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Hello, my name is Marina De Pablo. I am an education practice liaison for the LEAP project, at the UW-Madison School of Nursing. I will be presenting the next section of the Public Health Nurse Orientation on Services to Prevent and Control Communicable Disease that covers Immunizations.

After completing the module, participants should be able to apply safe immunization practices to their own nursing practice, and locate resources to guide safe immunization practice.

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The Wisconsin Immunization Program addresses the Healthy People 2010 Objective that states: Achieve and maintain 90% vaccination coverage levels for universally recommended vaccines among young children.

The fourth section within the Bureau of Communicable Disease is the Immunization program. The program provides vaccines and technical assistance to health care providers, conducts surveillance and investigation of vaccine preventable diseases, operates the Wisconsin Immunization Registry, and conducts educational activities to encourage prompt and complete immunization. The program implements state law that requires immunizations for children entering day care centers and schools. It is also responsible for Wisconsin’s distribution of the National Pharmaceutical Stockpile and conduct of mass immunization or prophylaxis in the event of an emergency. The mission of the program is to strive to eliminate the transmission of vaccine preventable disease through effective immunization programs and outbreak control measures. Utilizing best practice strategies and evidence-based programming, the steps to achieve this mission include:

• Improving the effectiveness of immunization delivery systems.

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• Increasing immunization access for all. • Identifying and eliminating racial, ethnic and other disparities. • Protecting the community through high immunization rates.

This list of terms is specific to the practice of immunizations. Refer to the resource page for more information if you are not familiar with the terms or need a refresher.

Many of the communicable diseases can be prevented by immunizations. Immunizations are a type of Primary Prevention that aims at intervening before pathological changes have begun, during the natural history stage of susceptibility. Keep in mind that providing immunizations is a delegated function requiring a medical provider’s orders because it entails administering a medication to an individual. Delegated functions are one of the 17 public health nursing interventions covered in the Public Health Intervention Model. More information on delegated functions is available in Wisconsin Statute Chapter 441 of the board of nursing rules and regulations. Local Health Departments have standing medical orders to authorize immunization administration. Locate your agency’s standing medical orders to assure safe practice.

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Excellent resources are available from the Wisconsin Immunization Program, and from each regional office. An immunization consultant and Public Health Nurse Consultant is available in each region to assure safe immunization practice.

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. The following slides provide specific resources on professional standards related to administration of vaccines.

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Each agency has a specific set of immunizations policies, procedures, and guidelines that you will want to locate and be familiar with. The policies and procedures are based on guidelines established by the State Immunization Program.

The CDC and American Academy of Pediatrics has a colorful array of books that serve as excellent resources for safe immunization practice. The pink book is a reference about all vaccinations and is generally updated annually. The yellow book is specific to international travel and is also updated regularly. The Red Book describes clinical manifestations, etiology, epidemiology, diagnostic tests, treatment, isolation of the hospitalized patient, and control measures for infectious disease, and is updated every 3 years. The Advisory Committee on Immunizations, or ACIP, provides the current immunization recommendations for all age groups.

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The Center for Disease Control and Prevention regularly updates recommendations and guidelines. They also have a phone line for up to date information on immunizations. The Immunization Action Coalition is an excellent resource for current immunization information and includes tools such as checklists, Vaccine Information Sheets, temperature logs, and screening questionnaires.

Storage and handling of vaccines is a critical component of an immunization program. Some of the important elements of storage and handling includes: having the correct type of refrigerator, rotating stock, checking and recording temperatures twice a day and troubleshooting if a temperature is out of range, having a back-up generator, and having a policy and procedure in place in a case of an emergency such as a prolonged power outage. The Center for Disease Control and Prevention guidelines for storage and handling of vaccines is a good resource for more information on this topic.

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The following slides provide general recommendations for safe immunization practice. All patients should be screened for contraindications and precautions for each scheduled vaccine. Many state immunization programs and other organizations have developed and make available standardized screening tools.

These Centers for Disease Control and Prevention documents provide information on the contraindications and precautions to consider when administering vaccines. Few true contraindications exist so it is important to know what is fact versus myth when providing immunization services. Web links to these documents can be found on the module resource page.

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The Epidemiology and Prevention of Vaccine Preventable Diseases, or Pink Book, also provides guidelines for spacing of live virus vaccines, immunizing immunocompromised people, the components of each vaccine including preservatives, and minimal ages and intervals for immunizations.

Parents or guardians and patients are exposed through the media to information about vaccines, some of which is inaccurate or misleading. Healthcare providers should be prepared to discuss the benefits and risks of vaccines using Vaccine Information Statements, or VISs, and other reliable resources. Vaccine Information Statements are information sheets produced by the Centers for Disease Control and Prevention that explain both the benefits and risks of a vaccine to adult vaccine recipients and the parents of children and adolescents.

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Federal law requires that Vaccine Information Statements be provided whenever vaccinations are given. A notation needs to be made in each patient's permanent medical record at the time vaccine information materials are provided indicating: (1) the edition date of the Vaccine Information Statement distributed (2) the date the VIS was provided (3) the name, address and title of the individual who administers the vaccine, (4) the date of administration, and (5) the vaccine manufacturer and lot number of the vaccine used

Immunization providers should follow Standard Precautions to minimize the risks of spreading disease during vaccine administration. The single, most effective disease prevention activity is good handwashing. Hands should be washed thoroughly with soap and water or cleansed with an alcohol based waterless antiseptic between patients, before vaccine preparation or any time hands are visibly soiled. Gloves are not required to be worn when administering vaccines unless the person administering the vaccine is likely to come into contact with potentially infectious body fluids or has open lesions on the hands. It is important to remember that gloves cannot prevent needlestick injuries.

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Needlestick injuries should be reported immediately to your supervisor, with appropriate care and follow-up given as directed by CDC. Safety needles or needle-free injection devices should be used to reduce the risk of injury.

Each vaccine vial should be carefully inspected for damage or contamination prior to use. The expiration date printed on the vial or box should be checked. Vaccine can be used through the last day of the month indicated by the expiration date unless otherwise stated on the package labeling. Expired vaccine should never be used. Some vaccines require reconstitution, which should be done according to manufacturer guidelines. Diluent solutions vary; use only the specific diluent supplied for the vaccine. Once reconstituted, the vaccine must be either administered within the time guidelines provided by the manufacturer or discarded. Changing the needle after reconstitution of the vaccine is not necessary unless the needle has become contaminated or bent.

CDC strongly discourages filling syringes in advance, because of the increased risk of administration errors. Once the vaccine is in the syringe it is difficult to identify the type or brand of vaccine. Other problems associated with this practice are vaccine wastage, and possible bacterial growth in vaccines that do not contain a preservative. Furthermore, medication administration guidelines state that the individual who administers a medication should be the one to draw up and prepare it. An alternative to prefilling syringes is to use syringes filled and supplied by the vaccine manufacturer. Syringes other than those filled by the manufacturer are designed for immediate administration, not for vaccine storage. In certain circumstances, such as a large influenza clinic, more than one syringe can be filled. One person should prefill only a few syringes at a time, and the same person should administer them. Any syringes left at the end of the clinic day should be discarded. Under no circumstances should MMR, varicella, or zoster vaccines ever be reconstituted and drawn prior to the immediate need for them. These

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live virus vaccines are unstable and begin to deteriorate as soon as they are reconstituted with diluent. Once a vaccine is drawn into a syringe, the content should be indicated on the syringe. There are a variety of methods for identifying or labeling syringes, for example, keep syringes with the appropriate vaccine vials, place the syringes in a labeled partitioned tray, or use color coded labels or preprinted labels.

Administering a vaccine by the recommended route is imperative for vaccine efficacy and to reduce the risk of local reactions. Now we’ll talk about administering subcutaneous injections. Subcutaneous injections are administered into the fatty tissue found below the dermis and above muscle tissue. This tissue can be found all over the body. The usual sites for vaccine administration are the thigh for infants <12 months of age, and the upper outer triceps of the arm for persons >12 months of age. If necessary, the upper outer triceps area can be used to administer subcutaneous injections to infants. Follow standard medication administration guidelines for site assessment and selection and site preparation. The recommended needle size for subcutaneous injections is 5/8“ length and 23-25 gauge. To avoid reaching the muscle, pinch up the fatty tissue, insert the needle at a 45° angle and inject the vaccine into the tissue. Withdraw the needle and apply light pressure to the injection site for several seconds with a dry cotton ball or gauze. 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. Although this practice is advocated by some experts, the procedure is not required because no large blood vessels exist at the recommended injection sites.

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Intramuscular, or IM, injections are administered into muscle tissue below the dermis and subcutaneous tissue.

The recommended needle gauge for intramuscular injections is a 22- to 25-gauge needle. The needle should be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue, but not so long as to involve underlying nerves, blood vessels, or bone. Decision on needle size and site of injection must be made for each person on the basis of the size of the muscle, the thickness of adipose tissue at the injection site, the volume of the material to be administered, injection technique, and the depth below the muscle surface into which the material is to be injected. For the majority of infants younger than 12 months, the anterolateral aspect of the thigh is the recommended site for injection because it provides a large muscle mass. The muscles of the buttock have not been used for administration of vaccines in infants and children because of concern about potential injury to the sciatic nerve, which is well documented after injection of antimicrobial agents into the buttock. Injection technique is the most important factor to ensure efficient intramuscular vaccine delivery. For the majority of infants, a 1-inch, 22-25-gauge needle is sufficient to penetrate muscle in an infant's thigh. For newborn and premature infants in the first 28 days of life, a 5/8 inch needle usually is adequate if the skin is stretched flat between thumb and forefinger and the needle inserted at a 90-degree angle to the skin.

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For toddlers and older children between 12 Months and 10 Years, the deltoid muscle should be used if the muscle mass is adequate. The needle size for deltoid site injections can range from 22 to 25 gauge and from 5/8 to 1 inch on the basis of the size of the muscle and the thickness of adipose tissue at the injection site. For adults and adolescents, 11 Years or Older, the deltoid muscle is recommended for routine intramuscular vaccinations. The anterolateral thigh also can be used. Needle size should be based on the person’s weight and amount of adipose tissue. Follow standard medication administration guidelines for site assessment/selection and site preparation. To avoid injection into subcutaneous tissue, spread the skin of the selected vaccine administration site 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. Insert the needle fully into the muscle at a 90° angle and inject the vaccine into the tissue. Withdraw the needle and apply light pressure to the injection site for several seconds with a dry cotton ball or gauze. Similar to subcutaneous injections, aspiration is not required.

A separate needle and syringe should be used for each injection. A vaccine may be delivered in either a 1-mL or 3-mL syringe as long as the prescribed dosage is delivered. Syringe devices with engineered sharps injury protection are available and, in Wisconsin, required by the Occupational Safety and Health Administration or OSHA to reduce the incidence of needle stick injuries and potential disease transmission. Vaccine must reach the desired tissue site for optimal immune response. Therefore, needle selection should be based upon the prescribed route, size of the individual, volume and

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viscosity of the vaccine, and injection technique. Typically, vaccines are not highly viscous, and therefore a fine gauge needle, 22–25 gauge, can be used. This guideline for administering vaccines by dose, route, site and needle size is available at the website of the Immunization Action Coalition.

This slide reviews the anatomical sites discussed earlier and is available as a poster from California Distance Learning. This information is also available in the CDC Pink Book.

Used needles should not be detached from syringes, recapped or cut before disposal. All used syringe or needle devices should be placed in puncture proof containers to prevent accidental needle-sticks and reuse. Empty or expired vaccine vials are considered medical waste and should be disposed of according to state regulations.

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Vaccine safety issues and the need for multiple injections have increased the concerns and anxiety associated with immunizations. Healthcare providers need to display confidence and establish an environment that promotes a sense of security and trust for the patient and family, utilizing a variety of techniques to minimize the stress and discomfort associated with receiving injections. This is particularly important when administering vaccines to children. The healthcare provider must accommodate the patient's comfort, safety, age, activity level, and the site of administration when considering patient positioning and restraint. For a child, the parent or guardian should be encouraged to hold the child during administration. If the parent is uncomfortable, another person may assist or the patient may be positioned safely on an examination table Pain is a subjective phenomenon influenced by multiple factors, including an individual's age, anxiety level, previous healthcare experiences, and culture. Consideration of these factors is important as the provider develops a planned approach to the management of injections. A non-aspirin containing pain reliever may be considered to decrease discomfort and fever following vaccination. These products should be used only in age-appropriate doses. Age-appropriate non pharmacologic techniques may provide distraction from pain associated with injections. Diversion can be accomplished through a variety of techniques. One technique used by some providers is simultaneous administration of vaccines at separate sites. This procedure may decrease anxiety caused by anticipation of the next injection. The effectiveness of this procedure in decreasing pain or stress associated with vaccine injections has not been evaluated. This slide shows a poster available from the California Distance Learning site that demonstrates holding techniques to increase comfort and safety.

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When administering multiple vaccines, never mix vaccines in the same syringe unless approved for mixing by the Food and Drug Administration or FDA. If more than one vaccine must be administered in the same limb, the injection sites should be separated by 1-2 inches so that any local reactions can be differentiated. Vaccine doses range from 0.2 mL to 1 mL. The recommended maximum volume of medication for an intramuscular site varies among references and depends on the muscle mass of the individual, however, administering two intramuscular vaccines into the same muscle would not exceed any suggested volume ranges for either the vastus lateralis or the deltoid muscle in any age group. A subcutaneous vaccine administration into the same limb is acceptable since a different tissue site is involved. If a vaccine and an immune globulin preparation are administered simultaneously, for example, hepatitis B vaccine and hepatitis B immune globulin, a separate anatomic site should be used for each injection. The location of each injection should be documented in the patient’s medical record.

Deviation from the recommended route, site and dosage of vaccine is strongly discouraged and can result in inadequate protection. In situations where nonstandard administration has occurred, refer to the current ACIP General Recommendation on Immunization for specific guidance. Individuals with a bleeding disorder or who are receiving anticoagulant therapy may develop hematomas in intramuscular injection sites. Prior to administration of intramuscular vaccines the patient or family should be instructed about the risk of hematoma formation from the injection. Additionally, a physician familiar with the patient's bleeding disorder or therapy should be

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consulted regarding the safety of administration by this route. If the patient periodically receives hemophilia replacement factor or other similar therapy, intramuscular vaccine administration should ideally be scheduled shortly after replacement therapy. A 23-gauge or finer needle should be used and firm pressure applied to the site for at least 2 minutes. The site should not be rubbed or massaged.

Administration of a vaccine supplied in a vial or syringe that contains natural rubber should not be administered to an individual with a history of a severe anaphylactic allergy to latex, unless the benefit of vaccination clearly outweighs the risk of an allergic reaction. These situations are rare. Medical consultation and direction should be sought regarding vaccination. A local or contact sensitivity to latex is not a contraindication to vaccination. Syncopal or Vasovagal Response or fainting, may occur during vaccine administration, especially with adolescents and adults. Because individuals may fall and sustain injury as a result, the provider should have the patient sit during injections. A syncopal or vasovagal response is not common and is not an allergic reaction. However, if syncope develops, the provider should observe and administer supportive care until the patient is recovered.

Anaphylaxis is a life-threatening acute allergic reaction. Each facility that administers vaccines should have a protocol, procedures and equipment, including phone access to provide initial care for suspected anaphylaxis. Staff should be prepared to recognize and respond appropriately to this type of emergency situation. All staff should maintain current CPR

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certification. Emergency protocols, procedures and equipment and supplies should be reviewed periodically. For additional information on medical management of vaccine reactions in children, teens, and adults, see the current ACIP General Recommendations on Immunization, Immunization Action Coalition documents, the AAP Red Book, and the “Pink Book” appendix. Although both fainting and allergic reactions are rare, vaccine providers should strongly consider observing patients for 15 minutes after they are vaccinated.

The federal government has two reporting requirements for vaccines. The first is the provision of the Vaccine Information Statement to the recipient or recipient’s parent or guardian. The second is information about the vaccine administration. Five items must be documented:

1. the date the vaccinations was given, 2. the vaccine manufacturer and lot number of the vaccine administered, 3. the name and address where the information will be stored, and the signature and title of

the individual who administered the vaccine, 4. the edition, or date of publication, of the Vaccine Information Statement, 5. the date the Vaccine Information Statement was given to the patient. You are also

required to give the recipient or parent or guardian a record of the vaccines you administered.

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The Wisconsin Immunization Registry or, WIR (say word), is a computerized Internet database application that was developed to record and track immunization dates of Wisconsin's children and adults. Immunization registries are seen as an integral tool for assuring that children and adults receive their immunizations according to recommended schedules and can prevent over-immunizing. WIR is an example of a systems level intervention. As part of the Public Immunization Record Access feature, parents and legal guardians can now look up their child's immunization record in the WIR. This can decrease the number of requests to providers for immunization records from their patients. Several health care systems have their own immunization database that interfaces with the WIR, providing access to immunization records all over the state.

The Regional Early Childhood Immunization Network, or RECIN (say REESIN), is another immunization registry in Wisconsin. This system was privately developed by Marshfield Clinic and is used more extensively in the central part of the state. The two registry systems are connected to assure sharing of information.

VAERS (say Vares) is a national vaccine safety surveillance program co-sponsored by the CDC and the FDA. VAERS collects and analyzes information from reports of adverse events

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following immunization. Since 1990, VAERS has received over 123,000 reports, most of which describe mild side effects such as fever. Very rarely, people experience serious adverse events following immunization. By monitoring such events, VAERS can help to identify important new safety concerns. Anyone can submit a VAERS report. VAERS encourages the reporting of any clinically significant adverse event that occurs after the administration of any vaccine licensed in the United States. Report such events even if you are unsure whether a vaccine caused them. The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report: Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine. Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination. Information identifying the person who received the vaccine will not be made available to the public. You and/or your health care provider may be contacted for follow-up information after your initial report is received. While VAERS pertains to adverse reactions, please refer back to your agency's incident report policy and procedure for medications errors that may occur from vaccine administration.

The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program, or VICP. The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims. It provides compensation to people found to be injured by certain vaccines. Decisions are made by the U.S. Court of Federal Claims.

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The Vaccine for Children Program, or VFC, began October 1, 1994, and represents an unprecedented approach to improving vaccine availability nationwide by providing vaccine at no cost to VFC-eligible children through enrolled public and private providers. The VFC Program:

• provides public purchased vaccine, for eligible children, at no charge to VFC enrolled public and private providers

• Automatically covers vaccines recommended by the ACIP and approved by the CDC • Saves parents and enrolled providers out-of-pocket expenses for vaccine • Eliminates or reduces vaccine cost as a barrier to vaccinating eligible children • And encourages keeping children in their medical home for comprehensive health care.

The Wisconsin Student Immunization Law was passed in 1975, establishing required doses of vaccines for children in all Wisconsin schools and licensed day care centers. Wisconsin statute, Chapter 252, and administrative rule HFS 144 have been amended numerous times. This slide and the next give a brief historical overview of the changes that have occurred since 1975.

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Immunizations have been proven to be a key tool in preventing a number of serious communicable diseases. The Department of Health Services is committed to ensuring children get their recommended immunizations on time. In doing so, the department works with public and private health care providers, schools, community-based organizations and others in collaborative efforts to raise awareness to the threat vaccine preventable disease poses to health of children and the importance of on-schedule immunization. Schools play a huge role in these efforts through work in enforcing the requirements of the school immunization law. The work ensures that children receive the immunizations they need to prevent illness that could otherwise keep kids out of school. Local health departments assist the schools in assuring the students are up to date by assisting with record retrieval, providing immunizations for those who are encountering barriers to receiving them, and filing the annual reports with the immunization program. Licensed child care centers are also required to file their children’s immunization status annually with the state immunization program. School immunization laws change as new vaccines become available. The WI Immunization Program publishes a manual annually on immunization requirements that includes any changes in school immunization laws.