On May 13, 2020, Paul R. Rodríguez, New Jersey’s Acting Director of the Division of Consumer Affairs, issued an Administrative Order permitting licensed pharmacists in New Jersey to order and administer testing for COVID-19. Under the Administrative Order, pharmacists must use test kits approved by the Food and Drug Administration (FDA) or authorized pursuant to FDA’s Emergency Use Authorization (EUA) authority to test for the SARs-CoV-2 virus, the virus that causes COVID-19, or its antibodies. This is a significant step in expanding access to COVID-19 testing in the Garden State, as New Jersey has over 18,000 licensed pharmacists, all of whom may now administer FDA-approved tests at the over 2,000 pharmacy locations across the state. The Administrative Order is effective through the end of the public health emergency or state of emergency declared by Governor Phil Murphy in Executive Order No. 103, whichever is later.
New Jersey’s Administrative Order follows federal guidance from the Department of Health & Human Services (HHS) issued on April 8, 2020, which authorized licensed pharmacists to order and administer FDA-authorized COVID-19 test kits. Notably, the guidance from HHS stated that pharmacists will qualify as “covered persons” under the Public Readiness and Emergency Preparedness (PREP) Act, which may afford them immunity with respect to all claims for losses caused by, arising out of, relating to or resulting from the administration or use of FDA-authorized COVID-19 tests. For additional information regarding HHS’ guidance, please review our alert discussing the topic.
New Jersey’s Administrative Order explicitly waives numerous legal requirements that would typically pose an impediment to pharmacists ordering, administering and interpreting COVID-19 tests. For example, New Jersey pharmacists may now perform COVID-19 testing activities without entering into a collaborative practice agreement or protocol with a physician, without obtaining a prescription or standing order from a physician, and without physician supervision.
New Jersey pharmacists may perform COVID-19 testing specimen collection at, or immediately outside of, any registered pharmacy in the state and the pharmacist may send the specimen to an appropriate laboratory for analysis, without the need for a prescription or order from another health care provider. Additionally, pharmacists may perform specimen analysis on-site at the pharmacy (without the need to send the specimen to a laboratory for analysis) if (i) the COVID-19 test kit is CLIA-waived and (ii) the pharmacy has obtained a CLIA Certificate of Waiver from the Centers for Medicare and Medicaid Services (CMS). Currently, the FDA has deemed four COVID-19 test kits as CLIA-waived. Pharmacists performing specimen analysis should verify that the test kits administered at the point-of-care setting are deemed CLIA-waived by the FDA.
Prior to administering COVID-19 tests, pharmacists are required to provide patients with a written description of the COVID-19 test kit that will be used, the test kit’s purpose consistent with its FDA approval or EUA, and obtain the patient’s written signature on an informed consent form. Pursuant to the Administrative Order, pharmacists are not allowed to perform any type of specimen collection requiring venipuncture.
New Jersey’s Administrative Order further permits pharmacists to interpret patients’ COVID-19 test results and, if the specimen analysis is performed on-site, the pharmacist may provide the results directly to the patient. The Administrative Order permits pharmacists to provide such test results without first consulting with the patient’s treating physician. The Administrative Order also requires pharmacists to provide patients with information regarding follow-up care, as appropriate. If a pharmacist sends a patient’s specimen out for laboratory analysis, the Administrative Order requires the patient be provided with written information explaining how to obtain the test results, when the patient can expect to receive his or her results, and information regarding the need for follow-up care.
As a condition of being able to order and administer COVID-19 tests, pharmacists are required to collect and maintain certain patient data relating to any testing performed, including providing such information to the New Jersey Department of Health in the form, manner and frequency as the Commissioner of Health may require.
Pharmacists who intend to perform COVID-19 tests must notify the New Jersey Board of Pharmacy (BOP) and must adhere to the agency’s recordkeeping and safety precaution requirements. Notifications to the BOP should be sent via email to NJPharmacist@dca.lps.state.nj.usI with the subject line containing the following format: COVID19 TESTING – “Pharmacy permit number” – “Pharmacy Name” – “Pharmacy City.” The body of the email to the BOP should include the following information: (i) name and address of the pharmacy location; (ii) information about the COVID-19 test to be utilized; (iii) where the testing will take place (inside the pharmacy or immediately outside of the pharmacy); (iv) name of the pharmacist in charge; and (v) confirmation from the pharmacist in charge that (on the day this notification was sent to the BOP) he/she confirmed on the FDA website that the COVID-19 test is authorized for use by the FDA using this link. Pharmacists must also notify both the FDA and BOP of any suspected occurrence of false positive or false negative results and any significant deviations from the established performance characteristics of the test kit.
Permitting pharmacists to perform COVID-19 testing is an important step in expanding access and availability of such testing in the community and at point-of-care locations. To date, the FDA has authorized only one at-home specimen collection kit for the testing of COVID-19, but this home test kit is subject to several restrictions. For instance, this at-home test kit is available only to individuals who have been screened by a health care provider after completing an online questionnaire, and the specimen sample may only be sent to specified laboratories for COVID-19 diagnostic testing. This underscores the importance of the role pharmacists and pharmacies have in helping to order and administer COVID-19 tests.
Pharmacies, especially the pharmacies offering COVID-19 testing, should consider implementing the infection control strategies and recommendations set forth in the Guidance for Pharmacies issued by the Centers for Disease Control and Prevention (CDC). This guidance is intended to aid pharmacies in minimizing pharmacy staff members’ risk of exposure to the SARS-CoV-2 virus and to reduce the risk for patients visiting the pharmacy.
Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.