Health SecurityAhead of Print CommentaryFree AccessBuilding on Success Serving the Nation: Codifying Key Pharmacy Practice Authorities Beyond COVID-19Lisa M. Koonin, Sara E. Roszak, and Kayla M. McFeelyLisa M. KooninAddress correspondence to: Lisa M. Koonin DrPH, MN, MPH, Founder & Principal, Health Preparedness Partners, 1818-A Independence Square, Suite A, Atlanta, GA 30338 E-mail Address: lisakoonin@healthpreparednesspartners.comLisa M. Koonin, DrPH, MN, MPH, Founder and Principal, Health Preparedness Partners, Atlanta, GA.Search for more papers by this author, Sara E. RoszakSara E. Roszak, DrPH, MPH, Senior Vice President, Health and Wellness Strategy and Policy; National Association of Chain Drug Stores, Arlington, VA.Search for more papers by this author, and Kayla M. McFeelyKayla M. McFeely, PharmD, Senior Director, Pharmacy Care, Health and Wellness Programs; National Association of Chain Drug Stores, Arlington, VA.Search for more papers by this authorPublished Online:10 May 2023https://doi.org/10.1089/hs.2023.0085AboutSectionsPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail IntroductionDuring the COVID-19 pandemic, pharmacies have been at the frontlines serving as “critical access points for millions of Americans in receiving convenient and timely COVID-19 vaccines, treatments, and tests.”1 Federal emergency authorities2 were issued periodically during the pandemic that reduced barriers, removed restrictive practice policies, and improved access to COVID-19 vaccinations, tests, and treatments to the US population.These policies were enabled by the release of multiple emergency declarations. On January 31, 2020, Secretary of the US Department of Health and Human Services (HHS) Alex Azar, declared a public health emergency in response to the COVID-19 outbreak.3 On March 10, 2020, the HHS Secretary issued a Public Readiness and Emergency Preparedness (PREP) Act declaration,4 which was followed by multiple amendments, advisory opinions, and HHS guidance.2 On March 11, 2020, the World Health Organization announced that the COVID-19 outbreak was characterized as a pandemic.5 In response to this announcement, on March 13, 2020, then President Trump declared a national emergency6 and this declaration was renewed every 90 days until it was terminated on April 10, 2023.7BackgroundThe temporary federal policies, effective in all states, allowed trained pharmacists and pharmacy staff to provide vaccinations for COVID-19, influenza, and other diseases; tests for COVID-19; and treatment for COVID-19. Before the enactment of these policies, pharmacy staff had varying ability to provide these services based on individual state laws and regulations promulgated by boards of pharmacy. Before the emergence of the pandemic, licensed and trained pharmacists were authorized in every state and the District of Columbia to administer vaccinations to adults. In some states, a patient-specific prescription from another healthcare provider was required, or there were limitations on the type of vaccine that could be administered. Additionally, some states had vaccination administration restrictions based on the patient's age.8 Pharmacists in several states could perform certain tests for diseases and initiate certain therapies before the pandemic. However, pharmacists faced various restrictions that limited their ability to comprehensively implement such services at full scale.9 In addition, the authority of pharmacy technicians and interns to assist and support pharmacists in vaccination and testing was highly variable across states before the pandemic.10The PREP Act declaration and amendments, HHS advisory opinions, HHS guidance, and US Food and Drug Administration (FDA) authorities enacted between March 2020 and July 2022 temporarily lifted most of these state-specific age and practice restrictions. These federal policies authorized pharmacists to order and administer COVID-19 tests, COVID-19 vaccinations for individuals ages 3 years and older, childhood vaccines for persons ages 3 to 18 as recommended by the CDC Advisory Committee on Immunization Practices (ACIP), and specific COVID-19 treatments. In addition, these federal actions authorized pharmacy technicians and interns to administer COVID-19 tests, COVID-19 vaccinations for persons ages 3 years and older, all ACIP-recommended childhood vaccines for persons ages 3 to 18, and influenza vaccines to adults, preempting state-specific restrictions. When emergency declarations are terminated, states will once again set these policies for pharmacy staff.The IssueOn April 10, 2023, President Biden signed House Joint Resolution 7 into law, which ended the COVID-19 pandemic national emergency declaration.7 While this action ended the national emergency and set the target for terminating the public health emergency declaration, the expiration of the pharmacy PREP Act authorities was unspecified. On April 14, 2023, HHS released a fact sheet11 that announced a forthcoming amendment will extend selected PREP Act amendments relating to pharmacy practice through December 2024. Specifically, the fact sheet states that PREP Act immunity from liability will be extended for pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to individuals ages 3 years and older, consistent with other requirements), and administer FDA-authorized COVID-19 tests. The fact sheet also noted the PREP Act will continue to offer liability immunity for pharmacists prescribing and dispensing COVID-19 treatments, including the federally purchased antiviral Paxlovid (nirmatrelvir/ritonavir). HHS also issued a letter to governors on April 14, 2023, making them aware of the upcoming policy changes.12 These actions were called for by pharmacies and other stakeholders to provide clarity and certainty for maintaining access to patient care services, especially following the federal public health emergency expiration in May 2023.13,14However, this announcement clarified that after the public health emergency is terminated on May 11, 2023, practice authorities and liability coverage would no longer extend to pharmacists, interns, and technicians to administer routine childhood vaccines, with the exception of COVID-19 and influenza for those ages 3 years and older. Further, once these emergency policies expire in December 2024, pharmacists, pharmacy technicians, and pharmacy interns may no longer be able to administer COVID-19 and flu vaccinations, conduct testing for COVID-19, or provide direct access to COVID-19 treatments, unless their state explicitly allows for such practice.Accomplishments of Pharmacies During the COVID-19 PandemicSince the 2009-2010 H1N1 influenza pandemic when pharmacies first administered pandemic vaccine,15 pharmacies have served as a vital resource for pandemic planning and response.16,17 The US Centers for Disease Control and Prevention (CDC) includes pharmacies in its national plans as a key provider of pandemic vaccinations.18-20During the COVID-19 pandemic, CDC began active planning with pharmacies to serve as key immunizers once it was determined that vaccines would be manufactured and distributed. CDC initially engaged 21 retail pharmacy partners in the Federal Retail Pharmacy Program for COVID-19 Vaccination and provided vaccines and support to more than 41,000 locations nationwide.21 As of April 27, 2023, pharmacies in the program had provided more than 302.2 million COVID-19 vaccinations.22 During 2022-2023, more than two-thirds of adult COVID-19 vaccinations were administered at pharmacies.1Pharmacies have also provided more than 42 million COVID-19 tests.23 In April 2020, the federal government created a partnership with community pharmacies as part of the Community-Based Testing Sites program, which is now known as the Community Access to Testing program.24 More than 20,000 COVID-19 testing locations nationwide have been supported by pharmacies, as well as state and local sites,25 and over 70% of these sites are in areas with moderate to severe social vulnerability.26 Overall, pharmacies have provided 87% of the free tests administered through the program.27In July 2022, the FDA authorized state-licensed pharmacists to prescribe and dispense COVID-19 oral antivirals to eligible patients under certain protocols.28 Pharmacies have dispensed over 8 million courses of oral COVID-19 antivirals as of April 2023.29 HHS has reported that 35,000 of the 40,000 (87.5%) antiviral dispensing sites are pharmacies.11One study estimates that pharmacy personnel reached more than 150 million people during the pandemic, and averted more than 1 million COVID-related deaths, more than 8 million hospitalizations, and $450 billion in healthcare costs.23 Pharmacies were able to achieve these successes because of 3 key factors: years of experience safely and efficiently providing care to the public including vaccinations; pharmacy authorities granted by the PREP Act, its amendments, HHS guidance, and advisories; and adequate coverage and reimbursement for pharmacy-based services that were provided during the pandemic.30Rationale for Codifying Practice Authorities and Regulation for PharmaciesSome states have begun to permanently implement pharmacy practice authorities granted under the PREP Act to advance healthcare access for their residents. For example, in May 2022, Virginia became one of the few states where the full authorities were fully codified, including payment of Medicaid services.31,32 Virginia pharmacists are also authorized to initiate treatment for adults based on test results for strep, flu, urinary tract infections, and COVID-19 under a statewide protocol.33There are several key reasons for all states to maintain broad access (beyond the expiration of emergency authorities) to pharmacy-provided immunizations (including COVID-19 vaccines and other ACIP-recommended vaccines), COVID-19 testing, and the provision of COVID-19 treatments.Pharmacies Can Improve Access and Reduce Health InequitiesPharmacies are convenient and accessible sources of healthcare and pharmaceutical services, with approximately 89% of the US population living within 5 miles of a community pharmacy.34 A recent survey found that 86% of US adults said it is “very easy” or “somewhat easy” to access pharmacies, and pharmacies were rated the highest for accessibility among all healthcare destinations.35 Pharmacies typically offer extended hours, including evenings and weekends, when most healthcare providers' offices and clinics are closed.One of the most notable policy changes through the COVID-19 PREP Act and its amendments was the inclusion of pharmacy technicians as vaccinators and providers of COVID-19 tests. The authorization granted to pharmacy technicians allowed pharmacies to serve more patients and, at the same time, freed up pharmacists to provide other patient interventions requiring their clinical expertise. The authorizations also helped improve pharmacy workflow and reduced wait times for vaccinations.36 Before enactment of these temporary federal policies, only 3 states (Idaho, Rhode Island, Utah) authorized pharmacy technicians to administer some vaccines.10 However, at the time of writing, at least 27 states have authorized some level of vaccination authority for pharmacy technicians.37In many communities, pharmacies have provided critical services in light of substantial erosion of the public health workforce38 and understaffing of ambulatory clinics and practices.39 The nation faces a projected shortage of physicians and registered nurses within the next decade.40,41 These provider shortages limit the number of venues available to provide clinical services and place more reliance on pharmacies to continue providing vaccinations, tests, and COVID-19 treatments.Although pharmacies are present in almost every community, many rural communities have little or no access to other providers.42 In 2021, about 14% of US adults reported not having a personal healthcare provider (“medical home”), whereas more than twice the number of Hispanic adults (29%) reported not having an affiliation with a doctor or other healthcare provider.43 The situation is worse for children; overall, less than half (47%) of children have a usual source of care/medical home.44 In particular, there is a chronic shortage of pediatricians practicing in rural areas, resulting in limited access to care.45Additionally, there are well-documented gaps in the access to care and vaccination coverage among minority groups and vulnerable populations. Pharmacies have served as the primary providers of COVID-19 vaccines for these groups. Pharmacy staff initially vaccinated many residents of long-term care facilities.46 More than 43% of individuals vaccinated at pharmacies are from racial and ethnic minority groups, and half of the pharmacy COVID-19 vaccination sites are in areas of high social vulnerability.47 Recently HHS announced a new program that builds on the success of pharmacies reaching these populations, by providing continued access to free COVID-19 vaccinations and treatments for the uninsured at pharmacies, until December 2024.1 Pharmacy leaders recounted that one of the biggest successes of pharmacies administering COVID-19 vaccinations was their ability to serve existing patients and the wider community, including reaching underserved communities.30Possible Ongoing Need to Revaccinate the PopulationThere may be a need to revaccinate a large proportion of the population as public health officials are likely to recommend additional boosters or annual vaccinations. The FDA announced in mid-April 2023 an authorization for the administration of additional doses of COVID-19 vaccine boosters for people ages 65 years and older and people who are immunocompromised.48 The FDA and CDC advisory committees are deliberating whether to recommend annual vaccinations for all eligible people.49,50 In addition, the COVID-19 vaccine was recently added to ACIP's recommended vaccination schedules for children and adolescents ages 18 or younger and for adults ages 19 and older.51 Therefore, it is possible that a large proportion of the US population will need vaccinations on an ongoing basis, necessitating an adequate immunization workforce. Pharmacy staff will likely play important roles in this effort.Public Familiarity With Pharmacy Provision of Vaccinations, Tests, and TreatmentsThe public now considers pharmacies routine places to receive vaccinations, tests, and treatments, particularly as a result of the COVID-19 pandemic. There is substantial public support for maintaining policies that increased access to pharmacy services during the pandemic. National surveys conducted by Morning Consult in March 2022 and again in December 2022 found that 70% of US adults supported the continuation of pharmacy policies for improved access to vaccinations and 68% supported making these policies permanent.52 Those who received a COVID-19 vaccination booster from a pharmacy were even more supportive: 85% supported extending these policies and 84% favored making these policies permanent.53During the 2022-2023 influenza season, pharmacies provided a substantial proportion of influenza vaccinations to adults (39%), especially for those ages 65 years and older (45%), exceeding the proportion given at medical offices.54,55 During the 2021-2022 flu season, most children (67%) received their influenza vaccination at a medical office.56 However, about 15%56 of children received their influenza vaccination at a pharmacy that season, compared with about 7%57 of children during the 2019-2020 flu season (before the enactment of temporary pandemic policies). More than 46% of children ages 5 to 11 years who received a COVID-19 vaccination did so at a pharmacy.58Pharmacy Infrastructure Is Crucial for Emergency PreparednessMaintaining a permanent pharmacy-based infrastructure is needed for national emergency preparedness. Codifying these temporary federal authorities, which have proven safe and effective, into permanent state laws and regulations will enhance the nation's ability to respond to existing and emerging threats by securing a permanent, trained workforce that can immediately begin providing pandemic vaccines, tests, and treatments across the nation when needed. Allowing the pharmacy PREP Act policies to lapse without modernization across states would require pandemic programs to have to be reinstated and reactivated when needed, which could lead to delayed response efforts. Keeping pharmacies actively providing these services means they can “hit the ground running” during an emergency.Conclusion and Call to ActionThe successes of pharmacies during the COVID-19 pandemic have affirmed their important role in emergency response,59 as well as in providing daily, equitable access to care. The authorities granted under the COVID-19 PREP Act declarations have been pivotal because they allowed pharmacy staff to provide access to lifesaving pandemic countermeasures. It is important to retain this capability to respond to the ongoing circulation of the virus that causes COVID-19 and to ensure readiness for the next infectious disease outbreak, while also maintaining pharmacies as access points for vaccines, testing, and treatment for other routine and emerging health threats.Because many of these authorities will be retained through December 2024, governors and their teams, in addition to state legislators, regulators, and boards of pharmacy, will have a reasonable timeline to take action. Beyond public health emergencies, continuing these policies will support better healthcare access for all, including underserved populations, and advance improved health for the nation.AcknowledgmentsWe thank Shane Velez for his assistance in editing the manuscript.