• Registered healthcare professional listed in the legislation as able to practice under Patient Group Directions.

• 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

• 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.

• 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.

• 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 neck, 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

In the event of a supply interruption with aciclovir and it is unable to be procured: refer to valaciclovir PGD.

• Criteria for inclusion Valaciclovir

• Aciclovir
• Valaciclovir

• Aciclovir
• Valaciclovir

• Aciclovir
• Valaciclovir

• Aciclovir
• Valaciclovir

• Aciclovir
• Valaciclovir

• Aciclovir: Refer to the appropriate medical practitioner in the care pathway
• Valaciclovir: Refer to a prescriber if antiviral appropriate but falls outside of this PGD.

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

• POM
• Orally, tablets swallowed whole with water or dispersed in a minimum of 50mL of water before taking.

Medicines should be stored according to the conditions detailed in the Storage section below. However, in the event of an inadvertent or unavoidable deviation of these conditions a pharmacist must ensure the medicine remains pharmaceutically stable and appropriate for use if it is to be issued.

Where medicines have been assessed by a pharmacist in accordance with national or specific product recommendations/manufacturer advice as appropriate for continued use this would constitute off-label administration under this PGD.

The responsibility for the decision to release the affected medicines for use lies with the pharmacist.

Where a drug is recommended off-label consider, as part of the consent process, informing the individual/carer that the drug is being offered in accordance with national guidance but that this is outside the product licence.

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.

7 days
Treatment should be started immediately and 7 days of treatment completed.

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.

Stock must be securely stored according to organisation medicines policy and in conditions in line with SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk

Where it is known an individual is concurrently taking one of the following medicines, aciclovir must not be supplied under this PGD and the individual referred to a prescriber:

• Ciclosporin, tacrolimus or mycophenolate
• Aminophylline or theophylline

A detailed list of drug interactions is available in the SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk

A detailed list of adverse reactions is available in the SPC, which is available from the electronic Medicines Compendium website: www.medicines.org.uk and BNF www.bnf.org

The following side effects are listed in the product SPC/BNF as common with aciclovir (but may not reflect all reported side effects):

• Diarrhoea
• Vomiting and nausea
• Abdominal pain
• Headache
• Dizziness
• Fever
• Fatigue
• Skin rashes or reactions (including photosensitivity and urticaria)

Severe adverse reactions are rare, but anaphylaxis (delayed or immediate) has been reported and requires immediate medical treatment.

In the event of a severe adverse reaction, the individual must be advised to stop treatment immediately and seek urgent medical advice.

• Healthcare professionals and individuals/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: https://yellowcard.mhra.gov.uk
• Record all adverse drug reactions (ADRs) in the individual’s clinical record.
• Report via organisation incident policy.
• It is considered good practice to notify the individual’s GP in the event of an adverse reaction.

• Provide marketing authorisation holder's information leaflet (PIL) provided with the product.
• Provide the British Association of Dermatologists (BAD) patient information leaflet on shingles (herpes zoster infection)
• The NHS website has patient information on shingles.
• Give any additional information in accordance with the service specification.

• Explain the dose, frequency and method of administration.
• The individual/carer/parent/guardian should be advised to read PIL.
• Inform the individual/carer/parent/guardian of possible side effects and their management.
• Advise individual/carer/parent/guardian to take the medication at regular intervals and to finish the course even if symptoms improve.
• Advise individual/carer/parent/guardian to take the medication at regular intervals and to finish the course even if symptoms improve.
• Shingles usually resolves within 4 weeks – advise individual/carer/parent/guardian to seek medical advice if symptoms have not resolved within this time.
• Advise individual/carer/parent/guardian to seek medical advice if symptoms worsen rapidly or significantly at any time or do not improve after completion of treatment course.
• 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.
• Advise individual/carer/parent/guardian to seek medical advice if new vesicles are forming after 7 days of antiviral treatment, or healing is delayed.
• Advise individual/carer/parent/guardian to seek medical advice if pain is inadequately controlled by over-the-counter analgesia.
• 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.
• Advise individual/carer/parent/guardian to return any unused medicines to a pharmacy for disposal: do not dispose of medicines in the bin, down the sink or toilet.
• Advise individual/carer/parent/guardian to ensure the individual maintains adequate hydration particularly in the elderly to prevent renal impairment
• Explain that only a person who has not had chickenpox or the varicella vaccine can catch chickenpox from a person with shingles. The person with shingles is infectious until all the vesicles have crusted over (usually 5–7 days after rash onset).
• Advise individuals with shingles to:
  • Avoid contact with individuals who have not had chickenpox, particularly pregnant individuals, immunosuppressed individuals, and babies younger than 1 month of age.
  • Avoid sharing clothes and towels.
  • Wash their hands often.
  • Wear loose-fitting clothes to reduce irritation.
  • Cover lesions that are not under clothes while the rash is still weeping.
  • Avoid use of topical creams and adhesive dressings, as they can cause irritation and delay rash healing.
  • Keep the rash clean and dry to reduce the risk of bacterial superinfection. They should seek medical advice if there is an increase in temperature, as this may indicate bacterial infection.
  • Avoid work, school, or day care if the rash is weeping and cannot be covered. If the lesions have dried or the rash is covered, avoidance of these activities is not necessary.

• That valid informed consent has been given
• Individual’s name, address and date of birth
• Name of GP individual is registered with or record where an individual is not registered with a GP
• Name and registration number of registered healthcare professional operating under this PGD
• Specify how the individual has/has not met the criteria of the PGD
• Relevant past and present medical history and medication history
• Any known allergies and nature of reaction(s)
• Name/dose/form/quantity of medicine supplied
• Date and time of supply
• Documentation of cautions as appropriate
• Advice given, including advice given if individual excluded or declines treatment
• Details of any adverse drug reactions and actions taken
• Advice given about the medication including side effects, benefits, and when and what to do if any concerns.
• Any follow up and/or referral arrangements made.
• Any supply outside the terms of the product marketing authorisation
• The supply must be entered in the Patient Medication Record (PMR)
• That supply was made under a PGD
• Any safety incidents, such as medication errors, near misses and suspected adverse events
• Any additional requirements in accordance with the service specification:
  • The pharmacy contractor will ensure that a notification of the provision of the service is sent to the patient’s general practice on the day of provision or on the following working day. Where possible, this should be sent as a structured message in real-time via the NHS assured Pharmacy First IT system. In the absence of an automated digital solution or if there is a temporary problem with the system, this should be sent via NHSmail or hard copy.
  • Where an action is required by the General Practice team (such as booking the patient in for a follow up or appointment) an action message or alternative form of an URGENT ACTION communication (rather than the standard post event message) must be sent to the practice.
• All records should be kept in line with national guidance. This includes individual data, master copies of the PGD and lists of authorised practitioners.

Records must be signed and dated (or a password controlled e-records).

All records must be clear, legible and contemporaneous.

A record of all individuals receiving treatment under this PGD must also be kept for audit purposes in accordance with the service specification.