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

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, strength, formulation / Carvedilol 3.125mg, 6.25mg, 12.5mg, 25mg tablets
Oral 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
(Maximum/Minimum) / As appropriate per titration
Advice to Patients / v  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 / v  Contact G.P or heart failure nurse if any increased breathlessness/wheeze/dizziness/ heart failure symptoms. Temporary symptomatic deterioration may occur (20-30% cases) during initiation. This can usually be easily managed by adjusting other medication.
v  Do not stop taking without consulting doctor or heart failure nurse unless severe side effects
v  If diabetic may mask symptoms of hypoglycaemic episodes and enhance hypoglycaemia
v  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 other medicaments and other forms of interaction / ·  Enhanced hypotensive effects with other medications including ACE inhibitors/calcium channel blockers, tricyclic antidepressants (e.g. amitriptyline), phenothiazines (e.g. chlorpromazine), a-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 -

v  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.

v  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

v  British National Formulary (BNF) current edition http://bnf.org/bnf/index.htm

v  Borders Joint Formulary (BJF) http://intranet/new_intranet/microsites/index.asp?siteid=65&uid=1

v  SPC Eucardic www.medicines.org.uk

v  NICE Heart Failure Guidelines

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 / Signed / Date

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
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 / Signed / Date

Cardiology PGD no 3: Carvedilol 3.125mg-25mg tablets Page 5