The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) invites innovators to submit novel design solutions for its ASPIRE (A Specialized Platform for Innovative Research Exploration) Design Challenges.

NCATS Announces HEAL Design Challenges to Inspire Innovative Opioid Crisis Solutions

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) invites innovators to submit novel design solutions for its ASPIRE (A Specialized Platform for Innovative Research Exploration) Design Challenges. Supported through the NIH Helping to End Addiction Long-termSM (HEAL) Initiative, the goal of the Challenges is to reward and spur innovative and catalytic approaches toward solving the opioid crisis through development of: (1) novel chemistries; (2) data-mining and analysis tools and technologies; and (3) biological assays that will revolutionize discovery, development and pre-clinical testing of next generation, safer and non-addictive analgesics to treat pain, as well as new treatments for opioid use disorder and overdose.

NCATS anticipates that this integrated platform ultimately can be generalized to address many of the roadblocks in automated chemistry. Read more.

The NIH Back Pain Consortium (BACPAC) Research Program, a component of the NIH HEAL (Helping to End Addiction Long-term) Initiative, has published four RFAs.

NIH BACPAC Holds Public Webinar for 4 Requests for Applications

The NIH Back Pain Consortium (BACPAC) Research Program, a component of the NIH HEAL (Helping to End Addiction Long-term) Initiative, has published four RFAs. The NIAMS will hold a public applicant webinar on all four of the RFAs on Wednesday, December 19, 2018, from 11:00 AM - 1:00 PM EST. Read more.

Through some 30 new funding opportunities within the Helping to End Addiction Long-Term (HEAL) Initiative, the National Institutes of Health (NIH) is seeking research ideas for curbing opioid abuse and addiction from basic science to implementation research across all disciplines.

APS E-News | Advocacy Update Report | December 2018

NIH Announces HEAL Initiative Funding Opportunities

Through some 30 new funding opportunities within the Helping to End Addiction Long-Term (HEAL) Initiative, the National Institutes of Health (NIH) is seeking research ideas for curbing opioid abuse and addiction from basic science to implementation research across all disciplines in

• opioid addiction and overdose medications
• implementation science for preventing and treating addiction
• addiction prevention and treatment
• preclinical research on pain
• clinical trials on pain management
• improving outcomes in infants and children exposed to opioids.

NIH plans to award more than $850 million in support of HEAL Initiative research in 2019. This adds to a substantial investment made by NIH Institutes and Centers (ICs) in the areas of pain, addiction, complementary medicine, and much more.

“The NIH HEAL Initiative is taking an ‘all-hands-on deck’ approach to this crisis, garnering expertise from almost every NIH IC to attack the problem from all angles,” said NIH Director Francis Collins, MD PhD. “We are seeking applications from research institutions that understand innovative clinical trial design and a wide range of pain conditions to help us build a clinical trial network that can evaluate the full spectrum of potential strategies for pain management. For HEAL’s success, we will call upon expertise in modeling human organs on tissue chips so that we can study how the brain is altered by addiction and how to reverse these changes with medication.”

He added, “We recognize that the plan is ambitious, but we are confident that with the robust contributions of the research community we will improve treatments for opioid misuse and addiction, enhance pain management, and provide lasting solutions to the opioid crisis.”

Find more information about the HEAL Initiative and an overview of the research plan, on the NIH website.

A new pain pathway has been discovered, which mediates the “soothing” response after injury – like blowing on a burn or cradling a hurt hand.

New Pain Pathway Discovered

A new pain pathway has been discovered, which mediates the “soothing” response after injury – like blowing on a burn or cradling a hurt hand. The researchers contend that failing to account for this pathway could explain why new analgesic drugs developed in mice may fail to translate to humans.Read more.

The National Center for Complementary and Integrative Health (NCCIH), at the National Institutes of Health (NIH), is sponsoring a workshop on December 8, entitled "Evaluating the Therapeutic Potential of Cannabinoids: How to conduct research within the current regulatory framework".

Upcoming NCCIH Workshop

The National Center for Complementary and Integrative Health (NCCIH), at the National Institutes of Health (NIH), is sponsoring a workshop on December 8, 2018 to discuss the processes and issues related to conducting cannabinoid research. “Evaluating the therapeutic potential of cannabinoids: How to conduct research within the current regulatory framework” will bring together researchers, government officials, and industry representatives to discuss the processes and issues related to conducting cannabinoid research.

Read more.

The NIH, as part of the Helping to End Addiction Long-Term (HEAL) initiative is planning to release a Funding Opportunity Announcement for clinical trials on comparative effectiveness research.

Funding Opportunity Announcement for HEAL Pain Effectiveness Research Network

The NIH, as part of the Helping to End Addiction Long-Term (HEAL) initiative is planning to release a Funding Opportunity Announcement for clinical trials on comparative effectiveness research. A notice providing more information on the planned FOA was released and is available on the NIH Guide. Read more.

The National Academies of Sciences, Engineering, and Medicine is holding a workshop entitled "The Role of Nonpharmacological Approaches to Pain Management".

Upcoming NASEM Workshop

Workshop Objectives:

• Review the current state of evidence on the effectiveness of nonpharmacological treatments and integrative health models for pain management, as well as available evidence on use patterns and patient interest. Examples may include acupuncture, manual therapies, physical therapy and exercise, cognitive behavioral therapy, tai chi, yoga, meditation, and neurostimulation.
• Consider multimodal approaches and potential synergies between pharmacological and nonpharmacological approaches to pain management.
• Consider multimodal approaches and potential synergies between devices and nonpharmacological approaches to pain management.
• Discuss research gaps and key questions for further research.
• Examine health professions' current approaches for educating students, trainees, and practicing clinicians on nonpharmacological pain management, and discuss potential next steps to improve training and education within and across health professions.
• Explore policies, such as those related to reimbursement, that would enable broader dissemination and implementation of evidence-based nonpharmacological treatments when appropriate.

Read more and register.

This webinar will introduce the audience to several funding opportunity announcements (FOAs), all seeking to develop medical devices to treat pain.

NIH Webinar: Developing Medical Devices to Treat Pain

This webinar will introduce the audience to several funding opportunity announcements (FOAs), all seeking to develop medical devices to treat pain. These FOAs support different degrees of technological maturity. All focus on approaches that target the nervous system to provide therapeutic, rehabilitative, or diagnostic capability.

Read more and register.

Review key provisions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act.

APS E-News | Advocacy Update Report | November 2018

H.R. 6 Becomes Law

Now named the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act, its enactment brings to a close the legislative phase of a massive undertaking by multiple committees in both chambers of Congress.

Here are some key provisions summarized by the Pain Care Coalition:

• Medicaid Program Integrity: Section 1004 expands current state Medicaid drug utilization review activities by requiring Medicaid programs to implement safety checks to monitor opioid refills, concurrent opioid prescriptions, and antipsychotic medications prescribed to children. Medicaid providers will also be required to check relevant prescription drug monitoring programs before prescribing a Schedule II controlled substance and must also report all PDMP data and information to CMS (Section 5042).
• Electronic Prescribing for Medicare Drugs: Starting in 2021, all prescriptions for a Schedule II, III, IV, or V Controlled Substance covered under a Part D prescription drug plan or MA prescription drug plan will be required to be transmitted in accordance with an electronic prescription drug program established under Section 1860D of the Social Security Act.1 Exceptions will be made for situations such as economic hardship or when the prescribing practitioner and dispensing pharmacy are the same entity (Section 2003).
• Identifying At-Risk Beneficiaries: All prescription drug plans within the Medicare program will be required to develop and implement a drug management program for at-risk beneficiaries. Other provisions require Medicare Part D plans to classify any beneficiary with a history of opioid-related overdose as “at-risk.” Part D beneficiaries will be able to appeal this designation to an external entity (Section 2007).
• Prescribing Guidelines: The Food and Drug Administration (FDA) is required to develop opioid analgesic prescribing guidelines for acute pain treatment. The FDA will consult stakeholders and gather public input when developing these guidelines. The guidelines will be intended only to inform clinical decision making and are not meant to deny or restrict access to healthcare treatments (Section 3002).
• Increase Access to Medication-Assisted Treatment: Section 3201 increases the number of qualified healthcare providers that can prescribe or dispense buprenorphine, a well-known medication-assisted treatment (“MAT”). This provision authorizes clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists to prescribe MAT. Qualified physicians will now be able to prescribe MAT to as many as 100 patients upon becoming board-certified, and up to 275 patients 1 year after receiving the initial waiver.
• Outlier Providers: Under Section 6065, the Department of Health and Human Services will be required to notify and provide resources to providers who prescribe opioids above a threshold limit when compared to prescribers within the same specialty and geographic location. HHS is charged with establishing the threshold limits for outlier prescribers. However these thresholds will be determined based on informal consultation with stakeholders and could become a backdoor way for Medicare to implement prescribing guidelines.
• Pain Management Study: HHS is required to submit a report to Congress on how to improve reimbursement and coverage for multi-disciplinary, evidence-based, non-opioid chronic pain management. The report must include options for improving treatment and case management strategies for various high-risk patient populations (Section 6086).
• Prescription Drug Monitoring Programs (“PDMPS”): The CDC is authorized to provide grants to states to improve PDMPs, update PDMP program capabilities, promote community health interventions, and for the evaluation and development of interventions that prevent controlled substance overdoses. This will improve information sharing between states and support research activities related to combating the opioid crisis. The National All Schedules Prescription Electronic Reporting act (NASPER) is also rewritten to guide the use of grant funds for the improvement of state drug monitoring.
• Research: Various provisions provide for increased funding and expand the scope of opioid-related research. Section 7041 allows the National Institute of Health to use its “other transactions authority” to focus on the opioid crisis and on finding non-addictive alternatives for pain management. The bill also expands the scope of the Interagency Pain Research Coordinating Committee to identify risk factors for substance use disorders (“SUD”) and summarize advances in pain care research, including the use of nonpharmacologic treatments and non-addictive medical products (Section 7042).

Read H.R. 6.

Opioid prescribing remains high and varies widely by specialty, according to a new study, “Opioid Prescribing by Specialty and Volume in the U.S.,” in the American Journal of Preventive Medicine.

APS E-News | Advocacy Update Report | November 2018

Study Shows Opioid Prescribing Remains High

Opioid prescribing remains high and varies widely by specialty, according to a new study, “Opioid Prescribing by Specialty and Volume in the U.S.,” in the American Journal of Preventive Medicine. The findings in this study highlight important insights into opioid prescribing in the United States. A total of 209.5 million opioid prescriptions were dispensed in the United States from July 1, 2016, to June 30, 2017. The most common opioid prescribers were doctors in family, internal, and pain medicine; nurse practitioners, physician assistants, and dentists.

Key Findings

• Average number of opioid prescriptions written per prescriber was 215.8, with the highest among pain medicine (1,314.9) and physical medicine and rehabilitation (1,023.1) specialty groups, followed by orthopedics (438.7) and family medicine (428.4).
• Primary care physicians accounted for 35.8% of all prescriptions, non-physician prescribers accounted for 19.2%, and pain medicine specialists accounted for 8.9%.
• The proportion of opioids prescribed by physician assistants and nurse practitioners has increased since 2012 and is expected to continue to rise given their increased role in the healthcare system.

Read the study.

In a report issued September 14, the CDC estimates that 20 percent of US adults (50 million) have chronic pain and 8 percent (20 million) have high-impact chronic pain.

APS E-News | Advocacy Update Report | November 2018

CDC Publishes New Report on Chronic Pain Incidence

The 2016 National Pain Strategy called for more precise estimates of chronic pain and high-impact chronic pain which limits life activities. In a report issued September 14, the CDC estimates that 20 percent of US adults (50 million) have chronic pain and 8 percent (20 million) have high-impact chronic pain. Read the report.

The FDA has released a statement addressing efforts against drug shortages.

FDA is Advancing New Efforts to Address Drug Shortages

The FDA, along with other government agencies, industry, and stakeholders, is working to minimize the impact of drug shortages and maintain or restore availability of critical medicines for the patients who need them.

Read more.

The FDA recently approved a powerful new opioid with higher potency than fentanyl.

FDA Approves Powerful New Opioid

The FDA recently approved a powerful new opioid with higher potency than fentanyl, despite the sharp rise in fentanyl-related overdose and death in recent years. Despite these fears, this new drug may provide a powerful tool to alleviate pain in the worst sufferers, such as late stage cancer patients.

Read more.

The 2018 Future Leader Grant Recipients have been announced. Join us in congratulating the winners!

Congratulations to the 2018 Future Leader Grant Recipients!

Bryan Copits, PhD
Molecular mechanisms of somatosensory circuit assembly

Mary Janevic, PhD MPH
A new model to reach vulnerable older adults with pain self-management support

Behnaz Jarrahi, PhD
Machine Learning to Characterize Effects of Opioids on the Brain in Chronic Pain

These recipients were selected for demonstrating great merit and potential for success. This year's APS Future Leaders grants will be funded by the Mayday Fund. Two awards for $25,000 each are given to basic science pain research proposals and one award for $25,000 to a translational pain research proposal.

FDA commissioner, Dr. Gottlieb, issued a statement on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

FDA Issues Statement on SUPPORT for Patients and Communities Act

FDA commissioner, Dr. Gottlieb, issued a statement on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

Read more.

Patients at Akron General in Ohio hospital are getting non-opioid drugs to manage pain before and after operations.

Patients at Ohio Hospital Have Surgery Without Opioids

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

Read more.

The National Center for Advancing Translational Sciences (NCATS) has released NOT-TR-19-007, a Notice of Intent to Publish a Funding Opportunity Announcement for Tissue Chips to Model Nociception, Addiction, and Overdose.

Notice of Intent to Publish an RFA for Tissue Chips to Model Nociception, Addiction, and Overdose

The National Center for Advancing Translational Sciences (NCATS) has released NOT-TR-19-007, a Notice of Intent to Publish a Funding Opportunity Announcement for Tissue Chips to Model Nociception, Addiction, and Overdose. This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative and will be intended to create and test devices that can model the mechanisms or effects of nociception/pain-relevant signaling, addiction, or opioid use disorders (OUDs), using human tissues in in vitro microphysiological systems (MPS), also known as “tissue chips” or “organs-on-chip”. The FOA will invite applications for development and validation of highly reproducible and translatable in vitro MPS models that can be utilized for preclinical efficacy studies by providing information on the discovery and validation of translatable biomarkers, development of standardized methods for preclinical efficacy testing, and definitive efficacy testing of candidate therapeutics using best practices and rigorous study design. Neural and non-neural tissue platform development and validation will be supported. The FOA is expected to be published in December 2018, with an expected application due date in February 2019.

Read more.

The 2019 CSDA competition is now open and accepting pre-proposals. The deadline to submit pre-proposals is November 28, 2018 at 3 pm ET.

Clinical Scientist Development Award

The Doris Duke Clinical Scientist Development Award provides grants to early-career physician scientists to facilitate their transition to independent clinical research careers. The Clinical Scientist Development Award consists of $150,000 annual direct costs plus $15,000 (10 percent) annual indirect costs for three years. The priority of the CSDA program is to fund outstanding individuals with potential for clinical research careers, whose projects will address highly significant research questions and lead to career advancement. DDCF does not have funding priorities based on disease area or research type.

Read more.

The CDC National Center for Injury Prevention and Control has developed and released Quality Improvement and Care Coordination: Implementing the CDC Guideline for Prescribing Opioids for Chronic Pain.

APS E-News | Advocacy Update Report | October 2018

CDC Develops New Quality Improvement and Care Coordination Resource

The CDC National Center for Injury Prevention and Control has developed and released Quality Improvement and Care Coordination: Implementing the CDC Guideline for Prescribing Opioids for Chronic Pain. The quality improvement measures provided in the resource are intended to be flexible providers to choose interventions most appropriate for their practices and patient populations. The recommendations are voluntary and designed to apply evidence in CDC’s Guideline for Prescribing Opioids for Chronic Pain to clinical practice.

Learn More.

Beginning October 1, the U.S. Centers for Disease Control (CDC) Injury Center is providing funds through the Research Grants for the Primary or Secondary Prevention of Opioid Overdose.

APS E-News | Advocacy Update Report | October 2018

CDC Awards New Research Grants

Beginning October 1, the U.S. Centers for Disease Control (CDC) Injury Center is providing funds through the Research Grants for the Primary or Secondary Prevention of Opioid Overdose. More than $8.5 million per year over a 3-year project period will be awarded to support 12 grants (up to $750k per year per project). According to the CDC, the funding supports research that expands and advances understanding about what works to prevent opioid overdose and will improve the ability of state and local health departments to implement and improve interventions.