1. health and fitness
2. drugs

Pharm-Med Education International © 2014
Enhancing Patient Lives Through Training Excellence
Supplementary Course in
Dispensing and Rational Prescribing
FORMATIVE COMPETENCY ASSESSMENT
MODULE 2: ASSESSMENT OF THE PRESCRIPTION
Patient Case: Xolile Mguni
(Chapter 2: Volume 1 Course Manual)
MEMORANDUM
The Formative Competency Assessment instrument is designed to test deeper understanding of
the module and contains open questions which are structured to establish:
 The degree of the Learner’s overall familiarity with the content of the module by setting
‘Content’ questions that require simply that the Learner can quickly find the relevant
section and extract the points required to answer the question. These types of questions
test Foundational Competence – does the Learner know where to find the information?
 The degree to which the Learner is able integrate and apply knowledge of the module by
setting ‘Problem-based’ questions that test the ability to solve problems requiring the
application of the knowledge gained to real-life examples. These types of questions test
Practical and Reflexive Competence – is the learner able to demonstrate an Applied
Competence that will enable them to solve problems they will encounter in a Practical
Setting.
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IMPORTANT – PLEASE NOTE CAREFULLY
1) The Formative Competency Assessments contain questions that
are similar to those that will be set in the final Summative
Assessments.
2) The format of these FCA’s can be regarded therefore as an
example, or template, of what the final assessment paper will be
like.
3) You must compare your answers against this model answer as a
self-evaluation exercise.
4) Allocate yourself an assessed percentage mark. Where required,
MAKE A NOTE THE APPROPRIATE CORRECTIONS on your answer
sheet (use a red or green pen for this purpose)
______________________________________________________
YOUR completed Formative assessment must be included
in your PORTFOLIO of PRACTICAL ASSIGNMENTS
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DISPENSING FOR HEALTH PRACTITIONERS
FORMATIVE COMPETENCY ASSESSMENT
MEMORANDUM MODULE 2:ASSESSMENT OF THE PRESCRIPTION
(Chapter 1: Volume 2 Course Manual)
The patient is a male - Xolile Mguni.
He is 56 years old (mass 69.12kg and height 1.6m).
His medical record reflects the following diagnoses and problems:
1)
Non Insulin Dependent (Type 2) Diabetes Mellitus (BP normal: Averages130/80mmHg)
2)
Persistent complaints of heartburn, dyspepsia and hyperacidity
3)
In the last three months the patient has lost 12kg. This weight loss has not been
associated with any modification of diet or lifestyle.
4)
His medication compliance is good but his fasting blood glucose has been consistently
above 10 mmol/L as recorded at clinic visits over the last 18 months.
5)
His serum creatinine is 178 mcmol/L.
6)
His alcohol consumption is high and he smokes more than twenty cigarettes a day.
You receive the following prescription to repeat his chronic medications:Rx: Glibenclamide (Glycomin ® 5mg tablets - Aspen Pharmacare)
2 tablets twice a day : Supply 84 tablets
Rx: Metformin (Glucophage ® 850 mg tablets - Merck Pharmaceuticals)
1 tablet 3 times a day: Supply 84 tablets
Rx: Cimetidine ( Hexamet ® 400mg tablets – Hexal pharmaceuticals)
1 tablet 3 times a day : Supply 84 tablets
The prescription is endorsed to be repeated for 6 months at monthly intervals.
On questioning the patient and reviewing his medical history in his folder, you establish
that;
He takes 2 Anadin ® tablets once or twice a day on a daily basis for his headaches.
(Anadin tablets contain Aspirin 400 mg)
Systematically review the given patients history and consider the medication prescribed as well as the
OTC medication the patient is taking and the patients lifestyle information. With these factors in
mind:
1. List the therapeutic problems (including potential problems) that you identify in this case
 Explain what steps you would take to prevent of rectify each problem you identify.
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Before you work through Xolile Mguni’s case please make sure that you download the document
‘SAMF Monograph Extract; Drugs in Diabetes (2010 Ed 9).pdf’ from the Learning Portal of the PEI
Website. Alternatively request us to e-mail it to you. Use this document as the basis for your clinical
reference source as you work through Xolile’s case.
The reason we refer you to this earlier monograph extract as your source reference is because this
case study was compiled based on the clinical content of the monograph on ‘Drugs in Diabetes’ in the
9th edition of the SAMF. As with any medicines formulary, the content of this monograph has been
th
th
updated in subsequent editions (10 and 11 ) of the SAMF. Therefore, for the sake of consistency it is
more practical for all practitioners to use the same reference source to complete this learning exercise.
Procedure candidates are expected to follow in the above process
1)
2)
Calculate the patients BMI and Waist/Hip Ratio (if this information is available)
Review the patient’s lifestyle information to identify problems have to be addressed in this
area.
3) Assess the patients renal function (calculate the patients GFR).
4) Identify any incorrect quantity of medication that has been prescribed in the patient’s
prescriptions
5) Check the appropriateness of the medication that has been prescribed or that the patient is
taking. Questions that need to be answered ask in this respect are:
a.) What is each drug being used for and is it the best (optimal) medication to treat the
given condition
b.) Is the dose and dose-interval CORRECT for each drug prescribed for this particular
patient?
c.) How effective has each drug been (in the past) in treating the condition it is intended
for? (i.e. what do the clinical markers indicate)
d.) Are there unnecessary drugs in the patient regimen - is each medication really
necessary?e.) Identify any missing medication – i.e. has a necessary drug, that should be
prescribed, been omitted from the patient’s regimen?
6) Are there contra-indications to the use of any of the prescribed drugs in this patient?
7) Identify any adverse reactions to ANY medication this patient has been taking that may
have occurred in the patient
8) Identify any drug interactions to ANY medication this patient has been taking that may have
occurred or that should be anticipated in this patient with each prescribed drug in the given
regimen? These include: a.) Drug-food interactions
b.) Drug-disease interactions
c.) Drug-drug interactions
9) Summarise the recommendations and interventions you consider necessary in this patients
management
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1). Calculate the patients BMI and Waist/Hip Ratio
BMI
=
Mass
(Ht)2
=
=
69.12 Kg
(1.6 m) 2
27 Kg/m2
2). Review patient’s lifestyle to identify problems have to be addressed in this area
Gastro-intestinal complaints are being exacerbated by his lifestyle habits - namely:

Chronic use of Aspirin (Anadin)

Excessive alcohol intake

Smoking
3). Assess the patients renal function (calculate the patients GFR).
(GFR ml/min)
=
1.23 x (140 - 56) x 69.12
178 mol/litre
=
40.12 mL/min (Moderate RENAL IMPAIRMENT)
(Alternatively: GFR by MDRD Formula In African Male patients
2
GFR (mL/min/1.73m ) = 175 x [SrCr x 0.0113]
-1.154
= 175 x [178 x 0.0113]
x Age(years)
-1.154
-0.203
x 56(years)
x (1.21)
-0.203
x (1.21)
= 175 x [0.446] x [0.44] x (1.21)
= 41,6 mL/min
4). Identify any incorrect quantity of medication that has been prescribed in the patient’s
prescriptions
Glibenclamide
 Quantity Rx (at a dose of 2 tablets bd) should be 112 tablets and not 84 for 28 days
Cimetidine
 Quantity Rx (at a dose of 1 tablet tid) when intended for relief of heartburn, dyspepsia and
hyperacidity should not exceed 14 days supply.
 Quantity Rx should be 14 x 3 = 42 tablets
5). Appropriateness of the medication the patient is taking
To answer this, the following points need to be considered for each of the medications
(prescribed meds or OTC meds) the patient is taking:-
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a.) What is each drug being used for and is it an appropriate medication to treat
the specific condition it is intended for in this patient
b.) Is the dose and dose-interval CORRECT for each drug prescribed for this
particular patient?
c.) How effective has each drug been (in the past) in treating the condition it is
intended for in this patient? (i.e. what do the clinical markers indicate)
d.) Are there unnecessary drugs in the patient regimen - is each medication really
necessary?e.) Identify any missing medication – i.e. has a necessary drug, that should be
prescribed, been omitted from the patient’s regimen?
(1) Glibenclamide - Used for Type 2 DM
 Inappropriate in this patient - contraindicated when GFR<50 mL/min
(Glibenclamide has a long duration of action – T 1/2 ± 10 hrs - hypoglycemia is
common. For this reason it is contraindicated when GFR<50 mL/min)
 Dose is too high. Rx dose of 20 mg/day is too high - maximum recommended dose is 15
mg/day
(Injudicious prescription of high doses has led to fatalities due to hypoglycemia)
 Effectiveness – Has not been effective in this patient
(2) Metformin - Used for Type 2 DM
 Inappropriate in this patient because
(1) Dose – is too high. Patients GFR is 40 mL/min – Metformin dose should be ± 25% of
the prescribed dose. If it is used in a patient with GFR < 50 mL/min – upper daily
should be restricted to ±1000 mg/day (preferably in 2 divided doses (T1/2 is 1.5 – 3 hrs)
(2) Metformin should be avoided when Sr Creatinine > 130 – 132 umol/L
 Effectiveness – Has not been effective in this patient
(3) Cimetidine - Used for Gastritis
 Appropriate – for short term relief of patients gastric symptoms
 Inappropriate for long term use - it is being used to treat drug and lifestyle-related
gastric symptoms.
His GI effects are being caused by

his lifestyle factors (smoking and alcohol)

the high doses of Metformin and Glibenclamide
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
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his OTC use of Aspirin (in Anadin)
 Dose – is too high

Max recommended dose is 800mg/day - WHEN INTENDED FOR RELIEF OF
HEARTBURN, DYSPEPSIA AND HYPERACIDITY. Dose of 1200 mg/day is too
high

Duration of administration should not exceed 14 days
 Effectiveness – Has not been effective in this patient – evidenced by continuous use
(4) Aspirin
 Inappropriate in this patient

Is being used by the patient because of headache (ADR of Glibenclamide and
Cimetidine)

Is contributing to his GI effects and is has potential to cause adverse reactions –
especially combined with the other Rx drugs
(5) Unnecessary drugs
 Cimetidine

It is being used to treat drug and lifestyle-related gastric symptoms.

It’s use introduces complications into therapy because of its potential to interact
with other medications of the patient is receiving.
(6) Missing drugs
 Vitamin B 12 should be added to his regimen

between 30 – 40% of type 2 diabetes patients using metformin have vitamin B12
deficiency
 Insulin is missing from this patients therapy

Patient may now be a Type 1 diabetic with latent autoimmune diabetes of adulthood
(LADA).
6).
Contraindications
 Glibenclamide – contraindicated when GFR<50 mL/min
 Metformin – contraindicated when Sr Creatinine > 130 – 132 umol/L
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Adverse reactions
 Gastrointestinal symptoms – may be caused by

Metformin: high dose (in this pt with moderate renal impairment)

Glibenclamide

Aspirin

Alcohol
 Headache
8).

Glibenclamide - headache common

Cimetidine
Drug interactions
 Alcohol + Metformin – increases risk of lactic acidosis from in this patient
 Alcohol + Glibenclamide –

increases potential for hypoglycemia

Causes a disulfiram-like reaction (flushing headache, N/V)
 Aspirin + Glibenclamide

increases the risk of hypoglycemia especially in patients whose blood glucose well
controlled (slightly above the normal range)
 Cimetidine + Glibenclamide

increases the risk of hypoglycemia – particularly in this patient compromised renal
function

(Cimetidine can significantly increase the hypoglycemic effects of glibenclamide in
patient with diabetes (CYP 450 inhibition). The effect is not predictable)
 Cimetidine + Metformin

Cimetidine – may increase the frequency of side effects from metformin
(Cimetidine decreases renal tubular secretion of metformin (may increase the
amount of metformin in the blood by 40%).
 Cimetidine and Renal Function Estimation

Cimetidine increases Serum Creatinine – this patients renal function needs to be
reassessed in view of this
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9). Recommendations

Treatment in this patient should probably be with insulin. The patients recent weight
loss of 12kg without any modification of diet or lifestyle should arouse suspicion that the
patient has Latent Autoimmune Diabetes of Adult hood (LADA – occurs in 10 to 15% of
patients with Type 2 DM).

It appears from the doses of Metformin and Glibenclamide prescribed for this patient that
blood sugar control is not being achieved. If clinical circumstances after further tests warrant
continuing with oral hypoglycemics – consider

replace Glibenclamide with low doses of Gliclazide 40 mg – increase carefully (is also
long acting (T1/2 ± 10 – 12 hrs) and may also cause hypo’s but permitted with caution
in renal impairment or

replace Glibenclamide with Glipizide – increase doses up to 40 mg max / day in
divided doses (T1/2 2 – 4 hrs). Also causes less disulfiram reactions than other
Sulphonyl ureas.

Add Vit B12

Consider Enalapril - renoprotection

Advise the patient to use paracetamol in place of aspirin for his headaches and educate him
on the effects of alcohol as a cause of his G. I. problems.
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