The landscape of public health is constantly evolving, requiring agile legal and regulatory frameworks to address emerging challenges. One such framework in the United States is the Public Readiness and Emergency Preparedness (PREP) Act. This act empowers the Secretary of Health and Human Services (HHS) to issue declarations that provide liability immunity to certain individuals and entities involved in the development, distribution, and administration of medical countermeasures during public health emergencies.
Recently, an amendment to a PREP Act declaration was issued, focusing on expanding access to childhood vaccinations amidst the ongoing COVID-19 pandemic. This article delves into this amendment, explaining its purpose, key provisions, and implications for public health.
The Context: Public Health Emergency and Declining Vaccination Rates
The COVID-19 pandemic, declared a public health emergency in January 2020, has had far-reaching consequences beyond the direct impact of the virus itself. One significant collateral effect has been a decrease in routine childhood vaccination rates. As reported by the Centers for Disease Control and Prevention (CDC), disruptions in healthcare access, social distancing measures, and parental concerns about potential COVID-19 exposure during healthcare visits have contributed to this decline.
This drop in vaccinations poses a serious public health threat. Reduced immunization coverage increases the risk of outbreaks of vaccine-preventable diseases, potentially straining the healthcare system further and leading to avoidable adverse health outcomes, especially if concurrent with a resurgence of COVID-19 or seasonal influenza.
The PREP Act and Medical Countermeasures
To understand the amendment, it’s crucial to grasp the basics of the PREP Act. Enacted in 2005, the PREP Act authorizes the HHS Secretary to issue declarations providing liability immunity to “Covered Persons” against claims of loss resulting from the administration or use of “Covered Countermeasures” during a declared public health emergency. This immunity is intended to encourage the rapid development, distribution, and use of medical countermeasures, such as vaccines and treatments, during public health crises.
“Covered Persons” include manufacturers, distributors, program planners, qualified persons, and their officials, agents, and employees. “Qualified persons” are typically healthcare professionals authorized to prescribe, administer, or dispense countermeasures under state law. The definition also allows the Secretary to identify additional categories of persons as “qualified persons” in a declaration.
“Covered Countermeasures” encompass medical countermeasures, including vaccines, that are used to prevent, treat, or mitigate diseases, health conditions, or threats.
Expanding “Qualified Persons”: The Role of Pharmacists
The amendment in question focuses on expanding the definition of “qualified persons” to include state-licensed pharmacists and pharmacy interns under their supervision, specifically for the purpose of administering childhood vaccines. This expansion is a direct response to the concerning decrease in childhood vaccination rates during the pandemic.
Key Provisions of the Amendment:
The amendment identifies state-licensed pharmacists and supervised pharmacy interns as “qualified persons” under specific conditions when they order and administer vaccines to individuals aged three through 18. These conditions are designed to ensure patient safety and maintain quality of care:
- FDA-Authorized or Approved Vaccines: The vaccine must be authorized or approved by the Food and Drug Administration (FDA).
- ACIP Immunization Schedule: Vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices (ACIP) standard immunization schedule.
- Pharmacist Training: Licensed pharmacists must complete a practical training program of at least 20 hours approved by the Accreditation Council for Pharmacy Education (ACPE). This program must include hands-on injection technique, clinical evaluation of vaccine indications and contraindications, and recognition and treatment of emergency reactions.
- Pharmacy Intern Training: Licensed or registered pharmacy interns must also complete a practical training program approved by ACPE, covering the same areas as pharmacist training.
- CPR Certification: Both licensed pharmacists and licensed or registered pharmacy interns must hold a current certificate in basic cardiopulmonary resuscitation (CPR).
- Continuing Education: Licensed pharmacists are required to complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
- Recordkeeping and Reporting: Pharmacists must comply with recordkeeping and reporting requirements, including informing the patient’s primary care provider (when available) and submitting information to state or local immunization information systems (vaccine registries). They must also adhere to adverse event reporting requirements and review vaccine registries before administration.
- Well-Child Visit Recommendation: Pharmacists must inform childhood vaccination patients and their caregivers about the importance of well-child visits with a pediatrician or other primary care provider and refer patients as appropriate.
These requirements align with many existing state laws that already permit pharmacists to administer vaccines to children, demonstrating a harmonization of federal and state efforts to enhance vaccine access.
Rationale for Including Pharmacists
Several factors underpin the decision to include pharmacists as qualified persons for childhood vaccinations:
- Accessibility: Pharmacies are widely accessible, with nearly 90% of Americans living within five miles of a community pharmacy as of 2018. They often offer extended hours and greater convenience compared to traditional doctor’s offices.
- Trusted Healthcare Professionals: Pharmacists are trusted healthcare professionals with established patient relationships. They also have strong ties with local medical providers and hospitals, facilitating appropriate referrals when necessary.
- Existing Role in Vaccination: Pharmacists already play a significant role in adult vaccination, particularly for influenza. Expanding their role to childhood vaccines leverages their existing infrastructure and expertise.
- Addressing Healthcare Disparities: Pharmacists can improve vaccine access in underserved areas or for populations with limited access to pediatricians and primary care providers.
By leveraging the accessibility and expertise of pharmacists, the amendment aims to significantly expand the reach of childhood vaccination programs, mitigating the risks associated with declining immunization rates.
Impact and Public Health Benefits
This amendment is expected to have several positive impacts on public health:
- Increased Vaccination Rates: By making vaccinations more readily available through pharmacies, the amendment aims to increase childhood vaccination rates and reduce the risk of outbreaks of vaccine-preventable diseases.
- Reduced Strain on Healthcare System: Expanding the pool of vaccinators can alleviate pressure on pediatricians and primary care providers, particularly during periods of high demand or public health emergencies.
- Prevention of Avoidable Illnesses: Increased vaccination coverage will prevent numerous cases of childhood infectious diseases, reducing suffering and improving overall public health.
- Liability Protection: The PREP Act liability immunity provides reassurance to pharmacists and pharmacy interns, encouraging their active participation in vaccination efforts without fear of unwarranted lawsuits related to vaccine administration (except in cases of willful misconduct).
Relationship with the National Vaccine Injury Compensation Program
It’s important to note that the PREP Act amendment does not affect the National Vaccine Injury Compensation Program (NVICP). The NVICP is a federal program that provides compensation to individuals who have suffered certain injuries from specific vaccines. Covered countermeasures under the PREP Act that are also subject to the NVICP are covered by the PREP Act for liability immunity and injury compensation only to the extent that compensation is not provided under the NVICP. This ensures a consistent and comprehensive framework for vaccine-related injury claims.
Clarification of Disease Category
The amendment also clarifies the category of disease, health condition, or threat for which Covered Countermeasures are recommended. It explicitly states that this category includes not only COVID-19 but also other diseases, health conditions, or threats that may have been caused by COVID-19, including the decrease in childhood immunization rates and the resulting increase in infectious diseases. This clarification reinforces that addressing the decline in childhood vaccinations is considered a crucial component of the public health response to the COVID-19 pandemic.
Conclusion: Strengthening Public Health Preparedness
The amendment to the PREP Act declaration, expanding the scope of “qualified persons” to include pharmacists for childhood vaccinations, represents a significant step towards strengthening public health preparedness and response. By leveraging the accessibility and expertise of pharmacists, this amendment aims to enhance vaccine access, improve childhood immunization rates, and mitigate the broader public health consequences of the COVID-19 pandemic. This proactive approach underscores the adaptability of the PREP Act framework in addressing evolving public health needs and ensuring the well-being of communities.
