Document Details Title Patient Group Direction (PGD) Salbutamol Aerosol Inhaler and salbutamol Nebulised Solution Trust Ref No 1569-34313 Local Ref (optional) Main points the document Treatment of acute exacerbation of asthma covers Who is the document Clinical staff treating Asthma aimed at? Author Rita O Brien Approval process Approved by Quality and Safety Delivery Group (Committee/Director) Approval Date 10 January 2017 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Quality & Operations Category Policy Sub Category Patient Group Direction Review date 30 January 2019 Distribution Who the policy (PGD) will Clinical areas providing treatment for asthma be distributed to Method Email notification of entry onto webpage Document Links Required by CQC Regulation 12 Required by NHLSA Other Amendments History No Date Amendment 1 December 2014 Scheduled review: Doses based on BTS guidelines 2 December 2016 Scheduled review: no changes Page 1 of 7
PATIENT GROUP DIRECTION Salbutamol Aerosol Inhaler and salbutamol Nebulised Solution Lead clinicians consulted in the development of this PGD Andrew Thomas Head of Nursing and Quality Rachel Mole Clinical Service Manager Cath Molineux Consultant Nurse Narinder Kular Consultant Nurse If any signatures are missing below, then the PGD is not valid APPROVED FOR USE BY: Medicines Management Group Doctor Dr Emily Peer Associate Medical Director 19/12/2016 Pharmacist Rita O Brien Chief Pharmacist 10/01/2017 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Steve Gregory Director of Nursing and Operations 10/01/2017 Page 2 of 7
STAFF CHARACTERISTICS Employed or contracted by Shropshire Community Health NHS Trust Eligible professional with current registration Specialist competencies or qualifications: The clinical manager has evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in the PGD. Provide evidence of training, annual updates and Continuing Professional Development undertaken. The clinical manager has proof of training by the health care professional on the legal aspects of supply or administration of medicines under a Patient Group Direction The clinical manager has assessed the competency (against the national framework) of the healthcare professional to work to a Patient Group Direction at least every 2 years. Has undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. Must have access to all relevant sources of information e.g. information issued by the Department of Health (DH), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD). The practitioner needs to re inforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession s Code of Professional Conduct and Ethics. YOU MUST BE AUTHORISED BY NAME BY YOUR MANAGER UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Page 3 of 7
CLINICAL CONDITION Clinical need addressed Inclusion criteria Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF Exclusion under this Patient Group Direction does not necessarily mean contraindicated but outside the remit of this PGD Caution / need for further advice Management of excluded patients Action for patients not wishing to receive care under this PGD Treatment of acute exacerbation of asthma Adults or children requiring bronchodilation or with signs and symptoms of acute asthma according to current British Thoracic Society Guidelines No consent Patients with known or reported sensitivity to salbutamol Hyperthyroidism, myocardial insufficiency, arrhythmias, diabetes, hypertension, susceptibility to QT interval prolongation, or other severe cardiac disease Pregnancy and breast-feeding. Concurrent therapy with a β blocker Headache due to vasodilation Referral to doctor, independent prescriber or other appropriate emergency service if necessary Document action and advice given Refer to doctor or independent prescriber Page 4 of 7
Drug details Name form and strength of medicine Legal classification Route / method Dose / Frequency Prescription Only Medicine (POM) By Mouth by inhalation Either salbutamol aerosol inhaler (100 micrograms/metered inhalation) or By aerosol inhalation via large-volume spacer (and a close-fitting face mask if child under 3 years) ADULT and CHILD 2 10 puffs each inhaled separately, repeated after 10 20 minutes if necessary salbutamol nebuliser solution (2.5mg or 5mg nebules) By inhalation of nebulised solution (via oxygen-driven nebuliser if available) CHILD UNDER 5 YEARS CHILD 5 11 YEARS 2.5 mg every 20 30 minutes if necessary 2.5 5 mg every 20 30 minutes if necessary ADULT AND CHILDREN OVER 12 YEARS 5 mg every 20 30 minutes if necessary Number of times treatment may be administered Quantity to be supplied or administered Side effects Full details of side effects are available in the SPC. Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at www.yellowcard.gov.uk Additional Information As above per episode of exacerbation. As above Side-effects of the beta 2 agonists include fine tremor (particularly in the hands), nervous tension, headache, muscle cramps, and palpitation. Other side-effects include tachycardia, arrhythmias, peripheral vasodilation, myocardial ischaemia, and disturbances of sleep and behaviour. Paradoxical bronchospasm (occasionally severe), urticaria, angioedema, hypotension, and collapse have also been reported. High doses of beta 2 agonists are associated with hypokalaemia Store in a cool, dry place, away from direct heat and light. Page 5 of 7
Advice to patient / carer Patients should be advised to make regular appointments with their GP, asthma nurse or clinic and to ensure they carry their inhaler with them at all times. Ensure patients are aware of when and how to use their inhaler. Follow up Referral to doctor or independent prescriber if necessary i.e. if not responding to the initial challenge then return to BTS guidance and refer Error reporting Any incidents or near miss issues must be reported via the organisation s internal reporting system (Datix). RECORD KEEPING Documentation needed / treatment records to be kept for audit purposes A computer or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Patient s name, address, date of birth and GP Manufacturer / brand of product, batch number, expiry date Dose Date of administration, route Advice given to patient / carer Details of staff who administered (sign and print name) Details of any adverse drug reactions, and action taken including informing GP Reconciliation stock balances should be reconcilable with receipts, administration, records and disposal on a patient by patient basis. REFERENCES British National Formulary British National Formulary for Children Summary of Product Characteristics www.medicines.org.uk British Thoracic Society guidance on asthma management October 2014 https://www.britthoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-quick-referenceguide-2014/ Clinical Knowledge Summaries Page 6 of 7
Register of practitioners qualified to administer and / or supply Name of clinical team manager under this Patient Group Direction Signature of clinical team manager Date: All PGD documentation must be kept for 8 years and for children until the child is 25 years old A copy of this page should be retained by the authorising manager for audit purposes. Please state clinical area where this PGD is in use Healthcare professional individual declaration: I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD PGDs DO NOT REMOVE INHERANT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence. All practitioners operating in accordance with this PGD should have a current, signed copy of it readily available for reference. If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber. Name of professional (please print) Signature Authorising Manager (Must sign against each entry) Date of authorisation Page 7 of 7