The tests themselves might not be without inherent limitations as well. It remains to be seen what the sensitivity and specificity of each test will be, which could create problems for patients and providers alike. For example, the OTC HIV tests require antibody formation which typically takes between 3-6 weeks, and thus patients might interpret this as a false negative if they test too early, leading to obvious public health ramifications. False positives are likely to lead to unnecessary antimicrobial therapy and subsequent unwarranted therapy, whereas false negative results might ultimately create a greater burden on the healthcare system.
Finally, the patients who might gain the most benefit from self identifying sexually transmitted infections may not have access to these tests let alone treatment, either due to cost or stigma. The HIV and HCV tests have been marred by this issue to some degree as well. This segues to the question of whether these devices will be truly available OTC or available at the discretion of a pharmacist. Regardless of this decision, the role of the pharmacist could certainly be impacted, as pharmacists would have a critical role in triaging patients appropriately as well as in determining which patients may derive benefit from using these tests.
Despite the possible short-comings and details that still need to be worked out, these tests have the capacity to foster collaboration between pharmacists and physicians and ultimately provide meaningful benefit to patients. Point-of-care testing is already being integrated into patient care in many community pharmacies and thus the infrastructure is in place for these tests to also be successfully integrated. While the discussion is still in its infancy, it is difficult not to be “cautiously optimistic” about their potential.
David Cluck, PharmD is an assistant professor in the Department of Pharmacy Practice at East Tennessee State University, Gatton College of Pharmacy. He joined the college after completing a specialty residency in infectious diseases at Wake Forest Baptist Medical Center. Dr. Cluck maintains a clinical pharmacy practice in infectious diseases at Johnston Memorial Hospital in Abingdon, VA as well as a weekly outpatient HIV clinic with the ETSU HIV Center of Excellence. He is an active member of ACCP, IDSA, SIDP and AAHIVM.
- US Food and Drug Administration. FDA executive summary: over-the-counter diagnostic tests for the detection of pathogens causing infectious diseases. FDA website. www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/ UCM515522.pdf. Published August 16, 2016. Accessed September 18, 2016.
- CDC. Get Smart: know when antibiotics work. CDC website. www.cdc.gov/getsmart/community/index.html. Updated April 2015. Accessed September 18, 2016.
- Obama B. Executive Order -- Combating Antibiotic-Resistant Bacteria. Washington, DC: Office of the Press Secretary, The White House; 2014. https://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria. Accessed September 18, 2016.
To stay informed on the latest in infectious disease news and developments, please sign up for our weekly newsletter.