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1 Patient Group Direction 2155 version 2.0 Administration / Supply of Inhaled Salbutamol in Asthma by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Date of Introduction: June 2017 Review Date: May 2019 Developed By Name Signature Date Physician Pharmacist Lead Professional Emergency Department Consultant Senior Manager MIU Services / Nurse Consultant Emergency Care Unit Note: The Lead Professional is responsible for ensuring the co-ordination, composition, consultation, revision and distribution of the PGD to practitioners who will be using the PGD as well as ensuring that the PGD is no longer used if becomes out of date and once it has expired. The Clinical Effectiveness Department will write to the Lead Professional approximately 4 months before the review date as a reminder that a review is required. Ratified on behalf of: TORBAY AND SOUTH DEVON NHS FOUNDATION TRUST Medicines Management Committee Chair Signed: Name: Clinical Director Pharmacy and Prescribing Date: Lead Officer Signed: Name: Medical Director Date: June 2017 May 2019 Page 1 of 10

2 Patient Group Direction 2155 version 2.0 Administration / Supply of Inhaled Salbutamol in Asthma by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Objective To enable emergency nurse practitioners (including paramedics) in ED and in MIUs to provide effective management of asthma. 1. Clinical Condition Definition of condition/situation Facilities required Management of asthma in adults and children Salbutamol inhalers and nebules Nebuliser Oxygen Criteria for inclusion Criteria for exclusion All adults and children aged 2 years and over presenting with moderate, acute severe or life threatening acute asthma Hypersensitivity to salbutamol or any of the excipients Action if excluded Action if patient refuses medication Refer to medical practitioner and document in patient s records Refer to Accident and Emergency urgently by 999 and document action if presenting at MIU Document informed refusal in patient s records and action taken: a) Referral to protocol b) Referral to appropriate medical practitioner 2. Characteristics of Staff Qualifications required Minor Injury Practitioner (nurse or paramedic) working in community MIU. Emergency Nurse Practitioners (or paramedic) working in ED Additional requirements Working knowledge of relevant Trust Policies, including Medicines Policy and associated Standard Operating Procedures, Anaphylaxis Policy and Consent Policy. Working knowledge of relevant Trust protocols. Evidence of continuing professional development, and any training and competence relevant to this PGD. Working knowledge of the NMC Standards for Medicines Management 2007, (updated 2010) and other relevant codes of professional practice. Working knowledge of the NMC Standards of Proficiency for Paramedics (September 2014), Standards of Proficiency paramedics.pdf and other relevant codes of professional practice. June 2017 May 2019 Page 2 of 9

3 3. Description of Treatment Name of Medicine Supplied Name of Medicine Administered Legal Class Storage Salbutamol pressured metered dose inhaler (pmdi) 100micrograms per actuation. Salbutamol nebuliser solution 2.5mg in 2.5ml. Salbutamol nebuliser solution 5mg in 2.5ml. As above POM (Prescription Only Medicine) Metered dose inhaler: Store below 30 C. Protect from frost and direct sunlight. The canister should not be broken, punctured or burnt, even when apparently empty. The therapeutic effect of this medication may decrease if the canister is cold. Nebuliser solutions: Store below 25 o C. Protect from light after removal from foil. Three month expiry once removed from foil packaging Please refer to current summary of product characteristics for manufacturers storage recommendations for each product. Dose to be used (including criteria for use of differing doses) Treatments should be administered as per current British Thoracic Society / SIGN British Guideline on the Management of Asthma. (NB. If a patient has signs and symptoms across categories always treat according to their most severe feature). For dosing schedules, refer to the total dose section following. Method or route of administration Inhalation from pressured Metered Dose Inhaler (pmdi) via spacer (plus face mask if appropriate) or nebulised VIA HIGH FLOW OXYGEN starting from 6L/min (caution may need to reduce to 4L/min in COPD) June 2017 May 2019 Page 3 of 9

4 Total dose and number of times drug to be given. Details of supply (if supply made) NB: In acute severe / life threatening situation, call 999 ambulance and arrange urgent transfer to acute hospital when presenting to MIU and discuss with doctor. Treat according to the dosing schedule below. Continuous reassessment of the patient is essential, with early transfer to acute hospital if no improvement observed for all degrees of exacerbation: All classification as per BTS guideline 2016: Adults and children aged over 12 years: Moderate and Acute Severe asthma Salbutamol pmdi, 4 puffs initially via spacer [given one puff at a time, with tidal breathing and inhaled separately] and then give a further 2 puffs every 2 minutes according to response up to a maximum of 10 puffs or Salbutamol 5mg nebuliser solution administered via oxygen-driven nebuliser Assess response to treatment and repeat salbutamol dose if necessary, whilst seeking further medical advice. Other treatments will be required as per protocol Life-threatening asthma: Salbutamol 5mg nebuliser solution administered via oxygen-driven nebuliser or Salbutamol pmdi, 4 puffs initially via spacer [given one puff at a time, with tidal breathing and inhaled separately] and then give a further 2 puffs every 2 minutes according to response up to a maximum of 10 puffs If transfer delayed to A&E, salbutamol dose may be repeated if necessary, whilst seeking further medical advice. Other treatments will be required as per protocol. Refer to medical practitioner Children aged over 5 years to 12 years: Moderate asthma Salbutamol pmdi, 2 puffs administered via spacer and mouth piece [given one puff at a time, with tidal breathing and inhaled separately] and then give 1 puffs every seconds up to maximum of 10 puffs according to response Assess response to treatment and repeat salbutamol dose if necessary, whilst seeking further medical advice (if poor response arrange admission if presenting to MIU). Other treatments may be required as per protocol Severe asthma: Salbutamol pmdi, 2 puffs administered via spacer and mouth piece [given one puff at a time, with tidal breathing and inhaled separately] and then give 1 puffs every 30-60seconds up to maximum of 10 puffs according to response or Salbutamol 5mg nebuliser solution administered via oxygen driven nebuliser via facemask Assess response to treatment and repeat salbutamol dose after 15 minutes if poor response arrange admission if presenting at MIU Other treatments will be required as per protocol Life-threatening asthma: Salbutamol 5mg nebuliser solution administered via oxygen-driven nebuliser via face mask and arrange admission if presenting at MIU If transfer delayed from MIU, salbutamol dose may be repeated after 20 minutes if necessary, whilst seeking further medical advice. Other treatments will be required as per protocol Refer to medical practitioner June 2017 May 2019 Page 4 of 9

5 Total dose and number of times drug to be given. Details of supply (if supply made) Children aged 2 years to 5 years: Moderate asthma: Salbutamol pmdi, 2 puffs via spacer, plus face mask [given one puff at a time, with tidal breathing and inhaled separately] ] and then give 1 puff every seconds up to maximum of 10 puffs according to response Assess response to treatment and repeat salbutamol dose if necessary, whilst seeking further medical advice. If poor response seek further medical advice Other treatments may be required as per protocol Severe asthma: Salbutamol 2.5mg nebuliser solution administered via oxygen-driven nebuliser using face mask or Salbutamol pmdi, 2 puffs via spacer, plus face mask [given one puff at a time, with tidal breathing and inhaled separately] ] and then give 1 puff every seconds up to maximum of 10 puffs according to response Assess response to treatment and repeat salbutamol dose after 15minutes if necessary, whilst seeking further medical advice. If poor response, seek further medical advice or arrange admission if presenting to MIU Other treatments will be required as per protocol Life-threatening asthma: Salbutamol 2.5mg nebuliser solution administered via oxygen-driven nebuliser using face mask If transfer delayed from MIU, salbutamol dose may be repeated after 20 minutes if necessary, whilst seeking further medical advice. Other treatments will be required, as per protocol Refer to medical practitioner Infants under 2 years: ASSESS and REFER all infants under 2 years to a medical practitioner where available or refer direct to Emergency Department via 999 ambulance if presenting to MIU Give salbutamol pmdi via spacer and close fitting facemask, administering one puff every seconds up to a maximum of 10 puffs, or give nebulised salbutamol 2.5mg nebuliser solution via oxygen-driven nebuliser. Urgently seek further medical advice if not responding. June 2017 May 2019 Page 5 of 9

6 Total dose and number of times drug to be given. Details of supply (if supply made) Patient presenting with non-acute asthma: As per BTS Guidelines, for occasional relief bronchodilator. Doses administered by aerosol inhalation via pressurised metered dose inhaler (pmdi): Adults and children 2 years and above: micrograms (1-2 puffs); for persistent symptoms up to 4 times a daily. If salbutamol inhaler is supplied to the patient to take home, supply one inhaler appropriately labelled with: Patient s name Drug name Strength and form Clear dosage instructions The date of supply Name and address of supplier. Where appropriate, a spacer device (with face mask if necessary for infants) should be provided. This should be recorded in the patient s clinical records. Instruct patient to take 1 or 2 puffs, according to appropriate dosing schedule, when required. If frequency of use exceeds four-hourly intervals patient should seek medical advice. Contra-indications See exclusion criteria Cautions Interactions Potential side-effects and adverse reactions Cautions are relative as salbutamol is intended for use in emergencies and its use should not be delayed in an acute situation. Use with caution in patients with uncontrolled hyperthyroidism, cardiovascular disease, arrhythmias, severe and untreated hypertension. These patients should have a lower threshold for transfer to an acute hospital if not responding to treatment in an acute situation. Patients on beta-blockers (may need higher dose of salbutamol to reverse bronchoconstriction) If patient is taking any other medications consult BNF Appendix 1 for any potential interactions. Salbutamol and non-selective β-blocking drugs such as propranolol, should not usually be prescribed together Some side effects may be experienced such as tremor, headache and palpitations See SPC / BNF for full list Unusual or life threatening reactions require immediate medical attention. Indicate other issues for patients / carers to consider e.g. drug food interactions, likelihood to effect ability to drive / work etc. Management of potential side-effects and adverse reactions Unusual or life threatening reactions require immediate medical attention. Explain the current course of action to patient/carer. Some side effects may be experienced such as tremor, headache and palpitations if these persist to see their G.P. June 2017 May 2019 Page 6 of 9

7 Advice and information to patient/carer including follow-up Unusual or life threatening reactions require immediate medical attention. Explain the current course of action to patient/carer. The need for urgent medical assessment where appropriate. Advice on course of action to be taken if attack recurs. For patients being transferred to secondary care from MIUs, ensure a copy of the clinical treatment record is sent with the patient. A copy will also be sent to the surgery in the normal manner. Advice regarding future asthma management, including need for appointment with GP asthma clinic, where appropriate. Some side effects may be experienced such as tremor, headache and palpitations Specify method of recording supply /administration including audit trail The following will be recorded in the patient s records: The diagnosis and treatment The dose administered and/or the quantity supplied The route of administration The frequency of administration The time and date of supply/administration The signature and name of the person supplying/administering the medication and phrase PGD or if documenting in Symphony, an electronic signature recorded by the system is acceptable & endorse PGD. Document allergies and other adverse drug reactions clearly in patient records and inform the GP and other relevant practitioners/patient/carer for further reporting and action if required. Report any adverse drug reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) through the yellow card reporting system ( 4. Other Information Follow up treatment: Arrangements for medicine supply: Arrangements for medical referral: Lines of accountability: As per clinical protocol, to see G.P. or Practice Asthma Nurse. Stock is available in MIUs & ED Medical referral should be made as detailed in the protocol Individual nurses are accountable for their own practice under the code of professional conduct laid down by the NMC (Nursing and Midwifery Council 2002 section 1) Individual paramedics are accountable for their own practice under the HCPC Standards of Proficiency for Paramedics (September 2014) Minor Injury Practitioners are accountable to the senior practitioner on duty and their line manager June 2017 May 2019 Page 7 of 9

8 5. Appendices References used in the development of this PGD: Audit details BNF 72 BNF for children 2016/17 Current SPC Ventolin 2.5mg and 5mg (Accessed ) Current SPC Ventolin Evohaler 100mcg (Accessed ) South and West Devon Formulary. (Accessed ) BTS/SIGN British Guideline on the Management of Asthma 2016 Periodic audit of compliance. Case note review of identified patients. We will ask nurses to identify patients they have given medication against PGD and review the appropriateness and documentation against the criteria. Training Medical treatment: As per clinical protocol Competency assessment: Ongoing CPD benchmarked competency assessment in clinical protocol. Frequency of training / review process: Ongoing review / supervision. Please refer to the summary of product characteristics for full information This Patient Group Direction is operational from the start of June 2017 and expires end of May 2019 Version History Version Date Brief Summary of Change Owner s Name V 1.0 May 2017 Two year review of PGD. Content transferred to the Trust s current PGD template v 2.0 June 2017 Amendment of Characteristics of Staff to include paramedics working in ED Torbay and South Devon NHS Foundation Trust Torbay and South Devon NHS Foundation Trust For more information on the status of this document, contact: Medicines Governance Team Administrator Pharmacy Department Torbay Hospital tsdft.medicinesgovernance@nhs.net Date of Issue June 2017 Reference PGD 2155 v 1.0 Salbutamol Path V:Medicines Governance/PGDs/PGD 2155 v 1.0 Salbutamol June17-May19 June 2017 May 2019 Page 8 of 9

9 Patient Group Direction 2155 version 2.0 Administration / Supply of Inhaled Salbutamol in Asthma by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Objective To enable emergency nurse practitioners (including paramedics) in ED and in MIUs to provide effective management of asthma. The individual practitioners named below are authorised to operate within the above PGD, being employees of Torbay and South Devon NHS Foundation Trust CLINICAL AREA LOCATION / DEPARTMENT The following list must be kept with a copy of the PGD in each clinical area using that PGD. Each practitioner will receive and sign for an individual copy of the PGD. Only fully competent, qualified and trained professionals may operate within PGDs. I agree to administer/supply the above preparation in accordance with this Patient Group Direction and I have received an up to date copy of the ratified PGD: NAME (please print) PROFESSIONAL TITLE SIGNATURE AUTHORISING MANAGER (please print) MANAGER S SIGNATURE DATE June 2017 May 2019 Page 9 of 9

10 Document Control Information This is a controlled document and should not be altered in any way without the express permission of the author or their representative. Please note this document is only valid from the date approved below, and checks should be made that it is the most up to date version available. If printed, this document is only valid for the day of printing. Ref No: 2155 Document title: Salbutamol, Admin / Supply of in ED s and in MIU's Purpose of document: Patient Group Direction Date of issue: 23 June 2017 Next review date: 31 May 2019 Version: 2 Last review date: Author: Physician Pharmacist Lead Professional Directorate: Pharmacy Equality Impact: The guidance contained in this document is intended to be inclusive for all patients within the clinical group specified, regardless of age, disability, gender, gender identity, sexual orientation, race and ethnicity & religion or belief Committee(s) approving the document: Clinical Director of Pharmacy Medical Director Date approved: 16 June 2017 Links or overlaps with other policies: All TSDFT Trust Strategies, policies and procedure documents Does this document have training implications? If yes please state: Please select Yes No Does this document have financial implications? If yes please state: Is this document a direct replacement for another? If yes please state which documents are being replaced: Document Amendment History Date Version no. Amendment summary Ratified by: 02 June New Clinical Director of Pharmacy Medical Director 23 June Amended Chair, Medicines Management Committee Medical Director Collated by Clinical Effectiveness Salbutamol, Admin / Supply of in ED and in MIU's Document Control Information