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October 2015 What’s new in BNF 70? Enter A CPPE interactive PDF learning programme
October 2015
What’s new in BNF 70?
Enter
A CPPE interactive PDF learning programme
Welcome toWhat’s new inBNF 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).
Learning with CPPEThe 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.
Contents
3 How to use this learning programme
4 About What’s new in BNF 70?
5 Learning objectives
6 Case studies – introduction
7 Case studies
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Click on a title to go directly to that section.
Next steps
39 Programme credits
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© Copyright Controller HMSO 2015
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How to use this learning programmeThis 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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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 linksWhere 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.
About What’s new in BNF 70?
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Learning objectivesBy 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 recommend 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 – introductionThis 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 studiesThe 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.
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Solifenacin
Dimethyl fumarate
Lipegfilgrastim
Pimecrolimus TramadolAceclofenac
Lisdexamfetamine
TacrolimusAmiodarone in chronic hepatitis C
Hydroxyzine
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Solifenacin
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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.
Suggested answer
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Don’t forget to save your answers
1. How appropriate is the current clinical plan for treating Sarah’s urinary frequency and urgency?
ONE
Click to return to the case studies menu
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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Don’t forget to save your answers Click to return to the case studies menu
2. What action would you recommend?
Suggested answer
TWO
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.
Tacrolimus
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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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Don’t forget to save your answers
1. What advice would you give to Ben and the GP about switching brands of tacrolimus?
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Click to return to the case studies menu
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.
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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Don’t forget to save your answers
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Suggested answer
2. Ben is concerned about the side-effects of tacrolimus. How would you address his concerns?
FOUR
Click to return to the case studies menu
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Amiodarone in chronic hepatitis CAmare 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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Don’t forget to save your answers
1. What monitoring is recommended for the concomitant use of sofosbuvir and amiodarone?
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Suggested answer
FIVE
Click to return to the case studies menu
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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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.
Don’t forget to save your answers
2. Amare develops bradycardia two days after initiation of sofosbuvir. What action should be taken?
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Suggested answer
FIVE
Click to return to the case studies menu
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LipegfilgrastimJohn 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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Suggested answer
Don’t forget to save your answers
1. What is the appropriate dose regimen for lipegfilgrastim and does John have any risk factors to
consider?
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Click to return to the case studies menu
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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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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Suggested answer
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 about lipegfilgrastim. How would you respond to John?
Don’t forget to save your answers Click to return to the case studies menu
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LisdexamfetamineEleanor 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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Suggested answer
Don’t forget to save your answers
1. What starting dose would you recommend? What would be the maximum daily dose for Eleanor?
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Click to return to the case studies menu
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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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.
Suggested answer
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?
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Don’t forget to save your answers Click to return to the case studies menu
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Dimethyl fumarateAlice 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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Suggested answer
Don’t forget to save your answers
1. What are the monitoring recommendations before starting Alice on dimethyl fumarate and what would need monitoring once the drug has been started?
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Click to return to the case studies menu
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.
NICE has a technology appraisal on dimethyl fumarate (TA320). NextBack Contents
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.
Suggested answer
2. How would you talk to Alice about recognising the signs and symptoms of PML?
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Don’t forget to save your answers Click to return to the case studies menu
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HydroxyzineJoan 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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Don’t forget to save your answers Click to return to the case studies menu
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.
Suggested answer
1. What specific risk factors relating to the use of hydroxyzine should you assess?
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Don’t forget to save your answers Click to return to the case studies menu
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.
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?
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TramadolJake 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.
1. What dose would you recommend for Jake’s moderate and sometimes severe pain following his surgery?
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Don’t forget to save your answers Click to return to the case studies menu
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.
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.
2. Jake 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?
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Don’t forget to save your answers Click to return to the case studies menu
PimecrolimusEnna 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?
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Don’t forget to save your answers Click to return to the case studies menu
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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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.
2. The consultant decides to wait until after the baby is born to trial pimecrolimus. Could Enna be prescribed pimecrolimus whilst she is breastfeeding?
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Don’t forget to save your answers Click to return to the case studies menu
AceclofenacMargaret 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?
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Don’t forget to save your answers Click to return to the case studies menu
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.
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.
2. What advice would you give to her doctor to help manage her pain and inflammation?
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Don’t forget to save your answers Click to return to the case studies menu
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Next stepsNow that you have completed the case studies, what’s next?
You might like to:
n revisit 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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CreditsCPPE programme manager Caroline Barraclough, regional manager, East Midlands
AuthorsBeth Carney, prescribing advisor and medicines management lead, Nottingham West CCGJo Clarke, tutor, CPPENuala Hampson, primary care pharmacist, Rushcliffe CCGImran Jawaid, sessional GP, Royal Tunbridge Wells, KentFatema Karimjee, medicines management pharmacist, Nottingham City CCGTony Perkins, clinical pharmacist, Plymouth Community HealthcareNeil Powell, antibiotics and HIV pharmacist, Royal Cornwall HospitalKevin Ratcliffe, consultant pharmacist, Reach Out Recovery, Birmingham
EditorsKatie L Page, clinical writer, BNF Publications Heenaben Patel, content manager, BNF PublicationsTerri Lucas, editor, CPPE
DisclaimerWe 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 trademarksCPPE 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.
ProductionGemini West, 25 Hockeys Lane, Fishponds, Bristol, BS16 3HHT: 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 CPPEFor 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 School1st Floor, Stopford BuildingThe University of ManchesterOxford RoadManchester M13 9PT
For information on all our programmes and events: visit our website www.cppe.ac.uk
Share your learning experience with us:email us at [email protected]
Funded by: Developed by:
Suggested answers
Contents
Solifenacin1. How 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.
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Solifenacin2. 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.
Tacrolimus1. 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.
Tacrolimus2. 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.
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Amiodarone in chronic hepatitis C1. 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.
Amiodarone in chronic hepatitis C2. 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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Lipegfilgrastim1. 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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Lipegfilgrastim2. 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 chemotherapy-induced neutropenia John is suffering from.
John might like to know more about the side-effects of lipegfilgrastim, which include:
n rashn gastrointestinal disturbancesn 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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Lisdexamfetamine1. 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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Lisdexamfetamine2. 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.
Dimethyl fumarate1. 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 fumarate2. 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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Hydroxyzine1. What specific risk factors relating to the use of hydroxyzine should you assess?
The following risk factors should be considered:
n age (elderly patient) n past medical history (hypertension)n concomitant medicines (amlodipine)n 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.
Hydroxyzine2. 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.
Tramadol1. 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.
Tramadol2. Jake 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.
Pimecrolimus1. 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.
Pimecrolimus2. 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.
Aceclofenac1. 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.
Aceclofenac2. 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.
