ABPI Practice Test Question

Question 1

Endotoxins and exotoxins are produced by bacteria and are responsible for many of the symptoms of bacterial infection.

Which row A to D correctly shows the characteristics of one of these two toxin types?

A. Exotoxin - lipopolysaccharide - Specific effects such as cell breakdown
B. Exotoxin - soluble protein - General symptoms such as fever and vomiting
C. Endotoxin - lipopolysaccharide - General symptoms such as fever and vomiting.
D. Endotoxin - soluble protein - Specific effects such as cell breakdown

Answer 1

Row D.

Exotoxins are usually soluble proteins which are produced and release into the body by bacteria as they metabolise and reproduce. Some damage cell membranes causing cell breakdown or internal bleeding and other act as competitive inhibitors to neurotransmitters and other directly poison cells.

Endotoxins are lipopolysaccharies, part of the outer layer of gram negative bacteria. tend to cause symptoms such as fever, vomiting and diarrhoea.

Question 2

Which cell structure is found in both yeast and bacteria?

Select one:
A. Vacuole
B. Cell wall
C. Nucleus
D. Capsule

Answer 2

B. Cell wall.

Question 3

The graph below shows how the activity of an enzyme is affected by temperature.

Use this information to decide which statement below is the best explanation of the cause of hypothermia.

Hypothermia is caused by:

Select one:
A. metabolic enzymes becoming overactive at low temperatures
B. deactivation of metabolic enzymes at temperatures below 20 degrees Celsius
C. low temperatures decreasing the activity of metabolic enzymes.
D. heat destroying the enzymes which carry out cellular reactions

Answer 3

C. low temperatures decreasing the activity of metabolic enzymes.

Question 4

Schizophrenia is an example of a disease caused by …

Select one:
A. mental illness
B. genetic factors
C. environmental factors
D. genetic and environmental factors

Answer 4

D. genetic and environmental factors.

The use of recreational drugs such as cannabis can sometimes trigger mental illness in people who have a genetic tendency to diseases such as schizophrenia.

Question 5

The symptoms of hay fever are caused by:

Select one:
A. changes in cell membrane permeability due to the release of histamine
B. an immune response resulting in antibody formation
C. mast cells releasing large quantities of mucus
D. antibody release in the nasal mucosa

Answer 5

A. changes in cell membrane permeability due to the release of histamine

Question 6

Why does a B cell carry out endocytosis?

Select one:
A. To extract antigens
B. To form a digestive vesicle
C. To trigger T helper cells
D. To clear away dead pathogens

Answer 6

C. To trigger T helper Cells.

When a B-cell detects and engulfs the same pathogen/antigen it becomes another type of antigen presenting cell.
A T-helper cell from the actice clone produced earlier recognises the antigen presented by the B cell and binds to it.
This triggers the release of cytokines from the T helper cell.

Question 7

The sensation of pain that occurs during inflammation is caused by which of the following?

Select one:
A. Leakage of lymph into tissues
B. Heat loss as a result of vasodilation
C. Increased pressure on nerve endings
D. Increased blood supply to the capillaries

Answer 7

C. Increased pressure on nerve endings

Question 8

he curve below shows the way in which antibody concentration changes over a period of time as a particular pathogen is encountered.

A = exposure to antigen A
B =
C =
D = Second exposure to antigen A.

Which point A to D indicates the point at which B memory cells are activated?

Select one:
A. Point A
B. Point B
C. Point C
D. Point D

Answer 8

Point D.

Question 9

During the preclinical development of a new medicine, what term is used to describe the study of the drug’s bodily absorption, distribution, metabolism and excretion?

Select one:
A. Pharmacodynamics
B. Pharmacogenetics
C. Pharmacokinetics 
D. Pharmacology

Answer 9

C. Pharmacokinetics

Question 10

Read the two statements below:

1. In vivo testing of a potential medicine is essential, as in vitro testing alone may not reflect the toxic effects seen in a whole living organism.
2. In vitro testing of a potential medicine is of limited use because it cannot directly identify toxic effects on target cells.

Which of the following responses is correct?

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect Correct
D. Statement 1 is incorrect and statement 2 is correct

Answer 10

C. Statement 1 is correct and statement 2 is incorrect

In vitro = in cells
In vivo = whole organism.

In vitro tests using different types of cells can look for toxic effects;

Question 11

If the duration of a clinical trial in the intended patient population is to be longer than six months, which row of the table below (A, B, C or D) indicates the pre-clinical requirements for animal studies?

A = rodent: 3 months, non rodent: 6 months
B = rodent: 6 months, non rodent: 3 months
C = rodent: 9-12 months, non rodent: lifetime
D = rodent: lifetime, non rodent: 9-12 months.

Select one:
A. Row A
B. Row B 
C. Row C
D. Row D

Answer 11

Row D.

Question 12

Read the two statements below:

Statement 1:
Molecules identified as having activity as potential medicines are described as ‘lead compounds’.

Statement 2:
The process by which small changes are made to molecules in order to improve their activity as potential medicines is known as ‘lead optimisation’.

Which of the following responses is correct?

Select one:
A. Both statement 1 and statement 2 are true
B. Statement 1 is true and statement 2 is false
C. Statement 1 is false and statement 2 is true
D. Both statement 1 and statement 2 are false

Answer 12

A. Both statement 1 and statement 2 are true

Question 13

Read the two statements below:

1. Pharmacodynamic and pharmacokinetic studies in animals can aid understanding of whether a potential medicine is effective and acceptably safe.
2. In vivo testing of a potential medicine is essential as in vitro testing alone may not reflect the toxic effects seen in a whole living organism.

Which of the following response is correct?

Select one:
A. Statements 1 and 2. are correct and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect Incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 13

A. Statements 1 and 2. are correct and statement 2 explains statement 1

Question 14

Why are patients over the age of 65 no longer excluded from participating in clinical trials?

Select one:
A. It was considered unethical
B. They make more reliable subjects
C. They often have more free time to take part in trials
D. There was a lack of knowledge about whether these individuals could be treated with certain medicines

Answer 14

D. There was a lack of knowledge about whether these individuals could be treated with certain medicines

Question 15

What is ‘informed consent’ in the context of a clinical trial?

Select one:
A. Approval of a new medicine by NICE for GP prescription
B. Authorisation of the study by the MHRA and local ethics committees
C. Patient agreement to be truthful in their reports of a medicine’s effects
D. Patient agreement to participate after explanation of the benefits and risks

Answer 15

D. Patient agreement to participate after explanation of the benefits and risks

Question 16

Read the two statements below:

1. Controlled comparison of an existing medicine with an investigational medicinal product eliminates the need to use a placebo within some phase 3 clinical trials.
2. The baseline improvement is expected to be the same for the group receiving the existing medicine and that receiving the investigational medicinal product.

Which of the following responses is correct?

Select one:
Read the two statements below:

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1 Incorrect
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 16

A. Statements 1 and 2 are correct, and statement 2 explains statement 1

Question 17

Read the two statements below:

1. Patients under the age of 18 and over the age of 65 are always excluded from phase three clinical trials.
2. A medicine can have significantly different effects and side effects in elderly people from those in young people.

Which of the following responses is correct?

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 17

D. Statement 1 is incorrect and statement 2 is correct

Question 18

Read the two statements below:

1. Children, pregnant women and those over the age of 65 are no longer automatically excluded from phase 3 clinical trials.
2. Marketing authorisation require that the groups of patients entered into a clinical trial reflect the eventual users of a medicine as far as possible.

Which of the following responses is correct?

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 18

A. Statements 1 and 2 are correct, and statement 2 explains statement 1

Question 19

The data below relates to the number of patients treated in nine trials.

14, 18, 20, 21, 24, 26, 26, 28, 30

What is the mean of the data?

Select one:
A. 20
B. 23
C. 24
D. 26

Answer 19

B. 23

Add all the data values and divide the total by the number of data values.

Question 20

Hormone replacement therapy (HRT) can be used to alleviate many of the symptoms of menopause, including palpitations. In a randomised controlled double-blind study 10 menopausal women experiencing palpitations were randomly assigned to receive either active HRT (n=5) or placebo (n=5). They were then asked to keep a record of the number of palpitation events for a period of two months.

Their results are as follows:

What are the standard deviation values for each group (HRT and placebo)?

Select one:
A. HRT = 4.32; placebo = 6.06
B. HRT = 4.32; placebo = 5.42
C. HRT = 4.83; placebo = 5.42
D. HRT = 4.83; placebo = 6.06

Answer 20

Calculating the standard deviation (SD)

1. Find the mean value of the data
2. Find the difference between each value in the list from the mean
3. Square the differences
4. Calculate the mean vlaue of the squared differences.
5. Take the square root of this mean. This is the SD of the sample.

Question 21

When Standard Deviations (SD) are calculated, the value of one SD on either side of the mean will include between 60% and 70% of the data. What is the most likely SD for the 15 items in the data shown below? (You are not expected to do a full calculation to find the SD in this question, although that may be required in other questions.)

23, 25, 25, 28, 30, 34, 34, 36, 37, 38, 42, 44, 47, 48, 49 (mean = 36)

Select one:
A. 6
B. 9 Correct
C. 12
D. 15

Answer 21

B. 9

Question 22

What is the mean value for the data below?

81, 79, 73, 75, 76, 80, 42, 80, 80

Select one:
A. 74
B. 76 
C. 79
D. 80

Answer 22

A. 74

Question 23

The data below is taken from an analysis of several studies, all of which examined whether or not bisphosphonates have an effect on the level of pain experienced with osteoarthritis. For each population, both the groups given bisphosphonates and the groups given the placebos, the pain experienced was scored on a standardised scale.

Which statement below accurately reflects these data?

Select one:
A. The studies show that less pain is experienced when a higher dosage of risedronate is used
B. In the Spector study using 5mg risedronate, fewer people experienced pain scoring less than 7 than experienced greater pain
C. In the Bingham Nth Am study using 5mg risedronate, there is 95% confidence that the range of scores is within 1.39 of the mean
D. In the Bingham EU study using 15mg risedronate and placebo, there is 95% confidence that the difference in the pain experienced would score between 1.93 and 2.47

Answer 23

D. In the Bingham EU study using 15mg risedronate and placebo, there is 95% confidence that the difference in the pain experienced would score between 1.93 and 2.47

Question 24

The following pieces of information were all correctly included in a safety report for a pharmacovigilance department. Which one is mandatory?

Select one:
A. The patient was lactating.
B. The date the report was received
C. The reporter was the dispensing pharmacist
D. The dosage was in accordance with the authorised product information

Answer 24

A. The patient was lactating.

Question 25

A patient is prescribed a company drug and there is no improvement in his condition. How should this be reported?

Select one:
A. Adverse drug reaction Incorrect
B. Unlisted adverse reaction
C. Special safety situation
D. Adverse event

Answer 25

C. Special safety situation

An adverse drug reaction is defined as a response to a drug which is noxious and unintended and which occurs normally used in man for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function.

An AE is an untoward medical occurrence in a patient administered a pharma product whether or not the occurrence is related to or considered to have a casual relationship with the treatment.

Question 26

Which of the following statements is an accurate reflection of the responsibilities of a pharmacovigilance department?

Select one:
A. They should make regular surveys of HCPs
B. They should attend all relevant scientific meetings or symposia
C. They should direct and control all patient support programmes.
D. They should be involved at the outset of medical educational grant programmes

Answer 26

D. They should be involved at the outset of medical educational grant programmes

Question 27

Which of the following would be classed as an unexpected adverse reaction to a medicine?

Select one:
A. One that is life-threatening
B. One that is noxious and unintended
C. One that occurs at doses normally used in humans
D. One that is not consistent with the summary of product characteristics

Answer 27

D. One that is not consistent with the summary of product characteristics

Question 28

Which organisation is responsible for issuing Yellow Cards?

Select one:
A. ABPI
B. EMA
C. MAH
D. MHRA

Answer 28

D. MHRA

Question 29

Which of the following actions are possible consequences of failure to comply with PV regulations?

1. A triggered inspection
2. Non-urgent safety restrictions
3. Compulsory retraining of the responsible individuals

Select one:
A. 1 and 2 only
B. 1 and 3 only
C. 2 and 3 only
D. 1, 2 and 3

Answer 29

B. 1 and 3 only

Question 30

A doctor has informed a pharmaceutical representative of an adverse event associated with a company product. The doctor refuses to identify the details of dose, duration, patient or associated special safety situation. What should the pharmaceutical representative do?

Select one:
A. Report the doctor to the European Medicines Agency
B. Document the event but not submit it to the pharmacovigilance department
C. Report the doctor to the Medicines and Healthcare products Regulatory Agency
D. Document the event for the PV department and inform them that the reporter refuses to provide further information

Answer 30

D. Document the event for the PV department and inform them that the reporter refuses to provide further information

Question 31

Which of the following statements is an accurate reflection of product safety information at the time of authorisation?

Select one:
A. The product is believed to have an overall positive effect on the target population Incorrect
B. The product is believed to have a positive benefit-risk balance on the general population
C. The product has been proven to have a neutral or positive effect on the general population
D. The product has been proven to have a positive benefit-risk balance on the target population

Answer 31

D. The product has been proven to have a positive benefit-risk balance on the target population

Question 32

Which statement about cell membranes is correct?

Select one:
A. Generally the phospholipids have a hydrophilic part which is buried in the lipid bilayer and a hydrophobic part which can be involved in a variety of activities
B. Generally the phospholipids have a hydrophobic part which is buried in the lipid bilayer and a hydrophilic part which can be involved in a variety of activities Incorrect
C. Generally the proteins have a hydrophilic part which is buried in the lipid bilayer and a hydrophobic part which can be involved in a variety of activities
D. Generally the proteins have a hydrophobic part which is buried in the lipid bilayer and a hydrophilic part which can be involved in a variety of activities

Answer 32

D. Generally the proteins have a hydrophobic part which is buried in the lipid bilayer and a hydrophilic part which can be involved in a variety of activities

Question 33

The in vivo effects of a drug are difficult to determine because:

Select one:
A. cells in a laboratory do not show typical behaviour
B. cells do not survive for long in a laboratory
C. cellular processes vary from one individual to another.
D. drug testing in whole organisms is not possible

Answer 33

C. cellular processes vary from one individual to another.

Question 34

In phase 1 clinical trials blood and urine samples are collected at regular intervals to establish a potential drug’s pharmacokinetic profile. This would include the drug’s absorption and elimination by the body, and which of the following?

Select one:
A. Biotransformation and side effects
B. Distribution and biotransformation 
C. Distribution and efficacy
D. Efficacy and biotransformation

Answer 34

B. Distribution and biotransformation

Question 35

Why are the stomach and intestines particularly suitable as routes of drug administration?

They have a large surface area
They have muscular waves of contraction
They have a rich blood supply

Select one:

1. 1 and 2 only
2. 1 and 3 only.
3. 2 and 3 only
4. 1, 2 and 3

Answer 35

2. 1 and 3 only.

Question 36

Read the statements below:

Statement 1:
Some individuals are unable to metabolise certain drugs and so may suffer side effects at much lower doses than others.

Statement 2:
Some individuals inherit a faulty gene that, in its normal form, codes for the production of an enzyme in a biotransformation pathway.

Which of the following responses is correct?

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 36

A. Statements 1 and 2 are correct, and statement 2 explains statement 1

Question 37

Read the statements below:

Statement 1:
Increasing the dose of an agonist can reverse the blocking effect of its competitive antagonist.

Statement 2:
A competitive antagonist binds reversibly to, but does not activate, its specific receptor.

Which of the following responses is correct?
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1 Incorrect
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 37

A. Statements 1 and 2 are correct, and statement 2 explains statement 1

Agonist is the term used when a drug molecules activated receptors in a cell.

An antagonist is a drug molecules that binds to a receptor but does not activate the receptor.

A competitive antagonist binds reversibly to a receptor and the tissue response can be returned to normal by increasing the dose of an agonist.

Question 38

The illustration below shows the chromosome complements of four individuals.

Which individual has the genetic disorder known as Turner’s Syndrome?

Answer 38

The one with only one X chromosome instead of the usual 2.

It is a genetic defect in women, they are infertile, they have female external genitalia but no ovaries and therefore cannot menstruate or become pregnant.

Kelinefelters syndrome is where there is XXY.

Question 39

In type 1 diabetes which organ is defective?

Select one:
A. Kidney
B. Liver
C. Pancreas
D. Spleen

Answer 39

C. Pancreas.

Question 40

Which of the following is an example of a pathogen that enters the body through direct contact with another person?

Select one:
A. Bilharzia
B. Gonorrhoea
C. Malaria
D. Tuberculosis

Answer 40

B. Gonorrhoea

Question 41

Which of the following types of medicine would be used to treat HIV/AIDS?

Select one:
A. Antibacterial
B. Antibiotic
C. Antifungal
D. Antiviral

Answer 41

D. Antiviral

Question 42

Which statement about microorganisms in humans is true?

Select one:
A. They include helminths, fungi, viruses and bacteria
B. The normal flora contains many pathogens
C. Pathogens can be beneficial or neutral
D. The body flora can aid digestion

Answer 42

D. The body flora can aid digestion

Question 43

Osteoporosis and Alzheimer’s disease are examples of:

Select one:
A. autoimmune conditions Incorrect
B. congenital conditions
C. degenerative conditions
D. metabolic conditions

Answer 43

C. degenerative conditions

Question 44

An antigen:

Select one:
A. fights disease in the body
B. is a protein on a cell 
C. is produced to fight pathogens
D. neutralises poisons in the body

Answer 44

B. is a protein on a cell

Question 45

Which of the following correctly describes the term ‘translational medicine’ in the context of drug development?

Select one:
A. The process used to ensure that information from preclinical research carried out in different countries is interpreted correctly in all research documentation
B. The process used to ensure that information obtained from research in preclinical animal models is transferred effectively to early clinical research in humans
C. The process used to ensure that information obtained from clinical research in humans is transferred effectively to the final documentation provided to GPs
D. The process used to ensure that information obtained from early in vitro research is transferred effectively to research in preclinical animal models

Answer 45

B. The process used to ensure that information obtained from research in preclinical animal models is transferred effectively to early clinical research in humans

Question 46

What is ‘systems biology’ in the context of drug development?

Select one:
A. Studying how different body systems interact with a new drug.
B. Use of data from different studies to predict a molecule’s behaviour.
C. Aggregation of data to provide a larger cohort size for statistical analysis.
D. Measurement of the impact of a new drug on its target body organs.

Answer 46

B. Use of data from different studies to predict a molecule’s behaviour.

Question 47

A double-blind trial is one in which …

Select one:
A. the dose of the medicine is given in two unknown quantities
B. the trial is repeated twice without anyone’s knowledge of the outcome
C. neither the doctor nor the patient know which medicine is being taken
D. two different medicines are tested against one another without the patient knowing

Answer 47

C. neither the doctor nor the patient know which medicine is being taken

Question 48

Read the following description of a clinical trial study:

‘Patients are allocated by computerised code to one of two groups, one to receive the active drug and the other a placebo; neither doctor nor patient is aware of which preparation is being given at the time.’

Which clinical trial phase is being described?

Select one:
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4

Answer 48

C. Phase 3

Question 49

A group of patients that have an identifiable disease are asked to supply data on their past exposure to a specific environmental factor. These data are then compared with those obtained from a similar group who have been exposed to the environmental factor but do not have the disease. What type of observational clinical study is this?

Select one:
A. Case control
B. Cross-sectional
C. Prospective longitudinal cohort
D. Retrospective longitudinal cohort

Answer 49

A. Case control

Question 50

Some requirements of clinical trials are given below:

1. Use of healthy volunteers
2. Use of volunteers who have the target disease
3. Monitoring for the appearance of side effects
4. Monitoring of the therapeutic effect of the IMP on body systems

Both phase 2 and phase 3 of the clinical trial of an investigational medicinal product (IMP) would require which of the above?

Select one:
A. 1 and 3 only
B. 2 and 3 only
C. 1, 3 and 4 only
D. 2, 3 and 4 only

Answer 50

D. 2, 3 and 4 only

Question 51

Pharmacovigilance during phase 4 of a clinical trial involves careful monitoring of:

Select one:
A. a medicine’s efficacy in the wider population
B. a medicine’s long term benefits and rarer risks
C. the most effective ways to use the medicine
D. the frequency of a medicine’s prescription by a GP

Answer 51

B. a medicine’s long term benefits and rarer risks

Question 52

A new medicine (X) produces a 25% improvement in patient recovery. Another medicine (Y) produces only a 5% improvement in patient recovery. Medicine X is used to treat a condition which occurs in 1 in 1000 adults. Medicine Y is used to treat a condition which is common throughout the population. Which of the following statements is correct?

Select one:
A. Medicine X is better than medicine Y
B. Medicine Y is better than medicine X
C. Medicine Y will be more expensive to administer
D. More information is needed before you can draw any conclusions about which is better

Answer 52

D. More information is needed before you can draw any conclusions about which is better

Question 53

The following are the number of successful outcomes in a series of trials of the same drugs in the same circumstances. Which trial is most successful?

Select one:
A. 7 out of 230 people cured
B. 6 out of 125 people cured
C. 3 out of 75 people cured
D. 1 out of 30 people cured

Answer 53

B. 6 out of 125 people cured

Question 54

Hormone replacement therapy (HRT) can be used to alleviate many of the symptoms of menopause. In a randomised controlled double blind study 400 menopausal experiencing hot flushes were assigned to receive either active HRT (n=200) or placebo (n=200). They were then asked to keep a record of the number of hot flushes for a period of two months.

After two months 143 women in the HRT therapy group reported a substantial improvement in their symptoms, compared with 29 women in the placebo group.

What is the risk ratio for the hormone replacement therapy study?

Select one:
A. 0.17
B. 0.20
C. 0.33
D. 0.40

Answer 54

C. 0.33

Question 55

When collecting safety information from a reporter, a UK pharmaceutical representative should follow the code of practice set out by:

Select one:
A. the EU
B. the European Medicines Agency
C. the Association of the British Pharmaceutical Industry
D. the Medicines and Healthcare products Regulatory Agency
Feedback

Answer 55

C. the Association of the British Pharmaceutical Industry

Question 56

A practice nurse informs a pharmaceutical representative that an adverse event has occured due to a dispensing error by a pharmacist. Who will the company PV department contact for additional information?

Select one:
A. The nurse
B. The patient
C. The pharmacist
D. The head of the nurse's practice

Answer 56

A. The nurse.

Question 57

A pharmaceutical representative becomes aware of the following incidents:

1. A pregnant woman uses an off-label drug.
2. A drug is prescribed to a ten year old patient.
3. A patient experiences migraine, although this is not thought to be related to the prescribed drug.
4. A pregnant woman is prescribed a drug in accordance with the authorised product information.

Which of these incidents should be reported?

Select one:
A. 1, 2 and 3 only 
B. 1, 2 and 4 only
C. 1, 3 and 4 only
D. 1, 2, 3 and 4

Answer 57

C. 1, 3 and 4 only

Question 58

The patient information leaflet states that mild headaches may occur with a drug. A patient experiences a severe migraine. How should this incident be categorised?

Select one:
A. Adverse event
B. Adverse drug reaction
C. Special safety situation
D. Unlisted adverse reaction

Answer 58

D. Unlisted adverse reaction

Question 59

Which of the following statements correctly describes the situation for a medical representative after an adverse event?

Select one:
A. Adverse events must always be reported
B. No need to report it if the reporter has already completed a yellow card
C. No need to report if the event happened when the medicine was used off-label
D. No need to report if the event is already listed in the summary of product characteristics

Answer 59

A. Adverse events must always be reported

Question 60

Read the two statements below:

1. Less common adverse events are more likely to be reported during phase 4 post-marketing use of a drug.
2. Researchers are not required to report less common adverse events during phase 3 clinical trials.

Which of the following responses is correct?

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
Read the two statements below:

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 60

C. Statement 1 is correct and statement 2 is incorrect

Question 61

Which of the following explain why all ADRs are not discovered during a clinical trial?

1. Relative to the general population, a trial covers a small sample size
2. Only patients who fit specific inclusion and exclusion criteria can participate in clinical trials
3. The time limit for establishing an ADR is five years, which is usually too long for a clinical trial

Select one:
A. 1 and 2 only
B. 1 and 3 only
C. 2 and 3 only
D. 1, 2 and 3

Answer 61

A. 1 and 2 only

Question 62

Which of the following statements complies best with the rules on data privacy?

Select one:
A. A patient’s personal data should not be collected Incorrect
B. Personal data should be included in all reports submitted to the MHRA but must not be published
C. A patient’s personal data should be collected by the PV department but removed from all reports to the MHRA
D. Personal data should be included in adverse event reports submitted to the MHRA but must not be published

Answer 62

C. A patient’s personal data should be collected by the PV department but removed from all reports to the MHRA

Question 63

Read the two statements below:

1. The ABPI Code of Practice states that companies must have a scientific service to compile and collate all information, whether received from medical representatives or from any other source, about the medicines which they market.
2. Pharmacovigilance information is used continuously to build up the safety profile of a medicine so that companies can advise prescribers and users of any changes as necessary.

Which of the following responses is correct?

Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1 Correct
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 63

A. Statements 1 and 2 are correct, and statement 2 explains statement 1.

Question 64

To maintain a constant intracellular environment, a cell membrane must be …

Select one:
A. Semi-permeable
B. Selectively permeable
C. Fully permeable
D. Impermeable

Answer 64

B. Selectively permeable

Question 65

Which of the following enables chemicals to be transported out of a cell?

Select one:
A. Glycoprotein
B. Golgi apparatus
C. Phospholipid
D. Vesicle

Answer 65

D. Vesicle

Question 66

Here are four aspects involved in the use of medicines.

1. The distribution of receptors within tissue types
2. The effect on whole organisms
3. The method of administration
4. The possible side effects
   Which of these must the formulation of a medicine take into account?

Select one:
A. 1 and 3 only
B. 2 and 4 only 
C. 1, 2 and 4 only
D. 1, 3 and 4 only

Answer 66

A. 1 and 3 only

Question 67

The two-compartment model of the body divides the body into which two parts?

Select one:
A. The blood and the lymph
B. The peripheral tissues such as heart and kidney and the central tissues such as fat and skin
C. The central tissues such as heart and skin and the peripheral tissues such as fat and liver
D. The central tissues such as heart and brain and the peripheral tissues such as fat and skin

Answer 67

D. The central tissues such as heart and brain and the peripheral tissues such as fat and skin

Question 68

Three of the following are oral routes of drug administration; which one is not?

Select one:
A. Capsule
B. Emulsion
C. Granule
D. Pessary

Answer 68

D. Pessary

Question 69

Read the statements below:

Statement 1:
Drugs that irritate the digestive tract are often better administered by parenteral methods.

Statement 2:
Vomiting may reduce the absorbed dose of a drug that is administered orally.

Which of the following responses is correct?
Select one:
A. Statements 1 and 2 are correct, and statement 2 explains statement 1
B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1
C. Statement 1 is correct and statement 2 is incorrect
D. Statement 1 is incorrect and statement 2 is correct

Answer 69

B. Statements 1 and 2 are correct, but statement 2 does not explain statement 1