Version Control This PGD has been agreed by the following organisations FCMS PDS Medical Doncaster CCG Lancashire CCGs including East Lancashire, Fylde and Wyre and North Lancashire CCGs Change history 31/07/17 V02 Review. No changes needed. 28/08/17 V02 Review. Adjustments to dose ranges. Clarification of advice on short courses/stopping abruptly. Minor editing changes. 18/09/17 V02 Adjusted age exclusions. Addition of further follow up advice. 28/08/2017 Page 1 of 8
CLINICAL CONTENT OF PATIENT GROUP DIRECTION Staff Characteristics Qualifications Specialist competencies or qualifications Continuing training and education Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Received training to undertake administration and supply of medicines under PGD. Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. 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 individual scope or practice. Clinical Details Indication Treatment of exacerbations of asthma or COPD. Inclusion criteria Patients with the above indications. Exclusion criteria Hypersensitivity to prednisolone, corticosteroids or any constituent of the product. Pregnancy or breast feeding. Patients already taking the relevant corticosteroid dose that would be advised for management of the exacerbation. Systemically unwell with infection unless anti-infective therapy is also employed. Patients with ocular herpes simplex. Previous steroid induced psychosis or mental health adverse effects. Previous steroid myopathy. Severe renal or hepatic impairment. Active peptic ulceration. Active tuberculosis. Immunosuppressed patients. Active chickenpox or measles. Age under 2 years. Patients taking aldesleukin, amphotericin, etoposide, methotrexate, mifamurtide, retinoids, ritonavir. PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available. Precautions Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous 28/08/2017 Page 2 of 8
Management of excluded patients Action for patients not wishing / unable to receive care under this PGD steroid psychosis. Diabetes mellitus, pre-diabetic states, or family history of diabetes: may increase blood glucose levels. Glaucoma or family history of glaucoma: may be precipitated or worsened. Hypertension or congestive heart failure: may increase BP or oedema. Epilepsy. Osteoporosis: increased fracture risk (although relevance of a single course unlikely to be significant). Recent myocardial infarction: risk of rupture. Hypothyroidism. Do not administer vaccines until sufficient interval has elapsed following corticosteroid use. Patients taking antihypertensives (raised BP), antiplatelets and NSAIDs (increased GI risks stop NSAID if possible), erythromycin (increased corticosteroid levels), isoniazid (reduced levels), rifamycins (reduced corticosteroid effect), coumarin anticoagulants (INR check required), hypoglycaemic (increased blood glucose), carbamazepine, phenytoin, phenobarbital, primidone, carbimazole (reduced corticosteroid levels), itraconazole (increased corticosteroid levels), ciclosporin (increased prednisolone levels), diuretics (antagonised effects), tetracyclines (possible raised intracranial pressure), antacids (co-administration reduces steroid availability). Consider if any indication for hospital referral: o See BTS/SIGN guideline for more information all patients with severe or life-threatening asthma. o See NICE/GOLD COPD guideline. Discuss with GP or Clinical Lead or refer. Make patient aware of risks and potential consequences of not taking medicine. Discuss any alternatives if available. Discuss alternative options with GP or Clinical Lead. Document discussion with patient. 28/08/2017 Page 3 of 8
Description of Treatment Name of medicine Prednisolone Formulation and route Oral tablets and soluble tablets Strength 5mg Dosage Adults with COPD: 30mg (6x 5mg tablets) immediately and then each morning for 7 days. Adults and children 12 years and over with asthma: 40mg (8x 5mg tablets) immediately and then each morning for at least 5 days. Children 1 month to 11 years with asthma: o If not currently taking oral corticosteroids: 1mg per kg bodyweight (maximum 40mg) immediately and then each morning for 3 days. o If currently already taking oral corticosteroids: 2mg per kg bodyweight (maximum 60mg) immediately and then each morning for 3 days. Repeated dose instructions Duration of treatment Quantity to supply Legal status Special precautions Adverse effects Short courses (up to 21 days use) may be stopped abruptly unless: Patient has received more than 40mg daily for more than 1 week. Patient is on maintenance oral corticosteroids. Patient has had repeated oral corticosteroid courses in the recent past. Patient has stopped maintenance oral corticosteroid treatment in the last year. Patients who have other reasons for potential adrenocortical insufficiency. Patients who have repeatedly taken doses in the evening. In these cases seek advice on how to wean off oral corticosteroids. See above See above Sufficient pre-packed boxes of 28, 30, 40 or 42 tablets to complete appropriate course POM Explain indications, contraindications and cautions (refer to BNF) Dyspepsia, abdominal distension, acute pancreatitis, oesophageal ulceration and candidiasis; musculoskeletal effects: muscle weakness, vertebral and long bone fractures, tendon rupture; endocrine effects: menstrual irregularities and amenorrhoea, hirsutism, weight gain, hypercholesterolemia, hyperlipidaemia, negative nitrogen and calcium balance, increased appetite; increased susceptibility to and severity of infection, reactivation of dormant tuberculosis; neuropsychiatric effects: psychological dependence, insomnia, increased intracranial pressure with papilledema in children (usually after withdrawal), aggravation of schizophrenia, aggravation of epilepsy; ophthalmic effects: glaucoma, 28/08/2017 Page 4 of 8
papilledema, posterior subscapular cataracts, corneal or scleral thinning and exacerbation of ophthalmic viral or fungal disease, increased intra-ocular pressure, exophthalmos; also impaired healing, petechiae, ecchymosis, facial erythema, suppression of skin test reactions, urticaria, hyperhidrosis, skin atrophy, bruising, telangiectasia, myocardial rupture following recent myocardial infarction, congestive heart failure, leucocytosis, hyperglycaemia, thromboembolism, nausea, malaise, hiccups, headache, vertigo. This is not a complete list. Refer to BNF or SPC (summary of product characteristics) for full information. Advice necessary All patients given a course of oral prednisolone for an exacerbation of asthma MUST be strongly advised to make a follow up appointment with their usual care team a need for prednisolone signifies a loss of asthma control which may require adjustment to ongoing treatment. Provide the patient with the manufacturer s Patient Information Leaflet. Advise on dose and administration with reference to the cautionary label information and give any further instructions to aid compliance. Advise on storage or expiry details and to dispose of any unused medicines appropriately. Give advice on practical self-care if appropriate, including management of likely symptoms (including fever management where appropriate). Make patient aware of potential adverse effects and the action to take if they occur. Provide appropriate worsening advice describing the range of signs and symptoms to monitor for and the action to take if they occur. Consider whether the provision of health promotion material is appropriate e.g. on smoking or lifestyle factors. Provide any advice relevant to the patient from the Precautions section above. Use of a steroid warning card if duration of treatment indicates. Ensure patient has supply of inhaled beta2 agonist, any preventative therapies and that inhaler technique is correct. Patients with asthma requiring nebulisation have had an exacerbation: o This normally mandates preventative therapy (e.g. with an inhaled corticosteroid) for a minimum of the next two years. o Refer back to own surgery for follow up management. Use as an opportunity to educate regarding correct asthma/copd care. Communicate the event promptly to the patient s own surgery so that they can take appropriate follow up steps Prescribing guidance Doncaster, East Lancashire, Fylde and Wyre and North Lancashire CCG local guidelines. Relevant NICE guidelines and advice from Clinical Knowledge Summaries. 28/08/2017 Page 5 of 8
Records and Follow Up Referral arrangements Inform GP as soon as possible. Advise if worsening or no improvement to seek further medical advice. Records to be kept Patient s name, address, date of birth and consent given. Contact details of GP (if registered). Diagnosis. Dose and form administered. Batch and expiry details. Advice given to patient (including side effects). Signature / name of staff who administered or supplied the medication. If relevant, signature / name of staff who removed / discontinued the treatment. Details of any adverse drug reaction and actions taken, including documentation in the patient s medical record. Referral arrangements (including self-care). Any serious side effects attributable to drug should be recorded and medicine management advised via yellow card system found in BNF. Follow up Advise follow up with GP/ Practice nurse. Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction. 28/08/2017 Page 6 of 8
Patient Group Direction Owner Details of PGD owner FCMS (NW) Ltd Newfield House Vicarage Lane Blackpool FY4 4EW Patient Group Direction Authorisation Lead Doctor MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION Lead Pharmacist Dr Jonathon Bundy Magnus Hird Lead Nurse Lead Paramedic Alison O Connor Organisational Authorisation for FCMS Organisational Authorisation for Doncaster CCG Suzy Layton Patient Group Direction Peer Review Reviewed by Wendy Lambert, Nurse Practitioner 28/08/2017 Page 7 of 8
Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT. IT IS YOUR RESPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION. NOTE TO AUTORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THIS PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION. Name of Professional Signature Authorising Manager Date 28/08/2017 Page 8 of 8