SUPPLEMENTARY COURSE IN DISPENSING AND RATIONAL …pei-cme.com/prime/learning/p04/documents/assessment_p04.pdf · Supplementary Course in Dispensing and Rational Prescribing ISBN:0-620-33652-8

Pharm-Med Education International © (2013): Enhancing Patient Lives Through Training Excellence

Supplementary Course in Dispensing and Rational Prescribing ISBN:0-620-33652-8 May 2013: 5th

Edition

PHARMACY EDUCATION INTERNATIONAL© 2013: Enhancing Patient Lives through Training Excellence

Page - 1

Supplementary Course in

Dispensing and Rational Prescribing

FORMAL ASSESSMENT – MODULE p04

The FORMAL ASSESSMENT of this module only has ONE part:

Part 1: A FORMATIVE COMPETENCY ASSESSMENT (FCA) QUESTION PAPER

IDENTIFY AND DESCRIBE AN ADVERSE DRUG REACTION IN GEORGE M’s CASE

Part 2: PRACTICAL ASSIGNMENT

THERE IS NO PRACTICAL ASSIGNMENT FOR THIS MODULE

In the process of completing this FORMAL ASSESSMENT you are required to:

1) have the attached declaration of authenticity COUNTERSIGNED by a designated responsible

person

2) go to the PEI Learning Portal, click on the “assessments” button and select the option “Click for

Declaration of Authenticity for the Formal Competency Assessment”. Complete this statement

of authenticity and then click the ‘SUBMIT’ Tab to submit your completed declaration online

3) return to the learning portal and download the model answers for this FCA by selecting the “Click

to download formative assessment memorandum (model answers)”option. Use this model

answer to mark and correct your FCA.



Edition


Page - 2

MODULE p04

FORMATIVE COMPETENCY ASSESSMENT

MODULE p04: DESCRIBE AND REPORT ON AN ADVERSE

REACTION IN GEORGE M’s CASE

(Chapter 6: Volume 1 Course Manual)

Formative Competency Assessments (FCA's) are presented at the

end of every Course Module. When you have studied the sections

of a module, and answered the online quizzes on these sections,

when you get to the end of the module you are prompted to

answer the final course quiz.

When you achieve a mark of 80% for this quiz you are then

prompted to apply for the Formative Competency Assessment

question paper (questionnaire).

The FORMATIVE COMPETENCY ASSESSMENT (FCA) for this

module is set in the form of a QUESTION PAPER which tests your

KNOWLEDGE, UNDERSTANDING and PRACTICAL APPLICATION of

the foundational principles covered in this section of the

dispensing course training material.

IMPORTANT: PLEASE TAKE NOTE OF THE FOLLOWING POINTS WITH RESPECT TO THIS FCA:-

1) Your FINAL WRITTEN ASSESSMENT PAPER will include a selection of questions on this Module which

will be SIMILAR IN FORMAT AND CONTENT to those set in this FORMATIVE COMPETENCY

ASSESSMENT

2) Because of the implications of Point 1 above YOU ARE STRONGLY ADVISED NOT TO TAKE SHORT

CUTS IN COMPLETING THIS FCA – IF YOU DO SO YOU MAY COMPROMISE YOUR CHANCES OF

PASSING THE FINAL WRITTEN ASSESSMENT.

3) In answering the questions set in this FORMATIVE COMPETENCY ASSESSMENT you are required to:-

o Refer to the relevant sections of your training material (lecture presentations and course manuals)

o Read each question carefully – make sure you are clear about what the question asks

o Attempt to answer each question with DUE DILIGENCE and to the BEST OF YOUR ABILITY.

o Use a pen with either BLACK or BLUE INK to fill in your answers in the space provided on the

question paper.

o When you have completed the FORMATIVE COMPETENCY ASSESSMENT question paper you must

request the MEMORANDUM (Model Answers). You must refer to this memorandum and use it to

mark your answers.

o In places where you have answered a question incorrectly, or left information out, use a RED PEN

to MARK your answers and FILL IN the correct information where necessary



Edition


Page - 3

PRACTITIONER DECLARATION OF AUTHENTICITY

When you have completed this Formative Competency Assessment (FCA), you must sign this declaration

of authenticity

It confirms that, after having studied the various sections contained in the module, that you have

attempted to complete the assessment to the best of your ability and that it is your own attempt and that

you have not copied it from someone else or allowed another learner to copy it from you.

This declaration must be signed by the learner and countersigned by a NOMINATED Verifier, Supervisor,

Tutor, Assessor or Mentor

FORMATIVE COMPETENCY ASSESSMENT MODULE p04: ADVERSE DRUG

REACTIONS; IDENTIFY AND DESCRIBE AN ADVERSE DRUG REACTION IN THE

GIVEN CLINICAL CASE OF GEORGE M.

Learner Statement of Authenticity

I confirm that I have duly completed this Formative Competency Assessment to the best of my ability

and that it is entirely my own work and it does not include any work completed by anyone other than

myself. I have completed the Assessment in accordance with PEI’s instructions and I have not, or will

not, allow another learner to copy this work from me.

Signature: ____________________________ Date: __________________

Learner Name (Print): ______________________________________________

Statutory Body: ____________________ Prof. Reg. No: ___________________ (HPCSA; SANC; SAPC)

Verifier Statement of Authenticity

I confirm that, to the best of my knowledge, that the work contained in this Assignment, and

completed in accordance with the Assignment brief, is the individual work and effort of

______________________________(Learner Name)

Signed: ______________________________ Date: _______________

Name: ___________________________________________________

Capacity: ___________________________________________________ (VERIFIER / SUPERVISOR / TUTOR / FACILITATOR / ASSESSOR

This completed FORMAL ASSESSMENT must be included in your

PORTFOLIO of PRACTICAL ASSIGNMENTS



Edition


Page - 4

DISPENSING FOR HEALTH PRACTITIONERS

FORMATIVE COMPETENCY ASSESSMENT DATE: ______________________________

NAME (PRINT) __________________________________

SIGNATURE __________________________: SANC/HPCSA Reg. No: _______________

MODULE: DESCRIBE HOW YOU WOULD CONFIRM AND REPORT A

SUSPECTED ADVERSE DRUG REACTION TO AMIODARONE IN A PATIENT

The patient is a male – George Mitchell

Past Medical History

George M is a 68-year-old clinically obese white male (92 Kg; 1.73m; Waist 133cm; Hip 95cm) who

has suffered from poorly controlled hypertension since age 48. His antihypertensive medication has

remained unchanged for the last 12 years.

George M was diagnosed with coronary heart disease in the first week of November of the preceding

year and underwent a triple Coronary Artery Bypass Graft (CABG).

In the 2nd week of January of the current year, after complaints of feeling light-headed and

experiencing nausea and palpitations, an ECG revealed the presence of Persistent Atrial Fibrillation for

which Amiodarone was prescribed by George M’s specialist.

Therapy was initiated with Cordarone® (Amiodarone). He was started on 200 mg Cordarone 3 times

a day, for one week, followed by 200mg twice a day for the second week. He continued on 100 mg

Cordarone twice a day thereafter. The drug was effective at this dosage in controlling his arrhythmia. He

was told that he would be closely monitored for the next 6 months.

He was also prescribed Warfarin 5mg per day for anticoagulation with the instruction to keep regular

appointments for INR monitoring and adjustment of the Warfarin dose.

Acute Medical Problem

On the 20th of f May George M returned to his general practitioner with complaints of fatigue, laboured

breathing, non-cardiac chest pains, respiratory crackle, cough with phlegm (clear), nasal congestion. He

also complained of “feeling depressed” and asked his GP if he could prescribe something for this.

His GP diagnosed George M to be suffering from an upper and lower respiratory tract infection for

which he prescribed Kestine® (Ebastine) 10mg in the morning (30) and Erythrocin® (Erythromycin) 500mg

four times a day for 14 days. He also prescribed Prozac® (Fluoxetine) 20mg in the morning (30)

Three days later on 23rd May, George M’s wife, phoned the general practitioner asking what to do?

Her husband had complained of shortness of breath and palpitations and had fainted after an afternoon cup

of tea. At this point George M’s medications were:

• Chronic Meds

� Cordarone® (Amiodarone) 100 mg twice a day

� Warfarin 5 mg daily – Monday to Friday

� Inderal LA® (Propranolol) 80 mg twice a day

� Ridaq® (Hydrochlorothiazide) 25 mg in the morning



Edition


Page - 5

• Acute Meds

� Erythrocin® (Erythromycin) 500mg four times a day

� Kestine® (Ebastine) 10 mg in the morning

� Prozac® (Fluoxetine) 20mg in the morning

This case history suggests that the patient’s problems may be due to:

1) Misdiagnosis of the presenting symptoms of a possible Adverse Drug Reaction to Amiodarone by

George M’s General Practitioner on the 20th of May, followed by

2) Inappropriate prescribing resulting in Drug Interactions that precipitated his acute problem of

Syncope.

ASSESSMENT TASK: INVESTIGATE THE POSSIBILITY OF AN ADVERSE DRUG

REACTION TO AMIODARONE IN PATIENT GEORGE M

PROCEDURE TO FOLLOW TO COMPLETE THIS ASSIGNMENT TASK

1) Refer to your Medicines Formulary to identify the possible Adverse Reaction to Amiodarone that

George M may have suffered.

2) Assuming that the suspected symptoms resolve when Amiodarone is withdrawn, follow the

processes described in the online material and in Chapter 6, Sections 3 and 9 (i) and (ii) and 11 of

the Volume 1 Course Manual: Clinical Components of Dispensing to depict how this case can be

used to:

(i) identify the presence of predisposing factors to the ADR in the patient concerned.

(ii) list the symptoms of the ADR as they are reported in the medical literature and compare

them to the suspected ADR experienced by the patient.

(iii) establish the causality of the ADR using

(a) the 5–Point Probability Scale and

(b) the Naranjo Scale.

(iv) attempt to establish the incidence of the ADR as reported in medical literature.

(v) categorize the severity of the ADR using the CTCAE Criteria

(vi) suggest a possible Underlying Mechanism and Classification that the ADR falls into.

(vii) attempt to Classify the ADR into a Category. Specifically, you need to consider whether the

ADR can be classified into one or more of the following categories:

(a) Predictable – that is, is it a Type A; C; D; E, or F adverse reaction

(b) Unpredictable – that is, is it a Type B (Bizarre) adverse reaction which can be

identified as being based on one or more of the following mechanisms:

(i) Pharmacogenetic,

(ii) Hypersensitivity (Types 1 to 4) or

COMPLETE THIS FORMATIVE COMPETENCY ASSESSMENT ON THE FORM PROVIDED

IT WILL SERVE AS A GUIDE TO THE PROCEDURE YOU ARE REQUIRED TO FOLLOW

WHEN YOU UNDERTAKE YOUR PRACTICAL ASSIGNMENT ON THIS MODULE



Edition


Page - 6

DISPENSING FOR HEALTH PRACTITIONERS

FORMATIVE COMPETENCY ASSESSMENT DATE: ______________________________

NAME (PRINT) __________________________________

SIGNATURE __________________________: SANC/HPCSA Reg. No: _______________

MODULE 5 – DESCRIBE HOW YOU WOULD CONFIRM AND REPORT A SUSPECTED ADVERSE DRUG REACTION TO AMIODARONE IN A PATIEN

Patient Demographic data Patient General Information

Family Name: Sex M F Date of Birth

Mass (Kg) Height (m) BMI (m/h2)

First Name: Waist (cm) Hip (cm) Waist:Hip

# Condition Date Dx # Condition Date Dx

1 2

3 4

ADVERSE REACTION DETAILS

Suspected product (Brand Name)

Active Ingredient(s) Date of ADR & Time of ADR

CURRENT MEDICATIONS

INN name of Active(s) Dose Prescribed for



Edition


Page - 7

INFORMATION ON ADVERSE REACTION

Symptoms, Mechanism and Suggested management of Adverse Reaction

Symptoms

Possible Mechanism:

Suggested Management:

Treatment given (Drugs & Nursing) and Outcome

Suggested Treatment :

Predicted Outcome:

CATEGORISE THE SEVERITY OF THE ADVERSE REACTION (CTCAE Criteria)

Mild (Grade 1) Moderate (Grade 2) Severe (Grade 3) Life Threatening

(Grade 4) � Asymptomatic or

mild symptoms;

� Clinical or diagnostic observations only;

� Intervention not indicated

� Minimal, local or noninvasive intervention

indicated;

� Limiting age-appropriate instrumental ADL*

� Severe or medically significant but not immediately life-

threatening;

� Hospitalization or prolongation of hospitalization indicated;

� Disabling;

� Limiting self care ADL**

� Life-threatening consequences;

� Urgent intervention indicated

CLASSIFY THE PROBABILITY THAT THE ADR IS DUE TO THE SUSPECTED DRUG

Definite Probable Possible Conditional Doubtful

� Onset corresponds with start of drug

� ADR corresponds to known reaction of drug

� Ceases when drug stopped

� Returns on starting drug



� Ceases when drug stopped

� Cannot be ascribed to patients disease or other Therapy



� Can be ascribed to patients disease or other Therapy


� ADR does NOT correspond to known ADR of drug

� ADR does not comply with any of these criteria

Naranjo Adverse Reaction Score

õ 9 definite ADR 5 – 8 probable ADR 1 – 4 possible ADR ï 0 doubtful ADR is due to drug



Edition


Page - 8

Naranjo scale for estimating the probability of an ADR

QUESTION YES NO

DON’T

KNOW or

NOT DONE

SCORE

1 Are there previous conclusive reports in the

medical literature on this reaction? + 1 0 0

2 Did the adverse event appear after the

suspected drug was administered? + 2 – 1 0

3

Did the adverse reaction improve when the drug

was discontinued or a specific antagonist was

administered?

+ 1 0 0

4 Did the adverse reaction reappear when the drug

was readministered? + 2 – 1 0

5

Are there alternative causes (other than the

drug) that could have caused the reaction on

their own?

– 1 + 2 0

6 Did the reaction reappear when a placebo was

given? – 1 + 1 0

7 Was the drug detected in the blood (or other

fluids) in concentrations known to be toxic? + 1 0 0

8

Was the reaction more severe when the dose

was increased or less severe when the dose was

decreased?

+ 1 0 0

9 Did the patient have a similar reaction to the

same or similar drug in any previous exposure? + 1 0 0

10 Was the adverse event confirmed by any

objective evidence? + 1 0 0

Total Naranjo Score

YOUR COMMENTS ON YOUR INTERPRETATION OF THE NARANJO SCORE



Edition


Page - 9

Interpretation of the Scores in the Naranjo Scale

NB: For the information necessary to correctly interpret the answers to these Questions, refer to the

document ‘Naranjo_ADR_instructions.pdf’ which is attached as a Note N in the Online component of

Module 5 of the Dispensing Course: Adverse Drug Reactions. In our past experience, many

practitioners DO NOT interpret, or apply, the following Naranjo Questions correctly. Pay particular

attention to the following directions to correctly interpret the following questions:

Question 1: The answer “Yes” (+1) applies if there have been two or more published reports in which the

adverse reaction has been described in detail or if the adverse reaction is listed in a reliable source (e.g.

medical textbook, review article on ADR’s or the product package insert).

Question 3: The answer “Yes” (+1) applies if the adverse event diminishes or disappears at any time after

stopping the medication, or if the reaction disappears upon administration of a specific pharmacologic

antagonist (for example, a beta receptor agonist like Salbutamol is administered to counteract a dangerous

bronchospasm induced by a beta blocker like Atenolol) The answer “No” (0) applies if the adverse event

does not improve or improves in response to a nonspecific therapy or an antidote to another medication or

treatment of the underlying disease.

Question 4: An answer of “Yes” (+2) indicates that when the medication was stopped, the adverse

event resolved or improved, and there was an unequivocal reappearance or worsening of the reaction

when the medicine was restarted in a similar dose and by the same route. Note – the Naranjo scale also

allows for a “Yes” if the causal association is well known and rechallenge cannot be done for clinical

or ethical reasons.

Question 5: This question assesses alternative explanations for the adverse event. Because adverse

events are often nonspecific and can be manifestations of the disease being treated or an unrelated,

concurrent disease or condition, other diagnoses need to be considered and excluded. The answer

“No” (+2) applies if alternative causes have been excluded, based upon a systematic and complete

evaluation. The answer “Yes” (-1) applies when there is an alternative cause or explanation.

Question 7: This question applies specifically to dose dependent adverse reactions when blood,

urine, tissue or other specimen concentrations of the medicine are available. The answer “Yes” (+1)

applies if the concentration is in the accepted toxic or supratherapeutic range. “No” (0) applies if the

concentration is below the toxic range. The answer “Do not know” (0) applies if drug levels are not

available or are inconclusive.

Question 8: This question evaluates the dose response relationship of medication and the adverse

reaction. “Yes” (+1) applies if the adverse event was more severe or worsened when the dose of the

medication was increased, or was less severe and improved when the dose was decreased. “No” (0)

applies if there was no appreciable change in the severity of the adverse event with dose modification.

Question 9: This question is directed at the patients past medical history of adverse reactions to the

same or a structurally related drug. “Yes” (+1) applies when there is documentation of a previous similar

reaction to the specific drug or a related medication.

Question 10: This question assesses the quality of the data on which the adverse event is assessed.

“Yes” (+1) indicates that either (1) there is laboratory test documentation of the adverse event or (2) that

the event was directly observed by a qualified person (for example, a skin rash described in nursing or

physician notes).



Edition


Page - 10

SUMMARY PRACTITIONERS’ COMMENTS AND RECOMMENDATIONS

1) Predisposing factors to an ADR in George M

2) Identify the ADR to Amiodarone from the Symptoms described

3) Establish the causality of the ADR

4) Establish the Incidence of the Adverse Reaction



Edition


Page - 11

SUMMARY PRACTITIONERS’ COMMENTS AND RECOMMENDATIONS

5) Establish the severity of the ADR

6) Suggest an Underlying Mechanism for the ADR

PRACTITIONER NAME ____________________________

PRACTITIONER SIGNATURE __________________________ DATE ________________



Edition


Page - 12

ADDITIONAL READING

Although the information required to complete this assessment successfully is contained

both in the Dispensing Course manual as well as in the Amiodarone monograph in the

SAMF, in reality when you are confronted with a suspected adverse reaction to a

particular drug, it is always prudent to verify the information contained in these sources

with additional references from the medical literature which give more insight into the

problem being investigated to confirm the conclusions you have come to.

For more background information on this assessment download the FOLLOWING

ARTICLE.

Amiodarone: Guidelines For Use And Monitoring

Siddoway L.A.

American Family Physician: Volume 68, Number 11 / December 1, 2003

Downloadable from http://www.aafp.org/afp/2003/1201/p2189.html

See also the following links to Wikipedia:

http://en.wikipedia.org/wiki/Type_III_hypersensitivity

http://en.wikipedia.org/wiki/Hypersensitivity_pneumonitis

Documents

SUPPLEMENTARY COURSE IN DISPENSING AND RATIONAL …pei-cme.com/prime/learning/p04/documents/assessment_p04.pdf · Supplementary Course in Dispensing and Rational Prescribing ISBN:0-620-33652-8