Update on Management of Pediatric Acute Otitis Media

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     Abstract and Introduction

    Abstract

     Acute otitis media (AOM) is a common pediatric infection that is typically managed in the outpatient setting. While

    Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis are the most common bacterial cause,

    other organisms including viruses can cause AOM. The American Academy of Pediatrics and American Academy of 

    Family Physicians recently released an updated clinical practice guideline for the diagnosis and management of AOM.

    First-line antibiotic treatment for AOM is amoxicillin or amoxicillin-clavulanate, and alternative agents include

    cephalosporins and clindamycin. Pharmacists are in a key position to improve outcomes for children with AOM by

    recommending appropriate therapy, monitoring for adverse effects, and ensuring adherence to the immunization

    schedule.

    Update on the Management of Pediatric Acute Otitis Media

    Elias B. Chahine, PharmD, BCPS (AQ-ID); Ashley N. Johnson, PharmD, BCPS;

     Angelica Costanzo, PharmD Candidate

    US Pharmacist. 2014;39(7):27-30.

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    Introduction

    With over 80% of children experiencing at least one episode of acute otitis media (AOM) by age 3 years, this condition is

    the most common one for which children are prescribed antibiotics in the United States. [1,2] Healthcare-associated costs

    for AOM account for approximately $2.88 billion annually in the U.S., in addition to significant indirect costs attributed to

    caregivers' lost time.[3,4]  AOM, often referred to as a middle ear infection, is characterized by the rapid onset of signs

    and symptoms of inflammation in the middle ear such as pain, fever, and impaired hearing.[1,5]  AOM is most prevalent

    in children aged 2 years of age who present with a unilateral infection

    and acute ear drainage during the summer months. [8] AOM attributed to S pyogenes  is less frequently associated with

    concurrent fever, other signs of an upper respiratory infection, and previous antibiotic treatment within the past month. [8]

    Prompt identification of this pathogen is essential, as it is associated with higher rates of tympanic perforation and

    mastoiditis (infection of the mastoid bone) than other pathogens.[8]

    Staphylococcus aureus  is not generally associatedwith AOM except in hospitalized infants who are commonly infected with S aureus and gram-negative organisms.[1,6]

     Although viruses alone are rarely the only contributing causes of AOM, viruses frequently associated with AOM include

    rhinovirus, respiratory syncytial virus, influenza virus, enteroviruses, and coronaviruses. [5,6]

    Clinical Presentation and Diagnostic Considerations

    The most common symptom reported by children with AOM is otalgia, or ear pain. [1]  Additional symptoms that may be

    seen with AOM are otorrhea (ear discharge), fever, and irritability. [1]  However, in younger children who are preverbal, the

    symptoms vary from changes in sleeping or eating habits to excessive crying to tugging, rubbing, and/or holding of the

    ear.[1,5,6]  Unlike previous diagnostic recommendations that relied only on symptoms, the most recent AAP/AAFP

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    guideline for the diagnosis and management of AOM recommends more stringent otoscopic findings to confirm the

    diagnosis. [1,7]

    In assessing AOM, it is essential to distinguish AOM from otitis media with effusion (OME) because the latter should not

    be treated with antibiotics.[1] Failure to correctly diagnose AOM can lead to inappropriate antibiotic use and subsequentl

    antibiotic resistance.[9] A diagnosis of AOM in children should be made when either severe bulging of the tympanic

    membrane or new onset of otorrhea not due to acute otitis externa is present. [1]  A diagnosis of AOM in children may be

    made in the presence of mild bulging of the tympanic membrane and onset of otalgia in 102.2°F.[1]  Additionally, recurrent AOM is

    categorized as three or more documented and separate episodes within 6 months or four or more episodes within 12

    months with at least one episode being in the past 6 months. [1,10]

    Treatment

    To determine the most appropriate treatment for AOM, several factors must be taken into consideration, including the

    patient's characteristics such as age and allergies, whether the infection is unilateral or bilateral, and severity of signs

    and symptoms. Antibiotics should be prescribed in children aged 6 months and older who are experiencing severe signsand symptoms with either unilateral or bilateral AOM. Antibiotics are also indicated in patients aged 24 months with either unilateral or bilateral nonsevere AOM, an observation and a follow-up within 48

    to 72 hours prior to initiating antibiotics may be offered to assess patient improvement. [1]  If no improvement is noticed o

    symptoms have worsened, antibiotic therapy is then warranted for these patients.[1]

    summarizes antibiotic regimens commonly used in the treatment of pediatric AOM, and details their side-effect profiles.[1,11]  The recommended antibiotic for the treatment of AOM in patients who have not received amoxicillin within the last

    30 days and have no concurrent purulent conjunctivitis or allergy to penicillin is a high-dose amoxicillin.[1]  Amoxicillin is

    recommended due to its effectiveness against the common bacterial pathogens associated with AOM as well as its

    favorable side-effect profile, low cost, tolerable taste, and relatively narrow spectrum of activity. For patients who haveused amoxicillin within the last 30 days, have purulent conjunctivitis, or experience recurrent AOM unresponsive to

    amoxicillin, antibiotic therapy with additional beta-lactamase coverage, such as high-dose amoxicillin-clavulanate, is

    preferred. A cephalosporin is recommended in patients who have a mild penicillin allergy, and clindamycin is

    recommended in patients with severe penicillin allergy. [1,12] Macrolides and sulfonamides are not routinely recommended

    because of their limited effectiveness against the common pathogens associated with AOM.[1]

    Table 1. Antibiotic Regimens Commonly Used in the Treatment of Pediatric AOM

    Antibiotic Dosage  Route of 

    Administration

    Frequency of 

    Administration

    Duration

    of Therapy

    First-line Agents

     Amoxicillin 80–90 mg/kg/day (max 3 g daily) Oral Twice daily 5–10 days

     Amoxicillin-

    clavulanatea  90 mg/kg/day of amoxicillin (max 3 g daily) Oral Twice daily 5–10 days

    Alternative Agents in Children With Mild Allergy to Penicillins

    Cefdinir 14 mg/kg/day (max 600 mg daily) Oral  Once to twice

    daily  5–10 days

    Ceftriaxone 50 mg/kg/day (max 1 g daily) IM or IV Once daily 1–3 days

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    Cefpodoxime 10 mg/kg/day (max 400 mg daily) Oral Twice daily 5–10 days

    Cefuroxime 30 mg/kg/day (max 1 g daily) Oral Twice daily 5–10 days

    Alternative Agents in Children With Severe Allergy to Penicillins and Cephalosporins

     Azithromycin  10 mg/kg/day on day 1, then 5 mg/kg/day (max

    500 mg on day 1, then 250 mg daily)  Oral Once daily 5 days

    Clarithromycin 15 mg/kg/day (max 1 g daily) Oral Twice daily 5–10 days

    Clindamycinb 30–40 mg/kg/day (max 1.8 g daily) Oral 3 times daily 5–10 days

    Erythromycin-

    sulfisoxazolec  50 mg/kg/day of erythromycin (max 2 g daily) Oral 3–4 times daily 5–10 days

    aFor children who received amoxicillin in the previous 30 days, who have concurrent conjunctivitis, or for whom coverage

    of resistant organisms is desired.bMay be used in combination with a third-generation cephalosporin.c Avoid in children with allergy to sulfa drugs.

     AOM: acute otitis media; max: maximum. Source: References 1, 11.

    Table 2. Selected AEs Associated With Antibiotics Commonly Used in the Treatment of Pediatric AOM

    Antibiotic AEs

    Penicillins: amoxicillin, amoxicillin-

    clavulanate

    Cross-reactivity between penicillins and cephalosporins, GI upset,

    hepatotoxicity, hypersensitivity reactions

    Cephalosporins: cefdinir, cefpodoxime,

    ceftriaxone,a  cefuroxime

    Cross-reactivity between penicillins and cephalosporins, GI upset,

    hypersensitivity reactions

    Lincosamide: clindamycin   Clostridium difficile  infection, GI upset, hepatotoxicity

    Macrolides:  azithromycin,

    clarithromycin, erythromycin

     Altered cardiac conduction, GI upset, hepatotoxicity, interactions through

    CYP3A4 inhibition

    Sulfonamide: sulfisoxazole  Blood dyscrasias, cross-reactivity with sulfa drugs, GI upset,

    hepatotoxicity, hypersensitivity reactions, photosensitivity

    a AEs also include pain and injection-site reactions.

     AE: adverse effect; AOM: acute otitis media; GI: gastrointestinal. Source: References 1, 11.

     All patients who have been prescribed antibiotics should be monitored for signs and symptoms of improvement including

    a decrease in inflammation and/or pain and return to afebrile status. If the patient has not improved in 48 to 72 hours or 

    if the patient has persistent severe symptoms after initial treatment, it is recommended that the current antibiotic be

    changed. [1,12]  If the patient was initially on amoxicillin, he or she should be switched to amoxicillin-clavulanate or a 3-day

    regimen of ceftriaxone.[1]

    In the first 24 hours, the sole use of antibiotics is unlikely to provide adequate pain relief in patients with AOM. [13]

    Whether or not antibiotics are prescribed, oral analgesics are recommended in the absence of any contraindications. [1]

    The recommended treatment options for mild-to-moderate pain associated with AOM are acetaminophen and ibuprofen,

    which are considered equally efficacious.[14]  In patients experiencing moderate-to-severe pain, opioid analgesics can be

    prescribed for symptom control. Aspirin should be avoided in children with viral illnesses because of an increased risk of 

    Reye syndrome.[1,11]  In addition, topical agents such as benzocaine, lidocaine, and procaine should be avoided in the

    presence of perforated tympanic membrane.[1]

    Prevention

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    The vaccines commonly recommended for preventing pediatric AOM, along with their schedules according to the CDC

     Advisory Committee on Immunization Practices, are listed in .[1,15] Adherence to the influenza and pneumococcal

    vaccine schedules has been shown to decrease the frequency of AOM. [1,15] The use of antibiotics for prophylaxis is not

    recommended in patients with infrequent episodes of AOM. However, children with recurrent AOM may have a small

    benefit with long-term low-dose antibiotic prophylaxis, but clinicians must consider the potential of bacterial resistance,

    cost, and adverse effects.[14] Avoiding passive tobacco exposure is recommended, as it may reduce the incidence of 

     AOM.

    Table 3. Recommended Vaccines for the Prevention of Pediatric AOM

    Vaccine Recommendation Dosage

    Pneumococcal conjugate

    vaccine (PCV13)

    Recommended for all children via IM

    administration

    4 dosesa: 2 months, 4 months, 6

    months, and 12–15 months

    Pneumococcal polysaccharide

    vaccine (PPSV23)

    Recommended for high-risk childrenb only

    via IM administration  1 to 2 doses: 2–18 y

    Inactivated influenza vaccine

    (IIV)

    Recommended for all children via IM

    administration  1 dose annuallyc: ≥6 months

    Live attenuated influenza

    vaccine (LAIV)

    Recommended for healthy children only via

    intranasal administration  1 dose annuallyc: ≥2 y

    aChildren aged 14–59 months who received an age-appropriate series of PCV7 should receive a single supplemental

    dose of PCV13.bHigh-risk children include those with certain underlying medical conditions and those with a cochlear implant.cChildren aged 6 months to 8 years who have never received the influenza vaccine previously or who received only one

    dose during the previous influenza season should receive 2 doses separated by at least 4 weeks. All other children

    should receive 1 dose annually.

     AOM: acute otitis media. Source: References 1, 15.

    Because the greatest reduction in AOM occurrence was seen in patients who were solely breastfed until 6 months of age, breastfeeding is encouraged for at least 4 to 6 months to decrease recurrent episodes of AOM. Finally, avoiding

    supine bottle feeding and reducing pacifier use in children aged ≥6 months can reduce the incidence of AOM. [1]

    The Pharmacist's Role

     AOM is one of the most common diagnoses in which antibiotics are prescribed in children.[2] Within the last 10 years,

    there has been a dramatic decline in the development and approval of new antibiotics. Pharmacists should engage with

    other healthcare professionals to promote the judicious and appropriate use of antibiotics to optimize patients' outcomes

    while balancing the consequences of overtreatment, particularly antimicrobial resistance.[16–18]

    Pharmacists play a vital role in patient education by counseling caregivers on the appropriate use of antibiotics in thetreatment of AOM. In addition, pharmacists are well positioned to provide recommendations regarding nonprescription

    analgesics. Lastly, pharmacists can assist in preventing AOM by serving as immunization advocates, facilitators, and

    administrators, where allowed by law.

    References

    1. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media.

    Pediatrics. 2013;131:e964-e999.

    2. Marom T, Tan A, Wilkinson GS, et al. Trends in otitis media-related health care use in the United States, 2001–

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    2011. JAMA Pediatr . 2014;168:68–75.

    3. Ahmed S, Shapiro NL, Bhattacharyya N. Incremental health care utilization and costs for acute otitis media in

    children. Laryngoscope. 2014;124:301–305.

    4. Alsarraf R, Jung CJ, Perkins J, et al. Measuring the indirect and direct costs of acute otitis media. Arch

    Otolaryngol Head Neck Surg . 1999;125:12–18.

    5. Klein JO. Otitis externa, otitis media, and mastoiditis. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell,

    Douglas, and Bennett's Principles and Practices of Infectious Diseases. 7th ed. Philadelphia, PA: Churchill

    Livingstone Elsevier; 2010:832–834.

    6. Kerschner JE. Otitis media. In: Kliegman RM, Stanton BF, St. Gemell JW, et al. eds. Nelson Textbook of 

    Pediatrics. 19th ed. Philadelphia, PA: Elsevier Saunders; 2011:2199–2205.

    7. Coker TR, Chan LS, Newberry SJ, et al. Diagnosis, microbial epidemiology and antibiotic treatment of acute otitis

    media in children: a systematic review. JAMA. 2010;304:2161–2169.

    8. Segal N, Givon-Lavi N, Leibovit E, et al. Acute otitis media caused by Streptococcus pyogenes  in children. Clin

    Infect Dis. 2005;41:35–41.

    9. Harmes KM, Blackwood A, Burrows HL, et al. Otitis media: diagnosis and treatment.  Am Fam Physician.

    2013;88:435–440.

    10. Rubin MA, Gonzalez R, Sande MA. Pharyngitis, sinusitis, otitis, and other upper respiratory tract infections. In:

    Kasper DL, Fauci AS, eds. Harrison's Infectious Diseases. New York, NY: McGraw-Hill Companies, Inc;

    2010:179–181.

    11. Lexi-Comp Online [online database]. Hudson, OH: Lexi-Comp, Inc; 2014. www.lexi.com. Accessed March 1,

    2014.

    12. CDC. Get smart: pediatric treatment guidelines. www.cdc.gov/getsmart/campaign-materials/pediatric-

    treatment.html. Accessed March 1, 2013.

    13. Marchetti F, Ronfani L, Nibali SC, et al. Delayed prescription may reduce the use of antibiotics for acute otitis

    media: a prospective observation study in primary care. Arch Pediatr Adolesc Med . 2005;159:679–684.

    14. Hoberman A, Pardise JL, Rocketette HE, et al. Treatment of acute otitis media in children under 2 years of age.

    N Engl J Med . 2011;364:105–114.

    15. CDC. Immunization schedules. www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html. Accessed March 5,

    2014.

    16. Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America, theInfectious Diseases Society of America, and the Pediatric Infectious Diseases Society. Infect Control Hosp

    Epidemiol . 2012;33:322–332.

    17. Hersh AL, Jackson MA, Hicks LA; American Academy of Pediatrics Committee on Infectious Diseases. Principles

    of judicious antibiotic prescribing for upper respiratory tract infections in pediatrics. Pediatrics. 2013;132:1146–

    1154.

    18. Vaz LE, Kleinman KP, Raebel MA, et al. Recent trends in outpatient antibiotic use in children. Pediatrics.

    2014;133:375–385.

    http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.htmlhttp://www.cdc.gov/getsmart/campaign-materials/pediatric-treatment.htmlhttp://www.lexi.com/

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