HHS Expands Telehealth Access In Response to COVID-19

In an effort to prevent and respond to the coronavirus disease 2019 (COVID-19) pandemic, the United States Department of Health and Human Services (HHS) has awarded $20 million to increase telehealth access and infrastructure for health care providers and families. The funds, which are awarded through the Health Resources and Services Administration (HRSA), will increase capability; capacity and access to telehealth and distant care services for providers, pregnant women, children, adolescents, and families; and assist telehealth providers with cross-state licensure.

“This new funding will help expand telehealth infrastructure that is already being used during the pandemic to provide essential care, especially to the most vulnerable, including pregnant women and children with special health care needs,” said HHS Secretary Alex Azar in a press release. “This funding will also help clinicians use telehealth nationally by streamlining the process to obtain multi-state licensure.”

HRSA’s Maternal and Child Health Bureau awarded a total of $15 million to four recipients; each award supports a key area in maternal and child health, including pediatric care, maternal health care, state public health systems, and family engagement for children with special health care needs. HRSA’s Federal Office of Rural Health Policy awarded a total of $5 million to two recipients through the Licensure Portability Grant Program, which will assist telehealth clinicians nationally on licensure and credentialing to meet emerging needs related to COVID-19.

FDA Issues Guidance to Clarify DSCSA Exemptions and Exclusions During COVID-19 Pandemic

The Food and Drug Administration (FDA) continues to monitor requests related to provisions of the Drug Supply Chain Security Act (DSCSA) to ensure adequate distribution of finished prescription drug products are available to combat COVID-19. As such, FDA has recently issued new guidance to help clarify the scope of the public health emergency exemption and exclusion under the DSCSA. The guidance, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency, includes FDA’s policy regarding the exercise of its discretion in the enforcement of authorized trading partner requirements under the Federal Food, Drug, and Cosmetic Act for certain distributions involving other trading partners that may not be authorized trading partners.

The policies described in the FDA guidance apply only during the COVID-19 public health emergency. This guidance is being implemented without prior public comments. Instead, public comments may be submitted to FDA at any time for consideration by mail or through the online portal using instructions in the document. Questions about the guidance may be sent to drugtrackandtrace@fda.hhs.gov.

NCPDP Issues Industry Guidance to Aid Pharmacists in Expanding COVID-19 Testing

The National Council for Prescription Drug Programs (NCPDP) released an industry guidance to help aid pharmacists in expanding COVID-19 testing. Specifically, the NCPDP Emergency Preparedness Information Version 1.7 document provides guidance to assist pharmacists in their expanded role of administering tests (eg, serology tests) and other services during the COVID-19 pandemic. In addition, the document addresses certain emergency preparedness processes and procedures that could be established as daily occurrences to be invoked at a moment’s notice, mitigating urgent training for emergency situations.

The guidance, which is ready for immediate universal adoption, addresses some areas to consider to facilitate the exchange of data through NCPDP’s interoperable industry standards, including the different types of tests, product/service identifiers for FDA-authorized tests and test kits, and the scope of pharmacist-provided services, to name a few.

“Swift federal authorization of pharmacists to order and administer tests has empowered and expanded pharmacists’ front-line role in the nation’s response and recovery to the COVID-19 pandemic,” said Lee Ann Stember, president and CEO of NCPDP, in a press release. “Pharmacists are often the first point of contact for many patients and can provide easier and more convenient access to testing for patients who need it.”

GAO Releases Report on Challenges of CS Disposal in Home Hospice Care Settings

When hospice patients pass away at home, they often leave behind unused controlled substances (CS), which can be diverted and misused by anyone with access to them, according to a new report from the Government Accountability Office (GAO). The report, released in response to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), outlines the findings of a review conducted of select home hospices’ disposal practices and the challenges they face. Prior to the enactment of the SUPPORT Act in 2018, state laws varied in how they allowed qualified hospice programs to collect and destroy a patient’s remaining medications.

Six of the seven hospice programs contacted by GAO for the report indicated they were actively disposing leftover CS, with the remaining program awaiting promulgation of state law granting such authority. In addition, hospice officials identified best practices for preventing diversion and disposing of CS, including prescription drug counts performed by hospice employees to determine if CS are being used properly, use of lock boxes to limit access to CS in situations where diversion is suspected to be a risk, and having a witness for the disposal of unused CS.

The officials also identified challenges their hospice employees have faced when disposing of CS in patients’ homes, including the cost of certain disposal methods, a lack of a witness to the disposal process, and inconsistencies between state laws and federal law concerning which hospice employees may dispose of CS.

May 19 FDA Drug Topics Webinar to Address the Agency’s Bad Ad Program

A new FDA Drug Topics webinar will soon be available as part of the Center for Drug Evaluation and Research, Division of Drug Information’s series of educational webinars targeting the needs of all health care providers and students. The webinar, titled “FDA Drug Topics: FDA’s Bad Ad Program,” will be held May 19, 2020, at 1 PM (EST), and is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students. The webinar will provide an overview of prescription drug promotion and its regulation, along with information on how health care professionals can report potentially false or misleading prescription drug promotion to FDA.

Additional information, including how to register and an overview of the webinar and related continuing education credits, is available on the Division of Drug Information Webinars section of the FDA website.