Patient Group Direction for the supply of Bisoprolol 1.25mg tablets up to maximum 10 mg orally to adult Heart failure patients attending Heart failure clinics or on home visits in NHS Borders

This document authorises the supply of Bisoprolol 1.25mg tablets up to 10mg tablets by cardiac specialist/heart failure nurse to adult heart failure patients who meet the criteria for inclusion under the terms of the document

The cardiac specialist/heart failure nurse seeking to supply Bisoprolol 1.25mg tablets up to 10mg tablets must ensure that all clients have been screened and meet the criteria before supply takes place

The purpose of this Patient Group Direction is at present specialist nurses have to spend time looking for and asking the doctor to prescribe the drug when they have not met or examined the patient as nurse led clinics/visits. Will allow patient visits to run more smoothly and reduce the time they have to wait.

This direction was authorised on October 2011

The direction will be reviewed by October 2013

PGD reviewed by: Dr Helen Oxenham, Paul Neary, Gillian Donaldson

Clinician Responsible for Training and Review: Gillian Donaldson

Patient Group Direction for the supply of Bisoprolol 1.25mg up to 10 mg 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: bisoprolol

Name of medicine, Strength,Formulation / Bisoprolol
1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg tablets
Legal status / Prescription only medicine (POM)
Storage / Do not store above 25 degrees C and protect from light
Dose / 1.25mg titrated at minimum intervals of 1-2 weeks as tolerated to maximum 10mg.
The summary of product characteristics for CardicorÒ recommends the following dosage scheme; only increase dose if tolerated by the patient.
Week / Target dose
1 / 1.25mg daily
2 / 2.5mg daily
3 / 3.75mg daily
4-7 / 5mg daily
8-11 / 7.5mg daily
12 onwards / 10mg daily
Route/method / Oral, swallowed whole
Frequency / Once daily
Total dose Quantity
(Maximum/Minimum) / As appropriate for titration.
Advice to Patients
Follow up Arrangements
Relevant Warnings / 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.
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.
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.
Heart failure nurse will follow up patient within one month to titrate dose further if tolerated
As above in advice to patients

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
·  Not reached optimal dose of ACE-inhibitor/Angiotensin II receptor antagonist
·  Hypersensitivity to bisoprolol or any excipients
·  Patients prescribed any of the following: verapamil, diltiazem, phenytoin, clonidine, moxonidine, methyldopa, flecaininde, propafenone, disopyramide
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-arrhythmic e.g.amiodarone, digoxin (see B.N.F)
·  Insulin and oral antidiabetic drugs - enhanced effects
Check BNF for other medication in combination may have enhanced hypotensive effects.

3. Records-Copy to patients medical records, 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 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

Quantity supplied / received

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 degrees 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.

v  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)

v  Sources of Evidence used for the PGD creation:

British National Formulary – Current Edition

SPC Cardicor www.medicines.org.uk

NICE Heart Failure Guidance

Cardiology PGD no 2: Bisoprolol 1.25mg-10mg tablets Page 5