Patient Group Direction for the supply of Ramipril starting dose 1.25mg or 2.5mg daily up to 5mg twice daily or 10 mg daily to Patients with documented LVSD attending Heart failure clinics or on home visits This document authorises the supply of Ramipril 1.25mg daily up to 10 mg daily by cardiac/heart failure specialist nurses to patients with documented LVSD who meet the criteria for inclusion under the terms of the document The cardiac/heart failure specialist nurses seeking to supply or administer Ramipril 1.25mg daily up to 10 mg daily must ensure that all patients have been screened and meet the criteria before supply takes place The purpose of this Patient Group Direction is to ensure optimum doses of ACE used as per SIGN guidelines, allow better continuity of care, and reduce GP visits. 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: Claire Stein, Helen Oxenham, Gillian Donaldson Cardiology PGD no 5: Ramipril Page 1 Patient Group Direction for the supply of Ramipril 1.25mg once daily up to 5mg twice daily or 10 mg once daily without a prescription for a named individual by Cardiac/Heart failure specialist nurses employed by NHS Borders in Borders General Hospital/Community 1. This Patient Group Direction relates to the following specific preparation: Name of medicine, Ramipril 1.25mg, 2.5mg, 5mg, 10mg capsules Strength,Formulation Legal status Prescription only medicine (POM) Storage Store in a dry place below 25 degrees C and protect from light. Dose Start dose 1.25mg then double dose at no less than two weekly intervals to maximum 10 mg daily/ or 5mg in twice daily dose. Route/method Oral Frequency Once a day or split into twice daily when daily dose higher than 1.25mg Total dose Quantity Supply as per requirements of titration. (Maximum/Minimum) Advice to Patients Explain that treatment given as much to prevent worsening of heart failure and increase survival as to improve symptoms and reduce admissions to hospital Symptoms may take from a few weeks to few months to improve Advise to report dizziness/symptomatic hypotension rash or cough Advise to avoid NSAIDS and salt substitutes high in K+ Cardiology PGD no 5: Ramipril Page 2 Follow up Arrangements Contact G.P or heart failure nurse if any increased dizziness/ heart failure symptoms. Do not stop taking without consulting doctor or heart failure nurse unless severe side effects Encourage patients to weigh themselves daily and to consult doctor or heart failure nurse if they have persistent weight gain of 1kg for > 2days. Heart failure nurse will follow up patient within two weeks of commencement/up-titration to check electrolytes. If baseline Creatinine increased by more than 50% or 200micromol/l consider stopping other vasodilators, NSAIDS or reducing diuretics if no fluid retention. If renal impairment persistsreduce dose of ramipril and recheck blood chemistry within 1 week. See HFN Specialist Guidelines. Relevant Warnings If potassium rises to 5.5mmol/l or greater reduce dose of ramipril If potassium remains above 5.5mmol/l despite reducing ramipril dose stop ramipril If Creatinine increases by 100% or above 310micromol/l stop ramipril If symptomatic hypotension (systolic BP90mmHg) stop calcium channel antagonists, consider reducing diuretic if no fluid retention, reduce dose or stop ramipril Cardiology PGD no 5: Ramipril Page 3 2. Clinical condition Clinical Condition Patients with heart failure due to left ventricular to be treated systolic dysfunction. Criteria for inclusion Documented LVSD K+ level 5.5mmol/l or less. Systolic BP > 90mmHg Creatinine less than 221 micromol/l Urea less than 15mmol/l Criteria for Systolic BP < 90mmHg exclusion Significant renovascular disease Pregnancy/breastfeeding Hypersensitivity to Ramipril or other ACEI Severe aortic stenosis K+ greater than 5.5mmol/l History of angioedema hepatic impairment (as ramipril pro-drug, lisinopril not pro-drug) Action if excluded 1. Record reason for exclusion clearly in notes/heart failure database 2. Consider alternative treatment eg ARB 3. Optimise other heart failure medications 4. Inform consultant cardiologist/physician Action if declines As for action if excluded Interactions with Enhanced hypotensive effects with other other medicaments medications including nitrates, beta and other forms of blockers/calcium channel-blockers, anxiolytics/hypnotics, antipsychotics, interaction blockers (e.g. tamsulosin), MAOIs, nitrates, angiotensien-ll receptor antagonists, vasodilators (e.g. hydralazine), clonidine, corticosteroids, diuretics, levodopa, moxonidine, methyldopa, levodopa Alcohol (See B.N.F) Enhanced hypoglycaemic effect with insulin, metformin, and sulphonylureas Increased risk of renal impairment along with NSAID. Increased risk of hyperkalaemia with potassium sparing diuretics e.g.spironolactone, eplerenone Lithium - reduced excretion (increased plasma lithium concentrations) Cardiology PGD no 5: Ramipril Page 4 3. Records- Cardiac nurse specialists office, dictated letter in patient records in main stores and copy to G.P records. Heart Failure Database when available. 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 who 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. Reason for exclusion. Quantity supplied / received and current stock balance 2. Preparation, audit trail, data collection and reconciliationStock 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 degrees C and protect 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 (2010) and NMC Standards for Medicines Management (2010) Sources of Evidence used for the PGD creation: British National Formulary – Latest edition Summary of Product Characteristics - Zestril, Carace – www.medicines.org NICE Heart Failure Guidelines Cardiology PGD no 5: Ramipril Page 5