In addition to recently enacted local, state and federal protections for frontline healthcare providers, your malpractice insurance may cover COVID vaccine administration. While it may not include specific references to COVID-19, the typical malpractice insurance issued to pharmacists provides coverage in some instances of patient injury subject to the terms, conditions and exclusions of the policy. That may also include injury resulting from vaccine administration. However, patients may file claims in the event of injuries. Therefore, you must be aware of the ways to manage and mitigate liability risk when administering COVID vaccines.
Here are answers to some common questions about the potential liabilities facing pharmacists who administer COVID vaccines.
What Types of Claims May Result from COVID-19 Vaccination?
While the COVID-19 pandemic is an unprecedented event, it may not be possible to foresee all of the types of claims that may result, based upon a review of previous non-COVID-19 vaccine-related claims, they may involve:
- Patients who sustain injuries or experience adverse events due to improper administration of the injection. Examples include damage to the muscles, tendons, or nerves in the shoulder or upper arm. These events may occur when the vaccine is injected too deeply or too high up on the shoulder.
- Patients who experience serious complications post-vaccination, where the provider failed to obtain informed consent and the patient asserts that had there been knowledge of the potential side effects, consent would have been withheld.
- The vaccine administrator did not obtain informed refusal, and the patient later asserts lack of awareness of the risks associated with refusal of the vaccine.
- The vaccine administrator does not monitor the individual appropriately after giving the injection, and the patient experiences an allergic reaction or faints, suffering injuries.
- A patient misses the second injection due to a lack of follow-up by the vaccine administrator and then contracts the virus.
How Pharmacists May Reduce the Risk of Malpractice Lawsuits When Administering COVID Vaccines
Although you may not be able to eliminate all
liability risks, you may reduce exposure to these risks by taking the following steps:
Make Sure You Comply with Local Immunization Licensing Regulations
First, you should ensure that you and any other healthcare providers in your pharmacy fulfill the immunization certification or licensing requirements specific to your jurisdiction
In most states, pharmacists must pass the APhA Pharmacy-Based Immunization Delivery
certificate training. Your state may also require you to purchase professional liability insurance that covers vaccine administration and also maintain CPR and/or Basic Life Support (BLS) certification. Some states have additional regulations, such as mandatory continuing education or regular license renewal.
Depending upon your location, your pharmacy may also require a vaccine administration protocol or standing order issued by a physician.
Educate Patients and Obtain Informed Consent or Refusal
You should make every effort to educate patients on the COVID vaccine. Good practices in this regard include, but are not limited to:
- Providing patients with vaccine information sheets in their preferred language
- Conducting and documenting informed consent discussions in a language the patients can understand
- Asking patients to sign an informed consent form
- Ensuring that patients are aware of their vaccination schedules, including sending reminders
Educate Yourself and Your Colleagues
Ensure that you and any other healthcare providers in your pharmacy are familiar with the most recent vaccination procedures, standards, and risk prevention protocols. A staff member may also be designated to monitor updates issued by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and other regulators.
Follow Vaccination Safety Protocols
Store, handle, and administer all vaccines as per the relevant manufacturer’s guidelines and follow basic safety protocols for vaccine administration. You may also wish to consult the recent report
issued by the Institute for Safe Medication Practices (ISMP) on potential concerns when administering COVID vaccines.
Track, Follow Up, and Report Any Issues
Enter all vaccinations into your state vaccine monitoring program in accordance with applicable requirements and consider creating a follow-up system to ensure that patients receive their second injection. You may suggest to patients the CDC’s dedicated smartphone app, the V-safe After Vaccination Health Checker
, that sends automatic second-dose reminders.
You should also consult the CDC COVID-19 Vaccination Interim Operational Guidelines
, which set forth the relevant documentation, tracking, reporting, and other immunization requirements. Additionally, you must enter any serious adverse events and vaccination errors in the Vaccine Adverse Event Reporting System (VAERS)
Other Legal Protections for Pharmacists Administering COVID Vaccines
Below are three of the legal protections available to pharmacists:
1. The PREP Act
In 2005, Congress passed the Public Readiness and Emergency Preparedness (PREP) Act
. The purpose of this legislation was to provide healthcare providers with certain immunities from legal liability to facilitate the implementation of measures during public health emergencies.
On March 17, 2020, HHS Secretary Alex Azar signed a declaration
extending the PREP Act immunities to measures against the COVID-19 pandemic. Since then, there have been several amendments to the declaration to clarify the activities and persons eligible for protection under the Act. These include pharmacists and other entities authorized to manufacture, deliver, distribute, administer, and/or dispense COVID vaccines.
The legal immunity from claims related to COVID vaccine countermeasures came into effect on December 3, 2020. It will remain in force until October 1, 2024, or the final day of the federal health emergency, whichever is sooner.
2. HIPAA Rules
On January 19, 2021, the HHS Office for Civil Rights announced
that it would not enforce violations of the so-called HIPAA Rules of the Health Information Technology for Economic and Clinical Health (HITECH) Act
and the Health Insurance Portability and Accountability Act (HIPAA)
during the current health emergency. HHS determined that it would exercise enforcement discretion by not imposing penalties for health care providers for the good faith use of online or web-based scheduling applications for the scheduling of individual COVID-19 vaccinations during the public health crisis.
Therefore, pharmacists and other healthcare providers who use online applications to schedule COVID vaccination appointments in good faith should not face penalties for non-compliance with the HIPAA privacy and security regulations related to protected health information (PHI). While this offers some protection relative to scheduling and technology, pharmacists should continue to adhere to consistent patient privacy practices.
3. Local and State-Specific Measures
Apart from the federal liability protections above, many states and local jurisdictions have introduced some immunities for healthcare providers relative to anti-COVID measures. Therefore, to ensure that you understand the full extent of your rights and protections, as well as the dates covered by these immunities, remain knowledgeable with respect to relevant laws and regulations.
Cover Yourself Against Legal Risks
The U.S. vaccination efforts against COVID-19 are underway, this immunization effort may give rise to some challenges for pharmacists and other healthcare providers on the frontline.