stimulants should be systematically screened for alcohol, stimulant, and other substance use disorders,” they said.

Despite limitations such as a small sample size, the fact that the sample (metropolitan Boston) may not generalize to other areas and interviews instead of biological testing to determine SUDs, the study shows that “college students who misuse prescription stimulants are clearly struggling” due to the high rates of ADHD and SUD and lower quality of life associated with stimulant misuse.

Wilens told ADAW that he was surprised that the rates of ADHD were so low. “I expected higher rates,” he said. “Probably most surprising was that of the subsample we intensely examined for stimulant use disorder, over one-half of misusers actually had a diagnosable stimulant use disorder,” he said. “In other words, it is not true that stimulant misusers only use once or twice. In fact, a sizeable number actually may have an addiction to the stimulant they are misusing — it may not be so benign.”

This is one of the few studies that has examined stimulant misusers in depth and in a controlled manner, noted Wilens. In particular, these misusers preferred immediate-release vs. extended-release stimulants, which suggests that practitioners should not prescribe immediate-release products to higher-risk groups.

Disentangling self-medication from addiction is particularly complicated with prescription stimulants, Wilens admits. However, ADHD does exist among misusers, and can’t be discounted. “Essentially every study I complete in which there is some instrument of self-medication shows a signal of self-medication,” Wilens said.

8/29/2016 12:00 AM

Almost two years ago, ADAW reported that most adolescents with opioid use disorders do not get medications that are recommended as the first-line treatment for adults, but rather get detoxification and abstinence-based treatment (see ADAW, Nov. 24, 2014). The result of such treatment was, in many cases, relapse, and, in some, death from overdose. Experts told us that long-term maintenance with buprenorphine, which is approved for ages 16 and up, is far preferable.

However, little has changed, with many young people still getting drug-free treatment, relapsing and overdosing. So last week, the American Academy of Pediatrics (AAP) took the step of urging all its members to get waivered so that they can provide access to buprenorphine for their patients.

In “Medication-Assisted Treatment of Adolescents With Opioid Use Disorders,” published in Pediatrics online August 22, the AAP noted that resources are needed to communicate information about the effective treatments, as well as to develop new treatment especially for this age group. Some adolescents manage to function well despite severe opioid use disorder, but the rate of spontaneous remission is low, according to the AAP.

Almost two years ago, ADAW reported that most adolescents with opioid use disorders do not get medications that are recommended as the first-line treatment for adults, but rather get detoxification and abstinence-based treatment (see ADAW, Nov. 24, 2014). The result of such treatment was, in many cases, relapse, and, in some, death from overdose. Experts told us that long-term maintenance with buprenorphine, which is approved for ages 16 and up, is far preferable.

However, little has changed, with many young people still getting drug-free treatment, relapsing and overdosing. So last week, the American Academy of Pediatrics (AAP) took the step of urging all its members to get waivered so that they can provide access to buprenorphine for their patients.

In “Medication-Assisted Treatment of Adolescents With Opioid Use Disorders,” published in Pediatrics online August 22, the AAP noted that resources are needed to communicate information about the effective treatments, as well as to develop new treatment especially for this age group. Some adolescents manage to function well despite severe opioid use disorders, but the rate of spontaneous remission is low, according to the AAP.

The medications

Methadone is a full opioid agonist with a long half-life that has more than 50 years of demonstrated effectiveness. However, most methadone programs cannot admit patients younger than 18 years. Buprenorphine, a partial opioid agonist, can be prescribed by physicians once they complete 8 hours of training and are given a waiver. Naltrexone, an opioid antagonist, prevents the effects of opioids and is not abusable, but there is no research supporting its efficacy in adolescents. However, it also reduces alcohol cravings, and the injectable extended-release version “may be a good therapeutic option for adolescents and young adults with co-occurring alcohol use disorder, as well as those living in unstable or unsupervised housing,” the AAP said.

There have been two studies proving the effectiveness of buprenorphine in adolescents: one by Lisa A. Marsch, Ph.D., in 2005 (see ADAW, Oct. 10, 2005) and one by George Woody, M.D., in 2008 (see ADAW, Nov. 10, 2008). Woody’s study was for 6 months with a taper, and those teens who tapered relapsed, showing that maintenance is essential. John R. Knight, M.D, director of the Center for Adolescent Substance Abuse Research at Boston Children’s Hospital and one of the first pediatricians to have a buprenorphine license, told us two years ago that maintenance should be the standard of care for adolescents as it is for adults. “People need to get on maintenance, and not be tapered down,” he said. Meanwhile, Woody, whose trial showed that buprenorphine was effective in adolescents but only before they were tapered off it, told us it was difficult to recruit subjects, because those under 18 had to get parental consent, and most didn’t want to tell their parents.

In general, youth have lower treatment retention than adults, and retention is associated with long-term recovery.

Buprenorphine does have the potential for addiction — it is an opioid — but for people who have already become tolerant, this is not the main issue. Maintenance on the medication has been shown to be effective in adults and in adolescents. But “confusion, stigma, and limited resources” restrict access to buprenorphine treatment for both adolescents and adults, said the AAP.

Even addiction treatment programs often do not offer buprenorphine, the AAP noted. “Policies, attitudes, and messages that serve to prevent patients from accessing a medication that can effectively treat a life-threatening condition may be harmful to adolescent health,” the AAP said.

Below are the recommendations from the AAP:

  • Opioid addiction is a chronic relapsing neurologic disorder. Although rates of spontaneous recovery are low, outcomes can be improved with medication-assisted treatment. The AAP advocates for increasing resources to improve access to medication-assisted treatment of opioid-addicted adolescents and young adults. This recommendation includes increasing both resources for medication-assisted treatment within primary care and access to developmentally appropriate substance use disorder counseling in community settings. Pediatricians have access to an AAP-endorsed buprenorphine waiver course at http://www.aap.org/mat.
  • The AAP recommends that pediatricians consider offering medication-assisted treatment to their adolescent and young adult patients with severe opioid use disorders or discuss referrals to other providers for this service.
  • The AAP supports further research focus on developmentally appropriate treatment of substance use disorders in adolescents and young adults, including primary and secondary prevention, behavioral interventions and medication treatment.

Pediatricians and child psychiatrists

One problem is that pediatricians may be leery of using buprenorphine for their patients. “There is general consensus that medication therapy helps to reduce relapse in patients with opioid use disorder,” Sharon Levy, M.D., lead author of the recommendations, told ADAW. “While there is a smaller evidence base in adolescents, the findings have been consistent with research in adults. With this statement, the American Academy of Pediatrics is supporting greater access to medication therapy in the community. As with any other disorder, youth with opioid use disorders should be treated in the least restrictive setting. Unfortunately, there are too few physicians prescribing medications for patients with opioid use disorders to meet the demand for adults seeking treatment, and the situation is even more dire for adolescents, who should be treated by professionals who are experienced working with this age group. In that regard, this statement is a call to action — for physicians who work with adolescents to become waivered and prescribe and for prescribers to get training in working with this age group.”

“In my area of the country, New England, heroin use among teens appeared to take a significant jump in the mid-’90s,” Stuart Gitlow, M.D., past president of the American Society of Addiction Medicine (ASAM), told ADAW after the AAP recommendations were released. “It was about that time when heroin began to be available in sufficiently pure form that it could be snorted rather than injected. According to my patients, this eliminated what had previously been seen as a barrier to use by younger individuals. From a ‘Do No Harm’ perspective, if a young patient is regularly using narcotics, there is no question in my mind that provision of buprenorphine reduces risk of morbidity and mortality.” Gitlow, who is the American Medical Association delegate from ASAM as well as executive director of the Annenberg Physician Training Program in Addictive Disease and an associate professor at the University of Florida, said that, in fact, not offering treatment does more harm. “Not offering pharmacotherapy to this particular age group leaves those most at risk in grave danger of following the usual disease course,” he said.

“Addictive disease often has its onset when a patient is of the age to be seen by pediatricians and/or child psychiatrists,” added Gitlow. Of all the chronic disease states impacting adults, addictive disease is the one that should be most commonly identified by pediatricians given its incidence and prevalence within the age range of their patients, he said. “It isn’t, of course, and this represents an enormous oversight,” he said. “If the treating clinicians don’t know the disease is there, we can’t hope that they will treat it, whether with medication or not.”

This is why the first step is that pediatricians must screen for addictive disease, said Gitlow. The need for a separate certification requirement to provide buprenorphine is a “continuing barrier,” he said. Like many, he wondered why full-agonist treatment with opioids for pain can be prescribed to many patients with no limit, while buprenorphine treatment for opioid use disorders has caps of 30, 100 and 275 patients per physician, depending on training.

Bottom Line…

It’s time for pediatricians to be buprenorphine treatment providers, to help their young patients access treatment, says the AAP.

From the Field
9/19/2016 12:00 AM

Opioid addiction is a disorder of brain structure and function. It is an illness. And the most effective treatment for this illness is medication. And as with any illness, the medication that should be used is the one that proves most effective for that patient. And yet, there are those that argue we should limit the medications we use to fight this epidemic of opioid addiction and death.

We’re dying out there. Look at the number of overdoses that have occurred in the last month to heroin and to fentanyl- or carfentanyl-laced heroin. If something, anything, can be used to save lives, then please, let’s put ideology aside and let’s do that. When used as a medication, prescribed by a physician, diacetylmorphine — prescription heroin — stabilizes brain function and allows the person to become well, stay well and, most importantly, stay alive. And this treatment is for those that are refractory to the other medications used to treat this medical condition. Methadone and buprenorphine don’t work for them. So, because those treatments failed, should we just discard the people?

According to the NAOMI study, the countries that have established heroin treatment programs — Switzerland, the Netherlands, the United Kingdom, Germany, Spain, Denmark, Belgium, Canada and Luxembourg — have all reported positive results for those individuals who are refractory to methadone and buprenorphine treatment.

It sounds radical, the provision of heroin to those addicted to heroin. But do understand, a drug is just a drug. It just does what it does. This controversy over using heroin as a treatment to control opioid addiction — it’s not about the data. It’s not about the research. It’s about stigma, ideology and people protecting their turf.

In a previous ADAW issue, Robert Lubran, then with the Substance Abuse and Mental Health Services Administration, stated, “It’s not difficult to find individuals who will prefer access to heroin over methadone maintenance treatment” (see ADAW, Aug. 31, 2009). He seems to believe this is a bad thing. I do not. If we can get more people into treatment, if heroin treatment will do that, how many lives can we save? And every life is someone’s son, it is someone’s daughter, and we would not only be saving them but also their mothers and fathers from the devastating loss of their child. We should be doing everything we can to keep them alive. And, yes, that includes treatment with diacetylmorphine.

The NAOMI studies show that, for those refractory to methadone or buprenorphine, heroin-assisted treatment is effective, with retention rates of about 88 percent. But there seems to be a problem. The acceptance of this form of treatment is opposed by some in the treatment field.

This is not a game. This is not a “my treatment is better than your treatment” contest. This is about saving lives. Heroin can produce addiction, or it can be used to stabilize (with medication) an addiction. It is how we use it that determines its effects. In this epidemic, we have an obligation to do everything we can to save lives. If the use of heroin-assisted treatment will do that, and the data show that it will, then please, put the ideologies aside, put the financial interests aside, push back on the stigma and let’s do everything we can to reduce the harm of this epidemic to those who suffer from this disorder of brain structure and function we call opioid addiction. Because every death, every loss, is someone’s son or daughter, and their lives are precious too.

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.

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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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