PIC Education Committee- Online Educational Modules
Social and Economic Aspects of Immunizations
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Vaccine Safety and Liability
There are various aspects of vaccine safety including storing and handling vaccines to ensure potency, administering vaccines correctly, and educating patients and answering their questions.
Proper vaccine administration includes using appropriate supplies and administration techniques as well as exercising proper vaccine handling techniques. These aspects of vaccine handling are more thoroughly described in the educational module titled, “Technical Aspects of Vaccines.”
Appropriate patient education includes providing information about recommended vaccines and being able to answer questions about vaccine safety. Current concerns about vaccine safety may include MMR and autism, thimerosal or other vaccine ingredients, too many vaccines, and vaccine testing. Multiple studies have shown no scientific basis for these concerns; however, being able to address questions and provide additional sources of information are imperative to maintaining patient trust and stopping the spread of disease.
Providers have a responsibility to make sure that vaccines are administered appropriately and safely and that questions and concerns are answered. All immunization discussions with parents should be documented, and if parents refuse to immunize their children, providers should have them sign a declination form. This documentation may be needed if an unimmunized patient gets a vaccine-preventable disease and tries to hold the provider liable.
Vaccine Information Statements (VISs) must be provided anytime a vaccine is administered; this is a legal requirement for providers. VISs are written by the Centers for Disease Control and Prevention (CDC). They are available in English at www.cdc.gov/vaccines/Pubs/vis/default.htm and in other languages at www.immunize.org, the Web site of the Immunization Action Coalition.
Some parents want information beyond that which is offered on a VIS. There are many reliable resources including the CDC, Vaccine Education Center at The Children’s Hospital of Philadelphia, Immunization Action Coalition, Every Child by Two, National Network for Immunization Information, American Medical Association, and American Academy of Pediatrics.
There are also public organizations that advocate on behalf of vaccines. Some of these include Voices for Vaccines, Families Fighting Flu, Parents of Kids with Infectious Diseases, Meningitis Angels, and National Meningitis Association.
An important aspect of provider and patient education is how to determine reliability of information. Scientific studies should be blinded, well-controlled, and randomized. They also should be published in peer-reviewed journals and be reproducible. Similarly, web sites and media reports should be examined for their reliability.
Finally, providers need to be aware of cultural competency. Cultural competency is defined as values, principles, policies and behaviors appropriate to the population being served. Five elements of practicing cultural competency include acknowledgement of differences, understanding of culture, self-assessment, acquiring competency skills, and understanding patient behavior in the context of culture.
Childhood vaccines are financed depending upon the family’s financial situation. Vaccines for some children are covered by private insurance; however, infants and children up to 18 years of age who are from families who receive Medicaid or are Medicaid-eligible, who do not have health insurance, or who are under-insured qualify for a federally-funded program called the Vaccines for Children (VFC) program. Some health departments use additional funds, such as those distributed through section 317 of the Public Health Act.
Adult vaccines may or may not be covered by private insurance. Those adults that qualify for Medicare or Medicaid get some vaccines through those programs. In some places, local governments use funds supplied by section 317 of the Public Health Act to supply vaccines for adults.
In clinical settings, healthcare workers must have an awareness of patient financing status, understand insurance procedures, and monitor payments or co-pays.
There are many immunization stakeholders in communities. These groups may work together or independently to promote immunizations. Stakeholders may include coalitions, universities and colleges, departments of health, media, and others.
To learn more about the ideas covered in this section, visit the following:
Vaccine safety and liability:
Vaccine Safety and Liability
Administering vaccines safely
(Note: A full protocol for administering vaccines safely can be found in the ‘Technical Aspects of Immunizations’ module. This discussion is directed to the social and economic responsibilities of administering immunizations.)
Vaccines should be stored in a proper vaccine storage unit (refrigerator and freezer unit with separate doors) at the appropriate temperature. Proper staffing is essential, and the institution should have standing orders for each vaccine so that staff can take advantage of all opportunities to immunize. A standing order allows nurses or other licensed practitioners to administer vaccines even when a physician is not on-site. Sample standing orders can be found at the Immunization Action Coalition Web site at www.immunize.org.
Patient education is another important step in administering a vaccine. This includes providing the Vaccine Information Statements (VIS) for each vaccine being given and answering any questions the patient or parent may have. The nurse or medical assistant should organize immunization paperwork and/or reference materials (VIS, Vaccine Adverse Event Reporting System reports, etc.). Previous vaccination history should be verified and patients should be screened for possible contraindications. Current VIS can be found in English at www.cdc.gov/vaccines and in many additional languages, at www.immunize.org.
Proper injection site, correct needle gauge and length, and appropriate disposal of all sharps are essential. Patients should remain in or near the office for about fifteen minutes after immunization to monitor them for an immediate, serious adverse reaction to immunization. It is advisable to exercise greater caution when immunizing adolescents for either psychological or physiological reasons, as they tend to be more dramatic about immunizations.
Vaccine safety concerns
For additional information about vaccine safety concerns and helpful patient handouts, see the Vaccine Education Center at The Children’s Hospital of Philadelphia Web site at www.vaccine.chop.edu.
Patients or their parents may have questions related to vaccine safety. Some of the more prominent concerns are discussed below:
MMR and autism
Multiple epidemiological studies have shown that the measles-mumps-rubella (MMR) vaccine does not cause autism. Since autism is often diagnosed within the first years of a child’s life and this is also when children receive many vaccines, the two may be considered causal rather than coincidental. The overwhelming answer to this myth is that there is no such link. It was found that autistic children were not more likely to have been given the MMR vaccine. In addition, children diagnosed with autism were not given the MMR vaccine more recently than those children without autism.
Thimerosal and other vaccine ingredients
Thimerosal is defined as an ethylmercury-containing preservative used in some vaccines and other products since the 1930s to prevent contamination. Though it still is used in some doses of the influenza vaccine, in 1999 thimerosal was eliminated from all other childhood vaccines. Since 1999, multiple studies have shown that the thimerosal previously contained in vaccines does not cause autism.
Other vaccine ingredients have also been questioned for safety, including aluminum and polysorbate 80 (also known as Tween 80). None of these ingredients have been shown to be unsafe at the levels contained in vaccines.
Too many vaccines
All vaccines are tested with other vaccines that will be given at the same time before they are released and recommended. These are called concomitant use studies. Although the number of vaccines has increased since last century, the number of immunological components in those vaccines has decreased. For example, the smallpox vaccine contained 200 immunological components. However, with today’s technology all fifteen vaccines commonly given to children only contain 150 immunological components combined. In addition, children face many immunological challenges every day from bacteria and viruses present in their environments.
Not tested enough
Vaccines are thoroughly tested before they are recommended for use in a large group of citizens. They must undergo four phases of testing and continue to be monitored after being licensed and recommended for use. To learn more, go to the Vaccine Preventable Diseases and Vaccines module.
Addressing Vaccine Safety Concerns
To address vaccine safety concerns, healthcare professionals should educate clients about the etiology, signs, and symptoms of autism as well as how vaccines work.
Healthcare providers should communicate with their patients and use materials, Web sites and handouts that explain myths about vaccines. Helpful materials can be found at www.vaccine.chop.edu, www.cdc.gov/vaccines, and www.cispimmunize.org, among other sources. Consult the additional resources section for a list of sources.
According to the CDC, healthcare professionals can make sure vaccines are safe by ensuring proper storage and administration, administration according to the CDC/AAP/AAFP-approved immunization schedules, and assessment for contraindications. They can also ensure safety by managing any side effects, documenting them with VAERS, and explaining vaccine benefits and risks to all patients.
Parents have many vaccine concerns and in some cases refuse vaccinations for their child. According to the CDC, “liability to a provider in case of an occurrence of a vaccine-preventable disease in an unimmunized patient can be addressed by documenting in writing all immunization discussions and parent refusals in the patient’s record”.
The American Academy of Pediatrics offers a refusal to vaccinate form.
Mandated education is information that is required to be given to patients when any vaccines are given. This information is given in the form of Vaccine Information Statements (VIS). The VIS are written by the CDC and discuss the risks and benefits of receiving vaccines and how to handle common minor effects such as low-grade fever or sore arm or leg. Federal law requires that a VIS be given out before each dose of each vaccine is administered. VIS are available in languages other than English from the Immunization Action Coalition at www.immunize.org.
Additional Sources of Information
Many parents and patients will ask healthcare professionals for additional, reliable sources of information about vaccines. It is important for healthcare providers to know where to direct these people for reliable and accurate information. The Centers for Disease Control and Prevention (or CDC) offers textbooks, flyers, brochures, posters videos, stickers and many other resources appropriate for parent education about vaccines. Many other organizations provide materials for educating about vaccines, including the Vaccine Education Center at The Children's Hospital of Philadelphia (www.vaccine.chop.edu), Immunization Action Coalition (www.immunize.org), Every Child by Two (www.ecbt.org), and the National Network for Immunization Information (www.immunizationinfo.com). Consult the resources section for more information.
Some reliable Web resources include:
The Centers for Disease Control and Prevention (or CDC) posts information for travelers, infants, toddlers, adults, pregnant women, college students and young adults. There are also resources specifically for healthcare workers, racial and ethnic populations and kid-friendly sites. Their Web site is www.cdc.gov/vaccines.
The Vaccine Education Center at The Children’s Hospital of Philadelphia (or VEC) explains the science behind how vaccines work, when they should be given, who recommends getting vaccines, if vaccines are safe and whether they are necessary. Their Web site is www.vaccine.chop.edu.
Parents PACK is a program of the Vaccine Education Center at The Children’s Hospital of Philadelphia. Parents can sign up to receive a monthly email newsletters. Their Web site is www.vaccine.chop.edu/parents.
The Immunization Action Coalition (or IAC) provides vaccine information to healthcare professionals and the public. One of their main goals is to increase immunization rates. They also focus on disease prevention. Their Web sites are www.immunize.org and www.vaccineinformation.org.
Every Child By Two (or ecbt) is dedicated to raising awareness and protecting children from vaccine preventable diseases. The organization also works to increase access to immunizations for children. Their Web sites are www.ecbt.org and www.vaccinateyourbaby.org.
The National Network for Immunization Information (or NNii) is provides parents, patients, healthcare providers, policy makers and media with the most current research and findings about vaccine safety. NNii works in collaboration with the Infectious Diseases Society of America, Pediatric Infectious Disease Society, American Academy of Pediatrics, American Nurses Association, National Association of Pediatric Nurse Practitioners, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, and University of Texas Medical Branch. The Web site is www.immunizationinfo.org.
The American Medical Association (or AMA) provides current information about vaccine safety, current research on vaccines and perceived risks and benefits for adolescents and adults. The Web site is www.ama-assn.org.
The American Academy of Pediatrics (or AAP) has information about immunization schedules, safety and vaccine studies. They have a Web site dedicated to immunizations at www.cispimmunize.org.
In addition to professional organizations, there are various parent and public advocacy groups. Some of the larger, national organizations include:
Voices for Vaccines is a non-profit advocacy organization that provides the most current information based on scientific evidence. Their Web site is www.voicesforvaccines.org .
Families Fighting Flu is an organization of families who have experienced the death of a child due to complications from infection with influenza. The goal of the organization is to reduce the number of deaths due to influenza. The group works to educate people about the importance of children receiving the flu vaccine. Their Web site is www.familiesfightingflu.org.
Parents of Kids with Infectious Diseases (or PKIDS) is a group dedicated to educating the public about infectious diseases, how they are transmitted and what can be done to prevent them. It is a non-profit organization that also works to help support families of children living with infectious diseases such as HIV/AIDS, hepatitis, and other chronic diseases. The group provides families with financial, educational and emotional support. Their Web site is www.pkids.org.
Meningitis Angels works to increase awareness of meningitis among not only college students, but also infants and toddlers. The group provides information on the most recent immunization requirements, meningitis research, and educational materials. Message boards and chat rooms are available as a source of support for families to share their stories of loss and survival. Their Web site is www.meningitis-angels.org.
The National Meningitis Association (or NMA) is a nonprofit organization founded by parents whose children have died or live with disabilities resulting from meningitis. The goal of the NMA is to increase awareness of meningitis especially among young adults and adolescents. The NMA posts information on educational programs, recent news and research regarding meningitis. Their Web site is www.nmaus.org.
It is important that healthcare providers are able to evaluate information for reliability and accuracy and be ready to discuss how to evaluate information with their patient population. There are three main types of information to be evaluated; these include scientific studies, Web sites and media reports.
To ensure that a scientific study is reliable and legitimate, it is important to look for the following: 1.) the study took place in a clinical setting 2.) the study was a randomized, controlled trial 3.) a double blind study took place 4.) the study was published in a peer-reviewed journal 5.) the study was replicated with the same outcome. It is also important to identify who funded the research, who performed the research and where the research was published. In looking at the results of the study, it is important to pay attention to whether the results were statistically significant and whether coincidence, correlation and causation could be differentiated.
Many Web sites discuss the risks and benefits of receiving vaccines. However, it is important to be sure the information on a Web site comes from a reliable source. Checking the date of each article that the Web site posts will ensure that the information is the most up-to-date. It is also important to check the source of the information. Medical centers, government agencies and university websites contain the most reliable information. When searching a Web site, it is important to compare the information posted with other well-known, reliable Web sites. The National Network for Immunization Information (NNii) defines the criteria to look for in ensuring that websites have credible information at http://www.immunizationinfo.org/parents/evaluatingWeb.cfm. The CDC also posts information on how to evaluate information on the Internet. A reliable Web site should post who wrote the site (with contact information and credentials), when it was last updated. The information presented should be unbiased. Health information found on a Web site should be discussed directly with a healthcare professional.
Evaluating media reports is similar to evaluating websites. It is most important to verify where the information has been obtained, whether this is an original finding or a finding that has been reproduced in several other studies, the size of the study, and evaluating how strong the is relationship between the findings. Whether information in the story is anecdotal or based on scientific findings is also important. Additionally, be cautious with celebrity spokespeople as they may not have the scientific expertise to evaluate information. To learn more about evaluating media reports, visit the Canadian Women’s Health Network site at http://www.cwhn.ca/network-reseau/2-1/research.html.
Cultural competence is defined as values, principles, policies and behaviors that can be applied successfully across a variety of different cultures. It is essential that healthcare providers practice cultural competence. One way to view cultural competency is with five elements whereby healthcare providers must:
- Acknowledge that cultural differences exist,
- Have a full understanding of their own culture,
- Perform self-assessments,
- Learn about different cultures and skills for working with cultures, and
- Look at patient behavior within the context of that person’s culture.
There are many places to get additional information about cultural competency. For healthcare providers the National Center for Cultural Competence (NCCC) posts resources for performing self-assessments, language access, and evidenced based practice studies on working with cultural competence issues. The NCCC also posts information specifically for families and patients.
Their Web site is http://www11.georgetown.edu/research/gucchd/nccc/foundations/frameworks.html#ccdefinition.
The Institute for Family-Centered Care focuses on developing collaborative relationships between patients, families and healthcare providers. The goal of this organization is to encourage family strengths, choice and independence while providing care that meets the individual needs of the family or patient. Their Web site is http://www.familycenteredcare.org/.
The cost of childhood vaccines is covered by different programs depending upon the financial situation of each family.
If the family has private insurance, it may cover recommended vaccines for children. It is best to check with the insurance company directly to obtain the most up-to-date information on immunization coverage for each plan.
Vaccines for Children Program (or VFC) is a federal government-sponsored program. The program provides free vaccines to children who receive Medicaid or are eligible for Medicaid, or who are Alaskan Native or Native American. State or local health departments may supplement the federal VFC program by expanding the free vaccine eligibility to other groups. The Web site provides information for states, healthcare providers, and families. Healthcare providers can sign up to participate in this program and families can obtain information on where to find healthcare providers participating in this program. More information is available on the CDC website: http://www.cdc.gov/vaccines/programs/vfc/default.htm. Information can also be found on state or local health department Web sites.
The Center for Disease Control established Section 317 that provides vaccines for children whose families are ineligible for immunization by the Vaccines for Children program. Section 317 also permits vaccines to uninsured or underinsured adults in some cases. Each state decides which aspects of immunizations to allocate these funds toward. More information is available on the CDC website: http://www.cdc.gov/ncird/progbriefs/downloads/grant-317.pdf
Financing of adult immunizations is not as well established as that for children.
If adults have private insurance, their plan may or may not cover immunizations.
Medicare is a health insurance program for people who are a.)65 years of age or older b.)under 65 years of age with certain disabilities or c.) any age with End Stage Renal Disease. Medicare has two parts to the insurance program (A and B) and also prescription drug coverage (part D). Appropriate health insurance plans vary according to patient needs. Premiums and co-pays all vary according to plans. The following shots are covered: influenza, hepatitis B, and pneumoccocal. The Web site for information about Medicare is http://www.medicare.gov/,
Medicaid is a health insurance program for low-income families and individuals. Payment is made directly to health care providers not patients. Each state has different guidelines as to who is eligible to receive Medicaid services. Having low income does not guarantee Medicaid eligibility. More information can be found at http://www.cms.hhs.gov/home/medicaid.asp
Section 317 is a section of the Public Health Act that allocates money to states to support immunizations. Some states choose to allocate their section 317 funds to adult immunizations. Information about Section 317 can be found http://www.cdc.gov/ncird/progbriefs/downloads/grant-317.pdf
Financing in Clinical Practice
In private practice settings, staff must be aware of each patient’s insurance status in regard to immunizations. For example, because VFC vaccines are provided by the government, they can not be given to patients with private insurance.
Healthcare providers must also become familiar with how to correctly code and bill for immunizations in order to receive proper payment from insurance companies. Reimbursement for vaccines and administration of vaccines varies with each insurance company and from state to state.
For insurance coverage, each vaccine is itemized with a specific CPT code. The CPT code is then linked to the diagnosis code (or ICD 9 code). The CPT code describes what the healthcare provider did during the patient visit. The diagnosis code defines who received the service and which service was administered during the visit.
Office staff in the provider’s office should be responsible for billing or filing claims to insurance companies. It is the responsibility of this staff to collect co-pays from patients at the time of the visit. Co-pays vary according to the patient’s insurance plan. Information about co-pays can generally be found on the patient’s insurance card. The total cost of the visit may not be covered by the insurance company. Once the insurance company has paid a certain amount of money back to the provider for the visit, a follow-up bill may be sent to patients for services not covered.
For people who work in immunizations or who have interest and belief in the importance of vaccines, there are places that you can seek in your community to find out more, and work with others toward better immunization rates. These include immunization coalitions, universities and colleges, and local health departments.
Coalitions take on initiatives that educate both providers and the public. The following are national resources which support these initiatives:
American Immunization Registry Association
Center for Disease Control and Prevention (CDC)
The Immunization Action Coalition (IAC)
Every Child by Two (ecbt)
The Immunization Coalitions Technical Assistance Network (IZTA)
Universities and colleges
Student health centers and colleges of nursing are good resources for immunization education. Student, community and public education initiatives are all executed through universities and colleges.
Departments of Health
To find more information about how to work on immunizations, get vaccines, or find others who are interested in immunizations, contact your local or state health department.
Many vaccine-related stories are reported by the media. Checking these stories for accuracy and writing letters to the editors about vaccine-related issues are other ways to work in your community to promote the importance of immunizations and encourage accurate and full coverage of immunization issues.
Other community stakeholders may include hospitals, clinics, employee health personnel, parent-teacher organizations, child day care centers, nursing mother groups, and school nurses as well as citizens. Learning what networks exist in your community and becoming active are good ways to ensure the health of your community.
To learn more about the ideas covered in this section, visit the following:
Vaccine Safety Concerns:
Vaccine Information Statements (VIS):
Parent and Healthcare Worker Handouts:
http://www.vaccine.chop.edu under the “Order Educational Resources” section
Gold, R. Your Child’s Best Shot: A Parent’s Guide to Vaccination (Canadian Pediatric Society,
Ottawa, Ontario, 2002).
Humison, S and C Good. Vaccinating Your Child: Questions & Answers for the Concerned Parent
(Peachtree Publishes Ltd., 2000, (www.peachtree-online.com).
Offit, PA. Vaccinated: One Man’s Quest to Defeat the World’s Deadliest Diseases
(Smithsonian Books, 2007).
Offit, PA and LM Bell. Vaccines: What You Should Know (Wiley, 2003).
UPDATED: July 2009