Public Health England

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1 Agenda item: Enclosure Number TBC Shropshire Clinical Commissioning Committee meeting: Patient Group Direction (PGD) for oseltamivir 75mg and 30mg capsules for the treatment of influenza Title of the report: Responsible Director: Patient Group Direction (PGD) for oseltamivir 75mg and 30mg capsules 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 oseltamivir 75mg and 30mg capsules for the treatment of influenza. Key issues or points to note: Practices in Shropshire currently do not have a PGD for the supply of oseltamivir 75mg and 30mg capsules 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 oseltamivir. 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 oseltamivir 75mg and 30mg capsules 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 oseltamivir is commissioned by the Yes CCG. Last year the supply of oseltamivir cost the CCG 6, 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 cost of supplying oseltamivir could increase considerably in Yes the 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 oseltamivir 75mg and 30mg capsules for the treatment of seasonal influenza Residents/users and staff of care facilities (with or without nursing) For the supply of oseltamivir 75mg and 30mg capsules by registered Nurses and Pharmacists 1 Reference: Version no: Valid from: 26 July 2018 Review date: 26 July 2020 Expiry date: 26 July Oseltamivir 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. 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 oseltamivir under PGD to care home residents 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 PGD Website. 2 This includes any relevant amendments to legislation (eg 2013 No235, 2015 No.178 and 2015 No.323).

4 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: Any queries regarding the content of this PGD should be addressed to: Version number Change details Change history Date Original PGD template developed 11 December Template reviewed; put into new PHE format and changes to clinical and organisational content made Review: updates to title and criteria for inclusion: wording changed to residents/users and staff of care facilities amendments to inclusion and exclusion criteria additions to actions to be taken if the patient is excluded renal impairment definitions added information regarding not splitting packs additions to patient advice updated references minor typographical changes for consistency with other PGDs. 07 January 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, PHE Respiratory Diseases Department Lipi Begum Health Protection Nurse Public Health England North West London Health Protection Team 05 June June June 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 / Head of Virology, 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 of 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 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). Additional requirements Continued training requirements 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 B: 1. When all of the following circumstances apply: national surveillance schemes have indicated that influenza virus is circulating in the community 3 as advised by the Chief Medical Officer (CMO) 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), oseltamivir 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 staff 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 risk group), OR if aged years must be in one of the defined risk groups below: chronic (long-term) respiratory disease such as severe asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis 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) Criteria for exclusion 6 Action to be taken if the patient or carer declines treatment chronic heart disease, such as heart failure chronic kidney disease at stage three, four or five chronic liver disease 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 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 symptoms 5. In addition, use after 48 hours of contact with any case during the infectious period is indicated if advised by the local PHE Centre HPT. Individuals will not be considered for treatment with oseltamivir 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 oseltamivir phosphate or any of the excipients in the preparation they are taking other drugs with clinically significant drug interactions eg chlorpropamide, methotrexate, phenylbutazone they are severely unwell they have been symptomatic with this episode of influenza-like illness for more than 48 hours they have new or worsening breathing difficulties or chest pain they have disturbance of consciousness, delirium or excessive drowsiness they have significant vomiting or are unable to drink fluids Advise the individual or carer of the possible consequences of refusing the treatment, the risk of spreading the disease to others in the care home, complications and alternative sources of treatment. 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 carer declines treatment (continued) Action to be taken if the patient is excluded Additional information Document the refusal and the 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 zanamivir (see PGD for treatment with zanamivir in care facilities). Any individual excluded under this PGD who is not suitable for treatment with zanamivir should be referred to local NHS services for advice without delay. Individuals who are severely unwell, have new or worsening breathing difficulties or chest pain or have been symptomatic with this episode of influenza-like illness for more than 48 hours must be referred for medical advice. Individuals excluded under this PGD may be suitable for treatment with oseltamivir if clinically assessed and prescribed. It is normal practice to administer only one neuraminidase inhibitor to an individual at a time. Therefore supply either oseltamivir or zanamivir but not both. If the Health Protection Team has advised that the confirmed or dominant circulating influenza strain is higher risk for oseltamivir resistance and the patient is immunocompromised (due to disease or treatment eg adults taking steroids at a dose equivalent to prednisolone at 20mg or more per day) discuss with an infection specialist for advice

11 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 Oseltamivir 75mg capsules Oseltamivir 30mg capsules POM - Prescription only medicine No Yes, when used outside the periods when national surveillance indicates that influenza virus is circulating generally in the community - see footnote below 7 or after 48 hours of contact with any case during the infectious period if advised by the local PHE Centre HPT. Where a product is recommended off-label consider, as part of the consent process, informing the individual/patient/carer that the product is being offered in accordance with national guidance but that this is outside the product licence. Oral Capsules should be swallowed whole with water. For individuals with swallowing difficulties, the capsules can be opened and the contents mixed with a small amount of sweetened food, such as syrup, dessert toppings, sauce or sugared water, just before administration (see Patient Information Leaflet). Treatment should be initiated as soon as possible, ideally within 12 hours of onset of symptoms but certainly within the first two days (48 hours) of onset of symptoms. One 75mg capsule twice daily, every 12 hours, for 5 days, preferably with food to reduce to risk of nausea or vomiting Renal impairment 8 No known chronic renal impairment Moderate impairment (CrCL ml/min)* Severe impairment (CrCL 11-30mL/min)* Established renal failure (CrCL 10mL/min) ++ Haemodialysis * Dose One 75mg capsule twice a day for 5 days One 30mg capsule twice a day for 5 days One 30mg capsule once a day for 5 days One 30mg capsule once only Refer to a medical practitioner 7 The product licence covers treatment of influenza when influenza virus is circulating in the community. However NICE guidelines recommend oseltamivir can be used during localised outbreaks of ILI outside the periods when national surveillance indicates that influenza virus is circulating generally in the community, in at-risk people living in long-term residential or nursing homes (care homes). 8 PHE guidance on use of antiviral agents for the treatment and prophylaxis of seasonal influenza v8 (September 2017)

12 (continued overleaf) Dose and frequency of administration (continued) Duration of treatment Quantity to be supplied Storage Disposal Drug interactions Identification & management of adverse reactions Peritoneal dialysis * One 30mg capsule once only * Source: Summary of Product Characteristics ++ The recommendations for haemo(dia)filtration and established renal failure are based on expert opinion Individuals with no known renal problems should be supplied with a full dose; if there is a history of renal failure supply as per latest documented creatinine clearance (CrCL) results. If the individual is definitely known to have chronic renal impairment and CrCL results are not available, consider if they are suitable for treatment with zanamivir (see PGD for treatment with zanamivir in care homes). Also refer to special considerations section for further information. For individuals without renal impairment weighing >23kg to 40kg: supply 60mg (two 30mg capsules ) twice a day for 5 days (ref: PHE guidance on use of antiviral agents for the treatment and prophylaxis of seasonal influenza v8 (September 2017)) See dosage schedule above No known chronic renal impairment: 10 x 75mg capsules Moderate renal impairment 9 : 10 x 30 mg capsules Severe impairment 10 : 5 x 30mg capsules Established renal failure 10 : 1 x 30mg capsule Haemodialysis: see dosage schedule above Peritoneal dialysis: 1 x 30mg capsule For individuals weighing >23kg to 40kg: 20 x 30mg capsules When supplying under PGD, this should be from the manufacturer s original pack or over-labelled pre-packs so that the individual s name, the date and additional instructions can be written on the label at the time of supply. As split packs cannot be supplied, an over-supply might be required. Individuals must be advised to take any remaining capsules to a community pharmacy for destruction. Do not store above 25 o C Any unused product or waste material should be disposed of in accordance with local requirements. Individuals taking the following medicines are excluded from this PGD: chlorpropamide methotrexate phenylbutazone The Green Book states that administration of influenza antiviral agents within two weeks of administration of a live attenuated influenza vaccine may adversely affect the effectiveness of the vaccine. Frequently reported adverse reactions include nausea, vomiting, abdominal pain and dyspepsia. 9 See page 9

13 (continued overleaf) Identification & management of adverse reactions (continued) Reporting procedure of adverse reactions Written information to be given to patient or their carer These reactions may only occur on a single occasion, on either the first or second treatment day, and resolve spontaneously within one to two days. However, if symptoms persist, individuals should consult a healthcare professional. Individuals should be advised not to discontinue treatment without consulting a doctor or pharmacist. Other commonly reported adverse reactions include bronchitis, dizziness (including vertigo), fatigue, headache, insomnia, herpes simplex, nasopharyngitis, upper respiratory tract infections, sinusitis, cough, sore throat, pyrexia, rhinorrhoea, limb pain, pain. 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 scheme. Supply the marketing authorisation holder's patient information leaflet (PIL). Patient advice /follow up Inform the individual or their carer: that taking the medication with food can reduce nausea or vomiting. that the capsules can be opened and taken with a small amount of sweetened food as explained in the PIL of any possible side effects and their management to seek medical advice in the event of a severe adverse reaction. to seek advice if common side effects do not spontaneously resolve 48 hours after presentation. to complete the course. to read the PIL before taking the medication if an over-supply has been required, individuals must be advised to take any remaining capsules to a community pharmacy for destruction 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 worsens. Special considerations / additional information Oseltamivir is not recommended for treatment of individuals who are aged less than 65 years and who are not in at risk groups. Use of oseltamivir is not a substitute for influenza vaccination. The protection against influenza lasts only as long as oseltamivir is administered. The British Geriatrics Society has provided advice on situations where

14 no renal function information is available. Records 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 if an over-supply has been required, record this and that advice to return the remaining product to a community pharmacy for destruction has been given All records should be clear, legible and contemporaneous. A record of all individuals receiving treatment under this Patient Group Direction 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, if oseltamivir has been supplied under this PGD.

15 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 _data/file/664972/influenza-like_illness_in_care_homes.pdf National flu immunisation programme 2017/ _data/file/600880/annual_flu letter_2017to2018.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) _data/file/648758/phe_guidance_antivirals_influenza_201718_fina L.pdf Green Book Chapter 19 Influenza Updated December NHS/ UKMI Medicines Q and As: Oseltamivir or zanamivir can mothers breastfeed after treatment for influenza? NICE Medicines Practice Guideline 2 (MPG2): Patient Group Directions NICE MPG2 Patient group directions: competency framework for health professionals using patient group directions Health Technical Memorandum 07-01: Safe Management of Healthcare Waste. Department of Health 20 th March

16 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 healthcare 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.