NHSE Acute otitis media PGDs
Characteristics of staff
Qualifications and professional registration
  • Registered healthcare professional listed in the legislation as able to practice under Patient Group Directions.
Initial training
  • The registered healthcare professional authorised to operate under this PGD must have undertaken appropriate education and training and be competent to undertake clinical assessment of patients ensuring safe provision of the medicines listed in accordance with the specification.
  • To deliver this service, the registered healthcare professional should have evidence of competence in the clinical skills and knowledge covered in the Centre for Pharmacy Postgraduate Education (CPPE) Pharmacy First Service self-assessment framework.
  • Before commencement of the service, the pharmacy contractor must ensure that pharmacists and pharmacy staff providing the service are competent to do so and be familiar with the clinical pathways, clinical protocol and PGDs. This may involve completion of training
Competency assessment
Ongoing training and competency
  • Individuals operating under this PGD are personally responsible for ensuring they remain up to date with the use of all medicines and guidance included in the PGD – if any training needs are identified these should be discussed with the senior individual responsible for authorising individuals to act under the PGD and further training provided as required.

The decision to supply any medication rests with the individual registered health professional who must abide by the PGD and any associated organisational policies.

Otigo®
Clinical condition or situation to which this PGD applies

Local symptomatic relief of pain from acute otitis media (AOM) in children aged 1 year and over and young people (under 18 years of age).

Criteria for inclusion
  • Informed consent
  • Individuals aged 1 year and over and under 18 years of age
  • Signs and symptoms of acute otitis media using the appropriate NICE CKS guidance:
    • In older children: earache
    • In younger children: holding, tugging or rubbing of the ear(s) (also non-specific symptoms: fever, crying, poor feeding, restlessness, behavioural changes, cough or rhinorrhoea may also be present)
    AND (on otoscopic examination):
    • Distinctly red, yellow or cloudy tympanic membrane OR
    • Moderate-severe bulging of the tympanic membrane, with loss of normal landmarks and an air-fluid level behind the tympanic membrane.
  • Pain not adequately controlled with regular doses of (over the counter) paracetamol or ibuprofen, using a dosing schedule appropriate for the age and weight of the child. (For further information see: Mild to moderate pain and NSAIDs-prescribing issues).
  • Individuals with moderate – severe symptoms.
Criteria for exclusion
  • Consent refused and documented in the individual’s clinical notes
  • Individuals under 1 year of age or over 18 years of age
  • Pregnancy or suspected pregnancy in individuals under 16 years of age
  • Severely immunosuppressed individuals as defined in Chapter 28a Green book):
      Individuals with primary or acquired immunodeficiency states due to conditions including:
      • acute and chronic leukaemias, and clinically aggressive lymphomas (including Hodgkin’s lymphoma) who are less than 12 months since achieving cure
      • individuals under follow up for a chronic lymphoproliferative disorders including haematological malignancies such as indolent lymphoma, chronic lymphoid leukaemia, myeloma, Waldenstrom’s macroglobulinemia and other plasma cell dyscrasias (N.B: this list not exhaustive)
      • immunosuppression due to HIV/AIDS with a current CD4 count of below 200 cells/μl.
      • primary or acquired cellular and combined immune deficiencies – those with lymphopaenia (<1,000 lymphocytes/ul) or with a functional lymphocyte disorder
      • those who have received an allogeneic (cells from a donor) or an autologous (using their own cells) stem cell transplant in the previous 24 months
      • those who have received a stem cell transplant more than 24 months ago but have ongoing immunosuppression or graft versus host disease (GVHD)
      Individuals on immunosuppressive or immunomodulating therapy including:
      • those who are receiving or have received in the past 6 months immunosuppressive chemotherapy or radiotherapy for any indication
      • those who are receiving or have received in the previous 6 months immunosuppressive therapy for a solid organ transplant
      • those who are receiving or have received in the previous 3 months targeted therapy for autoimmune disease, such as JAK inhibitors or biologic immune modulators including B-cell targeted therapies (including rituximab but for which a 6 month period should be considered immunosuppressive), monoclonal tumor necrosis factor inhibitors (TNFi), T-cell co-stimulation modulators, soluble TNF receptors, interleukin (IL)-6 receptor inhibitors, IL-17 inhibitors, IL 12/23 inhibitors, IL 23 inhibitors (N.B: this list is not exhaustive)
      Individuals with chronic immune mediated inflammatory disease who are receiving or have received immunosuppressive therapy
      • moderate to high dose corticosteroids (equivalent ≥20mg prednisolone per day) for more than 10 days in the previous month
      • long term moderate dose corticosteroids (equivalent to ≥10mg prednisolone per day for more than 4 weeks) in the previous 3 months
      • any non-biological oral immune modulating drugs e.g. methotrexate >20mg per week (oral and subcutaneous), azathioprine >3.0mg/kg/day; 6-mercaptopurine >1.5mg/kg/day, mycophenolate >1g/day) in the previous 3 months
      • certain combination therapies at individual doses lower than stated above, including those on ≥7.5mg prednisolone per day in combination with other immunosuppressants (other than hydroxychloroquine or sulfasalazine) and those receiving methotrexate (any dose) with leflunomide in the previous 3 months
      Individuals who have received a short course of high dose steroids (equivalent >40mg prednisolone per day for more than a week) for any reason in the previous month.
  • Immunosuppressed individuals: individuals who are immunosuppressed or are currently taking immunosuppressants (including systemic corticosteroids*) or immune modulators, but who do not meet the definition of severe immunosuppression (see above). [For equivalent doses in children, see Chapter 6 Green Book]
    * does not include:
    • replacement corticosteroids for individuals with adrenal insufficiency
    • corticosteroid inhalers or corticosteroids applied topically (e.g. to the skin, ears, eyes, nasal cavity)
    • intra-articular, -bursal or -tendon corticosteroid injections.
  • Hypersensitivity to the active substances or to any of the excipients within the formulation (see Summary of Product Characteristics for further details). Acceptable sources of allergy information include individual/carer or National Care Record.
  • Individuals with mild symptoms: Ask the individual to return to Community Pharmacy within 3-5 days if no improvement for pharmacist reassessment.
  • Known perforation (infectious or traumatic) of the tympanic membrane (i.e. perforated or “burst” eardrum) (including otorrhea, myringotomy, presence of a grommet or other ventilation tube) of the affected ear(s)
  • Individuals with evidence of, or suspected, foreign body in the ear canal of the affected ear(s)
  • Individuals with recurrent infection – defined as three or more documented and separate acute otitis media episodes (with an absence of middle ear disease between episodes) in the preceding 6 months, or four or more episodes in the preceding 12 months with at least one episode in the past 6 months
  • Individual is at high risk of complications due to pre-existing co morbidity (e.g. children with significant heart, lung, kidney, liver or neuromuscular disease, severe immunosuppression or immunosuppression, cystic fibrosis and young children who were born prematurely)
  • Individuals most likely to benefit from an oral antibiotic (see separate PGDs):
    • Individuals under 18 years of age with acute otitis media and otorrhea (ear discharge after tympanic membrane perforation)
    • Individuals under 2 years of age with bilateral (in both ears) acute otitis media.
  • Otitis Media with visible effusion (glue ear)
  • Individuals with a temperature over 39°C.
  • Individuals with suspected meningitis (neck stiffness, photophobia, mottled skin)
  • Individuals with suspected mastoiditis (pain, soreness, swelling, tenderness behind the affected ear(s))
  • Individuals with suspected intracranial (brain) abscess (severe headache, confusion or irritability, muscle weakness)
  • Individuals with suspected sinus thrombosis (headache behind or around the eye(s))
  • Individuals with facial nerve paralysis (drooping of the face)
  • Individuals with cholesteatoma
  • Any individual identified with symptoms of severe/life-threatening infection or systemic sepsis: refer urgently via ambulance
  • Possible cancer:
    • Bloody/blood stained discharge from ear(s)
  • Individuals with haemoglobinopathies or Glucose-6-phosphate dehydrogenase (G6PD) deficiency (or other risk factors for methemoglobinaemia).
Cautions including any relevant action to be taken
  • Individuals who are subject to anti-doping tests should be advised against using Otigo® as this medicinal product contains an active substance which may give positive results in anti-doping tests.
Specific information for suspected infection to be provided
Action to be taken if the individual is excluded
  • Record reasons for exclusion in the appropriate clinical record.

Individuals where treatment is not indicated:

  • Provide TARGET RTI leaflet (TARGET RTI leaflets in other languages are also available).
  • Provide self-care advice including:
    • Advise regular doses of paracetamol or ibuprofen (over the counter and where appropriate) for pain, using a dosing schedule appropriate for the age and weight of the child. (For further information see: Mild to moderate pain and NSAIDs-prescribing issues).
    • Explain that evidence suggests decongestants and antihistamines (over the counter) do not help with symptoms.
  • Advise individual/carer/parent/guardian to seek medical advice if symptoms worsen rapidly or significantly or the individual becomes systemically very unwell.

Refer urgently to a prescriber for further assessment if:

  • Individual is systemically unwell, but not showing signs or symptoms of sepsis
  • Individual has signs of a more serious illness
  • Individual is at high risk of complications due to pre-existing co morbidity (e.g. children with significant heart, lung, kidney, liver or neuromuscular disease, severe immunosuppression or immunosuppression, cystic fibrosis and young children who were born prematurely)
  • Possible cancer suspected:
    • Bloody/blood stained discharge from ear(s)
  • Individuals where treatment under this PGD is not indicated/permitted but upper respiratory symptoms are present and require further assessment.

Refer urgently to A&E for further assessment if:

If sepsis is suspected refer the individual urgently to A&E

For children: see Healthier Together guidance (otitis media (earache)) for further information on appropriate signposting and information sheets.

Action to be taken if individual/carer//guardian declines treatment
Arrangements for referral for medical advice
  • Refer to the appropriate medical practitioner in the care pathway
Description of treatment
Amoxicillin
Clinical condition or situation to which this PGD applies

Acute otitis media in children aged 1 year and over and young people (under 18 years of age)

Criteria for inclusion
  • Informed consent
  • Individuals aged 1 year and over and under 18 years of age:
    • Individuals under 2 years of age with bilateral (in both ears) acute otitis media AND
      • Symptoms for > 3 days OR
      • Severe symptoms based on clinical global impression
    OR
    • Individuals under 18 years of age with acute otitis media and otorrhea (discharge after eardrum perforation)
  • Signs and symptoms of acute otitis media using the appropriate NICE CKS guidance:
    • In older children: earache
    • In younger children: holding, tugging or rubbing of the ear(s) (also non-specific symptoms: fever, crying, poor feeding, restlessness, behavioural changes, cough or rhinorrhoea may also be present)
    AND (on otoscopic examination):
    • Distinctly red, yellow or cloudy tympanic membrane OR
    • Moderate-severe bulging of the tympanic membrane, with loss of normal landmarks and an air-fluid level behind the tympanic membrane.
    • Perforation of the tympanic membrane and/or sticky discharge in the external auditory canal.
Exclusions & Additional Prescribing Details Links
Description of treatment
Clarithromycin
Clinical condition or situation to which this PGD applies

Acute otitis media in children aged 1 year and over and young people (under 18 years of age), where amoxicillin is not appropriate due to hypersensitivity.

Criteria for inclusion
  • Informed consent
  • Individuals aged 1 year and over and under 18 years of age:
    • Individuals under 2 years of age with bilateral (in both ears) acute otitis media AND
      • Symptoms for > 3 days OR
      • Severe symptoms based on clinical global impression
    OR
    • Individuals under 18 years of age with acute otitis media and otorrhea (discharge after eardrum perforation)
  • Signs and symptoms of acute otitis media using the appropriate NICE CKS guidance:
    • In older children: earache
    • In younger children: holding, tugging or rubbing of the ear(s) (also non-specific symptoms: fever, crying, poor feeding, restlessness, behavioural changes, cough or rhinorrhoea may also be present)
    AND (on otoscopic examination):
    • Distinctly red, yellow or cloudy tympanic membrane OR
    • Moderate-severe bulging of the tympanic membrane, with loss of normal landmarks and an air-fluid level behind the tympanic membrane.
    • Perforation of the tympanic membrane and/or sticky discharge in the external auditory canal.
  • Known hypersensitivity to amoxicillin, any penicillin or any of the components within the formulation of amoxicillin – see Summary of Product Characteristics. Acceptable sources of allergy information include individual/carer/parent/guardian or National Care Record.
    OR
  • History of severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam antibiotic (e.g. cephalosporin, carbapenem or monobactam). Acceptable sources of allergy information include individual/carer/parent/guardian or National Care Record.
Exclusions & Additional Prescribing Details Links
Description of treatment
Erythromycin
Clinical condition or situation to which this PGD applies

Acute otitis media in young people aged 16 or 17 years of age who are pregnant or where pregnancy is suspected and where amoxicillin is not appropriate due to hypersensitivity.

Criteria for inclusion
  • Informed consent
  • Individuals aged 16 or 17 years of age with acute otitis media and otorrhea (discharge after eardrum perforation)
  • Signs and symptoms of acute otitis media using the appropriate NICE CKS guidance:
    • In older children: earache
    AND (on otoscopic examination):
    • Perforation of the tympanic membrane and/or sticky discharge in the external auditory canal.
  • Pregnancy or suspected pregnancy
  • Known hypersensitivity to amoxicillin, any penicillin or any of the components within the formulation of amoxicillin – see Summary of Product Characteristics. Acceptable sources of allergy information include individual/carer/parent/guardian or National Care Record.
    OR
  • History of severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam antibiotic (e.g. cephalosporin, carbapenem or monobactam). Acceptable sources of allergy information include individual/carer/parent/guardian or National Care Record.
Exclusions & Additional Prescribing Details Links
Description of treatment
Key references

Key references

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