← All articles
Pharmacy Services
Pharmacy First: Acute Otitis Media in Children
How to assess acute otitis media under the NHS Pharmacy First service, when antibiotics are actually indicated, when ear drops are appropriate, and why most children should receive watchful waiting with analgesia.
About this service
Acute otitis media (middle ear infection) is one of the most common reasons parents bring children to community pharmacy. It is also one of the Pharmacy First conditions where antibiotics are most frequently supplied unnecessarily.
The NHS Pharmacy First pathway for acute otitis media covers children aged 1 year and over and young people under 18. It provides access to two treatments: Otigo ear drops (phenazone and lidocaine) for pain relief, and amoxicillin for antibiotic treatment. These are governed by separate Patient Group Directions (PGDs) with different criteria.
The most important clinical principle in this pathway is that most children with acute otitis media do not need antibiotics. Most cases resolve within 3 days without treatment. Antibiotics under PGD 7b are reserved for two specific groups. Every other presentation should be managed with oral analgesia, watchful waiting, and safety netting. The ear drops PGD (7a) provides an additional option for moderate to severe pain not controlled by oral analgesia, where the eardrum is intact.
Otoscopy is required to confirm the diagnosis under both PGDs. Pharmacists must be competent in the use of an otoscope before delivering this service.
Who to offer the service to
Include
- Aged 1 year and over and under 18 years
- Signs and symptoms of acute otitis media confirmed by otoscopic examination (see assessment criteria below)
- NHS eligibility requirements apply
Exclude
- Under 1 year old: outside the Pharmacy First pathway. Refer to GP or NHS 111.
- Aged 18 and over: outside the Pharmacy First pathway.
- Pregnancy under 16: excluded. For pregnant individuals aged 16 or 17, a separate erythromycin PGD (7d) applies.
- Severely immunocompromised: refer to GP same day
- Temperature above 39 degrees Celsius: refer to GP or NHS 111. Do not supply antibiotics or ear drops.
- Recurrent acute otitis media (3 or more separate episodes in the past 6 months, or 4 or more in the past 12 months with at least one in the past 6 months): refer to GP
- High-risk children (significant heart, lung, kidney, liver, or neuromuscular disease; cystic fibrosis; born prematurely): refer to GP
- Cholesteatoma: refer to GP
- Glue ear (otitis media with effusion): outside this pathway. Refer to GP.
- Foreign body in the ear canal: refer to GP
- Bloody or blood-stained ear discharge: possible cancer. Refer urgently to GP.
- Complications suspected (mastoiditis, meningitis, intracranial abscess, sinus thrombosis, facial nerve paralysis): refer to A&E urgently (see red flags)
- Sepsis suspected: call 999
How to deliver the service
- Screen for red flags before assessment Before taking a history, check for complications. Mastoiditis (pain, swelling, or tenderness behind the ear), suspected meningitis (neck stiffness, photophobia, mottled skin), intracranial abscess (severe headache, confusion, muscle weakness), sinus thrombosis (headache behind or around the eye), and facial nerve paralysis (drooping of the face) all require immediate referral to A&E. Sepsis signs require 999. Temperature above 39 degrees Celsius requires referral rather than treatment under this pathway.
- Confirm age and check for exclusions The pathway covers children aged 1 year and over and under 18. Confirm there is no recurrent otitis media, no high-risk co-morbidity, no cholesteatoma, and no glue ear. Check for bloody ear discharge (possible cancer: refer urgently to GP). Confirm allergy status before selecting any medicine.
- Perform otoscopy and confirm the diagnosis Otoscopy is required for both the ear drops and the antibiotic PGD. Clinical symptoms alone (earache, tugging at the ear) are not sufficient. The tympanic membrane must show at least one confirmatory finding: distinctly red, yellow or cloudy colouring; moderate to severe bulging with loss of landmarks; or perforation with discharge. A mildly pink or injected membrane alone may not confirm acute otitis media.
- Apply the three-tier treatment decision Work through the tiers in order. Tier 1 (antibiotics): supply amoxicillin only if the child is under 2 with bilateral AOM and symptoms lasting more than 3 days or severe symptoms, OR any child has AOM with otorrhoea. Tier 2 (ear drops): supply Otigo only if the child has moderate to severe pain not controlled by oral analgesia and the eardrum is intact. Tier 3 (watchful waiting): all other presentations, including unilateral AOM in children aged 2 and over without otorrhoea.
- Counsel, advise on analgesia, and safety net For all presentations: advise regular paracetamol or ibuprofen dosed by weight, not by age alone. Explain that most children improve within 3 days without antibiotics. Decongestants and antihistamines are not recommended and do not help. Safety netting: return if symptoms are not improving within 3 days, if the child becomes more unwell, if ear discharge develops (stop ear drops if in use and seek advice), or if there is any swelling or tenderness behind the ear. Advise seeking urgent help if signs of meningitis, facial drooping, or sepsis develop.
- Document and submit the claim Record: age confirmed, otoscopic findings described, laterality (unilateral or bilateral), presence or absence of otorrhoea, treatment tier selected and rationale, medicine supplied (name, dose, quantity, batch number, expiry date if antibiotic), allergy status confirmed, analgesia advice given, safety netting provided. Submit the claim on PharmOutcomes contemporaneously.
Treatment decision by presentation
| Result | Action | Urgency |
|---|---|---|
| Red flags present | Mastoiditis, meningitis, intracranial abscess, sinus thrombosis, or facial nerve palsy: A&E urgently. Sepsis: call 999. Temperature above 39 degrees Celsius: refer to GP or 111. Do not supply any medicine. | A&E / 999 / GP |
| Under 2 years, bilateral AOM, symptoms more than 3 days or severe | Supply amoxicillin. Children 1-4 years: 250mg three times daily for 5 days. Check penicillin allergy. Use clarithromycin by weight if allergic. | Antibiotics |
| Any age, AOM with otorrhoea | Supply amoxicillin. Children 5-17 years: 500mg three times daily for 5 days. Do not use ear drops. Eardrum is perforated. | Antibiotics |
| Moderate-severe pain, intact eardrum, oral analgesia insufficient | Supply Otigo ear drops: 4 drops up to three times daily, maximum 7 days. Continue oral analgesia alongside. Stop drops and seek advice if ear discharge develops. | Ear drops |
| All other presentations (most children) | Watchful waiting. Paracetamol or ibuprofen by weight. Advise most children improve within 3 days. Safety net and return if not improving. | Self-care |
Step 1: Confirm Acute Otitis Media on Otoscopy
Clinical symptoms alone are not sufficient. Otoscopic examination is required to confirm the diagnosis under both the ear drops and antibiotic PGDs. The tympanic membrane must show at least one of the following findings.
| Otoscopic finding | What to look for | Notes |
|---|---|---|
| Distinctly abnormal tympanic membrane colour | Red, yellow, or cloudy appearance | Normal tympanic membrane is translucent and pearly grey |
| Moderate to severe bulging | Loss of normal landmarks, air-fluid level behind the membrane | Even mild redness without bulging may not confirm AOM |
| Perforation with discharge | Hole in the tympanic membrane with sticky discharge in the canal | Otorrhoea after perforation is itself a criterion for antibiotics |
Step 2: Decide on Treatment (Three-Tier Pathway)
Work through the tiers in order. Most children will fall into Tier 3 (watchful waiting). Antibiotics apply only to the specific groups in Tier 1.
| Tier | Criteria | Action |
|---|---|---|
| Tier 1: Antibiotics (PGD 7b) | Child under 2 years with BILATERAL AOM AND symptoms for more than 3 days OR severe symptoms based on clinical impression | Supply amoxicillin. Check penicillin allergy first. |
| Tier 1: Antibiotics (PGD 7b) | ANY child with AOM AND otorrhoea (ear discharge from a perforated eardrum) | Supply amoxicillin. Do not use ear drops if eardrum is perforated. |
| Tier 2: Ear drops (PGD 7a) | Child 1-17 years with AOM confirmed on otoscopy, moderate to severe pain NOT controlled by regular paracetamol or ibuprofen, and intact eardrum | Supply Otigo ear drops. Do not use if eardrum is perforated. |
| Tier 3: Watchful waiting | All other presentations: unilateral AOM aged 2+, mild to moderate pain controlled by oral analgesia, no otorrhoea | Paracetamol or ibuprofen by weight. Safety net. Review if not improving within 3 days. |
Amoxicillin Doses (PGD 7b)
Amoxicillin is taken orally three times daily (every 8 hours), with food or water, for 5 days.
| Age group | Dose | Notes |
|---|---|---|
| Children aged 1 to 4 years | 250mg three times daily for 5 days | Oral suspension available: 125mg/5mL or 250mg/5mL |
| Children aged 5 to 17 years | 500mg three times daily for 5 days | Capsules or oral suspension. Note: three times daily, not twice. |
| Penicillin allergy | Clarithromycin: dose by weight using BNF for Children | Follow PGD 7c. Weight-based dosing is required for all ages. |
| Pregnant aged 16 or 17 (penicillin allergy) | Erythromycin: follow PGD 7d for dose | A separate erythromycin PGD applies for this group. |
Otigo Ear Drops (PGD 7a)
Otigo (phenazone 40mg/lidocaine 10mg/g) ear drops provide topical pain relief. They are not antibiotics and do not treat infection.
| Detail | Information | Notes |
|---|---|---|
| Dose | 4 drops into the affected ear(s), up to three times daily | Warm the bottle between hands before each use |
| Duration | Until symptoms resolve, maximum 7 days | Stop and seek advice if ear discharge develops during treatment |
| Key exclusion | Must NOT be used if the eardrum is perforated (including otorrhoea, grommet, or myringotomy) | Perforated eardrum = refer to antibiotic PGD or GP |
| Mild symptoms | Do not supply if symptoms are mild and oral analgesia is adequate | Advise return in 3 to 5 days if no improvement |
Recording and submission
- Complete the consultation record contemporaneously on PharmOutcomes. All Pharmacy First otitis media consultations require a record, including those managed with watchful waiting only.
- Key information to record:
- Patient name, date of birth, NHS number
- Age confirmed and within pathway criteria
- Presenting symptoms and duration
- Otoscopic findings: laterality (unilateral or bilateral), tympanic membrane appearance, presence or absence of perforation or otorrhoea
- Eligibility criteria confirmed and exclusions checked (recurrent AOM, temperature, high-risk co-morbidities)
- Treatment tier selected and clinical rationale
- Medicine supplied: name, strength, dose, frequency, duration, quantity, batch number, expiry date
- Penicillin allergy status confirmed
- Oral analgesia advice given (dose by weight)
- Safety-netting advice given
- Referral made if applicable
⚠ Common service pitfalls
- Supplying antibiotics for unilateral AOM in a child aged 2 or over without otorrhoea. This is the most common error in this pathway. A child aged 2 or over with unilateral AOM and an intact eardrum does not meet the PGD criteria for amoxicillin. Watchful waiting is the correct approach.
- Diagnosing acute otitis media without otoscopy. Clinical symptoms alone (earache, tugging at the ear, crying) are not sufficient. Otoscopy is required to confirm the diagnosis and to check for perforation before supplying ear drops.
- Using ear drops when the eardrum is perforated. Otigo ear drops must not be instilled into an ear with a perforated tympanic membrane. Otorrhoea (ear discharge) is a sign of perforation. If the eardrum is perforated, the ear drops are excluded and the antibiotic pathway applies.
- Getting the amoxicillin frequency wrong. The dose for AOM is three times daily (every 8 hours), not twice daily. Children aged 1-4 years: 250mg three times daily. Children aged 5-17 years: 500mg three times daily.
- Supplying antibiotics for a child with a temperature above 39 degrees Celsius. This is an exclusion criterion under both PGDs. Refer rather than treat.
- Not checking for mastoiditis. Tenderness, swelling, or redness over the mastoid bone behind the ear is a serious complication requiring urgent referral to A&E. It can be missed if the examination focuses only on the ear canal.
- Recommending decongestants or antihistamines. The Pharmacy First PGD explicitly states these do not help with acute otitis media and are not recommended.
- Advising analgesia by age rather than by weight. Paracetamol and ibuprofen doses for children should be based on weight, not age alone. Dose by age can significantly under-dose a heavier child.
- Not recognising glue ear. Otitis media with effusion (glue ear) presents differently from acute otitis media, typically with hearing loss rather than acute pain, and with a retracted or dull membrane rather than a bulging or cloudy one. Glue ear is outside this pathway. Refer to GP.
Key takeaways
- Antibiotics are only indicated for two specific groups: children under 2 with bilateral AOM and symptoms lasting more than 3 days or severe symptoms, and any child with AOM and otorrhoea. All other presentations require watchful waiting with oral analgesia.
- Otoscopy is required to confirm the diagnosis under both PGDs, and to check whether the eardrum is perforated before using ear drops. Ear drops must not be used if there is a perforation.
- Amoxicillin for AOM is dosed three times daily (not twice): 250mg TDS for ages 1-4 years and 500mg TDS for ages 5-17 years, both for 5 days.
Download the checklist
Professional disclaimer: This article is for educational purposes
to support healthcare professionals' clinical decision-making. It does not replace
independent professional judgement, local pathways, NICE guidance, or standard
medical literature. Members of the public must not use this resource for
self-diagnosis and should seek prompt advice from a qualified healthcare
professional if experiencing chest pain, palpitations, fainting, or breathlessness.