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.
Flucloxacillin
Clinical condition or situation to which this PGD applies
Infected insect bite(s) and sting(s) in children aged 1 year and over and adults.
Criteria for inclusion
- Informed consent
- Individuals aged 1 year and over
- Diagnosis of infected insect bite or sting using the appropriate diagnostic (NICE CKS) guidance.
- Clear evidence of infection that is present or worsening at least 48 hours after the initial bite(s) or sting(s) with 3 or more of the following symptoms:
- Redness of the skin (erythema may be more difficult to distinguish on darker skin tones)
- Pain or tenderness to the area
- Swelling of the skin
- Skin surrounding the bite(s) or sting(s) feels hot to touch
AND any of the following: - Redness or swelling of the skin surrounding the bite(s) or sting(s) is spreading
- Evidence of pustular discharge at site of bite(s) or sting(s)
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
- 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
- Known hypersensitivity to flucloxacillin, any penicillin or any of the components within the formulation of flucloxacillin – see Summary of Product Characteristics Acceptable sources of allergy information include individual/carer 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 or National Care Record.
- Inability to absorb oral medications and/or inability to swallow oral dosage formulations (i.e. capsules or oral solution (or oral suspension))
- Individuals following a ketogenic diet
- Failed previous antibiotic for this episode of infected insect bite or sting
- Any individual suspected of having a systemic reaction to an insect bite or sting i.e. angio-oedema or anaphylaxis
- Previous systemic allergic reaction to the same type of bite or sting
- Known comorbidity which may complicate or delay resolution of infection (for example peripheral arterial disease, chronic venous insufficiency, lymphoedema or morbid obesity).
- Severe pain out of proportion to the wound (may indicate presence of toxin-producing bacteria)
- Significant collection of fluid or pus at site of infection (for incision and drainage, where appropriate)
- No clear evidence of infection (Initial inflammation around the site of the bite should be managed in accordance with self-care advice; including analgesia, oral antihistamines and topical steroids (over the counter))
- Human bite or animal bite or scratch
- Insect sting/bite in the mouth or throat, or around the eyes
- Puncture wound contaminated with freshwater or sea water, soil or manure. May require alternative antibiotics or further management such as tetanus prophylaxis.
- Bite or sting occurred while travelling outside the UK with concern of insect borne disease e.g. malaria, tick borne encephalitis
- Bite or sting caused by an unusual or exotic insect
- Insect bites caused by ticks (where tick present or presentation indicative of tick bite): due to risk of Lyme disease
- Evidence of erythema migrans (bullseye rash, which may appear as a bruise on brown or black skin) on examination: due to risk of Lyme disease
- Systemically unwell
- Any individual identified with symptoms of severe/life-threatening infection or systemic sepsis: refer urgently via ambulance
- Previous or current known met(h)icillin-resistant Staphylococcus aureus (MRSA) colonisation or infection
- Individuals with previous or current history of liver disease
- Individuals with a previous history of flucloxacillin associated jaundice/liver dysfunction
- Known Chronic Kidney Disease (CKD) stage 5 (eGFR <15ml/min/1.73m²)
- Individuals at risk of high anion gap metabolic acidosis (HAGMA) (e.g. malnutrition, sepsis, renal impairment) who are recently or currently taking paracetamol.
- Less than 3 days before receiving, or within 3 days after receiving, oral typhoid vaccine
- Concurrent use of any interacting medicine as listed in Drug Interactions section of this PGD
Cautions including any relevant action to be taken
- Breastfeeding individuals: Flucloxacillin can be used in breastfeeding individuals: monitor nursing infant for gastro-intestinal disturbances, oral candida infection, hypersensitivity and rash.
- Caution should be exercised when supplying flucloxacillin to individuals taking coumarin anticoagulants (e.g. warfarin, acenocoumarol, phenindione): rises in INR reported. Individuals should be advised to have their INR monitored while on treatment with flucloxacillin and should be counselled re: seeking medical attention if any episode of bleeding develops while taking.
- Caution should be exercised when supplying flucloxacillin capsules or oral solution (or oral suspension) to individuals who should avoid the following excipients:
- Lactose, sucrose, fructose and sorbitol: Individuals with rare hereditary problems of galactosaemia, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption, sucrase-isomaltase deficiency, fructose-1,6-bisphosphatase deficiency (also known as hereditary fructose intolerance): check the individual list of excipients available in the SPC before supplying.
- Aspartame: Individuals with phenylketonuria (PKU) must not use medicines containing aspartame. Check the individual list of excipients available in the SPC before supplying.
Specific information for suspected infection to be provided
- Provide TARGET self-care leaflet
- Provide information on insect bites and stings:
- NHS Website – Insect bites and stings
- And, where relevant, provide the following information:
- UKHSA – Tick Awareness
- The Anaphylaxis Campaign – Insect sting allergy – the facts.
Action to be taken if the individual is excluded
- Record reasons for exclusion in the appropriate clinical record.
Individuals where treatment is not indicated:
- Advise individual/carer/parent/guardian of alternative non antibiotic treatment if antibiotic not indicated and provide TARGET self-care leaflet and safety netting advice.
- Some individuals may wish to consider oral antihistamines to help relieve itching, even though there is uncertainty about their effectiveness.
- Ask the individual to draw a line around the border of erythema (or take clear photos of the area) and to return to Community Pharmacy for pharmacist reassessment if:
- Symptoms worsen at any time OR
- Do not improve after 3 days of self-care.
Refer urgently to a prescriber for further assessment if:
- Individual is systemically unwell, but not showing signs or symptoms of sepsis
- Individual is systemically well but with a comorbidity (for example peripheral arterial disease, chronic venous insufficiency, or morbid obesity) which may complicate or delay resolution of infection
- Severe pain out of proportion to the wound
- Individual has significant collection of fluid or pus at site of infection
- Animal bite or scratch
- Human bite
- Evidence of erythema migrans (bullseye rash, which may appear as a bruise on brown or black skin)
- Bite or sting that occurred while travelling outside of the UK with concern of insect borne disease e.g. malaria
- Bite or sting caused by an unusual or exotic insect
- Individuals where treatment under this PGD is not indicated/permitted but dermatological symptoms are present and require further assessment
Refer urgently to A&E for further assessment if:
- Any individual suspected of having a systemic reaction to an insect bite or sting i.e. angio-oedema or anaphylaxis
- Previous systemic allergic reaction (e.g. angio-oedema or anaphylaxis) to the same type of bite or sting
- Individual is severely immunosuppressed and has signs or symptoms of infection
- Has been stung on the mouth, throat or tongue and is at risk of airway obstruction
- Has been stung around the eyes and is at risk of compromised vision
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 of alternative treatment available using TARGET self-care leaflet.
- Provide information on insect bites and stings:
- NHS Website – Insect bites and stings
- And, where relevant, provide the following information:
- UKHSA – Tick Awareness
- The Anaphylaxis Campaign – Insect sting allergy – the facts.
Arrangements for referral for medical advice
- Refer to a prescriber if antibiotic appropriate but falls outside of this PGD.
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 year 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 year 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
Infected insect bite(s) and sting(s) 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
- Diagnosis of infected insect bite or sting using the appropriate diagnostic (NICE CKS) guidance.
- Clear evidence of infection that is present or worsening at least 48 hours after the initial bite(s) or sting(s) with 3 or more of the following symptoms:
- Redness of the skin (erythema may be more difficult to distinguish on darker skin tones)
- Pain or tenderness to the area
- Swelling of the skin
- Skin surrounding the bite(s) or sting(s) feels hot to touch
AND any of the following: - Redness or swelling of the skin surrounding the bite(s) or sting(s) is spreading
- Evidence of pustular discharge at site of bite(s) or sting(s)
- Known hypersensitivity to flucloxacillin, any penicillin or any of the components within the formulation of flucloxacillin – 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 a prescriber if antibiotic appropriate but falls outside of this PGD.
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:
- 500mg 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
Infected insect bite(s) and sting(s) 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 1 year and over
- Diagnosis of infected insect bite or sting using the appropriate diagnostic (NICE CKS) guidance.
- Clear evidence of infection that is present or worsening at least 48 hours after the initial bite(s) or sting(s) with 3 or more of the following symptoms:
- Redness of the skin (erythema may be more difficult to distinguish on darker skin tones)
- Pain or tenderness to the area
- Swelling of the skin
- Skin surrounding the bite(s) or sting(s) feels hot to touch
AND any of the following: - Redness or swelling of the skin surrounding the bite(s) or sting(s) is spreading
- Evidence of pustular discharge at site of bite(s) or sting(s)
- Pregnancy or suspected pregnancy
- Known hypersensitivity to flucloxacillin, any penicillin or any of the components within the formulation of flucloxacillin – 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.
- Indicate any off-label use (if relevant)
- 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