Consultation Group: See relevant page in the PGD. Review Date: May Expiry Date: May 2020

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Patient Grup Directin Fr The Administratin Of Salbutaml Via A Spacer By Nurses and Pharmacists Wrking Within NHS Grampian Fr Pst Brnchdilatr Lung Functin Assessment Or Reversibility Testing Lead Authr: Primary Care Respiratry Nurse, Aberdeen City H&SCP Cnsultatin Grup: See relevant page in the PGD Apprver: Medicine Guidelines and Plicies Grup Signature: Signature: Identifier: NHSG/PGD/Sal_COPD/ MGPG865 Review Date: May 2019 Expiry Date: May 2020 Date Apprved: May 2017 A Patient Grup Directin is a specific written instructin fr the supply r administratin f named medicines in an identified clinical situatin. It is drawn up lcally by Dctrs, Pharmacists and ther apprpriate prfessinals, apprved by the emplyer and advised by the relevant prfessinal advisry cmmittees. In mst cases, apprpriate clinical care is prvided n an individual basis by a specific prescriber t a specific individual patient. Patient Grup Directins shuld nly be cnsidered where they ffer a benefit t patient care withut cmprmising patient safety in any way. Uncntrlled when printed Versin 2

This dcument is als available in large print and ther frmats and languages, upn request. Please call NHS Grampian Crprate Cmmunicatins n (01224) 551116 r (01224) 552245. Revisin Histry: Date f change Nvember 2016 March 2017 March 2017 March 2017 March 2017 March 2017 March 2017 Apprval date f PGD that is being superseded Nvember 2014 Nvember 2014 Nvember 2014 Nvember 2014 Nvember 2014 Nvember 2014 Nvember 2014 Summary f Changes 2 yearly update t new PGD template. Statement added regarding using prfessinal judgement. The spacer shuld be cmpatible with the pmdi being used added. Shake inhaler befre use added. Additinal infrmatin regarding dsing added in line with updated SIGN Guidance. Infrmatin regarding ethanl cntent f inhalers remved. Statement regarding single use fr spacers added. Sectin heading Precautins and Special Warnings Rute/Methd f administratin Rute/Methd f administratin Dsage/Ttal Dse Cncurrent Medicatins/Drug Interactins Strage requirements Subject: Patient Grup Directin Identifier: NHSG/PGD/Sal_COPD/MGPG865 Replaces: NHSG/PGD/Sal_COPD/MGPG696, Versin 1 Keywrd(s): Patient Grup Directin PGD salbutaml nurse pharmacist assessment testing via spacer pst brnchdilatr lung functin assessment reversibility testing Plicy Statement: It is the respnsibility f the individual nurse r pharmacist and their line managers t ensure that they wrk within the terms laid dwn in this PGD and t ensure that staff are wrking t the mst up t date PGD. By ding s, the quality f the services ffered will be maintained, and the chances f staff making errneus decisins which may affect patient, staff r visitr safety and cmfrt will be reduced. Supervisry staff at all levels must ensure that staff using this PGD act within their wn level f cmpetence. The lead authr is respnsible fr the review f this PGD and fr ensuring the PGD is updated in line with any changes in clinical practice, relevant guidelines, r new research evidence. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865 - i -

Review date: The review date fr a PGD needs t be decided n a case-by-case basis in the interest f patient safety. The expiry date shuld nt be mre than 3 years frm the date the PGD was authrised. Dcument: Drafted: Octber 2014 Cmpleted: Nvember 2014 Apprved: Nvember 2014, May 2017 (published June 2017) UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865 - ii -

Patient Grup Directin Fr The Administratin Of Salbutaml Via A Spacer By Nurses and Pharmacists Wrking Within NHS Grampian Fr Pst Brnchdilatr Lung Functin Assessment Or Reversibility Testing Clinical indicatin t which this PGD applies Definitin f situatin/cnditin This Patient Grup Directin (PGD) will authrise trained nurses and pharmacists wrking within NHS Grampian t administer salbutaml via a spacer t individuals aged 16 years and ver fr the purpse f assessing pst brnchdilatr lung functin, r brnchdilatr reversibility as part f the diagnstic prcess, when a diagnsis f Chrnic Obstructive Pulmnary Disease (COPD) r Asthma is suspected. This PGD shuld be used in cnjunctin with the recmmendatins in the current British Natinal Frmulary (BNF) and individual Summary f Prduct Characteristics (SPC). Inclusin criteria Salbutaml may be administered t adults ver 16 years f age wh require pst brnchdilatr lung functin r brnchdilatr reversibility assessment, as part f the diagnstic prcess when a new diagnsis f COPD r asthma is suspected. Patients must be able t use an inhaler via a spacer device and als a peak flw meter and/r a spirmeter. Exclusin criteria Patients may receive the administratin f salbutaml via a spacer under this PGD unless they have: Knwn anaphylactic hypersensitivity t any f the cmpnents. Knwn cntraindicatins t perfrming a spirmetry test (nly if spirmetry is being used as the test t asses lung functin). UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-1 -

Precautins and special warnings Salbutaml via a spacer device shuld be used with cautin in patients wh have the fllwing cnditins; hwever it shuld be nted that these cnditins d nt exclude patients frm receiving therapy. Nurses and pharmacists shuld exercise their prfessinal judgement with regard t administering salbutaml. If there is any dubt as t the patient s suitability they shuld be discussed with a GP: Hyperthyridism Cardivascular disease Arrhythmias Susceptibility t QT-interval prlngatin Hypertensin Thyrtxicsis Diabetes. In additin the administratin f salbutaml via a spacer shuld be restricted during pregnancy r breast-feeding t situatins where the benefit t the mther is likely t utweigh any ptential risk t the fetus/nenate. Patients shuld nt have used ther brnchdilatrs within the time perids given belw as this wuld affect the utcme f the lung functin test results. Shrt acting beta 2 agnists within 4-6 hurs. Lng acting beta 2 agnists within 12 hurs. Lng acting muscarinic r lng acting ral thephylline preparatins within 24 hurs. Salbutaml inhalatin may rarely cause paradxical brnchspasm with an immediate increase in wheezing after administratin. Medical advice shuld be sught immediately if this ccurs. Hypersensitivity reactins including angiedema, urticaria, brnchspasm, hyptensin and cllapse are very rare. Refer t Patient Grup Directin fr the administratin f adrenaline (epinephrine) in cases f suspected anaphylactic reactins by qualified health prfessinals. Referral criteria Patients wh fall int the categries detailed in the exclusin criteria. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-2 -

Actin if excluded frm treatment If a patient is excluded frm this PGD because f life threatening asthma, then the PGD fr administering salbutaml nebulised thrugh xygen shuld be immediately used, and medical supprt sught. If a patient is excluded frm treatment under this PGD because f reasns ther than life threatening asthma, medical advice shuld be sught refer t a dctr. The reasn why the patient was excluded under the PGD will be dcumented in the patient s medical ntes. Actin if patient declines treatment Patient shuld be advised f the risks and cnsequences f nt receiving treatment. Recrd utcme in Patient Medicatin Recrd if apprpriate and refer the patient t their General Practitiner/Cnsultant (relevant medical practitiner). Cnsent Prir t the administratin f the drug, valid cnsent must be btained. Cnsent must be in line with current NHSG Staff Plicy fr Obtaining Cnsent fr Clinical Prcedures and Healthcare Interventins. See link belw. http://nhsgintranet.grampian.sct.nhs.uk/depts/qgru/clinicalgv ernance/pages/cnsent.aspx Descriptin f treatment available under the PGD Name f medicine Salbutaml 100 micrgram pressurised metered dse inhaler (pmdi) Legal status Salbutaml 100 micrgram pmdi is a Prescriptin-nly Medicine (PM). Frm/Strength Pressurised inhalatin, suspensin. Each metered dse cntains 100 micrgrams salbutaml (as sulphate). Rute/Methd f administratin Salbutaml shuld be administered via a spacer which shuld be cmpatible with the pmdi being used. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-3 -

Always shake inhaler befre use. The clinician must ensure the patient des nt tuch the pmdi during the test and t minimise any risk f crss infectin, ensure that between patients, the muthpiece and casing f the device are cleaned as per manufacturer s instructins. Mst salbutaml pmdis cntain 200 dses f 100mcg and subsequently shuld last fr up t 50 tests but expiry dates and any damage t the pmdi shuld always be checked prir t use. The salbutaml pmdi des nt need t be single patient use, but nly if used fr the purpse f this PGD. It can be reused in future tests if stred as described in strage sectin. Dsage/Ttal Dse Adults 16 years f age and lder: Dse - 400 micrgrams (4 puffs r actuatins) - This shuld be administered as ne actuatin f 100mcg at a time int the spacer. Each actuatin shuld be fllwed by 5 tidal breaths by the patient using the spacer. After each cycle f actuatin and 5 tidal breathes, wait 30 secnds and repeat again shaking the inhaler between each actuatin. D this a ttal f 4 times. Frequency f administratin Maximum effect f medicatin 4 puffs r actuatins, nce nly 15 Minutes Duratin f treatment Single dse f 400 micrgrams. Strage requirements The salbutaml inhaler shuld be stred in a lcked cupbard belw 30 C, prtected frm frst and direct sunlight. As with mst inhaled medicatins in aersl canisters, the therapeutic effect f this medicatin may decrease when the canister is cld. The canister shuld nt be brken, punctured r burnt, even when apparently empty. Spacers are intended fr single patient use nly and after the test shuld be either given t the patient fr hme use (if the presence f respiratry disease is cnfirmed) r discarded. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-4 -

Fllw-up (if applicable) Patients shuld nt leave if they are feeling at all unwell withut speaking t the nurse r pharmacist first. If necessary a dctr r the patient s GP shuld be cntacted fr advice. The test results shuld be dcumented and the patient asked t see their GP r practice nurse t discuss the results r any pssible new diagnsis in greater detail. Advice t patient (Verbal) Advice shuld be given n what t expect and what t d fr majr and minr reactins. Advice t patient (Written) The Patient Infrmatin Leaflet (PIL) cntained in the medicine(s) shuld be made accessible t the patient, parent, guardian, r persn with parental respnsibility. Where this is unavailable, r unsuitable, sufficient infrmatin shuld be given in a language that they can understand. Cpies f PIL and SPCs fr all medicines can be fund at http://www.medicines.rg.uk r http://www.mhra.gv.uk/spcpil/index.htm Cncurrent Medicatins/Drug Interactins Prpranll and ther nn-cardiselective ß-adrenceptr blcking agents antagnise the effects f salbutaml and shuld nt usually be prescribed tgether. Salbutaml may therefre be less effective in patients n lng term ß-blcking therapy. Mnamine xidase inhibitrs, tricyclic antidepressants and digxin increase the risk f cardivascular effects. Hypkalaemia ccurring with β2 agnist therapy may be exacerbated by treatment with xanthines, sterids, diuretics and lng-term laxatives. Identifying and managing pssible adverse reactins Cmmn side effects include headache, dizziness, fine tremr (particularly in hands) and tachycardia. As with ther inhalatin therapy, paradxical brnchspasm may ccur with an immediate increase in wheezing after dsing. This shuld be treated immediately with an alternative presentatin r a different fast-acting inhaled brnchdilatr. Salbutaml via large vlume spacer shuld be discntinued immediately, the patient assessed, and, if necessary, alternative therapy instituted. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-5 -

This list is nt exhaustive. Please als refer t current BNF/BNFC and manufacturers SPC fr details f all ptential adverse reactins. BNF: https://www.medicinescmplete.cm/mc/bnf/current/ https://www.medicinescmplete.cm/mc/bnfc/current/ SPCs/PILs: https://www.medicines.rg.uk/emc/ http://www.mhra.gv.uk/spc-pil/index.htm If an adverse reactin des ccur give immediate treatment and infrm relevant medical practitiner as sn as pssible. Reprt the reactin t the MHRA using the Yellw Card System. https://yellwcard.mhra.gv.uk/ Medical advice in cases f anaphylaxis Injectins f IM adrenaline/epinephrine 1:1000 must be available t treat an anaphylactic reactin shuld this ccur. Medical advice must be sught as sn as pssible frm a dctr if any patient develps any signs f hypersensitivity. If there is a delay in medical supprt arriving and the cnditin f the patient is deterirating then an emergency ambulance must be called n 999 r direct via ambulance cntrl r dial 2222 (hspital internal) accrding t lcal prcedure, r seek urgent medical advice. (Refer t Patient Grup Directin fr the administratin f adrenaline (epinephrine) in cases f suspected anaphylactic reactins by qualified health prfessinals) http://www.nhsgrampian.cm/grampianfi/files/pgd_adrenaline. pdf. Facilities and supplies required The fllwing shuld be available at sites where the medicatin is t be administered: Apprpriate strage facilities. An acceptable level f privacy t respect patient s right t cnfidentiality and safety. Resuscitatin equipment. Access t medical supprt (this may be via the telephne). Apprved equipment fr the dispsal f used materials. Clean and tidy wrk areas, including access t hand washing facilities. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-6 -

Cpies f the current PGD fr the medicine specified in the PGD. PGD fr the administratin f Adrenaline (epinephrine) in cases f suspected anaphylactic reactins by qualified health prfessinals. Characteristics f staff authrised t supply/administer medicine under PGD Prfessinal qualificatins Registered Nurses as recgnised by the Nursing and Midwifery Cuncil (NMC) and Pharmacists whse name is currently n the register held by the General Pharmaceutical Cuncil (GPhC). Specialist cmpetencies Be cmpetent t assess the patient s capacity t understand the nature and purpse f the administratin in rder fr the patient t give r refuse cnsent. Has undertaken apprpriate training t carry ut clinical assessment f patients leading t a diagnsis that requires treatment accrding t the indicatins listed in the PGD. Be aware f current treatment recmmendatins and be cmpetent t discuss issues abut the drug with the patient. Have been trained and assessed as being cmpetent in the administratin f the drug. Onging training and cmpetency Have attended basic life supprt training which is required t be updated annually. Have undertaken the NHS e-anaphylaxis training sessin (and annual updates) which cvers all aspects f the identificatin and management f anaphylaxis. This can be accessed via eksf, r the AT Learning tl. Maintain their skills, knwledge and their wn prfessinal level f cmpetence in this area accrding t their individual Cde f Prfessinal Cnduct. The practitiner must be familiar with the SPC fr all medicines supplied in accrdance with this PGD. UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-7 -

Prfessinal managers/lead Nurses will be respnsible fr Ensuring that the current PGD is available t staff prviding care under this directin. Ensuring that staff have received adequate training in all areas relevant t this PGD and meet the requirements abve. Maintain up t date recrd f all staff authrised t administer drug specified in PGD. Dcumentatin Authrisatin f administratin Nurses wrking within NHS Grampian can be authrised t administer the drug specified in this PGD by their Nurse Manager/Cnsultant/practice GPs. Pharmacists wrking within NHS Grampian can be authrised t administer the drug specified in this PGD by the Directr f Pharmacy. All authrised staff are required t read the PGD and sign the Agreement t Administer Medicines Under PGD (Appendix 1). A certificate f authrisatin (Appendix 2) signed by the authrising dctr/manager shuld be supplied. This shuld be held in the individual practitiners recrds, r as agreed lcally. Recrd f administratin/ supply An electrnic r paper recrd fr recrding the screening f patients and the subsequent administratin f the drug specified in this PGD must be cmpleted in rder t allw audit f practice. This shuld include: Name and address f patient Patient CHI N and date f birth Details f parent/guardian, r persn with parental respnsibility where applicable Cnsultant/General Practitiner details Risk grup, if apprpriate Findings f physical examinatin, if apprpriate Exclusin criteria, recrd why the drug was nt administered Reasn fr giving Cnsent t the administratin (if nt btained elsewhere) Signature and name in capital letters f practitiner wh administered the drug Date drug given Recrd f any adverse effects (advise patient s dctr). UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-8 -

These recrds shuld be retained: Fr children and yung peple, retain until the patient's 25th birthday r 26th if the yung persn was 17 at the cnclusin f treatment. Fr 17 years and ver retain fr 6 years after last date f entry, fr 3 years after death, r in accrdance with lcal plicy, where this is greater than abve. Audit All recrds f the drug specified in this PGD will be filed with the nrmal recrds f medicines in each practice/service. A designated persn within each H&SCP/practice/service will be respnsible fr auditing cmpletin f drug frms and cllatin f data. References Medicines and Healthcare prducts Regulatry Agency http://www.mhra.gv.uk/spc-pil/index.htm Salbutaml Sulphate 100 micrgrams Inhaler Date f revisin f text 23/03/16, accessed 02/11/16 British Natinal Frmulary https://www.medicinescmplete.cm/mc/bnf/current/ accessed 02/11/16 Management and Mnitring f Patient Grup Directin PGD Cnsultative Grup The cnsultative grup is legally required t include a medical practitiner, a pharmacist and a representative f the prfessinal grup wh will prvide care under the directin Frances Adamsn Susan Allan Anne Cassn Alisn Davie Kris McLaughlin Mrag Reilly Medicines Management Specialist Nurse Practice Nurse, Peterhead Health Centre Lng Term Cnditins, Anticipatry Care Nurse Specialist Pharmacist: Lead Pharmacist Aberdeen City H&SCP GP, Stnehaven Health Centre Lead Authr: Respiratry Lead Aberdeen City H&SCP UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-9 -

Authrising Managers Dr Nick Fluck Medical Directr, NHS Grampian Mr David Pfleger Directr f Pharmacy and Medicines Management, NHS Grampian Prfessr Amanda Crft Directr f Nursing, Midwifery and AHPs, NHS Grampian UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-10 -

Appendix 1 Health Care Prfessinal Agreement t Administer Medicines Under Patient Grup Directin I: (Insert name) Wrking within: e.g. H&SCP, Practice Agree t administer medicines under the directin cntained within the fllwing Patient Grup Directin Patient Grup Directin Fr The Administratin Of Salbutaml Via A Spacer By Nurses and Pharmacists Wrking Within NHS Grampian Fr Pst Brnchdilatr Lung Functin Assessment Or Reversibility Testing I have cmpleted the apprpriate training t my prfessinal standards enabling me t administer medicines under the abve Patient Grup Directin. I agree nt t act beynd my prfessinal cmpetence nr utwith the recmmendatins f the Patient Grup Directin. Signed: Print Name: Date: Prfessinal Registratin N: UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-11 -

Appendix 2 Certificate Of Authrisatin T Administer Medicines Under Patient Grup Directin This authrises: Wrking within: e.g. H&SCP, Practice T administer medicines under the fllwing Patient Grup Directin Patient Grup Directin Fr The Administratin Of Salbutaml Via A Spacer By Nurses and Pharmacists Wrking Within NHS Grampian Fr Pst Brnchdilatr Lung Functin Assessment Or Reversibility Testing The abve named persn has satisfied the training requirements and is authrised t administer medicines under the abve Patient Grup Directin. The abve named persn has agreed nt t act beynd their prfessinal cmpetence nr utwith the recmmendatins f the Patient Grup Directin Signed: Authrising Manager/Dctr Print Name: Date: UNCONTROLLED WHEN PRINTED Review Date: May 2019 Identifier: NHSG/PGD/Sal_COPD/MGPG865-12 -