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.
Fluticasone | Mometasone
Clinical condition or situation to which this PGD applies
Acute sinusitis (rhinosinusitis) in children aged 12 years and over and adults.
Criteria for inclusion
- Informed consent
- Individuals aged 12 years and over
- Signs and symptoms of acute sinusitis using the appropriate NICE guidance
- Diagnosis of acute sinusitis using the appropriate NICE CKS guidance.
- Presence of ONE of the following signs/symptoms (which suggests acute sinusitis is more likely):
- Nasal blockage (obstruction/congestion) OR
- Nasal discharge (anterior/posterior nasal drip)
AND ONE or more of the following: - Facial pain/pressure (or headache) OR
- Reduction (or loss) of the sense of smell (in adults) OR
- Cough during the day or at night (in children)
- Symptom duration of more than 10 days with no improvement
Criteria for exclusion
- Consent refused and documented in the individual’s clinical notes
- Individuals under 12 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.
- Hypersensitivity to the active substance, fluticasone furoate, a glucocorticoid (or steroid), or to any of the excipients within the formulation – see Summary of Product Characteristics Acceptable sources of allergy information include individual/carer or National Care Record.
- Failed previous intranasal steroid for this episode of sinusitis
- Symptom duration of less than 10 days
- Individuals with blurred vision or other visual disturbances
- Individuals with known or suspected glaucoma or raised intraocular pressure
- Individual with untreated localised infection involving the nasal mucosa, such as herpes simplex.
- Individuals who have experienced nasal trauma or undergone nasal surgery where full healing has not occurred.
- Epistaxis
- Foreign body inserted into nasal passage
- Recurrent sinusitis (4 or more annual episodes of sinusitis without persistent symptoms in the intervening periods)
- Chronic sinusitis (sinusitis that causes symptoms that last for more than 12 weeks)
- Anatomic defect(s) causing nasal obstruction
- Co-morbidities complicating management such as nasal polyps.
- Individual has signs of a more serious illness or condition (i.e. red flag symptoms) (e.g. intraorbital (within the eye) or periorbital (around the eye) complications: such as periorbital oedema (swelling) or cellulitis, displaced eyeball, double vision, ophthalmoplegia (paralysis/weakness of the eye muscles), or newly reduced visual acuity (reduced vision), intracranial complications such as swelling over the frontal bone, symptoms or signs of meningitis, severe frontal headache or focal neurological signs).
- Any individual identified with symptoms of severe/life-threatening infection or systemic sepsis: refer urgently via ambulance
- Possible cancer:
- Unilateral (one sided) polyp or mass or bloody nasal discharge present
- Persistent unilateral symptoms, such as nasal obstruction, nasal discharge or nosebleeds, crusting or facial swelling
- Individuals currently taking oral, inhaled, topical or parenteral corticosteroids for any indication – to reduce the risk of adrenal insufficiency
- Concurrent use of any interacting medicine as listed in Drug Interactions section of this PGD
Cautions including any relevant action to be taken
- Advise individual/carer/parent/guardian to seek medical advice if the individual develops any blurred vision or other visual disturbances during treatment (MHRA/CHM advice)
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).
- Little evidence that nasal saline (salt water) or nasal decongestants (over the counter) help relieve nasal congestion, but individuals may want to try them. [Water used should be boiled and cooled, sterile, distilled or filtered (using a < 1micron filter)].
- No evidence to support the use of oral decongestants, antihistamines, mucolytics, steam inhalation or warm face packs for this indication.
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 acute sinusitis is usually caused by a virus, can take 2–3 weeks to resolve, and most people will get better without treatment.
- Where intranasal steroids are unlikely to of benefit: provide self-care advice
- Advise individual/carer/parent/guardian to seek medical help if symptoms worsen rapidly or significantly or if they do not improve after 3 weeks.
Refer urgently to a prescriber for further assessment if:
- Individual is severely immunosuppressed or immunosuppressed
- Individual is systemically unwell, but not showing signs or symptoms of sepsis
- Possible cancer suspected:
- Unilateral (one sided) polyp or mass or bloody nasal discharge present
- Persistent unilateral symptoms, such as nasal obstruction, nasal discharge or nosebleeds, crusting or facial swelling
- 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:
- Signs of a more serious illness or condition (e.g. intraorbital (within the eye) or periorbital (around the eye) complications: such as periorbital oedema (swelling) or cellulitis, displaced eyeball, double vision, ophthalmoplegia (paralysis/weakness of the eye muscles), or newly reduced visual acuity (reduced vision).
- Signs of intracranial complications such as swelling over the frontal bone, symptoms or signs of meningitis, severe frontal headache or focal neurological signs).
If sepsis is suspected refer the individual urgently to A&E
For children: see Healthier Together guidance (rhinosinusitis/persistent runny nose) 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 Fluticasone
- Name, strength & formulation of drug
- Fluticasone furoate 27.5 micrograms/dose nasal spray
- Legal category
- POM
- Route / method of administration
- Intranasal
- Off-label use
- Fluticasone furoate 27.5 micrograms/dose nasal spray is not licensed for the treatment of sinusitis but use for this indication and at this dose is supported by NICE guidance……more
- Dose and frequency of administration
- Children 12–17 years and adults:
- Two actuations (27.5 micrograms/actuation) in each nostril twice daily (total dose 110 micrograms twice daily)
- Children 12–17 years and adults:
- Duration of treatment
- 14 days
- 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
Description of treatment Mometasone
- Name, strength & formulation of drug
- Mometasone furoate monohydrate 50 micrograms/dose nasal spray
- Legal category
- POM
- Note: ONLY the supply of the prescription-only medicine (POM) (and not pharmacy only (P)) is permitted under this PGD.
- Route / method of administration
- Intranasal
- Off-label use
- Mometasone furoate monohydrate 50 micrograms/dose nasal spray is not licensed for the treatment of sinusitis but use for this indication and at this dose is supported by NICE guidance……more
- Dose and frequency of administration
- Children 12–17 years and adults:
- Two actuations (50 micrograms/actuation) in each nostril twice daily (total dose 200 micrograms twice daily).
- Children 12–17 years and adults:
- Duration of treatment
- 14 days
- 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
Phenoxymethylpenicillin (Penicillin V)
Clinical condition or situation to which this PGD applies
Acute bacterial sinusitis (rhinosinusitis) in children aged 12 years and over and adults.
Criteria for inclusion
- Informed consent
- Individuals aged 12 years and over
- Signs and symptoms of acute sinusitis using the appropriate NICE guidance
- Diagnosis of acute sinusitis using the appropriate NICE CKS guidance.
- Presence of ONE of the following signs/symptoms (which suggests acute sinusitis is more likely):
- Nasal blockage (obstruction/congestion) OR
- Nasal discharge (anterior/posterior nasal drip)
AND ONE or more of the following: - Facial pain/pressure (or headache) OR
- Reduction (or loss) of the sense of smell (in adults) OR
- Cough during the day or at night (in children)
- Symptom duration of more than 10 days with no improvement
- Presence of TWO or more of the following signs/symptoms (which suggests acute bacterial sinusitis is more likely):
- Marked deterioration after an initial milder phase
- Fever (>38°C)
- Unremitting purulent nasal discharge
- Severe localised unilateral pain, particularly pain over the teeth (toothache) and jaw
- Persistent symptoms despite use of high-dose nasal corticosteroid (off-label) for 14 days
OR - High-dose nasal corticosteroid (off-label) unsuitable
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
- 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 12–17 years and adults:
- 500 mg four times a day
- Children 12–17 years and adults:
- 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 bacterial sinusitis (sinusitis) in children aged 12 years and over and adults where phenoxymethylpenicillin is not appropriate due to hypersensitivity.
Criteria for inclusion
- Informed consent
- Individuals aged 12 years and over
- Signs and symptoms of acute sinusitis using the appropriate NICE guidance
- Diagnosis of acute sinusitis using the appropriate NICE CKS guidance.
- Presence of ONE of the following signs/symptoms (which suggests acute sinusitis is more likely):
- Nasal blockage (obstruction/congestion) OR
- Nasal discharge (anterior/posterior nasal drip)
AND ONE or more of the following: - Facial pain/pressure (or headache) OR
- Reduction (or loss) of the sense of smell (in adults) OR
- Cough during the day or at night (in children)
- Symptom duration of more than 10 days with no improvement
- Presence of TWO or more of the following signs/symptoms (which suggests acute bacterial sinusitis is more likely):
- Marked deterioration after an initial milder phase
- Fever (>38°C)
- Unremitting purulent nasal discharge
- Severe localised unilateral pain, particularly pain over the teeth (toothache) and jaw
- Persistent symptoms despite use of high-dose nasal corticosteroid (off-label) for 14 days
OR - High-dose nasal corticosteroid (off-label) unsuitable
- Known hypersensitivity to phenoxymethylpenicillin (penicillin V), any penicillin or any of the components within the formulation of phenoxymethylpenicillin 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 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 12–17 years and adults:
- 500mg twice daily (every 12 hours)
- Children 12–17 years and adults:
- 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
Erythromycin
Clinical condition or situation to which this PGD applies
Acute bacterial sinusitis (sinusitis) in adults 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
- Signs and symptoms of acute sinusitis using the appropriate NICE guidance
- Diagnosis of acute sinusitis using the appropriate NICE CKS guidance.
- Presence of ONE of the following signs/symptoms (which suggests acute sinusitis is more likely):
- Nasal blockage (obstruction/congestion) OR
- Nasal discharge (anterior/posterior nasal drip)
AND ONE or more of the following: - Facial pain/pressure (or headache) OR
- Reduction (or loss) of the sense of smell (in adults) OR
- Cough during the day or at night (in children)
- Symptom duration of more than 10 days with no improvement
- Presence of TWO or more of the following signs/symptoms (which suggests acute bacterial sinusitis is more likely):
- Marked deterioration after an initial milder phase
- Fever (>38°C)
- Unremitting purulent nasal discharge
- Severe localised unilateral pain, particularly pain over the teeth (toothache) and jaw
- Persistent symptoms despite use of high-dose nasal corticosteroid (off-label) for 14 days
OR - High-dose nasal corticosteroid (off-label) unsuitable
- Pregnancy or suspected pregnancy
- Known hypersensitivity to phenoxymethylpenicillin (penicillin V), any penicillin or any of the components within the formulation of phenoxymethylpenicillin 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
Doxycycline
Clinical condition or situation to which this PGD applies
Acute bacterial sinusitis (rhinosinusitis) in children 12 years and over and adults where phenoxymethylpenicillin is not appropriate due to hypersensitivity.
Criteria for inclusion
- Informed consent
- Individuals aged 12 years and over
- Signs and symptoms of acute sinusitis using the appropriate NICE guidance
- Diagnosis of acute sinusitis using the appropriate NICE CKS guidance.
- Presence of ONE of the following signs/symptoms (which suggests acute sinusitis is more likely):
- Nasal blockage (obstruction/congestion) OR
- Nasal discharge (anterior/posterior nasal drip)
AND ONE or more of the following: - Facial pain/pressure (or headache) OR
- Reduction (or loss) of the sense of smell (in adults) OR
- Cough during the day or at night (in children)
- Symptom duration of more than 10 days with no improvement
- Presence of TWO or more of the following signs/symptoms (which suggests acute bacterial sinusitis is more likely):
- Marked deterioration after an initial milder phase
- Fever (>38°C)
- Unremitting purulent nasal discharge
- Severe localised unilateral pain, particularly pain over the teeth (toothache) and jaw
- Persistent symptoms despite use of high-dose nasal corticosteroid (off-label) for 14 days
OR - High-dose nasal corticosteroid (off-label) unsuitable
- Known hypersensitivity to phenoxymethylpenicillin (penicillin V), any penicillin or any of the components within the formulation of phenoxymethylpenicillin 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
- Doxycycline 100mg capsules
- Doxycycline 50mg capsules
- Doxycycline 100mg dispersible tablets
- Legal category
- POM
- Route / method of administration
- 50mg or 100mg capsules: Orally, swallowed whole with plenty of water while sitting or standing well before (at least one hour before) bedtime.
- 100mg dispersible tablets: Orally, after allowing to disperse in a small amount of water, while sitting or standing well before (at least one hour before) bedtime.
- If gastric irritation occurs, doxycycline can be taken with food or milk.
- Off-label use
- Dose and frequency of administration
- Children 12–17 years and adults:
- 200mg as a single dose on the first day and then 100mg once daily for 4 days
- Children 12–17 years and adults:
- 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