0206 bnf 62 lp complete layout 1 - cppe · the overall aim of this learning@lunch flex programme on...

WTM0206/1October 2011

Learning portfolio

What’s new in BNF 62?

learning@lunch flexsolutions for national hospital pharmacy learning needs

Learning portfolio

Learning with CPPEThe Centre for Pharmacy Postgraduate Education (CPPE) is funded by the Department ofHealth and offers continuing professional development opportunities for pharmacists andpharmacy technicians providing NHS services in England. We are based in the University ofManchester’s School of Pharmacy and Pharmaceutical Sciences.

CPPE offers a wide range of learning opportunities for the pharmacy workforce. Our fulllearning portfolio is available on the internet at: http://www.cppe.ac.uk.

AcknowledgementsCPPE programme managerCeinwen Mannall, regional manager, East Midlands

AuthorsKristy Link, tutor, CPPENeil Powell, tutor, CPPESharon Warren, tutor, CPPEEmma Graham-Clark, consultant pharmacist, critical care, Sandwell and West BirminghamHospitals NHS TrustJaime Miks, palliative care pharmacist, University Hospitals Coventry and Warwickshire

EditorsCeinwen Mannall, regional manager, East Midlands, CPPENeil Condron, editor, CPPEShama Wagle, assistant editor, British National Formulary

External websitesCPPE is not responsible for the content of any non-CPPE websites mentioned in thisprogramme or for the accuracy of any information to be found there.

Acknowledgements CPPE acknowledges the support of the British National Formulary for allowing us to uselinks and text from their publication.

ProductionPeacock Design & Print Limited.

Published in October 2011 by the Centre for Pharmacy Postgraduate Education, School ofPharmacy and Pharmaceutical Sciences, University of Manchester, Oxford Road,Manchester M13 9PT.http://www.cppe.ac.uk


learning@lunch flex

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About this learning@lunch flex programme

The overall aim of this learning@lunch flex programme on the British NationalFormulary (BNF) 62 is to support pharmacists and pharmacy technicians in keepingup to date with the latest changes to the BNF.

Learning objectives

On completion of this learning programme, you should be able to:

About this learning portfolio

We have developed this learning portfolio as part of the learning@lunch flexprogramme on BNF 62. The learning and activities in the learning@lunch flexseries will help you to think about changing your practice and demonstrate yourcontinued fitness to practise.

• take appropriate action when the international normalised ratio is elevated in apatient taking warfarin

• select appropriate antibacterial therapy for high severity community-acquiredpneumonia

• select appropriate vasodilator therapy for intermittent claudication in a patient withperipheral arterial disease

• recommend an appropriate second generation antipsychotic and recommendappropriate monitoring

• identify suitable treatment for moderate Alzheimer’s disease and recommendappropriate monitoring

• recognise potential for rebound acid hypersecretion when a proton pump inhibitor isstopped and provide appropriate advice to minimise risk

• advise on reducing the risk of osteonecrosis of the jaw and atypical femoral fractureswith bisphosphonates

• assess the risk of bladder cancer with pioglitazone treatment and recommendappropriate monitoring

• advise suitable contraception for a woman commencing carbamazepine therapy• advise whether it is appropriate for a woman taking carbamazepine to breast-feed

and recommend appropriate monitoring.

Learning portfolio

Case studies

Time to discuss: 5 minutes per case study.

Each case study has two questions for you to discuss. You will be directed to a relevantBNF section to support your discussion. Your facilitator will indicate which case studies aremost relevant to your learning community.

CASE STUDY 1 – Managing a raised international normalised ratio for a patienttaking warfarin

Stuart Lowe is a 56-year-old male admitted to the respiratory ward with a severeexacerbation of chronic obstructive pulmonary disease. You remember Stuart from aprevious admission last month when he was diagnosed with a deep vein thrombosis. Todayhis international normalised ratio (INR) is 2.7.

His current drug therapy is:• doxycycline 200 mg stat, followed by 100 mg daily for 4 days• aminophylline 450 mg stat, followed by aminophylline infusion 500 mg in 500 mL

sodium chloride 0.9 percent, rate of administration 45 mL/hour• oxygen 24 percent• salbutamol 5 mg by nebulisation, six times daily• ipratropium 500 micrograms by nebulisation, six times daily• prednisolone 30 mg daily for 7 days• warfarin variable dose depending on INR.

There is no target INR endorsed on Stuart’s drug chart.

BNF Section: 2.8.2 – Pages: 146-147

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What is the target INR for Stuart and what other endorsements will you make on thechart?

Later that week, Stuart’s INR has risen to 8.5 with no signs of bleeding. What action shouldbe taken?

Learning portfolio

CASE STUDY 2 – An elderly lady with pneumonia

Doris Roberts, aged 75, is admitted with a temperature of 38.1°C, a productive cough,right-sided chest pain and shortness of breath.

Her chest X-ray shows consolidation of the right, lower lobe of her lungs.

• Heart rate = 105 beats per minute• Respiratory rate = 32 breaths per minute• Blood pressure = 120/75 mmHg• Urea = 7.5 mmol/L (3-6)• White blood cell count = 18 x 109/L (4-11 x 109) • Renal and liver function are normal

She has a CURB-65 score of 3 and is diagnosed with severe community-acquiredpneumonia. She is started on oxygen and intravenous cefotaxime and clarithromycin.

BNF Section: 5.1, Table 1 – Page: 330

What changes will you recommend to Doris’s initial antibacterial therapy?

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You discover that Doris lives in a residential care home and takes Symbicort® inhaler forchronic obstructive pulmonary disease. How does this alter your recommendation?

CASE STUDY 3 – Peripheral arterial disease

You are reviewing Bryan Johnson, aged 50, in the diabetes clinic. He complains of severeaches and pain in his legs while walking. The pain, which occurs mainly in his calves, goesaway after five to ten minutes of rest.

He smokes 20 cigarettes a day and drinks 30 units of alcohol per week. He has a longhistory of type 2 diabetes and hypertension.

• Blood pressure = 125/75 mmHg• Body mass index = 26 kg/m2

• HbA1c = 75 mmol/mol • Fasting blood glucose = 7.5 mmol/L

His current medication includes:• metformin 1 g twice daily• simvastatin 40 mg daily• ramipril 10 mg daily.

You plan to add gliclazide 80 mg daily to his therapy. However, you suspect that he mayhave intermittent claudication due to peripheral arterial disease and ask the doctor in clinicto confirm this.


Learning portfolioWhat’s new in BNF 62?

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If vasodilator therapy is necessary, which drug will you recommend?

What other advice can you provide to this patient to help improve his symptoms?

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CASE STUDY 4 – Second generation antipsychotic drugs

Lisha O’Caine, aged 32, has schizophrenia that has been well controlled for several yearson trifluoperazine 20 mg twice daily. However, she recently stopped taking thisantipsychotic when she developed tardive dyskinesia.

Over the past six months Lisha has experienced two episodes of hallucinations withagitation. The psychiatrist asks your advice on a suitable choice of second generationantipsychotic drug for Lisha, who has type 1 diabetes.

Lisha’s medications include:• Insuman® Comb 50.

Her diabetes is well controlled with:• fasting blood glucose = 5 mmol/L• HbA1c = 45 mmol/mol• body weight = 64 kg• body mass index = 22 kg/m2.


Which second generation antipsychotic will you recommend?

What monitoring will you recommend for Lisha?

Learning portfolio

CASE STUDY 5 – Memantine in moderate Alzheimer’s disease

You receive a prescription for Edith Burton, a 72-year-old woman, who is prescribedmemantine 5 mg daily. The electronic prescribing system shows that Edith was diagnosedwith moderate Alzheimer’s disease in the memory clinic.

Her daughter in law informs you that this is Edith’s first drug treatment for Alzheimer’sdisease. She also takes bendroflumethiazide 2.5 mg daily and simvastatin 40 mg at night.Edith has been forgetting to take her medicines and prepare her meals, and she requireshelp with dressing. She can no longer organise the gardening and remember when toattend to the different plants.

Edith’s renal and hepatic function are both normal.

BNF Section: 4.11 – Pages: 323-325

What changes will you recommend to Edith’s prescription for memantine?

What monitoring is necessary with donepezil?

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CASE STUDY 6 – Rebound acid hypersecretion with proton pump inhibitors

Ethel Hopkins, aged 50, has been admitted to the medical ward complaining of severeheartburn, upper abdominal pain and difficulty swallowing.

Her medication on admission included:• paracetamol 500 mg tablets, two tablets four times a day when required• Maalox® suspension 10 mL, four times a day when required.

An endoscopy revealed oesophagitis with no signs of ulceration or stricturing. She is startedon omeprazole 20 mg once daily.

Ethel has recently reduced her intake of cigarettes from 15 to about 10 a day.

BNF Section: 1.3.5 – Pages: 43-44, 54-55

When can rebound acid hypersecretion occur with proton pump inhibitors?

How can you reduce Ethel’s risk of developing rebound acid hypersecretion afteromeprazole?

Learning portfolio

CASE STUDY 7 – Bisphosphonates and osteoporosis

Ada Paluch, a 66-year-old-lady, is transferred to the care of the elderly ward with an acuteexacerbation of her chronic obstructive airways disease. During her stay, a DEXA scanshows a T score of -3.0 and she is started on alendronic acid 70 mg once weekly.

She also has a history of rheumatoid arthritis and takes sulfasalazine.

Her last dental examination took place a year ago and was satisfactory.

Renal and hepatic function is normal.

She tells you that she is finding it difficult to stop smoking and is craving for a cigarettewhile in hospital.


What advice will you provide to reduce Ada’s risk of developing osteonecrosis of the jaw?

What advice will you provide to reduce Ada’s risk of developing atypical femoral fractures?

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CASE STUDY 8 – Pioglitazone and bladder cancer

Petra Bonich, a 50-year-old lady with type 2 diabetes, is attending for a review of herdiabetes in the outpatient clinic.

Petra has been referred by her GP because her blood glucose levels have been poorlycontrolled for some time and she is unwilling to consider insulin therapy.

Her recent blood tests showed: • HbA1c = 75 mmol/mol• fasting blood glucose = 8 mmol/L• hepatic and renal function are normal• urea and electrolytes within normal ranges.

Urine dipstick showed glucose +++, protein +, no blood.

Petra is a known smoker with a body mass index of 25 kg/m2 and her past medical historyshows nothing else of relevance.

Her current medications include:• metformin 1 g twice daily• gliclazide 160 mg twice daily • simvastatin 40 mg each night• ramipril 5 mg daily.

Petra has worked as a shop assistant in a department store for many years.

The registrar is considering starting Petra on pioglitazone, but is aware of new safetyconcerns with this drug and seeks your advice.


Learning portfolio

What risk factors, if any, does Petra have for bladder cancer?

How should treatment with pioglitazone be monitored and what symptoms should Petrabe advised to report?

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CASE STUDY 9 – Oral contraception and drugs that induce liver enzymes

Zoe Walsh, a 28-year-old, is admitted to the medicines admission unit with a generalisedtonic-clonic seizure. She presented with a similar seizure a year ago.

The only medication she takes is the combined oral contraceptive Microgynon 30®.

The patient is reviewed on the post-take ward round and prescribed carbamazepine. Thejunior doctor seeks your advice regarding the potential for interactions betweencarbamazepine and Microgynon 30®.


What changes will you recommend to Zoe’s contraception?

Zoe is switched to a tricycling regimen of Loestrin 30® and Loestrin 20®, but reportsbreakthrough bleeding after several months. What adjustments are necessary to hercontraception?

Learning portfolio

CASE STUDY 10 – Epilepsy and breast-feeding

Tracie Jones, aged 30, has just given birth to a full-term healthy baby girl.

Tracie takes carbamazepine 400 mg twice daily for epilepsy and wants to know whethershe can breast-feed her daughter.


Should Tracie breast-feed?

If Tracie decides to breast-feed, how should the infant be monitored?

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Next stepsYou can access a reflective essay question at my CPPE record on the CPPE website. Ifyou would like to learn more about some of the contraception topics covered in thisprogramme, you might find CPPE’s Emergency contraception e-learning programmehelpful – you can access this at http://www.cppe.ac.uk/e-learning.

You may also wish to review the following list to check you have covered all key areas.

You have reached the end of the activities for this learning@lunch flex event; theremainder of this booklet contains the suggested answers to the case studies. Youmay wish to spend some time after the event looking through these withcolleagues.

At the end of the event you should be able to:

take appropriate action when the international normalised ratio is elevated in apatient taking warfarin

select appropriate antibacterial therapy for high severity community-acquired pneumonia

select appropriate vasodilator therapy for intermittent claudication in a patientwith peripheral arterial disease

recommend an appropriate second generation antipsychotic and recommendappropriate monitoring

identify suitable treatment for moderate Alzheimer’s disease and recommendappropriate monitoring

recognise potential for rebound acid hypersecretion when a proton pumpinhibitor is stopped and provide appropriate advice to minimise risk

advise on reducing the risk of osteonecrosis of the jaw and atypical femoralfractures with bisphosphonates

assess the risk of bladder cancer with pioglitazone treatment and recommend appropriate monitoring

advise suitable contraception for a woman commencing carbamazepine therapy

advise whether it is appropriate for a woman taking carbamazepine to breast-feed and recommend appropriate monitoring.

Well can you?

Learning portfolio

Suggested answers to:Case studies

By this stage, you will have completed this learning@lunch flexlearning programme on BNF 62. You may, or may not, haveworked through all of these case studies at your session.

The case studies and our suggested answers or discussion points are listed below.

CASE STUDY 1 – Managing a raised international normalised ratio for a patienttaking warfarin

Stuart Lowe is a 56-year-old male admitted to the respiratory ward with a severeexacerbation of chronic obstructive pulmonary disease. You remember Stuart from aprevious admission last month when he was diagnosed with a deep vein thrombosis (DVT).Today his international normalised ratio (INR) is 2.7.

His current drug therapy is:• doxycycline 200 mg stat, followed by 100 mg daily for 4 days• aminophylline 450 mg stat, followed by aminophylline infusion 500 mg in 500 mL

sodium chloride 0.9 percent, rate of administration 45 mL/hour• oxygen 24 percent• salbutamol 5 mg by nebulisation, six times daily• ipratropium 500 micrograms by nebulisation, six times daily• prednisolone 30 mg daily for 7 days• warfarin variable dose depending on INR.

There is no target INR endorsed on Stuart’s drug chart.


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What is the target INR for Stuart and what other endorsements will you make on thechart?

Later that week, Stuart’s INR has risen to 8.5 with no signs of bleeding. What action shouldbe taken?

Suggested answer

For treatment of DVT the target INR is 2.5. Stuart’s INR of 2.7 is satisfactory because it iswithin 0.5 units of the target value.

Stuart has been prescribed both doxycycline and prednisolone which can interact withwarfarin; the BNF advises that the anticoagulant effect of coumarins is possibly enhancedby tetracyclines, and that the anticoagulant effect of coumarins may be enhanced orreduced by corticosteroids. Both interactions are listed as potentially serious. Stuart’s INRshould therefore be monitored closely during his admission. You should alert the doctorto the interactions and endorse these interactions on the drug card.

Suggested answer

Stuart’s warfarin should be stopped. Phytomenadione (vitamin K1) 1-5 mg should beadministered by mouth, using the intravenous preparation orally, which is an unlicenseduse. If the INR is still too high after 24 hours then the dose of phytomenadione should berepeated. Warfarin should be restarted when the INR has fallen below 5.

Learning portfolio

CASE STUDY 2 – An elderly lady with pneumonia

Doris Roberts, aged 75, is admitted with a temperature of 38.1°C, a productive cough,right-sided chest pain and shortness of breath.

Her chest X-ray shows consolidation of the right, lower lobe of her lungs.

• Heart rate = 105 beats per minute• Respiratory rate = 32 breaths per minute• Blood pressure = 120/75 mmHg• Urea = 7.5 mmol/L (3-6)• White blood cell count = 18 x 109/L (4-11 x 109) • Renal and liver function are normal

She has a CURB-65 score of 3 and is diagnosed with severe community-acquiredpneumonia. She is started on oxygen and intravenous cefotaxime and clarithromycin.

BNF Section: 5.1, Table 1 – Page: 330

What changes will you recommend to Doris’s initial antibacterial therapy?

You discover that Doris lives in a residential care home and takes Symbicort® inhaler forchronic obstructive pulmonary disease. How does this alter your recommendation?

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Suggested answer

As this patient does not have risk factors for infection with unusual organisms, herantibacterial therapy can be switched to a narrower spectrum antibacterial regimen thatis less likely to cause Clostridium difficile infection, such as benzylpenicillin plusclarithromycin, or benzylpenicillin plus doxycycline.

Suggested answer

This patient has a co-morbidity (chronic obstructive pulmonary disease) and lives in along-term residential care home − these are risk factors for infection with unusualorganisms in high severity community-acquired pneumonia, and Doris should beprescribed broad spectrum antibacterials. In these circumstances, co-amoxiclav plusclarithromycin is used in preference to cefotaxime plus clarithromycin.

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CASE STUDY 3 – Peripheral arterial disease

You are reviewing Bryan Johnson, aged 50, in the diabetes clinic. He complains of severeaches and pain in his legs while walking. The pain, which occurs mainly in his calves, goesaway after five to ten minutes of rest.

He smokes 20 cigarettes a day and drinks 30 units of alcohol per week. He has a longhistory of type 2 diabetes and hypertension.

• Blood pressure = 125/75 mmHg• Body mass index = 26 kg/m2

• HbA1c = 75 mmol/mol • Fasting blood glucose = 7.5 mmol/L

His current medication includes:• metformin 1 g twice daily• simvastatin 40 mg daily• ramipril 10 mg daily.

You plan to add gliclazide 80 mg daily to his therapy. However, you suspect that he mayhave intermittent claudication due to peripheral arterial disease and ask the doctor in clinicto confirm this.


If vasodilator therapy is necessary, which drug will you recommend?

Suggested answer

Naftidrofuryl oxalate is recommended for the treatment of intermittent claudication inpatients with peripheral arterial disease in whom vasodilator therapy is consideredappropriate. It can alleviate symptoms and improve pain-free walking distance inmoderate disease. Patients should be assessed for improvement after three to sixmonths.

Cilostazole, pentoxifylline and inositol nicotinate are not recommended by the NationalInstitute for Health and Clinical Excellence for the treatment of intermittent claudicationin patients with peripheral arterial disease.

Learning portfolio

What other advice can you provide to this patient to help improve his symptoms?

CASE STUDY 4 – Second generation antipsychotic drugs

Lisha O’Caine, aged 32, has schizophrenia that has been well controlled for several yearson trifluoperazine 20 mg twice daily. However, she recently stopped taking thisantipsychotic when she developed tardive dyskinesia.

Over the past six months Lisha has experienced two episodes of hallucinations withagitation. The psychiatrist asks your advice on a suitable choice of second generationantipsychotic drug for Lisha, who has type 1 diabetes.

Lisha’s medications include:• Insuman® Comb 50.

Her diabetes is well controlled with:• fasting blood glucose = 5 mmol/L• HbA1c = 45 mmol/mol• body weight = 64 kg• body mass index = 22 kg/m2.


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Suggested answer

Peripheral arterial occlusive disease is associated with an increased risk of cardiovascularevents.

You should explain that the pain in his legs is related to his uncontrolled diabetes, and tothe fact that he smokes, drinks excess alcohol and is overweight. He should be givenadvice on lifestyle changes to reduce his cardiovascular risk, including information onsmoking cessation, weight reduction and reduction of excessive intake of alcohol. Exercisetraining can improve symptoms of intermittent claudication.

You should find out what his fasting lipid profile was like before he started simvastatin tosee if this was high enough to suggest familial hypercholesterolaemia. Aspirin in a dose of75 mg daily can also be used to reduce his risk of cardiovascular disease.

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Which second generation antipsychotic will you recommend?

Suggested answer

Second generation antipsychotic drugs should be prescribed if extrapyramidal side-effectsare a particular concern. Of these, aripiprazole, clozapine, olanzapine and quetiapine areleast likely to cause extrapyramidal effects.

Schizophrenia itself is associated with insulin resistance and diabetes; the risk of diabetesis increased in patients with schizophrenia who take antipsychotic drugs. Of the secondgeneration antipsychotic drugs, amisulpride and aripiprazole have the lowest risk ofdiabetes and are least likely to cause weight gain.

With the exception of clozapine, there is little meaningful difference in efficacy betweenthe different antipsychotic drugs, and response and tolerability to each drug varies.Choice is influenced by the patient’s medication history, the degree of sedation requiredand consideration of individual patient factors such as risk of extrapyramidal side-effects,weight gain, impaired glucose tolerance, QT interval prolongation or the presence ofnegative symptoms.

Aripiprazole would be a more suitable choice for this patient because it has a low risk ofextrapyramidal effects, hyperglycaemia and weight gain. Aripiprazole has negligible effecton the QT interval and hyperprolactinaemia is not usually clinically significant.

Learning portfolio

What monitoring will you recommend for Lisha?

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Suggested answer

Full blood count, urea and electrolytes and liver function tests should be checked beforestarting aripiprazole and then annually thereafter.

Blood lipids and weight should be measured at baseline, at three months (weight shouldbe measured at frequent intervals during the first three months) and then yearly.

Although Lisha will be self-monitoring her blood glucose, her fasting blood glucose andHbA1c should be monitored at baseline and then regularly during treatment.

Her physical health should be monitored at least once per year and this should includeassessment of cardiovascular disease risk; patients with diabetes are at increased risk ofcardiovascular disease. An electrocardiogram may be performed before initiatingtreatment, particularly if physical examination reveals specific cardiovascular risk factors.

As aripiprazole is not normally associated with symptomatic hyperprolactinaemia,monitoring of prolactin concentration should only be considered if symptoms occur.

She should also be monitored for any signs of relapse of her schizophrenia.

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CASE STUDY 5 – Memantine in moderate Alzheimer’s disease

You receive a prescription for Edith Burton, a 72-year-old woman, who is prescribedmemantine 5 mg daily. The electronic prescribing system shows that Edith was diagnosedwith moderate Alzheimer’s disease in the memory clinic.

Her daughter in law informs you that this is Edith’s first drug treatment for Alzheimer’sdisease. She also takes bendroflumethiazide 2.5 mg daily and simvastatin 40 mg at night.Edith has been forgetting to take her medicines and prepare her meals, and she requireshelp with dressing. She can no longer organise the gardening and remember when toattend to the different plants.

Edith’s renal and hepatic function are both normal.

BNF Section: 4.11 – Pages: 323-325

What changes will you recommend to Edith’s prescription for memantine?

Suggested answer

The National Institute for Health and Clinical Excellence recommends that memantine isonly used for moderate Alzheimer’s disease in patients who are unable to takeacetylcholinesterase inhibitors and for patients with severe disease. Acetylcholinesteraseinhibitors (donepezil, galantamine or rivastigmine) are first-line treatment options for mildto moderate disease.

You ask the memory clinic to review Edith’s treatment and a new prescription fordonepezil is supplied.

Learning portfolio

What monitoring is necessary with donepezil?

CASE STUDY 6 – Rebound acid hypersecretion with proton pump inhibitors

Ethel Hopkins, aged 50, has been admitted to the medical ward complaining of severeheartburn, upper abdominal pain and difficulty swallowing.

Her medication on admission included:• paracetamol 500 mg tablets, two tablets four times a day when required• Maalox® suspension 10 mL, four times a day when required.

An endoscopy revealed oesophagitis with no signs of ulceration or stricturing. She is startedon omeprazole 20 mg once daily.

Ethel has recently reduced her intake of cigarettes from 15 to about 10 a day.

BNF Section: 1.3.5 – Pages: 43-44, 54-55

When can rebound acid hypersecretion occur with proton pump inhibitors?

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Suggested answer

The benefit of donepezil treatment should be assessed by repeating the cognitiveassessment at around three months. Edith’s carers should also be asked to report anychanges in her memory, behaviour and ability to do tasks. Donepezil should bediscontinued if Edith is not responding to therapy.

Acetylcholinesterase inhibitors can cause dose related cholinergic effects such asgastrointestinal symptoms (nausea, vomiting, diarrhoea), insomnia, headache, dizzinessand muscle cramps. This is why they are initiated at a low dose and increased accordingto response and tolerability. Edith should be monitored for these effects.

Suggested answer

Rebound acid hypersecretion and protracted dyspepsia may occur after stoppingprolonged treatment with a proton pump inhibitor.

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How can you reduce Ethel’s risk of developing rebound acid hypersecretion afteromeprazole?

Suggested answer

A proton pump inhibitor should be prescribed for appropriate indications at the lowesteffective dose for the shortest period; the need for long-term treatment should bereviewed periodically. Ethel should be reassessed if symptoms persist despite treatmentfor four to six weeks.

Ethel should be warned about the potential risk of rebound acid hypersecretion afterstopping omeprazole. When her symptoms have abated, her treatment should be titrateddown to a level which maintains remission (eg, by reducing the dose of omeprazole or bygiving it intermittently on an as required basis). She could also try replacing Maalox® withan alginate-containing antacid.

You should ask Ethel if she is taking any other prescribed or over-the-counter medicationbecause drugs such as NSAIDs, bisphosphonates, calcium antagonists, nitrates,theophylline and corticosteroids may exacerbate symptoms of gastro-oesophageal refluxdisease (GORD).

Ethel should be advised about lifestyle changes to reduce her symptoms of GORD, suchas avoiding excess alcohol and aggravating foods such as fats. Other measures includeweight reduction and raising the head of the bed. Smoking may aggravate GORD and sheshould be given advice on smoking cessation.

Learning portfolio

CASE STUDY 7 – Bisphosphonates and osteoporosis

Ada Paluch, a 66-year-old-lady, is transferred to the care of the elderly ward with an acuteexacerbation of her chronic obstructive airways disease. During her stay, a DEXA scanshows a T score of -3.0 and she is started on alendronic acid 70 mg once weekly.

She also has a history of rheumatoid arthritis and takes sulfasalazine.

Her last dental examination took place a year ago and was satisfactory.

Renal and hepatic function is normal.

She tells you that she is finding it difficult to stop smoking and is craving for a cigarettewhile in hospital.


What advice will you provide to reduce Ada’s risk of developing osteonecrosis of the jaw?

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Suggested answer

Osteonecrosis of the jaw has been reported very rarely with bisphosphonates.

Like all patients being initiated on a bisphosphonate, Ada should have a dental check-up(and any necessary remedial work should be performed) before starting treatment, or assoon as possible after starting treatment.

During bisphosphonate treatment, Ada should be advised to maintain good oral hygiene,receive routine dental check-ups, ensure any dentures are fitted well and report any oralsymptoms.

Ada should be encouraged to stop smoking and given access to smoking cessationinterventions because smoking is a risk factor for osteoporosis and for developingosteonecrosis of the jaw, and it causes a progressive decline in lung function in chronicobstructive pulmonary disease.

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What advice will you provide to reduce Ada’s risk of developing atypical femoral fractures?

CASE STUDY 8 – Pioglitazone and bladder cancer

Petra Bonich, a 50-year-old lady with type 2 diabetes, is attending for a review of herdiabetes in the outpatient clinic.

Petra has been referred by her GP because her blood glucose levels have been poorlycontrolled for some time and she is unwilling to consider insulin therapy.

Her recent blood tests showed: • HbA1c = 75 mmol/mol• fasting blood glucose = 8 mmol/L• hepatic and renal function are normal• urea and electrolytes within normal ranges.

Urine dipstick showed glucose +++, protein +, no blood.

Petra is a known smoker with a body mass index of 25 kg/m2 and her past medical historyshows nothing else of relevance.

Suggested answer

Atypical femoral fractures have been reported rarely with bisphosphonates, mainly inpatients receiving long-term treatment for osteoporosis.

Ada should be advised to report any thigh, hip, or groin pain during her treatment withalendronic acid.

Ada’s need to continue bisphosphonate treatment for osteoporosis should be re-evaluatedperiodically based on an assessment of the benefits and risks of treatment, particularlyafter five or more years of use.

If Ada is suspected to have an atypical femoral fracture, discontinuation of bisphosphonatetreatment should be considered after an assessment of the benefits and risks of continuedtreatment.

Learning portfolio

Her current medications include:• metformin 1 g twice daily• gliclazide 160 mg twice daily • simvastatin 40 mg each night• ramipril 5 mg daily.

Petra has worked as a shop assistant in a department store for many years.

The registrar is considering starting Petra on pioglitazone, but is aware of new safetyconcerns with this drug and seeks your advice.


What risk factors, if any, does Petra have for bladder cancer?

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Suggested answer

The European Medicines Agency has advised that there is a small increased risk ofbladder cancer associated with pioglitazone use. Before initiating treatment withpioglitazone, patients should be assessed for risk factors of bladder cancer including age,smoking status, exposure to certain occupational or chemotherapy agents (eg,cyclophosphamide) or previous radiation therapy to the pelvic region. Pioglitazone iscontraindicated in patients with a history of bladder cancer or in those who haveuninvestigated macroscopic haematuria.

Athough Petra has no contraindications to the use of pioglitazone, she smokes, which is arisk factor for cancer. She should be encouraged to stop smoking and advised aboutinterventions for smoking cessation.

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How should treatment with pioglitazone be monitored and what symptoms should Petrabe advised to report?

Suggested answer

If Petra responds adequately to treatment and there are no other significant changes toher health, the benefits of pioglitazone would continue to outweigh the risks.

The safety and efficacy of pioglitazone therapy should be reviewed after three to sixmonths and pioglitazone should be stopped if Petra does not respond adequately totreatment. The National Institute for Health and Clinical Excellence has recommendedthat treatment with pioglitazone is continued only if HbA1c concentration is reduced byat least 0.5 percent within six months of starting treatment.

Petra should be advised to report promptly any haematuria, dysuria or urinary urgencyduring treatment with pioglitazone.

She should be monitored for signs of bone fractures because there is an increased risk ofthese occurring with pioglitazone, particularly in women.

Liver function should be monitored before treatment and periodically thereafter. Sheshould be advised to seek immediate medical attention if symptoms such as nausea,vomiting, abdominal pain, fatigue and dark urine develop; treatment should bediscontinued if jaundice occurs.

She should be monitored for signs of heart failure and treatment should be discontinuedif any deterioration in cardiac status occurs. Her weight should also be monitored aspioglitazone can cause weight gain.

Learning portfolio

CASE STUDY 9 – Oral contraception and drugs that induce liver enzymes

Zoe Walsh, a 28-year-old, is admitted to the medicines admission unit with a generalisedtonic-clonic seizure. She presented with a similar seizure a year ago.

The only medication she takes is the combined oral contraceptive Microgynon 30®.

The patient is reviewed on the post-take ward round and prescribed carbamazepine. Thejunior doctor seeks your advice regarding the potential for interactions betweencarbamazepine and Microgynon 30®.


What changes will you recommend to Zoe’s contraception?

Zoe is switched to a tricycling regimen of Loestrin 30® and Loestrin 20®, but reportsbreakthrough bleeding after several months. What adjustments are necessary to hercontraception?

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Suggested answer

Carbamazepine induces hepatic enzyme activity and can considerably reduce theeffectiveness of combined oral contraceptives such as Microgynon 30®. It is likely that Zoewill take a long-term course (over two months) of carbamazepine. She should be advisedto change to a contraceptive method that is unaffected by enzyme inducers (eg, someparenteral progestogen-only contraceptives or intrauterine devices) for the duration oftreatment and for four weeks after stopping.

If this is not acceptable to her, the dose of combined oral contraceptive should be adjustedto provide ethinylestradiol 50 micrograms or more daily and this should be used as atricycling regimen (ie, taking three packets of monophasic tablets without a break,followed by a shortened tablet-free interval of four days). This regimen should becontinued for the duration of treatment with the enzyme-inducing drug and for fourweeks after stopping.

Suggested answer

Once other causes of breakthrough bleeding are ruled out, the dose of ethinylestradiolcan be increased by increments of 10 micrograms to a maximum of 70 micrograms daily.Alternatively, Zoe could use additional precautions or change to a method ofcontraception that is not affected by enzyme-inducing drugs.

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CASE STUDY 10 – Epilepsy and breast-feeding

Tracie Jones, aged 30, has just given birth to a full-term healthy baby girl.

Tracie takes carbamazepine 400 mg twice daily for epilepsy and wants to know whethershe can breast-feed her daughter.


Should Tracie breast-feed?

If Tracie decides to breast-feed, how should the infant be monitored?

Suggested answer

Women taking antiepileptic monotherapy should generally be encouraged to breast-feed;if a woman is on combination therapy or if there are other risk factors, such aspremature birth, specialist advice should be sought.

The amount of carbamazepine in breast milk is probably too small to be harmful, but theinfant should be monitored for possible adverse reactions.

Suggested answer

The infant should be monitored for sedation, feeding difficulties, adequate weight gainand developmental milestones. She should also be monitored for adverse effectsassociated with carbamazepine.

Serum-drug concentration monitoring should be undertaken in the breast-fed infant ifsuspected adverse reactions develop; if toxicity develops it may be necessary tointroduce formula feeds to limit the infant’s drug exposure, or to wean the infant offbreast milk altogether.

Learning portfolio

Notes

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Notes

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