Pharmacy First: Acute Otitis Media in Children

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,³ and amoxicillin for antibiotic treatment.² These are governed by separate Patient Group Directions (PGDs) with different criteria. This article is based on the NHS England Pharmacy First service specification and NHSBSA Patient Group Directions effective from 1 October 2025.

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.¹ Antibiotics under PGD 7b are reserved for two specific groups.² 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.³

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)
• Registered with a GP or able to access NHS services; valid consent obtained
• Pharmacist is named and authorised under the relevant PGD(s) by their organisation before supplying^2,3

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: outside this pathway. Pregnant individuals aged 16 or 17 with a documented penicillin allergy may be eligible for erythromycin under PGD 7d; apply PGD 7d criteria in full before supply.
• Severe immunosuppression or on immunosuppressant therapy: refer to GP same day.
• Temperature above 39 degrees Celsius: urgent assessment required. Call 999 if sepsis or serious illness features are present; otherwise refer to same-day 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: refer urgently for assessment to exclude trauma, foreign body, severe infection, or other serious pathology.
• Complications suspected (mastoiditis, meningitis, intracranial abscess, sinus thrombosis, facial nerve paralysis): refer to A&E urgently (see red flags).
• Sepsis suspected: call 999.
• Additional exclusions for amoxicillin (PGD 7b): do not supply if the child has chronic kidney disease stage 4 or 5; is on a ketogenic diet; is currently receiving long-term amoxicillin; has already had a failed antibiotic course for this AOM episode (refer to prescriber); is unable to swallow or absorb oral medication; or has a history of severe immediate hypersensitivity to any other beta-lactam antibiotic.²
• Interaction medicines (amoxicillin): allopurinol, methotrexate, probenecid, or oral typhoid vaccine (if taken within 3 days before or after oral typhoid vaccine): amoxicillin cannot be supplied under PGD 7b. Refer to a prescriber.²
• Additional exclusions for Otigo ear drops (PGD 7a): do not supply if the child has G6PD deficiency, a haemoglobinopathy (such as sickle cell disease or thalassaemia), or any other condition associated with risk of methaemoglobinaemia. Note: Otigo contains lidocaine, which may cause a positive anti-doping test.³

How to deliver the service

1. Screen for red flags before assessment Before taking a history, check for complications. Mastoiditis (pain, redness, swelling, or tenderness behind the ear, especially with protrusion of 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. A temperature above 39 degrees Celsius requires urgent assessment: call 999 if sepsis or serious illness features are present; otherwise refer to same-day GP or NHS 111. For children under 5 with fever, apply the NICE traffic-light fever assessment before proceeding.⁶ Do not supply antibiotics or ear drops under this pathway if any red flag applies.
2. Confirm age and check for exclusions The pathway covers children aged 1 year and over and under 18. Children under 1 are outside the Pharmacy First AOM pathway and should be referred for medical assessment, not just to the GP, as severity must be assessed in person. Confirm there is no current recurrent otitis media pattern (3 or more episodes in 6 months or 4 or more in 12 months with at least one in the preceding 6 months), no significant chronic illness (heart, lung, kidney, liver, or neuromuscular disease; cystic fibrosis; prematurity; or other PGD-defined high-risk condition), no cholesteatoma, and no glue ear. Check for persistent or unexplained bloody ear discharge (refer urgently to GP or ENT depending on local pathway). Confirm allergy status before selecting any medicine.
3. 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. Before examining, confirm that the child does not have a grommet or history of myringotomy: either would exclude the use of Otigo ear drops. 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 acute spontaneous tympanic membrane perforation with otorrhoea. A mildly pink or injected membrane alone may not confirm acute otitis media.
4. Apply the three-tier treatment decision Oral analgesia is first-line treatment for all children, regardless of antibiotic eligibility. Work through the tiers in order. Tier 1 (antibiotics):² 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 acute spontaneous tympanic membrane perforation and otorrhoea. Tier 2 (ear drops):³ 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. Do not supply antibiotics solely because symptoms are painful or parents request them.^1,2
5. Counsel, advise on analgesia, and safety net For all presentations: advise regular paracetamol or ibuprofen dosed by weight, not by age alone. Use one agent first; consider alternating only if distress persists before the next dose. Ibuprofen should be avoided in children who are dehydrated, have chickenpox, have significant asthma sensitivity to NSAIDs, or where there is renal risk or clinician concern. Before estimating analgesia dose, check or estimate the child's weight. Explain that most children improve within 3 days without antibiotics and most cases resolve fully within 7 to 10 days.¹ Decongestants and antihistamines are not recommended and do not help.¹ Safety netting: seek medical help if symptoms worsen rapidly or significantly, the child becomes very unwell, or symptoms have not started to improve after 3 days.¹ Advise seeking urgent help immediately if signs of meningitis, facial drooping, or sepsis develop, or if there is any swelling, redness, or tenderness behind the ear. Advise seeking review if hearing loss develops or persists after the infection resolves. If amoxicillin suspension has been supplied: keep in the fridge after reconstitution; use the measuring syringe or spoon provided; discard any remaining suspension after 14 days. Warn about possible side effects including rash, diarrhoea, and signs of allergic reaction; advise seeking urgent medical help for any severe reaction or signs of anaphylaxis. If macrolide supplied under PGD 7c: apply the full PGD exclusion criteria before supply, including QT-prolonging drug interactions and significant hepatic impairment. If Otigo ear drops have been supplied: warm the bottle gently between the hands before instilling drops to reduce dizziness caused by cold drops. Do not insert cotton buds or anything else into the ear canal. Stop the drops and seek medical advice immediately if ear discharge develops, as this may indicate tympanic membrane perforation.³
6. Document and submit the claim Record: patient name, date of birth, NHS number, and address; age confirmed and within pathway criteria; GP practice details or no-GP status; presenting symptoms and duration; otoscopic findings (laterality, tympanic membrane appearance, presence or absence of perforation or otorrhoea); all PGD eligibility criteria and product-specific exclusions checked (PGD 7b and 7a); if referred or excluded: reason for exclusion and referral destination recorded; treatment tier selected and clinical rationale; medicine supplied (name, strength, dose, frequency, duration, quantity, batch number, expiry date); penicillin allergy status confirmed; valid informed consent obtained; oral analgesia advice given (dose by weight); TARGET Treating Your Infection leaflet provided;² safety-netting advice given; consultation outcome (including whether antibiotic was issued or deferred); referral destination and reason if applicable; GP notification or update record completed via PharmOutcomes; pharmacist name and GPhC registration number; date and time of supply. Submit the claim on PharmOutcomes or equivalent approved Pharmacy First IT system contemporaneously.²

Treatment decision by presentation

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.

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.

Amoxicillin Doses (PGD 7b)

Amoxicillin is taken orally three times daily (every 8 hours), with food or water, for 5 days.

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.

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 (where available), and address
  • GP practice details or no-GP status
  • Age confirmed and within pathway criteria
  • Valid informed consent obtained (verbal consent acceptable)
  • Presenting symptoms and duration
  • Otoscopic findings: laterality (unilateral or bilateral), tympanic membrane appearance, presence or absence of perforation or otorrhoea
  • All PGD eligibility criteria confirmed; product-specific exclusions checked for PGD 7b (amoxicillin) and PGD 7a (Otigo) as applicable; reason for any exclusion or referral recorded
  • 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)
  • TARGET Treating Your Infection leaflet provided
  • Safety-netting advice given
  • Consultation outcome (whether antibiotic was issued, ear drops supplied, or watchful waiting advised)
  • GP notification submitted via PharmOutcomes
  • Referral destination and reason, where applicable
  • Pharmacist name and GPhC registration number
  • Date and time of supply

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 acute spontaneous tympanic membrane perforation causing 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. Oral analgesia is first-line for all children regardless of antibiotic eligibility.

Download the checklist