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FDA Warns CBD May Overpromise and Underdeliver

Image result for CBD has become a popular additive to items like foods and edibles. Getty Images Gels, creams, and pills containing cannabidiol (CBD), the non-psychoactive, potentially therapeutic compound in the cannabis plant, have proliferated at a seemingly exponential rate in the past five years.  The industry is poised to double in growth each year between now and 2024, according to cannabis consumer research firm BDS Analytics.  But CBD is still in a regulatory gray area, with the Food and Drug Administration (FDA) in the process of wading through scientific and public commentTrusted Source to refine its regulatory strategy toward CBD products.  In the meantime, the agency has started to issue warnings over manufacturers’ more egregious claims about CBD’s therapeutic effects.  The latest warning Most recently, the agency warnedTrusted Source a CBD manufacturer for making unsubstantiated medical claims about CBD’s health benefits, including claims that the compound could treat Alzheimer’s disease and kill breast cancer cells.  “Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care,” said acting FDA Commissioner Dr. Ned Sharpless, in a statementTrusted Source.  “Additionally, there are many unanswered questions about the science, safety, effectiveness, and quality of unapproved products containing CBD,” he said.  The manufacturer, Curaleaf, responded in a statement that they “immediately began an extensive review of its website and social media platforms to remove all statements that FDA identified as noncompliant.”  They also said that many of the products cited by the FDA have been discontinued and that they’re working to ensure their products are compliant with FDA regulations.  “Our industry needs, wants, and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace,” said Joseph Lusardi, CEO of

Gels, creams, and pills containing cannabidiol (CBD), the non-psychoactive, potentially therapeutic compound in the cannabis plant, have proliferated at a seemingly exponential rate in the past five years.

The industry is poised to double in growth each year between now and 2024, according to cannabis consumer research firm BDS Analytics.

But CBD is still in a regulatory gray area, with the Food and Drug Administration (FDA) in the process of wading through scientific and public commentTrusted Source to refine its regulatory strategy toward CBD products.

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New Form for Reporting Drug Overdoses

The Texas Department of State Health Services (DSHS) has created an online form for physicians and other health care professionals to report overdoses from controlled substances such as opioids, cocaine, and methamphetamines.

Previously, physicians reported overdoses from these “Penalty Group 1” drugs only via phone call or by faxing a paper form to the Texas Poison Center Network.

The new electronic form replaces phone and fax reporting. It is expected to make reporting and collecting overdose data more efficient, DSHS officials said.

State law requires physicians or the person in charge of a facility in which an overdose occurs or is treated to report the overdose to the DSHS.

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FDA to Speed Review of Generic Versions of Opioid Overdose Antidote

FDA to Speed Review of Generic Versions of Opioid Overdose Antidote

The US Food and Drug Administration (FDA) on Monday said it would prioritize and expedite the review of generic versions of drugs indicated for the emergency treatment of opioid overdoses.

The decision follows FDA’s approval in April of the first generic of the life-saving naloxone nasal spray, commonly known as Narcan.

Under the “Public Health Emergency” prioritization factor in MAPP 5240.3, FDA says it will expedite the review of all abbreviated new drug applications (ANDAs) that reference new drug applications (NDAs) for drugs indicated for the emergency treatment of known or suspected opioid overdose. The NDAs include the Narcan injection and nasal spray, Evzio auto-injector and Revex injection.

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Texas Prescription Monitoring Program

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The Texas State Board of Pharmacy is pleased to announce an enhancement to the Prescription Monitoring Program (PMP).

On July 17, 2019, all approved PMP users will have access to an advanced analytics and patient support tool called NarxCare. In addition to the existing PMP functionality, NarxCare will aggregate and analyze prescription information from providers and pharmacies and present visual, interactive information, as well as advanced analytic insights, machine learning risk scores and more to help physicians, pharmacists and care teams to provide better patient safety and outcomes up front, for every patient, every time. NarxCare also provides tools and resources that support patients’ needs and connects them to treatment, when appropriate.

With this enhancement, healthcare providers will have access to all features and functions of NarxCare with a consistent look and feel for users who access the solution through the PMP web portal. It also enables delivery of NarxCare within Electronic Health Records (EHR) and Pharmacy Management Systems for those prescribers and dispensers in Texas who choose to access NarxCare through integration within their healthcare IT system via Appriss Health’s PMP Gateway solution.

Instructional videos on how to navigate NarxCare and how to interpret the NarxCare score are available for viewing.

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Texas Prescription Monitoring Program Statewide Integration

 

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More Information About Statewide Integration

The Texas State Board of Pharmacy has partnered with Appriss Health to provide this integration option to all Texas Healthcare providers utilizing the service called PMP Gateway. PMP Gateway is a multi-state query system that provides access to a majority of state PMPs. PMP Gateway facilitates communication, information transfer, integration, and support for the state approval process, and the EHR and Pharmacy Management System vendor development process.

Integrating TX PMP AWARxE data within an EHR and/or a Pharmacy Management System provides a streamlined clinical workflow for providers. The integration eliminates the need for providers to have to log in separately to the PMP. Instead, the EHR or Pharmacy Management System automatically initiates a patient query and returns the patient's controlled substance prescription record directly within the provider's EHR or Pharmacy Management System.

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Chronic Pain Task Force on Opioids and What Happens Now

Chronic Pain Task Force on Opioids and What Happens Now

 

Dr. Vanila Singh

“50 million people have chronic pain—20 million of those have high impact chronic pain—and there is an absolute need as a medical community and larger society to get educated on what the best treatments are.”

That was the task defined by Dr. Vanila Singh, the Chairperson of the Pain Management Inter-Agency Task Force.

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TDI-Division of Workers' Compensation Plan-Based Audit

All,

 On May 8, 2019, the Texas Department of Insurance, Division of Workers’ Compensation (DWC) solicited and received constructive input from workers’ compensation system participants on the proposed Physical Medicine and Rehabilitation Services Plan-Based Audit (Plan-Based Audit). DWC appreciates the input provided by system participants. All comments were carefully considered and discussed. The commissioner of workers’ compensation approved the Plan-Based Audit on May 29, 2019.  All medical quality reviews initiated on or after January 1, 2019, will follow the approved Medical Quality Review Process (Process) in effect. The Process and Plan-Based Audit are posted on the TDI website at:www.tdi.texas.gov/wc/hcprovider/medadvisor.html.  Please advise your members and staff. 

 If you have any questions regarding this memo, contact myself or Mary Landrum at 512-804-4814 and [email protected].

Dr. Owen is the New DWC Medical Advisor

Congratulations to TPS Emeritus Board Member and Past President Dr. Owen
for his new role as DWC Medical Advisor


The Texas Department of Insurance, Division of Workers’ Compensation (DWC) is pleased to announce that Dr. Graves T. Owen, M.D. will serve as DWC Medical Advisor and Jennifer Hopens will serve as Deputy Commissioner of the Appeals Panel.

Dr. Owen is a board-certified anesthesiologist with fellowship training in interdisciplinary pain management. After completing his fellowship training in pain management, Dr. Owen went on to practice interdisciplinary pain management in Round Rock for 24 years. In addition to his practice, Dr. Owen published numerous articles and frequently lectured on pain management topics. He also served as president of the Texas Pain Society and board chairman for the Texas Pain Foundation.  Dr. Owen has served on DWC’s Medical Quality Review Panel since 2010.

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TPS Attends TMB Stakeholder Meeting 06/04/2019

Texas Pain Society Attends Texas Medical Board Stakeholder Meeting 06/04/2019


                                                                           Left to Right: C.M. Schade, MD, PhD, Larry Driver, MD, Richard Hurley, MD

 Many thanks to TPS Past Presidents Drs. Larry Driver, Richard Hurley and C.M. Schade for spending a day in Austin to be a part of the Texas Medical Board (TMB) Enforcement Stakeholder Group Meeting. 

Texas Pain Society has been a long-time stakeholder with the TMB and works year-round to provide input on rules that affect our members ability to provide care for pain patients in Texas. 

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Patient-Centered Care Is Key to Best Practices in Pain Management

Patient-Centered Care Is Key to Best Practices in Pain Management

Summary: Dr. Vanila Singh explains the work of the Pain Management Best Practices Inter-Agency Task Force.


 

On May 10, the Pain Management Best Practices Inter-Agency Task Force voted on its final recommendations, which emphasize the importance of providing balanced, individualized, patient-centered pain management to ensure better clinical outcomes for pain that improve quality of life and functionality for patients. The group recommended a broad framework of approaches for treating acute and chronic pain. Following is an interview with Dr. Vanila Singh on the task force’s work.

Q: Dr. Singh, the Pain Management Best Practices Inter-Agency Task Force, a federal advisory committee that you chaired, just voted on final recommendations for pain management best practices. What was the Task Force's charge?
A: We were charged by section 101 of the Comprehensive Addiction and Recovery Act of 2016 (CARA) - PDF to propose updates to best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain.

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Pain Management Task Force Issues Final Report on Best Practices for Treatment of Pain

Pain Management Task Force Issues Final Report on Best Practices for Treatment of Pain

The Pain Management Best Practices Inter-Agency Task Force, a federal advisory committee established by the Comprehensive Addiction and Recovery Act of 2016 - PDF, today released its final report on acute and chronic pain management best practices, calling for a balanced, individualized, patient-centered approach.

To ensure best practices for the treatment of pain, the Task Force final report underscores the need to address stigma, risk assessment, access to care and education. It also highlights five broad categories for pain treatment: medications, interventional procedures, restorative therapies, behavioral health, and complementary and integrative health approaches.

“There is a no one-size-fits-all approach when treating and managing patients with painful conditions,” said Vanila M. Singh, M.D., MACM, Task Force chair, and chief medical officer of the HHS Office of the Assistant Secretary for Health. “Individuals who live with pain are suffering and need compassionate, individualized and effective approaches to improving pain and clinical outcomes. This report is a roadmap that is desperately needed to treat our nation’s pain crisis.”

The Task Force was created in the midst of a national opioid epidemic, but also at a time when an estimated 50 million adults in the United States experience chronic daily pain. As such, the report emphasizes safe opioid stewardship by recommending more time for history-taking, screening tools, lab tests, and clinician time with patients to establish a therapeutic alliance and to set clear goals for improved functionality, quality of life, and activities of daily living.  Medication disposal and safe medication storage are also emphasized for patient safety.

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TexMed 2019 Pain Lectures

TexMed 2019 - Texas Pain Society - Pain Lectures Success!

Many thanks to Drs. Tim Zoys & C.M. Schade for co-chairing the 2019 Texas Pain Society Program! Thank you to our amazing speakers for their time and energy and expertise to educate attendees about the most current standards for pain management. Each year this program continues to grow and attract more and more attendees, this year was another full room with over 140 attendees! 

                    

Primary Care Pain Medicine: State-of-the-Art 2019 
Presented by Brian Bruel, MD, Director, Pain Medicine, Baylor College of Medicine, Houston

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CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain

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CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain

Some policies, practices attributed to the Guideline are inconsistent with its recommendations


 

Media Statement

Embargoed Until: Wednesday, April 24, 2019, 5 PM, EDT
Contact: Media Relations
(404) 639-3286


 

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TPS Lectures During TexMed

Mark Your Calendars and Plan to Attend the Texas Pain Society Lectures During TexMed 2019


Date:
Friday, May 17, 2019

Location: Hilton Anatole Hotel, Dallas, Texas - West Wing, Coronado A
Time: 7:3oam - 11:30am


Pain Medicine Program Agenda

7:30 AM: Welcome and Introductions

7:30 AM: (ETHICS) Primary Care Pain Medicine: State-of-the-Art 2019 
Presented by Brian Bruel, MD, Director, Pain Medicine, Baylor College of Medicine, Houston


8:00 AM: (ETHICS) Texas Medical Board Updates & Top 50 Pitfalls 
Presented by Sherif Zafraan, MD, President, Texas Medical Board, Houston 









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US warns docs not to abruptly halt opioid pain treatment

From AP News

US warns docs not to abruptly halt opioid pain treatment
April 9, 2019

FILE - This Aug. 29, 2018, file photo shows an arrangement of prescription oxycodone pills in New York. U.S. health officials Tuesday, April 9. 2019, warned doctors not to abruptly stop prescribing opioid painkillers to patients who are taking them for chronic pain ailments, such as backaches. (AP Photo/Mark Lennihan, File)

WASHINGTON (AP) — U.S. health officials Tuesday warned doctors not to abruptly stop prescribing opioid painkillers to patients who are taking them for chronic pain ailments, such as backaches.

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CDC Clarifies Pain Guideline Not Intended to Deny Opioids Access to Cancer Patients/Survivors

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April 9, 2019

The Centers for Disease Control and Prevention (CDC) issued a key clarification on its Guideline for Prescribing Opioids for Chronic Pain. The clarification comes as a result of a collaborative effort by ASCO, the American Society of Hematology (ASH), CDC, and the National Comprehensive Cancer Network (NCCN) to clarify CDC’s opioid prescribing guideline to ensure appropriate implementation for people with cancer, cancer survivors, and patients with sickle cell disease.

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