 Welcome to the Immunization Encounter, Critical Issues. We are coming to you today from the Centers for Disease Control and Prevention in Atlanta, Georgia. I am Dr. Andrew Kroger and I will be your host for this program. This program is unique among the immunization education programs usually presented by CDC. We will not talk very much about vaccines or vaccine recommendations. Instead, we will concentrate on many of the other immunization related issues that you face every day in your office or clinic, such as vaccine storage and handling, vaccine administration, and screening for contraindications. We have two instructors for today's program. Donna Weaver is a nurse educator in the National Center for Immunization and Respiratory Diseases at CDC. Ms. Weaver has a master's degree in nursing and has been working in immunization programs since 1996. Our second instructor is Dr. Iabode Beiselo. Dr. Beiselo is a pediatrician and a medical officer in the National Center for Immunization and Respiratory Diseases at CDC. In this program, we will address issues and activities that immunization providers encounter every day. The program will be divided into three sections, activities before, during, and after the immunization encounter. We will begin with a discussion of pre-encounter activities that occur before your patient arrives. In this section, we will concentrate on vaccine storage and handling and preparing for an emergency. The second section of the program will cover activities that occur during the immunization encounter. In this section, we will discuss parent and patient education and the use of vaccine information statements, screening for contraindications and precautions, and vaccine administration. In our third section, we will discuss post-encounter activities, primarily documentation and record keeping. Let's look at the objectives for this program. After this program, we hope you will be able to do these things and much more. Locate resources relevant to current immunization practice, list procedures for appropriate vaccine storage and handling and emergency preparedness, and name a strategy for communicating about immunization risks and benefits. List critical issues involved in patient screening and vaccine administration, and describe recommendations for post-vaccination care and record keeping. And for pharmacists, select and implement strategies to prevent or detect disease in the target population. We receive many questions from providers about these topics, in particular, vaccine storage and handling, vaccine administration, and vaccine contraindications. We will address many of these questions during the course of this program. We will also provide you with resources to locate more information on these topics. Our program will begin after this brief pause. This program is divided into three main sections. The pre-encounter phase, before the person arrives, the encounter phase, when the person is in the office, and the post-encounter phase, after the person leaves the office. For each of these immunization and counter phases, we will review the activities that should be a routine part of that phase. We will then discuss some of these activities in detail. Donna will review for us the key pre-encounter activities. Thanks, Andrew. There are many activities that should take place before the patient arrives at your office. Most of these activities are not specific for one patient, but are components of a good immunization delivery system in your office or clinic. One of the most important pre-encounter activities for your office is staff training and education. Competency-based orientation and continuing education for staff are critical to providing safe, effective, and caring immunization services. Training and education is not a one-time event, but a systematic ongoing program. Patient reminders are one of the most effective strategies for raising and maintaining high immunization coverage levels. Call or send patients a note to remind them about their upcoming appointment and remind them to bring their immunization record. Make your life easier by participating in an immunization information system or registry if one is available in your area. Adequate clinic supplies and patient education materials should be available. Check your inventory first thing in the morning. Be sure that you have adequate materials and supplies on hand before your clinic day begins. You certainly do not want to run out of syringes or vaccine before the day has ended. Prescreen the medical records for recommended immunizations. We strongly recommend that medical records be screened before the patient arrives to assess the need for recommended immunizations. You should do this even if the patient is scheduled for something other than immunizations. This will help you to avoid a missed opportunity and can save time on the appointment day. Every person to whom you administer a dose of vaccine is dependent on your vaccine storage and handling procedures. There is very little room for error when it comes to proper storage of your vaccine supply. Likewise, every person to whom you administer a dose of vaccine is potentially dependent on your office's emergency preparedness. The procedures and protocols you have in place in the unlikely event of a medical emergency such as an allergic reaction. These last two activities, vaccine storage and handling and emergency preparedness are critical components of good immunization practice. We would like to discuss both of them in more detail beginning with vaccine storage and handling. The success of efforts against vaccine preventable diseases is attributable in part to proper storage and handling of vaccines. Exposure of vaccines to temperatures outside the recommended ranges can adversely affect their potency and reduce the protection they provide. Vaccines must be stored properly from the time they are manufactured until they are administered. The cold chain begins with the manufacturer and continues with the transfer of vaccine to the distributor, transfer from the distributor to the provider's office and administration to the patient. Proper storage temperatures must be maintained at every link in the chain. During this segment, we will cover general guidelines for proper vaccine storage and handling. Specific storage and handling recommendations for each vaccine are available in the manufacturer's product inserts and several other resources, which will be included on the resource webpage for this program. Yabo? Thanks Andrew. There are a few immunization issues more important than the appropriate storage and handling of your vaccine supply. This is also one of the most common vaccine delivery problems that we encounter at CDC. If vaccine storage or handling failure can affect large numbers of your patients and result in embarrassment, expense and potential liability for your practice. Every facility that stores vaccines should develop and maintain a detailed, written vaccine storage and handling protocol. This protocol should include information for accepting vaccine deliveries and guidelines for storage and handling. Each facility should assign responsibilities to one person for ensuring that vaccines are carefully handled in a safe, documented manner. Since no one works every single day, facilities should also deconate a backup person. All staff working with vaccines should be familiar with storage and handling guidelines. Your office should provide training on vaccine storage and handling to staff. Proper vaccine storage and handling begins the moment the vaccine arrives. Vaccine shipments should be examined on arrival. Examine the shipping container and its contents for any evidence of damage during transport. Cross check the contents with the pack and slip to be sure they match. Finally, check the shipment date to determine how long the package was in transit. If the interval between shipment from the supplier and arrival of the product at your office was more than 48 hours, it could mean the vaccine has been exposed to excessive heat or cold that might alter its integrity. Each shipment should be recorded on an inventory log. This log should include the name of each vaccine, the number of doses for each vaccine received, the data was received, the condition of the vaccines upon arrival, the name of the vaccine manufacturers, the lot numbers and the expiration dates for each vaccine. If there are any discrepancies with the pack and slip or concerns about the vaccine shipment, immediately store the vaccine properly and mark do not use until the integrity of the vaccine is determined. You will then need to contact the manufacturer or your state immunization program for further guidance. Who you contact will depend on who shipped the vaccine to you and your agency or state policy. Vaccine storage units must be selected carefully and used properly. Refrigerators without freezers and standalone freezers are usually better at maintaining the required temperatures. However, a combination refrigerator freezer unit sold for home use is acceptable for vaccine storage if the refrigerator and freezer components each have a separate exterior door. Some state immunization programs may have more specific storage unit requirements for VFC providers. Any refrigerator or freezer used for vaccine storage must be able to maintain the required temperature range throughout the year. It must be large enough to hold the year's largest vaccine inventory and must be dedicated to the storage of biologics. Food and beverages should not be stored in vaccine storage units. Keeping food and beverages in the storage unit leads to frequent opening of the door, which leads to temperature instability. CDC discourages the use of small single door or dorm style refrigerators like the one shown here. This type of unit may be used for temporarily storing small quantities of inactivated vaccines, MMR, live attenuated influenza vaccine, or rotavirus vaccine only if the refrigerator compartment can maintain a constant temperature. The vaccine should be returned to the primary storage unit at the end of the clinic day. However, it is impossible for the freezer component to maintain the required temperature range. This type of unit must never be used to store varicella, MMRV, and zoster vaccines. Most vaccines require refrigerator storage temperatures of 35 to 46 degrees Fahrenheit, which is 2 to 8 degrees Celsius, with an average temperature of 40 degrees Fahrenheit, or 5 degrees Celsius. Vaccines that are stored in the freezer must be kept at 5 degrees Fahrenheit, which is minus 15 degrees Celsius or colder. Both types of influenza vaccine in activated and live attenuated must be stored in the refrigerator. LAIV no longer requires freezer storage. All vaccines that contain live varicella virus must be stored in the freezer at 5 degrees Fahrenheit or colder. This includes single antigen varicella vaccine, MMRV, and zoster vaccine. MMR may be stored in either the freezer or the refrigerator. If you're using both the refrigerator and freezer to store vaccines, be careful not to make the freezer so cold that the refrigerator temperature drops below the recommended temperature range. Andrew? Proper temperature monitoring is key to proper cold management. Check the temperatures twice a day, once in the morning, and once before you leave at the end of the work day. Post a temperature log like this on the door of the refrigerator or freezer and record the temperature readings twice daily. It is important to keep temperature logs for at least three years unless state statutes or rules require a longer period. As the refrigerator or freezer ages, you can track recurring problems or identify how long problems have existed. While it is important to document the temperatures, documentation is not enough. Equally important is taking immediate action when the temperatures fall outside the recommended range. It may be a problem that can be solved easily, such as a door that was left open or a unit was unplugged. On the other hand, there may be a more serious problem with the unit. After all, all refrigerators eventually fail. It could also be a power failure or some type of emergency or disaster situation that will require alternative storage for the vaccine until the situation is corrected. It is very important that staff know whom to contact in case of a malfunction or disaster. If the problem is short term, usually two hours or less, you can probably maintain the temperature in the unit by adding ice or ice packs and keeping the door closed. If there is an extended period of time before the situation can be corrected, then you should move the vaccine to another storage unit. It is critical that every clinic have a written emergency vaccine retrieval and storage plan. The most important part of this plan is to identify a location with a backup generator where a provider can move their vaccine in the event of an emergency, such as an equipment failure or power outage. Consider contacting a local hospital, the Red Cross, or a long term care facility as a backup site. If the vaccine can be moved to this site within 30 minutes, it can be transported in insulated containers or coolers. If the location is more than 30 minutes away and you have a large quantity of vaccine, you should consider renting a refrigerated truck to transport your vaccine. Also remember, whenever there is a question about the integrity of the vaccine, contact the vaccine manufacturer and or your state immunization program for guidance. Donna? If you discover that your refrigerated vaccine has been exposed to freezing temperature, even if the vaccines do not appear to have been frozen, you should keep the exposed vaccine refrigerated, but segregated so it will not be used. Then contact the manufacturer or your state immunization program for advice. You should do the same thing if your freezer temperature rises above five degrees Fahrenheit during other than the normal defrost cycles. Both the refrigerator and freezer compartments should have their own thermometer. The thermometer should be placed in the central part of the storage compartment, not against the wall. Here are some examples of thermometers that can be used, including biosafe liquid, continuous graphic and minimum maximum. If you are using a continuous recording thermometer, even though it is recording the temperatures for you, it should still be checked twice each day to make sure the temperatures are in range. Thermometers are a critical part of good storage and handling practice. CDC recommends using only certified calibrated thermometers for measuring vaccine storage unit temperatures. More information about these thermometers is available on the program resources webpage. To keep the refrigerator and freezer cold, the unit must be in good working condition and it must have power at all times. There are several things you can do to prevent problems. Your refrigerator should have a plug guard or a safety lock plug so that it cannot be inadvertently pulled out. You may want to install a temperature alarm to alert staff to after-hours emergencies, particularly if large vaccine inventories are maintained. Label the circuit breakers to alert janitors and electricians not to unplug the vaccine storage unit or turn the power off. You can do this by posting a warning sign like this at the plug on the refrigerator and at the circuit breaker box. Vaccine should be stored in the center of the refrigerator compartment away from the walls and coils. This allows air to freely circulate around and through the vaccine stacks and provides even cooling to all stored vaccine. To avoid confusion, vaccine of the same type should be stacked and rose. Vaccine stored in the freezer compartment should also be located in the center of the compartment and away from sides of the unit. You can help stabilize the temperature in the refrigerator by keeping containers of water inside. This liquid bulk helps keeps the temperature stable, particularly when the refrigerator is being opened and closed all day. Remove the vegetable bins and shelf and put water containers in their place as shown here. The same principle applies to the freezer. Store extra cold packs or blue ice in the freezer. Not only will they help keep the temperature stable with frequent opening and closing of the door, they will also help keep the temperature stable in the event of a power failure. Providers should never store vaccines in the door of the freezer or the refrigerator or in the vegetable bins. The temperatures in these areas are not stable. Use these areas to store liquid bulk and coal packs. However, be careful when storing ice packs and water bottles in the doors that the added weight does not compromise a good seal when the doors are closed. You should learn from previous situations or mistakes. Whenever there is a violation of the vaccine handling protocol or another vaccine storage problem, document the occurrence. Use the experience as a learning opportunity when training new staff so that a similar situation can be avoided in the future. Yabo? Thanks, Diana. We are frequently asked about storing biologic specimens such as blood and urine in the same storage unit as vaccine. We prefer that vaccines be kept in a dedicated storage unit, but we understand this is not possible in some offices. If you must store biologic specimens in the same unit as vaccines, be sure the specimens are stored on a lower shelf than your vaccine supply. This is to assure that if a specimen leaks, your vaccine will not be contaminated. Check and rotate vaccine stock weekly so that vaccines with the shortest expiration dates are in the front to be used first. If the expiration date on the vial is identified only as month and year, the vaccine does not expire until the last day of the month indicated on the vial. Expired vaccine, even if only one day after the expiration date, should never be administered. Promptly remove expired vaccine from the refrigerator or freezer and dispose of it appropriately. If the expired vaccine is VFC vaccine, you should first contact your state immunization program so that the expired vaccine can be accounted for. Most vaccines are supplied in single dose vials or syringes, but a few vaccines such as inactivated influenza and inactivated polio are supplied in multi-dose vials. Multi-dose vials contain a bacteriostatic agent that functions as a preservative, usually thimerosol or 2-phenoxyethanol. A multi-dose vial can be used until the date of expiration unless it becomes visibly contaminated. Single-dose vials do not contain a bacteriostatic agent and are meant for one-time use only. Once opened, they must be discarded at the end of the clinic day. Liophilized or freeze-dried vaccines are in a powder form and must be reconstituted before use. Vaccine diluents such as sterile water or saline can be stored in the refrigerator or at room temperature. Do not freeze vaccine diluent. Once a liophilized vaccine has been reconstituted, the clock is running. Reconstituted vaccines must be used within a specified timeframe or that must be discarded. Meningococcal polysaccharide vaccine, single-dose vials, MMRV, varicella and zoster vaccines, as well as trihibid and pentasil, which contain active, must be used within 30 minutes of reconstitution. Yellow fever vaccine must be used within one hour. MMR must be used within eight hours. An active reconstitutive of .4% sodium chloride diluent must be administered within 24 hours. Meningococcal polysaccharide vaccine, multi-dose vials can be used up to 35 days after reconstitution if stored and handled properly. Vaccines reconstituted beyond these limits should not be administered. The best way to avoid such waste is to reconstitute and draw up vaccines immediately before administration. MMRV and varicella vaccine that have not been reconstituted may be stored in the refrigerator compartment for up to 72 hours. MMRV and varicella vaccine must be discarded if not used within 72 hours at refrigerator temperature. These vaccines should never be refrozen. Zoster vaccine must be kept in the freezer at all times. Another common inquiry we receive concerns pre-filling or drawing up doses of vaccine before they are actually needed. We strongly discourage filling syringes in advance for a number of reasons. The most important reason to avoid this practice is that filling a syringe before it is needed increases the risk for administration errors. Once in a syringe, it is difficult to tell which vaccine is which. Pre-filling syringes also increases vaccine wastage. On-use syringes you have pre-fills should be discarded at the end of the clinic day. Finally, pre-filling syringes may result in bacterial growth in the vaccines that do not contain a preservative such as vaccines supplied in single-dose vials. As an alternative to pre-filling syringes, consider using manufacturer-supplied pre-fill syringes for large immunization events such as community influenza clinics. Syringes other than those filled by the manufacturer are designed for immediate administration and not for vaccine storage. However, if you have a reason to draw more than one dose of vaccine, you should only pre-fill a few syringes at a time which you will administer yourself. Any syringes of vaccine other than those filled by the manufacturer should be discarded at the end of the clinic day. In keeping with nursing medication administration guidelines, CDC recommends that the person who prepares the vaccine should be the same person who administers the vaccine. When using manufacturer pre-fill syringes that do not already have a needle attached, wait until you're ready to administer the vaccine before attaching a needle. When the needle is attached, the sterile seal is broken, and if not used, the syringe should be discarded at the end of the clinic day. Vaccines should always be stored in the refrigerator or freezer until they are needed. Even if you anticipate using vaccines throughout the day, do not leave them sitting out on a medicine tray or counter. Donna? Occasionally, vaccines must be transported between clinics or administered at sites where there is no permanent storage unit. In these situations, you must still maintain appropriate storage temperatures. Always use insulated containers for vaccine transport. A thermometer must be placed in each container so that the temperature can be monitored and documented hourly. Craft paper, newspaper, or bubble wrap should be used to keep the vaccine from coming in direct contact with the ice and inadvertently freezing. MMRV, varicella, and zoster vaccines can only be transported and temporarily stored using dry ice. Other vaccines should be stored in separate containers with regular ice. And remember, never touch dry ice without wearing heavy-duty gloves and eye protection. Vaccine inventory control is a critical part of vaccine quality management. As part of inventory control, providers should conduct a monthly vaccine inventory to be sure they have enough to meet their needs. However, avoid stocking excessive vaccine supplies as this leads to vaccine wastage when vaccines become outdated. Also include diluents in the stock control procedures and ensure adequate diluent supplies are available. Vaccines may only be reconstituted with the specified diluent. Diluents are not interchangeable except the sterile water used to reconstitute MMR, varicella, MMRV, and zoster vaccines. Providers should monitor the expiration date of their vaccines and diluent supplies and rotate stock to avoid waste from expiration. Expired vaccine and diluent should never be used. The resources webpage for this program has many useful storage and handling resources including temperature logs, vaccine storage requirements, and warning signs for your electrical plugs and breaker box. Other helpful tools are available from CDC. A vaccine storage and handling toolkit with detailed storage and handling guidelines, videos, forms, posters, and an interactive game is available on the Vaccines and Immunization website. This is the main page of the online toolkit. A CD version of the toolkit is also available from our online catalog. Check the resources webpage for information on how to order a copy for your office. In order for patients to be protected by vaccines, vaccines must be stored and handled with care. With a few simple steps and good practices to maintain proper vaccine storage and handling, we can ensure that the full benefit of immunization is realized. Andrew? Donna, the U.S. Pharmacopeia states that vials must be wasted 30 days after opening. Does this apply to multi-dose vaccines like meningococcal polysaccharide vaccine? Well, we get that question a lot. And CDC and FDA and the manufacturers have basically all agreed that as long as the vaccines are stored and handled properly and they appear normal, then they can be used up until the expiration date that's on the vial. So like with meningococcal polysaccharide vaccine, the manufacturer's product insert states that once the multi-dose vial is reconstituted, then you can use it up to 35 days as long as it's stored and handled properly and has a normal appearance. Good. Yabo, space is always a problem with refrigeration. Can we store or for providers that think of storing vaccines in the vegetable bin, can those bins be removed and then use that space for storage? No, we actually prefer that you do not do that because that area is very close to the motor of the refrigerator and could be too warm. So we recommend that that space only be used for storing say water bottles. Okay, good. Donna, we talk about exposure to light. That's sometimes an issue. How much light and what type of light, ambient light versus artificial light can damage vaccines? That's another question that we get a lot. We really don't have specific detailed data on this. Of course, it depends on the individual vaccine, what the light was, how much exposure of the light. So that's a very hard question to answer. The best thing to keep yourself from having a problem is to treat all of your vaccines as if they're light sensitive. I mean, we know the live vaccines are sensitive and of course, even HPV, which is an inactivated vaccine. But just treat them all as if they're light sensitive, keep them in their original packaging until you're ready to use them and then you won't have a problem. Thank you, Donna. Thank you, Yabo. Thanks. The final pre-encounter activity relates to emergency preparedness. Unfortunately, we cannot eliminate all unexpected events. So it becomes crucial to plan and prepare for emergencies. We all want to perform flawlessly when an emergency occurs and a familiar practice plan helps that happen. There are a variety of emergency situations that can arise in a day in the life of an office or clinic. Storms and other natural disasters can damage your facility or knock out your power. You should have a contingency plan for this sort of situation, particularly loss of power. Protecting your vaccine supply should be a high priority. Then there are medical emergencies. Anything can happen in a medical provider's office, from heart attacks to delivery of babies to injuries. But for this program, we will focus on two office setting emergencies that could be vaccine related, syncope and serious allergic reactions. Prevention of an emergency is the first consideration in developing an emergency plan. Screening for allergies and reactions following prior vaccine doses can prevent an emergency from occurring. We will discuss screening for contraindications and precautions later in the program. Serious allergic reactions are rare following vaccination. In contrast, syncope is more common. Syncope is a sudden loss of consciousness commonly known as a vasovagal response or fainting. Providers who vaccinate adolescents and young adults need to be especially aware of this issue and how to prevent it. Reports of syncope to the vaccine adverse event reporting system, VAERS, increased significantly in 2007 compared with previous years. Syncope is reported most often in adolescents and young adults, but it may occur in children and older adults as well. Provider reporting of syncope may have increased because most of our newest vaccines are recommended for adolescents. VAERS reports of syncope from 2005 through 2007 were more likely to involve females 11 through 18 years of age. It would anticipate increased reporting of events involving females since human papillomavirus vaccine is only recommended for females and is recommended as a three-dose series. Injury following syncope is a public health concern. 76 percent of syncope reports that resulted in injury involved adolescents. Although only seven percent of recent syncope reports were classified as serious, potentially life-threatening injuries involving head trauma were described, including one death. The fatality resulted from intracranial hemorrhage caused by head trauma in a 15-year-old boy. 70 percent of syncopal episodes occur within 15 minutes of vaccination. To reduce the risk of syncope and subsequent injury, the Advisory Committee on Immunization Practices recommends that providers strongly consider observing patients for 15 minutes after they are vaccinated. Providers should also be aware of presyncopal symptoms and take appropriate measures to prevent injury if weakness, dizziness, or loss of consciousness occurs. In fact, we recommend that you have adolescents and adults seated during vaccination and the observation period to decrease the risk of injury should they faint. While this is especially important for adolescents and young adults, it is a good idea that everyone you vaccinate be seated. Remember that a syncopal episode is not a contraindication for future doses of the vaccine. Syncope is not the same as an allergic reaction. If indicated, the person should receive subsequent doses on schedule. Also, in May 2008, an article summarizing various reports of syncope after vaccination was published in Morbidity and Mortality Weekly Report. We will include a link to this article on the Program Resources webpage. Yabo? Another potential vaccine-related emergency is a severe allergic reaction or anaphylaxis. Severe allergic reactions are rare, but you need to be prepared to deal with this should it occur. It is critical that a vaccination provider be aware of their patient's allergies to components of the vaccine, such as gelatin, eggs, or an antibiotic. The components of each vaccine are listed in the product insert that comes with the vaccine. If you discover that a person has had a severe allergic reaction to egg, you could look through all the product inserts of vaccines you intend to administer that day and look for ones that contain egg protein. Or you could do this in an easier way. Here is a table that lists vaccine components and lists which vaccines contain that component. It is a valuable tool when a patient reports an allergy to a specific substance that may be included as a component of the vaccine. The table is available on the Program Resources webpage. Of course, it is possible that there can be allergies not known to the patient or provider until symptoms are experienced. When a reaction unexpectedly occurs, early detection of allergic symptoms and management of anaphylaxis can be life-saving. Symptoms of anaphylaxis include facial flushing, anedema, urticaria or hives, swelling of the mouth, wheezing, and shortness of breath. Immediate recognition and treatment may avoid a more severe and life-threatening reaction. It sounds simple, but when the flush face of an upset, crying child becomes more than expected, the child may in fact be in the initial stages of an allergic reaction. The facial flushing may increase and progress to facial edema, wheezing, and shortness of breath. When office staff perform their regular review of their emergency plan, it is also an opportunity to be sure that emergency contact confirmation is current. Emergency phone numbers should be posted on or near each telephone and kept up to date. The staff responsible for calling emergency assistants should know what to say and how to describe their office location. Emergency response personnel tell us that time spent in finding a provider's office inside of a building can be critical. It is very beneficial to assign a staff member the responsibility of meeting ambulance personnel at the building entrance and securing an elevator. All office personnel should have current CPR certification and know whether emergency equipment is located. Donna? Every office should have an emergency kit and it should be inspected periodically to be sure it is up to date and functioning properly. Emergency kits come in many sizes and shapes. Every office should have an emergency kit or box of equipment that is kept in a specific centrally located place. The equipment should be placed in the box in a way that is easily seen and retrieved. So what should be in your kit? An important piece of equipment is the oral airway. More than one size of airway should be in the emergency box. The sizes and number of airways depend upon the provider's patient population. For example, a pediatric office will most likely have a fewer number of airway sizes than a family practice office that sees patients of a greater range of sizes. One or more resuscitation bags should be included depending upon the ages of the patient population. A demonstration on how to use the equipment given by the vendor representative or other expert along with regularly scheduled practice is vital. A stethoscope and blood pressure cuff should be in the emergency equipment supply along with ammonia capsules and at least three syringes, needles and some alcohol swabs. Your kit should contain emergency drugs, particularly epinephrine and diphenhydramine. Some emergency kits include these medications in pre-filled syringes supplied by the manufacturer. Epinephrine is administered intramuscularly. It can be administered into the same site as the vaccine injection to slow the absorption of the vaccine. The dose is determined by either the body weight or age of the person. It is helpful to have a table in your kit that lists these dosages. The dose can be repeated in 10 to 20 minutes if indicated by symptoms. Diphenhydramine hydrochloride commonly known by its brand name of Benadryl may shorten an allergic reaction, but its effect is delayed rather than immediate. Depending upon the severity of the symptoms, it may or may not be useful. Diphenhydramine hydrochloride is also given by body weight. One final point concerning emergency preparation. No matter how well a protocol is written, it is helpful only when office staff are well prepared and ready to act. Office staff should keep their CPR certifications current. Emergency procedures should be reviewed periodically and training updates provided to staff. Documenting training in a personnel folder may be helpful in promoting staff competency. Of course, training new staff in the office emergency plan is critical and should be part of their orientation. Severe allergic reactions are rare events, but because they can be fatal if not managed properly, your staff must be ready to respond. One of them has had all their shots. One of them has a record of all their immunizations and was immunized at the prescribed time. From so many potentially life-threatening diseases, only one of them is protected. Unfortunately, it's not the two children. If your child is between 15 and 24 months, make sure she's had her last set of shots. Please immunize because our children can't protect themselves. In this segment of the program, we will discuss activities that occur during the immunization encounter while the person is in the office or clinic. The critical issues during the encounter phase include screening, primarily for contraindications and precautions to vaccination. Identifying persons who should not be vaccinated is the key to a safe immunization practice. Patient and parent education is critical to clear vaccine risk communication. Appropriate vaccine administration technique delivers the vaccine to the correct tissue and clear aftercare instructions helps the parent or vaccine recipient manage discomfort from the injection. These are all critical issues during the immunization encounter. We will discuss each of them beginning with screening. Screening for contraindications and precautions to vaccination is a critical part of the immunization encounter. Not only does thorough screening provide an opportunity to prevent possible adverse reactions, but it also provides an opportunity to build rapport with the patient and parent, address their concerns and answer any questions. The first information you will want to obtain is the patient's prior immunization history. This information should be located on one page in the patient's medical record. If not, encourage parents or patients to bring their personal records so that you can include this information in each person's chart. A verbal history of previous immunizations is not sufficient evidence. You should accept as valid only immunizations that are documented in writing and dated. Influenza and pneumococcal polysaccharide vaccines are exceptions to this rule. If a written record is not immediately available, we recommend that you consider giving the vaccines that are indicated at that visit based on a person's age. This avoids a missed opportunity while the patient or parent continues to search for the immunization records. Once you have the immunization history, it is time to screen for medical contraindications or precautions. When the setting allows, we recommend that you provide patients or parents with the screening questionnaire and the vaccine information statement or VIS while they are waiting to be seen. The VIS includes information that will help the patient or parent respond to the questions on the screening form. We will talk more about VISs in a few minutes. Donna? The key to reducing the risk of a serious adverse reaction is screening for contraindications and precautions. Every person who administers vaccines should screen every person before giving the vaccine. Contraindications to vaccination can change from one dose of vaccine to the next dose, so everyone should be screened prior to every dose, even if they were screened during a prior visit. Many states have developed screening questionnaires for use in their clinics. You can develop your own sheet or you can adapt one that has already been developed. The Immunization Action Coalition has developed good one-page screening sheets for both children and teens, as you see here, and for adults. They list all the screening questions that need to be asked. The child screening form can be completed by the parent while waiting to be seen. On the back of the form, there is a paragraph explaining why each question is being asked. This is a very helpful feature to remind your staff why they are asking these questions in the first place. Effective screening is not difficult or complicated. It can be accomplished with just a few questions. It is important for you to understand the reasons for the questions on the screening form, so we would like to take a few minutes to review them and the rationale for asking them. The first question is simple. Is the child sick today? The first question addresses whether the child has a moderate or severe acute illness, which is a precaution to vaccination. If the child has been examined, this question may not be necessary or already may have been answered. There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse reactions. But with moderate or severe acute illness, vaccine should be delayed until the illness has improved. This avoids confusing a symptom of the illness such as fever with a vaccine adverse reaction or vice versa. Mild illness such as otitis media or an upper respiratory infection is not a contraindication to vaccination, nor is taking antibiotics a reason to withhold a vaccine in a person who is otherwise not very sick. The second question is, does the child have an allergy to any medication, food or vaccine? A severe allergic reaction to a vaccine or vaccine component is a contraindication to subsequent doses of that vaccine or to a vaccine containing that component. For instance, an anaphylactic reaction to eggs is a contraindication to influenza and yellow fever vaccines. We suggest that you inquire about allergies in a generic way rather than read the parent list of every component of every vaccine. Most parents will not recognize most of the components anyway, but they will know if the child has ever had an allergic reaction severe enough to seek medical attention, which is what you are trying to find out. If you do identify a person who has had a severe allergic reaction to a product that may be in a vaccine, the next challenge is to figure out which vaccines might contain that product. To make this task easier, you need a listing of vaccine contents. A comprehensive table of vaccine components also called Excipients is available from the Program Resources webpage. Remember that a local reaction, such as redness or swelling at the site of injection, is not a contraindication to subsequent doses of that vaccine. The third question is, has the child had a serious reaction to a vaccine in the past? This open-ended question is intended to identify allergic reactions following previous vaccine doses. It can also help identify conditions following pertussis vaccine. In usual circumstances, vaccines are deferred when precautions are present, but situations may arise when the benefit of the vaccine outweighs the risk. For instance, a child who had a temperature of 105 following a prior dose of DTAP might still be vaccinated if there were an outbreak of pertussis in the community. The fourth question is, has the child had a seizure, brain, or nerve problem? DTAP and TDAP are contraindicated in children who have a history of encephalopathy within seven days following wholesale DTP or DTAP vaccine. An undiagnosed neurologic problem is a precaution to the use of DTAP and TDAP. For children with a stable neurologic disorder, including seizures unrelated to vaccination, or for children with a family history of seizure, you should vaccinate as usual. In these children, you should consider the use of acetaminophen or ibuprofen to minimize the fever. A history of Guillain-Barre syndrome is a precaution for tetanus-containing, influenza, and meningococcal conjugate vaccines. The fifth question is, has the child had asthma, lung disease, heart disease, kidney disease, metabolic disease, such as diabetes, or a blood disorder? This question is to identify possible contraindications to one of the two types of influenza vaccine. Children with any of these health conditions should not be given the intranasal, live, attenuated influenza vaccine. These children should be vaccinated with the inactivated, injectable influenza vaccine. Yavo? Thanks, Donna. One of the most important conditions to identify during screening is the presence of immunosuppression. Since many different conditions and therapies can produce immunosuppression, there are two screening questions to probe for this. The first is, does the child have cancer, leukemia, AIDS, or any other immune system problem? Live virus vaccines such as MMR and varicella are usually contraindicated in persons with severe immunodeficiency. However, MMR and varicella are recommended for persons infected with HIV who do not have evidence of severe immunosuppression. Varicella vaccine is contraindicated in persons with cellular immunodeficiency, but may be administered to persons with humoral immunodeficiency. All inactivated vaccines may be given to immunosuppressed persons, although the response to the vaccine may be suboptimal. Also remember that having an immunosuppressed person in the household is not a contraindication to vaccination of a healthy child. The next question is also related to immunosuppression. Has the child taken cortisone, prednisone, other steroids, or anti-cancer drugs, or had x-ray treatments in the past three months? High daily doses of corticosteroids for more than 14 days can cause significant immunosuppression and increase the chance of an adverse reaction following a live vaccine. Live vaccines should not be administered for at least a month following prolonged high-dose steroid therapy or for at least three months following cancer chemotherapy. Persons receive an aerosolide steroid such as inhalers for asthma, topical preparations, or low or moderate daily or alternate day doses of steroids for fewer than 14 days can receive live vaccines during treatment. As with other immunosuppressive conditions or therapies, inactivated vaccines may be administered to a person receiving high-dose steroid therapy, although the response to the vaccine could be reduced. The next question probes for recent receipt of antibody-containing products. Has the child received a transfusion of blood or blood products or been given a medicine called immune or gamma-globulin in the past year? Passively acquired antibody may reduce the effectiveness of MMR and varicella vaccines. However, passive antibody does not reduce the effectiveness of Zoster vaccine. MMR, MMRV, and single antigen varicella vaccines generally should not be given to persons who have recently received antibody-containing blood products. This question might also identify unreported illnesses that might not have been revealed in earlier questions since blood products are usually given for specific indications. Depending on what product was being administered and the dose, it may be necessary to defer MMR and varicella vaccines for up to 11 months after the blood product. Table four in the general recommendations of immunization list the most commonly used antibody-containing preparations in the United States. It also lists the recommended waiting period between the blood product and administration of MMR or varicella vaccine. Every office should have a copy of this table. It is available on the resources webpage. The next question is, is the child or teen pregnant or is there a chance she could become pregnant during the next month? This question should be asked of all females of child-bearing age, including young adolescents. MMR and varicella vaccines are contraindicated within a month of and during pregnancy due to the theoretical risk of virus transmission to the fetus. Sexually active females who receive MMR or varicella vaccine should be instructed to practice careful contraception for one month following receipt of either vaccine. With the exception of human papilloma virus vaccine, inactivated vaccines may be given to pregnant women when indicated. It is not necessary to inquire about pregnancy and household contacts. Having a pregnant woman living in the household is not a contraindication to the administration of any vaccine to other household members except smallpox vaccine. The final screening question is, has the child received any vaccinations in the past four weeks? The intent of this last question is to identify persons who recently received a live virus vaccine. The advisory committee on immunization practices recommends that two live virus vaccines not given on the same day be separated by at least 28 days. If the vaccine given recently was an inactivated vaccine such as DTAP or hepatitis B vaccine, it is not necessary to defer any vaccine. In addition to the child and teen screening form, the immunization action coalition has developed a screening form for adults. It contains the same questions that are on the child and teen form. Both the child and the adult screening forms as well as other vaccine related material for providers and patients are available free from the immunization action coalition website. But whether you use the IAC form or some other form, the important thing is that you ask these questions before administering vaccines to people of any age. Your patients are depending on you to make vaccines as safe as they can be. Screening every patient is one way to do this. Andrew? Yabbo, in the context of screening for possible precautions, how do we define acute illness? What are what your providers kind of be looking for? Is it the fever or...? That's a good question, Andrew. We get that often. Fever is not the only indicator of a moderate or severe illness. It's really the clinical picture that the patient presents with at the time and their provider will make the determination whether or not they are considered too ill to receive a vaccine. But fever is not the only component of that. What about patients that might be hospitalized? We hear about that a lot. Can patients in the hospital receive vaccine? Again, that is a question we hear frequently. There is no formal recommendation on that at this point. What we have counseled providers on is that at the time of discharge, hopefully when the patient is stable enough to go home, they're not as ill, that will probably be a more appropriate time to give the vaccine. Donna, when it comes to antibody-containing blood products, we heard about the interval you need. Is there any interval between the receipt of respiratory syncytial virus, antibody, and live vaccines like MMR or varicella? We've had that question a lot too, because there used to be a product out respogam that did require an interval, because not only were there RSV antibodies in the product, but there were other antibodies that could interfere with the vaccines. But the one that we use now, Palovisumab or a brand name is Cinegis, is a monoclonal antibody. That means that the only antibody in the product is respiratory syncytial virus antibody, so that's not going to interfere with vaccines. So there's no interval that you need to worry about. Okay, so no interval. Great. Yabo, allergy, screening for allergies and latex. Can providers remove rubber stoppers from vaccine vials if they know that their patient has a latex allergy? All right, good question. We actually do not recommend this procedure, because in reality, the vaccine has already been exposed to the rubber, so there's still a small risk of exposure of the patient to the rubber. Great. Thank you. Donna, pregnancy testing. You talked about screening for pregnant. Do we need to actually do a pregnancy test before administering live vaccines like MMR and varicella or HPV vaccine also? No, we do not recommend routine pregnancy testing. What we recommend that you do is ask the patient if she could be pregnant or is planning to become pregnant within the next four weeks. And if the answer is no, the only other thing we would say is check and find out what kind of birth control method that they're using. But other than that, we just recommend that you counsel them not to become pregnant within the next four weeks after receiving the vaccine because of the theoretical risk to the fetus and then vaccinate. Thank you, Donna. Thank you, Yabbo. Another critical component of the immunization encounter is patient and parent education. As healthcare providers, we know that immunizations are among the most cost-effective and widely used public health interventions. We also know that no medication, not even a vaccine, is 100 percent safe or effective. As the incidence of vaccine-preventable diseases is reduced, the disease threat is less visible. Public focus has changed from the risk of disease to concerns associated with the vaccines themselves. Before you administer any vaccine, you have a responsibility to discuss each vaccine's benefits and risks with the patient or parent. The cornerstone of immunization patient education is the vaccine information statement, or VIS. Every healthcare provider, public or private, who administers a vaccine covered by the National Childhood Vaccine Injury Act, is required by law to provide a copy of the most current VIS with each dose of vaccine, not only the first dose, but every dose. CDC encourages healthcare providers to use all available VISs, whether the National Childhood Vaccine Injury Act covers the vaccine or not. It is just good practice. Healthcare providers should also encourage the patient or their representative to take the VIS home. This is important because the VIS contains information that may be needed later, including the recommended schedule for that vaccine and information about how to identify and report adverse reactions. Healthcare providers are not required by federal law to obtain the signature of the patient or their representative acknowledging receipt of the VIS. Vaccine information statements are not designed as informed consent documents. But while the federal government does not require written informed consent for vaccinations, some states or organizations may require a signature. You should consult your agency or state immunization program to determine if there are any specific informed consent requirements. Documentation that the VIS was given is required by federal law. Healthcare providers must note in each patient's permanent medical record or in a permanent office log or file the date printed on the VIS and the date the VIS is given to the vaccine recipient or their legal representative. Every VIS is dated. The date is always located in the corner of the second page of the document and sometimes on the first page as well. This is the date that must be recorded in the patient's medical record. VIS is changed periodically. Paying attention to this date also helps to ensure that your office always has the most current version of each VIS. In 2008, a multi-vaccine VIS became available. This VIS includes DTAP, IPV, hepatitis B, pneumococcal conjugate, Hib, and rotavirus vaccines. It can be used for infants and children anytime at least one of these vaccines is being administered. You still need to record the date of the document and the date it was given to the parent. All English language vaccine information statements are available from CDC and state immunization programs. You will also find audio versions of the VISs on the CDC vaccines and immunization website. VISs are available in 36 languages on the Immunization Action Coalition website. We will have a link to all the vaccine information statements on Program Resources website. The healthcare provider's patient education responsibilities do not end with the vaccine information statement. Education is an interactive process, an exchange of information. We need to listen, hear our patient's concerns, and then be prepared to address those concerns. With vaccine safety issues so prominent in the media and on websites, effective communication with the parent is more important than ever. We thought it would be helpful for you to hear about effective communication from someone with experience doing this. Patricia Stinchfield, Director of Pediatric Infectious Disease and Immunology at the Children's Hospital of St. Paul, Minnesota, has many years of experience in this area. We asked Ms. Stinchfield to describe for us her strategies for effective communication about vaccines. The need for clear and effective communication about vaccines has never been more important than it is now. There are many reasons for this. One important reason is that many parents are confused or fearful because of misinformation about vaccines that they've seen on television or on a website. These programs and websites often exaggerate the risk from vaccines while downplaying or even ignoring the benefits. But parents look to you, their trusted, expert, concerned healthcare provider for sound scientific advice. We currently have the highest childhood immunization levels ever documented in the United States. The result of such high vaccination coverage levels is record low disease rates. Today, most parents and many providers have never seen many of the diseases that we prevent with vaccines. We want to keep immunization rates high and disease rates low. So even though the benefits of vaccination may not be readily apparent to parents, effective communication about vaccines from the trusted provider remains critical. Parents have many concerns about vaccines and most relate to vaccine safety. These concerns include the number of vaccines in the routine schedule or the number of injections an infant may receive at a single visit. They are concerned that all these vaccines could cause an immune system overload. Parents are also concerned about preservatives and other ingredients such as thimerosal that may be present in the vaccine. One of the most pervasive vaccine safety concerns today is association with vaccination with autism spectrum disorders or other developmental disabilities. These issues have been addressed scientifically and none has been shown to have merit. An infant's immune system is capable of responding to far more antigens than are present in all our childhood vaccines. More than a dozen studies during the last decade have clearly shown that children who are vaccinated or receive thimerosal containing vaccines are not more likely to develop autism than children who are not vaccinated. Unfortunately, good science alone has not been sufficient to put these issues to rest. So you need to be familiar with them and be prepared to discuss them with parents. It is important that parents understand that ensuring the safety of vaccines is an ongoing process. We constantly monitor vaccine safety in a number of ways including the vaccine adverse event reporting system and other post licensure systems. Remind parents that we will not hesitate to remove a vaccine from the market if there is a question about its safety. We all care about the safety of vaccines. There are many challenges to effective communication with parents. One of the biggest challenges is just finding the time to communicate with them. You may only have 15 minutes for a well child visit and you have many topics to talk about in that short time. Immunization is just one of them. To try to get at the time factor, some clinics have recorded telephone messages for parents on hold or have video kiosks in their waiting room. Others give a reputable book to new parents or conduct group teaching. For instance, they'll hold a vaccine education class one or two nights a week when parents can sit down with the provider or watch a video and have their questions answered by an expert. Another challenge is that the science of vaccines and immunology is complicated. Education level appropriate materials can be very helpful for this. The vaccine information statements which need to be used each time a child is vaccinated are written at a sixth grade level. Language barriers can be very challenging. We tend to speak in medical jargon that may not translate well for non-English speaking parents. We need to try to avoid this and use language appropriate materials and interpreters as much as possible. Vaccine information statements are available in many languages. Use a VIS in the language the parent prefers to read. And last one of our challenges is information resources. Where do parents get their information? Are they using the internet? Are they watching television? Are they reading newspapers or tabloid magazines? Of course they are and these sources may contain information that may not be accurate. We want to provide the parent with reliable websites if they want to do more research. A good place to start is the Allied Vaccine Group at www.vaccine.org. This site has links to several other reputable sources for good vaccine information such as the American Academy of Pediatrics, the Vaccine Education Center at the Children's Hospital of Philadelphia, and the Immunization Action Coalition. Well let's talk more about our shared goals of safety for our children. But what is safe? Does safe mean no chances of harm? We can't really say that for vaccines because no vaccine is 100% safe. Does safety mean that there is no harm from the disease? We can't say that either because no vaccine is 100% effective. It is important to communicate realistic expectations about vaccines, including the adverse reactions that might occur. The local redness and swelling of the baby's leg is to be expected. Communicate that receiving vaccines is far less risky than being unimmunized. To do nothing is to take a risk and we have to remind parents of that. Research indicates that physicians generally say little to parents about immunization. Parents, on the other hand, say they want to hear from their providers. They want vaccine information from their trusted advisor at their clinic, more so than their mother's or the person next door. In fact, one of the most important factors that influence a parent's decision to vaccinate their child is a clear and unequivocal recommendation of the vaccine from the provider. So what do we do? What are our strategies to reduce the myths and the misperceptions? The first thing we should do is listen to the parent. Show your empathy and establish rapport with the parents. Try to find out what is at the root of their misunderstanding. Show that you care about what they think and that they can trust you. Is there a fear-based issue? Is it a lifestyle decision? Do they have a knowledge deficit? If we don't get to the bottom of where their thinking is coming from, it will be difficult to know how to best communicate. What was their previous experience with vaccination? Maybe someone in their family or someone they know had an adverse reaction to a vaccine or a medical event that was perceived to be an adverse reaction. What are their emotions? What are their beliefs? Once you can determine the source of their concerns, you can more effectively address it. One of the things we can do as clinicians is to be a role model. We can remind our patients that we are up to date on our vaccines such as influenza, hepatitis B, and Tdap. Remind parents that we recommend vaccines to our patients and that we practice what we preach. We do this because we know it's the right thing to do. Speak from your experience. Tell parents about children that you have seen who have been hurt or who have died from a vaccine-preventable disease. Telling those real stories makes a difference. We're not sure why it takes a crisis or an outbreak to motivate people to have the vaccination as they should, but storytelling does seem to help motivate parents. Here are some additional practical suggestions on how to approach vaccine communication challenges. Determine the level of understanding the parent has. Ask them what their experience has been. Have they had a problem with vaccines before? Make sure it's a two-way conversation, not just a lecture or reading off the vaccine information statement. Make time for their comments and encourage questions. Engage in a dialogue with trust and understanding. Try to keep the conversation focused. You want to control without being controlling. This can be difficult when emotions run high. Be evidence-based. Being evidence-based means having current science-based information, provide supporting information such as package insert if the parents want it, or direct them to a reliable website on their topic of concern. Keep your message simple. Simple is definitely better. A one-sentence description of the disease will usually suffice. This is one reason why providing and discussing the vaccine information statements is so helpful. All that you need is there. Always advise the parents what to expect after the vaccination. Remind them that local reactions are normal, but also tell them what to do in the unlikely event of a severe adverse reaction. They should know who to call and what to do. This information is on the vaccine information statement. Encourage them to take the document home with them. Finally, emphasize the return visits so they keep on the recommended schedule, and every time they return, check their vaccination status to reduce missed opportunities to vaccinate. Consider every visit a vaccination visit. Sometimes parents will tell you that they came in at two months and they got several shots. They thought that was all that they needed. No one told them that childhood vaccines require multiple visits during the first two years of a child's life. Remind them that we are never done with vaccination throughout our lifetime, so encourage them to always ask, does my child need any vaccines at this visit? There are many vaccine communication challenges in our practice settings today. We need to determine the origin of those concerns and address them with effective communication strategies. We need to always emphasize to parents that vaccine safety is a top priority for all of us. We share the same goal, the health and safety of our vaccines and of our children. This knowledge, along with an honest and compassionate dialogue with parents, should help you resolve many of these challenges. Know that you are the expert on vaccinating children and your knowledgeable, compassionate, enthusiastic support will assist parents in keeping their children healthy. During her presentation, Ms. Stinchfield mentioned the Vaccine Adverse Event Reporting System, or VAERS. VAERS is the cornerstone of post-licensure vaccine safety monitoring in the United States. Unfortunately, we do not have time during this program to provide detailed information about VAERS. However, we have included information and links for VAERS on the program resources webpage. The webpage also has information and links for the Vaccine Injury Compensation Program. Appropriate vaccine administration is critical to vaccine effectiveness. The recommended site, route, and dosage for each vaccine are based on clinical trials, practical experience, and theoretical considerations. Vaccines may not protect your patients if they are administered incorrectly. If the wrong site or needle length is used to administer a vaccine, there may be an increased risk of a local adverse reaction. An education plan that includes competency-based training on vaccine administration should be considered for everyone who administers vaccines. Donna, will you get us started with the Vaccine Administration Fundamentals? Thanks, Andrew. Delivering vaccine into the appropriate tissue promotes optimal antibody response to the vaccine and reduces the risk of a local adverse reaction. It is important that you know the route of injection for each of the vaccines you use in your practice. This is a list of vaccines that should be administered by the subcutaneous route. Those vaccines are anthrax, Japanese encephalitis, measles, mumps, and rubella-containing vaccines, either as trivalent vaccine or in combination with varicella vaccine, meningococcal polysaccharide, varicella, zoster, and yellow fever. Please note that there may be a labeling change for anthrax vaccine in 2009 to allow for intramuscular administration. This is a list of vaccines that should be administered by the intramuscular route. Vaccines given I am include any product containing diphtheria, tetanus, and pertussis, hemophilus influenza type B, hepatitis A, hepatitis B, inactivated influenza, pneumococcal and meningococcal conjugate, rabies, and typhoid VI vaccines. Two vaccines inactivated polio and pneumococcal polysaccharide vaccines can be administered by either the subcutaneous route or the intramuscular route. For these two vaccines, neither the vaccine manufacturer nor the ACIP recommends one route or the other. With IPV and pneumococcal polysaccharide, the clinician can choose the route. For all other vaccines, the manufacturers recommended route should be used. Subcutaneous injections are administered into the fatty tissue found below the dermis and above muscle tissue. Subcutaneous tissue is present in most areas of the body. The usual subcutaneous sites for vaccine administration are the thigh and the upper outer triceps area of the arm. The upper outer triceps area can be used to administer subcutaneous injections to infants. The recommended needle size for subcutaneous injection in all age groups is a 23 to 25 gauge 5 eighths inch needle. A longer needle could penetrate the muscle, particularly if given at an incorrect angle. To avoid reaching the muscle, the fatty tissue is pinched up and the needle is inserted at a 45 degree angle. A more perpendicular approach is used for intramuscular injection. The majority of vaccines administered by injection are given by the intramuscular route. Incorrect intramuscular technique can reduce vaccine effectiveness and increase local adverse reactions, so proper technique is critical. Intramuscular injections are administered into muscle tissue below the dermis and subcutaneous tissue. The amount of overlying subcutaneous tissue depends on the person and the site. Although there are several IM injection sites on the body, the routinely recommended IM sites for vaccine administration are the vastus lateralis muscle in the intralateral thigh and the deltoid muscle in the upper arm. Injection at these sites reduces the chance of involving neural or vascular structures. The site depends on the age of the person and the degree of muscle development. The deltoid muscle is most commonly used in older children and adults. The deltoid muscle can be used in toddlers if the muscle mass is adequate. It is important to use anatomic landmarks to locate the site so that the injection is given into the center of the muscle. The gluteus should not be used to administer vaccines. Injection in the gluteus risk injection into fat or damage to nerve tissue. A 22 to 25 gauge needle is recommended for intramuscular injections. The needle length must be adequate to reach the muscle and is based on the size of the individual. A 5 eighths inch needle may be considered for newborns in the first 28 days of life and for premature infants. The recommended needle length for an infant is generally one inch. The recommended needle length for older children can range from 5 eighths to 1 and 1 fourth inch depending on the injection site, the size of the muscle and the thickness of the fatty tissue at the injection site. A 5 eighths inch needle is adequate only for the deltoid muscle and only if the skin is stretched flat between the thumb and forefinger and the needle inserted at a 90 degree angle to the skin. A longer needle should be used for the interlateral thigh. For adolescents and adults, the deltoid muscle is the routinely recommended site, although the interlateral thigh can be used. The needle length generally ranges from one inch to one and one half inch depending on the person's sex, weight, the size of the muscle and amount of fatty tissue at the injection site and the technique used. This can all seem rather complicated. Fortunately, there is a table in the general recommendations on immunization, table seven, that lays all this out. We will make the table available to you on our program resources webpage. To avoid injection into subcutaneous tissue, the skin of the selected site can be spread taut between the thumb and forefinger, isolating the muscle. Another technique acceptable mostly for pediatric and geriatric patients is to grasp the tissue and bunch up the muscle. The needle should be inserted fully into the muscle at a 90 degree angle. Remember, injection technique is the most important parameter to ensure efficient intramuscular vaccine delivery. There are a few other issues related to vaccine administration that seem to generate a lot of questions. Yabba will review these. Thanks, Donna. Other important vaccine administration issues include infection control, sites for simultaneous administration and latex allergy. Hand hygiene is recommended between each patient. When working at a site where it is not feasible to wash your hands before each patient, an alcohol-based waterless antiseptic can be used between patients and in situations where your hands become soiled. Gloves are not required by the Occupational Safety and Health Administration or OSHA for vaccine administration unless there is the potential for exposure to blood or body fluids, the person administering the injection has open lesions on the hands, or it is an agency policy. Just remember, gloves cannot prevent a needle stick injury. You should never detach, recap, or cut a used needle before disposal. All used syringe and needle devices should be placed in a puncture-proof container to prevent needle sticks and reuse. Used injection equipment should be disposed of as infectious medical waste. Safety needles or needle-free injection devices also can reduce the risk for injury and should be used whenever they are available. Here are a few more points about vaccine administration. It is not necessary to change needles between drawing or reconstituting vaccine and administration of the vaccine unless the needle is contaminated or bent. Use a new syringe and needle to drop each vaccine to be administered. When administering multiple vaccines, never mix vaccines in the same syringe unless they are approved for mixing by the Food and Drug Administration, and no attempt should ever be made to transfer vaccines from one syringe to another. Vaccines approved for mixing will be packaged together or indicated in the product insert. If more than one vaccine is administered in the same limb, the injection sites should be separated by at least one inch if possible. This separation allows any local reactions to be differentiated. Vaccines that contain tetanus and diphtheriotoxoids may cause more soreness than other vaccines, so you may want to give this vaccine a loan or in the limb with a subcutaneous injection. We receive many questions about spacing of injections in a single limb. This spacing is a recommendation and not an absolute rule. Considering the number of injections needed at each visit in the first two years of life, there may be circumstances where separation of each site by one inch or more is not feasible. We are not aware of any evidence that less than one inch separation between injection sites reduces the effectiveness or safety of a vaccine. But you should try to put the most reactive vaccines, such as TD containing vaccines and pneumococcal conjugate vaccine, into different limbs if you can. You should also develop a system so that everyone in your office administers the same vaccine into the same anatomic location. This way, if a local adverse reaction occurs, anyone can easily determine which vaccine is most likely to be responsible. A standardized vaccine administration map can help you do this. Here's an example of such a map. It suggests the anatomic area for each injection. This version was provided to us by the Michigan Department of Community Health and the Alliance for Immunization in Michigan. They have graciously allowed us to show it to you and to post it on the resources webpage. Please consider using this site map or one similar to standardize the vaccine administration procedures in your office. Aspiration is the process of pulling back on the plunger of the syringe prior to injection to ensure that the medication is not injected into a blood vessel. Aspiration is not required before administration of a vaccine. It is an option based on personal preference. Although this practice is advocated by some experts and most nurses are taught to aspirate before injection, there's no evidence that this procedure is necessary when administering vaccines. There are no reports of any person being injured because of failure to aspirate. In addition, the veins and arteries within the reach of a needle in the anatomic areas recommended for vaccination are too small to allow an intravenous push of vaccine without blowing out the vessel. A 2007 study from Canada compared infants' pain response using slow injection, aspiration, and slow withdrawal to another group using rapid injection, no aspiration, and rapid withdrawal. Based on behavioral and visual pain scales, the group that received the vaccine rapidly without aspiration experienced less pain. No adverse events were reported with either vaccination technique. A link to the steady results is included on the program resources webpage. If you prefer to aspirate and blood appears, the needle should be withdrawn, the dose discarded, and a new needle, syringe, and vaccine dose should be used to administer the injection at a different site. One way to avoid the need to discard an expensive dose of vaccine and possibly minimize the patient's pain is just not to aspirate in the first place. Many people, particularly healthcare personnel, claim to have latex allergies. Latex allergy is most often a contact type allergy. There has been only one published report of an anaphylactic reaction following vaccine administration in a patient with known severe allergy to latex. A person with an anaphylactic allergy to latex generally should not receive vaccine supplied in vials or syringes that contain natural rubber. Persons with latex allergies that are not anaphylactic, such as contact allergy to latex gloves, can receive vaccine supplied in vials or syringes that contain dry natural rubber or natural rubber latex. With the number of injections that were given in immunization practice today, both healthcare providers and parents are concerned about adequate pain control. Comfort measures and distraction techniques may help children cope with the discomfort associated with vaccination. Remember that pain is a subjective phenomenon influenced by multiple factors, including a person's age, anxiety level, previous healthcare experiences, and culture. A variety of measures ranging from topical anesthetics to diversionary techniques are discussed in the ACIP General Recommendations on Immunization. Dana? We would like to end our discussion of vaccine administration with a few words about non-standard vaccination practices and vaccine administration errors. We have become increasingly concerned about the growing number of questions we receive asking what to do when the wrong vaccine or the wrong vaccine dose has been administered or the wrong route was used. The first type of vaccine administration error is administration of the wrong vaccine formulation. Since the approval of Tdap and Zoster vaccines, we have heard of several instances where the wrong vaccine was administered. When young children receive Tdap instead of pediatric DTAP, they do not receive adequate amounts of diphtheria toxoid and pertussis antigens. This can place a young infant who has not completed a primary series of DTAP at increased risk for pertussis. If an adolescent or adult receives DTAP instead of Tdap, they are at increased risk for an exaggerated local reaction because they have received excess diphtheria toxoid and pertussis antigens. Even more concerning is when we hear about a young toddler receiving Zoster vaccine instead of varicella vaccine. This exposes the child to a dose of vaccine virus 14 to 15 times the prescribed dose. Another concern related to administering the correct vaccine is using the correct diluent with vaccines that require reconstitution. We frequently receive questions about the effectiveness of a vaccine when the wrong diluent has been used. Vaccine safety and efficacy data are based on using the prescribed diluent. Vaccine manufacturers and CDC do not test vaccines using the wrong diluent to find out what will happen. We almost always recommend that doses reconstituted with the wrong diluent be repeated. You must not only carefully check the label on the vaccines you administer, but also the diluent to ensure that the appropriate product is used. Remember, standard medication guidelines require that the medication label is checked at least three times before administration. Similarity in product names and packaging also increase the risk of medication errors. We suggest that you do not store products with similar names or packaging close to each other in the refrigerator or freezer. A third administration error we hear about is the wrong route of administration. Earlier we discussed several factors involved in ensuring that a vaccine is injected into the correct tissue. The first step in this process is verifying the route that should be used for a particular vaccine. For example, a common error is the inadvertent administration of meningococcal conjugate vaccine by the subcutaneous route. Meningococcal polysaccharide vaccine should be administered by the subcutaneous route, but the newer meningococcal conjugate vaccine should be administered by the intramuscular route. We also have received reports of purified protein derivative or PPD, which is used for tuberculin skin testing, being confused with TD, resulting in intradermal administration of TD. Administration errors like these not only increase the risk of adverse reactions and suboptimal immune response, but they also diminish the trust and confidence that parents and patients have in their health care provider. Be sure that staff are adequately trained in standard vaccine administration practices and are oriented to the proper administration of new vaccine products. We have included a list of error prevention strategies on the resource webpage that should help you and your staff anticipate and prevent similar errors. Remember, your patients are counting on you. Yabo. Thanks. Care of patients after the shots and instructions for patients and parents are an important part of the vaccine administration process. We have already discussed safety measures to avoid injury if someone faints and emergency procedures should an allergic reaction occur. Let's discuss aftercare instructions. We recommend that you discuss the instructions and provide a written copy before the vaccines are administered. It is unlikely that patients who have just received injections or parents who are trying to comfort a child are able to concentrate on aftercare instructions. Here is an example of written aftercare instructions. This document was produced by the Immunization Action Coalition and is available on the program resources webpage. Parents should be prepared to give their child a little extra TLC and patients after receiving immunizations. Young children need reassurance that everything is all right and parents are encouraged to cuddle and soothe their baby. An infant may also be comforted by a bottle, pacifier, or breastfeeding. Older children often respond positively to hugs, praise, and little rewards. Some vaccines can cause discomfort for a few days after the shots are given. Children and adults may be fussy, experience some redness, warmth and tenderness at the injection site, and have a low-grade fever following vaccination. MMR and varicella vaccines may cause a rash or fever about a week after vaccination. The vaccine information statement for each vaccine will tell parents and patients what kind of adverse reactions to expect. Provide patients and parents with a copy of the VIS that they can take home with them. Parents should be instructed on how to manage fever and pain that may occur following vaccination. Either acetaminophen or ibuprofen can be given as age appropriate if necessary. Aspirin should never be given to a child because of the risk of RISE syndrome. Other things the parent can do if the child has a fever include giving plenty of fluids to drink, dress the child in light clothing, and do not cover or wrap the child tightly. The parent can also sponge the child in a few inches of lukewarm water. If the patient's arm or leg is swollen, warm and red, they can get a clean washcloth from with cool water and place it on the tender area to ease the discomfort. Let the parent know that the child may not eat as usual for the next day or two, but not to be alarmed as long as an adequate amount of fluids are tolerated. Parents also should be given clear instructions about when to contact the healthcare provider. Parents should call if the child has any of the following. Is fussy for more than 24 hours? Has a rectal temperature of 105 degrees Fahrenheit or higher? The child is pale or limp? Crying continuously for more than three hours? Or if the crying is not normal, like a high pitch cry? If the child is shaking, twitching or jerking? Or if the parent has any other concerns about the way the child looks or acts? Minor events such as pain and redness at the injection site are common. Good aftercare instructions will prepare the parent to reduce their anxiety and reduce the number of telephone calls you need to handle. If you think these childhood diseases are a thing of the past, you are dead wrong. Immunize your kids by age two. Call 1-800-986-KIDS for a free immunization schedule. Now we are ready to move to the post-encounter phase of the immunization encounter. Let's look at activities for you to consider. The first is documentation and record keeping. We frequently receive questions about required documentation and record maintenance. We're going to discuss this issue in more detail in a moment, but first let's review the other post-encounter activities. Clinic cleanup and medical waste disposal. It is important for all staff to be knowledgeable about OSHA guidelines regarding infection control and waste disposal. Adequate clinic supplies. Take time to restock your materials and supplies so that you will not be caught short during your next immunization encounter. Patient recall. We strongly recommend that you contact patients who missed their appointment to reschedule. Quality assurance and improvement activities typically include peer and record reviews. Assessment of vaccination coverage levels in your patient population should be a component of every office's quality improvement program. An assessment can help identify missed opportunities and assure your patients are protected as well as possible. Information about assessment of vaccination coverage in your practice is available on the program resources webpage. Documentation and record keeping is a critical post-encounter activity. A medical record is the backbone of a patient care plan. Healthcare providers need access to information about a person's medical history and vaccination status before immunizations are scheduled and given. Accurate documentation allows timely immunizations and helps prevent unnecessary disease. A complete list of past immunizations also avoids the cost and inconvenience associated with over immunization and laboratory testing. Yabo, tell us more about maintaining immunization records. Sure, Andrew. There are two immunization records that providers should maintain. The record in the office medical chart and the record being held by the person being vaccinated. The information that should be included on these records is similar. Let's talk first about the office immunization record. An immunization record is considered part of the person's permanent medical record and should be maintained as part of each patient's chart. The immunization record should be located in the front of the patient's chart for quick review at each visit. Providers report that vaccine coverage improves and missed opportunities are eliminated simply by keeping vaccine documentation at the front of the chart. Placing the immunization record at the front of the chart avoids this crucial information being out of sight and out of mind. When a provider sees the record it is a reminder to review it to be sure the patient is up to date. Placing the immunization record at the front of the chart applies to everyone, children and adults. Although there may be some variation from one practice to another or one state to another, all records, print and electronic should include the following information. The entry begins with the type of vaccine, dose number and dose amount. The manufacturer is noted as well as the vaccine lot number and expiration date. The date the vaccine was administered and the anatomic site of vaccine administration. Finally, the name of the person given the vaccine, the office address and publication date of the vaccine information statement should be noted. The publication date is printed on each VIS. There is one footnote to charting vaccine lot numbers. A diluent that is an active component has a separate lot number that should be recorded if the vaccine components are used separately. If the two components are used together as supplied by the manufacturer only a single lot number needs to be recorded. Currently this applies only to the combination vaccines, pentasil and trihibit because the diluent is a vaccine, DTAP for trihibit or a DTAP IPV combination for pentasil. For both products the liquid vaccine is used to reconstitute the hip component of the vaccine. You may be wondering why the lot number for vaccine needs to be charted at all. The answer is that if a particular lot of vaccine is ever recalled the lot number in your chart will indicate which of your patients may need to be notified. How long should your office retain medical immunization records? The length of time medical records should be kept by each office or clinic varies by state. We believe immunization records should be kept indefinitely. Donna what about lost immunization records? We often get questions about reconstructing immunization records that are either lost or incomplete. Let's talk about incomplete immunization records first. Families change vaccine providers for a variety of reasons. This may result in one person having several medical records located in different provider offices with each record showing an incomplete series of immunizations. When the person's medical records are located it is perfectly acceptable to review all dated properly documented doses and consolidate the information into a single immunization record. It is wise for all of us to keep a personal immunization record separate from the office medical record. Parents need to know that a personally held record for each of their children is critical in documenting vaccines required for child care or school entry. Adults need a personally held immunization record for employment or international travel. When a record documenting one or more immunizations is lost the history of having the vaccine is lost. CDC frequently receives requests for copies of personal immunization records. There is no national database of immunization records so we cannot help individuals obtain their immunization histories. If the patient or parent does not have their personal immunization record you should contact other health care providers to obtain the history. Child care centers or schools may also have a record of their immunizations. If a reasonable search does not locate a record the person should be vaccinated according to age. Administering doses that may have already been given is safe and assures protection. Serologic testing for some antigens such as measles and tetanus can be considered. This is a good opportunity to talk about the advantages of Immunization Information Systems or Immunization Registries. Having a readily accessible central repository of Immunization records helps assure that people get the vaccines they need. Registries ultimately save time, money and inconvenience for everyone. We are seeing the need for Immunization Information Systems today more than ever before. We know that nationally 20 percent of children move by the age of two and change providers for this or other reasons. This leads to incomplete documentation in a single medical record. The childhood immunization schedule is complex. An Immunization Information System can help simplify the process of deciding which vaccine is due at a visit. Parents and patients become complacent about returning for vaccination appointments when the disease rate is low. An Immunization Information System can help generate reminder and recall notices for patients who miss appointments. Finally, a centralized Immunization Information System can facilitate the exchange of vaccine information among providers and improve continuity of care. We strongly encourage all providers to participate in a local or state Immunization Information System if one is available in your area. Much more information on this topic is available on our website. Office policies that place a priority on maintaining Immunization records provide benefits to the staff as well as the patients. For example, patients receive the benefit of timely age-appropriate immunization each time they visit the office. The staff benefits when they are able to demonstrate high vaccination coverage among their patient population and the satisfaction of knowing their patients are protected from dangerous diseases. Every patient should have a single complete Immunization Record in the front of the chart. This will act as a reminder to check vaccination status of your patient at every visit and facilitate review. All information about the vaccines administered and the vaccine information statements given to the patient should be recorded. You should retain these records indefinitely and be sure to emphasize the need for the patient to keep and maintain their personally held Immunization Record. Andrew? Donna, why don't we take a step back and talk a little bit about vaccine administration? Isn't it necessary to change needles between drawing up the vaccine and administering? That's a question that we get fairly often. The only time we recommend that you have to change the needle is if after you drop the vaccine it gets contaminated or it's bent then certainly you would want to change it before you administer the vaccine. Yeah, it's a lot of sense. Yabo, what happens if you have a patient that comes in and they don't have any records but they think they might have immunity? Can you treat them as immunized? Well, we recommend that you only accept written documented records. With the exception of influenza and pneumococcal polysaccharide vaccine, we recommend that everything else needs to be written and documented in order to be accepted as evidence that the person did receive the vaccination. So if you're not sure, go ahead and re-vaccinate. In some cases, serologic testing may be used, for example, to test for immunity to measles, rubella, or tetanus. For more details on serologic testing, you may consult the ACIP General Recommendations. Sounds like a good idea. Great. Donna, what if expired vaccine is given to a patient? Can you can you count that dose? No, you cannot count that dose. Expired vaccine is expired vaccine, and those are not valid doses. If the vaccine that was given is an inactivated vaccine, then you can repeat the vaccine as soon as you realize that this has occurred. If it's a live vaccine, then you need to wait at least four weeks, 28 days that is, four weeks before repeating the dose. But the best thing to do is just avoid this in the first place by rotating stock, being sure that you're checking those expiration dates, and making sure that there's not any expired vaccine left in your refrigerator or freezer that somebody might pick up and administer. So difference between difference between live and inactivated vaccines, but best to just avoid it in the first place. Absolutely. Yabbo. Storage question. Some providers have elaborate automated systems for monitoring their vaccine. They have alarm systems set up. Do they still need to actually physically monitor their storage units? Good question, Andrew. Unfortunately, automated systems and alarms can fail. And so there's no substitute for a human checking the refrigerator and the freezer twice a day in the morning when the clinic opens and at the end of the clinic day to ensure that vaccines are in a protected environment. Sounds good. Donna, another storage question. When we talk about temperature storage, why do we recommend not freezing diluents? Well, the main reason is because those vials are not designed for freezing. So if the liquid in there were to freeze, it could crack the vial. You may not even see the crack, but then, you know, it's contaminated. And the other reason is if your diluent is not, you know, saline or sterile water, then those diluents, if it's a vaccine, it needs to be stored in the refrigerator. Otherwise, if it's, you know, the sterile water, the saline either store it in the refrigerator or in the door of the refrigerator or you can store it in the cabinet. Thank you, Donna. Thank you, Yabbo. This brings us to the close of this edition of the Immunization Encounter. We hope the information we have presented in this program will help make your immunization practice a little less complicated. Continuing Education Credit is available for this program only through the CDC-ATSDR Training and Continuing Education Online System at www.2a.cdc.gov forward slash tce online. You must have a verification code to apply for Continuing Education Credit for this program. The verification code for this program is LB348F. That is, L is in Lima, B as in Bravo, 3, 4, 8, F as in Foxtrot. Please write it down and enter it when prompted in the online training and education system. Throughout this program, we have mentioned several immunization resources. You will find links to these and much more on our program resources webpage at www.cdc.gov slash vaccines. Click on the education and training section, then the webcast link. Choose Immunization Encounter from the list to find all the materials we have discussed on the program today. If your patients or their parents have immunization-related questions, you can refer them to the CDC Info Contact Center. You can reach the contact center toll-free at 800-CDC-INFO. The CDC Info Contact Center is staffed 24 hours a day, seven days a week. You and your staff can use the internet to email questions, comments, or requests to the National Center for Immunization and Respiratory Diseases. Our email address is nipinfo at cdc.gov. Thank you for joining us today. It has been our pleasure to bring this program to you. Goodbye.