Patient Group Direction for the supply of Carvedilol 3.125mg-25mg tablets to heart failure patients attending heart failure clinics or on home visits in NHS Borders This document authorises the supply or administration of carvedilol 3.125mg tablets twice daily up to maximum 25mg tablets twice daily, orally by cardiac specialist/heart failure nurses to heart failure patients who meet the criteria for inclusion under the terms of the document The cardiac specialist/heart failure nurse seeking to supply carvedilol 3.125mg tablets twice daily up to maximum 25mg twice daily tablets, orally; must ensure that all clients have been screened and meet the criteria before supply takes place The purpose of this Patient Group Direction is: to ensure patient on optimum dose of Carvedilol allowing continuity of care and reduce visits to GP This direction was authorised on: October 2011 The direction will be reviewed by: October 2013 Clinician Responsible for Training and Review: Gillian Donaldson PGD reviewed by: Helen Oxenham, Gillian Donaldson Cardiology PGD no 3: Carvedilol 3.125mg-25mg tablets Page 1 Patient Group Direction for supply of carvedilol 3.125mg tablets up to 25 mg tablets orally without a prescription for a named individual by cardiac specialist nurses/heart failure nurses employed by NHS Borders in Borders General Hospital or on community home visits 1. This Patient Group Direction relates to the following specific preparation: Name of medicine, Carvedilol 3.125mg, 6.25mg, 12.5mg, 25mg tablets strength, Oral formulation formulation Legal status Prescription only medicine (POM) Storage Store in a dry place below 25 degrees C and protect from light Dose 3.125mg twice daily titrated as tolerated at intervals of not less than two weeks to maximum 25mg twice daily in patients with severe chronic heart failure. The dose of carvedilol should double at each increase. In patients weighing less than 85kg with mild to moderate chronic heart failure the maximum daily dose is 25mg twice daily. In patients weighing more than 85kg with mild to moderate chronic heart failure the maximum daily dose is 50mg twice daily. Route/method Oral Frequency Twice daily Total dose Quantity As appropriate per titration (Maximum/Minimum) Advice to Patients Explain that treatment given as much to prevent worsening of heart failure as to improve symptoms. If symptomatic improvement occurs this may develop slowly over 3-6 months or longer. Relevant Warnings Contact G.P or heart failure nurse if any increased breathlessness/wheeze/dizziness/ heart failure symptoms. Temporary symptomatic deterioration may occur (2030% cases) during initiation. This can usually be easily managed by adjusting other Cardiology PGD no 3: Carvedilol 3.125mg-25mg tablets Page 2 medication. Do not stop taking without consulting doctor or heart failure nurse unless severe side effects If diabetic may mask symptoms of hypoglycaemic episodes and enhance hypoglycaemia Encourage patients to weigh themselves daily and to consult doctor or heart failure nurse if they have persistent weight gain. Follow up Arrangements Heart failure nurse will follow up patient within no more than one month to titrate dose further if tolerated 2. Clinical condition Clinical Condition to be treated Adults with stable chronic mild /moderate/severe heart failure with reduced systolic ventricular function Criteria for inclusion Adults with clinical condition above and: No signs of acute heart failure on clinical examination Pulse greater than 60bpm Systolic BP greater than 90mmHg (If lower discuss with consultant cardiologist) Criteria for exclusion Decompensated heart failure Marked bradycardia (Less than 60bpm) Asthma/severe COPD Hypotension (Systolic less than 90mmHg) Sick sinus syndrome Pregnancy/breast feeding Second/third degree blocks First degree block (discuss with cardiologist) Sinoatrial block Peripheral arterial disease Untreated Phaeochromocytoma Acute failure within past 6 weeks Change in therapy in past 2 weeks Hypersensitivity to carvedilol or any excipients Patients prescribed any of the following: verapamil, diltiazem, phenytoin, clonidine, moxonidine, methyldopa, flecaininde, propafenone, disopyramide Patients prescribed ciclosporin Action if excluded Inform consultant cardiologist/physician Action if declines Inform Referring doctor and document informed refusal Interactions with Enhanced hypotensive effects with other Cardiology PGD no 3: Carvedilol 3.125mg-25mg tablets Page 3 other medicaments and other forms of interaction medications including ACE inhibitors/calcium channel blockers, tricyclic antidepressants (e.g. amitriptyline), phenothiazines (e.g. chlorpromazine), -blockers (e.g. tamsulosin), MAOIs, nitrates, baclofen, tizanidine (See B.N.F) Alcohol Increased myocardial depression with other anti-arrhythmics e.g. amiodarone, digoxin (see B.N.F) Insulin and oral antidiabetic drugs enhanced effects Ciclosporin – carvedilol may affect ciclosporin levels – do not co-prescribe Check BNF for other medication in combination may have enhanced hypotensive effects. 3. Records-Copy to patients medical record, specialist nursing record and G.P 1. The following records should be kept (either paper or computer based):The GP practice, clinic, hospital, and ward or department The patient name and CHI number The medicine name, dose, route, time of dose(s), and where appropriate, start date, number of doses and or period of time, for which the medicine is to be supplied or administered Drug batch number and expiry The signature and printed name of the approved healthcare professional that supplied or administered the medicine The patient group direction title and/or number Whether patient met the inclusion criteria and whether the exclusion criteria were assessed Quantity supplied / received and current stock balance 2. Preparation, audit trail, data collection and reconciliation:Stock balances should be reconcilable with receipts, administration, records and disposals on a patient by patient basis. 3. Storage: - Store in a dry place below 25°C and protected from light 4. Professional Responsibility All Health Professionals will ensure he/she has the relevant training and is competent in all aspects of medication, including contra-indications and the recognition and treatment of adverse effects. He/she will attend training updates as appropriate. For those involved in immunization, regular anaphylaxis updates are mandatory. Nurses will have due regard for the NMC Code of Professional Conduct, standards for conduct, performance and ethics (2008) and NMC Standards for Medicines Management (2008) 5. References British National Formulary (BNF) current edition http://bnf.org/bnf/index.htm Borders Joint Formulary (BJF) http://intranet/new_intranet/microsites/index.asp?siteid=65&uid=1 SPC Eucardic www.medicines.org.uk NICE Heart Failure Guidelines Cardiology PGD no 3: Carvedilol 3.125mg-25mg tablets Page 4 Patient Group Direction for administration of carvedilol 3.125mg-25mg tablets to heart failure patients attending heart failure clinics or on home visits by registered nurses employed by NHS Borders This Patient Group Direction is approved for use by the under-signed : Job Title Name Senior Doctor/Dentist for relevant clinical area Ross Cameron NHS Borders Director of Pharmacy Alison Wilson NHS Borders Senior Health Professional for Clinical Area Sheena Wright Signed Date PGD AUTHORISED ON ……/……/…….. Signed by ADTC CHAIRPERSON: ……………………………………………….. Name: ………………………………………………………………………………… The Health Professionals named below, being employees of NHS Borders are authorised to provide and/or administer this medication under this Patient Group Direction and agree to provide and/or administer this medication in accordance with this Patient Group Direction Name of Health Professional Job Title Cardiology PGD no 3: Carvedilol 3.125mg-25mg tablets Signed Date Page 5