Pharmacy Based Vaccinations

Protection Against Harmful Diseases

Vaccination remains one of the easiest, safest, and most efficient ways to protect humans from dangerous diseases. By means of the body’s innate defenses, vaccinations help create resistance to infection by preparing the immune system to respond quicker to a virulent encounter and avoid serious illness. 

According to the World Health Organization (WHO), today there are vaccines for several diseases, some of which include diphtheria, influenza, measles, pertussis, tetanus, hepatitis and now, COVID. The WHO estimates that existing vaccines save the lives of approximately 3 million people yearly. Those that get vaccinated help reduce the spread of disease, in some cases preventing severe illness or even death.

In this course, we will examine the immunization duties of the pharmacist. From counseling patients on vaccination recommendations, assessing for vaccination appropriateness, administering vaccines, and monitoring patients for adverse events, pharmacists play a significant role in providing immunization services to the public. Via a discussion of regulatory requirements, we will review some of the recent authority changes and the most current vaccination recommendations.

What is Vaccination, Immunization, and Inoculation?

The words vaccination, immunization and inoculation are often erroneously used interchangeably. Each has its own unique meaning although for the most part, they refer to similar concepts. 

Vaccination – describes the actual administration of an antigen, through any known route of administration, either nasally, intramuscularly, or orally, for the purpose of inducing immunity.

Immunization – refers to the specific process or act by which an individual achieves immunity or resistance to a communicable disease. This process occurs as a result of an administered vaccine.

Inoculation – is also the act or process of introducing an antigen into a living being with the objective to promote antibody production. It also refers to the implant of a toxin or harmful microorganism in a live environment, person, animal, or plant for the intent of research.

Despite of their differences, vaccination and immunization are designed to protect people from deadly diseases. They produce an acquired (adaptive) immune response. Upon attacking and neutralizing the specific antigen, memory cells are left behind to initiate an assault should the pathogen be re-encountered, reducing the possibility of symptomatic illness if infection occurs.

Role of the Pharmacist in Vaccination Administration

Pharmacists have always been strong promoters of health and illness prevention. They are the most accessible healthcare professional to the public and are highly regarded and trusted by their patients. As part of their role in disease prevention, pharmacists advocate for as well as administer vaccinations.

Now more than ever, it is imperative to make the counseling time with the patient more informative and engaging. By routinely screening patients for their vaccination needs, a pharmacist can identify those that can benefit from vaccines they have yet to receive.

In order to participate in the immunization effort, pharmacists must be properly trained in both, counseling patients to help guide them as to what vaccines they need based on CDC recommendations, evaluate for precautions/contraindications, and in how to correctly administer the vaccines. Since each state has different rules governing their pharmacists and the authority given to them for vaccination, pharmacists must be familiar with the vaccination administration rules established by their state.

Pharmacist Legal Authority to Vaccinate

For the privilege to administer vaccines, pharmacists must check with their state board to receive true legal authority. Each state has specific legislation authorizing a pharmacist to administer vaccines that depends on several different factors.

For example, some states allow pharmacists to vaccinate only on the order of a physician or doctor’s protocol, yet other states allow the pharmacist to prescribe and administer vaccinations independently. Then, there are states that allow a pharmacist to administer only certain predetermined, listed vaccines.

Authority also is dependent on the age of the individual receiving the vaccine. Some states allow a pharmacist to vaccinate children as young as 2 years of age. While other states, have authorized a pharmacist to immunize people of any age.

The pharmacy technicians, as of recently, following the need for vaccinators during the COVID pandemic, have also been given authority by some states to administer vaccinations. The table in an upcoming slide best summarizes current vaccination administration rules.

Vaccination Administration Rules by State

When looking at a pharmacist’s authority to administer vaccinations in each state, there are three principal categories to consider. First, which vaccines are pharmacists allowed to administer? Those vaccines recommended by CDC/ACIP, or all those vaccines specifically approved by the FDA, or just the precise vaccines that the state statue lists?

Second, does the pharmacist have independent authority? Is the pharmacist free to decide which vaccines are necessary and administer them or does she have to receive a prescription from a physician or follow a prearranged doctor’s protocol?

Lastly, is the patient’s age relevant? If so, is it for certain specific vaccines or any vaccine? Since certain vaccines are age specific, like the shingles, pneumococcal, and HPV, are pharmacists bound by the age recommendations?

The table in the following slide depicts the best way to summarize these three main categories as it relates to the pharmacist vaccination authorization in each state.Types of Vaccines

Prescriber Protocol or Prescription

Age Limits

*only certain vaccines, ²*with prescription, ³*adult dose/any age

These tables are intended to demonstrate the complexity of the various, sometimes overlapping requirements between states. To review specific pharmacist and pharmacy technician vaccination administration authority, check with your state board of pharmacy. Check your Knowledge Question and Scenario 1

Check your Knowledge Question and Scenario 1 – Answers

Training Requirements for Vaccination Administration

The PREP Act

As with all pharmacist’s responsibilities, vaccination administration also requires extensive training prior to becoming a routine undertaking. Due to the declaration of a national state of public health emergency because of COVID-19, the PREP (Public Readiness and Emergency Preparedness) Act was activated. 

The PREP Act empowers the Secretary of the Department of Health and Human Services to afford, by activation of the PREP Act, protection from liability (for those without deliberate wrongdoing), from a resultant loss following administration of countermeasures for diseases. The disease must be deemed a significant high risk to public health. The PREP Act also indemnifies those institutions or persons participating in the advancement process, production, testing, and dissemination of the countermeasures.

Under the PREP Act, the Department of Health and Human Services has given new authority to pharmacists and pharmacy interns. A pharmacist can order and administer vaccines that are recommended by the Advisory Committee on Immunization Practices (ACIP). The vaccines must be those approved by the Food and Drug Administration (FDA). 

 The pharmacy interns, under the supervision of a pharmacist, are allowed to administer these same vaccines. The authority has been extended to vaccinate any person that is of the age of three and over. This mandate supersedes any state law or regulation currently in place for the remainder of the COVID-19 pandemic.

The PREP Act, also expanded the vaccination administration authority for other qualified vaccinators besides pharmacists, pharmacy interns and pharmacy technicians. For vaccination training, the Act concurs with the state board requirements for an ACPE (Accreditation Counsel for Pharmacy Education) vaccine administration training course. Additionally, a basic cardiopulmonary resuscitation course is also required, such as BLS which is what is traditionally recommended for pharmacists.

To clarify, the Public Readiness and Emergency Preparedness Act is designed to specifically provide protection from liability, it differs from, and does not depend on other emergency declarations. 

State Board of Pharmacy

The state boards of pharmacy, as mentioned before, have similar but different directives for their vaccination authority and may have their own distinct training requirements as well. In the state of Texas, the training obligations include the completion of an ACPE 20-hour vaccine administration certification course. The course must include practical instruction on injection technique, clinical assessment of vaccine indications and contraindications, and detailed instruction on what to do in case of emergencies such as vaccine reactions.

The course must include written study material, contain hands-on training in vaccine administration, and meet Center for Disease Control and Prevention (CDC) training guidelines. More specifically, it should cover the recommended standards for pediatric, adolescent, and adult immunization practices and immunization schedules. It should provide a basic overview in immunology, the essentials on vaccine protection and vaccine preventable diseases.

Discussion on vaccine management, storage and obtaining informed consent is also required in the course. Emphasis should be given on the physiology and vaccine administration techniques. The 20-hour course is also expected to contain the ins and outs of pre- and post-vaccine assessment and required counseling. It should give guidance on the immunization record requirement and record retention.

Finally, the course must include information on the possible vaccine adverse events. It should give instruction on how to identify adverse events as well as to how to properly respond to them. Moreover, it should provide directives on how to document and report them. A minimum of 3 hours of continuing education dedicated to vaccination related material every two years is required for license renewal in Texas. 

During the Public Health Emergency due to COVID-19, the PREP Act for the vaccine administration authority was amended to allow all pharmacists to vaccinate children ages 3 to 18, regardless of their state laws. The training requirements remain the same.

Centers for Disease Control and Prevention (CDC)

The CDC, because of the availability of the COVID-19 vaccine, and the great need to recruit many vaccinators to help with the massive effort of trying to vaccinate every individual that wants to receive it, have their own training requirements.

The CDC website offers the CDC Training Modules. One of their modules gives a general overview of vaccination best practices for healthcare providers. The site also offers detailed training on each specific vaccine available for use, currently the Janssen COVID-19 vaccine (Johnson and Johnson), Moderna COVID-19 vaccine, and Pfizer-BioNTech COVID-19 vaccine.

A second training is called the “You call the shots: Vaccine Administration”. This is an additional initial requirement that provides a certificate as proof of completion. It can also be used to meet continuing education obligations. It is composed of a sequence of modules which include a discussion about vaccine preventable illnesses and provides an explanation on the most recent vaccination recommendations. 

Each vaccine or disease state such as polio, chickenpox and influenza are referenced separately in their own individual CDC module. These educational training sessions are frequently updated and contain the latest recommendations and best practices.

The third training requirement is “You call the shots: Vaccine Storage and Handling”. The proper handling and storage of vaccines is crucial for them to work as expected. Consequently, emphasis is given to obtaining the necessary knowledge on the managing and storing of each vaccine. 

The CDC explicitly states that the modules on their website can be used as training or modules from another site such as state or local health department, worksite, medical professional organization, even from a nursing or medical school. As long as it is documented training and is available for review by regulatory inspectors.Outside the CDC, a comparable program would include training in the following: pre- and post-clinical considerations, the management and storage of vaccines, preparations and administration requirements, recommendations on how to address vaccine induced anaphylaxis, documentation and reporting requirements for vaccines, and counseling information. 

Recommended Vaccinations for Children

The best way a parent can protect their children from serious diseases is by vaccinating them against these diseases. To avoid a severe bout of these illnesses that can probably cause hospitalization or even death, early immunization is key. 

The following vaccination schedule for children has been recommended by the Advisory Committee on Immunization Practices (ACIP). Then reviewed, approved, and subsequently adopted by the American Academy of Pediatrics, Centers for Disease Control and Prevention (CDC), and American Academy of Family Physicians. 

Vaccination Recommendations for Children

Birth – Hepatitis B (HepB-1stdose)

Before being discharged from the hospital, newborns receive the first dose of the Hepatitis B series which is given to help prevent chronic liver swelling that may result in liver damage or liver cancer.

One to Two Months – HepB-2nddose, Diphtheria, tetanus, and whooping cough (pertussis) (DTaP), Haemophilus Influenzae type b (Hib), Polio (IPV), Pneumococcal (PCV-13), Rotavirus (RV).

These preliminary vaccines will require boosters and are provided at this early age to initiate immunity and start providing protection.

Check your Knowledge Question & Scenario 2

Check your knowledge Question & Scenario 2 – Answers