FDA Removes Black Box Warning On Smoking Cessation Medications

fdaThe FDA has determined that the risk of serious side effects on mood, behavior, or thinking with the smoking cessation medicines varenicline and bupropion is lower than previously suspected.  Following case reports of serious changes in mood and behavior in patients taking these medicines, led the FDA to require that a Boxed Warning be added to the labels in 2009.

The FDA continues to evaluate the safety and effectiveness of drugs after they go on the market. Recent large clinical trials have demonstrated that the risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization. The results of the trials confirm that the benefits of stopping smoking outweigh the risks of these medicines.

The FDA is also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial. The patient Medication Guide that explains the risks associated with the use of the medicines will continue to be provided with every patient prescription; however, the risk evaluation and mitigation strategy (REMS) that formally required the Medication Guide will be removed.

Source: FDA

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AMA Releases Guidelines for mHealth Apps

Mobile health apps and associated digital health devices, trackers and sensors can vary greatly in functionality, accuracy, safety and effectiveness. While physicians enthusiastic and optimistic about digital health innovation and its potential medical benefits, some mHealth apps and devices that are not safe and can pose threats to the health and safety of patients. AMA policy acknowledges the need to expand the evidence base necessary to show the accuracy, effectiveness, safety and security of mHealth apps.

The new AMA principles aim to foster the integration of digital health innovations into clinical practice by promoting coverage and payment policies that are contingent upon whether mHealth apps and related devices are evidence-based, validated, interoperable and actionable,

Patient privacy and data security in digital health are also key AMA concerns since mHealth apps and devices can be subject to data breaches that disclose personal health information. The new AMA policy encourages physicians and the mobile app industry to promote patient awareness of the varying levels data privacy and security afforded by mHealth apps.

The following AMA principles support the use of mHealth apps and associated devices, trackers and sensors by patients, physicians and others that:

  • Support the establishment or continuation of a valid patient-physician relationship;
  • Have a clinical evidence base to support their use in order to ensure mHealth app safety and effectiveness;
  • Follow evidence-based practice guidelines, to the degree they are available, to ensure patient safety, quality of care and positive health outcomes;
  • Support care delivery that is patient-centered, promotes care coordination and facilitates team-based communication;
  • Support data portability and interoperability in order to promote care coordination through medical home and accountable care models;
  • Abide by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services facilitated by the app;
  • Require that physicians and other health practitioners delivering services through the app be licensed in the state where the patient receives services, or be providing these services as otherwise authorized by that state’s medical board; and
  • Ensure that the delivery of any services via the app be consistent with state scope of practice laws.

Source:  AMA

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November is National Alzheimer’s Disease Awareness Month

logo_alzPresident Ronald Reagan designated November as National Alzheimer’s Disease Awareness Month in 1983. At the time, fewer than 2 million Americans had Alzheimer’s; today, the number of people with the disease has soared to nearly 5.4 million.  Help raise awareness for Alzheimer’s disease in your practice, community, among your colleagues and friends.

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For more information
http://alz.org

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New Center for Medicare and Medicaid Services Fee Schedule Improves Primary Care Reimbursement

cmsThe Center for Medicare and Medicaid Services (CMS) released a new, final Medicare fee schedule for 2017. The new fees will pay primary care clinicians for work that was previously not compensated or undercompensated – including patients with chronic illnesses and those with cognitive and behavioral problems.

According to the CMS, the changes will more accurately recognize and reward the cognitive work and care management performed by primary care physicians and other clinicians who do not specialize in procedures. For example, the proposed fee schedule creates new codes to pay for certain evaluation and management (E/M) services that previously were bundled into other payment codes and that were considered undervalued by many primary care physicians.

The new fee schedule includes billing codes for:

  • Comprehensive assessment and care-planning for patients with cognitive impairments such as dementia
  • Chronic-care management that goes beyond routine chores such as talking to patients on the phone about medication issues
  • Collaboration with mental health specialists to treat patients with behavioral problems
  • Prolonged evaluation and management services that occur outside of a patient visit

Another area that will improve in primary care is an expanded  pilot project for preventing diabetes in 2018. Under the Medicare Diabetes Prevention Program, patients at high risk for developing type 2 diabetes can go to a community-based program that promotes exercise, a better diet, and weight loss. Besides preventing diabetes, Medicare hopes to save several thousand dollars a year per beneficiary in healthcare costs.

Sources
CMS.gov

Medscape News

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World Mental Health Day

World Mental Health Day (10 October) is a day for global mental health education, awareness and advocacy. It was first celebrated in 1992 at the initiative of the World Federation for Mental Health, a global mental health organization with members and contacts in many countries. On this day, each October, thousands of supporters observe an annual awareness program to bring attention to Mental Illness and its major effects on people’s lives worldwide.

The Huffington Post highlights the 5 Distressing Realities About The State Of Mental Health In America.

1. Suicide rates are on the rise.
2. The media is inaccurately representing mental illness and violence.
3. Mental health disorders are the costliest health condition in America.
4. Doctors don’t take mental illness as seriously as they should.
5. Mental health has not been given its due during the election cycle

General information about World Mental Health Day and resource links from WHO

Sources:

World Health Organization
Huffington Post

 

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New Study Highlights Impact of Workplace Depression

sppeA new study of 8,000 employees from Brazil, Canada, China, Japan, Korea, Mexico, South Africa and the USA reveals that workplace depression is a major problem across different cultures and economies, with “wide and devastating” consequences for thousands of organizations worldwide and collectively costing more than US$246 billion a year.

Most research on workplace depression has been done in Western, high-income countries, and little is known about how the relationship between depression and workplace productivity varies across countries. Labor market circumstances and culture may influence the relationship between depression and workplace productivity.

Although the impact of depression on workplace productivity is universal, there were significant inter-country differences in terms of the prevalence of employees with depression taking time off work, number of days taken off, level of presenteeism and ratio of presenteeism to absenteeism. Individuals living in a country with a higher prevalence of depression diagnoses had higher levels of presenteeism. It may be that prevalence of depression diagnoses also reflects comfort in seeking treatment and or disclosing one’s diagnosis. Previous research has shown that a cultural context which is more open and accepting of mental illness is associated with higher rates of help-seeking, antidepressant use and empowerment, and lower rates of self-stigma and suicide among people with mental illness

These findings suggest that the impact of depression in the workplace is considerable across all countries, both in absolute monetary terms and in relation to proportion of country (gross domestic product) GDP. Overall, depression is an issue deserving much greater attention, regardless of a country’s economic development, national income or culture.

Source: Global patterns of workplace productivity for people with depression: absenteeism and presenteeism costs across eight diverse countries

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Changes to ICD-10 Mental Health Codes October 1st

icd-10The mental health chapter of the International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10) will take effect October 1 and reflect the updated diagnoses in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Each year on October 1, the International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10), is updated to reflect diagnostic changes in medicine.
The American Psychiatric Association has advocated that changes be made to ICD-10 to reflect the updated diagnoses in DSM-5. These include changes to align the terminology used in DSM-5 with that used in the mental health chapter of ICD-10. In response, the Fiscal Year 2017 version of ICD-10, which takes effect October 1, will include most of DSM-5’s terminology.

In some cases, new codes have been added to ICD-10 to accommodate the new diagnoses that were added to DSM-5. The new codes will allow more accurate diagnostic recording, improved communication among clinicians, and better means for collecting prevalence data.

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Sources: Psychiatric News
Printable PDF of new codes from APA

 

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FDA Approves Devices for Assessing Cognitive Function After Brain Injury

fdalogoThis week the Food and Drug Administration (FDA) has approved two computerized cognitive tests that can assess cognitive skills immediately following a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

According to the FDA, “ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. The results are compared to an age-matched control database or to a patient’s pre-injury baseline scores, if available.

ImPACT software runs on a desktop or laptop and is intended for use with those aged 12 to 59. The ImPACT Pediatric runs on an iPad and is designed for children aged 5 to 11. The FDA reviewed ImPACT through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first of a kind and for which there are special and general controls to provide a reasonable assurance of safety and effectiveness of the devices.

FDA Announcement
ImPACT Applications

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Patients With Bipolar Disorder Wait Six Years Before Receiving Diagnosis and Treatment

CJPIn a new study published in the Canadian Journal of Psychiatry, researchers conducted a meta-analysis of 27 studies involving 9,415 patients and found that bipolar patients wait six years on average from the time their symptoms start to show up before they get proper diagnosis.

A meta-analysis that assessed studies reporting estimates of the age of onset (AOO) and indicators of the age at initial management of BD. The pooled estimate for the interval between the onset of BD and its management was 5.8 years A longer interval was found in studies that defined the onset according to the first episode (compared to onset of symptoms or illness) and defined management as age at diagnosis (rather than first treatment or first hospitalization). Recent studies that used a systematic method to establish the chronology of illness, among studies with a smaller proportion of bipolar I patients, and among studies with an earlier mean age of onset reported longer intervals.

The researchers concluded that “There is currently little consistency in the way researchers report the AOO and initial management of BD. However, the large interval between onset and management of BD presents an opportunity for earlier intervention.”

Canadian Journal Of Psychiatry
July 26, 2016

 

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Brainwaves and Text Messaging

eegNew research published in Epilepsy and Behavior shows that sending text messages on a smartphone can change the rhythm of brain waves.  People communicate increasingly via text messaging, though little is known on the neurological effects of smartphone use. A neurologist and director of the epilepsy monitoring unit and epilepsy center at the Mayo Clinic in Jacksonville, Florida found a unique EEG ‘texting rhythm’ in approximately 1 in 5 patients who were using their smartphone to text message while having their brain waves monitored.

While the use of smartphones has drastically increased within the past few years, little is known about their influence on neurophysiological processes. Researchers have observed more patients using personal electronic devices to communicate by text messaging during video-EEG monitoring. As a result, they have encountered a reproducible, stimulus-coupled, time-locked, 5–6-Hz, generalized, frontocentral-predominant, theta rhythm that occurs during active texting. The researchers define it as a texting rhythm (TR) evoked by the use of smartphones. This TR is unique to texting on personal communication devices and the study authors are unclear whether the TR reflects a benign form of midline frontal theta or a biomarker that may have application in industry or health care and certainly  merits further investigation.
Source:

Epilepsy & Behavior June 2016

 

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