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
- Individuals operating under this PGD must be assessed as competent or complete a self-declaration of competence to operate under this PGD (see an example authorisation record sheet in Appendix A) [Pharmacy First PGD master authorisation sheet]
- Individuals operating under this PGD are advised to review their competency using the NICE Competency Framework for health professionals using patient group directions.
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.
Hydrogen peroxide 1% cream
Clinical condition or situation to which this PGD applies
Localised non-bullous impetigo in children over 1 year and adults who are systemically well and not at high risk of complications.
Criteria for inclusion
- Informed consent
- Individuals aged 1 year and over
- Signs and symptoms of impetigo using the appropriate diagnostic (NICE CKS) guidance.
- Localised (3 or fewer lesions/clusters present) non-bullous impetigo
Criteria for exclusion
- Consent refused and documented in the individual’s clinical notes
- Individuals under 1 year of age
- Pregnancy or suspected pregnancy in individuals under 16 years of age
- Currently breastfeeding with impetigo lesion(s) present on the breast (see Cautions for advice when treating impetigo lesion(s) not on the breast(s) in breastfeeding individuals)
- Severely immunosuppressed individuals as defined in Chapter 28a Green book):
- 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)
- 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)
- 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 with primary or acquired immunodeficiency states due to conditions including:
Individuals on immunosuppressive or immunomodulating therapy including:
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.Individuals with chronic immune mediated inflammatory disease who are receiving or have received immunosuppressive therapy
- 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 hydrogen peroxide or any of the components within the formulation – see Summary of Product Characteristics Acceptable sources of allergy information include individual/carer or National Care Record.
- Failed previous topical or oral treatment (including antimicrobials) for this episode of impetigo
- Recurrent impetigo (defined as 2 or more episodes in the same year)
- Currently active underlying skin condition (e.g. currently uncontrolled episode of eczema (atopic dermatitis) or contact dermatitis, or current episode of scabies, chickenpox or eczema herpeticum)
- Any open wounds affecting the application area or the immediate vicinity
- Widespread (4 or more lesions/clusters present) non-bullous impetigo
- Bullous impetigo (characterised by flaccid fluid-filled vesicles and blisters (often with a diameter of 1-2cm) which can persist for 2-3 days. Lesions rupture, leaving a thin, flat, yellow-brown crust).
- Systemically unwell
- Signs/symptoms of a more serious condition/illness (e.g., swelling, large blisters, pain, pus or spreading redness)
- Any individual identified with symptoms of severe/life-threatening infection or systemic sepsis: refer urgently via ambulance
- Impetigo near the eyes: hydrogen peroxide can be irritant
- Individuals using topical iodine, permanganates or other strong oxidising agents.
Cautions including any relevant action to be taken
- Breastfeeding individuals: avoid direct contact between infant and impetigo lesion(s). Wash hands after applying hydrogen peroxide 1% cream and before touching the infant.
- Hydrogen peroxide cream can be irritant. A mild sensation of burning may be experienced for a short time after application and this is normal.
Specific information for suspected infection to be provided
- Provide information on impetigo (British Association of Dermatologists)
- Provide information on impetigo (NHS)
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 individual/carer/parent/guardian with information on impetigo and safety netting advice.
- Advise individual/carer/parent guardian to seek medical advice if:
- Symptoms worsen rapidly or
- Symptoms worsen significantly
Refer to a local health protection team (or a consultant in Communicable Disease Control) for further assessment if:
- Suspect a significant local outbreak (e.g. in a nursing home, crèche, school etc.)
Refer urgently to a prescriber for further assessment if:
- Bullous impetigo (characterised by flaccid fluid-filled vesicles and blisters (often with a diameter of 1-2cm) which can persist for 2-3 days. Lesions rupture, leaving a thin, flat, yellow-brown crust)
- Individual is systemically unwell, but not showing signs or symptoms of sepsis
- Individuals considered to be clinically at high risk of complications (e.g. severely immunosuppressed or immunosuppressed and infection is localised)
- Recurrent impetigo (defined as 2 or more episodes in the same year)
- Individuals where treatment under this protocol is not indicated/permitted but dermatological symptoms are present and require further assessment
Refer urgently to A&E for further assessment if:
- Individual is severely immunosuppressed or immunosuppressed and infection is widespread
- Signs/symptoms of a more serious condition/illness (e.g, swelling, large blisters, pain, pus or spreading redness) are present and complications of impetigo (e.g. cellulitis, Staphylococcal scalded skin syndrome, or other deep soft tissue infection) are suspected.
If sepsis is suspected refer the individual urgently to A&E
Action to be taken if individual/carer/ parent/guardian declines treatment
- Document advice given.
- Provide safety netting advice and advise individual/carer/parent/guardian on alternative treatment available using information on impetigo.
- Refer to a prescriber if appropriate.
Arrangements for referral for medical advice
- Refer to the appropriate medical practitioner in the care pathway
Exclusions & Additional Prescribing Details Links
- Criteria for exclusion
- Cautions including any relevant action to be taken
- Specific information for suspected infection to be provided
- Action to be taken if the individual is excluded
- Action to be taken if the individual/carer/parent/guardian declines treatment
- Arrangements for referral for medical advice: Refer to the appropriate medical practitioner in the care pathway
Description of treatment
- Name, strength & formulation of drug
- Hydrogen peroxide 1% (10mg/1g) cream (e.g. Crystacide® 1% cream)
- Legal category
- P
- Route / method of administration
- Topical (cutaneous application) to the affected area(s) of the skin.
- Dose and frequency of administration
- Children 1 year and over and adults:
- Apply a thin layer to the affected area(s) up to 3 times a day
- Use enough of the cream to cover the lesion(s) with a thin layer of cream.
- A dry film will appear on the skin after each application, this can be washed off with water. Hands should be washed after this also.
- Duration of treatment
- 5 days
- Treatment should be started immediately and 5 days of treatment completed.
- Quantity to be supplied
- Storage
- Drug interactions
- Identification & management of adverse reactions
- Management of and reporting procedure for adverse reactions
- Written information to be given to individual/carer/parent/guardian
- Individual advice / follow up treatment
- Records
Fusidic acid 2% cream
Clinical condition or situation to which this PGD applies
Localised non-bullous impetigo in children over 1 year and adults who are systemically well and not at high risk of complications.
Criteria for inclusion
- Informed consent
- Individuals aged 1 year and over
- Signs and symptoms of impetigo using the appropriate diagnostic (NICE CKS) guidance.
- Localised (3 or fewer lesions/clusters present) non-bullous impetigo
- AND Hydrogen peroxide 1% cream is:
- Unsuitable (e.g., impetigo around the eye(s)) OR
- Ineffective (and impetigo remains localised)
Exclusions & Additional Prescribing Details Links
- Criteria for exclusion
- Cautions including any relevant action to be taken
- Specific information for suspected infection to be provided
- Action to be taken if the individual is excluded
- Action to be taken if the individual/carer/parent/guardian declines treatment
- Arrangements for referral for medical advice: Refer to the appropriate medical practitioner in the care pathway
Description of treatment
- Name, strength & formulation of drug
- Fusidic acid 20mg/g (2%) cream
- Legal category
- POM
- Route / method of administration
- Topical (cutaneous application) to the affected area(s) of the skin.
- Off-label use
- Dose and frequency of administration
- Children 1 year and over and adults:
- Apply a thin layer to the affected area(s) three times daily.
- Use enough of the cream to cover the lesion(s) with a thin layer of cream.
- Duration of treatment
- 5 days
- Treatment should be started immediately and 5 days of treatment completed.
- Quantity to be supplied
- Storage
- Drug interactions
- Identification & management of adverse reactions
- Management of and reporting procedure for adverse reactions
- Written information to be given to individual/carer/parent/guardian
- Individual advice / follow up treatment
- Records
Flucloxacillin
Clinical condition or situation to which this PGD applies
Widespread non-bullous impetigo in children aged 1 year and over and adults who are systemically well and not at high risk of complications.
Criteria for inclusion
- Informed consent
- Individuals aged 1 year and over
- Signs and symptoms of impetigo using the appropriate diagnostic (NICE CKS) guidance.
- Widespread (4 or more lesions/clusters present) non-bullous impetigo.
Exclusions & Additional Prescribing Details Links
- Criteria for exclusion
- Cautions including any relevant action to be taken
- Specific information for suspected infection to be provided
- Action to be taken if the individual is excluded
- Action to be taken if the individual/carer/parent/guardian declines treatment
- Arrangements for referral for medical advice: Refer to the appropriate medical practitioner in the care pathway
Description of treatment
- Name, strength & formulation of drug
- Flucloxacillin 250mg capsules
- Flucloxacillin 500mg capsules
- Flucloxacillin 125mg/5mL oral solution (or oral suspension) x 100mL
- Flucloxacillin 125mg/5mL sugar free oral solution (or oral suspension) x 100mL
- Flucloxacillin 250mg/5mL oral solution (or oral suspension) x 100mL
- Flucloxacillin 250mg/5mL sugar free oral solution (or oral suspension) x 100mL
- Legal category
- POM
- Route / method of administration
- Orally 1 hour before or 2 hours after food. Capsules should be swallowed whole.
- Note: Flucloxacillin sugar free oral solution (or oral suspension) may have a poor taste potentially leading to reduced compliance. After discussion with individual/carer/parent/guardian consider sugar containing preparation.
- Children should be encouraged (where possible) to swallow solid oral dose forms (i.e. tablets or capsules):
- Medicines for Children: has useful guides on how to give medicines, including giving tablets and giving capsules.
- KidzMed is an eLfH resource for healthcare professionals teaching children to swallow pills.
- Off-label use
- Dose and frequency of administration
- Children aged 1 and over and under 2 years of age:
- 125 mg four times a day
- Children 2–9 years:
- 250 mg four times a day
- Children 10–17 years and adults:
- 500 mg four times a day
- Children aged 1 and over and under 2 years of age:
- Duration of treatment
- 5 days
- Treatment should be started immediately and 5 days of treatment completed.
- Quantity to be supplied
- Storage
- Drug interactions
- Identification & management of adverse reactions
- Management of and reporting procedure for adverse reactions
- Written information to be given to individual/carer/parent/guardian
- Individual advice / follow up treatment
- Records
Clarithromycin
Clinical condition or situation to which this PGD applies
Widespread non-bullous impetigo in children aged 1 year and over and adults, where flucloxacillin is not appropriate due to hypersensitivity.
Criteria for inclusion
- Informed consent
- Individuals aged 1 year and over
- Signs and symptoms of impetigo using the appropriate diagnostic (NICE CKS) guidance.
- Widespread (4 or more lesions/clusters present) non-bullous impetigo.
- Known hypersensitivity to flucloxacillin, any penicillin or any of the components within the formulation of flucloxacillin formulations – 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
- Criteria for exclusion
- Cautions including any relevant action to be taken
- Specific information for suspected infection to be provided
- Action to be taken if the individual is excluded
- Action to be taken if the individual/carer/parent/guardian declines treatment
- Arrangements for referral for medical advice: Refer to the appropriate medical practitioner in the care pathway
Description of treatment
- Name, strength & formulation of drug
- Clarithromycin 250mg tablets
- Clarithromycin 125mg/5mL oral suspension (or oral solution) x 70mL
- Clarithromycin 250mg/5mL oral suspension (or oral solution) x 70mL
- Legal category
- POM
- Route / method of administration
- Orally, tablets swallowed whole with water (taken with or without food).
- Note: Clarithromycin oral suspension (or oral solution) can cause a bitter after-taste. This can be avoided by drinking juice or water soon after intake of the oral suspension (or oral solution).
- Off-label use
- Dose and frequency of administration
- Children 1–11 years:
Body-weight:- up to 8 kg: 7.5 mg/kg twice daily (every 12 hours)
- 8–11 kg: 62.5 mg twice daily (every 12 hours)
- 12–19 kg: 125 mg twice daily (every 12 hours)
- 20–29 kg: 187.5 mg twice daily (every 12 hours)
- 30–40 kg: 250 mg twice daily (every 12 hours)
- Children 12–17 years and adults:
- 250mg twice daily (every 12 hours)
- Children 1–11 years:
- Duration of treatment
- 5 days
- Treatment should be started immediately and 5 days of treatment completed.
- Quantity to be supplied
- Storage
- Drug interactions
- Identification & management of adverse reactions
- Management of and reporting procedure for adverse reactions
- Additional facilities and supplies
- Written information to be given to individual/carer/parent/guardian
- Individual advice / follow up treatment
- Records
Erythromycin
Clinical condition or situation to which this PGD applies
Widespread non-bullous impetigo in young people and adults aged 16 years and over who are pregnant, or where pregnancy is suspected and where flucloxacillin is not appropriate due to hypersensitivity.
Criteria for inclusion
- Informed consent
- Individuals aged 16 years and over
- Signs and symptoms of impetigo using the appropriate diagnostic (NICE CKS) guidance.
- Widespread (4 or more lesions/clusters present) non-bullous impetigo.
- Known hypersensitivity to flucloxacillin, any penicillin or any of the components within the formulation of flucloxacillin formulations – 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
- Criteria for exclusion
- Cautions including any relevant action to be taken
- Specific information for suspected infection to be provided
- Action to be taken if the individual is excluded
- Action to be taken if the individual/carer/parent/guardian declines treatment
- Arrangements for referral for medical advice: Refer to the appropriate medical practitioner in the care pathway
Description of treatment
- Name, strength & formulation of drug
- Erythromycin 250mg tablets
- Erythromycin 250mg gastro-resistant tablets
- Erythromycin 500mg tablets
- Erythromycin 125mg/5mL oral suspension (or oral solution) x 100mL
- Erythromycin 125mg/5mL sugar free oral suspension (or oral solution) x 100mL
- Erythromycin 250mg/5mL oral suspension (or oral solution) x 100mL
- Erythromycin 250mg/5mL sugar free oral suspension (or oral solution) x 100mL
- Erythromycin 500mg/5mL oral suspension (or oral solution) x 100mL
- Erythromycin 500mg/5mL sugar free oral suspension (or oral solution) x 100mL
- Legal category
- POM
- Route / method of administration
- Orally, with water (just before or with food).
- Tablets should be swallowed whole.
- Off-label use
- Dose and frequency of administration
- Young people and adults aged 16 years and over:
- 500mg four times daily
- Young people and adults aged 16 years and over:
- Duration of treatment
- 5 days
- Treatment should be started immediately and 5 days of treatment completed.
- Quantity to be supplied
- Storage
- Drug interactions
- Identification & management of adverse reactions
- Management of and reporting procedure for adverse reactions
- Written information to be given to individual/carer/parent/guardian
- Individual advice / follow up treatment
- Records
Individual advice / follow up treatment
The following SHORTENED VERSION is to allow simpler pathway intergration and the information is common to all PGDs, please check the individual PGD each time from the links above.
- Explain the dose, frequency and method of administration.
- The individual/carer/parent/guardian should be advised to read PIL.
- Advise individual/carer/parent/guardian to seek medical advice if symptoms worsen rapidly or significantly at any time.
- Advise individual/carer/parent/guardian to seek immediate medical attention (by calling 999 or going to A&E) if the individual develops signs or symptoms of sepsis.
- The individual/carer/parent/guardian should be advised to seek medical advice in the event of an adverse reaction or if any other new symptoms develop.
- Individual/carer/parent/guardian should be advised of the following:
- Impetigo is contagious and transmission occurs directly through close contact with an infected individual or indirectly via contaminated objects (e.g. toys, clothing, or towels).
- Individuals, and if appropriate their family and carers/guardians, should be advised on good hygiene measures to reduce the spread of impetigo to other body areas and to other people.
- To help stop impetigo spreading or getting worse (while it’s still contagious), the following advice can be given to affected people:
- Stay away from school or work (inform school or nursery of infection) until the individual is no longer contagious. Individuals are no longer contagious 48 hours after treatment has started OR when the lesions are healed, dry and crusted if no treatment is provided.
- Food handlers are required by law to inform employers immediately if they have impetigo
- Wash hands with soap and warm water before and after applying the cream
- Wash flannels, sheets and towels at a high temperature
- Wash or wipe down toys with detergent and warm water.