23 Infectious Diseases and Immunizations
Infections are among the most common reasons for children to be taken to their health care provider for a sick visit. Although viruses are the most frequent cause of childhood infectious illnesses, bacterial infections (particularly of the skin and mucosal surfaces) are also common. The ability to distinguish serious infections from those that resolve with minimal or no intervention is an important skill for primary care providers. Nearly as important as the medical care provided to the sick child is the ability to effectively communicate with, educate, and support the often frustrated and anxious parents. Additionally, the provider must include preventive education, including vaccinations, in the routine delivery of primary health care.
Pathogenesis of Infectious Diseases
Bacteria are the dominant life form on earth and are found virtually everywhere in the environment. They are often controlled by viruses. Humans become colonized with bacteria on the skin and mucosal surfaces (including the upper respiratory and gastrointestinal tracts) shortly after birth. These bacteria are generally harmless and may be beneficial because many normal flora can minimize colonization by potentially pathogenic organisms (Table 23-1). Infectious agents cause disease when the balance between harmless colonization and protective immunity is disrupted in favor of harmful proliferation of a microorganism. Dangerous viruses are rare, fortunately, because of their inability to meet all three criteria at once: inflicting serious harm, going unrecognized by the immune system, and being able to efficiently spread.
TABLE 23-1 Common Distribution Sites of Normal Microflora∗ Found in Humans
| Bacterium | Very Commonly or Commonly Found in These Locations | Notes |
|---|---|---|
| Aerobic Bacteria | ||
| Gram Positive | ||
| Staphylococcus aureus | Skin, hair, naso-oropharynx, lower GI, cerumen | Rarely found in the vagina and conjunctiva; trachea, bronchi, lungs, and sinuses are normally sterile; has potential for being a pathogenNew study shows that high levels of MRSA bacteria in the nose are indicative of MRSA colonization in the axilla, groin, perineum; if screening cultures are done, culturing the nose will produce reliable results of colonization in other areas (Mermel et al, 2011) |
| Staphylococcus epidermidis | Skin, hair, naso-oropharynx, adult vagina, urethra, conjunctiva, ear (including cerumen), lower GI | Occasionally found in the vagina of prepubertal females; found in low numbers in “normal” urine, probably as result of contamination from urethra and skin areas |
| Streptococci | Skin, hair, naso-oropharynx, lower GI, cerumen, mouth, nasal passages, nasopharynx | Occasionally found in urethra and conjunctiva; group B uncommonly found in oropharynx and postpubertal vagina |
| Skin, conjunctiva, nasopharynx; less commonly in adult vagina and urethra | Uncommon in GI tract | |
| Mouth; less common in pharynx | Has the potential of being a pathogen | |
| Nasopharynx, mouth; rarely found in conjunctiva, ear, vagina | Has the potential of being a pathogen | |
| Mouth, pharynx; rarely skin, conjunctiva, ear, adult vagina | Has the potential for being a pathogen | |
| Nasopharynx, mouth, skin | ||
| Bifidobacterium bifidum | Lower GI | |
| Enterococcus faecalis | Lower GI, postpubertal vagina; occasionally found in mouth, urethra | Rarely found in pharynx; has potential of being a pathogen |
| Propionibacterium acnes | Skin | |
| Gram Negative | ||
| Acinetobacter johnsonii | Skin, urethra, adult vagina | |
| Corynebacterium | Skin, cerumen, naso-oropharynx, mouth, lower GI, urethra, adult vagina | |
| Citrobacter diversus | Lower GI | |
| Enterobacter | Lower GI, prepubertal vagina, mouth, axillary area | Has the potential of being a pathogen |
| Escherichia coli | Lower GI, vagina, mouth, urethra | Has the potential of being a pathogen |
| Haemophilus influenzae | Nasopharynx, but not commonly; rarely conjunctiva, ear | Has the potential of being a pathogen |
| Kingella kingae (formerly referred to as Moraxella kingae) | Pharynx | Has the potential of being a pathogen (cause of invasive infections in young children) |
| Klebsiella pneumoniae | Nose, colon, axillary area | |
| Lactobacillus spp. | Pharynx, mouth, lower GI, adult vagina | |
| Moraxella catarrhalis | Nasopharynx | |
| Morganella morganii | Lower GI | |
| Mycobacterium spp. | Skin, lower GI, urethra; rarely nasopharynx, mouth | |
| Mycoplasma | Mouth, naso-oropharynx, lower GI, vagina; rarely urethra | |
| Neisseria spp. (e.g., N. mucosa) | Nasopharynx (90%-100% of population); less commonly in conjunctiva, mouth, urethra, vagina | N. meningitidis occurs in nearly 100% of the population as normal flora in the pharynx; less commonly in nose, mouth, vagina; N. meningitidis has the potential for being a pathogen |
| Proteus spp. | Lower GI, vagina, skin, nasopharynx, mouth | |
| Pseudomonas aeruginosa | Lower GI, but not commonly; rarely in pharynx, mouth, urethra; lungs of patients with cystic fibrosis (CF) | Has the potential of being a pathogen |
| Anaerobic Bacteria | ||
| Bacteroides spp. | Lower GI, urethra; rarely adult vagina | Has the potential of being a pathogen |
| Clostridium spp. | Lower GI; rarely mouth | Less commonly found in adult vagina, skin; can be found in small numbers in urine, but is probably a contaminant. Has the potential for being a pathogen. |
| Streptococcus spp | Mouth, colon, adult vagina | |
| Spirochetes (a distinct form of bacteria) | Pharynx, mouth, lower GI | |
| Fungi | ||
| Actinomycetes spp. | Pharynx, mouth | |
| Candida albicans | Skin, conjunctiva, mouth, lower GI, adult vagina | Can be found in voided urine, but is a contaminant |
| Cryptococcus spp. | Skin | |
| Protozoa | Mouth, lower GI, adult vagina | |
| Viruses | The role of viruses as normal flora is undetermined. | |
GI, Gastrointestinal; MRSA, methicillin-resistant Staphylococcus aureus.
∗ Normal microflora in humans consist of indigenous microorganisms that colonize human body tissues and live in a mutualistic state without producing disease. An individual’s microflora depends on genetics, age, sex, stress, nutrition, and diet. A pathogen is a microorganism (or virus) than can produce disease. Normal flora can become pathogens when a host is compromised or weakened (endogenous pathogen); other microorganisms can invade a host during times of disease only (obligate pathogens) or lowered resistance (opportunistic pathogens). More than 200 species of bacteria are known to comprise the normal microflora. Skin microflora can also include yeast (Malassezia furfur), molds (Trichophyton mentagrophytes var. interdigitale), and mites (Demodex folliculorum). The spinal fluid, blood, urine, and tissues are normally sterile; the cervix is normally sterile, but can demonstrate flora similar to those in the upper area of the vagina. Antibiotics can have a minor to major effect on the microflora (e.g., ampicillin has a major effect; erythromycin a moderate effect; and sulfonamides and penicillins have minor effects).
Data from Burton GR, Engelkirk PG: Microbiology for the health sciences, ed 5, Philadelphia, 1996, Lippincott Williams & Wilkins, p 177; Mikat DM, Mikat KW: A clinician’s dictionary guide to bacteria and fungi, ed 4 (revised), 1983, distributed by Eli Lilly and Company, pp 60-64; Mermel LA, Cartony JM, Covington P, et al: Methicillin-resistant Staphylococcus aureus (MRSA) colonization at different body sites: a prospective, quanititative analysis, J Clin Microbiol 2011 Jan 5. [Epub ahead of print]; Tannock GW, editor: Medical importance of the normal microflora, Boston, 1999, Kluwer Academic Publishers, pp 3-5; Todar K: The normal bacteria flora. In Todar, K, editor: Todar’s online textbook of bacteriology, 2008. Available at www.textbookofbacteriology.net/normalflora.html (accessed Dec 12, 2010).
Clinical Findings
Most infectious illnesses in pediatrics are diagnosed solely based on history and physical examination. Laboratory testing is generally reserved for unusual, serious, or difficult to diagnose cases.
History
The goal of a comprehensive history is the generation and prioritization of differential diagnoses for that particular individual based on symptomatology and history. Crucial aspects of the history that help distinguish infectious illnesses from other types of diseases or assist in determining the responsible pathogen include:
• The history of present illness with a careful analysis of the presenting symptoms. When did the symptoms start? What other symptoms were associated with the illness? Were there periods when the patient seemed improved or even back to normal? Details about the presenting history are critically important and can help narrow the differential diagnosis from a broad list of possibilities. As an example, fever is most commonly associated with infectious illnesses, but also occurs with rheumatologic or oncologic diseases.
• A comprehensive past medical history. Careful questioning makes certain diagnoses more or less likely. A history of asthma in a teenager with fever and cough, for example, is suspicious of atypical pneumonia. Determine place of birth.
• Current and recent medications. Recent antibiotic use may affect the provider’s ability to interpret negative culture results or be important information to know in the case of methicillin-resistant Staphylococcus aureus (MRSA) tissue infection. Include any nonprescription, herbal, or natural health products that may have recently been used.
• Immunizations. Adherence to recommended vaccine schedules (including age and spacing of vaccines) is an important consideration if the child’s symptoms suggest a disease usually prevented by vaccines.
• Family history, particularly regarding infectious illness. Important information includes a history of any relative (first or second degree) with a known immune deficiency, with numerous infections or difficulty recovering from infections, or with a history of recurrent miscarriages. Any of these may raise suspicion for an immune deficiency. A strong history of autoimmune disease in the family may suggest possible rheumatologic diagnoses as opposed to an infectious process.
• Social history. Attendance at daycare or school or living in a crowded setting is associated with increased exposure to viral infections. A history of travel to areas with endemic illnesses is important to elicit (e.g., area endemic for Lyme disease, malaria, or parasitic illnesses). A sexual history obtained under confidential conditions is very important for accurate assessment of the adolescent and for males who have sex with males.
• Exposure history, including any known contacts with individuals with similar symptoms. In addition to suggesting a presentation consistent with epidemic illness (e.g., as occurs with viruses, such as influenza or enterovirus), a comprehensive, in-depth exposure history can provide important clues in diagnosis of infections that might otherwise not be considered. Specific questions include any contact with individuals with known illnesses or at high risk for certain illnesses, such as tuberculosis (TB) or human immunodeficiency virus (HIV) or contact with animals or animal by-products (e.g., hides, waste, blood). Other exposures of importance include environmental tobacco smoke or mold.
• Complete review of symptoms. Some presenting features of the illness may be discounted or forgotten by parents or patients and are recalled only when direct questions are asked.
• Diet history. Any ingestion of raw milk or undercooked or raw meats and/or fish; history of pica.
Physical Examination
A complete physical examination is necessary; however, the differential diagnoses generated during the process of taking the history can stimulate the examiner to provide extra focus on certain aspects of the examination.
Physical findings that may be encountered with infectious diseases include:
• Abnormal vital signs (e.g., fever, tachypnea, low blood pressure [concerning for dehydration and/or septic shock]).
• Irritability is nonspecific in ill children, but may raise concern for meningitis or Kawasaki disease. Lethargy raises concern for meningitis (particularly in infants and younger children).
• A stiff or painful neck (suggestive of meningitis).
• A new murmur (may herald the possibility of endocarditis or rheumatic fever).
• Refusal to walk (can be a manifestation of deep tissue infections [e.g., pyomyositis], osteomyelitis, septic arthritis, or meningitis).
• Skin or mucous membrane changes (exanthema or enanthema, respectively) are common with viral illness, and characteristic rashes are typically associated with specific illnesses (e.g., chickenpox).
Diagnostic Aids
Laboratory Studies
In selected circumstances, laboratory evaluation can help clarify a diagnosis or rule out a serious illness that may be under consideration. When in doubt, consulting with knowledgeable laboratory personnel not only can aid in the appropriate test(s) being ordered, but can save valuable resources and time. The following factors should be considered when determining which diagnostic tests to order if an infectious disease is suspected:
• The quality of the specimen sent to the lab strongly affects the reliability of the results. For example, pus aspirated from a skin infection is generally more likely to grow the pathogen of concern than is a surface swab and has the added advantage of allowing the specimen to undergo a Gram stain. The collection site of the microbiologic specimen needs to be appropriately cleansed to minimize possible skin contamination.
• The timing of sample collection affects the degree to which the results help in diagnosis. Bacterial cultures collected after the administration of antibiotics may remain negative, even with active infection. Acute and convalescent titers or certain blood chemistries can help in a diagnosis or monitor response to treatment.
• The amount of any specimen can affect the laboratory’s ability to process the sample correctly.
• Microbiologic samples can require special handling and should be transported to the laboratory promptly. The laboratory should be contacted if there is any question regarding the collection and transport of samples.
• Be prepared to prioritize test requests when only a limited quantity of specimen can be collected.
Complete Blood Count
A complete blood count (CBC) provides information on the relative amount of different cell types in the circulation. From an infectious disease standpoint, the white blood cell (WBC) count is generally the most useful piece of information obtained from the CBC. It is often elevated (leukocytosis) in bacterial infections and may be decreased (leukopenia) in some viral infections. A differential WBC count is often obtained along with a CBC; bacterial infections often (but not always) cause increases in the neutrophil (or polymorphonuclear cell) count and may cause an elevation in bands (immature neutrophils). Normal values for total white cell count and the differential vary with age (see Appendix C, Table C-1). Medications may also commonly affect the WBC count. Steroids can increase the white count, for example, and the long-term use of certain medications can decrease the white count. The clinical state of the patient may also need to be considered in the interpretation of the white count (e.g., overwhelming bacterial sepsis can lead to decreased WBCs).
C-Reactive Protein
The C-reactive protein (CRP) is among the serum measures known as “acute phase reactants,” referring to parameters found in blood that increase in the setting of acute inflammation. Serious bacterial infections are more likely to lead to an increased CRP than other types of infections (Maheshwari, 2006). Although the optimum value above which CRP is most highly predictive of bacterial rather than viral infection has not been established, it is generally uncommon for a viral infection to result in a CRP more than about 10 mg/dL in young children (Hsiao and Baker, 2005). In addition, CRP is sometimes a beneficial tool for monitoring the body’s response to treatment in certain infections. For example, the CRP often is elevated in osteomyelitis before antibiotic treatment, but usually falls rapidly with effective therapy.
Inflammatory processes other than infection may lead to an elevated CRP, including trauma, rheumatologic diseases, and oncologic diseases. Persistent elevations of CRP may be related to adiposity (Puder et al, 2010). Of note, different laboratories may report CRP in different units (usually either mg/L or mg/dL; 10 mg/L equals 1 mg/dL).
Procalcitonin
Along with CRP and WBC, serum procalcitonin (Pro-CT) is considered a promising biomarker for differentiating certain viral infections from serious bacterial infections; in some cases it has proven to be a better marker of sepsis than the erythrocyte sedimentation rate (ESR), WBC, CRP and interleukin-6 (IL-6) (Tasabehji et al, 2008). Procalcitonin is a protein that has activity similar to a hormone and a cytokine. It is produced by several cell types and many organs in response to proinflammatory stimuli, particularly due to bacteria (Hatzistilianou, 2010). Pro-CT levels tend to rise and fall more quickly than CRP during onset and control of bacterial infections (Long and Nyquist, 2008). It may prove to be a valuable tool when the ability to draw and process blood cultures is limited (Fan et al, 2010; Galetto-Lacour and Gervaix, 2010). Its usefulness has been studied for bacterial pneumonia; fever without origin in children 1 week or less of age or 1 month to 36 months of age; bacterial infection in febrile neutropenic children with cancer; diarrhea-associated hemolytic-uremic syndrome; bacterial causes of acute hepatic disease; septicemia versus systemic inflammatory response syndrome; bacterial versus aseptic meningitis; and various diseases that involve inflammatory processes (e.g., Crohn disease, systemic lupus erythematosus [SLE]) (Long and Nyquist, 2008).
Erythrocyte Sedimentation Rate
The ESR is another measure of inflammation and reflects the observation that red blood cells (RBCs) settle more rapidly when acute phase proteins (such as fibrinogen) are present in serum than when they are not. Although the ESR is not a specific test for infection, it is useful in helping evaluate fever of unknown origin and, like CRP, can be used to monitor response to therapy. A low sedimentation rate (<10 mm/hr) is unlikely if the cause of prolonged unexplained fever is a bacterial infection. Bartonella infection, mycobacterial infection, or abscesses are typically associated with an elevated ESR. Similarly, viral infections result in mean ESR values around 20 mm/hr (90% <30 mm/hr), with the exception of adenovirus, which may be associated with values higher than 30 mm/hr. The ESR can be more than 60 mm/hr in children with fever of unknown origin who have bacterial or mycobacterial infection, collagen vascular disease, or inflammatory pseudotumor (Long and Nyquist, 2008).
During the waxing and waning period of infection, the ESR tends to increase and resolve more slowly as compared with CRP values. ESR is considered a useful marker to evaluate the effectiveness of therapy when long-term antibiotics are needed. Thus, it is used when managing diseases (such as osteomyelitis) whereby effectiveness of treatment is judged, in part, by the normalization of the ESR. Like CRP, the ESR is often elevated in noninfectious conditions, causing inflammation, particularly rheumatologic diseases, for which ESRs greater than 100 mm/hour are common. Anemia also causes a nonspecific increase in the ESR.
Cultures, Stains, and Antimicrobial Susceptibility Testing
The usefulness of microbiologic testing is absolutely dependent on the quality of the sample obtained for evaluation and on the correct choice of test for the given clinical situation. Details of appropriate tests for given infections are discussed in the sections about the infectious agents.
Bacterial infections occurring in an otherwise normal child typically result in migration of WBCs to the site of infection, especially neutrophils. The presence of pus can assist in the diagnosis of some infections.
Staining methods can be useful in certain clinical situations, such as when fungal or other infections are suspected. Antigen detection immunofluorescence or antibody assays (e.g., complement fixation tests [CFTs], immunofluorescence [IF] techniques, enzyme-linked immunosorbent assays [ELISAs]) are often used in the diagnosis of viral infections. There are many diagnostic staining methods available (certain commonly used staining tests are covered in more detail under specific infections).
Specimens from fluids or tissue can be sent for bacterial, viral, or fungal cultures; however, the laboratory may need to be notified in cases of certain suspected pathogens to provide specific instruction for the most accurate evaluation of the sample. Additional testing of bacteria may be done on cultured samples to evaluate susceptibility to the more common antibiotics that could be used. Of particular importance is the growing emergence of MRSA, and providers need to know the resistance patterns within their communities. In some communities, MRSA may be susceptible to doxycycline, trimethoprim-sulfamethoxazole (TMP-SMX), or clindamycin; however, susceptibility testing for a given isolate is needed to be sure that an appropriate antibiotic has been chosen (see later discussion about MRSA and Klebsiella resistance).
Deoxyribonucleic Acid Testing
Deoxyribonucleic acid (DNA) testing has become increasingly common in the in-patient setting and is being used more frequently in clinical practice. These tests generally rely on polymerase chain reaction (PCR) to amplify pathogen-specific DNA, followed by detection using labeled DNA or ribonucleic acid (RNA) probes. Specimens of fluid or tissue may be evaluated by PCR. Pathogens that are commonly detected by PCR include Neisseria gonorrhoeae, Chlamydia trachomatis, HIV, Bordetella pertussis, herpesviruses, and enteroviruses.
Serologic Tests
For some infections, diagnosis by culture is difficult or impractical. In specific situations, tests that rely on the generation of an antibody response may be useful. Various methods can be used to detect the presence of antibodies to specific infectious organisms, though cross-reactivity may cause false-positive and false-negative test results. Specific organisms that often rely on serologic diagnosis include HIV, West Nile virus, Bartonella henselae, and Mycoplasma pneumoniae.
Imaging Techniques
Plain Films
Radiographs remain a common modality to assist in the diagnosis of many infections including bone, sinus, and lung infections.
Computed Tomography Scans
Deeper infections, such as abscesses, often require evaluation via computed tomography (CT) scanning.
Magnetic Resonance Imaging
Magnetic resonance imaging (MRI) is the most sensitive imaging modality used in the evaluation of osteomyelitis. It is also often used for brain imaging in cases of encephalitis.
Ultrasound
Ultrasonographic imaging can be used to evaluate the visceral organs, including the liver, spleen, and kidney, for fluid collections suspicious of abscess. It is also commonly used in evaluating kidney anatomy in patients with initial urinary tract infections (UTIs). Echocardiography is a specialized ultrasonographic technique used in the diagnosis, evaluation, and monitoring of endocarditis or Kawasaki disease.
Nuclear Imaging
Several nuclear imaging techniques have been used in evaluating possible infections, including indium-labeled WBC scans (“tagged white cell scans”), gallium scans, bone scans, and positron-emission tomography (PET) scans. Some of these techniques may have limited use in pediatrics, although the bone scan remains useful in the diagnosis of osteomyelitis (Lee and Worsley, 2006).
General Management Strategies
Preventing the Spread of Infection
Thorough and frequent handwashing is the most effective means of preventing the spread of infection. In addition to educating parents and patients on the importance of proper handwashing, it is crucial that health care providers demonstrate proper handwashing during the care of their patients. There is no excuse for not properly cleaning hands before the examination of a patient. Alcohol-based hand rubs may be substituted for soap and water in most cases as long as the ethanol content is at least 40% but preferably at least 60% or more (Reynolds et al, 2006). Such gels are ineffective against controlling the spread of Clostridium difficile. The Centers for Disease Control and Prevention (CDC) recommend using gloves and washing hands with soap and water after being in contact with individuals with C. difficile–associated disease (CDC, 2010a).
Specific guidance that should be given to children and parents includes:
• Hands should be washed after using the bathroom, before meals, and before preparing foods. The proper technique includes scrubbing with soap and water for at least 20 seconds (the time it takes to sing “Happy Birthday” twice), rinsing with warm water, and drying completely.
• Avoiding finger-nose and finger-eye contact, particularly if exposed to someone with a cold.
• Using a tissue to cover the mouth and nose when coughing or sneezing may help prevent the spread of pathogens. If a tissue is unavailable, the upper sleeve should be used (not the hands).
Use of Antibiotics
It is generally known that antibiotics are often prescribed for conditions that do not require their use and that such inappropriate prescribing patterns are likely to contribute to the emergence of resistant bacteria. The CDC has a task force dedicated to tracking the emergence of drug-resistant pathogens and preventing their spread (www.cdc.gov/drugresistance/actionplan/taskforce). One of the risk factors associated with inappropriate prescriptions in children is pressure from the parents to prescribe antibiotics. Providers are encouraged to educate patients and parents about the role and efficacy of antibiotics and to assume a more “targeted therapy” approach when prescribing. The CDC provides brochures, posters, and information sheets that may be helpful in explaining the importance of judicious use of antibiotics. Knowledge about emerging resistance patterns, local epidemiology, and susceptibility patterns of bacterial agents within their practice communities will better arm the provider to appropriately prescribe. An unexpected benefit found from the flu vaccine has been that the number of antibiotic prescriptions written for respiratory infections has decreased. This in turn ultimately has resulted in lowered overall rates of antibiotic-resistant bacteria (Kwong et al, 2009).
Prevention of Infection Through the Use of Vaccines
Immunization is the process by which the body is artificially induced to mount a defense against certain foreign antigens. In this way the immune system is primed to provide future protection with the next exposure to these same antigens. This is achieved by either (1) active immunization that involves introducing either a vaccine or toxoid (inactivated toxin) or by (2) passive immunization that involves administering an exogenous antibody, such as an immune globulin (IG). The specific agents employed in each type of immunization are discussed in the following sections.
Childhood immunization is not only a mainstay of preventive disease control but it is also cost effective. However, continued efforts must be maintained and strengthened (Pickering et al, 2009; Rongkavilit, 2010). Active immunization has been achieved by the administration of live attenuated and inactivated forms of vaccines. Vaccines exist to combat infections from Haemophilus influenzae type B (HiB), meningococcus, diphtheria, pertussis, tetanus, polio, measles, mumps, rubella, human papillomavirus (HPV), hepatitis A and B (HA and HB), influenza, varicella, rabies, typhoid, zoster, Japanese encephalitis, rotavirus, yellow fever, and pneumococcus; all but five are on the routine recommended vaccine schedule for all or specific populations of children and adolescents. Primary care providers may still encounter children with these illnesses because not all routine vaccines have been given as part of preventive health care during childhood or adolescence (see following discussion on parental refusal to vaccination).
Providers must continue to educate parents and patients about the need to keep immunizations current; parents may question this need because many of these diseases have low rates of occurrence in the U.S. Furthermore, the high incidence of global travel leaves underimmunized populations vulnerable to reintroduction of preventable diseases from endemic countries. Preventable epidemics may result.
Barriers to Vaccination
Primary care providers are frequently faced with immunization issues: shortages of vaccines, vaccine refusal, vaccine schedule changes, and unique immunization needs of special populations. Shortages of vaccine have resulted from manufacturing pitfalls. Recent efforts by the U.S. Department of Health and Human Services (USDHHS) include increasing manufacturing capacity to respond to both seasonal and pandemic influenza vaccines by securing adequate egg supplies year-round; providing better guidance for and contracts with vaccine manufacturers; and focusing on cell-based vaccines. In cases of shortages, the CDC provides tiered guidelines for priority administration.
Product recalls, new vaccines, changing immunization schedules, program funding issues, and provider confusion can lead to inadequate immunization rates and levels of disease protection. Medical providers also report inadequate reimbursement, storage and stocking issues, documentation hassles, language barriers, counseling issues, and safety concerns as reasons for not offering vaccinations onsite (Riley, 2006). System barriers such as vaccine costs, a lack of centralized vaccine registry and universal vaccination records, and the complexity of the immunization schedule may also affect immunization rates (Stevenson, 2009).
Several demonstration and research projects have had success in raising immunization rates including community partnerships that involve school-based immunization programs. Such programs reach a large population of underimmunized children. They also bypass difficulties, such as lack of adequate insurance (Rodewald and Orenstein, 2006) or lack of priority on the part of families for preventive care measures (Rusk, 2006).
Parents refuse vaccinations for their children based on many issues: concerns of vaccine safety, including safety of vaccine ingredients; inadequate safety testing; concerns that they may cause learning disabilities; and concerns that they are painful. Some parents express a cynical belief that vaccines are recommended for the profit of pharmaceutical companies, medical providers, and government agencies. The success of vaccine programs has decreased the incidence of disease leaving many people with no experience or awareness of the seriousness of vaccine-preventable diseases. Some parents believe that vaccine-preventable diseases are not very serious and that natural immunity is superior to immunity from a vaccine. Some cite religious reasons for avoiding vaccinations, and others believe that the number of vaccines given overloads or weakens a child’s immune system. There has been a great deal of negative and high-profile media attention concerning a risk of autism (not supported by evidence) associated with vaccination despite overwhelming evidence that no such association exists (Chatterjee and O’Keefe, 2010; National Network for Immunization Information, 2009; Price et al, 2010).
Some helpful points to keep in mind when discussing immunizations with parents include (Amer, 2009):
• Listen: Understand that parents may not use the same decision-making processes that medical providers use.
• Be familiar with common myths regarding the dangers of vaccines and be prepared to address them. Inform concerned parents that all childhood vaccines are available in thimerosal-free forms.
• Be honest and respectful when discussing the known risks and benefits of vaccination and attempt to correct misperceptions or misinformation.
• Emphasize the balance between risks and benefits of vaccination and that the risk associated with disease is far greater than the risk of a serious adverse vaccine reaction.
• Provide parents with printed educational materials from a reliable source, such as the local health department, and encourage parents to visit reputable websites for more information (e.g., the Immunization Action Coalition, the National Network for Immunization Information, the CDC, and the American Academy of Pediatrics [AAP]).
Some medical providers have explored the option of dismissing patients from their practice because of parental refusal of vaccinations. Dismissal may adversely affect access to care and health outcomes for a child (Phillips, 2010). Over time, with subsequent visits, the opportunity for education, the development of respectful communication and an ongoing relationship may help parents to reconsider their choices about immunization. When parents decline immunization it is important to document vaccine discussions and ask parents to sign a vaccine refusal form (available at www.cispimmunize.org/pro/pdf/RefusaltoVaccinate_2pageform.pdf). The AAP discourages patient dismissal but supports it when there is a substantial level of distrust, notable differences in the philosophy about care, or poor communication between provider and patient or family. Advanced notice is requisite (Diekema and AAP Committee on Bioethics, 2005).
Vaccines for Children Program
The Vaccines for Children (VFC) program enables medical providers to obtain all or most Advisory Committee on Immunization Practices (ACIP)-authorized vaccines without cost. These vaccines are provided free to children younger than 19 years of age who are Medicaid eligible, are uninsured, are Native American or Alaska Native. To date the VFC program pays for 50% of all vaccines administered to children in the U.S. under the age of 6 years (Smith, 2010). In addition, children whose insurance does not cover immunizations (underinsured) are eligible to receive vaccines at federally qualified health centers and rural health clinics. All states receive a set level of federal VFC funds. Some states augment that amount to cover more vaccines.
Providers wishing to participate need only to contact their local state Medicaid office to enroll; they need not be a Medicaid-participating provider. Free vaccines plus their shipping costs and an administrative fee, which varies from state to state, are included in this incentive package; there is a minimum of paperwork for the provider.
Vaccine Shortages
The Vaccine Management Business Improvement Project is in charge of addressing all problems related to vaccine shortages including vaccine procurement, ordering, distribution, and management. In addition, federal legislative proposals are underway to ensure federal-private sector partnerships to provide necessary incentives and protections to quickly bring additional and better vaccines to market. Ongoing information regarding vaccine shortages and expected procurement data are available at the National Center for Immunization and Respiratory Disease website (www.cdc.gov/vaccines/vac-gen/shortages).
Medical providers should develop their own tracking system to recall patients whose vaccinations were delayed because of supply shortages. During such times providers should check with the websites of AAP, ACIP, and National Immunization Program recommendations regarding vaccine deferrals, prioritization of high-risk children, and suspensions of school and childcare entry requirements.
Vaccine Safety and Resources for Providers
Informed consent is critical when discussing the benefits and risks of vaccination. The National Childhood Vaccine Injury Act of 1986 (Public Law 99–660, amended by Public Law 101–239) calls for standardized consent forms (Vaccine Information Statement [VIS]). All practitioners are required to use these forms to fulfill their duty to warn the public about possible adverse events. VIS forms are available in 30 different languages on the CDC website. The act also requires that the vaccine lot number, site of inoculation, and name of the person administering the vaccine be included in the medical record. Some state laws require a parental signed consent form. People administering vaccines should be knowledgeable about the signs and symptoms of an allergic reaction and be prepared to treat such a reaction.
The National Childhood Vaccine Injury Act also requires health care providers to report vaccine-related adverse events that occur after immunization so that unexpected patterns and safety concerns can be addressed. The suspected events are to be reported to the USDHHS Vaccine Adverse Event Reporting System (VAERS), using their standard confidential form. Information on which vaccine-associated injuries are reportable as well as official report forms can be downloaded from www.vaers.hhs.gov or from the U.S. Food and Drug Administration (FDA) website.
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