NABP and FSMB Issue Joint Statement on Inappropriate Prescribing and Dispensing of Medications Related to COVID-19
NABP and the Federation of State Medical Boards (FSMB) have issued a joint statement in response to recent reports that some health care providers are abusing prescribing and dispensing privileges during the coronavirus disease 2019 (COVID-19) pandemic. Specifically, reports have found that some physicians are inappropriately prescribing medications (including chloroquine, hydroxychloroquine, and azithromycin) to prevent or treat COVID-19 for themselves or their family members, and that some pharmacies and hospitals may be stockpiling these medications in anticipation of future demand.
In the joint statement, NABP and FSMB remind health care providers that it is essential to carefully follow established guidance and clinical evidence in making decisions regarding prescribing, and that patients with appropriate needs have access to approved medications. In addition, the organizations note that physicians, pharmacists, pharmacies, and hospitals have an ethical duty to put the needs of patients first, and this includes observing strict prescribing guidelines.
Physicians, pharmacists, hospitals, and other organizations are encouraged to visit the COVID-19 web resource pages made available on the NABP website and on the FSMB website for questions about prescribing, licensing, and other regulatory matters.
President Trump Invokes Defense Production Act as New COVID-19 Hotspots Emerge
President Donald J. Trump has invoked the Defense Production Act of 1950 to compel American manufacturers to produce respirators and other needed medical equipment during the COVID-19 pandemic. The number of infections continues to grow with recent surges seeping into major cities such as Detroit, MI; Chicago, IL; and New Orleans, LA, according to The Washington Post. Relevant developments over the last few days include:
- Approximately 265 million Americans in 32 states, 81 counties, 18 cities, the District of Columbia, Puerto Rico, and one territory are now under orders to stay at home except for certain activities or to work at essential businesses, such as grocery stores.
- Food and Drug Administration (FDA) has posted questions and answers related to consumer use of hand sanitizer.
- FDA has taken steps to increase supply of ventilators and respirators during the emergency.
- Centers for Disease Control and Prevention (CDC) has updated their strategies for optimizing supplies of personal protective equipment.
As of this writing more than 160,000 COVID-19 infections and over 2,800 fatalities have been reported in the United States, according to CDC. New York remains the center of the pandemic in the US, with at least 75,000 cases. Worldwide, the COVID-19 has claimed at least 36,500 lives and more than 750,000 have been infected with the virus, according to World Health Organization (WHO).
Pharmacists are encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information about the outbreak and for emergency information for pharmacists and other health care providers. In addition, the American Pharmacists Association has created a COVID-19 resource center for pharmacists.
FDA Issues First Emergency-Use Authorization for Anti-Malaria Drugs to Treat Certain Hospitalized Patients Diagnosed With COVID-19 if a Clinical Trial is Not Available
FDA issued an emergency-use authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to certain hospitalized teen and adult patients with COVID-19, when a clinical trial is not available or feasible. While there are no currently approved treatments for COVID-19, hydroxychloroquine sulfate and chloroquine phosphate have shown activity in laboratory studies, and anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients.
The EUA requires that fact sheets that provide important information about using hydroxychloroquine sulfate and chloroquine phosphate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. SNS will work with the Federal Emergency Management Agency to ship donated doses to states.
This is the first EUA for a drug related to COVID-19. FDA has issued an EUA for multiple diagnostics, for several other medical devices such as respiratory devices and a system for decontaminating them to allow for their reuse, and ventilators and ventilator equipment due to COVID-19.
Experimental Coronavirus Drug Remdesivir Being Made Available Through Expanded Access Program
Originally developed as a potential treatment for Ebola and Marburg viruses, the experimental drug remdesivir is being made available to doctors through a government-approved expanded access program to accelerate emergency use for severely-ill patients diagnosed with COVID-19.
Gilead Sciences Inc announced in an open letter that remdesivir is being made available outside of the six ongoing clinical trials and is investigating whether it is effective as a treatment for COVID-19. “The urgency comes from knowing the desperate need among patients and the lack of any approved treatment,” said Gilead’s Chairman and CEO Daniel O’Day. “The responsibility is to ensure that remdesivir, an investigational medicine, is effective and safe before it is distributed for use worldwide.”
While there is no data to show whether it is safe and effective at treating COVID-19, a WHO panel in January 2020 said that remdesivir was considered to be the most promising therapeutic candidate based on its broad antiviral spectrum, and existing data based on human and animal studies.
HHS OCR Issues Bulletin on Civil Rights Laws, HIPAA Guidance During COVID-19 Pandemic
The Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS) issued a bulletin to ensure that covered entities do not unlawfully discriminate against people with disabilities when making decisions about their treatment during the COVID-19 pandemic. According to OCR, entities covered by civil rights authorities must keep in mind their obligations under laws and regulations that prohibit discrimination on the basis of race, color, national origin, disability, age, sex, and exercise of conscience and religion in HHS-funded programs.
The Americans with Disabilities Act, Section 504 of the Rehabilitation Act, the Age Discrimination Act, and Section 1557 of the Affordable Care Act, which prohibits discrimination in HHS-funded health programs or activities, are enforced by OCR and these laws will remain in effect during the COVID-19 crisis.
“HHS is committed to leaving no one behind during an emergency, and helping health care providers meet that goal. Persons with disabilities, with limited English skills, and older persons should not be put at the end of the line for health care during emergencies,” said OCR Director Roger Severino in a press release.
The bulletin also addresses the flexibilities of Health Insurance Portability and Accountability Act (HIPAA) rules in response to the COVID-19 crisis, including guidance on telehealth remote communications, how first responders and others may disclose protected health information about individuals exposed to COVID-19, and how health care providers can share information with CDC, family members of patients, and others, to help address the COVID-19 emergency.
New York State Attorney General Asks Online Registrars to De-List COVID-19 Scam Websites
In a series of letters written to top internet domain registrars – companies that manage the reservation of internet domain names – New York Attorney General Letitia James has requested that individuals trying to unlawfully and fraudulently profit from COVID-19 have their registrations halted, and websites de-listed.
According to a press release, the Office of the Attorney General has discovered a significant number of domain names related to “coronavirus” that are being used to conduct phishing campaigns and other attacks. One recent study found that 3% of domains registered since January that mention coronavirus are actively malicious, and another 5% are categorized as “suspicious.” Many of the sites have marketed fake treatments and vaccines, but some have also created fake charities and coronavirus-related investment opportunities.
“In this time of uncertainty, it’s more important than ever that we remain cautious when it comes to companies and individuals selling coronavirus-related products and services over the internet,” said Attorney General James in the press release. “These scam sites are not only stoking fear in the hearts and minds of Americans, but are profiting off their appalling deception.”
US House Subcommittee Holds Hearing to Address Substance Use Disorder Legislation
On Tuesday, March 3, 2020, the Subcommittee on Health of the Committee on Energy and Commerce held a legislative hearing to address a number of bills that expand access to substance use disorder treatment. The hearing, “Combatting an Epidemic: Legislation to Help Patients with Substance Use Disorders,” included testimony from HHS, the Centers for Medicare & Medicaid Services, and Drug Enforcement Administration, as well as professionals from various health providers and national advocacy organizations.
Subcommittee members discussed the status of several not yet implemented provisions of the 21st Century Cures Act and Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. They also discussed 14 bills to further expand access to substance use disorder treatment, including the Medicaid Reentry Act (H.R. 1329), Opioid Workforce Act of 2019 (H.R. 3414), and Suspicious Order Identifying Act of 2019 (H.R. 4814).