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)
- 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.
Clinical condition or situation to which this PGD applies
Shingles (herpes zoster) infection in adults aged 18 years and over.
Aciclovir: Criteria for inclusion
- Informed consent
- Adults aged 18 years or over
- Diagnosis of shingles following the appropriate NICE CKS guidance
- Diagnosed with shingles within 72 hours of rash onset AND ANY of the following:
- Non-truncal involvement (e.g. shingles affecting the limbs, or perineum).
- Moderate or severe pain (consider using a validated pain assessment scale, such as the Visual Analog Scale or Pain Scales produced by the British Pain Society (available in multiple languages))
- Moderate or severe rash (defined as confluent lesions)
- Aged over 50 years
OR
- Diagnosed with shingles within 7 days of rash onset AND ANY of the following:
- Continued vesicle formation
- Severe pain (consider using a validated pain assessment scale, such as the Visual Analog Scale or Pain Scales produced by the British Pain Society (available in multiple languages)).
- High risk of severe shingles (e.g. severe atopic dermatitis/eczema, see NICE CKS for further information)
- Aged 70 years and over
Aciclovir: Criteria for exclusion
- Consent refused and documented in the individual’s clinical notes
- Individuals under 18 years of age
- Individuals:
- Who are assisted in the taking of their regular medications (e.g. by visiting carers) where adherence with the five time daily regimen for aciclovir would not be achievable – consider valaciclovir. OR
- who are already prescribed 8 or more medicines per day where adherence with the regimen for aciclovir may not be achievable – consider valaciclovir. OR
- who are immunosuppressed (see below for definitions of immunosuppressed) – consider valaciclovir.
- Pregnancy or suspected pregnancy
- Currently breastfeeding with shingles sore(s) on the breast(s) (see Cautions for advice when treating shingles sore(s) not on the breast(s) in breastfeeding individuals)
- Severely immunosuppressed individuals as defined in Chapter 28a Green book):
Individuals with primary or acquired immunodeficiency states due to conditions including:
- Acute and chronic leukaemias, and clinically aggressive lymphomas (including Hodgkin’s lymphoma) who are less than 12 months since achieving cure
- Individuals under follow up for a chronic lymphoproliferative disorders including haematological malignancies such as indolent lymphoma, chronic lymphoid leukaemia, myeloma, Waldenstrom’s macroglobulinemia and other plasma cell dyscrasias (N.B: this list not exhaustive)
- Immunosuppression due to HIV/AIDS with a current CD4 count of below 200 cells/μl.
- Primary or acquired cellular and combined immune deficiencies – those with lymphopaenia (<1,000 lymphocytes/ul) or with a functional lymphocyte disorder
- Those who have received an allogeneic (cells from a donor) or an autologous (using their own cells) stem cell transplant in the previous 24 months
- Those who have received a stem cell transplant more than 24 months ago but have ongoing immunosuppression or graft versus host disease (GVHD)
Individuals on immunosuppressive or immunomodulating therapy including:
- Those who are receiving or have received in the past 6 months immunosuppressive chemotherapy or radiotherapy for any indication
- Those who are receiving or have received in the previous 6 months immunosuppressive therapy for a solid organ transplant
- Those who are receiving or have received in the previous 3 months targeted therapy for autoimmune disease, such as JAK inhibitors or biologic immune modulators including B-cell targeted therapies (including rituximab but for which a 6 month period should be considered immunosuppressive), monoclonal tumor necrosis factor inhibitors (TNFi), T-cell co-stimulation modulators, soluble TNF receptors, interleukin (IL)-6 receptor inhibitors., IL-17 inhibitors, IL 12/23 inhibitors, IL 23 inhibitors (N.B: this list is not exhaustive)
Individuals with chronic immune mediated inflammatory disease who are receiving or have received immunosuppressive therapy:
- Moderate to high dose corticosteroids (equivalent ≥20mg prednisolone per day) for more than 10 days in the previous month
- Long term moderate dose corticosteroids (equivalent to ≥10mg prednisolone per day for more than 4 weeks) in the previous 3 months
- Any non-biological oral immune modulating drugs e.g. methotrexate >20mg per week (oral and subcutaneous), azathioprine >3.0mg/kg/day; 6-mercaptopurine >1.5mg/kg/day, mycophenolate >1g/day) in the previous 3 months
- Certain combination therapies at individual doses lower than stated above, including those on ≥7.5mg prednisolone per day in combination with other immunosuppressants (other than hydroxychloroquine or sulfasalazine) and those receiving methotrexate (any dose) with leflunomide in the previous 3 months
- Individuals who have received a short course of high dose steroids (equivalent >40mg prednisolone per day for more than a week) for any reason in the previous month.
- Immunosuppressed individuals: individuals who are immunosuppressed or are currently taking immunosuppressants (including systemic corticosteroids*) or immune modulators, but who do not meet the definition of severe immunosuppression (see above). [For equivalent doses in children, see Chapter 6 Green Book]
- * does not include:
- Replacement corticosteroids for individuals with adrenal insufficiency
- Corticosteroid inhalers or corticosteroids applied topically (e.g. to the skin, ears, eyes, nasal cavity)
- Intra-articular, -bursal or -tendon corticosteroid injections.
- Known hypersensitivity to aciclovir or valaciclovir or any of the components within the formulation – see Summary of Product Characteristics. Acceptable sources of allergy information include individual/carer/parent/guardian or National Care Record.
- Individuals, for whatever reason, where medication cannot be started within 72 hours or 7 days of rash onset, whichever is used to determine eligibility for treatment (see criteria for inclusion)
- Inability to absorb oral medications and or inability to swallow oral dosage formulations (i.e. tablets or dispersible tablets)
- Current long-term use of oral aciclovir or valaciclovir (e.g. prophylaxis of HSV infection etc.)
- Failure to respond to treatment with acyclovir or valaciclovir for this episode of shingles
- Shingles rash onset over 7 days ago
- Individuals with any underlying neurological condition
- Shingles affecting the head and neck
- Suspected shingles in the ophthalmic distribution of the trigeminal nerve, especially with:
- Hutchinson’s sign (a rash on the tip, side or root of the nose, which is a prognostic factor for subsequent eye inflammation and permanent corneal denervation) OR
- Visual symptoms OR
- An unexplained red eye
- Serious complications are suspected:
- Meningitis (neck stiffness, photophobia, mottled skin)
- Encephalitis (disorientation, changes in behaviour)
- Myelitis (muscle weakness, loss of bladder or bowel control)
- Facial nerve paralysis (typically unilateral) (Ramsay Hunt syndrome)
- Any individual identified with symptoms of severe/life-threatening infection or systemic sepsis: refer urgently via ambulance.
- Individuals at risk of dehydration and unable to maintain adequate fluid intake.
- Known Chronic Kidney Disease (CKD) stages 4 or 5 (eGFR <30ml/min/1.73m²)
- Concurrent use of any interacting medicine as listed in Drug Interactions section of this PGD
Aciclovir: Cautions including any relevant action to be taken
- Breastfeeding individuals: avoid direct contact between infant and shingles sores. Aciclovir can be used in breastfeeding individuals; monitor nursing infant for diarrhoea, vomiting, rashes, irritability, lethargy and fever.
-
Caution should be exercised when supplying aciclovir tablets to individuals taking the following potentially nephrotoxic medicine(s):
- Individuals known to be taking another medication known to be nephrotoxic (including but not limited to: ACE inhibitors, ARBs, diuretics, NSAIDs, metformin) or known to cause renal impairment (see individual Summary of Product Characteristics or BNF). These individuals should be advised to maintain adequate fluid intake while on treatment with aciclovir and to avoid dehydration.
- Individuals known to be taking tenofovir disoproxil fumarate (used alone or in combination) for the treatment of hepatitis B, HIV pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)) should contact the provider of these medications to discuss the need for additional monitoring, due to the potential increased risk of renal impairment with concomitant nephrotoxic drugs. Aciclovir may be supplied under this PGD.
-
Caution should be exercised when supplying aciclovir tablets/dispersible tablets 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.
Aciclovir: Specific information for suspected infection to be provided
- Provide the British Association of Dermatologists (BAD) patient information leaflet on shingles (herpes zoster infection).
- Provide individual with advice on pain management: recommend to all individuals with mild pain, where appropriate, a trial of paracetamol, alone or combination with codeine or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (over the counter).
- Signpost eligible individuals to information and advice about receiving the shingles vaccine advising they discuss vaccination with their GP practice after they have recovered from this episode of shingles..
Aciclovir: Action to be taken if the individual/carer/parent/guardian 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 antiviral treatment if antiviral not indicated and provide the British Association of Dermatologists (BAD) patient information leaflet on shingles (herpes zoster infection) and safety netting advice.
- Signpost the patient to the NHS website containing patient information on shingles.
- Provide patient with advice on pain management: recommend to all individuals with mild pain, where appropriate, a trial of paracetamol, alone or combination with codeine or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (over the counter).
Refer urgently to a prescriber for further assessment if:
- Known or suspected pregnancy
- Pain inadequately controlled with over the counter analgesia
- Systemically unwell, but not showing signs or symptoms of sepsis
- 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:
- Individual is severely immunosuppressed
- Individual is immunosuppressed and rash is widespread or severe or individual is systemically unwell
- Serious complications such as meningitis, encephalitis, myelitis or facial nerve paralysis are suspected
- Shingles in the ophthalmic distribution of the trigeminal nerve:
- Hutchinson’s sign (rash on the tip, side or root on the nose)
- Visual symptoms
- Unexplained red eye
If sepsis or serious complications are suspected refer the individual urgently to A&E.
Aciclovir: Action to be taken if the individual/carer/parent/guardian declines treatment
- Document advice given
- Provide safety netting advice and advise individual/carer/parent/guardian of alternative treatment available using the British Association of Dermatologists (BAD) patient information leaflet on shingles (herpes zoster infection)
- Signpost the individual/carer to the NHS website containing patient information on shingles.
- Provide individual with advice on pain management
- Refer to a prescriber if appropriate
Description of treatment Aciclovir
Description of treatment Aciclovir- Name, strength & formulation of drug
- Aciclovir 200mg tablets/dispersible tablets
- Aciclovir 400mg tablets/dispersible tablets
- Aciclovir 800mg tablets/dispersible tablets
The 800mg tablets should be supplied in the first instance and 400mg or 200mg tablets supplied only if 800mg tablets are not available
- Legal category
- POM
- Route / method of administration
- Orally, tablets swallowed whole with water or dispersed in a minimum of 50mL of water before taking.
- Off-label use
- Dose and frequency of administration
- 800mg five times a day (at 4 hourly intervals, during waking hours – i.e. advise to take on waking then every 4 hours giving 5 doses over 16 hours).
- Doses should ideally be spaced evenly throughout the day.
- In the event of a missed dose, advise individuals to take it as soon as they remember. Unless it is nearly time for their next dose, where they can skip the missed dose and take their next dose at the usual time. Individuals should not take 2 doses at the same time and should complete the entire course.
- Duration of treatment
- 7 days
- Treatment should be started immediately and 7 days of treatment completed.
- Quantity to be supplied
- In line with the Pharmacy First service specification the best value product to meet the clinical need should be supplied from those listed within this PGD.
- Adults:
Appropriately labelled pack of 35 x 800mg tablets OR appropriately labelled pack of 70 x 400mg tablets OR appropriately labelled pack of 140 x 200mg tablets.
- 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 Valaciclovir
Description of treatment Valaciclovir- Name, strength & formulation of drug
- Valaciclovir 500mg tablets
- Valaciclovir 1g tablets
- Legal category
- POM
- Route / method of administration
- Orally, tablets swallowed whole with water
- Off-label use
- Dose and frequency of administration
- 1g three times a day
- Duration of treatment
- 7 days
- Treatment should be started immediately and 7 days of treatment completed
- Quantity to be supplied
- Adults: Appropriately labelled pack of 42 x 500mg tablets OR
appropriately labelled pack of 21 x 1g tablets
- Adults: Appropriately labelled pack of 42 x 500mg tablets OR
- 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