NHS Grampian Patient Group Direction For The Administration Of Sodium Chloride (0.9%) Via Nebulisation By Physiotherapists Working Within NHS Grampian Lead Author: Consultation Group: Approver: Highly Specialist See relevant page in the NHSG Medicines Respiratory Physiotherapist POD Guidelines and Policies Group Signature: Signature: f h Ac _. Identifier: NHSG/PGD/NaClphy/ MGPG921 Review Date: November 2019 Expiry Date: November 2020 Date Approved: November 2017 NHS Grampian have authorised this Patient Group Direction to help patients by providing them with more convenient access to an efficient and clearly defined service within the NHS Board. This Patient Group Direction cannot be used until Appendix 1 & 2 are completed. Uncontrolled when printed Version 5
Revision History: Date of change Approval date of PGD that is being superseded Summary of Changes 2 yearly update to new PGD template. Section heading NHS Grampian Identifier: Replaces: Keyword(s): NHSG/PGD/NaClphy/MGPG921 NHSG/PGD/NaClphy/MGPG744 PGD Patient Group Direction, PGD, Sodium Chloride, Nebuliser, Physiotherapist Policy Statement: It is the responsibility of individual physiotherapist and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. The lead author is responsible for the review of this PGD and for ensuring the PGD is updated in line with any changes in clinical practice, relevant guidelines, or new research evidence. Review date: The review date for a PGD needs to be decided on a case-by-case basis in the interest of patient safety. The expiry date should not be more than 3 years from the date the PGD was authorised. Document: Drafted: June 2017 Completed: October 2017 Approved: November 2017 (published January 2018) UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921 - i -
Organisational Authorisation This PGD is not legally valid until it has had organisational authorisation NHS Grampian Designation Name Signature Date Signed Medical Director Nick Fluck 06/12/2017 Director of Pharmacy David Pfleger Al-f Th 12/01/2018 Director of Nursing, Midwifery and Allied Healthcare Professionals Amanda Croft (IL rcp3 6-- 04/12/2017 Management and Monitoring of Patient Group Direction PGD Consultative Group The consultative group is legally required to include a medical practitioner, a pharmacist and a representative of the professional group who will provide care under the direction Name: Derek Nicol Dr Gordon Christie Hilary Thomson Alistair Duncan Alison Copland Margaret MacLeod Sarah Hughson Title: Lead Author: Highly Specialist Respiratory Physiotherapist Medical Professional: Consultant Respiratory Physician Acute Lead Physiotherapy Pharmacist: Specialist Palliative Care Pharmacist Clinical Pharmacist Highly Specialist Respiratory Physiotherapist Clinical Lead Physiotherapy UNCONTROLLED WHEN PRINTED Review Date; November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921 - - PGD for the administration of Sodium Chloride (as%) Via Nebulisation by physiotherapists Version 5 Template Version 2.2
Patient Group Direction For The Administration Of Sodium Chloride (0.9%) Via Nebulisation By Physiotherapists Working Within NHS Grampian Clinical indication to which this PGD applies Definition of situation/condition This Patient Group Direction (PGD) will authorise physiotherapists to administer Sodium Chloride (0.9%) via nebulisation to patients aged 16 and over for the treatment of pulmonary secretion retention. This will facilitate optimal treatment of patients who present with pulmonary secretion retention and associated difficulties with expectoration, leading to increased respiratory workload, increased respiratory rate, oxygen desaturation and potential respiratory compromise/failure. Administration of Sodium Chloride (0.9%) by physiotherapists is a useful adjunct to physiotherapy treatment. This PGD should be used in conjunction with the recommendations in the current British National Formulary (BNF) and individual Summary of Product Characteristics (SPC). Inclusion criteria All patients aged 16 and over, presenting with respiratory compromise secondary to pulmonary secretion retention where they, their parent, guardian or person with parental responsibility does not want specifically to consult with a doctor and are happy for the administration to be given by the physiotherapist. All patients with pulmonary secretion retention who demonstrate: Respiratory compromise/distress. Increasing difficulty expectorating. Increased work of breathing. Auscultatory changes (e.g. inspiratory/expiratory crackles and/or low pitched inspiratory/expiratory wheeze). UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-1 -
Exclusion criteria Patients may be administered Sodium Chloride (0.9%) via nebulisation under this PGD unless; They are under the age of 16 years. They present with severe bronchospasm. Precautions and special warnings Administration of Sodium Chloride (0.9%) via nebulisation may induce paradoxical bronchospasm in patients with hyperreactive airways. The physiotherapist must therefore assess the patient during and after administration and report any adverse reactions to medical staff. Referral criteria Patients who fall into the categories detailed in the exclusion criteria. Action if excluded from treatment Medical advice should be sought refer to General Practitioner/Consultant (relevant medical practitioner). The reason why the patient was excluded under the PGD will be documented in the appropriate patient record. Action if patient declines treatment The patient should be advised of the risks and consequences of not receiving treatment. Refer to General Practitioner/Consultant (relevant medical practitioner). Record outcome in Patient Medication Record if appropriate, or relevant patient record. Consent Prior to the administration of the drug, valid consent must be obtained. Consent must be in line with current NHSG consent policy. Description of treatment available under the PGD Name of medicine Sodium Chloride 0.9% w/v nebuliser solution. Ampoules of Sodium Chloride 0.9% w/v solution for injection BP may also be used for nebulisation if the above products are not available. UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-2 -
N.B. None of the above products are licensed for the treatment of pulmonary secretion retention. They are licensed for the dilution of other solutions for nebulisation. As such, Sodium Chloride 0.9% is used off-label when used under this PGD. Legal status Sodium Chloride 0.9% w/v are Prescription-only Medicines (PoMs). Form/Strength Sodium Chloride 0.9% w/v Nebuliser solution is available in 2.5mL ampoules. Sodium Chloride 0.9% w/v solution for injection is available in 5mL, 10mL and 20mL ampoules. Route/Method of administration The primary route of delivery will be via jet nebuliser driven by 6-8L/minute of oxygen therapy. However, in specific COPD patients with evidence of hypoxic drive, the nebuliser will be driven through air. If the patient demonstrates extreme difficulty with expectoration and secretions are very tenacious, the ultrasonic nebuliser or non-invasive ventilator device may be utilised as a route of delivery. This decision will be based on a detailed assessment by the physiotherapist. Dosage/Total Dose The maximum dose of Sodium Chloride 0.9% that may be administered on any one occasion is 5mL. The number and frequency of doses permitted will be based on an ongoing formal assessment by the physiotherapist. Maximum dose allowed under this PGD over 24 hours should not exceed 6 treatments. Duration of treatment Maximum of 6 treatments per 24 hours only. Storage requirements Do not store above 25 C. Do not refrigerate or freeze. For single use only. UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-3 -
Follow-up (if applicable) No follow up treatment is required. Patients should not leave if they are feeling unwell without speaking to the physiotherapist first. If necessary a doctor should be contacted for advice. Advice to patient (Verbal) Advice should be given on what to expect and what to do for major and minor reactions. Advice to patient (Written) The Patient Information Leaflet (PIL) contained in the medicine(s) should be made accessible to the patient, parent, guardian, or person with parental responsibility. Where this is unavailable, or unsuitable, sufficient information should be given in a language that they can understand. Copies of PIL and SPCs for medicines can be found at http://www.medicines.org.uk or http://www.mhra.gov.uk/spcpil/index.htm Concurrent Medications/Drug Interactions If the patient is already prescribed Sodium Chloride 0.9% for nebulisation on the main prescription sheet, the administration record should be checked to establish when it was last given. The patient should be assessed to ascertain whether it is appropriate to administer a further dose, ensuring that the maximum daily dose is not exceeded. There are no specific medicines that a patient takes that would exclude them from this PGD. Identifying and managing possible adverse reactions Adverse events related to the Sodium Chloride component of nebulised medicines are unlikely to cause any adverse effects. This list is not exhaustive. Please also refer to current BNF/BNFC and manufacturers SPC for details of all potential adverse reactions. BNF: https://www.medicinescomplete.com/mc/bnf/current/ https://www.medicinescomplete.com/mc/bnfc/current/ SPCs/PILs and risk minimisation materials: https://www.medicines.org.uk/emc/ http://www.mhra.gov.uk/spc-pil/index.htm http://www.medicines.org.uk/emc/medicine/22894#rmm UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-4 -
If an adverse reaction does occur give immediate treatment and inform relevant medical practitioner as soon as possible. Report the reaction to the MHRA using the Yellow Card System. https://yellowcard.mhra.gov.uk/ Facilities and supplies required The following should be available at sites where the medication is to be administered: Sodium Chloride 0.9% w/v nebuliser solution or ampoules of 0.9% w/v Sodium Chloride intravenous infusion BP. Jet nebuliser. Driving source (oxygen or air). Ultrasonic nebuliser or non-invasive ventilator device (where appropriate). Access to medical support (this may be via telephone). Immediate access to Epinephrine (Adrenaline) 1 in 1000 injection. Resuscitation equipment. Facilities for treating bronchospasm (oxygen, bronchodilators should be available). Safe storage areas for medicines and equipment. Approved equipment for the disposal of used materials. Clean and tidy work areas, including access to hand washing facilities. Copies of the current PGD for the drug specified in the PGD. Characteristics of staff authorised to administer medicine under PGD Professional qualifications Registered Physiotherapists as recognised by the Health and Care Professional Council (HCPC). Specialist competencies Approved by the organisation as; Competent to assess the patient s capacity to understand the nature and purpose of the administration in order for the patient to give or refuse consent. Having undertaken appropriate training to carry out clinical assessment of patients leading to a diagnosis that requires treatment according to the indications listed in the PGD. UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-5 -
Aware of current treatment recommendations and be competent to discuss issues about the drug with the patient. Competent in the administration of the drug. Restriction of administration to senior physiotherapists (AfC, Band 6 or above with a minimum of 2 years experience) will ensure advanced clinical reasoning prior to administration and will ensure ongoing monitoring of the patients treatment and condition. Ongoing training and competency All professionals working under this PGD must; Have attended basic life support training which is required to be updated annually. Have undertaken the NHS e-anaphylaxis training session or equivalent (including annual updates) which covers all aspects of the identification and management of anaphylaxis. This can be accessed via eksf, or the AT Learning tool/learnpro. Maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. Must be familiar with the SPC for all medicines administered in accordance with this PGD. Professional managers/lead Nurses will be responsible for: Ensuring that the current PGD is available to staff providing care under this direction. Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. Maintain up to date record of all staff authorised to administer drug specified in PGD. Documentation Authorisation of administration Physiotherapists working within NHS Grampian can be authorised to administer the drug specified in this PGD by the Head of Service for Physiotherapy, NHS Grampian. UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-6 -
All authorised staff are required to read the PGD and sign the Agreement to Administer Medicines Under PGD (Appendix 1). This should be held in the individual practitioners records, or as agreed locally. A Certificate of Authorisation (Appendix 2) signed by the authorising doctor/manager and staff working to the PGD, should be held as agreed locally. Record of administration/ supply A record of administration of Sodium Chloride 0.9% via nebulisation must be made on the main prescription sheet (Once Only Section). Please refer to the Instructions for NHS Grampian Staff on the In-Patient Prescribing and Administration of Medicines using the NHS Grampian Prescription and Administration Record, and in the physiotherapy notes. These records should be retained: For children and young people, retain until the patient's 25th birthday or 26th if the young person was 17 at the conclusion of treatment. For 17 years and over retain for 6 years after last date of entry, for 3 years after death, or in accordance with local policy, where this is greater than above. Audit All records of the drug(s) specified in this PGD will be filed with the normal records of medicines in each practice/service. A designated person within each H&SCP/practice/service will be responsible for auditing completion of drug forms and collation of data. References Medicines and Healthcare Products Regulatory Agency http://www.mhra.gov.uk/spc-pil/index.htm Saline Steri-Neb Date of revision of text 20/06/14, accessed 01/06/17. Electronic Medicines Compendium http://www.medicines.org.uk Saline Steripoule Date of revision of text 11/07/16, accessed 01/06/17. British National Formulary https://www.medicinescomplete.com/mc/bnf/current/ accessed 01/06/17. UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-7 -
Appendix 1 Health Care Professional Agreement to Administer Medicines Under Patient Group Direction I: (Insert name) Working within: e.g. H&SCP, Practice Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Administration Of Sodium Chloride (0.9%) Via Nebulisation By Physiotherapists Working Within NHS Grampian I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor out with the recommendations of the Patient Group Direction. Signed: Print Name: Date: Professional Registration No: UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-8 -
Appendix 2 Health Professionals Authorisation to Administer Medicines Under Patient Group Direction The lead nurse/professional of each clinical area is responsible for maintaining records of their clinical area where this PGD is in use, and to whom it has been disseminated. The manager who approves a healthcare professional to supply and/or administer medicines under the patient group direction, is responsible for ensuring that he or she is competent, qualified and trained to do so and for maintaining an up-to-date record of such approved persons in conjunction with the Head of Profession. The healthcare professional who is approved to supply and/or administer medicines under the direction is responsible for ensuring that he or she understands and is qualified, trained and competent to undertake the duties required. The approved person is also responsible for ensuring that administration or supply is carried out within the terms of the direction, and according to his or her code of professional practice and conduct. Patient Group Direction For The Administration Of Sodium Chloride (0.9%) Via Nebulisation By Physiotherapists Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-9 -
Patient Group Direction For The Administration Of Sodium Chloride (0.9%) Via Nebulisation By Physiotherapists Working Within NHS Grampian Local clinical area(s) where these healthcare professionals will operate under this PGD: Name of Healthcare Professional Signature Date Name of Manager Signature Date UNCONTROLLED WHEN PRINTED Review Date: November 2019 Identifier: NHSG/PGD/NaClphy/MGPG921-10 -