PV 2 Flashcards

1
Q

What are the two types of adverse drug reactions (ADRs)?

A

Type A and Type B

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2
Q

Describe Type A reactions.

A
  • Common
  • Predictable
  • Usually dose-dependent
  • Seldom fatal
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3
Q

Describe Type B reactions.

A
  • Uncommon
  • Unpredictable
  • Often independent of dose
  • Involve high rates of serious morbidity and mortality
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4
Q

Which body systems are commonly affected by ADRs?

A
  • Skin
  • Haematopoietic system
  • Lining of the gut
  • Liver
  • Kidneys
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5
Q

What are iatrogenic ADRs?

A
  • Usually uncommon or rare
  • Some are avoidable
  • Some are accidental
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6
Q

What question should clinicians ask for successful diagnosis of ADRs?

A

‘Could this be drug-induced - is this an ADR?’

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7
Q

What is pharmacoepidemiology?

A

The study of the use of, and effects of, drugs in large numbers of people.

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8
Q

How does pharmacovigilance relate to pharmacoepidemiology?

A

It is a branch focused on the study of drug events or adverse reactions on an epidemiological scale.

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9
Q

What are the methods used in pharmacovigilance?

A
  • Spontaneous ADR Reporting
  • Prescription Event Monitoring
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10
Q

What is the purpose of spontaneous ADR reporting?

A

To notify a central authority of suspected ADRs.

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11
Q

What is the ‘yellow card’ used for?

A

To report suspected ADRs in the United Kingdom.

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12
Q

What are the strengths of spontaneous ADR reporting?

A
  • Operates for all drugs throughout their lifetime
  • Affordable method for detecting rare ADRs
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13
Q

What is a major weakness of spontaneous ADR reporting?

A

There is gross under-reporting.

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14
Q

What does Prescription Event Monitoring (PEM) combine?

A

Public health surveillance and spontaneous reporting with formal epidemiological studies.

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15
Q

What is a major strength of PEM?

A

It provides both a numerator and a denominator for analysis.

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16
Q

What is a limitation of PEM regarding data collection?

A

Only 50%-70% of the green forms are returned.

17
Q

What are hypothesis-generating methods in pharmacovigilance?

A

Systematic methods used to identify patterns of events associated with medication use.

18
Q

What are hypothesis-testing methods in pharmacovigilance?

A
  • Case-Control and Case-Crossover Studies
  • Cohort Studies
  • Randomized Controlled Trials
19
Q

What criteria must be met for new drug approval?

A
  • Good quality
  • Effective
  • Safe for proposed purposes
20
Q

What are some ethical concerns in clinical trials?

A
  • Conflict of interest
  • Unethical patient recruitment
  • Inadequate informed consent
21
Q

What is a neglected aspect of drug safety monitoring?

A

Detection of drug interactions.

22
Q

What are the public concerns regarding pharmaceutical advertising?

A

It may adversely affect medical practice and clinical research.

23
Q

How does the Internet impact prescription drug safety?

A

It allows buying and selling prescription drugs without controls.

24
Q

What is the regulatory status of herbal products?

A

Regulation varies significantly from country to country.

25
Q

What is the importance of including herbal and traditional medicines in pharmacovigilance?

A

To ensure informed and safe use.

26
Q

What should be adequate for vaccines in immunization programs?

A

Safety surveillance.

27
Q

What concerns are raised about biological products?

A

Contamination of blood products by infectious organisms.