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.
Phenoxymethylpenicillin (Penicillin V)
Clinical condition or situation to which this PGD applies
Acute sore throat due to suspected streptococcal infection in children aged 5 years and over and adults.
Criteria for inclusion
- Informed consent
- Individuals aged 5 years and over
- Diagnosis of sore throat using the appropriate NICE guidance.
Diagnostic tool (children and adults)
FeverPAIN score for Strep pharyngitis (one point for each):
- Fever (high temperature) in previous 24 hours
- Purulent tonsils
- Attend rapidly (symptom onset ≤3 days)
- Severe tonsillar Inflammation
- No cough/coryza
FeverPAIN score of 4 or 5 with severe symptoms required for antimicrobial to be considered (see Action to be taken if the individual is excluded section).
Criteria for exclusion
- Consent refused and documented in the individual’s clinical notes
- Individuals under 5 years 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
- 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.
- Known hypersensitivity to phenoxymethylpenicillin (penicillin V), any penicillin 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.
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))
- Current long-term use of phenoxymethylpenicillin (e.g. prophylaxis in asplenia etc.)
- Individuals following a ketogenic diet
- Failed previous antibiotic for this episode of sore throat
- Recurrent sore throat/tonsillitis (7 or more significant episodes (with impact to individual and family) in the preceding 12 months or 5 or more episodes in each of the preceding two years, or 3 or more in each of the preceding three years)
- Previous tonsillectomy
- Post tonsillar or other throat surgery or procedure
- FeverPAIN score of 0 or 1: Do not offer an antibiotic. Ask the individual to return to Community Pharmacy after 1 week if no improvement for pharmacist reassessment.
- FeverPAIN score of 2 or 3: Do not offer an antibiotic. Ask the individual to return to Community Pharmacy within 3-5 days if no improvement for pharmacist reassessment.
- FeverPAIN score of 4 or 5 with mild symptoms: Ask the individual to return to Community Pharmacy within 3-5 days if no improvement for pharmacist reassessment.
- Symptoms indicating possible epiglottitis (do not examine throat and call an ambulance):
- Severe and acute onset of sore throat and fever
- Difficulty breathing, which may improve when leaning forward (especially in young children)
- Muffled or hoarse voice (especially in young children)
- Inspiratory stridor (noisy high pitched sound when breathing) (especially in young children)
- Pain and difficulty swallowing (especially in older children & adults)
- Drooling (especially in older children & adults)
- Irritability and restlessness
- Symptoms indicating possible scarlet fever:
- High temperature (may also be present in sore throat)
- Swollen glands in the neck (may also be present in sore throat)
- White coating on the tongue which later develops into “strawberry” red tongue
- Red cheeks (may be more difficult to see on darker skin)
- Pink-red skin rash that has a sandpaper feel (on darker skin the rash may be more difficult to see, but its rough texture should be apparent)
- Bright red skin in the creases of the underarm, elbow, and groin
- Symptoms indicating a possible quinsy:
- Fever
- Neck pain
- Trismus (inability to open the mouth)
- Muffled voice
- Displaced uvula
- Enlarged displaced tonsil
- Swelling of the peri-tonsillar region
- Symptoms indicating possible glandular fever (mostly in teenagers and young adults):
- A very high temperature (may also be present in sore throat)
- A severe sore throat (may also be present in sore throat)
- Swollen glands (either side of the neck) (may also be present in sore throat)
- Extreme tiredness or exhaustion
- Tonsillitis that is not getting better
- Symptoms indicating possible diphtheria:
- A thick grey-white coating that may cover the back of the throat, nose and tongue
- A high temperature (may also be present in sore throat)
- Sore throat (may also be present in sore throat)
- Swollen glands in the neck (may also be present in sore throat)
- Difficulty breathing and swallowing
- Any individual identified with symptoms of severe/life-threatening infection or systemic sepsis: refer urgently via ambulance
- Possible cancer:
- Persistent mouth ulcers
- Mass/unilateral swelling present
- Unable to swallow
- Bleeding or numbness in the mouth
- Red or white patches in the mouth
- Individuals over 45 years of age with unexplained hoarse voice, lasting 3 weeks or more
- Individuals currently taking/receiving the following medicines known to cause agranulocytosis (e.g. methotrexate, sulfasalazine, carbimazole, propylthiouracil, cotrimoxazole, valganciclovir, clozapine, carbamazepine, all chemotherapy)
- Known Chronic Kidney Disease (CKD) stages 4 or 5 (eGFR <30ml/min/1.73m²)
- 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: phenoxymethylpenicillin can be used in breastfeeding individuals: monitor nursing infant for gastro-intestinal disturbances, nausea, hypersensitivity, rashes and oral candida infection.
- Caution should be exercised when supplying phenoxymethylpenicillin 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 phenoxymethylpenicillin and should be advised to seek medical attention if any episode of bleeding develops while taking.
- Caution should be exercised when supplying phenoxymethylpenicillin tablets 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 the Treating Your Infection Respiratory Tract Infection (TYI-RTI) patient information leaflet (TARGET RTI leaflet) (TARGET RTI leaflets in other languages are also available).
- Advise that acute sore throat can last for around 1 week, but most people will get better within this time without antibiotics, regardless of cause (bacteria or virus).
- Provide self-care advice including:
- Paracetamol and ibuprofen (over the counter) can be used for pain and/or fever (where appropriate). (For further information see: Mild to moderate pain and NSAIDs-prescribing issues).
- Medicated lozenges and medicated throat sprays (over the counter) may help with pain, but adverse effects (including taste disturbance, numbness) are common
- Note: regular or increasing repeat purchase/request of throat lozenges or medicated throat sprays should trigger further questioning (suspected cancer red flag).
Action to be taken if the individual is excluded
- Record reasons for exclusion in the appropriate clinical record.
Individuals where treatment is not indicated:
- Where diagnostic tools (FeverPAIN score) indicate unlikely to benefit from antibiotics (FeverPAIN score of 0,1, 2 or 3): provide self-care advice
- Advise individual/carer/parent/guardian of alternative non antibiotic treatment if antibiotic not indicated and provide TARGET RTI leaflet (TARGET RTI leaflets in other languages are also available) and safety netting advice.
Refer urgently to a prescriber for further assessment if:
- Individual has signs or symptoms of scarlet fever or quinsy
- Individual has signs or symptoms of glandular fever
- Individual is immunosuppressed
- Individual is currently taking/receiving the following medicines known to cause agranulocytosis (e.g. methotrexate, sulfasalazine, carbimazole, propylthiouracil, cotrimoxazole, valganciclovir, clozapine, carbamazepine, all chemotherapy)
- Individual is systemically unwell, but not showing signs or symptoms of sepsis
- Possible cancer suspected:
- Persistent mouth ulcers
- Mass/unilateral swelling present
- Unable to swallow
- Bleeding or numbness in the mouth
- Red or white patches in the mouth
- Individuals > 45 years of age with unexplained hoarse voice, lasting 3 weeks or more.
- 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:
- Epiglottis suspected
- Diphtheria suspected
- Severe complications suspected (such as clinical dehydration, signs of pharyngeal abscess)
- Stridor present (noisy or high pitched sound when breathing)
- Individual is severely immunosuppressed
If sepsis is suspected refer the individual urgently to A&E
For children: see Healthier Together guidance (tonsillitis/sore throat) for further information on appropriate signposting and parent information sheets.
Action to be taken if individual/carer/ parent/guardian declines treatment
- Document advice given.
- Provide safety netting advice (detailed above) and advise individual/carer/parent/guardian of alternative treatment available using TARGET RTI leaflet (TARGET RTI leaflets in other languages are also available).
- Refer to a prescriber if appropriate
Arrangements for referral for medical advice
- Refer to the appropriate medical practitioner in the care pathway
Description of treatment
- Name, strength & formulation of drug
- Phenoxymethylpenicillin 250mg tablets
- Phenoxymethylpenicillin 125mg/5mL oral solution (or oral suspension) x 100mL
- Phenoxymethylpenicillin 125mg/5mL sugar free oral solution (or oral suspension) x 100mL
- Phenoxymethylpenicillin 250mg/5mL oral solution (or oral suspension) x 100mL
- Phenoxymethylpenicillin 250mg/5mL sugar free oral solution (or oral suspension) x 100mL
- Legal category
- POM
- Route / method of administration
- Orally, on an empty stomach (30 minutes before food or 2 hours after food).
- Tablets should be swallowed whole with water.
- Off-label use
- Dose and frequency of administration
- Children 5 years:
- 125 mg four times a day
- Children 6-11 years:
- 250 mg four times a day
- Children 12–17 years and adults:
- 500 mg four times a day
- Children 5 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
- 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
Acute sore throat due to suspected streptococcal infection in children aged 5 years and over and adults, where phenoxymethylpenicillin is not appropriate due to hypersensitivity.
Criteria for inclusion
- Informed consent
- Individuals aged 5 years and over
- Diagnosis of sore throat using the appropriate NICE guidance.
- Known hypersensitivity to phenoxymethylpenicillin (penicillin V), any penicillin or any of the components within the formulation of phenoxymethylpenicillin – 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
Diagnostic tool (children and adults)
FeverPAIN score for Strep pharyngitis (one point for each):
- Fever (high temperature) in previous 24 hours
- Purulent tonsils
- Attend rapidly (symptom onset ≤3 days)
- Severe tonsillar Inflammation
- No cough/coryza
FeverPAIN score of 4 or 5 with severe symptoms required for antimicrobial to be considered (see Action to be taken if the individual is excluded section).
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 500mg 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, with water (taken with or without food). Tablets should be swallowed whole.
- 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 5–11 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 5–11 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
Acute sore throat due to [suspected] streptococcal infection in young people and adults aged 16 years and over who are pregnant, or where pregnancy is suspected and where phenoxymethylpenicillin is not appropriate due to hypersensitivity.
Criteria for inclusion
- Informed consent
- Individuals aged 16 years and over
- Diagnosis of sore throat using the appropriate NICE guidance.
- Pregnancy or suspected pregnancy
- Known hypersensitivity to phenoxymethylpenicillin (penicillin V), any penicillin or any of the components within the formulation of phenoxymethylpenicillin – 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
Diagnostic tool (children and adults)
FeverPAIN score for Strep pharyngitis (one point for each):
- Fever (high temperature) in previous 24 hours
- Purulent tonsils
- Attend rapidly (symptom onset ≤3 days)
- Severe tonsillar Inflammation
- No cough/coryza
FeverPAIN score of 4 or 5 with severe symptoms required for antimicrobial to be considered (see Action to be taken if the individual is excluded section).
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