/PG

Patient Group Direction (PGD) for the Supply/Administration of:

SALBUTAMOL NEBULES – 2.5mg and 5mg

Prescription Only Medicine (POM)

YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES Walk In Centre Clients aged 2 years and over requiring treatment for Indication acute severe asthma or chronic bronchospasm unresponsive to conventional therapy.

Inclusion Criteria

Exclusion Criteria

Informed consent has been given in accordance with current PCT guidelines for the supply/administration of the medicine.

Adults and children aged 2 years and over presenting with any of the following: (i) Chronic bronchospasm, unresponsive to conventional therapy. (ii) Acute severe asthma. (iii) Bronchospasm secondary to anaphylaxis.

Administration of Salbutamol nebules should be considered alongside initiation of oral steroids, or only as a holding measure until ambulance arrival and onward referral.

Informed consent has not been given in accordance with current PCT guidelines for the supply/administration of the medicine.

Patients under 2 years of age.

Pregnant or breast-feeding mothers Known hypersensitivity to Salbutamol or other components of the preparation.

Patients who have previously suffered a significant Adverse Drug Reaction (ADR) in relation to the administration of Salbutamol Patients currently taking beta-blockers.

Cautions/Need for Further Advice

Approval Date: 10/2/2010

Additional Caution Required Patients with cardiovascular disease (ischemic heart disease, arthymia, heart failure, susceptibility to Q-T interval prolongation) – patients should be advised to seek medical help if they experience chest pain or other symptoms of worsening heart disease Diabetes – Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Thyrotoxicosis

PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Review Date: 10/2/2012 extended to 31/5/2012 Page 1

Hyperthyroidism Hypertension Patients who have received large doses of other sympathomimetic drugs (eg. Dopamine, ephedrine, pseudoephedrine, methylphenidate, noradrenaline etc) Potential drug interactions with: Digoxin – salbutamol may reduce plasma concentration of digoxin Corticosteroids – increased risk of hypokalaemia Diuretics – increased risk of hypokalaemia Theophylline – increased risk of hypokalaemia The CSM has advised that potentially serious hypokalemia may result from beta2-agonist therapy. Patients with severe asthma should have their plasma-potassium concentration regularly monitored.

Action if Patient Declines or is Excluded

Patients excluded should be referred immediately to A&E. This will be clearly documented in the patient’s record

DESCRIPTION OF TREATMENT Salbutamol (as Salbutamol Sulphate BP) solution for inhalation via a Name, Form & Strength nebuliser: of Medicine 2.5mg/2.5ml OR 5mg/2.5ml

Route/Method

Solution for inhalation via a nebuliser

Dosage

Children Aged 2 years to 12 years of age: ONE x 2.5mg nebule Adults and Children Over 12 years: ONE x 5mg nebule

Frequency

Duration of Treatment Maximum or Minimum Treatment Period Quantity to Administer Side Effects

Single dose - a response should be apparent within 10-15 minutes of inhaling the drug.

Failure to respond requires immediate referral to hospital Once only Once only Single dose Common side effects include: Tachycardia, tremor, headache Other less common side effects include: Palpitations, mouth and throat irritation, muscle cramps.

Rarer side effects include: Hypokalaemia, peripheral vasodilation, Respiratory, thoracic and mediastinal disorders, parodoxical bronchospasm, cardiac arythmias,

Approval Date: 10/2/2010

PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Review Date: 10/2/2012 extended to 31/5/2012 Page 2

hyperactivity, hypersensitivity reactions (including angioedema, urticaria, bronchospasm, hypotension and collapse This list is not exhaustive. Please refer to current BNF and product SPC for full details.

Report all serious suspected adverse reactions (ADRs) in adults, and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk.

Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant.

Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor.

It is the responsibility of the health professional identifying the ADR to report it.

Additional Facilities Advice to Patient/Carer/ Parent/Guardian Follow Up

The Nebules should be protected from light after removal from the foil tray and used within 3 months after removal from the foil overwrap Support and reassure the patient at all times.

Arrange appropriate referral to either GP or A&E. Advise patient to report any adverse reactions.

Onward referral to the patient’s own GP, A&E department or Local Care Direct may be required.

If patient declines document in notes Patients are excluded from administration or supply of treatment by a walk-in-centre nurse if they have any contra indications.

REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

Referral arrangements (including self-care) to be documented in patients notes.

If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct or A&E for further assessment and advice

Records/Audit Trail

Approval Date: 10/2/2010

The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary: Patient’s name, address, date of birth and consent given. If PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Review Date: 10/2/2012 extended to 31/5/2012 Page 3

consent is either refused or withdrawn, this decision should also be documented.

Contact details of GP if applicable Dose supplied and route Batch number and expiry date Advice given to patient (including side effects) Date supplied Name of staff who supplied the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient’s medical record.

Current medication Known allergies Diagnosis

STAFF CHARACTERISTICS Registered nurse with current registration working within NHS Qualifications Kirklees Walk In Centre

Specialist Training or Qualifications

Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent in working under PGDs for the supply and administration of medicines Has undertaken training and is competent in the recognition and treatment of anaphylaxis.

Has undertaken training and is competent in resuscitation skills.

Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Keep updated via departmental meetings and updates Has undertaken training appropriate to this PGD

Continuing Training & Education

References/Resources and Comments

Approval Date: 10/2/2010

The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice.

Practitioner should have access to current BNF and updated DH advice where appropriate.

Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation.

Keeps undated via departmental updates and meetings 1. Current edition of the British National Formulary (BNF) 2. Summary of Product Characteristics (SPC) available at: www.medicines.org.uk PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Review Date: 10/2/2012 extended to 31/5/2012 Page 4

3. LCD Patient Group Direction for nebulised salbutamol

This PGD is an updated version of: Walk In Centre PGD No 17, June 2007 It was updated for use in Kirklees Primary Care Trust by the individuals listed below Name Lisa Meeks Lucianne Ricketts

Position Specialist Technician, Community and Support Services Senior Medicines Management Adviser – Strategy and Operational Development

Date January 2010 January 2010

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health (if this is applicable) This will result in an unlicensed use of a licensed product following current DOH guidance.

Approval Date: 10/2/2010

PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Review Date: 10/2/2012 extended to 31/5/2012 Page 5

Individual Authorisation for the Supply/Administration of: Salbutamol 2.5mg or Salbutamol 5mg Solution for Nebulisation by NHS Kirklees Walk-in-Centre Nurses PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the nurse is willing to be professionally accountable for this work as defined in the NMC guidance of the Code of Professional Conduct.

Name of Professional

Signature

Authorising Manager and signature

Date

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials.

Authorising Managers For PCT staff this will be the team leader, or relevant clinical manager.

Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base.

Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.

Approval Date: 10/2/2010

PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Review Date: 10/2/2012 extended to 31/5/2012 Page 6

Authorisation This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting

Organisation Director of Patient Care and Professions

Kirklees Primary Care Trust Name:

Sheila Dilks

Signature: Assistant Director of Medicines Management and Prescribing

Name:

Date Neill McDonald

Signature: Medical Director

Name:

Date: Dr Judith Hooper

Signature: PEC Chair

Name:

Signature:

Date: Dr David Anderson

Date:

PGD No 75 - Salbutamol 2.5mg and 5mg Nebules Approval Date: 10/2/2010 Review Date: 10/2/2012 extended to 31/5/2012 Page 7