PHARMACEUTICAL

SCIENCE​
MONITORING AND
EVALUATION
___ ASSESSMENT QUESTIONS

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@brainy

2025
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ASSESSMENT PLAN QUESTION

Qn1: Identify and explain pharmacovigilance methods

ANSWER

1. Spontaneous reporting

2. Intensified ADRs reporting

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3. Targeted reporting
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4. Cohort event monitoring

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5. Electronic Health Record (EHR) mining

Qn2: Explain different ways of documenting and

reporting pharmacovigilance data

ANSWER

1. Spontaneous reporting

2. Clinical trial reporting

3. Expedited reporting
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4. Periodic safety update reporting

5. Patient reporting

Qn3: List and explain methods for detecting

substandard and counterfeit medicines

ANSWER

1. Thin Layer Chromatographic

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2. Visual inspection
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3. Test tube colour reactions

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4. Melting point determination

5. Use of cutting Edge technologies

Qn4: Differentiate between monitoring and

evaluation

ANSWER

-​ Monitoring- refers to conducting reviews on

continuous basis, the degree to which program
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activities are completed and performance targets

or milestones are being met
-​ Evaluation- refers to analysing progress towards
meeting established objectives, goals or results.

Qn5: Explain the importance of monitoring and

evaluation in pharmacy practice

ANSWER
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1. It helps to obtain information from patients and
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healthcare providers
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2. It helps to improve the process of pharmaceutical

care

3. It helps to obtain drug safety information to health

care professionals and other stakeholders

4. It helps to make informed decisions regarding

program operations and service delivery

5. It helps to ensure most effective and efficient use of

resources
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6. It helps to assess the extent to which the program is

having the desired impact.

7. It helps to monitor ADRs occurring when drugs are

taken along with traditional and herbal medicines.

Qn6: Explain factors hindering monitoring and

evaluation of medicines useny
ANSWER
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1. Poor record keeping, availability and accessibility of
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medical records
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2. Unsustainable system of regular monitoring and

evaluation of medicine use

3. Limited advocacy for culture of monitoring and

evaluation of medicine use

4. Economic factors

5. Patient factors

6. Inadequate number of human resource

7. Lack of expertise
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8. Inadequate monitoring tools

9. Limited consistency of resources allocation.

Qn7: Identify measures to improve monitoring and

evaluation of medicines uses

ANSWER

1. Clear availability and accessibility of medical record

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2. To establish sustainable system of regular
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monitoring and evaluation

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3. Clear communication of plans and targets

4. To promote advocacy on culture of monitoring and

evaluation of medicine use

5. Training personnel on importance of monitoring

and evaluation of medicine use as well as how to carry

6. Consistent allocation of resources

7. To increase more number of human resources

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Qn8: Explain the importance of pharmacovigilance

information.

ANSWER

1. To ensure equity of access to essential drugs

2. To provides evidence for regulatory authority to

approve new drugs

3. Provide evidence to show the new drug to be of

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good quality, effective and safe
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4. It is important study in post marketing researchers
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5. It help to detect drug interactions

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6. It assess the contribution of incentive ingredients(

excipients)

7. It helps to compare safety profiles of similar

medicines

8. It help in training health professionals

Qn9: List and explain methods for controlling

substandard and counterfeit medicines
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ANSWER

1. To reaffirm their commitment to fight against

counterfeit of medicinal products

2. To establish National Medicine Regulatory

Authority that have adequate legal mandate,
independence and institutional capacity

3. To control the manufacture, export, import and

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distribution of substandard and counterfeit medicines
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4. To develop and implement a sustainable human
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resources strategy for the pharmaceutical sector

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5. Continuing education and training programmes

6. Reliable supply systems and the requisite financial

resources

7. To monitor and regulate the prices of medical

products

8. To establish effective systems

9. To fighting illegal production, distribution and use

of these medical products
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10. To develop information, education and

communication strategies

END MARCH 2024

Qn11: Ways of reporting pharmacovigilance data

ANSWER
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1. Spontaneous reporting
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2. Clinical trial reporting

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3. Expedited reporting

4. Periodic safety update reporting

5. Patient reporting

Qn12: Factors hindering of monitoring and evaluation

ANSWER
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1. Poor record keeping, availability and accessibility of

medical records

2. Unsustainable system of regular monitoring and

evaluation of medicine use

3. Economic factors

4. Patient factors
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Qn13: Information that pharmacovigilance reports
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form should contain
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ANSWER
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1. Information on suspect medicine

2. Data from the patient on his/her disease

3. Concomitant medicines

4. Information on the notifying professionals

5. Risk factors

Qn14: Visual inspection in tablet dosage form

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ANSWER

1. You are meant to check for differences in the

physical appearance(colour, uniformity, size, shape,
consistency) of the drug

2. Pieces of tablet at the bottom of the container

(from abraded, crush or broken tablets)

3. Cracks or chips in the tablets, swelling, mottling,

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discoloration, fusion of tablet; appearance of crystal
on the walls of the container or on the tablet
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4. Also check the organoleptic properties( taste,

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colour, odor and mouthfeel) of the dosage form if you

have been using the medication

Qn15: List tools for monitoring and evaluation of

medicine uses

ANSWER

1. Level I questionnaire

2. Coordinator checklist
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3. Checklist for data collector

4. Level II survey forms number 1-17

ESSAY
Qn16: Explain six characteristics of good
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documentation practice in pharmacovigilance
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ANSWER
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1. They must be designed, prepared, reviewed and

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distributed.

2. They must be approved, signed and dated by the

authorized personnel

3. They must be written unambiguously

4. Reproductions of documents must be clear legible

5. All documentary entries must be periodically

reviewed and duly updated

6. Documents should not be handwritten

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Qn17: Explain ten methods for controlling

substandard and counterfeit medicine

ANSWER

1. To reaffirm their commitment to fight against

counterfeit medicinal products

2. To establish National Medicine Regulatory

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Authority that have adequate legal mandate,
ai
independence and institutional capacity
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3. To control the manufacture, export, import and

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distribution of substandard and counterfeit medicines

4. To develop and implement a sustainable human

resources strategy for the pharmaceutical sector

5. Continuing education and training programmes

6. Reliable supply systems and the requisite financial

resources

7. To monitor and regulate the prices of medical

products
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8. To establish effective systems

9. To fighting illegal production, distribution and use

of these medical products

10. To develop information, education and

communication strategies.

ny
ai
br
@