Public Health England

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1 Agenda item: Enclosure Number TBC Shropshire Clinical Commissioning Committee meeting: Patient Group Direction (PGD) for zanamivir inhalation powder for the treatment of influenza Title of the report: Responsible Director: Patient Group Direction (PGD) for zanamivir inhalation powder for the treatment of influenza Nicky Wide Author of the report: Public Health England Presenter: Liz Walker Purpose of the report: The purpose of this paper is to inform the CCC that NHS Shropshire Clinical Commissioning Group supports the use of this National Patient Group Direction (PGD) for the supply of zanamivir inhalation powder for the treatment of influenza. Key issues or points to note: Practices in Shropshire currently do not have a PGD for the supply of zanamivir inhalation powder for the treatment of influenza. This is a National PGD produced by Public Health England (PHE publications gateway number: ), which is valid from 26 July 2018 to 26 July This PGD should be used with reference to current Public Health England guidance and the Summary of Product Characteristics for zanamivir. Practitioners must not use this PGD template until it has been authorised by the CCG and Section 2 completed. This is a legal requirement (Human Medicines Regulations 2012). Practitioners should follow local policy or procedures to access authorised PGD documents. Actions required by CCC Members: The board is asked to approve this policy and confirm that the PGD for zanamivir for the treatment of influenza can be signed and authorised for use.

2 Monitoring form Agenda Item: Enclosure Number Does this report and its recommendations have implications and impact with regard to the following: 1 Additional staffing or financial resource implications This is a national PGD but zanamivir is commissioned by the CCG. Yes Last year, however, none was supplied on prescription in Primary Care. 2 Health inequalities No 3 Human Rights, equality and diversity requirements No 4 Clinical engagement This PGD has been peer reviewed by an expert panel and has Yes been agreed by the PHE Medicines Management Group and the PHE Quality and Clinical Governance Delivery Board. 5 Patient and public engagement No 6 Risk to financial and clinical sustainability The CCG might have to supply a large amount of zanamivir in the Yes event of a major flu epidemic. This risk can be mitigated by local engagement in the National Flu Prevention Campaigns

3 PHE publications gateway number: PATIENT GROUP DIRECTION (PGD) Supply of zanamivir inhalation powder for the treatment of seasonal influenza Residents/users and staff of care facilities (with or without nursing) For the supply of zanamivir inhalation powder by registered Nurses and Pharmacists 1 Reference: Version no: Valid from: 26 July 2018 Review date: 26 July 2020 Expiry date: 26 July Zanamivir treatment PGD Public Health England has developed this PGD Template for local authorisation Those using this PGD must ensure that it is organisationally authorised and signed in section 2 by an appropriate authorising person, relating to the class of person by whom the product is to be supplied, in accordance with the Human Medicines Regulations 2012 (HMR2012) 2. THE PGD IS NOT LEGAL OR VALID WITHOUT SIGNED AUTHORISATION IN ACCORDANCE WITH HMR2012 SCHEDULE 16 Part 2. Authorising organisations must not alter, amend or add to the clinical content of this document (sections 4, 5 and 6); such action will invalidate the clinical sign-off with which it is provided. As operation of this PGD is the responsibility of commissioners and service providers, the authorising organisation can decide which staff groups, in keeping with relevant legislation, can work to the PGD. Sections 2, 3 and 7 must be completed and amended within the designated editable fields provided. INDIVIDUAL PRACTITIONERS MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT. Practitioners and organisations must check that they are using the current version of the PGD. Amendments may become necessary prior to the published expiry date. Current versions of PHE PGD templates for authorisation can be found from: 1 PGDs can be used for the NHS and those services funded by the NHS that are provided by the independent, voluntary or charitable sectors. However, PGDs do not extend to independent and public sector care homes that provide healthcare entirely outside the NHS. An NHS body cannot authorise a PGD for a care home to supply or administer medicines under PGD. Therefore the supply of zanamivir under PGD to residents/users and staff of care facilities must be undertaken by NHS-employed healthcare professionals. The medicine may then be self-administered or administered by care home staff where there are appropriate governance arrangements in place. Further information is available on the NHS Specialist Pharmacy Service Website. 2 This includes any relevant amendments to legislation (eg 2013 No235, 2015 No.178 and 2015 No.323).

4 Any queries regarding the content of this PGD should be addressed to: Version number Change details Change history Date Original PGD template developed January inclusion criteria expanded to include care facilities, those with chronic kidney disease at stage three, four or five, morbid obesity (defined as a BMI of 40 and above), pregnant women at any stage of pregnancy (first, second or third trimesters) and use after 48 hours of onset of symptoms if advised by the local PHE Centre HPT. Additional information on pregnancy and breastfeeding Additional information on bronchospasm No dose modification is required for individuals with impaired renal or hepatic function or in older individuals Updated references Updated standard wording for consistency with PHE PGD templates June 2018

5 1. PGD development This PGD has been developed by the following on behalf of Public Health England: Developed by: Name Signature Date Pharmacist (Lead author) Doctor Registered nurse Jacqueline Lamberty Lead Pharmacist Medicines Management Services, Public Health England Dr Gavin Dabrera Interim Lead, Legionella and Influenza Preparedness Section, Public Health England Respiratory Diseases Department Lipi Begum Health Protection Nurse Public Health England North West London Health Protection Team 09 July July July 2018 This PGD has been peer reviewed by an expert panel in accordance with the PHE PGD Policy. It has been agreed by the PHE Medicines Management Group and the PHE Quality and Clinical Governance Delivery Board. Expert panel Name Dr Richard Pebody Mr Mark Borthwick Dr Mat Donati Dr Sally Millership Rosie Furner Designation Chair, Head PHE Respiratory Disease Department Consultant Pharmacist, Oxford University Hospitals NHS Foundation Trust Consultant Medical Virologist/ PHE South West Regional Laboratory, National Infection Service,, CCDC, East of England PHEC Community Services Pharmacist, East Sussex Healthcare NHS Hospital Trust

6 2. Organisational authorisations The PGD is not legally valid until it has had the relevant organisational authorisation. It is the responsibility of the organisation that has legal authority to authorise the PGD, to ensure that all legal and governance requirements are met. The authorising body accepts governance responsibility for the appropriate use of the PGD. Shropshire Clinical Commissioning Group authorises this PGD for use by the services or providers listed below: Authorised for use by the following organisations and/or services Shropshire Clinical Commissioning Group Limitations to authorisation N/A Organisational approval (legal requirement) Role Name Sign Date Director or Nursing, Dawn Clarke Quality & Patient Experience 01/11/2018 Additional signatories according to locally agreed policy Role Name Sign Date Head of Medicines Management Elizabeth Walker 24/10/2018 GP Governing Body Member & Clinical Director Dr Stephen James Organisations must add an individual practitioner authorisation sheet or list of authorised practitioners. This varies according to local policy but this should be a signature list or an individual agreement as included at the end of this PGD.

7 3. Characteristics of staff Qualifications and professional registration Additional requirements Continued training requirements Registered professional with one of the following bodies: nurses currently registered with the Nursing and Midwifery Council (NMC). pharmacists currently registered with the General Pharmaceutical Council (GPhC). Additionally practitioners: must be authorised by name as an approved practitioner under the current terms of this PGD before working to it must have undertaken appropriate training for working under PGDs for supply/administration of medicines must be competent in the use of PGDs (see NICE Competency framework for health professionals using PGDs) must be familiar with the product and alert to changes in the Summary of Product Characteristics must have access to the PGD and associated online resources should fulfil any additional requirements defined by local policy authorising organisation to insert any additional requirements THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT. Practitioners must ensure they are up to date with relevant issues and clinical skills relating to prophylaxis and treatment of influenza, with evidence of appropriate Continued Professional Development (CPD). Practitioners should be constantly alert to any subsequent recommendations from Public Health England and/or NHS England and other sources of medicines information. Note: The authorising organisation should ensure that staff working with this PGD are trained in addressing issues of consent, including those individuals with dementia. The healthcare professional working under this PGD should follow their existing organisational procedures in relation to consent.

8 4. Clinical condition or situation to which this PGD applies. Clinical condition or situation to which this PGD applies Criteria for inclusion Treatment of influenza A and/or B: 1. When all of the following circumstances apply: national surveillance schemes have indicated that influenza virus is circulating in the community 3 and the person is in an at-risk group, including being aged 65 years and over (see inclusion criteria) and the person has an influenza-like illness (ILI) and can start treatment within 48 hours of the onset of symptoms 2. Outside the periods when surveillance indicates that influenza virus is circulating in the community, if there is an outbreak of an ILI in a long-term residential or nursing home (care homes), zanamivir may be offered to at risk residents and staff as part of treatment for those who have symptoms of influenza. This is regardless of vaccination status. However, this should be done only if there is a high level of certainty that the causative agent in a localised outbreak is influenza, usually based on virological evidence of infection with influenza in the index case or cases. Health Protection Teams within Public Health England Centres will advise on whether influenza is the likely causative agent. This PGD will come into force only when either national surveillance schemes have indicated that influenza virus is circulating or when, in a localised outbreak, there is a high level of certainty that the causative agent is influenza (as advised by the local Health Protection Team). Individuals must: 1. Be a resident/user of a care facility or working in a care facility 4 and 2. Be exhibiting signs or symptoms of an influenza-like illness (ILI) 5 and 3. Either be aged 65 years and over (regardless of additional risk group), OR if aged years must be in one of the defined risk groups below: chronic (long-term) respiratory disease Note: those with asthma or COPD requiring regular inhaled or systemic steroids are excluded; see criteria for exclusion chronic heart disease such as heart failure 3 Public Health England uses information from a range of clinical, virological and epidemiological influenza surveillance schemes to identify periods when there is a substantial likelihood that people presenting with an influenza-like illness are infected with influenza virus 4 Care workers who are in an at risk group are at risk of complicated influenza and require treatment 5 Influenza is characterised in its early stages by sudden onset of pyrexia (fever) associated with aches, pains, loss of appetite. Sore throat, nausea, vomiting and harsh unproductive coughs are also common. Heavy colds are commonly confused with influenza. In older patients these symptoms may be mild or absent initially

9 (continued overleaf) Criteria for inclusion (continued) chronic liver disease chronic kidney disease at stage three, four or five chronic neurological disease such as Parkinson s disease or motor neurone disease, or learning disability diabetes immunosuppression due to disease or treatment, including individuals undergoing chemotherapy leading to immunosuppression, some rheumatological drugs, asplenia or splenic dysfunction, HIV infection at all stages, individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day morbid obesity (defined as a BMI of 40 and above) pregnant women at any stage of pregnancy (first, second or third trimesters) and up to 2 weeks post-partum 4. Be able to begin therapy within 48 hours of the onset of the symptoms. In addition, use after 48 hours of the onset of symptoms is indicated if advised by the local PHE Centre HPT. Criteria for exclusion 6 Individuals will not be considered for treatment with zanamivir under this PGD if the following criteria apply: they are not a resident/user or working in a care facility they are less than 13 years of age they have unstable medical conditions they have a known allergy to zanamivir or any of the excipients in the preparation, including lactose they are severely unwell they have been symptomatic for more than 48 hours unless otherwise advised by the local PHE Centre HPT they have new or worsening breathing difficulties or chest pain they have disturbance of consciousness, delirium or excessive drowsiness they have asthma or COPD requiring regular oral or inhaled corticosteroids, due to the increased risk of bronchospasm with zanamivir they are unable to use the inhaler device Action to be taken if the patient or their carer declines treatment Advise the individual or their carer of the possible consequences of refusing treatment, the protective effects of the treatment, the risks of infection, the risk of spreading the disease to others in the care facility, disease 6 Exclusion under this Patient Group Direction does not necessarily mean the medication is contraindicated, but it would be outside the remit of the PGD and another form of authorisation will be required

10 (continued overleaf) Action to be taken if the patient or their carer declines treatment (continued) Action to be taken if the patient is excluded Additional information complications and alternative sources of treatment. Document refusal and advice given in the individual s patient record. Inform the care home manager and the GP or care home doctor without delay. These individuals should be managed with bed rest, fluids and symptomatic remedies such as analgesics or referred to NHS services if necessary. All individuals and their carers should be advised to seek medical advice if symptoms worsen or do not improve within a week. Consider if the individual is suitable for treatment with oseltamivir (see PGD for treatment with oseltamivir in care facilities). Any individual excluded under this PGD who is not suitable for treatment with oseltamivir should be referred to local NHS services for advice without delay. Some individuals excluded under this PGD may be suitable for treatment with zanamivir if clinically assessed and prescribed. It is normal practice to administer only one neuraminidase inhibitor to an individual at a time. Therefore supply either zanamivir or oseltamivir but not both using this PGD. Pregnancy and breastfeeding: the SPC states the safe use of Relenza during pregnancy has not been established. In rats and rabbits zanamivir has been shown to cross the placenta. High doses of zanamivir were not associated with malformations in rats or rabbits and only minor alterations were reported. The potential risk for humans is unknown. Relenza should not be used in pregnancy unless the expected benefit to the mother is thought to outweigh any possible risk to the foetus. In rats zanamivir has been shown to be secreted into milk. There is no information on secretion into breast milk in humans. The use of zanamivir is not recommended in mothers who are breast feeding On the other hand the Specialist Pharmacy Service has published a Q&A factsheet which states: there are no data on zanamivir use during lactation but based on limited bioavailability the systemic exposure of a breastfed infant from maternal treatment, via any route, is expected to be insignificant. the overall consensus is that treatment with either oseltamivir or zanamivir is not a reason to discontinue, or put limitations on breastfeeding full-term or pre-term infants. Due to the very small amounts transferred into breast milk and the limited oral bioavailability of either drug, the benefits of breastfeeding are considered to outweigh any, albeit unidentified, risks. if an infant being breastfed by the mother receiving oseltamivir or zanamivir needs direct treatment or chemoprophylaxis, the recommended dose of oseltamivir or zanamivir for infants should be given. the UK Drugs in Lactation Advisory Service (UKDILAS) advises that, as a precaution, infants should be monitored for vomiting

11 and diarrhoea.

12 5. Description of treatment Name, strength & formulation of drug Legal category Black triangle Off-label use Route / method of administration Dose and frequency of administration Duration of treatment Zanamivir inhalation powder 5mg / dose POM - Prescription only medicine No No Inhalation of powder via Diskhaler (provided with the pack). See patient information leaflet (PIL) for instructions on how to use the Diskhaler. Two inhalations (2 x 5 mg blisters) twice a day. Treatment should be initiated as soon as possible within 48 hours of onset of symptoms. No dose modification is required for individuals with impaired renal or hepatic function or in older individuals 5 (five) days Quantity to be supplied One pack: contains 5 disks containing 4 blisters of zanamivir 5 mg/blister, with Diskhaler device. Storage Do not store above 30 o C. Disposal Drug interactions Identification & management of adverse reactions Reporting procedure of adverse reactions Any unused product or waste material should be disposed of in accordance with local requirements. None reported. Adverse effects associated with zanamivir are rare. They include rash, urticaria, bronchospasm, dyspnoea and throat tightness / constriction. There have been very rare reports of individuals being treated with zanamivir who have experienced bronchospasm and/or decline in respiratory function which may be acute and/or serious. Some of these individuals did not have any previous history of respiratory disease. Any individuals experiencing such reactions should discontinue zanamivir and seek medical evaluation immediately. Individuals with asthma or COPD requiring regular oral or inhaled corticosteroids are excluded from this PGD due to the increased risk of bronchospasm with zanamivir. A detailed list of adverse reactions is available in the Summary of Product Characteristics Any adverse reaction to the product should be documented in the medical records. Alert a doctor in the event of a serious adverse reaction. Report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting

13 scheme. Written information to be given to patient or their carer Supply the marketing authorisation holder's patient information leaflet (PIL). Patient advice /follow up Inform the individual or their carer of any possible side effects and their management. The individual or their carer should be advised to seek medical advice in the event of a severe adverse reaction. Advise the individual or their carer to read the PIL before using the medication. Promote bed rest, fluids and symptomatic remedies such as analgesics. Individuals should be referred to a doctor if breathing difficulties develop or if general health rapidly worsens. Special considerations / additional information Records Use of zanamivir is not a substitute for influenza vaccination. The protection against influenza lasts only as long as zanamivir is administered. Zanamivir may be supplied to individuals as an alternative to oseltamivir when the likely influenza strain is higher risk for oseltamivir resistance or an exclusion to oseltamivir applies. Record: whether valid informed consent was given name of the individual, address, date of birth and GP with whom the individual is registered name of the member of staff who supplied the product name and brand of product date of supply dose, form and route of administration of product; quantity supplied batch number and expiry date advice given; including advice given if the individual is excluded or declines treatment details of any adverse drug reactions and actions taken record supplied via Patient Group Direction (PGD) records should be signed and dated All records should be clear, legible and contemporaneous. A record of all individuals receiving treatment under this PGD should also be kept for audit purposes in accordance with local policy. It is recommended that the general practitioner for the individual is informed in writing when zanamivir has been supplied under this PGD.

14 6. Key references Key references Summary of Product Characteristics NICE guidelines on the use of amantadine, oseltamivir and zanamivir for the treatment of influenza TA168 issued February PHE Guidance on the management of influenza-like illnesses in care homes November nt_data/file/664972/influenza-like_illness_in_care_homes.pdf NHS Specialist Pharmacy Service page re NHS PGDs PHE guidance on use of antiviral agents for the treatment and prophylaxis of seasonal influenza v8 (September 2017) nt_data/file/648758/phe_guidance_antivirals_influenza_201718_f INAL.pdf Ambrozaitis A, Gravenstein S, Van Essen GA, Rubinstein E, Balciuniene L, Stikleryte A et al. Inhaled zanamivir versus placebo for the prevention of influenza outbreaks in an unvaccinated longterm care population. Journal of the American Medical Directors Association (6): Gravenstein S, Drinka P, Osterweil D, Schilling M, Krause P, Elliott M et al. Inhaled zanamivir versus rimantadine for the control of influenza in a highly vaccinated long-term care population. Journal of the American Medical Directors Association (6): Green Book Chapter 19 Influenza Updated December NICE Medicines Practice Guideline 2 (MPG2): Patient Group Directions NICE MPG2 Patient group directions: competency framework for health professionals using patient group directions. January Health Technical Memorandum 07-01: Safe Management of Healthcare Waste. Department of Health 20 th March

15 7. Individual practitioner authorisation sheet BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PATIENT GROUP DIRECTIONS DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE. Practitioner I confirm that I have read and understood the content of this Patient Group Direction and that I am willing and competent to work to it within my professional code of conduct. Signed....Date..... Name (Print) Designation Authorising manager Manager to give authorisation on behalf of INSERT NAME OF ORGANISATION for the named health care professional who has signed the PGD. Signed.. Date... Name (Print) Designation Note to authorising manager By signing above you are confirming that you have assessed the staff member as competent to work under this PGD and that they have the organisational approval to do so. You must give this signed PGD to each authorised practitioner as it shows their authorisation to use the PGD.