What’s new in BNF 70?
A CPPE interactive PDF learning programme
E n t er
October 2015
2
Welcome to
What’s new in
BNF 70?
Contents
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How to use this learning programme
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About What’s new in BNF 70?
Thank you for downloading this CPPE interactive learning programme.
We hope that you will find it a fun way to bring you up to date with the
latest changes in the British National Formulary (BNF).
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Learning objectives
Learning with CPPE
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Case studies – introduction
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Case studies
The Centre for Pharmacy Postgraduate Education (CPPE) offers a wide
range of learning opportunities in a variety of formats for pharmacy
professionals from all sectors of practice. We are funded by Health
Education England to offer continuing professional development for
all pharmacists and pharmacy technicians providing NHS services
in England. For further information about our learning portfolio,
visit: www.cppe.ac.uk
This document uses interactive features that are supported on most
mobile devices. If you are using this programme on a PC or laptop,
please ensure you are using an up-to-date version of Adobe Reader.
38 Next steps
39 Programme credits
Click on a title to go directly to that section.
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How to use this learning programme
This programme uses an interactive PDF format. You can navigate your way
through by using the arrows in the bottom right corner of each page. Where
directed, you can also navigate to sections by clicking on text or images. The
programme uses case studies and web links to help you explore the changes
in BNF 70. Web links are black and bold, like ‘CPD records’ in the paragraph
below. You will need to be connected to the internet to access the web links.
You will be able to type, save and view answers to the case studies. We would
recommend that you keep notes as you go along as these could be ideal to
generate CPD records.
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About What’s new in BNF 70?
This programme will keep you up to date with significant changes in the BNF that
are relevant to your clinical practice. You will need about 60 minutes to complete
the questions.
Before you start, make sure you have read the section of the BNF listing the key
changes for this edition. If you are using a print version of BNF 70, full details of
changes to this edition are on page xv.
You can access the BNF online through Medicines Complete by clicking on the
BNF image. If you are not already registered, you will need to do so. Click here
to register. UK-based individuals working for or on behalf of the NHS can register
for free and access the BNF and BNFC.
A note about web links
Where we think it will be helpful we have provided web links to take you directly
to an article or specific part of a website. However, we are aware that web links
can change. If you have difficulty accessing any web links we provide, please go
to the organisation’s home page or your preferred internet search engine and use
appropriate key words to search for the relevant item.
All web links were accessed on 24 September 2015.
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Learning objectives
By the end of this learning programme, you should be able to:
n locate information on changes in the latest BNF
n identify situations in the healthcare setting where the management of a patient
is affected by these changes
n r ecommend appropriate courses of action based on what you know about a
patient and the latest information in the BNF.
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Case studies – introduction
This programme contains ten case studies, each with two parts, to explore
significant changes to the BNF.
In these, there will be space for you to type answers to the questions. You can
save your answers by saving this document to your computer and you can
view our suggested answers by clicking on the Suggested answer links.
Some of the scenarios are based in primary care and some in secondary.
However, the decisions we ask you to make in each question will apply to your
practice, regardless of your area of work.
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Case studies
The case studies look at the following areas (click on a title to go straight to that case).
You will be able to return to this menu by clicking the link at the bottom of the page at the end of each question.
Solifenacin
Tacrolimus
Lipegfilgrastim
Amiodarone in chronic hepatitis C
Dimethyl fumarate
Hydroxyzine
Pimecrolimus
Lisdexamfetamine
Tramadol
Aceclofenac
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Solifenacin
Sarah Bellum is a 61-year-old woman with a current diagnosis of endogenous
Cushing’s syndrome. This condition is currently being managed with
ketoconazole on a maintenance dose of 400 mg twice a day. She does not take
any other medicines.
Sarah has visited her GP today as she has recently noticed that she is suddenly
having the urge to urinate and that this is happening with increasing frequency.
She states that she is not in any pain and that she is not passing any blood. The
GP decides to prescribe solifenacin 5 mg daily initially, telling Sarah that she can
increase to 10 mg daily after a week if the symptoms are not controlled.
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ONE
1. How appropriate is the current clinical plan for treating Sarah’s urinary frequency and urgency?
Suggested answer
BNF Chapter 7, Urinary frequency, enuresis, and incontinence – page 670
For further information, read about solifenacin succinate in the BNF.
You may also wish to read the summary of product characteristics (SPC) for Vesicare on the electronic Medicines
Compendium.
To increase your knowledge of renal disease and key drug management issues, access the CPPE e-learning programme
Renal medicine.
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TWO
2. What action would you recommend?
Suggested answer
BNF Chapter 7, Urinary frequency, enuresis, and incontinence – page 670
For further information, read about solifenacin succinate in the BNF.
You may also wish to read the SPCs for Vesicare and Flotros on the electronic Medicines Compendium.
If you would like to learn more about acute kidney injury and how to support your patients, access the
CPPE learning@lunch flex programme on acute kidney injury.
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Tacrolimus
Ben Portland, 28 years old, had a kidney transplant ten months ago, and as part
of his medicine regimen takes tacrolimus (Prograf). He is being regularly seen by
the specialists at his hospital.
Ben comes to your pharmacy and informs you he is struggling to get Prograf as
his regular pharmacy is unable to obtain it due to supply issues.
He has heard of a new brand, Envarsus. His friend Asif from hospital is taking
Envarsus and has not had any supply problems. Ben wants his GP to write him
a new generic prescription so he can get whatever brand is available as he is
concerned about stopping treatment.
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1. What advice would you give to Ben and the GP about switching brands of tacrolimus?
Suggested answer
BNF Chapter 8, Immune system disorders and transplantation – pages 720-723
For further information, read about Envarsus in the BNF.
You may also wish to read about Prograf on the electronic Medicines Compendium.
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FOUR
2. Ben is concerned about the side-effects of tacrolimus. How would you address his concerns?
Suggested answer
BNF Chapter 8, Immune system disorders and transplantation – pages 720-723
For further information, read about Envarsus in the BNF.
You may also wish to read about Prograf on the electronic Medicines Compendium.
To improve your knowledge of adverse drug reactions, access our three-part e-learning programme Adverse drug reactions:
Part1: Adverse drug reactions and medicines safety
Part 2: Reporting adverse drug reactions
Part 3: Patients and adverse drug reactions
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Amiodarone in
chronic hepatitis C
Amare Okoro is a 47-year-old patient with a history of drug and alcohol abuse
in his 20s and 30s. He has given up drugs and alcohol and has been “clean” for
over ten years.
He was diagnosed with paroxysmal ventricular arrhythmia in his late 30s. After
a trial of several treatments which were not tolerated, he was finally stabilised
on amiodarone 200 mg daily. He is reviewed annually by a cardiologist and his
condition is well controlled.
At his most recent cardiology review, about three months ago, he was in sinus
rhythm and his heart rate was 72 beats per minute at rest.
Over the last few months, Amare has been complaining of flu-like symptoms and
chronic fatigue. After multiple investigations, he has just been diagnosed with
chronic hepatitis C and started on a 12-week course of sofosbuvir 400 mg daily
and daclatasvir 60 mg daily.
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FIVE
1. What monitoring is recommended for the concomitant use of sofosbuvir and amiodarone?
Suggested answer
BNF Chapter 2, Arrhythmias – pages 88-89
For further information, read about amiodarone hydrochloride in the BNF.
You may also wish to read about Sovaldi on the electronic Medicines Compendium.
For further guidance on sofosbuvir for treating chronic hepatitis C, refer to the NICE technology appraisal guidance
TA330.
Visit the.Learningpharmacy.comTM floor on substance misuse to learn more about supporting people who misuse drugs
and other substances.
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FIVE
2. Amare develops bradycardia two days after initiation of sofosbuvir. What action should be taken?
Suggested answer
BNF Chapter 2, Arrhythmias – pages 88-89
For further information, read about amiodarone hydrochloride in the BNF.
You may also wish to read about Sovaldi on the electronic Medicines Compendium and the Yellow Card Scheme on the
MHRA website.
For further learning on management of chronic heart failure, access the Northern Ireland Centre for Pharmacy Learning
and Development (NICPLD) Cardiovascular disease e-learning programme.
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Lipegfilgrastim
John Burkov is a 43-year-old engineer and a regular patient of yours. He has
a history of coeliac disease (which is well controlled by diet), osteoporosis and
thyroid cancer. He has recently stayed in hospital after suffering pneumonia. John
has recovered well from the pneumonia and is now back at home with his family.
He is under the care of the oncologists and the ear, nose and throat (ENT) team.
His oncologist has decided to prescribe lipegfilgrastim to reduce the duration of
neutropenia and incidence of febrile neutropenia in cytotoxic chemotherapy.
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1. What is the appropriate dose regimen for lipegfilgrastim and does John have any risk factors to
consider?
Suggested answer
BNF Chapter 9, Neutropenia and stem cell mobilisation – page 840
For further information, read about drugs used in neutropenia in the BNF.
For interactive learning scenarios, visit the Coeliac disease floor on theLearningpharmacy.comTM.
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2. J ohn has been on a lot of different medicines and likes to be knowledgeable about his treatment,
so he asks you for further information about lipegfilgrastim. How would you respond to John?
Suggested answer
BNF Chapter 9, Neutropenia and stem cell mobilisation – page 840
For further information, read about drugs used in neutropenia in the BNF.
If you would like to learn more about cancer and the role of the pharmacy team access the CPPE Cancer: in relation to
pharmacy practice distance learning programme.
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Lisdexamfetamine
Eleanor Hadler is an 18-year-old college student. She has recently been
diagnosed with attention deficit hyperactivity disorder (ADHD). Over the last
month Eleanor has been taking methylphenidate hydrochloride which was
prescribed by a specialist; however, this has not been effective.
Eleanor’s medical history includes mild asthma controlled with inhalers and poor
renal function.
Eleanor is 164 cm tall and weighs 58 kg. Her estimated glomerular filtration
rate (eGFR) was measured last week and was 28 mL/minute/1.73 m2 which is
consistent with previous readings and is stable. Eleanor is not treated with any
type of dialysis.
The specialist wants to trial a prescription of lisdexamfetamine mesilate and
contacts you for advice on an appropriate dose regimen for Eleanor.
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1. What starting dose would you recommend? What would be the maximum daily dose for Eleanor?
Suggested answer
BNF Chapter 4, Attention deficit hyperactivity disorder – pages 271-272
For further information, read about principles of dose adjustment in renal impairment in the BNF.
NHS Education for Scotland’s learning programme The pharmaceutical care of people living with learning disabilities
details the characteristics, diagnosis and management of ADHD in children, adults and people living with learning
difficulties.
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2. S
ince starting lisdexamfetamine, Eleanor has not been sleeping well. Eleanor takes lisdexamfetamine
every evening with dinner because she finds the capsules hard to swallow. How would you respond?
Suggested answer
BNF Chapter 4, Attention deficit hyperactivity disorder – pages 271-272
For further information, read about lisdexamfetamine mesilate in the BNF.
You may also wish to read the SPC for Elvanse on the electronic Medicines Compendium.
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Dimethyl fumarate
Alice Carter is a 30-year-old lady with active relapsing-remitting multiple
sclerosis. She lives with her partner and works part-time as an artist. She is not
planning to conceive a baby. She has no other medical conditions and she is not
taking any other medicines.
It has been decided that dimethyl fumarate would be an option in the
management of her multiple sclerosis. Alice meets the criteria and does not have
highly active or rapidly evolving severe relapsing-remitting multiple sclerosis. The
manufacturer is providing dimethyl fumarate with the discount agreed in the
patient access scheme.
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1. What are the monitoring recommendations before starting Alice on dimethyl fumarate and what
would need monitoring once the drug has been started?
Suggested answer
BNF Chapter 8, Multiple sclerosis – page 727
For further information, read about dimethyl fumarate in the BNF.
You may also wish to read about Tecfidera on the electronic Medicines Compendium.
You can find out more about relapsing-remitting multiple sclerosis on the Multiple Sclerosis Society website.
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NICE has a technology appraisal on dimethyl fumarate (TA320).
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2. How would you talk to Alice about recognising the signs and symptoms of PML?
Suggested answer
BNF Chapter 8, Multiple sclerosis – page 727
For further information, read about dimethyl fumarate in the BNF.
Read the Drug safety update on the risk of PML in multiple sclerosis patients taking dimethyl fumarate and the MHRA
leaflet on the risk of infection when taking dimethyl fumarate.
Visit the Neurology floor on theLearningpharmacy.comTM to learn more about multiple sclerosis and other neurological
conditions.
To improve your consultation skills, attend one of our Confidence in consultation skills workshops, and access the
Consultation skills for pharmacy practice website or CPPE’s Consultation skills e-learning programme.
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Hydroxyzine
Joan Bridge is a 78-year-old widow who lives alone. She has hypertension and
has been taking amlodipine 5 mg once daily for over eight years. Recently she
has been suffering with intense itching. She has been to the pharmacy and tried
a few creams which gave her some relief but have not stopped the itching.
Her GP has prescribed hydroxyzine 100 mg once daily for chronic pruritus. She
takes no other regular medicines. She does not like taking tablets and wants to
know if she can stop taking her amlodipine, as she feels fine, so she only has to
take one tablet, her hydroxyzine. You invite Joan for a medication review.
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1. What specific risk factors relating to the use of hydroxyzine should you assess?
Suggested answer
BNF Chapter 3, Allergic conditions – page 248
For further information, read about antihistamines in the BNF.
Access the European Medicines Agency’s online information on hydroxyzine.
Visit the National Pharmacy Association website to find out more about the risks of hydroxyzine.
Access the CPPE Hypertension learning@lunch flex programme to improve your knowledge in this area.
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2.While you are talking to Joan, she tells you that her brother died suddenly when he was 30 years
old and she was informed that it was a result of “something wrong with his heart”.
Given Joan’s medical history and risk factors, is it appropriate for her to continue taking
hydroxyzine 100 mg once daily for her chronic pruritus?
Suggested answer
BNF Chapter 3, Allergic conditions – page 248
For further information, read about antihistamines in the BNF.
Access the European Medicines Agency’s online information on hydroxyzine.
Read the Drug safety update on the risks of QT-interval prolongation and Torsade de Pointes associated with hydroxyzine.
To increase your confidence in providing effective new medicine service consultations with patients on antihypertensives,
access the CPPE New medicine service – antihypertensives interactive PDF.
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Tramadol
Jake Thompson, a 35-year-old man who is normally fit and well with no previous
medical conditions, presented at the local hospital yesterday with abdominal
pain. Following a diagnosis of gall bladder infection he underwent a laparoscopic
cholecystectomy. Jake was discharged after his day surgery.
As he was still in moderate to severe pain, he was discharged from hospital with
an original pack of 30 tramadol capsules, 50 mg. Jake has come to you for
advice as he can’t fully remember all the directions he was given after his surgery.
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1. W
hat dose would you recommend for Jake’s moderate and sometimes severe pain following his
surgery?
Suggested answer
BNF Chapter 4, Pain – pages 373-374
For further information, read about tramadol hydrochloride in the BNF.
Access the CPPE Pain focal point to learn more about how you can support people with chronic pain to improve their
quality of life.
Access CPPE’s Pain: treatment and management distance learning programme for an overview of pain management.
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2. J ake is worried about his drive home today, as the tramadol this morning made him very drowsy.
What advice do you have for Jake regarding driving?
Suggested answer
BNF Chapter 4, Pain – pages 373-374
For further information, read about drugs and driving in the BNF.
Access the MHRA advice: Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new
legal offence.
The Department of Transport has published information about changes to the drug driving law and guidance for
healthcare professionals.
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Pimecrolimus
Enna Adebolawe is a 26-year-old lady who is 36 weeks pregnant with her first
child. Her pregnancy is going well with no complications. She has a history of
atopic eczema on her face and neck, which has particularly flared up during her
pregnancy.
She has been using beclometasone 0.1 percent cream in addition to Zerobase
emollient but has recently noticed that this has not been effective in controlling
her eczema. Her consultant decides that Enna is suitable for a trial of
pimecrolimus cream, Elidel.
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1. Is pimecrolimus suitable for Enna to try?
Suggested answer
BNF Chapter 13, Eczema and psoriasis – pages 1019-1020
For further information, read about pimecrolimus in the BNF.
You may also wish to read the SPC for Elidel on the electronic Medicines Compendium.
Access the NHS Education for Scotland Dermatology pocket guide: common skin conditions explained for further
information on practical advice and topical treatments.
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2. T
he consultant decides to wait until after the baby is born to trial pimecrolimus. Could Enna be
prescribed pimecrolimus whilst she is breastfeeding?
Suggested answer
BNF Chapter 13, Eczema and psoriasis – pages 1019-1020
For further information, read about pimecrolimus in the BNF.
You may also wish to read the SPC for Elidel on the electronic Medicines Compendium.
Access the NICE technology appraisal on tacrolimus and pimecrolimus for atopic eczema (TA82).
The Dermatology floor on theLearningpharmacy.comTM provides further learning and case studies to increase your
knowledge.
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Aceclofenac
Margaret Sutton is a 67-year-old patient with rheumatoid arthritis which is
currently managed with ibuprofen at a daily dose of 1.6 g. She has no history of
gastrointestinal ulceration or bleeding, but is also prescribed lansoprazole 15 mg
daily prophylactically. Her rheumatoid arthritis is moderately controlled.
Margaret is about to undergo hip replacement surgery and is likely to be
immobile for a long period of time. Her doctor is considering changing her
treatment to aceclofenac to manage her pain and inflammation following
the operation.
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1. How appropriate would aceclofenac be for Margaret?
Suggested answer
BNF Chapter 10, Pain and inflammation in musculoskeletal disorders – pages 916-917
For further information, read about NSAIDs in the BNF.
Access the CPPE Rheumatoid arthritis focal point programme to better understand the management of rheumatoid
arthritis.
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2. What advice would you give to her doctor to help manage her pain and inflammation?
Suggested answer
BNF Chapter 10, Pain and inflammation in musculoskeletal disorders – pages 916-917
For further information, read about NSAIDs in the BNF.
You may also find it useful to access the NICE advice on NSAIDs (KTT13) and the NICE clinical summary on NSAIDs.
Further information on NSAIDs can be found on the NSAIDs floor on theLearningpharmacy.comTM.
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Next steps
Now that you have completed the case studies, what’s next?
You might like to:
n r evisit the learning objectives. Are you confident that you have
achieved these?
n tackle the reflective essay that you can download from your
CPPE learning record
n complete a CPD entry
n email CPPE with any feedback you may have on your learning
experience
n take the BNF 70-themed CPPE e-challenge (issue 95).
We hope that you have enjoyed your learning. Come back for more
learning when we publish What’s new in BNF 71? next year.
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39
Credits
CPPE programme manager
Caroline Barraclough, regional manager, East Midlands
Authors
Beth Carney, prescribing advisor and medicines management
lead, Nottingham West CCG
Jo Clarke, tutor, CPPE
Nuala Hampson, primary care pharmacist, Rushcliffe CCG
Imran Jawaid, sessional GP, Royal Tunbridge Wells, Kent
Fatema Karimjee, medicines management pharmacist,
Nottingham City CCG
Tony Perkins, clinical pharmacist, Plymouth Community
Healthcare
Neil Powell, antibiotics and HIV pharmacist, Royal Cornwall
Hospital
Kevin Ratcliffe, consultant pharmacist, Reach Out Recovery,
Birmingham
Editors
Katie L Page, clinical writer, BNF Publications
Heenaben Patel, content manager, BNF Publications
Terri Lucas, editor, CPPE
Disclaimer
We have developed this learning programme to support your
practice in this topic area. We recommend that you use it in
combination with other established reference sources. If you are
using it significantly after the date of initial publication, then
you should refer to current published evidence. CPPE does not
accept responsibility for any errors or omissions.
Brand names and trademarks
CPPE acknowledges the following brand names and registered
trademarks mentioned throughout this programme: Elidel®,
Elvanse®, Envarsus®, Flotros®, Prograf®, Sovaldi®,
Tecfidera®, Vesicare®, Zerobase®.
Acknowledgements
CPPE acknowledges the support of the British National
Formulary for allowing us to use links and text from their
publication.
Production
Gemini West, 25 Hockeys Lane, Fishponds, Bristol, BS16 3HH
T: 0117 965 5252. www.gemini-west.co.uk
Published in October 2015 by the Centre for Pharmacy
Postgraduate Education, Manchester Pharmacy School, The
University of Manchester, Oxford Road, Manchester M13 9PT.
www.cppe.ac.uk
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Contacting CPPE
For information on your orders or bookings, or any general
enquiries, please contact us by email, telephone or post.
A member of our customer services team will be happy to
help you with your enquiry.
Email [email protected]
Telephone
0161 778 4000
By post
Centre for Pharmacy Postgraduate Education (CPPE)
Manchester Pharmacy School
1st Floor, Stopford Building
The University of Manchester
Oxford Road
Manchester M13 9PT
Share your learning
experience with us:
email us at [email protected]
Funded by:
For information on all our
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Developed by:
Suggested answers
Contents
Solifenacin
1. H
ow appropriate is the current clinical plan for treating Sarah’s urinary
frequency and urgency?
Antimuscarinic drugs should be used with caution in older people. Sarah is also
taking ketoconazole, a potent inhibitor of the cytochrome P450 enzyme CYP3A4,
which is the enzyme involved in the metabolism of solifenacin. This interaction
will potentially lead to increased levels of solifenacin, increasing the likelihood of
unwanted effects, in particular anticholinergic adverse effects as the frequency of
these are dose-related.
It is advised that the maximum dose of solifenacin should be restricted to 5 mg
daily when used simultaneously with ketoconazole.
In patients with severe renal impairment or moderate hepatic impairment the use
of solifenacin and ketoconazole together is contraindicated and an alternative
clinical plan could be considered.
Return to case study
Solifenacin
2. What action would you recommend?
If solifenacin is still the most appropriate treatment for Sarah, the dose should not
be increased above 5 mg daily. Sarah should be reviewed every 4-6 weeks until her
symptoms stabilise, and then every 6-12 months.
Sarah should be informed of the adverse effects of solifenacin, which include dry
mouth, constipation, dry eyes and blurred vision. To prevent the risk of a fall, let
Sarah know that she may feel dizzy or faint in hot environments.
Trospium may be an alternative option to consider as it is not metabolised by
the cytochrome P450 system. Before beginning treatment, Sarah should be
investigated for organic causes of frequency, urgency and urge incontinence. These
could include infections, kidney disease or heart disease and these causes should
be excluded. If trospium is used Sarah would have to be reassessed at intervals of
3-6 months to check if treatment is still necessary.
Return to case study
Tacrolimus
1. What advice would you give to Ben and the GP about switching brands of tacrolimus?
Ben and his GP should be advised that Envarsus is a modified-release formulation and
Prograf is an immediate-release formulation. So, in order to maintain his therapeutic
response to tacrolimus and the continued acceptance of his transplanted kidney, and to
prevent transplant rejection, he must ensure that he is always prescribed and dispensed
the same brand of tacrolimus. In Ben’s case, this brand is Prograf.
Ben may benefit from an organised prescription re-ordering schedule to allow for any
delay in obtaining his next prescription supply. If one community pharmacy is having
difficulty obtaining a supply, another may not, so he could see if a different pharmacy
can help. The manufacturer may also be able to provide a supply to ensure continued
treatment.
The BNF states that Envarsus is not interchangeable with other oral tacrolimus-containing
products and the Medicines and Healthcare products Regulatory Agency (MHRA)/
Commission of Human Medicines (CHM) advises that oral tacrolimus products should
be prescribed and dispensed by brand name only as any inadvertent switching between
brands can lead to toxicity and graft rejection.
Should there be a need to change the brand of oral tacrolimus, this should be done under
the close supervision of the specialist, so Ben would need referring back to the specialist if
a further supply of Prograf could not be obtained.
Return to case study
Tacrolimus
2. Ben is concerned about the side-effects of tacrolimus. How would you address his concerns?
As Ben has been on the medicine for a while it may be appropriate to ask if he thinks he is
suffering from any side-effects and to discuss the common ones with him. Many of the adverse
drug reactions stated in the patient information leaflet, BNF and the summary of product
characteristics are reversible and/or respond to dose reduction.
Common side-effects (may affect 1 in 100 to 1 in 10 people) include:
n sleep disturbances
n anxiety symptoms
n tinnitus
n blurred vision
n diarrhoea (this may increase Ben’s tacrolimus levels, which can cause toxicity, so it would be
appropriate to report diarrhoea to his GP).
It is important to let Ben know that tacrolimus can affect his vision or make him feel dizzy. If he
notices either of these side-effects it may not be safe for him to drive. Drinking alcohol can make
these side-effects worse.
Tacrolimus can affect the body’s immune system so he may be at increased risk of infections. You
can reassure him by reminding him that he is being monitored and that if he has any concerns he
can speak to his GP.
Ask Ben if he takes or is thinking about starting any herbal preparations or over-the-counter
medicines and discuss the potential interactions. In particular, there are common interactions with
St John’s wort, grapefruit juice and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen.
Return to case study
Amiodarone in chronic hepatitis C
1. What monitoring is recommended for the concomitant use of sofosbuvir and
amiodarone?
There is limited experience of the use of sofosbuvir with concomitant amiodarone
from clinical trials. There is a possible increased risk of bradycardia when
sofosbuvir is given with amiodarone. At present, the mechanism of the interaction
is unknown.
If amiodarone cannot be avoided because other anti-arrhythmics are not tolerated
or are contraindicated, close cardiac monitoring in an appropriate clinical setting
should be carried out for 48 hours following initiation of sofosbuvir, particularly in
patients at high risk of bradycardia. All patients should be monitored closely in the
first weeks of treatment.
Patients and carers should be advised of the symptoms of bradycardia and should
be advised to seek urgent medical assistance if they experience any of these.
Symptoms include shortness of breath, palpitations, dizziness and fainting.
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Amiodarone in chronic hepatitis C
2. Amare develops bradycardia two days after initiation of sofosbuvir. What
action should be taken?
Amiodarone should be stopped and Amare should be referred back to his hospital
cardiology team in order to determine the most appropriate course of action to
control the arrhythmia.
Due to the long half-life of amiodarone, the effect of the interaction may persist
for several weeks after withdrawal. Amare should receive appropriate monitoring
during this time.
Sofosbuvir is a black triangle drug so any adverse effect relating to its use should
be reported to the MHRA via the Yellow Card Scheme.
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Lipegfilgrastim
1. What is the appropriate dose regimen for lipegfilgrastim and does John have
any risk factors to consider?
Lipegfilgrastim is a granulocyte-colony stimulating factor (G-CSF) and should only
be used by specialists experienced in its use. It is administered via subcutaneous
injection in adults over 18 years at a dose of 6 mg (0.6 mL) for each chemotherapy
cycle, given approximately 24 hours after chemotherapy.
Patients with a recent history of pneumonia or pulmonary infiltrates may be at
higher risk of acute respiratory distress syndrome. As John has recently recovered
from pneumonia, caution would be needed in prescribing lipegfilgrastim and
treatment would need to be withdrawn if John developed signs of pulmonary
infiltration.
John’s spleen size should also be monitored during treatment due to lipegfilgrastim
treatment putting John at risk of splenomegaly and rupture.
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Lipegfilgrastim
2. John has been on a lot of different medicines and likes to be knowledgeable
about his treatment, so he asks you for further information. How would you
respond to John?
You can ask John if he has any specific questions about lipegfilgrastim and
neutropenia and you can offer general guidance.
Granulocyte-colony stimulating factors such as lipegfilgrastim stimulate the
production of neutrophils and may reduce the duration of the chemotherapyinduced neutropenia John is suffering from.
John might like to know more about the side-effects of lipegfilgrastim, which
include:
n rash
n gastrointestinal disturbances
n interstitial pneumonia.
You can signpost him to the patient information leaflet for more information about
common side-effects.
If John should experience pain in the upper left side of the abdomen or left
shoulder he should contact his doctor immediately as this could be a sign that
there is a problem with his spleen.
Due to his neutropenia, advice regarding steps to prevent infection, including:
good hygiene, avoiding contact with sick people, avoiding animal waste and using
an electrical shaver rather than razor to reduce the likelihood of cuts, would be
beneficial.
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Lisdexamfetamine
1. What starting dose would you recommend? What would be the maximum daily
dose for Eleanor?
The initial recommended dose for a 6-18 year old is 30 mg once daily in the
morning. This can be increased by 20 mg at weekly intervals to a maximum of
70 mg daily if necessary. Treatment should be discontinued if the response is
insufficient after one month.
In Eleanor’s case, her renal function must be considered. Her eGFR is 28 mL/
minute/1.73 m2. This would be classed as severe renal impairment.
Before using eGFR when adjusting drug dosages, it is important to ensure that the
patient’s body mass index (BMI) is within normal ranges. If the BMI is less than
18.5 kg/m2 or greater than 30 kg/m2 the absolute glomerular filtration rate or
creatinine clearance should be used to adjust doses.
Eleanor’s weight and height are normal for her age and her BMI is 21.6 kg/m2, so
eGFR can be used when adjusting Eleanor’s dose.
In severe renal impairment there are no changes to the initial dose of
lisdexamfetamine mesilate, but the maximum daily dose is 50 mg.
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Lisdexamfetamine
2. Since starting lisdexamfetamine, Eleanor has not been sleeping well. Eleanor
takes lisdexamfetamine every evening with dinner because she finds the
capsules hard to swallow. How would you respond?
Sleep disturbances are a common adverse reaction experienced by patients taking
lisdexamfetamine.
Eleanor can minimise the potential for sleep disturbances by taking it in the
morning. Lisdexamfetamine can be taken with or without food so there is no
specific requirement to take it with a meal.
To help with her swallowing difficulties, Eleanor can open the capsule and mix the
entire contents into soft food, such as yoghurt, or a glass of water or juice. She
should consume the entire mixture immediately.
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Dimethyl fumarate
1. What are the monitoring recommendations before starting Alice on dimethyl
fumarate and what would need monitoring once the drug has been started?
Before dimethyl fumarate is prescribed to Alice she must have her full blood count
(including lymphocytes) checked, as dimethyl fumarate may decrease lymphocyte
counts. Dimethyl fumarate has not been studied in patients with pre-existing
lymphopenia or in combination with other immunosuppressive medicines so it must
not be prescribed in these cases.
Once she is initiated on dimethyl fumarate, Alice must have a full blood count
(including lymphocytes) carried out every 6 to 12 months or more frequently
if clinically indicated. She will need to be monitored closely if she develops
lymphopenia or features of progressive multifocal leukoencephalopathy (PML), eg,
signs and symptoms of neurological dysfunction, and other opportunistic infections.
If PML is suspected, Alice must be advised to stop dimethyl fumarate immediately.
In addition to full blood counts, Alice would need to have her renal and hepatic
function monitored before treatment, after 3 to 6 months of treatment, then every
6 to 12 months thereafter, and as clinically indicated.
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Dimethyl fumarate
2. How would you talk to Alice about recognising the signs and symptoms of
PML?
Alice needs to know the risk of lymphopenia and potential risk of PML before she
starts taking dimethyl fumurate. Ask her if she feels confident that she is aware of
these risks.
Talk to Alice about the signs and symptoms of PML and let her know that she
should speak to her prescriber if her multiple sclerosis gets worse, if she notices any
new symptoms, or if she has a long-lasting fever or infection. Make sure that Alice
is aware that the symptoms of PML can be similar to the symptoms of multiple
sclerosis.
The MHRA has published a patient information leaflet for patients and carers.
Make sure you have copies of this leaflet available and give one to Alice. Let her
know that more information is available in the patient information leaflet contained
in the box of capsules.
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Hydroxyzine
1. What specific risk factors relating to the use of hydroxyzine should you assess?
The following risk factors should be considered:
n
n
n
n
age (elderly patient)
past medical history (hypertension)
concomitant medicines (amlodipine)
duration of hydroxyzine treatment.
Hydroxyzine is associated with a small risk of QT-interval prolongation and Torsade
de Pointes. These events are most likely to occur in patients who have risk factors
for QT-interval prolongation, such as concomitant use of medicines that prolong
the QT-interval, cardiovascular disease, family history of sudden cardiac death,
significant electrolyte imbalance (low plasma-potassium or plasma-magnesium
concentrations), or significant bradycardia.
The use of hydroxyzine is therefore contraindicated in patients with QT-interval
prolongation or who have risk factors for QT-interval prolongation.
Hydroxyzine use should also be avoided in elderly patients due to increased
susceptibility to side-effects. If use cannot be avoided, a maximum daily dose of
50 mg should be prescribed for the shortest period of time.
Talk to Joan about the use and benefits of her amlodipine and advise her not
to stop taking any prescribed medicines before speaking to her prescriber or
pharmacist.
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Hydroxyzine
2.While you are talking to Joan, she tells you that her brother died suddenly
when he was 30 years old and she was informed that it was a result of
“something wrong with his heart”.
Given Joan’s medical history and risk factors, is it appropriate for her to
continue taking hydroxyzine 100 mg once daily for her chronic pruritus?
Joan’s family history of sudden cardiac death in addition to her known hypertension
contraindicates the use of hydroxyzine.
Hypertension alone would not be a contraindication to the use of hydroxyzine.
However, there is a family history of sudden cardiac death and this is a recognised
risk factor for QT-interval prolongation and therefore would make the use of
hydroxyzine contraindicated.
If Joan did not have risk factors for QT-interval prolongation, the BNF recommends
to avoid the use of hydroxyzine in elderly patients due to increased susceptibility
to side-effects, vulnerability to anticholinergic effects and reduced elimination of
hydroxyzine. If the use of hydroxyzine in the elderly cannot be avoided then the
maximum daily dose should be reduced from 100 mg to 50 mg for the shortest
time possible.
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Tramadol
1. What dose would you recommend for Jake’s moderate and sometimes severe
pain following his surgery?
For Jake’s acute pain, the recommended oral dose for tramadol in the BNF is an
initial dose of 100 mg and then 50-100 mg every four to six hours, suggesting a
total of more than 400 mg daily is not usually required.
It would be advisable to ask Jake if he was given any other medicine on discharge
and if he has a follow-up appointment or letter which may state all his discharge
medicines, doses and advice given.
As he seems unclear about the advice given it would be a good idea to explain
more about tramadol and potential side-effects, and give him an opportunity
to ask questions following this information. Tramadol has an opioid effect and
enhancement of serotonergic and adrenergic pathways. It has fewer of the typical
opioid side-effects, for example, less constipation and less addiction potential.
Signpost him to the patient information leaflet for further information should he
require it and invite him to return to you if he has any further queries or concerns.
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Tramadol
2. J ake is worried about his drive home today, as the tramadol this morning made
him very drowsy. What advice do you have for Jake regarding driving?
As Jake felt very drowsy after taking his tramadol dose this morning it would not be
advisable for him to drive.
Tramadol can cause drowsiness which may affect performance of skilled tasks (eg,
driving); Jake should also be warned that such effects are increased by alcohol.
The BNF advises that driving should be avoided at the start of therapy with opioid
analgesics and following dose changes.
Jake must be made aware of our current laws on driving while on medication,
including the changes to the law introduced from March 2015. The law states you
should not drive if you feel sleepy or unable to concentrate due to the influence of
any drugs, whether prescribed or not.
Jake should be given suitable evidence, for example, the medicine’s patient
information leaflet, for his use of tramadol and be advised to carry this with him at
all times.
The MHRA has issued a patient leaflet about the law on driving while taking
certain drugs and The Christie NHS Foundation Trust has published a patient
information leaflet on driving when taking strong painkillers or other sedating
medicines. It would be useful to give Jake a copy of these leaflets or signpost him
to the online versions.
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Pimecrolimus
1. Is pimecrolimus suitable for Enna to try?
Pimecrolimus is recommended for the treatment of patients aged 2 years and
over with mild or moderate atopic dermatitis where treatment with topical
corticosteroids is either inadvisable or not possible. This could be due to:
n intolerance to topical corticosteroids
n lack of effect
n use on the face and neck where prolonged intermittent treatment with topical
corticosteroids may be inappropriate.
Pimecrolimus cream may be used on all areas of skin including the head, face,
neck and intertriginous areas but not on mucous membranes. Emollients can be
applied straight after using pimecrolimus cream. If there is no response after six
weeks or there is worsening of the eczema during treatment the pimecrolimus
should be discontinued.
The long-term safety of pimecrolimus is still being evaluated and therefore is
not usually considered for first-line treatment unless there is a specific reason to
avoid or reduce the use of topical corticosteroids. Treatment of atopic eczema
with topical pimecrolimus should be initiated only by prescribers experienced in
managing the condition.
There is no adequate data from the use of pimecrolimus in pregnant women.
Topical absorption after topical application is minimal; however, animal studies with
systemic use have shown toxicity. Therefore, it is recommended that Enna should
not use pimecrolimus during her pregnancy.
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Pimecrolimus
2. The consultant decides to wait until after the baby is born to trial
pimecrolimus. Could Enna be prescribed pimecrolimus whilst she is
breastfeeding?
The BNF advises caution in breastfeeding. This is largely due to the fact that the
use of pimecrolimus has not been studied in breastfeeding women and it is not
known whether it is excreted in the milk after topical application.
Breastfeeding mothers may use pimecrolimus, but should not apply it to the breast
to avoid unintentional oral uptake by the newborn. Care must be taken to ensure
the infant does not come into contact with the treated areas.
Therefore, as Enna will be using the pimecrolimus cream on her face and neck and
absorption is likely to be limited, she can use the cream whilst breastfeeding.
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Aceclofenac
1. How appropriate would aceclofenac be for Margaret?
Aceclofenac has stronger anti-inflammatory properties than ibuprofen and this will
help manage her pain. But her age, lack of mobility and potential longer term use
of this drug suggest there is an increased risk of a thrombotic event (eg, stroke
or myocardial infarction) and therefore aceclofenac would not be appropriate for
Margaret.
Cyclo-oxygenase-2 selective inhibitors, such as diclofenac (150 mg daily) and
ibuprofen (2.4 g daily), are associated with an increased risk of thrombotic events.
Although there are limited data regarding the thrombotic effects of aceclofenac,
treatment advice has been updated in line with diclofenac, based on aceclofenac’s
structural and metabolic similarity to diclofenac.
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Aceclofenac
2. What advice would you give to her doctor to help manage her pain and
inflammation?
In order to reduce the risk of a thrombotic event, it may be more appropriate
to prescribe naproxen (1 g daily) instead. Naproxen is similar in efficacy to
aceclofenac but is associated with a lower thrombotic risk.
Margaret should be monitored closely for side-effects as naproxen has a higher
incidence of side-effects than ibuprofen (particularly gastrointestinal effects).
All long-term NSAID treatment should be reviewed periodically and the lowest
effective dose of NSAID should be prescribed for the shortest duration possible.
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