Course Content
Introduction:
History of vaccines
Humans have been attempting to use what we now call vaccines for over 1000 years. There is evidence that an attempt to prevent disease using a rudimentary form of vaccination occurred in China in 1000 CE. Turkey and Egypt have records of similar attempts to prevent disease using tissues and fluids from sick patients.1 In 1796, English physician Edward Jenner developed the first smallpox vaccine and nearly 100 years later Louis Pasteur created a rabies vaccine.1 Since the work of Pasteur, the development of vaccines for infectious diseases has become refined with over 25 human diseases now controlled, in part, with vaccines.2 Vaccines to prevent over 10 other infectious diseases are currently in development world-wide.3
Vaccines exist to treat both viral and bacterial diseases. Vaccines provide protection against diseases spread from human to human, zoonotic diseases (diseases spread from animals to humans), and the environmental disease tetanus. These vaccines are estimated to save 2 to 3 million lives every year.1 The year 2020 clearly demonstrated how important finding vaccines for disease prevention is to world-wide health. Scientists around the globe are working to find vaccines that are effective in preventing the spread of the SARS-CoV-2 virus that is responsible for COVID. Even after successful vaccines have been identified scientists will continue to work to make improvements. Recent improvements in vaccine technology have resulted in combining vaccines to allow for fewer injections particularly for childhood vaccines. Measles, Mumps, Rubella, and Varicella have been successfully combined into a single vaccine allowing for 1 injection to cover these four childhood diseases. Other combinations include tetanus, diphtheria, and pertussis (whooping cough) in a single vaccine and a pneumococcal pneumonia vaccine that contains 23 different strains of pneumococcal pneumonia!4
History of vaccines in pharmacies
Vaccines were traditionally provided by physicians in their offices or by the military for active-duty service members. It wasn’t until a physician from the Centers for Disease Control and Prevention, William L. Atkinson, MD, MPH, focused attention on the accessibility and knowledge of pharmacists in the 1990’s that pharmacists became actively involved in providing vaccines to patients.5 Over the past 30 years, pharmacies have become centers for providing annual influenza vaccines and, in states where other vaccines are allowed, pharmacists have provided vaccines to fight tetanus, diphtheria, pertussis, pneumococcal pneumonia, the human papilloma virus, herpes zoster, and other infectious diseases. Pharmacy-provided vaccinations have helped the health care system improve vaccination rates across the country. It is this success that led the federal government to authorize pharmacists, under an amendment to the PREP Act (Public Readiness and Emergency Preparedness Act) to provide vaccines regardless of state practice laws.6 Time will tell if this federal allowance is permanent or only a temporary measure during a world-wide pandemic.
Patient access is one of the selling points for increased vaccination at pharmacies. Pharmacies are convenient locations for patients to receive vaccines. Pharmacies often have extended hours of operation when compared to traditional physician offices. Pharmacies report vaccines to immunization registries and communicate with other members of the health care team to allow all health care providers to track a patient’s vaccination history. Additionally, pharmacists are trained to properly screen patients for cautions and contraindications to vaccines. Pharmacy technicians who administer vaccines and manage the documentation are valuable members of the vaccination team and their value is growing daily.
Pharmacy technicians vaccinating
Like pharmacists, pharmacy technicians have been granted authority under federal law to provide vaccines, if a number of training conditions exist.7 It is anticipated that this authority will be time-limited and will be rescinded following the COVID pandemic. That is not an indication, however, that pharmacy technicians will lose the authority to vaccinate. In several states including: Idaho, Utah, Michigan, Nevada, Rhode Island, and Washington pharmacy technicians had the authority to vaccinate before the federal ruling.8 These statutes will remain, even when the federal authority is withdrawn. It is anticipated that many additional states will adopt scope of practice changes into their own laws to allow pharmacy technicians to continue to vaccinate. While the COVID pandemic has tragically taken over 286,000 lives in the United States and over 1.5 million world-wide;9 this pandemic is also providing an opportunity for pharmacy technicians to demonstrate that they are able to safely provide vaccines. Evidence of safety and efficiency when pharmacy technicians provide vaccines will be collected and this data will be used to further many policy changes. It is essential, that the data demonstrate safety. This educational activity is designed to promote safety in technician vaccinations on four levels: Safety for the administering pharmacy technicians, safety for the patients, safety for the pharmacies where vaccines are provided, and safety for the public.
Pharmacy Technician Safety:
PPE
Pharmacy technicians and all members of the healthcare team focus on the safety of their patients. That is an intrinsic component of professionalism. Focusing on personal safety is often not given equal attention but it must! In fact, it is essential that every member of the health care team is confident in refusing to place themselves in jeopardy. Pharmacy technicians should consider how to protect themselves when administering vaccines, particularly vaccines given by injection. Gloves must be worn at any time when there is a potential for exposure to someone else’s blood. It is well known that repeated exposure to latex can lead to a latex sensitivity,10 therefore non-latex gloves are recommended. Gloves should fit tight against the skin but should not impair movement of the fingers and should not be so tight as to leave an imprint at the wrist. Pharmacy technicians should learn to properly doff, or remove, gloves. Pharmacy technicians must learn to protect themselves from a blood exposure. It makes no sense to wear the proper gloves only to cause a subsequent exposure when removing them incorrectly! A video to show how to doff gloves correctly was prepared by the State of Minnesota and is available at https://www.youtube.com/watch?v=xueBYfElFEg
For most vaccinations, the pharmacy technician does not need to wear a protective mask or eye shield. A mask or eye shield should be chosen when there is wide-spread respiratory disease in the community, e.g., influenza, pertussis, measles, or SARS-CoV-2. This personal protective equipment (PPE) will protect the vaccine administrator in case the patient they are serving coughs or sneezes while the pharmacy technician is working near them. Remember, whether the pharmacy technician is wearing only gloves or is wearing gloves and additional PPE, hands should always be washed, or hand sanitizer used before donning (putting on) PPE. If hands are visibly dirty, they must be washed under running water using soap, hand sanitizer is NOT appropriate for removing visible soiling.11 When doffing (removing) PPE, use a gloved hand to remove the mask or face shield, then properly doff gloves and wash hands or use a hand sanitizer. If gloves are not available to provide protection, the pharmacy technician should refuse to provide vaccine.
In special circumstances, the pharmacy technician may have a need for additional protection. These may include a chronic illness, cancer chemotherapy, radiation therapy or other immune suppression. In these cases, the pharmacy technician will be asked to wear additional PPE for self-protection. There are currently no routine vaccines that cannot be administered safely while the person doing the administration is pregnant.12 Normal precautions are sufficient to protect the pregnant pharmacy technician who is administering a vaccine. There are vaccines that are not to be given to a pregnant patient, but, other than the smallpox vaccine, those same precautions do not extend to the vaccinator.
Sharps Containers
In addition to personal protective equipment the other essential tool for pharmacy technician safety is an appropriate sharps container. An appropriate sharps container is a sharps container that: is clearly labeled as a sharps container, is within easy reach following administration of a vaccine, and has sufficient remaining space to contain the used syringe and needle. When reviewing breaches in vaccination safety protocol, often failure to correctly use the sharps container is the leading cause of injury to members of the health care team.13 To guarantee that no attempt is made to recap a needle, when the needle cover is removed, throw it immediately into the garbage. Following the injection, activate the safety device on the needle and place it into the sharps container before doing anything else. The Occupational Safety and Health Administration (OSHA) requires that all needles used to give vaccinations have safety devices to protect the administrator from exposure to a needle stick.14,15 The employer is responsible for guaranteeing that only safety needles are used in the facility. If there is not immediate access to an appropriate sharps container or the pharmacy technician is being asked to vaccinate without safety needles, administering injectable vaccines should be refused.
Technique
Proper vaccine injection technique must focus on the safety of both the patient and the person administering the vaccine. The 23 steps to completing a proper intra-muscular injection are listed in Table 1. There are steps to ensure the safety of the vaccinating personnel: cleaning the hands, donning gloves, positioning the sharps container and positioning the patient. There are steps that ensure the safety of the patient, those will be discussed in the section on patient safety. There are other steps to assure that the mandatory record keeping is in order. Skipping any step can place the pharmacy technician or the patient in an unsafe situation and can jeopardize the facility where vaccines are being provided. Each of the steps to safety are interlinked and should be followed carefully.
As with many skills, the pharmacy technician’s technique will improve over time. The pharmacy technician must be accurate and safe from the very first vaccination, but improvements in work- flow will naturally occur with experience. The technician may find a smoother way to complete paperwork or a better way to incorporate the verification of vaccination history into the patient interview process. The key elements of pharmacy technician and patient safety, however, must be present at all times.
Patient Positioning
Patient positioning is a patient safety issue, but it is also a safety issue for the person administering the vaccine. While fainting during a vaccination is rare, a patient who faints while standing will fall quickly.16 The professional’s temptation will be to catch the falling patient. This can cause injury to professional and likely won’t help the patient. Patients must be seated or lying down when vaccines are injected, not just for their own safety, but for the administrator’s, as well. Finally, the pharmacy technician refines mechanics based on practice. Consistent positioning of the patient will allow for consistent mechanics, increasing safety for the administering pharmacy technician and for the patient.
Patient Safety:
Vaccine Schedules
The Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP ) publish recommendations for vaccinations based on age and on existing diseases or conditions.17 This information is presented in vaccine schedules. There are schedules for childhood vaccinations, adolescent vaccinations, adult vaccinations, and vaccinations necessary for certain medical conditions. The schedules also list precautions and contraindications to vaccinating. These schedules help guide members of the health care team in advising patients on which vaccines should be administered to protect their health and the health of the community. They also help to guide health care providers in which patients should not receive vaccines. All facilities administering vaccines should have access to vaccine schedules to review for patient safety, as well as to recommend the timing of the requested vaccine and other vaccines that may have been overlooked.
Screening Questions
Carefully screening patients before a vaccination is the best way to prevent vaccine adverse events. Screening questions identify any previous vaccine reactions. They provide the patient’s age to screen for dosing the correct vaccine based on age. Screening questions identify anything that may put the patient at risk: allergies, current medications, immune status, pregnancy. Well written screening questions are vaccine specific. There are a number of questions that are asked before providing a live-attenuated vaccine, such as Measles, Mumps, Rubella, and Varicella that are not asked when providing an inactive vaccine. When screening for the tetanus, diphtheria, and pertussis vaccine it is common to ask which hand the patient writes with. This is not a question routinely asked with other vaccines. The pharmacy technician has multiple roles in patient screening: assure that the patient receives the Vaccine Information Statement (VIS) before completing the screening questions.18 VIS are vaccine specific. The pharmacy technician must assure that the correct VIS has been provided to the patient or the caregiver and that the screening questions asked are matched to the correct vaccine. Before administering a vaccine, the pharmacy technician should review the screening questions and confirm any concerns or unexpected answers with the pharmacist before injecting the patient. Copies of the patient’s answers to the screening questions should be maintained in the patient’s medical record at the pharmacy.
Epinephrine
Very rarely someone has a severe allergic reaction to a vaccine. These reactions are often not predictable but put the patient at immediate risk. In order to protect against death or severe injury from a vaccine reaction, epinephrine must be immediately available at all times when vaccines are being administered. The pharmacy technician administering vaccines must also be trained to administer epinephrine if required. Training in basic cardio-pulmonary resuscitation (CPR) is also recommended and is required in some jurisdictions. All members of the health care team need to have the ability to save lives if the service they are providing can cause a serious reaction. If there is no epinephrine immediately available, or if there is uncertainty concerning the administration of epinephrine, the pharmacy technician should refuse to administer vaccine.
A severe allergic reaction to a vaccine will be an emergency, but it doesn’t need to become a crisis. Careful planning on the part of the facility can mitigate much of the risk. An emergency plan should be developed and practiced prior to administering any vaccine. Assure that every member of the health care team providing vaccines knows their role in managing an emergency. It is the duty of the person administering the vaccine to guarantee that epinephrine is immediately available. There needs to be a process to immediately notify the pharmacist that an allergic reaction is suspected. The steps for notifying emergency medical services (EMS) and calling an ambulance should be spelled out with everyone understanding who will make the call, what information needs to be provided to EMS and where that information can quickly be located. Who will stay with the patient until EMS can arrive? Who will keep curious on-lookers away from the emergency setting? Who will guide EMS to the patient’s location? Each of these decisions MUST be made and practiced in advance of giving the first vaccine.
The use of an epinephrine autoinjector device is the only exception to the rule that all sharps go immediately into a sharps container. The activated autoinjector should be placed beside the patient for presentation to EMS upon arrival. If there is a delay in the arrival of EMS and multiple doses of epinephrine are used, this will help in remembering how many doses were administered. It will also serve to provide the EMS personnel with the lot number and expiration date of all epinephrine used. The pharmacy technician can be helpful not only in administering the epinephrine, but in documenting the use. What time was the epinephrine administered? Which muscle was it injected into? How did the patient respond?
SIRVA
SIRVA is an acronym standing for Shoulder Injury Related to Vaccine Administration.19 It is the most common preventable technique error in administration of vaccines. Errors in selecting or reconstituting the vaccine are not considered to be technique errors. The injury occurs when the vaccine is injected too high on the deltoid and the shoulder joint is damaged. Proper landmarking will help avoid the shoulder joint and long-term injury to the patient. The techniques for landmarking are simple, but only prevent injury if used for every injection. Locate the acromion at the top of the shoulder and measure down 3 finger widths to locate the top of the target zone for the injection.20 After cleaning the skin over the deltoid muscle, the measurement should be repeated to assure the injection will avoid the shoulder joint.
Landmarking must be conducted for each injection. Even with a large arm, it is improper to estimate the target by sight. An injection protection patch, that is applied to the arm and injected through, can help clearly define the target for the injection. To use these patches, clean the arm as normal, using an expanding concentric circular motion, after allowing the skin to air dry (NEVER fan the skin to increase drying speed), measure from the acromion and apply the injection protection patch being careful not to touch the surface of the patch where the needle will be injected. The patch then clearly defines the injection site. Additionally, the patch will retain any blood from the injection, thus serving as additional protection for the vaccinator. Using an injection protection patch is not an excuse for failure to wear gloves.
The entire target area must be visualized. If the administrator is unable to see the target area because of a sleeve, the garment should be removed. Do not push a sleeve up so that it becomes so tight it acts like a tourniquet. Do not allow the patient to tug on the neck of a garment in an attempt to pull it down to expose the shoulder. Often it is trying to access the upper deltoid via the neck of a garment that results in SIRVA.20 Consideration should be given to protecting patient dignity for those circumstances where partial disrobing will be required to visualize the entire target area. Patient safety and accurate vaccine placement is the pharmacy technician’s primary concern do not allow patient reluctance to bare the entire deltoid to cause poor technique.
ISMP Report
A report on vaccination errors from the Institute for Safe Medication Practices (ISMP) highlights errors reported regarding vaccine administration. Most of the errors in the November 2020 report focus on wrong product, wrong diluent, wrong patient (based on age).21 A review of the Patient’s 5 Rights is appropriate based on this information. There are 5 components of vaccine administration that must be correct. These are often called The 5 Rights: The right patient, the right drug, the right dose, the right route (and site), and the right time.22
The right patient includes assuring that the correct patient has been identified and also includes the concept that the patient must be “right” to receive this vaccine. Is the vaccine age restricted, as it is with nasal influenza? Does the patient meet the age requirements in the labeling?
The right drug means that the correct vaccine has been selected. A careful triple check system will help avoid errors at this step. Does the vaccine match the VIS provided to the patient? Does the vaccine match the order verified by the pharmacist? Does the vaccine match what the patient says that s/he is expecting? The ISMP reports that patients have received insulin instead of vaccine because of poor storage decisions and failure to read labels.
The right dose involves verifying that the proper volume has been drawn into the syringe. Remember, bubbles in the syringe DECREASE the amount of vaccine given to the patient. If the vaccine needs to be reconstituted, does the diluent match the vaccine? Patients have died from improper reconstitution using the wrong diluent.
The right route covers more than simply knowing that most vaccines are injected. The right route also includes providing the injection into the right muscle and doing that safely. As previously discussed SIRVA can be avoided with proper technique and attention to detail.
The right time encompasses several “times.” Is the timing correct based on the ACIP dosing schedules? Is the timing correct based on the date of a previous vaccine? Is the timing correct as determined by the expiration of the vaccine? This may mean the expiration date presented by the manufacturer. Many vaccines expire quickly when a multi-dose vial has been entered, some as quickly as 6 hours later. Warming a vaccine to room temperature hastens the expiration date.
Warnings from the ISMP report on causative factors for errors in influenza vaccine administration include:21
Look-alike names, look-alike labels, and look-alike packaging.The pharmacy technician can help to combat each of these problems by managing the storage of the vaccines, the labeling of refrigerator or freezer compartments and using a triple-check system.Check the vaccine claimed from the refrigerator or freezer against the order (not the label).Then check the vaccine against the order when drawing up from a vial or preparing to administer.Finally check the vaccine against the VIS provided to the patient before administering.Many influenza vaccine trade names start with FLU {Fluzone, Fluarix, Flublok, etc.} so it is important that the verification process is designed to avoid any mistakes.The ISMP report also notes the inadvertent administration of Havrix instead of Fluarix and the administration of Boostrix instead of Fluarix.
Poor storage practices allowing for vaccine to be intermingled with other drugs resulted in the administration of insulin instead of the intended hepatitis B vaccine.Sadly, four of these mistakes resulted in the death of the patients.ISMP notes another fatal error where the diluent for the measles vaccine was replaced with a paralyzing agent, atracurium.
Giving a vaccine to a patient who was not eligible due to age was reported.Influenza nasal vaccine is not to be given to anyone over the age of 49, but miscalculation of age or miscommunication of the correct vaccine resulted in patients over the age of 49 receiving this vaccine.ISMP notes that language barriers can also be a challenge in calculating patient age and determining appropriateness of a vaccine.Flublok quadrivalent vaccine was administered to children under the age of 18 which is also a contraindication.
Not checking the immunization registry system resulted in patients getting: an additional dose of vaccine that they had already received; or getting a second dose in a series too soon; or most commonly, not receiving the second or third dose in a series because the need for these additional doses was not noted or acted upon.By way of example: Hepatitis B vaccine requires 3 doses; day one, three months from day one and six months from the first date of injection.
Patient Positioning revisited
The previous section on patient positioning discussed safety for the vaccine administrator. The requirement that the patient be seated or lying down is also a safety mandate for the patient. While fainting during vaccination may cause a patient to fall and create an injury. A standing patient may also attempt to pull away from the administrator. This movement can increase the risk of missing the target zone for injection. If the vaccine is administered too high SIRVA may be the result. If the motion causes the vaccine to be administered too low, damage to nerves is possible. The movement may also cause the vaccine not to be presented into the muscle resulting in decreased vaccine efficacy. Movement during a subcutaneous injection may cause skin ripping.
Considerations for patient positioning need to include the chair or seating chosen. Does the chair have handles to assist the patient in standing when the procedure is complete? Is the seating sufficient to hold patients who weigh over 250 pounds? When vaccinating patients seated in wheelchairs, the wheels should be locked to avoid the chair moving and causing vaccine injury. Another source of motion can occur when vaccinating patients in their vehicles. For safety and for efficiency, many facilities are offering “drive-up” or “parking lot” vaccinations. The pharmacy technician who is providing vaccines to patients in vehicles should insist that the vehicle be placed into park and turned off to prevent the vehicle from moving during the procedure. If the driver of the vehicle is unwilling to following these guidelines, the injection should be refused, and the patient should be instructed to enter the facility to receive the vaccination.
Business Safety:
Business “safety” seems illogical at first. It is easy to understand keeping people safe, but the ability to keep the business safe is also important. Sister Irene Kraus, the CEO of the Daughters of Charity National Health System, famously said, “If there is no margin, there is no mission.” This means that if the business can’t make money, it doesn’t matter what they aspire to do, they can’t do it. Likewise, if a pharmacy is in financial risk from failure to follow laws and regulations regarding vaccines, they will not be able to continue to provide vaccines or any other pharmacist service. The pharmacy technician can help assure that the business is safe by learning the requirements for vaccination that go beyond administration.
Documentation
There are documentation requirements that accompany vaccination programs. Pharmacy technicians have been trusted with maintaining pharmacy documentation for years. This talent can be valuable in protecting the patient and the business of the facility. Knowing what documentation is required is essential in providing vaccines legally and correctly. The law requires that patients or caregivers be provided VIS before being vaccinated. The VIS may be viewed on a screen, read from a posted copy, or provided on paper to the patient.18 Following the vaccination, the patient or caregiver must be provided a copy of the VIS if requested. Pharmacy technicians who are administering vaccinations need to ask the patient if they have been provided a copy of the VIS before administering the vaccine. Pharmacy technicians can also assure that the vaccine information statements are available for all vaccines in the facility. This preparation and organization can protect the facility, but more importantly guarantees that patients and caregivers have access to the information necessary for making decisions about receiving a vaccination.
Like the VIS, screening questions must be provided to the patient before a vaccine is administered. While screening questions may not be explicitly required by law, professional credentialling requirements require that practitioners meet the prevailing standard of care.23
Therefore, since screening for danger is considered to be prospective drug use review and prospective drug use review is a standard of care in pharmacy, administering the proper screening questions and evaluating the patient’s answers is required. While pharmacy technicians may not have sufficient clinical training to evaluate all dangers to the patients, the pharmacy technician can assure that screening questions are completely answered. Pharmacy technicians can also review the answers for any unexpected information. The pharmacy technician administering the vaccine must review the answers to the screening questions as a safety check to assure that no unusual answers had been overlooked during the verification process.
The vaccine administration record is the evidence that the vaccine was provided. The vaccine administration record contains the following patient information: the patient’s name, the patient’s birthdate, and identifying information such as address or medical record number. The administration record contains information about the vaccine including the manufacturer, the lot number, and the expiration date. The administration record, as the name implies, also includes information about the administration itself: the date of administration, the dose administered (usually 0.5cc), the site of administration (e.g., right or left deltoid), the route (intramuscular, subcutaneous, nasal), the date on the VIS and the date the VIS was provided to the patient, the name of the person administering the vaccine and that person’s signature. All of this information will be required if a report needs to be made to the Vaccine Adverse Event Reporting System (VAERS).24
Many jurisdictions have vaccine registries. Reporting to the vaccine registry is mandatory in some and voluntary in others. As previously discussed, adhering to prevailing standards of care may be mandatory and thus the duty to report to the registry may be mandatory through that requirement. In either case, reporting to the registry allows for safer patient care and for monitoring for necessary vaccinations. When the report is mandatory for the facility, properly reporting will also protect the facility. Robust vaccine registries are useful in promoting public health and improving communication about needed vaccines. Pharmacy technicians can be the key to improving vaccine reporting and to populating vaccine registries with essential information regarding patient vaccine status.25,26
Records Retention
Health care facilities are well aware of the need to retain and quickly access medical records. Most federal requirements for record keeping require that all records be retained for a minimum of two years. Many states, however, require that records be maintained for a longer duration. Vaccination records, however, should be maintained for 10 years or for 2 years after the age of majority is reached, whichever is longer.26 The pharmacy technician can assist in developing and maintaining the records retention process as this will be a process that is longer than most records retention in the facility. Failure to maintain proper records can adversely impact the license of the facility, the licenses of any supervising pharmacists, and potentially the credentials of the pharmacy technician on the vaccination team.
HIPAA
As with all health care services, vaccinations are subject to the Health Insurance Portability an Accountability Act (HIPAA)27 and the privacy protections that are a part of that law. Reporting to the vaccine registry is NOT a violation of HIPAA privacy protections, in fact, it is important to protecting the patient and in some cases, as discussed previously, to protecting the facility and the members of the vaccination team. All members of the health care team involved in vaccinations need to protect patient records and maintain patient privacy to the best of their ability. Yes, a patient may be seen receiving a vaccination in a facility. This alone is not a violation of the privacy protections of HIPAA. A general rule is that all of the privacy protections provided when dispensing a prescription should also be provided when giving a vaccine. Additional privacy may be required for patients who need to partially disrobe to allow for visualization of the entire vaccine target area.20
VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a program co-managed by the CDC and the United States Food and Drug Administration (FDA).24 This program monitors adverse events that occur after a vaccination. It is important to note that not everything that happens after a vaccination is due to the vaccination, but this program can determine if further research is needed. Consider two patients who each receive an influenza vaccine. The first patient has a sore arm at the site of injection. The second patient had a heart attack while shoveling snow. Both adverse events are reported to VAERS. The report of sore arm is something that the system expects, but the heart attack would be uncommon. The CDC and FDA would look for other reports of cardiac issues following influenza vaccination to determine if the heart attack was related to the vaccination or was merely a tragic event that would have occurred vaccine or not. Researchers often refer to this as the difference between causation and coincidence. For very rare side effects (those effects caused by the vaccination) it may take millions of vaccinations to find a pattern. The VAERS program is able to find these patterns and alert health care providers to cautions and contraindications to vaccination.
There is a federal requirement that some adverse events must be reported if the person administering the vaccine is aware that they occurred.24 Some of these reportable events include: anaphylaxis, encephalitis following a pertussis containing vaccine, chronic arthritis following a rubella containing vaccine, intussusception following a rotavirus vaccine, or SIRVA following an intramuscular deltoid injection. A full listing of reportable events may be found at https://vaers.hhs.gov/resources/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf
Work-Place Safety
There are a number of work-place safety issues that will impact the safety or risk management for the business. Is there sufficient lighting to guarantee that the vaccine administration process is safe and can follow the 5 Rights?22 Have all vaccine administrators been trained about blood borne pathogens? Blood Borne Pathogen training is an annual requirement. Does the work-place have a coordinated method for tracking this annual training? Have all people with a reasonable expectation of exposure to human blood – the administering members of the health care team and perhaps staff who are responsible for sanitizing the vaccination areas – been offered the Hepatitis B vaccine? If the vaccine was requested, has the series been completed BEFORE the member of the health care team has an exposure to human blood? Facilities using needles for injection are required to have needle stick policies, including a needle stick log and an evaluation of any needle sticks. Additionally, facilities are required to use safety needles for all human injections and to have a committee that determines which safety devices will be used. This committee must include professionals who are using the devices. Pharmacy technicians who administer vaccines by injection are eligible to serve on this decision-making body.15
Population & Public Health Safety:
Herd Immunity28,29
Recently, media reports have used the term “herd immunity” in relation to people getting an infection and recovering. The assumption is, that those who recover will be immune from the condition. That may, in fact, have been the original Darwin-like description of those animals that survived a variety of diseases. Today, however, scientists use the term “herd immunity” to describe the protection that is offered to people who cannot be vaccinated. Science uses the agri-business description of protecting the “herd” by vaccinating a critical number of the members of that herd. Let’s say that there are 100 head of cattle in a herd. They are roaming freely across grasslands and only 93 are located and vaccinated. The remaining 7 are protected because the 93 that were vaccinated cannot carry or transmit the disease. When describing herd immunity in relationship to vaccine preventable diseases, the goal is to vaccinate a large enough percentage of the population to protect those who cannot be vaccinated. There are a variety of reasons why someone cannot be vaccinated: no vaccine available, allergic reaction, current contradictory drug therapy, too young to be vaccinated, existing disease or pregnancy. In order to protect these vulnerable patients, those who are eligible to be vaccinated need to be vaccinated in order to protect the entire “herd” or community.
Herd immunity can only be attained by vaccinating a sufficient number of people. For some diseases the percent of the population who need to be vaccinated to achieve herd immunity for the rest has been calculated. 95% of the population must be vaccinated against measles to protect the remaining 5% against this deadly disease. Diphtheria requires approximately 85% of the population to be vaccinated to prevent the spread of this disease. Science has not yet calculated the vaccination rate needed to provide herd immunity against SARS-CoV-2. As rates of childhood vaccinations drop, the potential for a community, a state, or the country to lose herd immunity becomes a very real possibility. Pharmacies, pharmacists, and pharmacy technicians can help protect the public by advocating for vaccinations and being trained to provide them. Table 2 demonstrates that the United States is perilously close to losing herd immunity for a number of infectious diseases currently controlled with vaccines and herd immunity. Vaccination rates for measles and pertussis have fallen below optimal for protection of those who cannot receive vaccines. Vaccinations rates are expected to be lower following the COVID pandemic because people have been afraid to seek routine medical care. This will offer an incredible opportunity for pharmacy technicians to be a part of the solution in increasing vaccination rates and helping children “catch up” in routine vaccinations. World-wide success in the eradication of smallpox is attributable to effective vaccination programs, administered around the globe. Most recently, the continent of Africa was declared to be polio-free for the first time ever.30 The control of these diseases is a direct result of immunization programs and the work of public health professionals.
It is important to note that herd immunity is NOT a first-line strategy for disease prevention. Immunizations and proper personal hygiene are the first-line strategies in all cases. Personal vaccination is the best protection a person can have against infectious disease. Avoiding transmission by wearing a mask, staying home, washing or sanitizing hands is also very important. The concept of herd immunity as a protective strategy is intended to help protect those who cannot be vaccinated. It is NOT intended as a mechanism to avoid vaccination. Remember, herd immunity only exists for those diseases that are transmitted between humans. There is no herd immunity for a disease such as tetanus, where the bacteria exist in nature and is not shared between people. There is no human herd immunity for diseases spread by insects or other animals because protecting the humans does not stop the vector. For these diseases the only protection for the patient is to avoid exposure and receive their own vaccination.
Walking the Talk and Stopping Mis-Information
Pharmacy technicians are in a unique position to encourage vaccines and to stop mis-information. Often the first member of the pharmacy team that the patient or the caregiver encounters is the in-take pharmacy technician. When a patient or caregiver asks, “Have you had your vaccine?” It is important to be able to answer truthfully in the affirmative. This is known as “walking the talk.” No one can simultaneously advocate for vaccines and the public protection they provide and refuse to be vaccinated themselves. There will be vaccinators who cannot be vaccinated because of a medical condition or therapy. For these professionals, the best answer to the question, “Have you had your vaccine?” is, “No, I cannot be vaccinated, so you getting your vaccine protects us both.” People are motivated by their ability to help others and this message may be the impetus necessary to encourage someone to be vaccinated.
Pharmacy technicians should also encourage all colleagues to receive their vaccinations. The facility manager, the human resources personnel, everyone who is a part of the facility should be vaccinated to protect each other and the sick patients who are served in the facility. Many facilities offer buttons or stickers to recognize those on the staff who have been vaccinated. These team-building and positive recognitions are important in helping the vaccination team promote this service.
Walking the talk also means working to stop mis-information. Every member of the vaccination team has to understand that jokes about vaccines, forwarding memes that inaccurately depict vaccinations or anything else that may undermine public trust and understanding of vaccines is unacceptable and unprofessional. No one expects that every member of the health care team will actively try to refute bad information, but refusal to continue the distribution of bad information is expected.
Vaccine Hesitancy31,32,33
While pharmacies are making an impact in improving vaccination rates, there are several diseases where the American population is perilously close to falling below the needed vaccination rates to assure herd immunity. This is protective herd immunity against historically deadly disease such as measles and mumps that is waning because children are not up to date on their vaccines. This is due, in part, to a concept termed vaccine hesitancy. Vaccine hesitancy is a complex combination of factors that ultimately leads to patients or parents refusing vaccinations. While vaccine advocates can be frustrated by these refusals, it is imperative that all members of the health care team remember that patients do not make decisions they believe will be dangerous to them. When someone refuses a vaccine, there is a reason for making that decision. It is up to the health care team to be respectful and empathetic when addressing these concerns.
Vaccine hesitancy is not an “all or nothing” refusal in most cases. Patients may refuse one vaccine and be willing to accept another. Patients who are not able to receive a vaccine because of safety are not vaccine hesitant, they are ineligible to be vaccinated. While herd immunity, if achieved, will protect the hesitant and the ineligible, it is the patient who cannot receive a vaccine that is the focus of community health efforts to increase vaccination rates. Patients with a religious opposition to vaccinations are also not vaccine hesitant. They are ineligible to be vaccinated because of a non-medical reason. This doesn’t make their need for protection different from anyone else who cannot be vaccinated. It is important that every member of the health care team responds accurately and empathetically when talking with the vaccine hesitant.
There are several issues to be considered when dealing with vaccination hesitancy. These include understanding the concerns being expressed; providing accurate information at all times; and not arguing with the patient who is hesitant. While health care providers agree that vaccines are a personal and public necessity, these same members of the health care team often do not attempt to understand why anyone would refuse. Or, worse yet, they want to try to argue with the hesitant to try to change their minds. An old native American saying encourages that we all walk a mile in another’s moccasins to truly understand their perspective. Why is the patient or the parent hesitant? Are they making a decision based on a lack of information or on bad information? Do they want to know what the science indicates? Has there been a previous bad experience? Not necessarily an adverse reaction, but someone on the health care team who treated them poorly. Did someone belittle their fears? Did someone make derogatory comments about their choices? Did someone call them stupid? If these things happened, vaccine hesitance cannot be overcome until the burned bridge is mended. Honestly listen to the patient’s concerns. Don’t make judgements about those concerns until you truly understand them. Patient counseling is not a part of the pharmacy technician’s duties but gathering information from the patient is. This information will help the pharmacist talk with the patient.
There will be patients and caregivers who do not want to discuss their refusal of a vaccine. They are certain that they are correct and for them, that’s the end of the discussion. That doesn’t mean that the pharmacy technician should stop offering. If a patient is identified with a need for a vaccine, it should be offered, every time the patient is encountered. If there are multiple necessary vaccines, the patient should be informed that there are a multiple infectious diseases that can be prevented or lessened through the use of vaccine. The pharmacy technician who is charged with reviewing the vaccine registry or the patient history records is able to identify these missing and necessary vaccines. There is no way to know which offer might be accepted, but the un-made offer cannot be accepted!
The vast majority of patients appreciate being told that they are due or nearly due for a vaccine. Tetanus and diphtheria vaccines should be given every 10 years, or more often in certain cases. Helping to develop a system to identify when these vaccines are due are helpful to the patient, helpful to maintaining herd immunity (against diphtheria) and helpful to the profits of the institution.
Table 1: Steps for Proper Intramuscular Vaccination
Step | Action |
1 | Ask, “May I have your name?” {Right patient} |
2 | Ask, “What vaccine are you receiving today?” {Right drug} |
3 | Ask, “Did you receive the VIS for this vaccine?” |
4 | Check the answers to the screening questions {Right drug} |
5 | Set up sharps container |
6 | Verify you have a source of epinephrine readily available |
7 | Position patient – sitting or lying down |
8 | Wash hands or use hand sanitizer |
9 | Don gloves |
10 | Visualize target {Right route} |
11 | Clean injection site with alcohol, allow to air dry |
12 | Measure 3 finger widths from acromion {Right route} |
13 | Apply injection safety patch, if available |
14 | Check syringe for proper vaccine & any bubble {Right dose} |
15 | Ask, “Are there are any remaining questions?” |
16 | Position yourself to inject |
17 | Remove the needle cover and throw in garbage |
18 | Complete the injection |
19 | Activate safety device |
20 | Go straight to sharps |
21 | Properly doff gloves |
22 | Wash hands or use hand sanitizer |
23 | Complete paperwork |
Table 2 Vaccination % Required for Herd Immunity
Infectious Disease | Vaccination % Needed | US 2017 Vaccination Rates |
Diphtheria | 83 | 83.2% |
Measles | 92-95 | 91.5% |
Mumps | 75-86 | 91.5% |
Pertussis | 92-94 | 83.2% |
Polio | 50-93 | 92.7% |
Rubella | 83-85 | 91.5% |
Smallpox | 80-85 | world-wide elimination |
Step | Action |
1 | Ask, “May I have your name?” {Right patient} |
2 | Ask, “What vaccine are you receiving today?” {Right drug} |
3 | Ask, “Did you receive the VIS for this vaccine?” |
4 | Check the answers to the screening questions {Right drug} |
5 | Set up sharps container |
6 | Verify you have a source of epinephrine readily available |
7 | Position patient – sitting or lying down |
8 | Wash hands or use hand sanitizer |
9 | Don gloves |
10 | Visualize target {Right route} |
11 | Clean injection site with alcohol, allow to air dry |
12 | Measure 3 finger widths from acromion {Right route} |
13 | Apply injection safety patch, if available |
14 | Check syringe for proper vaccine & any bubble {Right dose} |
15 | Ask, “Are there are any remaining questions?” |
16 | Position yourself to inject |
17 | Remove the needle cover and throw in garbage |
18 | Complete the injection |
19 | Activate safety device |
20 | Go straight to sharps |
21 | Properly doff gloves |
22 | Wash hands or use hand sanitizer |
23 | Complete paperwork |
Conclusion:
Pharmacy technicians are integral members of the pharmacy team. Without pharmacy technicians, pharmacy services and the provision of drugs would be much less efficient than it is. Well trained pharmacy technicians are being allowed to provide vaccines in an effort to expand the services that the pharmacy team can offer and to improve access for patients seeking preventative care. A quality vaccination program, including pharmacy technicians administering vaccine, will demonstrate safety for the technicians, for the patients, for the businesses, and for the public. It will be exciting to see this proven in practice settings.
Reference and Resources:
The History of Vaccines, An Educational Resource by the College of Physicians of Philadelphia; 2000; https://www.historyofvaccines.org/timeline/all; accessed 21 Nov 2020.
Vaccines and Immunization; World Health Organization; 2020; https://www.who.int/teams/immunization-vaccines-and-biologicals/strategies/global-vaccine-action-plan; accessed 21 Nov 2020.
Tracking the New Vaccine Pipeline; World Health Organization; 2020; https://www.who.int/immunization/research/clinicaltrials_newvaccinepipeline/en/; accessed 7 Dec 2020.
Pneumovax product labeling; Merck Sharp & Dohme, Whitehouse Station, New Jersey; Sep 2020.
Hogue MD, Grabenstein JD, Foster SL, Rothholz MC; Pharmacist Involvement with Immunizations:A Decade of Professional Advancement; J Am Pharm Assoc. 2006; 46:168-182
US Department of Health & Human Services amendment to the PREP Act; Secretary Azar; 19 Aug 2020; https://www.hhs.gov/about/news/2020/08/19/hhs-expands-access-childhood-vaccines-during-covid-19-pandemic.html; accessed 22 Nov 2020.
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing; US Office of the Assistant Secretary for Health; Admiral Brett P Giroir, MD; 20 Oct 2020; https://www.hhs.gov/sites/default/files/prep-act-guidance.pdf; accessed 1 Dec 2020.
Pharmacy technicians gear up to immunize; Loren Bonner; APhA; 22 October 2020; https://www.pharmacist.com/article/pharmacy-technicians-gear-immunize?is_sso_called=1#:~:text=%E2%80%9CSeveral%20chain%20pharmacies%20are%20the,Island%2C%20Utah%2C%20and%20Nevada; accessed 21 Nov 2020.
Coronavirus Update; www.Worldometers.info; https://www.worldometers.info/coronavirus/?; accessed 10 Dec 2020.
Binkley HM, Schroyer T, Catalfano J; Latex Allergies:A Review of Recognition, Evaluation, Management, Prevention, Education, and Alternative Product Use; J Athl Train; 2003 Apr-Jun; 38(2): 133-140.
Proper Hand Hygiene; United States Occupational Safety and Health Administration; https://www.osha.gov/sites/default/files/2018-11/fy10_sh-20839-10_hand_hygiene.pdf; accessed 11 Dec 2020.
Immunization Action Coalition: Ask the Experts; https://www.immunize.org/askexperts/administering-vaccines.asp; accessed 12 Dec 2020.
Adefolalu AO; Needle Stick Injuries and Health Workers: A Preventable Menace; Ann Med Health Sci Res. 2014 Jul-Aug; 4(Suppl 2):S159-160.
Letter from Richard E. Fairfax, Director of Enforcement Programs to Wendy Gallart, Senior Marketing Manager BD Advanced Protection Technologies; 20 Feb 2003; https://www.osha.gov/laws-regs/standardinterpretations/2003-02-20; accessed 8 Dec 2020.
Occupational Safety and Health Administration Standard 1910.1030 Blood Borne Pathogens; https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030; accessed 27 Nov 2020.
Braun MM, Patriarca PA, Ellenberg SS; Syncope after immunization; Arch Pediatr Adolesc Med 1997; Mar;151(3):255-9.
Vaccination Schedules; CDC; https://www.cdc.gov/vaccines/schedules/index.html; accessed 1 Dec 2020.
National Vaccine Childhood Injury Act (42 USC 300aa-26); https://www.govinfo.gov/content/pkg/USCODE-2010-title42/pdf/USCODE-2010-title42-chap6A-subchapXIX-part2-subpartc-sec300aa-26.pdf; accessed 7 Dec 2020.
Bancsi A, Houle SKD, Grindrod KA; Should injury related to vaccine administration and other injection site events; Canadian Family Physician: Vol 65: Jan 2019; 40-43.
Cook IF. Best vaccination practice and medically attended injection site events following deltoid intramuscular injection. Hum Vaccin Immunother 2015;11(5):1184-91.
Learning from Influenza Vaccine Errors to Prepare for COVID-19 Vaccination Campaigns; Institute For Safe Medication Practices; 19 Nov 2020; https://ismp.org/resources/learning-influenza-vaccine-errors-prepare-covid-19-vaccination-campaigns; accessed 20 Nov 2020.
Grissinger M; The Five Rights A Destination Without a Map; PT 2010; Oct: 35(10): 542.
Grady A; The Importance of Standard of Care and Documentation; Virtual Mentor; 2005;7(11):756-758.
VAERS A National Program for Monitoring Vaccine Safety, US Centers for Disease Control and Prevention; https://www.cdc.gov/vaccinesafety/pdf/vaers_factsheet1.pdf [cdc.gov]; accessed 9 Dec 2020.
Crowcroft NS, Levy-Bruhl D; Registries:An essential tool for maximizing the health benefits of immunisaiton in the 21st century; Euro Surveill; 2017; Apr 72;22(17): 30523
About Immunization Information Systems; US Centers for Disease Control and Prevention (CDC); https://www.cdc.gov/vaccines/programs/iis/about.html; accessed 12 Dec 2020.
Summary of the HIPAA Privacy Requirements; United States Department of Health and Human Services; https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html; accessed 12 Dec 2020.
What is Herd Immunity?; Association for Professionals in Infection Control and Epidemiology (APIC); 23 Nov 2020; https://apic.org/monthly_alerts/herd-immunity/?gclid=Cj0KCQiA8dH-BRD_ARIsAC24umZ6wGTdhBq6GgR1zxL08FleB14MLxxYJ53ddAuX9tG6WhX4_1B0FWQaAsscEALw_wcB; accessed 22 Nov 2020.
What is Herd Immunity and How can we achieve it with COVID-19?; Johns Hopkins; https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.html; accessed 23 Nov 2020.
https://unfoundation.org/blog/post/wiping-out-wild-polio-in-africa-together/?gclid=CjwKCAiA7939BRBMEiwA-hX5J0N6lvTi3EU-jF3GqSzkjdmqWae1fQqmQePpd5I6Zv6apJiMVNuDDRoCF7EQAvD_BwE; accessed 21 Nov 2020.
MacDonald NE, the SAGE Working Group on Vaccine Hesitancy; Vaccine hesitancy: Definition, scope and determinants; Vaccine; 33(34), 4161-4164; 14 Aug 2015
The Lancet; Vaccine hesitancy a generation at risk;The Lancet Child and Adolescent Health; 3(5) 281; 1 May 2019.
Strategies for addressing vaccine hesitancy; World Health Organization; https://www.who.int/immunization/sage/meetings/2014/october/3_SAGE_WG_Strategies_addressing_vaccine_hesitancy_2014.pdf; accessed 24 Nov 2020.