Immunization Update for Pharmacy Technicians By Jeffrey Holm, 2018 Pharm.D. candidate, University of Michigan College of Pharmacy

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1 Immunization Update for Pharmacy Technicians By Jeffrey Holm, 2018 Pharm.D. candidate, University of Michigan College of Pharmacy Target Audience This continuing education activity was designed specifically for pharmacy technicians. Disclosure Statement The author has indicated that he does not have any conflicts of interest, nor does he have financial relationships with a commercial interest related to this activity. Learning Objectives At the end of this activity, participants should be able to: 1. Explain the general role of vaccines within the immune system. 2. Explain the types of vaccines that are available. 3. Explain the different immunization routes for vaccines and the recommended technique involved. 4. Identify potential roles of pharmacy technicians in regards to vaccinations in the pharmacy setting. Introduction Immunizations are a common practice within the pharmacy setting. Data from the Michigan Care Improvement Registry (MCIR) confirms that pharmacies administered 25.2 percent of all adult vaccines reported between July 1, 2016, and June 30, In addition, over a third of flu vaccines and more than half of zoster vaccines reported to MCIR were administered by pharmacies. 1 Community pharmacies are very accessible to patients, so this could be contributing to pharmacies becoming a more prominent setting to acquire vaccinations. While pharmacy technicians generally have little background in this area, they can be integrated into the workflow to make the vaccination process more efficient. This article will provide pharmacy technicians with a general introduction to vaccinations and their administration routes. It will also examine the roles pharmacy technicians could serve to ensure workflow is optimized while providing excellent service to the patient. The Immune System and Immunizations To fully understand how a vaccine works within the immune system, it is important to first address the immune response. When the body is exposed to something that it considers foreign, an immune response is initiated. Although there are many factors, the key cells involved in the immune response are called white blood cells. There are three primary types of white blood cells: macrophages, B- lymphocytes and T-lymphocytes. Macrophages are responsible for first identifying, then engulfing and destroying foreign matter or microorganisms as they present within the body. Upon destroying the foreign body, the macrophages leave behind residual pieces of the invader that are termed antigens. Technically, antigens are not the foreign invader itself, but are markers for that foreign body that the immune system is able to recognize and respond to. Those antigens are important for future recognition of the foreign bodies in question. B-lymphocytes are responsible for producing antibodies that are specific to certain antigens. Those antibodies will circulate the body until they come into contact with an antigen they are specific for. The antibodies bind the complimentary antigen, preventing it from eliciting its effect on the host. They also mark the invading matter for destruction by other immune cells. T-lymphocytes are primarily responsible for attacking cells within an already infected individual. Some T-lymphocytes also play a role when encountering a previously

2 identified antigen. Those T-cells are known as memory T-cells. Their niche is to begin attacking antigens quickly if they are re-introduced into the body. 2,3 First, a general background of the immune system is necessary to fully understand the mechanism of a vaccine. Vaccines are produced with the intent to mimic an infection without causing any illness to the patient. Generally speaking, all vaccines will provide the host with antigens that the immune system will respond to. Upon recognition of the antigens, the immune system will prime its immune response. Generally it takes about two weeks for the immune system to reach its full potential. Once at full potential, the host should quickly produce antibodies and attack foreign invaders with antigens that are similar to what the vaccine provided. Someone who was not vaccinated or previously exposed to the antigen through illness will not have the advantage of a primed immune response. Those individuals are more likely to experience symptoms related to the foreign body in question. It is still possible for immunized patients to experience symptoms of being sick when there is a foreign invader. However, the symptoms in immunized patients are typically less severe if any symptoms are noted. 2,3,17 STOP AND REFLECT Today you are seeing a 19-year-old female who is receiving her first flu shot. She is very concerned about getting sick and states that many friends and family members already have the flu. She asks you if the vaccine she is receiving will be working today. How do you respond? FEEDBACK You will want to explain that although her body should start responding to the vaccine today, it is unlikely that it will provide full immunity that quickly. It can take about two weeks before the immune system is at its full potential. Recommend necessary precautions to avoid illness given that her family members and friends are sick. Although staying away from sick individuals would be best, routine hand washing will be essential if she is around them. Also, advise her to try to avoid touching her mouth, nose and eyes as much as possible as those are common routes of infection. Types of Vaccines There are multiple types of vaccines currently on the market that are produced in different ways. How vaccinations are produced depends on what the vaccine is protecting against, how the bacteria or virus infects the host as well as how the immune system responds when a specific infection ensues. The region of the world where the vaccine will primarily be used is another consideration when developing vaccines. The main types of vaccines available include live attenuated vaccines, inactivated vaccines, subunit vaccines, toxoid vaccines and conjugate vaccines. 2,4,5 Live, attenuated vaccines are exactly as they sound. They contain versions of the living microorganism that have been weakened (attenuated) through the manufacturing process. These vaccines are very good at producing an immune response and are unlikely to cause illness. However, because the microorganisms are technically alive, there is potential for an infection to occur in patients with weakened immune systems, such as those receiving immunosuppressant agents. Patients with weakened immune systems are advised to not receive this type of vaccine. 2,4,5

3 Inactivating, or killing the microorganism through chemical or physical processes creates inactivated vaccines. These vaccines do not usually stimulate the immune system as effectively as the live, attenuated vaccines. As a result, a series of doses or boosters are often necessary with to promote sufficient stimulation of the immune system and/or a continued immunity. These vaccines are less likely to have a negative side effect than live, attenuated vaccines. In addition, they essentially have no increased risk of infection due to the vaccine itself. 2,4,5 Antigens, like previously described, are markers for foreign invaders to which the immune system recognizes and responds. Although there may be multiple antigens associated with a single microorganism, the immune system may recognize and respond to certain antigens more effectively than others. Vaccine manufacturers now have the ability to select and isolate the antigens that will elicit the most effective immune response. This can be accomplished one of two ways. The microorganism can be grown in a laboratory, where it is inactivated and the best antigens are collected; alternatively, antigens can be produced from the microorganism using special DNA recombinant technology. Upon collecting the best antigens, they can be formulated into vaccines. Vaccines produced in this way are termed subunit vaccines. Some subunit vaccines may contain only one antigen whereas others may contain multiple. Similar to inactivated vaccines, subunit vaccines do not contain the live microorganism and thus have a low potential for negative side effects, and they essentially carry no risk of infection. 2,4,5 Some bacteria secrete a toxin or harmful substance that is used to produce vaccines. The toxins responsible for the disease in question are inactivated through chemical methods and then formulated into their respective vaccines. Vaccines produced in this way are termed toxoid vaccines. The inactivated toxins within these vaccines are recognized by the immune system, which will lead to an immune response. After vaccination, if the toxin is re-introduced to a host, the immune system should be capable of attacking those toxins before they cause illness. Toxoid vaccines are very safe and cannot cause the disease they are preventing. 2,4,5 Certain bacteria may have an outer coating of sugar molecules that are called polysaccharides. The polysaccharide coating can disguise a bacterium s antigens and make it more difficult for the immune system to recognize and fight that infection. There are vaccines that contain antigens linked to polysaccharides called conjugate vaccines. They help the immune system recognize and protect the host against microorganisms containing polysaccharides. These vaccines are similar to subunit vaccines in that they contain the antigens from a microorganism but not the live microorganism itself. These vaccines also have a low potential for negative side effects and cannot cause the disease they are protecting against. 2,4,5 STOP AND REFLECT What differentiates an inactivated vaccine from a subunit vaccine? FEEDBACK An inactivated vaccine contains the entire microorganism that has been inactivated within a laboratory setting, whereas a subunit vaccine contains only the antibodies that are specific to a particular microorganism.

4 Vaccine Administration When addressing vaccines, there are multiple administration routes that should be described. Vaccines can be administered intranasally, orally or through an injection into the skin (intradermal injection), muscle (intramuscular injection) or fat (subcutaneous injection). It is important to understand which administration route should be used for each vaccine as well as the recommended technique involved. Table 1 can be referenced for routes of administration of vaccines and combination vaccines available in the United States. Although administration techniques will be addressed, recommended administration routes for available vaccines will not be described here. This information can be obtained from package inserts. Similarly, although administration instructions for specific vaccines will be described here, those instructions may differ between vaccines even if they are to be administered via the same route. Therefore, it is best to consult package inserts for administration instructions as well. 6,7 Prior to administration of vaccines, it is important to take general precautions and prepare appropriately. If available, immunization records should be obtained to confirm that the patient is indeed due for the vaccine in question. Hands should be either cleansed with an alcohol-based waterless antiseptic hand rub or washed with soap and water immediately prior to vaccine preparation and between each patient contact. Using gloves during administration is recommended to prevent coming in contact with a patient s body fluids. Gathering all supplies such as alcohol wipes, syringe, needle, vaccine, diluents (if necessary), adhesive bandage and sharps container is essential for an efficient encounter with the patient. Every vaccine should be visually inspected for particulate matter and/or discoloration prior to administration. Most vaccines should not be administered if those conditions are present. In addition, it is important to always check expiration dates to ensure the vaccine has not expired. 6,7 Intranasal vaccines are fairly simple to administer. Instructions for administering the intranasal version of the live attenuated influenza vaccine will described here, as this is the only available intranasal vaccine in the United States. The intranasal sprayer has a dose-divider clip that allows for administration of equal doses into each nostril. The first step is to remove the rubber tip protector from the vaccine. With the patient in an upright position, the tip of the intranasal sprayer is then inserted slightly into one nostril. The patient should be instructed to breathe normally. Next, the plunger should be depressed rapidly in one motion until the dose-divider clip prevents the plunger from going any further. Once the first dose has been administered, a second dose needs to be administered into the other nostril. Removing the dose-divider clip will allow the second dose to be administered. Once the dose-divider clip is removed, the pharmacist should place the intranasal sprayer tip just inside the other nostril. With the patient again breathing normally, the plunger should be depressed as rapidly as possible until it cannot go any further. Now, the vaccine has been fully administered and the applicator can be disposed of into an appropriate sharps container. It is important to note that even if the patient coughs or sneezes immediately after administration, the vaccine does not need to be repeated. Figure 1 illustrates correct technique for administering an intranasal vaccine. 6,7,8

5 Figure 1. Correct intranasal vaccine administration technique. 12 Even simpler than nasally administered vaccines, are orally administered vaccines. Although other oral vaccines are available, the oral administration directions for rotavirus will be specifically described here. To begin an oral vaccine administration, any fluid within the application tip should be cleared first. This will help prevent any loss of vaccine prior to administration. Holding the vaccine with the applicator tip up and tapping the tube should clear the fluid. Once cleared from the application tip, screwing the cap clockwise until it becomes tight will puncture the vaccine tube. The cap can then be removed by turning it counterclockwise. The vaccine should then be administered gently by squeezing the liquid into the patient s mouth toward one of the inner cheeks. The tube can be repeatedly squeezed until it is empty. The empty tube can then be disposed in an approved biological waste container according to local regulations. 7,9 For injectable vaccines, needles and syringes should always be sterile and disposable. Additionally, needles and syringes should never be reused and should be discarded immediately following administration in an appropriate sharps container. The sharps container should be within close proximity to allow prompt and safe disposal. Some vaccines may come in a pre-filled syringe that is essentially ready to be administered once the needle cap has been removed. For vials, the vaccine will need to be drawn up to the appropriate dose. No matter the case, aseptic technique must always be used as to avoid any contamination. For example, the vaccine vial should be swabbed with an alcohol pad prior to drawing up the vaccine. In addition, the needle and plunger shaft should not make contact with anything that is non-sterile. It may be best to draw up the vaccine prior to interaction with the patient in an attempt to avoid patient anxiety. However, this should be done at the discretion of the pharmacist. Package inserts can be referenced for more thorough instructions on drawing up vaccines. 6,7 Unless a needle has been damaged, contaminated, or the package insert states otherwise, it is ok to use the same needle for administration as what was used to draw up the vaccine. An alcohol pad (different from what may have been used on the vaccine vial) should be used to clean the injection site on the patient. It is recommended to use a circling motion starting at the center of the injection site and going out two-to-three inches when cleaning the injection site. The injection site should be

6 allowed to dry prior to vaccine administration. This is done to avoid any additional stinging that may be caused by the alcohol. Of note, some syringes may be equipped with a safety needle to prevent needle sticks. If equipped, the safety needle should be activated immediately following a vaccine administration. There are different safety needles available; however, they will not be described in further detail here. 6,7 When injecting via intradermal route, the vaccine will be injected in between the layers of a patient s skin. Specific administration instructions described here are recommended for Fluzone Intradermal vaccine. For Fluzone, the vaccine will come in a pre-filled microinjection system. The preferred injection site is the skin over the area of the deltoid muscle, which is the triangular shaped muscle on the outer aspect of the shoulder. Figure 2 illustrates where the injection site is located on the deltoid. If indicated, the vaccine should be shaken prior to administration. The needle cap can then be removed. The injection device should be placed in the pharmacist s hand between the thumb and middle finger while keeping the index finger free. Next, the needle is to be pierced through the patient s skin using light pressure perpendicular to the deltoid region (90-degree angle). Once the patient s skin has been pierced, the free index finger can be used to press the plunger to inject the vaccine. When the plunger is fully depressed, the vaccine has been completely administered. Once the vaccine has been completely administered, the needle should be withdrawn from the patient. If the vaccine syringe is equipped with a safety needle, the safety mechanism should be activated. The syringe should then be discarded in an appropriate sharps container. If the patient is bleeding, an adhesive bandage may be necessary. 7,10 Figure 2. Correct injection site on deltoid for intradermal and intramuscular vaccines. 13 For intramuscular injections, the vaccine may be in a prefilled syringe or in a vial that the vaccine needs to be drawn up from. injections, just as they sound, are to be injected into the muscle tissue of the patient. For patients aged less than three years, the front, outer portion

7 (anterolateral aspect) of the thigh is the preferred location. This location is illustrated in Figure 3. For patients three years of age and older, the deltoid is the preferred location for injection. Refer to Figure 2 for the correct deltoid injection site. 6,7 Needles used for intramuscular injections may vary between patients. An appropriate size needle should be used to reach deep into the muscle. The needle should be between 22 and 25-gauge and at least one inch in length. Patients aged three to 10 years may need a 1.25 inch needle for deeper penetration, while patients 11 years and older may need up to a 1.5 inch needle. In addition to age, a patient s body composition will need to be taken into consideration when selecting a needle. Someone who is overweight or obese may need a longer needle to penetrate into the muscle in comparison to someone who is thin. The pharmacist will need to make the clinical decision regarding needle length based on patient age, size and body composition. Once the needle and syringe have been appropriately selected, the injection site should be exposed and cleaned with an alcohol pad as previously described. Next, if not already drawn up, the correct dose should be drawn into the syringe. Once the injection site has dried, the pharmacist s non-dominant hand can be used to bunch up the muscle or hold it taut. With the pharmacist s dominant hand, the needle should be inserted at a 90-degree angle with the skin using a quick thrust. The plunger should then be pressed, injecting all of the vaccine into the patient s muscle. Once the vaccine has been completely administered, the needle should be withdrawn from the patient. A dry cotton-ball or gauze can be used to apply pressure to the injection site. If the syringe is equipped with a safety needle, the safety mechanism should be activated directly following the injection. It may be helpful to ask the patient to continue applying pressure while the pharmacist immediately discards the syringe in an appropriate sharps container. If there is any bleeding, an adhesive bandage can be used. 6,7 Figure 3. Correct injection technique (90 degree angle) and location (anterolateral aspect of thigh) for intramuscular injections administered to patients younger than three years of age. 14 Similar to intramuscular vaccines, subcutaneous vaccines may come in a prefilled syringe or need to be appropriately drawn up from a vial for administration. Needle size should be 23- to 25-guage and 5/8-inch in length. Subcutaneous injections are to be injected into the subcutaneous (fat) tissue between a patient s skin and muscle. The upper-outer triceps area of the arm is the preferred location for patients one year and older. The triceps are the large muscle group at the back of the

8 upper arm. The thigh is usually the preferred location for infants less than one year old. It may be easiest to have the patient seated in a relaxed position with their arm hanging. The triceps area should be exposed and the injection site cleaned with an alcohol pad as previously described. Once the injection site has dried and the vaccine is drawn up, the pharmacist s non-dominant hand can be used to plump the skin near the injection site. This is done to help prevent injection into the muscle. The needle should be inserted with the pharmacist s dominant hand at a 45-degree angle with the skin. Once inserted, the plunger can be pressed until all contents have been administered. The needle should then be withdrawn from the patient. If equipped with a safety needle, the safety mechanism should be activated directly following injection. The syringe should then be immediately discarded in an appropriate sharps container. A bandage should be sufficient to control any bleeding. Figure 4 illustrates correct subcutaneous vaccine administration. 6,7 Figure 4. Correct subcutaneous vaccine administration technique. 15 STOP AND REFLECT Today the pharmacist will be administering an intramuscular vaccine. The patient is 35-years-old and is obese. The pharmacist asks you, the pharmacy technician, to select an appropriate needle for injection. What gauge and length would be most appropriate to select? FEEDBACK Generally, the needle should be between 22 and 25-gauge and at least one inch in length. Since the patient is an adult and obese, a 1.5-inch needle will likely be most appropriate. Vaccine Adenovirus Anthrax Cholera Diphtheria, Tetanus, & Pertussis (DTaP) Diphtheria & Tetanus (DT) Haemophilus Influenzae type b (Hib) Administration Route Oral Oral

9 Hepatitis A Hepatitis B Herpes Zoster Human Papillomavirus (HPV) Influenza Japanese Encephalitis Measles, Mumps, Rubella Measles, Mumps, Rubella, Varicella Meningococcal Pneumococcal Polio Rabies Rotavirus Tetanus, (reduced) Diphtheria, (reduced) Pertussis (Tdap) Typhoid Varicella Yellow Fever Subcutaneous Intradermal,, Intranasal Subcutaneous Subcutaneous & Subcutaneous & Subcutaneous & Subcutaneous Oral & Oral Subcutaneous Subcutaneous Combination Vaccine DTaP, Polio DTaP, Hepatitis B, Polio DTaP, Polio, Hib Hib, Meningococcal Hepatitis A, Hepatitis B Administration Route Table 1: Vaccines and combination vaccines available in the United States that can be administered by intradermal, intramuscular, intranasal, oral or subcutaneous routes. 16 Role of the Pharmacy Technician Pharmacists have many responsibilities relative to vaccine administration. They are responsible for preparing and educating the patient regarding the vaccine they will receive, ensuring the vaccine is administered and documented appropriately as well as addressing any questions or concerns the patient may have. What about pharmacy technicians? What role do they hold in regards to vaccinations? Because community pharmacists have many responsibilities throughout their workday, the pharmacy technicians can play a valuable role in the vaccination process. It may be most efficient to have pharmacy technicians supply the patient with the necessary paperwork to read and/or complete prior to their vaccination. Technicians can also gather all necessary items for a vaccination, draw up the vaccine and seat the patient in a designated vaccination area. In addition, the technician can make note of any questions for the pharmacist to address prior to receiving a vaccination. This could allow for a more thorough discussion of the patient s questions or concerns should the pharmacist need to look up any information. In addition to the previous roles, pharmacy technicians can handle inventory management, patient scheduling, prescription processing and payments. 11

10 Although a pharmacy technician s role may differ between pharmacies, the roles described in this article could improve efficiency and patient satisfaction if they are not already being incorporated into the vaccination workflow. A pharmacy technician should always practice within the scope of their license, however. Additionally, approval of the pharmacist on duty must be sought prior to a pharmacy technician assuming any of the aforementioned roles. Conclusion In summary, it is important for pharmacists and pharmacy technicians to be knowledgeable about the general mechanism of vaccinations within the immune system. It is also important for them to work effectively and efficiently with pharmacists to ensure patient satisfaction. Although pharmacy technicians will not be administering vaccines, it is important to understand the different administration routes and the techniques involved with administration. If not already incorporated, the roles described in this article may be beneficial for vaccination workflow and patient satisfaction in regards to pharmacy technician involvement. With many vaccinations being performed within pharmacy practice, this information will hopefully aid in appropriate and efficient vaccine delivery that is satisfactory to patients. REFERENCES 1. Michigan Pharmacists Association, Michigan Department of Health & Human Services. Pharmacies & Immunizations in Michigan. Michigan Care Improvement Registry website. Paper.pdf. September Accessed Nov. 20, Centers for Disease Control and Prevention, American Academy of Family Physicians, American Academy of Pediatrics. Provider Resources for Vaccine Conversations with Parents. Centers for Disease Control and Prevention website. February Accessed Nov. 21, National Institute of Allergy and Infectious Diseases. How Do Vaccines Work?. National Institutes of Health website. April 19, Accessed Nov. 21, National Institute of Allergy and Infectious Diseases. Vaccine Types. National Institutes of Health website. April 3, Accessed Nov. 21, Mort, Molly, Baleta, Adele, Destefano, Frank, et al. Vaccine Safety Basics e-learning course. World Health Organization. website. Accessed Nov. 21, National Center for Immunization and Respiratory Diseases. General Best Practice Guidelines for Immunization: Vaccine Administration. Centers for Disease Control and Prevention. July Updated Oct. 4, Accessed Nov. 22, Immunization Action Coalition. Vaccinating Adults: A Step-by-Step Guide. Immunization Action Coalition website. October Accessed Nov. 21, FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) Nasal Spray, package insert. MedImmune, LLC. Gaithersburg, Maryland, RataTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) Oral Solution, package insert. Merck & Co., Inc. Whitehouse Station, Jew Jersey, 2017.

11 10. Fluzone Intradermal Quadrivalent, package insert. Sanofi Pasteur Inc. Swiftwater, Pennsylvania. March, Goad, J, Bach, A. The role of community pharmacy-based vaccination in the USA: current practice and future directions. Dovepress - Integr Pharm Res and Pract. 2015: Gathany, J, Atkinson, B. administering, H1N1, live, attenuated, intranasal, vaccine, laiv, female, recipient Accessed Nov. 28, British Columbia Institute of Technology. Medical diagram showing the deltoid site for intramuscular injection Accessed Dec. 9, Mills, A., injection, case, delivering, requisite, vaccination Accessed Nov. 9, Schmidt, J. An African-American man receiving a vaccination shot from his doctor. Accessed 11/28/ Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine- Preventable Diseases, 13 th Edition, Appendix B-1, B-2, B-3 and B-4. U.S. Vaccines: Table 1 and Table 2. May, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention website. May, Accessed Dec. 10, Commonwealth of Australia. Frequently Asked Questions. Immunise Australia Program. -asked-questions. June Accessed, Dec. 19, 2017.