Download PSA Questions Adverse Drug Reactions Template

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
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
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 page shows you the information provided to the
This assessment will not carry negative marks.
candidates before the start of the pilot assessments.
•
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
Prescribing Skills Assessment – Adverse Drug Reactions Item Authoring Tool
Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.
Slide compilation © 2012 The British Pharmacological Society & Medical Schools Council. All rights reserved.
Prescribing Skills Assessment – Format
Section
Description
Marks
Comments
1
Prescribing
80
8 items of 10 marks
2
Prescription Review
32
8 items of 4 marks each
3
Planning Management
16
8 items of 2 marks each
4
Communicating Information
12
6 items of 2 marks each
5
Drug Calculation Skills
16
8 items of 2 marks each
6
Adverse Drug Reactions
16
8 items of 2 marks each
7
Drug Monitoring
16
8 items of 2 marks each
8
Data Interpretation
12
6 items of 2 marks each
TOTAL MARKS
200
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
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
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
IM
IV
ORAL
SL
SC
intramuscular
intravenous
by mouth
sublingual
subcutaneous
Examination findings
BP
blood pressure (mmHg)
HR
heart rate (per minute)
HS
heart sounds
JVP
jugular venous pressure (centimetres)
RR
respiratory rate (per minute)
O2 sat arterial oxygen saturation (%)
Investigations
Hb
haemoglobin
WCC
white cell count
PT
prothrombin time
aPTT
activated partial thromboplastin time
Na+
K+
U
Cr
eGFR
Bili
ALT
Alk phos
serum sodium
serum potassium
serum urea
serum creatinine
estimated glomerular filtration rate
serum total bilirubin
serum alanine aminotransferase
serum alkaline phosphatase
ECG
CXR
AXR
US
electrocardiogram
chest X-ray
abdominal X-ray
ultrasound scan
Units
mmol/L millimoles per litre
µmol/L micromoles per litre
g/L
grams per litre
Others
PMH
DH
FH
SH
BNF
GP
KCl
COPD
past medical history
drug history
family history
social history
British National Formulary
general practitioner
potassium chloride
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
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
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, nonsteroidal 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].
This page contains information about the nature
and purpose of Adverse Drug Reactions items as
TD = Tomorrow’s Doctors (General Medical Council, 2009)
SPWG = Safe Prescribing
Working Group
Schoolsblueprint
Council, 2008)
described
in the(Medical
assessment
document
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
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.
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
Adverse Drug Reactions Item – Type A
ID
This item is worth 2 marks
ADR000
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)
You may use the
BNF at any time
ADVERSE EFFECT OPTIONS
A
Option A
B
Option B
C
Option C
D
E
Identify the correct
answer by placing a
tick in the column
on the right
Place 5 plausible
Option D adverse effect options
in the boxes provided
Option E
Answer box
Option A
Justification
Write a brief justification in this box
Option B
Justification
Write a brief justification in this box
Option C
Justification
Option D
Justification
Option E
Justification
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
☐
☐
☐
☐
☐
Adverse Drug Reactions Item – Type B
ID
This item is worth 2 marks
ADR000
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)
You may use the
BNF at any time
PRESCRIPTION OPTIONS
Identify the correct
answer by placing a
tick in the column
on the right
A
Option A
B
Option B
C
Option C Place 5 plausible drug
☐
D
Option D options in the boxes
☐
E
provided including the
Option E relevant dose and route
Answer box
Option A
Justification
Write a brief justification in this box
Option B
Justification
Write a brief justification in this box
Option C
Justification
Option D
Justification
Option E
Justification
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
☐
☐
☐
Adverse Drug Reactions Item – Type C
ID
This item is worth 2 marks
ADR000
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)
You may use the
BNF at any time
PRESCRIPTION OPTIONS
Identify the correct
answer by placing a
tick in the column
on the right
A
Option A
B
Option B
C
Option C
☐
D
Option D
☐
E
OptionPlace
E
5 plausible drug
☐
options in the boxes
provided including the
relevant dose and route
Answer box
Option A
Justification
Write a brief justification in this box
Option B
Justification
Write a brief justification in this box
Option C
Justification
Option D
Justification
Option E
Justification
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
☐
☐
Adverse Drug Reactions Item – Type D
ID
This item is worth 2 marks
ADR000
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)
You may use the
BNF at any time
MANAGEMENT OPTIONS
A
Option A
B
Option B
C
Option C
D
E
Identify the correct
answer by placing a
tick in the column
on the right
Answer box
Justification
Write a brief justification in this box
Option B
☐
☐
Place 5 plausible
Option Dmanagement options in the
Option E boxes provided including
the relevant dose and route
Option A
☐
Justification
Write a brief justification in this box
Option C
Justification
Option D
Justification
Option E
Justification
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
☐
☐
A
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
Adverse Drug Reactions Item – Type A
ID
This item is worth 2 marks
ADR101
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)
You may use the
BNF at any time
ADVERSE EFFECT OPTIONS
A
diarrhoea
☐
B
drowsiness

C
itching
☐
D
palpitations
☐
E
sweating
☐
Answer box
Option A
Justification
Morphine is associated with constipation, not diarrhoea.
Option B
Justification
Morphine acts on opioid receptors in the brain to depress neurotransmission
and potentially cause drowsiness.
Option C
Justification
Morphine is not associated with itching, although this symptom can occur
following withdrawal of opioid treatment or opiate use.
Option D
Justification
Morphine is associated with the development of palpitations but this is a less
common adverse effect than either drowsiness or nausea.
Option E
Justification
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.
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
B
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
Adverse Drug Reactions Item – Type B
ID
This item is worth 2 marks
ADR201
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)
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
☐
Answer box
Option A
Justification
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 B
Justification
Bisoprolol has little impact on renal function
Option C
Justification
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 D
Justification
Furosemide is a powerful loop diuretic, use of which can lead to dehydration
with consequent impairment of renal function.
Option E
Justification
Nifedipine is not known to cause renal impairment.
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
C
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
Adverse Drug Reactions Item – Type C
ID
This item is worth 2 marks
ADR301
Case presentation
A 33-year-old woman visits her GP to request treatment for shortterm 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)
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
☐

Answer box
Option A
Justification
Fluoxetine does not interact with the other drugs.
Option B
Justification
Folic acid has few significant interactions.
Option C
Justification
Norethisterone is a progestogen that does not have a significant interaction
with any of the other drugs listed.
Option D
Justification
Paracetamol does not interact with propranolol.
Option E
Justification
Salbutamol is a bronchodilator. It activates beta2-receptors and can also
induce tremor and anxiety. Its effects are likely to be antagonised by
propranolol, which is contraindicated in patients with asthma.
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
D
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.
Adverse Drug Reactions Item – Type D
ID
This item is worth 2 marks
ADR401
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 O2 sat is 86% (94–98) breathing air. A
nasopharyngeal airway is inserted and high-flow oxygen (targeted
to O2 sat 95%) commenced.
Question
Select the most appropriate option for the immediate management
of this adverse drug reaction.
(mark it with a tick)
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
☐
Answer box
Option A
Justification
This will not address the primary problem, which is oversedation caused by
midazolam. Adrenaline is effective in anaphylaxis and cardiovascular collapse.
Option B
Justification
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 C
Justification
Hydrocortisone and other corticosteroids will have no impact on respiratory
depression.
Option D
Justification
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 E
Justification
Phenylephrine is used to manage acute hypotension. There is no indication
for its use in this scenario.
Prescribing
Skills
– AdverseSociety
Drug Reactions
Item Authoring
Slide compilation
© 2012
TheAssessment
British Pharmacological
& Medical Schools
Council. AllTool
rights reserved.