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7 Risks Pharmacists Administering the COVID-19 Vaccine Should Be Aware Of

Pharmacists are on the front lines of COVID-19 vaccine administration in the United States, supporting the rollout ever since the Department of Health and Human Services (HHS) authorized state-licensed pharmacists to provide this service in December 2020.

The Federal Retail Pharmacy Program for COVID-19 Vaccination has brought together 21 national pharmacy partners independent pharmacy networks, federal governments, as well as US states and territories. The program is being implemented incrementally in accordance with vaccine availability. Ultimately, it is expected that the program will expand to include all of the country’s 40,000+ pharmacies.

As a pharmacist, you can play a valuable role in this vital public health initiative. However, you must follow all recent federal, state, and local guidelines to minimize professional risk. An understanding of some of the pharmacists’ risks for COVID-19 vaccine administration can help.


Pharmacists’ Risks for COVID-19 Vaccine Provision

Guidance for pharmacists’ COVID-19 vaccination strategies has been issued as part of the Public Readiness and Emergency Preparedness Act (PREP). In addition, individual states and local governments have issued restrictions and rules regarding details such as those individuals who qualify for vaccine eligibility. This guide provides a broad overview of the risks pharmacists may encounter if they are considering, or plan to administer the COVID-19 vaccine. It should not replace official federal, state or local governmental guidance regarding vaccine administration protocol.
Basic Eligibility for Pharmacists to Provide COVID-19 Vaccinations

Only authorized persons may administer a COVID-19 vaccination. For example, pharmacists with an active state license may have the authority to administer and order the vaccine. Pharmacists administering COVID-19 vaccinations must also have a current basic CPR certificate.

In contrast, pharmacy technicians licensed or registered according to state-specific requirements are authorized solely to administer the vaccine. They are not permitted to order the vaccine. Moreover, they may administer the vaccine only under the supervision of qualified pharmacy professionals.

If the state has no licensing or registration requirements for pharmacy technicians, the individual must have a Certified Pharmacy Technician (CPhT) credential from the Pharmacy Technician Certification Board (PTCB) or National Healthcareer Association (NHA).

The American Pharmacists Association (APhA) provides a more detailed overview of eligibility requirements for pharmacists, pharmacy technicians, student pharmacists, and retired pharmacists. Adhering to these rules can reduce pharmacists’ risks for COVID-19 vaccine administration.
Training Required for Pharmacists to Vaccinate

Pharmacists must complete a practical training program approved by the Accreditation Council for Pharmacy Education to vaccinate. The training must encompass at least 20 hours and the pharmacist must complete at least two hours of ACPE-approved education on immunization. This must be completed during each state’s licensing period. There may be additional state training requirements.
Pharmacist Employee Supervision Requirements

Be aware of the supervision requirements for administering COVID-19 vaccines. If you work in a pharmacy and require supervision, you should  ensure that supervision is provided. For example, pharmacy technicians are permitted to administer vaccines solely under the supervision of a qualified pharmacist.  
Guidance for Vaccine Storage and Handling

Infrastructure is a significant issue in safe and secure vaccine storage and handling. Considerations include the following:
  • COVID-19 vaccines must be safely locked in a secure location, e.g., locked freezer, refrigerator, safe, or automated dispensing device.

  • Policies and procedures must be established and implemented governing vaccine access, such as assigning who has access via key controls and passwords. For automated dispensing machines, biometric identification is preferable to passwords.

  • Traditional key-lock security must include protocols for tracking, securing, and replacing keys and changing locks if needed.

Read the APhA guide  “Vaccine Storage and Handling, A Guide to CDC VFC Recommendations” for more details.
Vaccine Administration Protocols

Pharmacists may administer only those vaccines that have been authorized or licensed by the Food and Drug Administration (FDA). Further, they must order vaccines according to guidance from the Centers for Disease Control and Prevention(CDC) Advisory Committee on Immunization Practices (ACIP). Vaccines should only be administered to approved individuals, such as those meeting minimum age requirements).
Record-Keeping and Reporting Requirements

As a pharmacist, you cannot simply administer a vaccine and then send a patient away. The pharmacy should develop a process to ensure that immunization data is appropriately collected, stored, and communicated to the patient (e.g., product, lot number, expiration).
This type of protocol helps to ensure that the appropriate dosage administration and intervals have been observed.

Further, the pharmacy should participate in a plan to identify, track, and report any adverse events via the HHS Vaccine Adverse Event Reporting System and Institute for Safe Medication Practices National Medication Errors Reporting Program (ISMP MERP). This data is critical to supplementing information regarding vaccine safety and efficacy. Note that state and local reporting requirements also may apply.
Well-Child Visit Notification Requirement for Minors

If a pharmacist administers the COVID-19 vaccine to an individual age 18 or younger, information must be provided to the individual and responsible adult of the importance of a well-child visit.  Referrals to a pediatrician or other licensed primary care provider may be presented, as appropriate. APhA provides tools that can help with information-sharing, including a well-child brochure.


Stay Up to Date with the Latest COVID-19 Vaccine Information

As the above resources indicate, risks encountered by pharmacists in administering the COVID-19 vaccine are diverse.  Notably, information surrounding COVID-19 vaccinations continues to evolve. It is thus important to access the most recent relevant guidelines pertaining to federal, state and local laws and regulations.

Here are some resources to consult: This list is not exhaustive. There may be additional resources with up-to-date guidelines, rules, and restrictions regarding pharmacist administration of the COVID-19 vaccine. It is important to do your research to ensure that you abide by local, state, and federal laws and regulations. Doing your homework in this area can help minimize pharmacists’ risks for delivery of the COVID vaccine.


Professional Liability Coverage with HPSO

Pharmacists are not immune to legal claims. Healthcare Providers Service Organization (HPSO) provides professional liability coverage for claims for injury or damage to a person arising from professional services provided by pharmacists. The APhA sponsors this coverage. With this added security, you can serve your community’s needs more confidently as a pharmacist administering the COVID-19 vaccination. Your insurance can also help cover you in case of incidents not related to COVID-19.
This publication is intended to inform Affinity Insurance Services, Inc., customers of potential liability in their practice. This information is provided for general informational purposes only and is not intended to provide individualized guidance. All descriptions, summaries or highlights of coverage are for general informational purposes only and do not amend, alter or modify the actual terms or conditions of any insurance policy. Coverage is governed only by the terms and conditions of the relevant policy. Any references to non-Aon, AIS, NSO, HPSO websites are provided solely for convenience, and Aon, AIS, NSO and HPSO disclaims any responsibility with respect to such websites. This information is not intended to offer legal advice or to establish appropriate or acceptable standards of professional conduct. Readers should consult with a lawyer if they have specific concerns. Neither Affinity Insurance Services, Inc., HPSO, nor CNA assumes any liability for how this information is applied in practice or for the accuracy of this information.

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