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

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.  

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 because their immune system is immature and their eustachian tubes are shorter and more horizontal than those of adults, leading to accumulation of secretions and infections.5

The American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) released an updated clinical practice guideline in February 2013 for the diagnosis and management of AOM in children aged 6 months to 12 years.1 The purpose of this review is to educate pharmacists on the proper management of pediatric patients presenting with AOM according to the AAP/AAFP guideline.

Risk Factors

Factors that may predispose children to an increased risk of developing AOM include Native American and Inuit ethnicity, low socioeconomic status, exposure to tobacco smoke, exposure to a large group of children in day care, cold weather, family history of recurrent AOM, and congenital anomalies such as cleft palate and Down syndrome.5 Limited evidence suggests pacifier use may also increase the risk of AOM.5 Receiving breast milk instead of formula milk and getting the pneumococcal as well as the annual influenza vaccine are two major factors that have been shown to positively decrease the incidence of AOM.5,6 The earlier in life that children experience their first episode of AOM, the more likely they are to have recurrent infections.5 Additionally, there is a greater incidence and severity of AOM in boys than in girls, and boys are more likely to require interventions to reduce the recurrence of AOM.6


The development of AOM is often initiated by an upper respiratory tract infection that causes congestion, which then leads to swelling of the eustachian tube that subsequently results in an obstruction behind which fluid and bacteria accumulate.5 The movement of infectious respiratory tract secretions and the development of middle ear inflammation contribute to the symptoms of AOM. Bacteria and viruses together account for 66% of cases of AOM; 27% of cases are caused by bacteria alone, and 4% are caused solely by a virus.1 Streptococcus pneumoniae, nontypeable Haemophilus influenzae, and Moraxella catarrhalis are the bacteria most commonly associated with AOM.1

The increased use of the pneumococcal conjugate vaccine (PCV7) has decreased the incidence of AOM caused by S pneumoniae; however, there has been an increase in the incidence of AOM caused by serotypes that are not included in the vaccine.1 ,7 Streptococcus pyogenes is suspected in children >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 associated with 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 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 subsequently 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 <48 hours or intense erythema of the tympanic membrane. Presence of middle ear effusion as evidenced by changes in the tympanic membrane upon otoscopy, such as bulging position, erythema, and/or impaired mobility, is required for a diagnosis of AOM. Uncomplicated AOM is classified as AOM without otorrhea. Severe AOM can be distinguished from mild-to-moderate AOM by the presence of severe ear pain for at least 48 hours or fever >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


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 signs and symptoms with either unilateral or bilateral AOM. Antibiotics are also indicated in patients aged <24 months who are experiencing nonsevere bilateral AOM.1 However, in children aged 6 to 24 months with nonsevere unilateral AOM and 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 or symptoms have worsened, antibiotic therapy is then warranted for these patients.1

TABLE 1 summarizes antibiotic regimens commonly used in the treatment of pediatric AOM, and TABLE 2 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 have used 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

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


The vaccines commonly recommended for preventing pediatric AOM, along with their schedules according to the CDC Advisory Committee on Immunization Practices, are listed in TABLE 3.1,15 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.

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 the treatment 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.  


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12. CDC. Get smart: pediatric treatment guidelines. 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. Accessed March 5, 2014.

16. Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America, the Infectious 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.

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