Thursday, November 30, 2017

Insurance Company Practices Limit Access to MH Care, Finds New Report

Behavioral health providers are paid significantly less than general medical and surgical clinicians providing the same services, according to a groundbreaking report published today by Milliman Inc. The analysis, commissioned by the Bowman Family Foundation, also found that use of out-of-network services by patients is extremely high for behavioral health compared with use of general medical and surgical services.

Together, the findings paint a stark picture of restricted access to affordable and much-needed treatment for mental illness and substance use, which is particularly troublesome in an era of escalating suicide rates and opioid overdose deaths. “The result,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., “is an unequal health care system for patients with mental illness or substance use disorders.”

Milliman analyzed insurance claims data for 42 million Americans from 2013 to 2015, comparing provider reimbursement for services and use of out-of-network services in all 50 states and the District of Columbia. The analysis found that general medical and surgical providers were paid rates an average of 20% higher than those of behavioral health providers for the same office visits billed under identical or similar codes. In 2015 alone, there were 24 states with reimbursement disparities ranging from 30% to 69%.

Milliman also found extraordinary discrepancies in the use of out-of-network providers. On average, 18.7% of behavioral health office visits were accessed out of network in 2015, while just 3.7% of primary medical/surgical office visits were accessed out of network. Moreover, 16.7% of inpatient facility behavioral health care was accessed out of network compared with just 4% of inpatient facility medical/surgical care.

In 2015, out-of-network use of behavioral health inpatient care compared with that of general medical and surgical care was approximately 800% higher in California, New York, and Rhode Island and over 1000% higher in Connecticut, Florida, New Hampshire, New Jersey, and Pennsylvania.

APA leaders said that the findings are evidence of a pattern of behavior by insurance companies that is forcing patients into costly out-of-network care. The result is that many patients have limited access to care and may abandon treatment altogether because they cannot afford it. In addition, the findings point to potential violations of federal and state parity laws, which require insurance companies to cover treatment for mental illness and substance use at the same levels as for other medical illnesses.

“This report echoes what APA has been saying for the past several years—that insurers are not maintaining adequate networks of mental health providers for patients and that psychiatrists are reimbursed less than primary care doctors for the same services,” Levin said. “We call upon state and federal regulators to ensure that insurance companies are abiding by parity laws already on the books.” 

For related information, see the Psychiatric News article “Enforcement of Parity Law Broadens to Include New Areas of Insurer Violations.

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Wednesday, November 29, 2017

Substance Use-Induced Psychosis Highly Correlated With Later Schizophrenia, Bipolar Disorder

As many as a third of all patients with substance use-induced psychosis may go on to develop schizophrenia or bipolar disorder within five years, according to a report published yesterday in AJP in Advance. The highest risk of conversion to either schizophrenia or bipolar disorder was for patients who experienced cannabis-induced psychosis, which had a conversion rate of 47.4%.

The findings suggest the need for early identification and rapid treatment. “It is important to diagnose new cases of schizophrenia and bipolar disorder as soon as possible and to initiate treatment without delay, because prolonged psychosis without treatment is associated with a worse prognosis,” wrote Marie Stefanie Kejser Starzer, M.D., and colleagues at Copenhagen University Hospital.

Starzer and colleagues analyzed data from the Danish Psychiatric Central Research Register, which has registered all inpatient psychiatric treatment since 1969 and outpatient treatment since 1995.

The study population consisted of 6,788 patients who received a diagnosis of substance-induced psychosis over a 20-year period and who did not have any previous record of treatment for schizophrenia spectrum disorders or bipolar disorder. Ten comparison subjects were selected for each case subject, matched on sex, year, and month of birth, and being alive at the date of the incident substance-induced psychosis of the corresponding case subject.

The case subjects were followed up from incident substance-induced psychosis, and comparison subjects from their corresponding match date, until the first occurrence of schizophrenia or bipolar disorder or until death, migration, or Aug. 14, 2014, whichever came first.

A total of 32.2% of all patients with substance use-induced psychosis converted to either schizophrenia or bipolar disorder. In addition to cannabis use, self-harm after a substance-induced psychosis was significantly linked to a higher risk of converting to both schizophrenia and bipolar disorder. Young age was associated with a higher risk of conversion to schizophrenia; the risk was highest for those in the range of 16 to 25 years.

Fifty percent of conversions to schizophrenia occurred within 3.1 years, and 50% of conversions to bipolar disorder occurred within 4.4 years.

“Based on the different risk factors identified in different analyses and the overall conversion rate of 32.2%, it seems most reasonable to suggest that all patients with a substance-induced psychosis should be offered follow-up,” the authors stated. Follow-up from incidence of substance-use induced psychosis should be at least two years, they wrote.

For related information, see the Psychiatric News article “Cannabidiol May Benefit Patients With Early Psychosis, Cannabis Misuse.”

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Tuesday, November 28, 2017

Denying Certain Requests May Reduce Patient Satisfaction

Patient satisfaction is acknowledged as an important part of patient-centered care; however, some controversy exists regarding how honoring patients’ requests fits into this paradigm. A study published yesterday in JAMA Internal Medicine found that denial of several types of patient requests is associated with lower patient-satisfaction ratings of the physician. Specifically, denials of requests for referral, pain medication, other new medications, and laboratory tests were associated with significantly worse patient satisfaction.

“In an era of satisfaction score–driven compensation of clinicians, the findings suggest the need to explore the utility of training clinicians to better handle patient requests, potentially optimizing the patient experience while also enhancing clinician career satisfaction,” Anthony Jerant, M.D., and colleagues at the University of California Davis School of Medicine, Sacramento wrote.

For the study, Jerant and colleagues asked 1,141 patients to rate their satisfaction immediately after 1,391 office visits with 56 family physicians. Patient satisfaction was measured using a scale composed of six items from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Adult Visit Survey, which included questions about whether the patients felt the physician communicated in a way they could understand, spent enough time with them, and whether they would be likely to recommend the physician to their family and friends.

Study participants were also asked whether during the appointment they had made requests for the following services and, if so, whether they perceived that the physician had fulfilled or denied these requests: referral to another clinician; new medications; or follow-up tests, including laboratory and radiology tests.

Among 1,319 visits, 897 (68.0%) included at least one request; 1,441 (85.2%) were fulfilled. Compared with fulfillment of a request in the respective category, denials of requests for pain medication, referral, other new medication, and laboratory tests were associated with a significantly worse patient satisfaction rating of the physician. In contrast, denials of requests for antibiotics and referrals for imaging tests were not associated with worse patient satisfaction.

“[I]t is no coincidence that antibiotic prescription and imaging test referral were not associated with lower satisfaction,” JAMA Internal Medicine Associate Editor Joseph S. Ross, M.D., M.H.S., wrote in a comment reflecting on the findings. He noted that “substantial attention has been devoted to preparing physicians to avoid frequently requested, low-value care such as these. We can train physicians to say no to other types of clinically inappropriate requests, while still reassuring patients and paying attention to their needs.”

For related information, see the Psychiatric Services article “Association Between Quality Measures and Perceptions of Care Among Patients With Substance Use Disorders.”

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Monday, November 27, 2017

Saliva Biomarkers May Help Predict Post-Concussion Syndrome in Youth

Biomarkers in saliva may help identify youth who are likely to take more time to recover following a concussion, according to a study published in JAMA Pediatrics.

Steven Hicks, M.D., Ph.D., and colleagues at Penn State College of Medicine found that measuring the salivary levels of five microRNAs (miRNAs)—small, noncoding RNA molecules that influence protein production throughout the body—can identify children with post-concussion syndrome (PCS) with about 85% accuracy. In comparison, the Sport Concussion Assessment Tool (SCAT3), the tool currently used to determine PCS, was about 65% accurate.

“The miRNAs associated with PCS have potential utility as a toolset for facilitating concussion management,” Hicks and colleagues wrote. “This tool could ease parental anxiety about expected symptom duration. An objective PCS tool could also inform clinical recommendations about return-to-play and school-based accommodations.”

Hicks and his team took saliva samples and performed SCAT3 assessments on 52 youth aged 7 to 21 who had recently had a concussion. The participants were re-evaluated with SCAT3 after four weeks, and patients with symptom scores of 5 or more were designated as having PCS; 30 of the participants met the criteria for PCS.

The researchers analyzed over 400 miRNAs from the patient saliva samples and identified 15 miRNA that were expressed differently among youth with and without PCS. With additional analysis, the researchers narrowed in on a set of five miRNAs (miR-320c-1, miR-133a-5p, miR-769-5p, let-7a-3p, and miR-1307-3p) that proved the most accurate at distinguishing patients with PCS from patients whose symptoms resolved.

In addition, elevated levels of three miRNAs were individually associated with specific PCS symptoms. MiR-320c-1 was associated with memory difficulty, miR-629 was associated with headaches, and let-7b-5p was associated with fatigue.

“To our knowledge, no single biomarker or biomarker panel has demonstrated adequate test characteristics to be widely used as an objective measure for diagnosing or monitoring recovery from a concussion or for predicting those who are at highest risk for a prolonged recovery,” wrote William Meehan III, M.D., and Rebekah Mannix, M.D., M.P.H., in an accompanying editorial. “If validated in larger, multisite clinical trials, using this salivary microRNA panel to diagnose and manage concussions could be a major advancement to the field.”

For related information, see the Psychiatric News article “Could Changes in Tau Predict Recovery Following Sport-Related Concussion?

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Wednesday, November 22, 2017

Study Highlights Need for PTSD Interventions for Cancer Patients

Research on adult cancer patients in Southeast Asia found a striking prevalence of posttraumatic stress disorder (PTSD), with about 1 in 5 (21.7%) experiencing symptoms of PTSD six months after being diagnosed with cancer. The study was published Monday in Cancer.

Although participants’ rates of PTSD declined with time, the data underscore the risk of developing persistent PTSD even years after cancer diagnosis and treatment, according to the authors of the study. About one-third of patients (34.1%) initially diagnosed with PTSD or some of its symptoms went on to develop chronic or worsening PTSD four years later. 

“There is a need for early identification of this subset of patients who have cancer with PTSD to design risk-targeted interventions,” concluded Caryn Mei Hsien Chan, Ph.D., of the National University of Malaysia in Kuala Lumpur and colleagues. 

Moreover, finding ways to monitor PTSD among patients living with cancer is critical because many of its symptoms, such as avoidance and cognitive difficulties, are enduring, which may potentially impact adherence to treatment, the authors noted. 

The study involved face-to-face interviews with 469 patients within one month of cancer diagnosis. Participants took the Hospital Anxiety and Depression Scale (HADS) at the outset and four weeks to six weeks later. Those who were found to have psychological distress underwent the PTSD module of the Structured Clinical Interview for DSM-IV (SCID) at six months. At the four-year follow-up, the SCID was used to assess PTSD in all 245 living patients, regardless of their HADS scores. 

The high rate of PTSD found in the study may be partly due to the higher risk of PTSD found in Asian patients with cancer, compared with patients of Caucasian descent, the researchers wrote. The researchers also included so-called “subsyndromal” PTSD cases: patients whose symptoms lasted less than one month or who did not meet the threshold for a DSM-IV diagnosis despite the presence of multiple symptoms.

The study also found that patients with breast cancer were 3.68 times less likely to have PTSD at the six-month follow-up than those with other types of cancer, but not at the four-year follow-up. “Because breast cancer is a very common malignancy, it is possible that greater societal understanding and the wider availability of support programs tailored for breast cancer (compared with fewer support programs for patients with other cancer types) initially serve as protective factors against PTSD,” the authors wrote.

For related information, see the Psychiatric News article “Mental Health Issues in Cancer Survivors Persist Long After Treatment Ends.”

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Tuesday, November 21, 2017

Long-Term Treatment of Tardive Dyskinesia With Valbenazine Appears Safe, Effective

Long-term treatment with valbenazine for tardive dyskinesia (TD) appears to be safe and well-tolerated while maintaining treatment effects seen in an earlier short-term trial, according to a report in the Journal of Clinical Psychiatry

In April, the Food and Drug Administration approved Ingrezza (valbenazine) capsules to treat adults with TD—a serious side effect associated with chronic use of antipsychotics—making it the first FDA-approved product for the condition. This approval was based in part on the results of a six-week trial, which compared changes in involuntary movements in patients with moderate-to-severe TD who took valbenazine (40 mg/day or 80 mg/day) or with those taking placebo daily. As was reported in the American Journal of Psychiatry (May 2017), treatment with valbenazine resulted in a significant reduction in patients’ Abnormal Involuntary Movement Scale (AIMS) dyskinesia score compared with placebo.

In the current study, Stuart A. Factor, D.O., of Emory University and colleagues tracked the long-term outcomes of 198 patients who entered a 42-week valbenazine extension period following the initial six-week trial. Safety assessments included treatment-emergent adverse events (TEAEs) and scales for suicidal ideation/behavior, treatment-emergent akathisia or parkinsonism, and psychiatric symptoms. Efficacy assessments included the AIMS and Clinical Global Impression of Change-Tardive Dyskinesia.

Of the 198 patients who entered the valbenazine extension period, 124 (62.6%) completed the 42-week treatment. During the extension period, 69.2% of participants had more than one TEAE, but the only events leading to study discontinuation in more than two participants were somnolence (n=3) and suicidal ideation (n=3). (The cases of suicidal ideation were treated and deemed to be unrelated to valbenazine, according to the report.) The incidence of “serious” TEAEs was 14.6 percent, with syncope the only serious TEAE reported in more than two participants.

TD improvement with valbenazine was sustained throughout the extension period, with statistically significant improvements relative to baseline in both dose groups. During a four-week washout period following discontinuation of valbenazine, AIMS scores increased, indicating that TD symptoms tended to return to baseline. The findings suggest that ongoing valbenazine treatment may be required to maintain TD improvements, according to the authors.

“Results of this extension study generally indicated that valbenazine was safe and well tolerated, and maintenance of treatment effect was apparent for both doses,” the authors wrote. “Further research is needed to better understand the long-term effects of valbenazine on TD and to identify the types of patients who might benefit most from this novel medication.”

For related information, see the Psychiatric News story “The Valbenazine Story: Small Company Makes Big Breakthrough.”

Tell Congress: Tax Cuts Shouldn't Hurt Patients

Congress is forging ahead with passing major tax reform that threatens patients' access to health care. The House-passed proposal takes away the medical expense deduction that helps some patients pay for their appointments, stays in inpatient psychiatric or substance use facilities, and medications. The Senate’s proposal calls for the repeal of the Affordable Care Act’s individual mandate, which would cause the number of uninsured Americans to increase by an estimated 13 million by 2027 and ultimately result in skyrocketing premium increases. 

The Senate is expected to vote on their reform package the first week of December. That means there is time for you to voice your opposition to tax reform proposals that harm access to mental health care. Write your federal lawmakers today!

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Monday, November 20, 2017

Hormonal Contraception May Increase Risk of Suicide, Study Suggests

Women who use hormonal birth control may be more likely to attempt or die by suicide than those who never use the medication, according to a study of women aged 15 to 33 in Denmark. The findings were published in AJP in Advance.

“Adolescent women experienced the highest relative risk,” wrote Charlotte Wessel Skovlund, Ph.D., and colleagues of the University of Copenhagen. “Patch, vaginal ring, and progestin-only products were associated with higher risks than oral combined [estrogen and progestin] products, and a similar association was suggested for suicide.”

To assess associations between their use of hormonal birth control and the risk of a first suicide attempt or suicide, Skovlund and colleagues followed a national cohort of Danish women who turned 15 during the study period, which extended from 1996 to 2013, and who had no history of hormonal contraceptive use. Women with prior suicide attempts, antidepressant use, and psychiatric diagnoses were excluded from the analysis.

The study included nearly half a million women followed on average for 8.3 years with a mean age of 21 years. A total of 6,999 first suicide attempts and 71 suicides were identified. The association between hormonal birth control and a first suicide attempt peaked after two months of use. 

Compared with women who never used hormonal birth control (“never users”), users of hormonal birth control aged 15 to 33 years had a relative risk of 1.97 for a first suicide attempt and 3.08 for suicide. The relative risk of a first suicide attempt increased rapidly after initiation of hormonal contraception use, compared with never use, and it remained at least doubled until one year after initial use. 

Following that, the risk estimates decreased, but remained higher compared with never users after more than seven years of use. The relative risk of suicide attempt with hormonal contraceptive use was for 2.06 for the 15-19 age group, 1.61 for the 20-24 age group, and 1.64 for the 25-33 age group.

“Our data indicate that adolescent women are more sensitive than older women to the influence of hormonal contraceptive on risk of a first suicide attempt,” the authors wrote. This age difference may be due to the fact “adolescent women are particularly vulnerable to risk factors for suicide attempt,” they noted.

They concluded, “Considering the severity of these little-recognized potential side effects of hormonal contraceptives, health professionals and women starting hormonal contraceptives should be informed about them.”

For related information, see the Psychiatric News article “Increased Risk of Depression Tied to Some Contraceptive Use.”

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Friday, November 17, 2017

FDA Expands Indication of Electric Stimulation Device to Treat Opioid Withdrawal Symptoms

The Food and Drug Administration (FDA) has approved the use of an electric stimulation device to help to reduce the symptoms of opioid withdrawal, marking the first time a device has been indicated for withdrawal symptoms.

The NSS-2 Bridge is a small device placed behind the patient’s ear that emits electrical pulses to stimulate cranial nerves. These stimulations provide relief from common withdrawal symptoms during the first few days of drug abstinence; these include sweating, tremors, stomach problems, insomnia, and joint pain.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment,” said FDA Commissioner Scott Gottlieb, M.D., in a press announcement. “While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy.”

The FDA marketing approval was granted based on an open-label pilot study of the effects of the nerve stimulator on 73 patients undergoing opioid physical withdrawal. The study found that the average clinical opiate withdrawal scale (COWS) scores of the participants dropped by about 63% after 20 minutes of use, and 85% after 60 minutes. After five days of use, 64 of the 73 participants (88%) successfully transitioned to medication-assisted treatment (MAT). Successful transition to MAT was defined as “those who returned to the clinic and received their first dose of maintenance medication,” the study authors noted in a report published in March in the American Journal of Drug and Alcohol Abuse.

The FDA reviewed the NSS-2 Bridge device through the de novo premarket review pathway, a regulatory pathway that fast-tracks low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can be compared. The device was developed by Innovative Health Solutions Inc., and was cleared by the FDA in 2014 for use in acupuncture.

To read more about this topic, see the Psychiatric News article “FDA Clears First Prescription-Based ‘Digital Therapeutic.”

Thursday, November 16, 2017

APA, Five Other Medical Groups Voice Opposition to Senate Proposal to Remove Individual Mandate

Repeal of the mandate under the Affordable Care Act (ACA) to buy health insurance is likely to raise premiums and increase the number of uninsured Americans, APA and five other medical specialty organizations said in a statement released today responding to provisions in the Senate tax reform bill that would eliminate the mandate.

“The Congressional Budget Office (CBO) estimates that repeal of the individual mandate will result in 13 million people becoming uninsured by 2027,” APA and the five other groups said. “Furthermore, repealing the mandate will increase premiums and destabilize the individual and small group markets.”

The five other organizations are the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American College of Obstetricians and Gynecologists, and the American Osteopathic Association. Together, they represent more than 560,000 physicians and medical students nationwide.

The so-called “individual mandate” requires individuals not otherwise covered by health insurance to buy insurance in the ACA health exchanges or pay a tax penalty. Advocates say that without the mandate to buy health insurance, only the sick would enroll, causing adverse selection and destabilization of insurance markets.

“Our members are the nation’s frontline physicians, providing care to individuals and families in communities large and small, urban and rural,” the groups stated. “They see each day the inherent value of having health care coverage. Health care coverage is the gateway to prevention and wellness and a guardrail in the event of a major health event. Having health care coverage and a continuous relationship with a physician are the two factors that have been proven the world over to increase quality and decrease cost.

“Additionally, increased access to affordable health care coverage is a major reason that bankruptcies related to health care have decreased significantly over the past five years. Health care coverage provides financial security to millions of people and protects them in the most challenging times of their life, especially those that have pre-existing conditions and conditions that require a high intensity of care over their lifetime.

“Our organizations oppose provisions in the Senate tax reform proposal that would repeal policies requiring individuals to purchase health care coverage,” they continued. “Our health care system needs improvements, and our organizations stand ready to work with the Senate to identify bipartisan and impactful reforms that will ensure a robust and competitive health care market. However, according to the Congressional Budget Office, repeal of the individual mandate in this form, absent additional reforms that would stabilize the insurance market, has the potential to raise health insurance premiums by a projected 20 percent and increase the number of uninsured Americans.”

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Wednesday, November 15, 2017

Naltrexone, Buprenorphine-Naloxone Found Equally Effective in OUD Patients Who Initiate Treatment

Extended-release naltrexone and sublingual buprenorphine-naloxone appear to be equally safe and effective at preventing opioid relapse in patients with opioid use disorder (OUD). However, it can be harder to initiate patients actively using opioids on naltrexone (due to required detox period) than buprenorphine-naloxone. These two findings were reported in a study published yesterday in The Lancet.

“Both medications are effective treatments for opioid use disorders versus counseling-only approaches or compared to placebo. What is now clear is how similar the outcomes are for those initiating treatment with either medication,” Joshua D. Lee, M.D., M.Sc., of NYU School of Medicine said in a press release. “Patients wanting naltrexone but who are unable to complete detox should be encouraged to start an agonist-based treatment like buprenorphine.”

Naltrexone (an opioid μ-receptor antagonist) differs from buprenorphine both in terms of induction and ongoing care. The medication cannot be initiated until patients are fully detoxified without risking precipitated withdrawal, but once initiated, naltrexone produces no opioid-like effects and no physiological dependence. In contrast, buprenorphine (a partial agonist) can be initiated as soon as patients are in mild-to-moderate withdrawal. Unlike naltrexone, buprenorphine maintains physiological opioid dependence, and withdrawal is likely to occur on discontinuation.

Lee and colleagues randomly assigned 570 patients with OUD to receive monthly injections of extended-release naltrexone (brand name Vivitrol) or daily buprenorphine-naloxone (brand name Suboxone) for 24 weeks. Study participants were 18 years or older and had used non-prescribed opioids in the past 30 days. Unlike patients in the buprenorphine-naloxone group, who received medication shortly after randomization, those assigned to naltrexone had to complete detoxification before receiving the first injection of medication. Detoxification was defined as not using an opioid for three or more days, having urine that tested negative for opioids, and having a negative naloxone challenge.

As expected, fewer patients successfully initiated naltrexone compared with buprenorphine/naloxone (72% versus 94%). Of the 474 patients who successfully began treatment, the proportion of opioid-relapse events over the course of the study was similar (52% for the naltrexone group versus 56% for the buprenorphine/naloxone group). The proportion of participants reporting adverse events and serious adverse events did not differ between the groups, with the exception of reactions at the injection site of naltrexone, all of which were of minor to moderate severity.

“Studies show that people with opioid dependence who follow detoxification with no medication are very likely to return to drug use, yet many treatment programs have been slow to accept medications that have proven to be safe and effective,” Nora D. Volkow, M.D., director of the National Institute on Drug Abuse, said in a press release. “These findings should encourage clinicians to use medication protocols, and these important results come at a time when communities are struggling to link a growing number of patients with the most effective individualized treatment.”

For related information, see the Psychiatric News PsychoPharm article “Psychiatrists Discuss Risks, Benefits of Medications for Opioid Use Disorder.”

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Tuesday, November 14, 2017

FDA Approves Abilify Pill With Embedded Digital Sensor to Track Ingestion

The Food and Drug Administration (FDA) on Monday approved Abilify MyCite—aripiprazole tablets with a sensor that digitally tracks if patients have ingested their medication.

The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

According to an FDA press release, the system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA press release. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA noted in its release that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur, the agency added.

The “digital health feedback system” (DHFS) has attracted the attention of clinician researchers interested in novel ways to improve medication adherence among patients with schizophrenia and bipolar disorder. In 2010, John Kane, M.D., and colleagues at Zucker Hillside Hospital and Massachusetts General Hospital partnered with Proteus Digital Health Inc.—the manufacturer of the DHFS technology—to characterize the feasibility and safety of the system in patients with bipolar disorder and schizophrenia. A principle concern at the outset was whether patients who may have paranoid or persecutory delusions would be amenable to using a device allowing others to monitor their behavior.

In a paper published in the Journal of Clinical Psychiatry (June 2013), Kane and colleagues found that of the 27 patients with schizophrenia or bipolar disorder who completed the study, none experienced a worsening of psychosis attributable to use of the DHFS, 19 found the DHFS concept easy to understand, and 24 said they believed the technology could be useful to them. (For the purposes of the study, the pill with the embedded DHFS was not pharmacologically active.) 

For related information, see the Psychiatric News article “Technologies Promise to Aid Medication Adherence, but Effectiveness Varies.”

Monday, November 13, 2017

ADHD Medication Use During Pregnancy Poses Modest Birth Risks

The use of attention-deficit/hyperactivity disorder (ADHD) medications during pregnancy can modestly increase the risk of some negative birth outcomes, according to a study published Friday in Pediatrics

Ulrika Nörby, Ph.D., of Lund University in Sweden and colleagues found that infants exposed to ADHD medications during pregnancy were about 50% more likely of being admitted to a neonatal intensive care unit (NICU) than infants whose mothers never took these medications and about 20% more likely to require care in a NICU than infants whose mothers used these medications before or after but not during pregnancy.

Infants exposed to ADHD medications in utero were also more likely to experience central nervous system–related disorders such as seizures (odds ratio=1.9) and were more often born preterm (odds ratio=1.3) compared with infants who were not exposed to these medications. 

“These findings warrant attention but are hardly reasons to abstain from ADHD medication during pregnancy if treatment is crucial for the woman,” Nörby and colleagues wrote. “Because women who used these drugs during pregnancy in many ways differed from the average pregnant population, it is uncertain to what extent these associations can be explained by the ADHD medication itself.” 

Nörby and colleagues analyzed data from Swedish birth and medical registries, including nearly one million single births recorded between July 1, 2006, and December 31, 2014. They identified 1,591 infants (0.2%) who were exposed to ADHD medication during pregnancy (1,464 were exposed to stimulants and 165 were exposed to atomoxetine).

“Despite the authors’ effort to control possible confounding by using a comparison group who carried a diagnosis of ADHD, it is an imperfect control condition,” Kimberly Yonkers, M.D., a professor of psychiatry, epidemiology, and obstetrics, gynecology, and reproductive sciences at Yale University, told Psychiatric News. “Women who used ADHD medication were clearly different in many ways from the other two groups.” 

Yonkers added that the authors did not have information related to the use of illicit substances and alcohol in these women, which could be a contributing factor. She noted that the study found women taking ADHD medications reported much higher levels of nicotine use than those who did not, so it is possible that other substance use by this group was higher as well.

To read more about mental health and pregnancy, see the Psychiatric News PsychoPharm article “Yes or No: Prescribing Antidepressants to Pregnant Patients” by Jennifer L. Payne, M.D., and the American Journal of Psychiatry article “ADHD and Pregnancy” by Marlene P. Freeman, M.D.

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Thursday, November 9, 2017

Antipsychotics May Increase Risk of Aspiration Pneumonia in Older Adults

Antipsychotics are commonly used in hospitals for non-psychiatric purposes, particularly to manage delirium in older hospitalized patients. A study published in the Journal of the American Geriatrics Society found that patients who received antipsychotics for a non-psychiatric purpose had about 40%-50% increased risk of aspiration pneumonia—an infection that occurs following the ingestion of solids or liquids into the lungs—than hospital patients without antipsychotic exposure.

“This association was robust through multiple analytical approaches and persisted when focusing on individuals with discharge diagnoses of delirium and dementia,” wrote lead author Shoshana Herzig, M.D., M.P.H., of Harvard Medical School and colleagues. The researchers also noted there was no association between antipsychotics and nonaspiration pneumonia, which supports the idea of a causal link between antipsychotic exposure and aspiration pneumonia.

Herzig and colleagues analyzed data on patients admitted to a large academic medical center in Boston from January 2007 through July 2013, excluding psychiatric hospitalizations (to focus on off-label antipsychotic use), transfers from other hospitals, or hospitalizations shorter than 48 hours.

Of the 146,552 hospitalizations included in the analysis, antipsychotics were used in 10,377 cases, or about 7%. Aspiration pneumonia occurred in 557 (0.4%) hospitalizations. The incidence of aspiration pneumonia was 1.2% in patients with antipsychotic exposure and 0.3% in unexposed individuals. After adjusting for factors such as patient age, length of hospital stay, and exposure to other medications, the authors found that antipsychotic exposure resulted in a 1.4-1.5 increased odds of aspiration pneumonia; the risks were the same for typical and atypical antipsychotics.

Herzig and colleagues also found that age did not impact the relative risk of aspiration pneumonia, but they pointed out that overall use of antipsychotics steadily increased with age. Exposure rates were 5.2% for patients 65 and under, 7.3% for patients 65-74, and 12.5% for patients 75 and older. As such, the absolute risks of aspiration pneumonia were higher in patients 75 and older.

“[O]ur findings suggest that targeting older adults for interventions aimed at improving antipsychotic prescribing practices will lead to the greatest absolute reduction in the occurrence of this costly and morbid complication,” the authors wrote.

To read more on this topic, see the Psychiatric News article “Mortality Risk High for Dementia Patients Taking Antipsychotics.


Wednesday, November 8, 2017

Guided Online CBT Program May Enhance Collaborative Care for Depression, Anxiety

Incorporating a computerized cognitive-behavioral therapy (CCBT) into a collaborative care program may lead to symptom improvements in patients with depression and anxiety beyond those reported by patients receiving usual care from a primary care physician (PCP), according to a study published today in JAMA Psychiatry

“Our report confirms the effectiveness of guided CCBT, highlights the critical importance of patient engagement with online interventions, and provides high-quality evidence about the limits and potential benefits of these emerging technologies,” wrote Bruce L. Rollman, M.D., M.P.H., of the University of Pittsburgh School of Medicine and colleagues.

The researchers recruited patients aged 18 to 75 years who were recently diagnosed with anxiety, generalized anxiety, panic, or depression from 26 primary care offices in Pittsburgh. Study participants were randomly assigned to one of three interventions for six months: (1) care manager–guided CCBT alone, (2) care manager–guided access to both CCBT and a moderated, password-protected Internet support group (CCBT+ISG), or (3) usual care under their PCP. 

Participants assigned to the CCBT program received an email and phone call from a care manager introducing the eight-session Beating the Blues CCBT program, which included text, audiovisual clips, and “homework” assignments on CBT techniques. Patients in the CCBT+ISG group were also encouraged to participate in moderated discussion boards or check out other resources on the Internet support group page. 

Care managers logged into the CCBT program’s portal to monitor patients’ progress, sent personalized feedback and encouragement via email, and called patients who either had not improved or failed to log in regularly. PCPs were regularly updated about their patients’ progress through electronic medical records. Participants in the usual care group were informed of their anxiety and mood symptoms, and referring PCP, but were not given treatment advice unless suicidality or significant worsening of symptoms was captured during assessments at three, six, and 12 months. 

Over the six-month period, 504 of 603 patients (83.6%) with CCBT access started the program and completed an average of 5.4 sessions. Overall, 228 of 302 patients (75.5%) in the CCBT+ISG arm logged into the Internet support group at least once; of these patients, 141 (61.8%) made at least one online comment or post. 

Patients receiving CCBT+ISG or CCBT alone reported significant improvements in mental health–related quality of life and mood and anxiety symptoms compared with patients receiving usual care at six months—improvements that were still evident when patients were reassessed six months after the intervention ended. The researchers also found that the more CCBT sessions the patients completed, the greater the improvement in their symptoms.    

“[A]lthough our ISG [Internet support group] did not produce any measurable benefit over CCBT alone, providing online CCBT to patients with depression and anxiety receiving primary care via a centralized collaborative care program is an effective strategy for delivering mental health care at scale,” the authors concluded.

For related information, see the Psychiatric News article “Early Follow-Up Is Key to Patient Success in Collaborative Care” and the American Journal of Psychiatry article Improving the Efficiency of Psychotherapy for Depression:Computer-Assisted Versus Standard CBT.”

(Image: iStock/izusek)

Tuesday, November 7, 2017

APA, Responding to Trump on Shooting, Seeks Action on Mental Health

In response to remarks by President Donald Trump this week that the deadly shooting in a Texas church Sunday morning was “a mental health problem,” APA called on the administration and Congress to strengthen and improve access to quality mental health care.

“We are deeply saddened by the senseless violence in a house of worship this weekend,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., in a statement following the shooting in which 26 people were killed and more than 20 injured when a gunman opened fire at a Baptist church. “We extend our deepest sympathies to the victims, the families, and the community of this tragedy.”

He added that though the president and lawmakers have made comments associating acts of violence with mental illness, research has consistently shown that people with mental illness are not more likely to be perpetrators of violence, but more likely to be victims. In his statement, Levin requested that lawmakers not perpetuate stigma by making premature statements.

“If lawmakers believe it is a mental health issue, why are they not seeking to ensure that more resources are being put into treating those with mental health issues?” Levin asked.

Levin said that for policymakers who are sincere about addressing mental health, a first step is to protect “essential health benefits” in the Affordable Care Act (ACA), which include treatment for mental illness and substance use; those essential health benefits have been targeted in repeated Republican attempts to repeal or replace the ACA. 

“More designated funding should be appropriated to the National Institute of Mental Health, National Institute on Drug Abuse, and National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health to focus on new research to help increase new knowledge on how to prevent, treat, and cure mental illness and substance use disorders,” Levin added. “In addition, APA calls on the administration, the Congress, and state legislators to take needed steps to ensure that access to mental health programs remain intact so people with mental illness and substance use disorders are getting the care they need. The American Psychiatric Association stands ready to help you achieve that goal.”

Monday, November 6, 2017

High Rates of Polypharmacy Found Among Adults With Intellectual Disability Seeking Psychiatric Care

By the time adults with intellectual disability sought specialized psychiatric outpatient services in a Canadian clinic, 70% had already been prescribed one psychotropic medication, and 22% had received three or more psychotropic medications, according to a study in Psychiatric Services in Advance. The findings underscore the importance of educating non-specialist providers about prescribing guidelines for this patient population.

“Understanding the demographic, organizational, and clinical characteristics that place individuals at greater risk of polypharmacy may help in the design of future intervention efforts,” wrote lead author Yona Lunsky, Ph.D., a professor in the Department of Psychiatry at the University of Toronto, and colleagues.

The researchers identified predictors of psychotropic polypharmacy using a retrospective chart audit for patients referred to a specialized psychiatric outpatient clinic for people with intellectual disabilities in Canada between 2005 and 2013. Predictors that psychotropic polypharmacy was likely to occur among these patients included (1) living in a supervised residential setting; (2) having a diagnosis of anxiety, mood, or psychotic disorder; (3) having a diagnosis of psychiatric complexity (two or more diagnostic categories); and (4) being a woman. 

In this study and a prior study, polypharmacy rates were not associated with the severity of intellectual disability or autism spectrum disorder.

The study sample consisted of 517 outpatients (199 females; 318 males) aged 15 to 73 in an urban, tertiary-level mental health care facility in Ontario, Canada. Before receiving specialist care, these individuals with intellectual disability received their medications from either family physicians or general psychiatrists. 

Of the 70% of the study patients prescribed at least one psychotropic medication, 146 (40%) had no psychiatric diagnosis on their intake form. One hundred and twelve (22%) referred to the service received three or more psychotropic medications concurrently, 30 of them without having any psychiatric diagnosis. The most commonly prescribed medication class was antipsychotics (n=275, 53%), followed by antidepressants (n=151, 29%). The most common interclass polypharmacy combination was antipsychotics, mood stabilizers, and antidepressants (n=52). 

“Although there are circumstances in which psychotropic polypharmacy may be warranted, guidelines suggest that intraclass polypharmacy be avoided, that medications for behavior management be offered in combination with psychological or other interventions, and that there be regular monitoring of medication use, with the goal of reducing multiple medications when possible,” the authors wrote. “Both psychiatrists and family physicians can play a role in the judicious use of medications for this vulnerable population.”

(Image: iStock/smartstock)

Friday, November 3, 2017

U.S. Senators, MH Advocates Among Recipients of American Psychiatric Excellence (APEX) Awards

APA today recognized five leaders in politics, journalism, and advocacy for drawing attention to the needs of people with mental illness and substance use disorders during the second American Psychiatric Excellence (APEX) Awards presentation in Washington, D.C.

Honorees included Resident Commissioner Jenniffer González-Colón (R-Puerto Rico; pictured at left with APA Assembly Speaker Theresa Miskimen, M.D.); Kathryn Farinholt, executive director of NAMI Maryland; U.S. Sen. Brian Schatz (D-Hawaii); U.S. Sen. Debbie Stabenow (D-Mich.); and Eric Eyre, a reporter for the Charleston Gazette-Mail.

As resident commissioner, Jenniffer Gonzalez-Colon is the sole representative from Puerto Rico to Congress and helped secure $36.5 billion in disaster aid for the island in the wake of Hurricane Maria. “This money will be essential as communities clean up, rebuild, and work to recover both physically and mentally,” said Miskimen before presenting the award to González-Colón.

Kathryn Farinholt helped develop the NAMI Family Support Group program, the “NAMI In Our Own Voice: Living With Mental Illness” training for NAMI representatives, and other signature NAMI programs.

Sen. Brian Schatz co-sponsored the Expanding Capacity for Health Outcomes (ECHO) Act, which was enacted in 2016 to help expand telemedicine and telepsychiatry. He is also a lead sponsor of the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, which is also designed to expand technology-supported access to health care. The CONNECT for Health Act is endorsed by APA. Accepting for Schatz, who could not attend, was his health policy advisor, Amy Grace, M.D., a pediatrician.

Sen. Debbie Stabenow has used her position on the Senate Finance Committee to protect “essential health benefits,” including mental health benefits, in recent efforts to reform or overturn the Affordable Care Act (ACA). She helped make mental health parity a priority in the ACA and has helped pass legislation to expand the health care workforce. Stabenow was unable to attend but her award will be presented to her at a later date.

Eric Eyre is a statehouse reporter for the Charleston Gazette-Mail whose reporting has examined the opioid crisis in West Virginia and the role of pharmaceutical companies in distributing opioids in the state. He received the 2017 Pulitzer Prize for his reporting.

“The APEX Awards were created to honor the people who work every day to make our communities a better safer place for people living with mental illness and substance use disorders,” said APA President Anita Everett, M.D., at the ceremony. “They have helped move the needle on so many different fronts—by working with people with mental illness and their families; fighting for resources so communities can recover from a major disaster; promoting new ways to deliver mental health care and substance use disorder treatments; and by speaking up about the deadly effects of opioids on communities throughout our country.”

APA CEO and Medical Director Saul Levin, M.D., M.P.A., added, “Each of these awardees in their own way has contributed to our common goal of making the United States a better, safer place for those with mental illness and substance use disorders.

(Image: David Hathcox)

Thursday, November 2, 2017

APA Pledges Support of Efforts to Address Opioid Crisis

Following the release of the final report by the President’s Commission on Combating Drug Abuse and the Opioid Crisis on Wednesday, APA pledged its support to work with the Trump administration, Congress, and states to address the nation’s opioid crisis.

“The APA welcomes the final report because it helps bring much-needed attention to this crisis,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. "Our organization trains thousands of clinicians each year in the diagnosis and treatment of those with opioid use disorders. Additionally, we are an active partner in the Providers’ Clinical Support System for Medication Assisted Treatment coalition funded by SAMHSA. This national initiative provides training and mentoring in response to the prescription opioid misuse epidemic and increases the availability of pharmacotherapies to address opioid use disorder.”

The 138-page report includes more than 50 recommendations, broken down into the following categories:
  • Federal funding and programs
  • Opioid addiction prevention
  • Opioid addiction treatment, overdose reversal, and recovery
  • Research and development
In an initial response to the report, APA was pleased to see that it includes some of its recommendations such as enforcement of the Mental Health Parity and Addiction Equity Act, the development of a national media campaign to address the stigma of substance use, improved data surveillance systems, and improved access to drug courts and medication-assisted treatment in the criminal justice system. While the report aims to provide a comprehensive strategy for addressing the opioid crisis, however, APA noted that it does not include a funding request to implement many of the recommendations.

In a letter addressed to President Donald Trump introducing the report, New Jersey Gov. Chris Christie, chairman of the President’s Commission on Combating Drug Abuse and the Opioid Crisis, wrote, “It is time we all say what we know is true: addiction is a disease. However, we do not treat addiction in this country like we treat other diseases. Neither government nor the private sector has committed the support necessary for research, prevention, and treatment like we do for other diseases.”

He continued, “As you will see in the Commission’s recommendations, the Federal Government has a number of avenues through which it can ensure that individuals with addiction disorders get the help they need, including changing CMS reimbursement policies, enforcing parity laws against non-compliant insurers, promoting access to rural communities through such tools as telemedicine, and incenting a larger treatment workforce to address the broad scope of the crisis.”

Levin added, “We are still reviewing the report’s contents for a full evaluation, but we stand ready to work with the administration, Congress, and the states to help provide education, funding, training, and support to address the opioid crisis.”

(Image: iStock/bboserup)

Wednesday, November 1, 2017

Long-Term Use of Hypnotics Up Significantly From 1999 to 2014, Study Finds

Long-term use of benzodiazepine (BZD) and non-benzodiazepine hypnotics (NBH) appears to have grown significantly during a 15-year period between 1999 and 2014, independent of demographic shifts, according to a report today in Psychiatric Services in Advance.

Because clinical guidelines suggest that both types of medications should be used on a short-term basis, the findings highlight “the pressing need for better delineation of appropriate medium- and long-term use of these medications,” wrote lead author Christopher Kaufmann, Ph.D., M.H.S., of the University of California, San Diego, and colleagues.

The researchers analyzed data from eight waves of the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2014. NHANES interviewers recorded medications used during the preceding month based on prescription bottles provided by participants, and participants reported duration of use for each medication. BZDs included alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, oxazepam, temazepam, and triazolam. NBHs included zolpidem, zaleplon, and eszopiclone.

Kaufmann and colleagues found that use of both types of drugs increased significantly over the study period, from 2.0% of respondents in 1999-2000 to 4.2% in 2013-2014 for BZDs and from 0.4% in 1999-2000 to 1.6% in 2013-2014 for NBHs. Trends were driven by increases in use of more than six months.

In 2013-2014, virtually all of the 96 listed NBHs (97.9%) were used for sleep problems, and of these 94 NBHs, 85.1% were used on a medium- or long-term basis. Among the 290 BZDs listed, 60.3% were used for anxiety problems, 29.3% for sleep problems, and 11.4% for mood problems. About 83% of BZDs used for anxiety problems were for medium- or long-term use, as were most BZDs used for sleep problems (84.7%) and mood problems (81.8%).

“Monitoring of long-term BZD and NBH use, particularly in vulnerable patients (for example, older adults), may be important for understanding the reasons for changing patterns of use of these medications and prevention of potential adverse health outcomes associated with their use,” the authors wrote. “Additionally, promoting the availability of behavioral sleep treatments may help reduce the need for pharmacological sleep interventions, because sleep problems remain a major reason for their long-term use.”

For related information, see the Psychiatric News article “Tips for Reducing Suicide Risk When Prescribing Hypnotics.”

(Image: vadimguzhva/


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