1. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Prescribing Skills Assessment Adverse Drug Reactions Item Authoring Tool This file contains a guide to authoring items as well as example items Please turn to the next page Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

2. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Information Given to Candidates This is a Prescribing Skills Assessment created by the Medical Schools Council and British Pharmacological Society with the aim of assessing knowledge, skills and judgement related to prescribing medicines. This assessment is designed for medical students who are in the final months of their undergraduate studies and are due to graduate shortly. We are asking you to identify yourself on the next page so that we can look for correlations between results of this test and the local assessment process. There will be 8 sections testing various aspects of prescribing, reviewing and advising about medicines as a Foundation doctor, mapped against the learning outcomes identified by the General Medical Council in Tomorrow’s Doctors (2009). You will have 2 hours to complete the whole assessment. The weighting of each section is summarised on the next page and the marks allocated to individual items within it will be clearly marked. This assessment will not carry negative marks. The invigilator will indicate the time when 30, 60, and 90 minutes have passed. You are allowed the use of a BNF and a calculator at any time. Commonly used abbreviations are provided on the page after next. Candidates should be allowed 5 minutes to go through this information This page shows you the information provided to the candidates before the start of the pilot assessments. Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

3. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool This page shows you the overall structure of the two hour assessment with the weighting of the individual sections. This document has been written to help you create items for the Adverse Drug Reactions section. Prescribing Skills Assessment – Format SectionDescriptionMarksComments 1Prescribing808 items of 10 marks 2Prescription Review328 items of 4 marks each 3Planning Management168 items of 2 marks each 4Communicating Information126 items of 2 marks each 5Drug Calculation Skills168 items of 2 marks each 6Adverse Drug Reactions168 items of 2 marks each 7Drug Monitoring168 items of 2 marks each 8Data Interpretation126 items of 2 marks each TOTAL MARKS200 Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

4. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Abbreviations Prescribing abbreviations daily once each day (usually in the morning) nightly once each day at bedtime 12-hrly twice each day (morning and evening) 8-hrly three times each day 6-hrly four times each day 4-hrly six times each day as required as often as necessary IMintramuscular IVintravenous ORALby mouth SL sublingual SCsubcutaneous Examination findings BPblood pressure (mmHg) HR heart rate (per minute) HSheart sounds JVPjugular venous pressure (centimetres) RRrespiratory rate (per minute) O 2 sat arterial oxygen saturation (%) Investigations Hb haemoglobin WCC white cell count PT prothrombin time aPTT activated partial thromboplastin time Na + serum sodium K + serum potassium U serum urea Cr serum creatinine eGFR estimated glomerular filtration rate Bili serum total bilirubin ALT serum alanine aminotransferase Alk phos serum alkaline phosphatase ECG electrocardiogram CXR chest X-ray AXR abdominal X-ray US ultrasound scan Units mmol/L millimoles per litre µmol/L micromoles per litre g/L grams per litre Others PMH past medical history DH drug history FH family history SH social history BNF British National Formulary GP general practitioner KCl potassium chloride COPD chronic obstructive pulmonary disease This page is provided to the candidates before the assessment and highlights acceptable abbreviations that you may use when authoring items Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

5. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool ADVERSE DRUG REACTIONS Reasoning and Judgement: Identifying likely adverse reactions of specific drugs, drugs that are likely to be causing specific adverse drug reactions, potentially dangerous drug interactions and deciding on the best approach to managing a clinical presentation that results from the adverse effects of a drug. Measurable action: Selecting likely adverse reactions of specific drugs, selecting drugs to discontinue as likely causes of specific reactions, avoiding potential drug-interactions and providing appropriate treatment for patients suffering an adverse event. Type A. This question type will require the candidate to identify likely adverse effects of a specific drug. Examples might include the adverse effects caused by commonly prescribed drugs, such as calcium channel blockers, beta 2 -agonists, non- steroidal anti-inflammatory drugs, aminoglycoside antibiotics, etc. Type B. This question type will require the candidate to consider a presentation that could potentially be caused by an adverse drug reaction and identify the medicine most likely to have caused the presentation. Examples might include newly recognised renal impairment, hepatic dysfunction, hypokalaemia, urinary retention, etc. Type C. This question type will require the candidate to consider a presentation where there are potential interactions between medicines currently being prescribed to a patient and identify those that might be clinically important. Examples might include interactions such as warfarin–statins, NSAIDs–ACE inhibitors, etc. Type D. This question type will require the candidate to consider a presentation where a patient is suffering an adverse drug event and decide on the appropriate course of action. Examples of adverse events might include acute anaphylaxis, excessive anticoagulation, drug-induced hypoglycaemia, diuretic-induced dehydration, etc. There will be one Adverse Drug Reaction section in the assessment, which will include eight items requiring identification of the most appropriate answer from a list of five. Each item will be worth 2 marks (making a total of 16 marks for this section). The purpose will be to demonstrate the ability to detect, respond to and prevent potential adverse drug reactions [TD 17(g) and 23(e)] [SPWG 8], and access reliable information about medicines [TD 17(f)][SPWG 7]. TD = Tomorrow’s Doctors (General Medical Council, 2009)SPWG = Safe Prescribing Working Group (Medical Schools Council, 2008) This page contains information about the nature and purpose of Adverse Drug Reactions items as described in the assessment blueprint document Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

6. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool The following pages are templates for creating Adverse Drug Reactions items of the four types (A-D). Good Adverse Drug Reactions items should: be based on a brief clinical scenario that might be expected to be faced by a Foundation doctor be based on common adverse effects, so that competent candidates are not faced with the need to refer constantly to the British National Formulary be based on a list of 5 options (drugs/adverse effects/interactions/actions) relating to the scenario, from which the candidate will be required to select the most appropriate avoid over-elaborate clinical scenarios, but contain sufficient information to allow a competent candidate to select the best option unambiguously contain 4 distracting options that, while plausible, are clearly less appropriate in relation to the clinical scenario than the correct answers. Please use the British National Formulary, to which the candidates will have access, as the ultimate arbiter of adverse reactions, interactions, etc. Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

7. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type A ADR000 ID This item is worth 2 marks You may use the BNF at any time ADVERSE EFFECT OPTIONS AOption A ☐ BOption B ☐ COption C ☐ DOption D ☐ EOption E ☐ Case presentation A [age]-year-old [man/woman/child] presents to [location and situation] complaining of [symptom that might be used as the focus for one of the questions] etc. PMH. She/he has suffered from …. [describe any past medical history relevant to the scenario]. DH. She/he normally takes …. [list any current prescriptions]. SH. [include any relevant social history] [Authors should try to adhere to this general layout but there is room for flexibility – the presentations should be fairly brief but contain sufficient information to allow the most likely adverse effect to be identified by a competent candidate] Question Select the adverse effect that is most likely to be caused by this treatment. (mark it with a tick) Place 5 plausible adverse effect options in the boxes provided Identify the correct answer by placing a tick in the column on the right Answer box Option AJustification Write a brief justification in this box Option BJustification Write a brief justification in this box Option CJustification Option DJustification Option EJustification Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

8. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type B ADR000 ID This item is worth 2 marks You may use the BNF at any time PRESCRIPTION OPTIONS AOption A ☐ BOption B ☐ COption C ☐ DOption D ☐ EOption E ☐ Case presentation A [age]-year-old [man/woman/child] presents to [location and situation] complaining of [symptom that might be used as the focus for one of the questions] etc. PMH. She/he has suffered from …. [describe any past medical history relevant to the scenario]. DH. She/he normally takes …. [list any current prescriptions]. SH. [include any relevant social history] [Authors should try to adhere to this general layout but there is room for flexibility – the presentations should be fairly brief but contain sufficient information about the patient and the adverse effect to allow the candidates to identify the most likely culprit drug] Question Select the prescription that is most likely to be contributing to the [insert adverse effect]. (mark it with a tick) Place 5 plausible drug options in the boxes provided including the relevant dose and route Identify the correct answer by placing a tick in the column on the right Answer box Option AJustification Write a brief justification in this box Option BJustification Write a brief justification in this box Option CJustification Option DJustification Option EJustification Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

9. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type C ADR000 ID This item is worth 2 marks You may use the BNF at any time PRESCRIPTION OPTIONS AOption A ☐ BOption B ☐ COption C ☐ DOption D ☐ EOption E ☐ Case presentation A [age]-year-old [man/woman/child] presents to [location and situation] complaining of [symptom that might be used as the focus for one of the questions] etc. PMH. She/he has suffered from …. [describe any past medical history relevant to the scenario]. DH. She/he normally takes …. [list any current prescriptions]. SH. [include any relevant social history] [Authors should try to adhere to this general layout but there is room for flexibility – the presentations should be fairly brief but there should be sufficient information about the patient and adverse reaction for the candidate to clearly identify the most likely interacting drug] Question Select the prescription that is most likely to interact with [the drug specified in the stem] to [describe the clinical problem here]. (mark it with a tick) Place 5 plausible drug options in the boxes provided including the relevant dose and route Identify the correct answer by placing a tick in the column on the right Answer box Option AJustification Write a brief justification in this box Option BJustification Write a brief justification in this box Option CJustification Option DJustification Option EJustification Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

10. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type D ADR000 ID This item is worth 2 marks You may use the BNF at any time MANAGEMENT OPTIONS AOption A ☐ BOption B ☐ COption C ☐ DOption D ☐ EOption E ☐ Case presentation A [age]-year-old [man/woman/child] presents to [location and situation] complaining of [symptom that might be used as the focus for one of the questions] etc. PMH. She/he has suffered from …. [describe any past medical history relevant to the scenario]. DH. She/he normally takes …. [list any current prescriptions]. SH. [include any relevant social history] [Authors should try to adhere to this general layout but there is room for flexibility – the presentations should be fairly brief but there should be sufficient information about the patient and adverse event for the candidate to clearly identify the most appropriate action at this point] Question Select the most appropriate option for the management of this adverse drug event. (mark it with a tick) Place 5 plausible management options in the boxes provided including the relevant dose and route Identify the correct answer by placing a tick in the column on the right Answer box Option AJustification Write a brief justification in this box Option BJustification Write a brief justification in this box Option CJustification Option DJustification Option EJustification Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

11. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool A Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

12. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type A ADR101 ID This item is worth 2 marks You may use the BNF at any time ADVERSE EFFECT OPTIONS A diarrhoea ☐ B drowsiness C itching ☐ D palpitations ☐ E sweating ☐ Case presentation A 67-year-old man has started to take oral morphine (Sevredol®) 10 mg 4-hrly for pain associated with a gastric carcinoma. Question Select the adverse effect that is most likely to be caused by morphine. (mark it with a tick) Answer box Option AJustification Morphine is associated with constipation, not diarrhoea. Option BJustification Morphine acts on opioid receptors in the brain to depress neurotransmission and potentially cause drowsiness. Option CJustification Morphine is not associated with itching, although this symptom can occur following withdrawal of opioid treatment or opiate use. Option DJustification Morphine is associated with the development of palpitations but this is a less common adverse effect than either drowsiness or nausea. Option EJustification Sweating and agitation are phenomena associated with withdrawal of opioid analgesics in dependent patients. They can occur as an adverse effect of morphine but less commonly than either drowsiness or nausea. Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

13. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool B Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

14. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type B ADR201 ID This item is worth 2 marks You may use the BNF at any time PRESCRIPTION OPTIONS A aspirin 75 mg orally daily ☐ B bisoprolol 5 mg orally daily ☐ C digoxin 125 micrograms orally daily ☐ D furosemide 160 mg orally daily E nifedipine m/r (Adalat LA) 30 mg orally daily ☐ Case presentation A 67-year-old man with chronic heart failure is admitted to hospital after his GP notices that his serum creatinine concentration has become acutely elevated from its baseline value of around 150 µmol/L (60–110) to 450 µmol/L. Question Select the prescription that is most likely to be contributing to the acute deterioration in renal function. (mark it with a tick) Answer box Option AJustification Aspirin is a non-steroidal anti-inflammatory drug but at this low cardiovascular preventative dose it is unlikely to have any significant effect on renal function. Option BJustification Bisoprolol has little impact on renal function Option CJustification Digoxin is a drug that has to be used with care in patients with renal impairment but is not, itself, a cause of renal impairment. Option DJustification Furosemide is a powerful loop diuretic, use of which can lead to dehydration with consequent impairment of renal function. Option EJustification Nifedipine is not known to cause renal impairment. Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

15. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool C Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

16. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type C ADR301 ID This item is worth 2 marks You may use the BNF at any time PRESCRIPTION OPTIONS A fluoxetine 20 mg orally daily ☐ B folic acid 5 mg orally daily ☐ C norethisterone 350 micrograms (Micronor®) orally daily ☐ D paracetamol 1 gm orally 8-hrly as required ☐ E salbutamol inhaler 200 micrograms as required Case presentation A 33-year-old woman visits her GP to request treatment for short- term relief of anxiety because she is about to take her law exams. PMH: Asthma, depression. Propranolol 40 mg orally daily is added to her current regular prescriptions (listed right). Question Select the prescription with which propranolol is most likely to interact. (mark it with a tick) Answer box Option AJustification Fluoxetine does not interact with the other drugs. Option BJustification Folic acid has few significant interactions. Option CJustification Norethisterone is a progestogen that does not have a significant interaction with any of the other drugs listed. Option DJustification Paracetamol does not interact with propranolol. Option EJustification Salbutamol is a bronchodilator. It activates beta 2 -receptors and can also induce tremor and anxiety. Its effects are likely to be antagonised by propranolol, which is contraindicated in patients with asthma. Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

17. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool D Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.

18. Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool Adverse Drug Reactions Item – Type D ADR401 ID This item is worth 2 marks You may use the BNF at any time MANAGEMENT OPTIONS A adrenaline (epinephrine) 500 micrograms IM ☐ B flumazenil 200 micrograms IV C hydrocortisone 200 mg IV ☐ D naloxone 400 micrograms IV ☐ E phenylephrine hydrochloride 2 mg SC ☐ Case presentation A 75-year-old man is having a colonoscopy and, because of marked anxiety, has been given three doses of midazolam 1 mg IV. Five minutes after the last injection his breathing is noted to be very shallow (RR 6/min) and the O 2 sat is 86% (94–98) breathing air. A nasopharyngeal airway is inserted and high-flow oxygen (targeted to O 2 sat 95%) commenced. Question Select the most appropriate option for the immediate management of this adverse drug reaction. (mark it with a tick) Answer box Option AJustification This will not address the primary problem, which is oversedation caused by midazolam. Adrenaline is effective in anaphylaxis and cardiovascular collapse. Option BJustification Flumazenil is a benzodiazepine antagonist drug that can be used to treat an overdose of midazolam as well as to reverse sedation with other benzodiazepines. Option CJustification Hydrocortisone and other corticosteroids will have no impact on respiratory depression. Option DJustification Naloxone is a mu opioid receptor antagonist but is unlikely to be of any benefit when respiratory depression seems likely to be secondary to midazolam Option EJustification Phenylephrine is used to manage acute hypotension. There is no indication for its use in this scenario. Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.