COVID-19 has forced the healthcare system to adapt to a unique set of circumstances. As reported in prior McGuireWoods updates, a number of state and federal developments have affected the practice of pharmacy during the COVID-19 pandemic. Earlier this month, the U.S. Department of Health & Human Services (HHS) issued guidance allowing pharmacists to perform COVID-19 tests to expand the availability of testing. More recently, to address the shortage of certain crucial drugs used in the treatment of COVID-19, the U.S. Food & Drug Administration (FDA) loosened restrictions to allow outsourcing facilities and compounding pharmacies to compound FDA-approved drugs.
Below are details about these developments, as well as a summary of recommendations issued by the Centers for Disease Control and Prevention (CDC) that pharmacies should follow to minimize the risk of exposure for their staff and customers during the COVID-19 pandemic.
1. Pharmacists May Administer COVID-19 Tests.
On April 8, 2020, HHS issued guidance allowing pharmacists to perform COVID-19 tests in an effort to expand the availability of rapid testing and reduce unnecessary travel to distant testing sites. According to the guidance, “pharmacists, in partnership with other healthcare providers, are well positioned to aid COVID-19 testing expansion.” Importantly, pharmacists are trusted healthcare professionals, with established relationships with patients in their communities. Most Americans live in close proximity to a retail or community pharmacy, which reduces travel to testing locations — an important mitigation measure. Pharmacists generally have strong relationships with local medical providers and hospitals to which they can refer patients for additional care if needed. In addition to COVID-19 tests, pharmacists will be allowed to perform antibody testing, which may determine whether a patient has already recovered from the infection, and may have immunity going forward. Understanding the scope of the population’s potential immunity to COVID-19 will be a critical component of any plan to reopen the economy.
According to the guidance, pharmacists qualify as “covered persons” under the Public Readiness and Emergency Preparedness Act (PREP Act), and are protected from any liability stemming from the administration of FDA-authorized tests, unless willful misconduct is involved. See 85 Fed. Reg. 15,198, 15,202 (March 17, 2020).
It is important to remember that, even under HHS’ guidance, state law continues to dictate the circumstances under which a pharmacist can order, administer and interpret COVID-19 tests. Many states already include the ordering and administering of point-of-care testing within the pharmacist’s scope of practice, which allows pharmacists to perform testing independently without a doctor’s order. Some states may require pharmacists to enter into protocols or collaborative practice agreements with prescribers, while others may allow pharmacists to perform tests only pursuant to a doctor’s prescription. Importantly, many states, such as Illinois, have issued temporary orders expanding the pharmacist’s scope of practice to include ordering, administering and interpreting point-of-care tests for COVID-19.
2. FDA Relaxes Requirements for Compounding COVID-19 Drugs.
On April 16, FDA issued its “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency.” The guidance document outlines FDA’s temporary policy to allow outsourcing facilities to compound certain critical drugs used in the treatment of hospitalized COVID-19 patients.
Outsourcing facilities are regulated under the Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 353b). Generally, outsourcing facilities are prohibited from compounding a drug that is “essentially a copy” of an FDA-approved product unless it appears on FDA’s drug shortage list. In addition, outsourcing facilities are required to use certain bulk drug substances listed in the FDA’s 503B Bulks List for compounding, and are required to comply with current good manufacturing practice (CGMP) requirements with regard to stability testing and the establishment of expiration dates.
Many hospitals have said they are experiencing difficulty in accessing FDA-approved, commercially available products. In the past few weeks, six drugs identified by HHS as priority drugs to treat COVID-19 patients have been added to the FDA drug shortage list: azithromycin tablets, propofol injectable emulsion, dexmedetomidine injection, etomidate injection, midazolam injection and cisatracurium besylate injection. The FDA drug shortage list now includes almost 20 drugs commonly used in an intensive care unit that are identified by the FDA as being in shortage.
Therefore, for the duration of the public health emergency, FDA will not take action against any outsourcing facilities for compounding a drug that is essentially a copy of an approved drug, for using a bulk drug substance that is not on FDA’s 503B Bulks List, or for not meeting CGMP requirements with respect to stability testing and expiration dates as long as all of the circumstances listed in the guidance are present. These circumstances include the following:
1) The compounded drug product appears on the list of drugs used for hospitalized patients with COVID-19.
2) The compounded drug product is provided directly to a hospital that informs the outsourcing facility it: (i) is treating patients with COVID-19, and (ii) has made reasonable attempts to obtain an FDA-approved drug product containing the same active ingredient for the same route of administration and has been unable to do so.
3) The bulk drug substances that the outsourcing facility uses to compound the drug product must conform with applicable USP monographs and sourcing from facilities registered with FDA, and must be accompanied by certificates of analysis.
4) The outsourcing facility’s practices regarding stability testing and expiration dates must meet the conditions for enforcement discretion.
In a separate guidance issued April 20, titled “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency,” FDA indicated that it will also allow compounding pharmacies regulated under Section 503A of the FD&C Act (21 U.S.C. § 353a) to compound certain critical drugs. Similar to outsourcing facilities, compounding pharmacies are generally prohibited from compounding commercially available drugs, unless certain conditions are met or to address a critical shortage. However, unlike the outsourcing facilities discussed above, compounding pharmacies regulated under Section 503A do not have to comply with CGMP requirements. Another important distinction is that compounding pharmacies are not generally allowed to prepare compounds in bulk. Rather, they are limited to preparing compounds pursuant to patient-specific orders. According to the guidance, FDA does not intend to take action against a pharmacy for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription if certain circumstances are present and the other conditions of Section 503A of the FD&C Act are met.
3. CDC Makes Recommendations to Protect Pharmacy Staff and Customers.
Pharmacies play an important role in providing medicines, therapeutics, vaccines and critical health services to the public. On April 3, the CDC published guidance for pharmacies to minimize the risk of exposing their staff and customers to COVID-19, using the principles of infection prevention and control and social distancing. The key elements of the CDC guidance include the following:
1) Advise staff who have a fever or respiratory symptoms to stay home and away from the pharmacy until they have recovered. Ensure that company policies related to sick leave are flexible and consistent with public health guidance.
2) Implement strategies to avoid direct contact with customers. Provide hand sanitizer on pharmacy counters for use by staff and customers. Encourage all prescribers to submit prescription orders via telephone or electronically to minimize the handling of paper prescriptions.
3) Use engineering controls where the customer and pharmacy staff interact, such as the pharmacy counter, to minimize close contact. This may include the use of Plexiglas barriers and signage regarding social distancing.
4) Use administrative controls and protocols to keep staff and customers separated by encouraging drive-thru pickups or deliveries when possible, limiting the number of customers allowed in the store at any given time, and making every effort to use alternatives to in-person counseling, such as telephone or electronic communications.
5) Pharmacies that are participating in COVID-19 testing should adhere to CDC guidelines regarding the use of personal protective equipment and the collection, storage and handling of specimens.
McGuireWoods has a dedicated team of experienced lawyers who will continue to monitor state and federal responses to COVID-19. Please contact the authors of this alert with any questions and for additional guidance on how pharmacists and other healthcare professionals are expanding their roles to diagnose and treat COVID-19. McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues.
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