Pharmacy regulator’s
insight
Lisa Smith
Assessment writing manager
November 2014
Baby died after 'decimal' error
A mistake over a decimal point caused the death of a Derby baby in March 2002 who was
given 10 times the recommended amount of heart medication (digoxin), a coroner has ruled.
The child received 222 micrograms instead of 22 micrograms.
Registration assessment
• Must be passed in order to register
• The purpose is to ensure that PRTPs demonstrate an
understanding of how to apply knowledge
appropriately and in a timely manner when making
professional judgements in pharmacy practice
contexts. In addition it ensures that candidates are
appropriately numerate to practice as a pharmacist
• National assessment
• The GMC has agreed to develop a single national
licensing examination
The registration assessment
• Closed book examination
– 90 questions in 90 minutes
• Open book examination
– Includes 20 pharmaceutical calculations
– 80 questions in 150 minutes
– No calculators
– References: BNF, BNF for Children
Pass requirements
• The overall mark is calculated by adding the marks
from both papers together to create a total. The
pass mark is usually 70%*, which equals:
• 119/170 overall and
• 14/20 in calculations
• *The Board of Assessors use an equating process to
ensure that each sitting of the assessment has the
same level of difficulty and so the pass mark can be
moved if necessary.
Peppermint water case
• 3-week old Matthew Young died after he had been
prescribed peppermint water to treat colic when he
was four days old
• Doubt about whether university and pre-registration
training led to an appreciation of the differences
between chloroform water in its different forms
• In 2002, RPSGB introduced a separate calculations
section into the registration assessment
You have been asked to prepare 300 mL Gentian Mixture, Alkaline, BP using the following
formula.
Gentian Mixture, Alkaline, BP
Concentrated Compound Gentian Infusion BP
Sodium Bicarbonate BP
Double-strength Chloroform Water BP
Water
1 mL
500 mg
5 mL
to 10 mL
As you have no double-strength chloroform water you decide to use concentrated chloroform
water.
FIRST STATEMENT
SECOND STATEMENT
The volume of Concentrated Chloroform
Water BPC required is 15 mL
Concentrated Chloroform Water BPC is 20
times the strength of Double-strength
Chloroform Water BP
Facility
%A
%B
%C
%D
%E
%None
0.69
6
3
5
69*
16
1
Number of candidates
Pass rates – June sittings
Percentage of candidates that passed
100.0%
94.5%
92.7%
91.1%
89.9%
86.5%
90.0%
94.6%
94.3%
86.7%
82.4%
85.5%
85.3%
77.8%
80.0%
70.0%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
2002
2003
2004
2006
2007
2008
2009
2010
2011
2012
2013
2014
Pass rates – September
sittings
Percentage of candidates that passed
100.0%
90.0%
83.9%
80.2%
80.0%
74.6%
71.4%
87.9%
80.6%
81.9%
81.9%
77.8%
73.3%
69.2%
70.0%
60.9%
58.2%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Calculations – pass rate
Percentage of candidates that passed Calculations section
100.0%
92.3%
95.1%
94.9%
98.0%
88.4%
90.0%
80.0%
89.7%
90.4%
Jun-13
Sep-13
94.0%
88.5%
76.1%
70.0%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
Jun-10
Sep-10
Jun-11
Sep-11
Jun-12
Sep-12
Jun-14
Sep-14
June 2014 – lowest marks
•
•
•
•
46% overall and 50% for calcs
51% overall and 30% for calcs
51% overall and 45% for calcs
53% overall and 35% for calcs
September 2014 feedback
In the open book paper a couple
of calculations were very
difficult and a lot of time was
spent on them which hindered
the time I had to complete the
open book paper
I wonder why there is no
syllabus for the exam? We are
basically meant to cram whole
BNF to pass the closed book
exam.
There were some ambiguous
question also with the
calculation for Endokay no 1
question not properly worded
Unfortunately, a couple of
questions in the calculations did
not have the right answers in
the options that were provided.
Some calculations question
were not clearly
understandable and were
made hard compare to June
exam
Q74 (OB) - The candidate
reported that there was no
correct answer.
However, I would
like to thank GPhC
for taking time to set
the Assessment.
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.49
0.34
0.05
11
33
49*
4
3
1
Water mineral analysis has revealed a fluoride ion content of 0.2 parts per
million. Which one of the following is the volume of En-De-Kay paediatric
drops that would provide an appropriate daily dose of fluoride ion for a
child who is 7 years old for the prophylaxis of dental caries?
A
0.15 mL
B
0.3 mL
C
0.6 mL
D
1 mL
E
1.32 mL
BNF for Children
Water content less than F- 300 micrograms/litre (0.3
parts per million)
By mouth
Child 6 months–3 years F- 250 micrograms daily
Child 3–6 years F- 500 micrograms daily
Child 6 years and over F- 1 mg daily
Water content between F- 300 and
700 micrograms/litre (0.3–0.7 parts per million)
Child 3–6 years F- 250 micrograms daily
Child 6 years and over F- 500 micrograms daily
Water content above F- 700 micrograms/litre (0.7
parts per million), supplements not advised
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.96
0.28
0.09
0
1
*96
0
2
0
A child is prescribed 150 micrograms of adrenaline (epinephrine) to
be given by intramuscular injection for anaphylactic shock. Which
one of the following is the volume of adrenaline 1 in 1000 that the
child should be given?
A
0.05 mL
B
0.1 mL
C
0.15 mL
D
0.2 mL
E
1.5 mL
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.93
0.45
0.07
0
1
3
*93
2
0
Mrs B has brought a prescription into your pharmacy for her 4-year-old
daughter, child B, for ranitidine 75 mg/5 mL oral solution. The dose on the
prescription is 4 mg/kg twice daily. Given that child B weighs 15 kg which
one of the following is appropriate dosage guidance for inclusion on the
label you produce for this medicine?
A
give 0.2 mL using the oral syringe provided twice a day
B
give 0.8 mL using the oral syringe provided twice a day
C
give 2 mL using the oral syringe provided twice a day
D
give 4 mL using the oral syringe provided twice a day
E
give 8 mL using the oral syringe provided twice a day
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.65
0.31
0.05
13
3
*65
11
7
2
Mrs D has been diagnosed with colorectal cancer. The oncologist decides to treat Mrs D
with capecitabine at a dose of 1.25 g / m2 twice daily for 14 days; subsequent courses
repeated after a 7-day interval.
Given that Mrs D has a body surface area of 1.65 m2 and capecitabine is available as a
500 mg tablet. How many tablets will she need for her first cycle of chemotherapy?
A
56 tablets
B
100 tablets
C
112 tablets
D
168 tablets
E
224 tablets
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.96
0.37
0.08
2
*96
1
1
1
1
If 400 mg of potassium permanganate is dissolved in 2.5 litres of
water what is the percentage strength of the resulting solution?
A
0.008% w/v
B
0.016% w/v
C
0.032% w/v
D
0.064% w/v
E
0.128% w/v
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.93
0.38
0.07
*93
2
3
1
1
0
Mrs D is prescribed morphine sulfate 240 mg to be given over 24 hours
using a syringe driver. Given that the morphine sulfate solution that is
used contains 20 mg/mL, the infusion rate should be set at:
A
0.5 mL/hour
B
1 mL/hour
C
2 mL/hour
D
5 mL/hour
E
10 mL/hour
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.90
0.37
0.06
2
2
3
*90
3
1
What weight of Aqueous Cream, BP is required to make 240 g of the
following formula?
Salicylic Acid BP 8%A
Zinc Oxide BP 10%
Starch BP
12%
Aqueous Cream BP to
100%
A
144 g
B
152 g
C
160 g
D
168 g
E
176 g
Facility
Biserial
St Err Biserial
%A
%B
%C
%D
%E
%None
0.58
0.21
0.05
11
18
*58
6
7
1
A 10-year-old boy of average build has been diagnosed with epilepsy and is
commencing on Epilim liquid (sodium valproate). His dose is 10 mg/kg daily for
the first week, increasing to 20 mg/kg daily for two weeks then stabilising at 25
mg/kg daily as a maintenance dose. How many 300 mL bottles of Epilim liquid
will be needed for the first eight weeks of therapy?
A
2
B
3
C
4
D
5
E
6
Future considerations
• Board of Assessors reviewing the assessment
• Multistage review
• Under consideration (confidential please!):
– Use of calculators
– Style of questions
– Number of questions
– Range of questions, syllabus
– Standard setting methodology
– Separate paper
Future considerations
• The national registration assessment seems here to
stay
• Some changes are likely for the sittings in 2016
Any questions?
Contact details
•
•
•
•
•
email Lisa.Smith@pharmacyregulation.org
web pharmacyregulation.org
twitter @TheGPhC
facebook.com/The GPhC
linkedin.com/company/general-pharmaceuticalcouncil