What Pharmacists Should Know

An outbreak of respiratory disease caused by a novel (new) coronavirus was first detected in China and has now been detected in more than 100 locations internationally, including the United States. Health and government officials are constantly learning new information about preventing, detecting, and treating the virus. Below are resources for pharmacists and other healthcare providers.

Controlled Substances

Drug Enforcement Administration (DEA) has posted information on the registration of emergency temporary sites, telemedicine prescriptions for controlled substances, controlled substance prescription refills, DEA-222 form exceptions, and more.

• Effective January 1, 2020 and until the end of the Department of Health and Human Services’ (HHS) public health emergency declaration, DEA-registered practitioners are exempt from limitations imposed by the “five percent rule”.
• DEA asks that reports of hydroxychloroquine and chloroquine hoarding be made to local DEA offices even though these drugs are not controlled substances.
• DEA has released guidance on the issuance of oral Schedule II prescriptions.
• DEA has provided a decision tree to help DEA-registered practitioners prescribe controlled substances without having to interact in-person with their patients. This chart only addresses prescribing controlled substances and does not address administering or direct dispensing of controlled substances, including by narcotic treatment programs (OTPs) or hospitals.
• For specific policy questions, email DEA.

Food and Drug Administration (FDA) has issued guidance about a temporary policy on the distribution of drug samples.

Emergency use authorizations

• FDA has revoked the emergency use authorization of chloroquine and hydroxychloroquine and has provided additional information for frequently asked questions
• FDA has provided an emergency use authorization on remdesivir

Personal Protective Equipment

• FDA issues temporary policy regarding non-standard personal protective equipment (PPE) for sterile compounding by pharmacies not registered as outsourcing facilities.
• FDA provides guidance for conserving PPE to assist health care organizations as they determine operations procedures during the outbreak. The full recommendations may be found in FDA’s letter, Surgical Mask and Gown Conservation Strategies – Letter to Healthcare Providers. FDA has also published a list of nine FAQs regarding surgical masks and gowns.
• The USP Compounding Expert Committee released a resource on Shortages of Garb and Personal Protective Equipment (PPE) for Sterile Compounding During COVID-19 Pandemic.
• CriticalPoint offers strategies for implementing these USP guidelines.
• ASHP is conducting biweekly surveys on the status of medical supplies during the COVID-19 pandemic.
• Hoarding or price gouging of PPE should be reported to the National Center for Disaster Fraud at 866/720-5721 or disaster@leo.gov.

Compounding and Compounding Hand Sanitizers

• The most recent update related to compounding from FDA can be found here. Information can also be found in the human drug compounding and drug shortages sections of the FDA website. Questions can be emailed to compounding@fda.hhs.gov
• Temporary policies for compounding of certain drugs for hospitalized patients are outlined below:
  • Outsourcing Facilities
  • Pharmacy Compounders not Registered as Outsourcing Facilities
• Temporary policies for compounding hand sanitizers are outlined below:
  • Manufacture of Alcohol for Incorporation Into Alcohol Based Hand Sanitizer Products
  • Preparation of Certain Alcohol-Based Hand Sanitizer Products
  • Compounding of Certain Alcohol-Based Hand Sanitizer Products
• USP has released resources for compounding hand sanitizers.
  • Compounding Alcohol-Based Hand Sanitizer During COVID-19 Pandemic
  • Hand Sanitizer Tool Kit for compounders, drug manufacturers, and other facilities

Telehealth

The Centers for Medicare and Medicaid Services (CMS) temporarily expanded access to telehealth services covered by Medicare so that more beneficiaries can receive services from their doctors and other health care providers without having to travel to a health care facility. The goal is to permit Medicare beneficiaries to receive care in their homes during the COVID-19 pandemic.

DEA has partnered with SAMHSA to ensure that those with opioid use disorder may be treated during the public health emergency and has released guidance on prescribing buprenorphine to new and existing patients via telephone.

Medical Licensing Waivers

A list of state medical licensure activity and emergency declarations can be found on the FSMB website.

COVID-19 Test Administration

HHS released information about COVID-19 testing plans by state and jurisdiction.

OASH’s Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act was released on April 8. Additional documentation was compiled by APhA to help pharmacists understand this guidance.

CDC has compiled resources and information for laboratories.

The Centers for Medicare & Medicaid Services (CMS) has released a document detailing how pharmacies and other suppliers can apply for waivers that will let them temporarily enroll as independent clinical diagnostic laboratories, which are regulated by the agency.