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The PREP Act and Pharmacist Administration of COVID-19 Vaccines


By Georgia Reiner, MS, Senior Risk Specialist, Healthcare Providers Service Organization (HPSO)


The light at the end of the dark tunnel of the COVID-19 pandemic is vaccination. The push is on to vaccinate large numbers of Americans, and pharmacists are being called on to help with the administration.


Pharmacists are essential vaccine providers and are being asked to engage in our nation’s fight against COVID. It’s important to understand the responsibilities and expectations associated with COVID-19 vaccine administration so you can meet the requirements of vaccine providers, understand liability protections and protect yourself from potential legal action. Those responsibilities include meeting requirements outlined in the US Department of Health and Human Services (HHS) Declaration Under the Public Readiness and Emergency Preparedness (PREP) Act for Medical Countermeasures Against COVID–19 and its amendments. These amendments authorize pharmacists (and in some cases pharmacy interns and technicians) to administer COVID-19 vaccines, provided they adhere to certain parameters. Pharmacists also need to adhere to other federal requirements, such as those from the CDC.



What is the PREP Act?
The PREP Act authorizes the HHS secretary to issue a declaration that provides immunity from liability for claims of loss related to countermeasures (such as vaccines or drugs) against public health emergencies. According to the PREP Act website (http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx), immunity means that “Courts must dismiss claims brought against any entity or individual covered by the PREP Act.”  Loss is broadly defined and includes death and physical, mental, or emotional injury, illness, disability, or condition.


Immunity, however, does not apply in the case of willful misconduct. Willful misconduct is defined in detail at www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx#immune3, but essentially refers to intentionally doing wrong. The willful misconduct must have “proximately caused death or serious injury,” according to an HHS advisory opinion. Willful misconduct lawsuits must be brought before a three-judge court in the US District Court for the District of Columbia. Further, plaintiff’s counsel can file suit, immunity or no immunity, if the plaintiff’s counsel believes the client was injured and that injury was the direct result of the healthcare professional providing or failing to provide professional services.


Ten declarations are currently in effect, including ones related to Ebola disease, Zika virus, and pandemic influenza. The most recent is the declaration for COVID-19, issued March 17, 2020. Four amendments have been added since then, with the fourth released on December 3, 2020.


COVID-19 vaccination declaration
The COVID-19 PREP Act declaration authorizes state-licensed pharmacists to administer COVID-19 vaccines that have been licensed or authorized by the FDA. Pharmacy interns and pharmacy technicians who meet state requirements may also administer the vaccines, but only under the supervision of a qualified pharmacist who is immediately available. (Note: Pharmacy technicians working in states without licensure and/or registration requirements must have Certified Pharmacy Technician certification from either the Pharmacy Technician Certification Board or the National Healthcareer Association.) Pharmacists should consider the declaration parameters and requirements throughout the vaccination process.


Training requirements
Before administering COVID-19 vaccines, pharmacists must meet training requirements, starting with completing immunization training required by the state(s) in which they are licensed. If the state doesn’t have any specific training, the pharmacist must complete a training program approved by the Accreditation Council for Pharmacy Education (ACPE). The program must be at least 20 hours long and should include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.


Pharmacists who supervise interns or technicians should know that these groups also have a training requirement: They must complete an ACPE-approved practical training program that includes the same content listed for pharmacists; however, no time requirement is specified. Pharmacists, interns, and technicians also must have completed basic CPR training.
The training requirements don’t end there. Pharmacists and technicians are required to complete at least 2 hours of ACPE-approved, immunization-related continuing pharmacy education during each licensing period.


CDC requirements
Providers administering the COVID-19 vaccine must sign an agreement with the CDC. The CDC COVID-19 Vaccination Program Provider Agreement covers recommendations, requirements, and other guidance from the CDC, including Advisory Committee on Immunization Practices (ACIP) recommendations (see CDC COVID-19 Vaccination Program Provider Agreement requirements). The agreement notes that providers who divert vaccines to someone not currently authorized to receive it are committing fraud. Providers also must administer COVID-19 vaccines regardless of a person’s ability to pay.


Screening and education
Pharmacists need to follow best practices related to vaccine administration. Before giving the vaccine, screen patients to determine their appropriateness for vaccination. The CDC has a useful tool with three categories: may proceed with vaccination, precaution to vaccination, and contraindication to vaccination (www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html).  Contraindications include a severe allergic reaction (for example, anaphylaxis) to any component in the vaccine or to a previous dose. Examples in the precaution category include patients who have a history of immediate allergic reactions to other vaccines or injectable therapies. If you are unsure if the patient should be vaccinated, it’s best to defer until a physician or nurse practitioner can conduct a more detailed evaluation. 


Before being vaccinated, patients need to review an FDA fact sheet for vaccines that are under emergency use authorization. You can download a fact sheet at www.cdc.gov/vaccines/covid-19/eua/index.html.


Be sure to monitor patients for at least 15 minutes after vaccination (30 minutes for those in the precaution category who have a history of a previous immediate reaction). Patient education should include information about minor and major possible adverse effects and what to do should they occur. You might mention the option of V-safe, a smartphone-based tool from the CDC that uses text messaging and web surveys to provide personalized health check-ins after someone receives a COVID-19 vaccine. The tool also sends a reminder if a second dose of vaccine is needed. Provide written material in the patient’s preferred language to refer to later and document education in the patient’s record.


Reporting and documentation
The CDC provider agreement specifies reporting requirements that pharmacists must follow. Much of the reporting information needed for the individual receiving the vaccine will already be in the person’s record, but you’ll also need to add the vaccine’s name, manufacturer, lot number, dose number, and expiration date; route of administration; vaccination site; and who administered the vaccine. The agreement notes that providers must “document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction as soon as practicable and no later than 72 hours after administration.” In addition, you’ll need to report vaccine inventory each day in VaccineFinder (www.cdc.gov/vaccines/covid-19/reporting/vaccinefinder.html).


Pharmacists also must report certain adverse events, including vaccine administration errors (even if they were not associated with an adverse event), serious adverse events as defined by the FDA (such as death or a life-threatening event), cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death to the Vaccine Adverse Event Reporting System (VAERS). You may also want to file a report with the Institute for Safe Medication Practices (ISMP; www.ismp.org/report-medication-error), which is analyzing errors and providing suggestions for avoiding them.


In addition, pharmacists should comply with recordkeeping and reporting requirements in the areas where they practice, such as documenting administered vaccines in state immunization information systems. And, of course, pharmacists must comply with any other federal requirements that apply to the administration of COVID-19 vaccines.


Protection under the PREP Act COVID-19 declaration does not mean you can worry less about documentation. In fact, HHS guidance related to the declaration encourages those covered to document the “reasonable precautions they have taken to safely use the covered countermeasures.” The COVID-19 vaccine is a covered countermeasure.


Be prepared
Pharmacists play a key role in the effort to administer the COVID-19 vaccine to as many people possible in the shortest amount of time possible. However, pharmacists need to adhere to federal, state, and local requirements related to preparing, administering, reporting, and record keeping. By doing so, they can deliver vaccinations confident that they are protecting themselves from legal action. 


Note: This information was current as of January 25, 2021. Check for updates at www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx and www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.


CDC COVID-19 Vaccination Provider Program Agreement requirements
Here’s a sample of what is included in the agreement. For complete information, go to www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html. Pharmacists need to adhere to the agreement to reduce the risk of legal action from not meeting requirements, especially if patient harm results. Be sure to sign up to receive email updates related to the content.

  • ACIP recommendations
  • Administration and reporting requirements
  • Requirements for safe immunization practice
  • Requirements for vaccine storage and handling
  • Requirements for reporting to VAERS.

Source: Centers for Disease Control and Prevention. CDC COVID-19 vaccination program provider requirements and support. 2021. www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.


COVID-19 vaccine resources
Here are a few resources related to pharmacists administering COVID-19 vaccines.

 

RESOURCES



Disclaimer: This risk management information was provided by Healthcare Providers Service Organization (HPSO). The information offered within this article reflects general principles only and does not constitute legal advice by HPSO or establish appropriate or acceptable standards of professional conduct. ​Readers should consult with an attorney if they have specific concerns. Healthcare Providers Service Organization is a registered trade name of Affinity Insurance Services, Inc., a licensed producer in all states (TX 13695); (AR Ins. Lic. 100106022); in CA & MN, AIS Affinity Insurance Agency, Inc. (CA 0795465); in OK, AIS Affinity Insurance Services, Inc.; in CA, Aon Affinity Insurance Services, Inc., (CA 0G94493), Aon Direct Insurance Administrators and Berkely Insurance Agency and in NY, AIS Affinity Insurance Agency. Neither Affinity Insurance Services, Inc. nor HPSO assumes any liability for how this information is applied in practice or for the accuracy of this information. ​