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1 Patient Group Direction 2154 version 2.0 Administration / Supply of Prednisolone in Acute 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of the PGD to practitioners who will be using the PGD as well as ensuring that the PGD is no longer used if becomes out of date and once it has expired.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 8

2 Patient Group Direction 2154 version 2.0 Administration / Supply of Prednisolone in Acute 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 Moderate, severe or life threatening asthma in patients aged 2 years and over. Prednisolone stock & TTA packs Criteria for inclusion Criteria for exclusion Action if excluded Action if patient refuses medication All adults and children aged 2 years and over presenting with moderate, acute severe or life threatening acute asthma Hypersensitivity to prednisolone and any excipients or hypersensitivity to other corticosteroids. High dose oral steroids having been taken in the last 12hours Children aged 2 to 12 years already receiving maintenance steroid tablets Refer to medical practitioner or non-medical prescriber if appropriate and document in patient s records Refer urgently to medical practitioner or dial 999 (when presenting to MIU) if patient clinically unwell. Document informed refusal in patient s records and refer to protocol, medical practitioner or nonmedical prescriber as appropriate and document in patient s records. Refer urgently to medical practitioner or dial 999 (when presenting to MIU) if patient clinically unwell. 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 Organisation Policies, including Medicines Policy and associated Standard Operating Procedures, Anaphylaxis Policy, Consent Policy and Injectable Medicines Policy and associated risk assessments where appropriate. Working knowledge of relevant Organisation 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 8

3 3. Description of Treatment Name of Medicine Supplied Name of Medicine Administered Legal Class Storage Dose to be used (including criteria for use of differing doses) Prednisolone tablets 5mg Prednisolone soluble tablets 5mg As above POM (Prescription Only Medicine) Store below 25ºC. Protect from light. Adults and children over 12 years: 40mg (eight tablets) Children over 5 years and up to and including12 years: 30mg (six tablets) Children 2-5 years: 20mg (four tablets ) Repeat dose in children who vomit within 1 hour of administration. Method or route of administration Total dose and number of times drug to be given. Details of supply (if supply made) Oral Administer a single first dose then supply appropriate TTA pack (unless being forwarded to secondary care or admitted). Adults and children over 12 years: 40mg first dose then 40mg daily for at least 5 days or until recovery Children over 5 years and up to 12 years: 30mg first dose then 30mg daily for 2 days (3 days total) Children 2-5 years: 20mg first dose then 20mg daily for 2 days (3 days total) First dose to be administered at the time of first presentation Subsequent doses to be taken in morning as a single dose with breakfast Supply appropriate number of TTA packs from Prednisolone 5mg tablets x28 or Prednisolone 5mg Soluble tablets x30 Adults and children over 12 years: 2 x 28 Prednisolone 5mg tablets Children over 5 years and up to 12 years: 1 x 28 Prednisolone 5mg or 1 x 30 Prednisolone 5mg soluble tablets Children 2-5 years: 1 x 30 Prednisolone 5mg soluble tablets All supplies must be appropriately labelled with the patient s name, drug name, strength and form, clear dosage instructions, the date of supply and name and address of supply centre. Contra-indications See exclusion criteria June 2017 May 2019 Page 3 of 8

4 Cautions Interactions Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with the following conditions and frequent patient monitoring is necessary: Hypertension or congestive heart failure. Liver failure / renal insufficiency. Epilepsy. Patients with a history of severe affective disorders and particularly those with a previous history of corticosteroid induced psychoses. Peptic ulceration. Tuberculosis: Those with a history of, or X-ray changes characteristic of tuberculosis. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of antituberculous therapy. Recent myocardial infarction (rupture). Chickenpox / measles: normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history should be advised that if exposed they should seek urgent medical attention. Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished. See BNF / SPC for all If patient is taking any other medications consult BNF Appendix 1 for any potential interactions. Rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, carbimazole and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore it may be necessary to adjust the dose of prednisolone accordingly. The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding. NSAIDs such as indometacin may increase the risk of GI ulceration. The possiblity of GI ulceration should be considered with concomitant use with any other NSAIDs. Antifungals: Increased risk of hypokalaemia with amphotericin. Avoid concomitant use. Ketoconazole reduces the metabolic and renal clearances of methylprednisolone, this may also occur with prednisolone. Corticosteroids should not be used concurrently with retinoids and tetracyclines due to increased intracranial pressure. The desired effects of hypoglycaemic agents (including insulin), antihypertensives and diuretics are antagonised by corticosteroids. The hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, beta-2-agonists, theophylline and carbenoxolone are enhanced. Ciclosporin increases the plasma concentration of prednisolone. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. Mifepristone reduces the effect of corticosteroids for 3-4 days after administration. Methotrexate may have a steroid sparing effect. There is evidence that the toxicity of methotrexate is increased. Etoposide metabolism may be inhibited by corticosteroids in vitro. This may lead to an increase in both efficacy and toxicity of the etoposide. Monitoring would be prudent. Oestrogens and progestogens increase plasma concentrations of corticosteroids. June 2017 May 2019 Page 4 of 8

5 Potential side-effects and adverse reactions The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment. Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose. Anti-inflammatory/immunosuppressive: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis. See other special warnings and precautions. Gastrointestinal: Abdominal distension, acute pancreatitis, dyspepsia, nausea, increased appetite, oesophageal candidiasis, oesophageal ulceration, peptic ulceration with perforation and haemorrhage, perforation of the small bowel, particularly in patients with inflammatory bowel disease. Endocrine/metabolic: Cushingoid facies, growth suppression in infancy, childhood and adolescence, hirsutism, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, menstrual irregularity and amenorrhoea, negative protein and calcium balance, suppression of the hypothalamo-pituitary adrenal axis, and weight gain. Although the frequency is not known, there is a risk for Cushing Syndrome. Fluid and electrolyte disturbance: Hypertension, nocturia, hypokalaemic alkalosis, potassium loss, sodium and water retention, risk of congestive heart failure in susceptible patients. Musculoskeletal: Avascular osteonecrosis, osteoporosis, proximal myopathy, tendon rupture, vertebral and long bone fractures, muscle weakness, wasting and loss of muscle mass. Dermatological: Acne, bruising, impaired healing, skin atrophy, striae, telangiectasia. Neuropsychiatric: A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), marked euphoria leading to dependence; aggravation of epilepsy, behavioural disturbances, irritability, nervousness, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Intracranial pressure with papilloedema in children (pseudotumour cerebri) usually after treatment withdrawal, psychological dependence. Ophthalmic: Corneal or scleral thinning, scleral perforation, exacerbation of ophthalmic viral or fungal disease, glaucoma, increased intra-ocular pressure, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy (frequency not know known). General: Hypersensitivity including anaphylaxis, leucocytosis, malaise, thromboembolism. See SPC / BNF for full list Unusual or life threatening reactions require immediate medical attention. Management of potential side-effects and adverse reactions 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. Some side effects may be experienced if these persist to see their G.P. Unusual or life threatening reactions require immediate medical attention. Soluble tablets are best taken dissolved in water but can be swallowed whole without difficulty. When dissolved in water the resulting solution must be drunk immediately by the patient. The patient should be followed up by their own GP practice 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. June 2017 May 2019 Page 5 of 8

6 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 The route of administration The frequency of administration and duration of treatment The time and date of 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 5. Appendices References used in the development of this PGD: BTS/SIGN British Guideline on the Management of Asthma revised 2016 BNF 72 Childrens BNF 2016/17 SPC Prednisolone 5mg tablets Actavis (Accessed ) SPC Soluble Prednisolone 5mg tablets Actavis (Accessed ) An Outcomes Strategy for Chronic Obstructive Pulmonary Disease (COPD) and Asthma in England -Department of Health, July 2011 Clinical Protocol for the initial emergency management of Asthma MIUs 2015 South and West Devon Formulary (accessed ) Quality Standard for Asthma, NICE quality standard 25, issued February 2013 Audit details 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. June 2017 May 2019 Page 6 of 8

7 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 2154 v 1.0 Prednisolone Path V:Medicines Governance/PGDs/MIUs/PGD v 1.0 Prednisolone June17-May19 June 2017 May 2019 Page 7 of 8

8 Patient Group Direction 2154 version 2.0 Administration / Supply of Prednisolone in Acute Asthma by Registered Practitioners employed by Torbay and South Devon NHS Foundation Trust Objective To enable registered nurses and 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 8 of 8

9 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: 2154 Document title: Prednisolone Admin / Supply of in ED 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: June 2017 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: Chair, Trust Medicines Management Committee Medical Director Date approved: 16 June 2017 Links or overlaps with other All TSDFT Trust Strategies, policies and procedure documents policies: 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, Trust Medicines Management Committee Medical Director Collated by Clinical Effectiveness Prednisolone Admin / Supply of in ED and in MIU's Document Control Information