Patient Group Direction for the supply of Bisoprolol 1.25mg tablets

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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
Cardiology PGD no 2: Bisoprolol 1.25mg-10mg tablets
Page 1
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,
Bisoprolol
Strength,Formulation 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg tablets
Legal status
Storage
Prescription only medicine (POM)
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
Cardicor recommends the following dosage
scheme; only increase dose if tolerated by the
patient.
Route/method
Week
1
2
3
4-7
8-11
12 onwards
Oral, swallowed whole
Frequency
Once daily
Total dose Quantity
As appropriate for titration.
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.
(Maximum/Minimum)
Target dose
1.25mg daily
2.5mg daily
3.75mg daily
5mg daily
7.5mg daily
10mg daily
Cardiology PGD no 2: Bisoprolol 1.25mg-10mg tablets
Page 2
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
Follow up
Arrangements
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
Relevant Warnings
As above in advice to patients
Cardiology PGD no 2: Bisoprolol 1.25mg-10mg tablets
Page 3
2. Clinical condition
Clinical Condition
Adults with stable chronic mild /moderate/severe
to be treated
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
Action if excluded
Action if declines
Interactions with
other medicaments
and other forms of
interaction
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 ACEinhibitor/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
Inform consultant cardiologist/physician
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Inform referring doctor and document informed
refusal
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Enhanced hypotensive effects with other
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-arrhythmic e.g.amiodarone, digoxin (see
B.N.F)
Insulin and oral antidiabetic drugs -
Cardiology PGD no 2: Bisoprolol 1.25mg-10mg tablets
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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 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 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.
 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 – Current Edition
SPC Cardicor www.medicines.org.uk
NICE Heart Failure Guidance
Cardiology PGD no 2: Bisoprolol 1.25mg-10mg tablets
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