Amber Drug Guidance - Leeds Medicines Formulary

Rifaximin 550mg tablets:
Leeds
Amber Drug Guidance for the treatment of hepatic
Encephalopathy
Amber Drug Level 2
Amber Level 2: ‘Medicines initiated by a specialist where
there is not a need for ongoing specific drug related
monitoring other than for general adverse effects (as listed in
the BNF and SPC). Relevant disease monitoring should be
undertaken. These medicines are considered suitable for GP
prescribing following specialist initiation, including titration of
dose and assessment of efficacy. The specialist will highlight if
they intend to undertake any monitoring as part of their
ongoing review process. All patients on Amber Level 2 drugs
should still be regularly reviewed in primary care regarding
their Amber Drug treatment. A brief prescribing guidance
document will be available for these drugs, but there is no
requirement for full Amber Drug Guidance’.
We have started your patient on rifaximin for hepatic
encephalopathy. We will continue to see the patient and prescribe
rifaximin until the patient (and their condition) is stable (minimum
period of 1 month). After this period the GP will be asked to take over
prescribing and disease monitoring. No additional monitoring specific
to the drug to be undertaken by the GP.
Drug:
Rifaximin 550mg tablets
Indication:
Hepatic encephalopathy not responsive to
lactulose or, if appropriate, metronidazole or
neomycin.
Classification:
Amber Level 2
Monitoring:
Routine disease monitoring should continue.
No additional monitoring specific to the drug to
be undertaken by the GP.
Liver Unit or Gastroenterology Clinic review after 1 month
Follow up:
See information in the Prescribing
Protocol for Rifaximin Use in the
management of hepatic encephalopathy
Patients will be reviewed by the Liver unit or Gastroenterology clinic 1
month after initiating treatment to assess effectiveness e.g. if there is
deterioration in the level of encephalopathy or failure to reduce hospital
admissions, then rifaximin will be stopped. If there is improvement then the
drug will be continued.
LFTs- baseline, month one and 3 monthly thereafter .This is to monitor the
patients disease not the use of rifaximin. This is the responsibility of LTHT.
Rifaximin 550mg tablet Amber 2 Drug Guideline
Date prepared: December 2014
Review date:
1
December 2017
The following is a summary of prescribing information only.
Consult the BNF and SPC for full and current prescribing
information. Link to Leeds formulary.
Please refer to the Leeds Teaching Hospitals Prescribing Protocol for
Rifaximin Use in the management of Chronic Hepatic Encephalopathy
included in the formulary
Communication
Contact Names and Details
Leeds Teaching Hospitals NHS Trust
Medicines Information phone number and e-mail: 0113 2064344
[email protected]
Medicines Information Patient Helpline phone number: 0113 2064376
Specialist who makes request via switchboard: LGI 0113 2432799
SJUH 0113 2433144
Prepared by:
Advanced Clinical Pharmacist Faye Croxen
Consultant - Dr.J Dillon Hepatology
Updated Jane Otter Prescribing Advisor Pharmacist November 2014 to add
use by consultant gastroenterologists as well as consultant hepatologists in
new Amber 2 template
Responsibilities
of Specialist
Responsibilities
of GP
 Diagnosis of condition and ensuring other treatment options have
been fully explored
 Checking for allergies, interactions and contra-indications
 To initiate treatment
 Liaison with the General Practitioner (GP) to take over prescribing of
the amber medicine using a written request
 Advising GP on dose to be prescribed
 Outlining to the GP when therapy may be reduced and stopped
assuming no relapse in patient’s condition. Review periods and follow
up arrangements to be agreed
 Responding to issues raised by GP
 Checking for allergies, interactions and contra-indications when taking
over prescribing and when changing any other medication
 Prescribing the amber medicine after receiving request from the
specialist
 Monitoring the patient’s overall health and wellbeing, observing
patient for evidence of ADRs and liaising with the specialist if
necessary. Routine disease monitoring should continue
 Ensuring advice is sought from the specialist if there is any significant
change in the patient’s physical health status that may affect
prescribing or appropriateness of the amber medicine
 Reducing/stopping treatment in line with the specialist’s request
Rifaximin 550mg tablet Amber 2 Drug Guideline
Date prepared: December 2014
Review date:
2
December 2017
Responsibilities
of patient/carer
 To be responsible for taking rifaximin as prescribed
 To understand the potential for adverse events and report these to the
GP
 To check with the community pharmacist that there are no
interactions with rifaximin, when buying any over the counter
medicines or herbal/homoeopathic products
 To check with dentists or other specialists who may prescribe
medicines that there are no interactions with rifaximin
 To contact the GP, Specialist or Medicines Information patient
helpline if further information or advice is needed about rifaximin
Rifaximin 550mg tablet Amber 2 Drug Guideline
Date prepared: December 2014
Review date:
3
December 2017

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