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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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Texas Board of Pharmacy Partners with Appriss Health to Provide Access to NarxCare Platform and Prescription Drug Monitoring Program Directly within Electronic Health Records and Pharmacy Management Systems

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LOUISVILLE, KY – July 23, 2019 – Appriss Health, provider of the most comprehensive platform for opioid stewardship and substance use disorder (SUD) in the U.S., today announced that it has partnered with the Texas State Board of Pharmacy (TSBP) to integrate prescription monitoring program (PMP) information into the electronic health record (EHR) systems of all prescribers and pharmacy management systems for all pharmacies in Texas with Appriss Health’s PMP Gateway solution. Additionally, the TSBP will make available the Appriss Health NarxCare susbstance use disorder platform designed to deliver additional clinical content to help identify patients at risk of an opioid overdose.

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Keep enforcing marijuana laws, Abbott, Patrick, Bonnen, Paxton tell prosecutors amid hemp law confusion

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AUSTIN -- State GOP leaders have told local prosecutors not to abandon prosecution of marijuana-possession cases because of recently passed legislation legalizing hemp.

In a joint letter to district and county attorneys, Gov. Greg Abbott, Lt. Gov. Dan Patrick, Speaker Dennis Bonnen and Attorney General Ken Paxton emphasized Thursday that "marijuana has not been decriminalized in Texas." Prosecutors should not toss low-level marijuana cases, they said. In fact, the new hemp legislation gives law enforcement a new tool in pressing cases for marijuana possession, the leaders said.

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The Opioid-Related Emergency Department Visits dashboard was recently updated.

Texas Department of State Health Services

The Opioid-Related Emergency Department Visits dashboard was recently updated.

There are 5 tabs:

1. An Overview page that provides a general overview of data by opioid type for 2017 
2. A Data Table Builder page that lets you choose parameters to generate a data table
3. A Maps page with opioid-related emergency department visits and rates by county
4. A Data Source & Other Resources page that contains methodology behind analyzing the data
5. An Archive page that has the previous dashboard for inpatient-emergency department visits




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Reduce Risk of Opioid Overdose Deaths by Avoiding and Reducing Co-Prescribing Benzodiazepines

A new MLN Matters Article SE19011 on Reduce Risk of Opioid Overdose Deaths by Avoiding and Reducing Co-Prescribing Benzodiazepines is available. Learn about the risk, key issues, and practices to reduce coprescribing.

CMS Proposes to Cover Acupuncture for Chronic Low Back Pain for Medicare Beneficiaries Enrolled in Approved Studies

 

On July 15, CMS proposed to cover acupuncture for Medicare patients with chronic low back pain who are enrolled participants either in clinical trials sponsored by the National Institutes of Health or in CMS-approved studies. Currently, acupuncture is non-covered by Medicare. CMS conducted evidence reviews to inform this proposal, and the agency recognizes that the evidence base for acupuncture has grown in recent years, but questions remain. “Today’s proposal represents the Trump Administration’s commitment to providing Americans with access to a wide array of options to support their health,” said HHS Secretary Alex Azar. “Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.” 

 

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An epidemic unmasked: 76 billion pain pills saturated America

 

America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012 as the nation’s deadliest drug epidemic spun out of control, according to previously undisclosed company data released as part of the largest civil action in U.S. history.

The information comes from a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States — from manufacturers and distributors to pharmacies in every town and city. The data provides an unprecedented look at the surge of legal pain pills that fueled the prescription opioid epidemic, which has resulted in nearly 100,000 deaths from 2006 through 2012.

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Court Ruling Offers Hope on Pain Clinic Registrations

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Physicians can encounter a web of confusion and unfairness when it comes to navigating the Texas Medical Board. The Travis County district court has given Texas physicians clarity and hope when it comes to certain medical board investigations.

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Prescribing Changes in Texas: Know What You Need to Know

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State lawmakers passed a number of changes to how prescriptions for certain pain medications must be written and processed, as part of a larger effort to fight prescription fraud and abuse. TMA will outline what prescribers can expect as a result of these changes in a free live webinar on July 31.

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UN health agency to remove controversial opiod guidelines

The World Health Organization notified U.S. lawmakers Wednesday that it will discontinue two publications on prescribing opioid painkillers in response to allegations that the pharmaceutical industry influenced the reports.

The pledge to remove the guidelines comes a month after U.S. Reps. Katherine Clark and Hal Rogers accused the WHO of being influenced by Purdue Pharma, the American manufacturer of the potent painkiller OxyContin. The lawmakers’ report claimed the guidelines, crafted in part by organizations with financial ties to the company, downplay the risk of opioids despite the American epidemic that has killed more than 390,000 since 1999.

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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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CMS Proposes to Update e-Prescribing Standards

On June 17, CMS issued a proposed rule  - External Link Policy - Opens in a new window  that would update the Part D e-prescribing program by adopting standards that ensure secure transmissions and expedite prior authorizations.

“Improving patients’ access to prescription drugs is a top priority for CMS,” said CMS Administrator Seema Verma. “This proposed rule would reduce the time it takes for a patient to receive needed medications and ease the prescriber burden by giving clinicians the flexibility and choice to complete prior authorization transactions electronically.”

Under the proposed change, clinicians would be able to choose to complete prior authorizations online, reducing burden for providers through a more streamlined process for performing prior authorization for Part D prescriptions. Clinicians who select the electronic option will typically be able to satisfy the terms of a prior authorization in real time and before a prescription is transmitted to a pharmacy, so patients do not arrive at a pharmacy counter to find that their prescription cannot be filled.

The proposed rule would implement new prior authorization transaction standards for the Part D e-Prescribing program as required by the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. The proposed standards would begin in January 2021.

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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].

Governor Abbott Signs Opioid Legislation

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