PV2 Flashcards
What are the two types of adverse drug reactions (ADRs)?
Type A and Type B
Describe Type A reactions.
- Common
- Predictable
- Usually dose-dependent
- Seldom fatal
Describe Type B reactions.
- Uncommon
- Unpredictable
- Often independent of dose
- Involve high rates of serious morbidity and mortality
Which body systems are commonly affected by ADRs?
- Skin
- Haematopoietic system
- Lining of the gut
- Liver
- Kidneys
What are iatrogenic ADRs?
- Usually uncommon or rare
- Some are avoidable
- Some are accidental
What question should clinicians ask for successful diagnosis of ADRs?
‘Could this be drug-induced - is this an ADR?’
What is pharmacoepidemiology?
The study of the use of, and effects of, drugs in large numbers of people.
How does pharmacovigilance relate to pharmacoepidemiology?
It is a branch focused on the study of drug events or adverse reactions on an epidemiological scale.
What are the methods used in pharmacovigilance?
- Spontaneous ADR Reporting
- Prescription Event Monitoring
What is the purpose of spontaneous ADR reporting?
To notify a central authority of suspected ADRs.
What is the ‘yellow card’ used for?
To report suspected ADRs in the United Kingdom.
What are the strengths of spontaneous ADR reporting?
- Operates for all drugs throughout their lifetime
- Affordable method for detecting rare ADRs
What is a major weakness of spontaneous ADR reporting?
There is gross under-reporting.
What does Prescription Event Monitoring (PEM) combine?
Public health surveillance and spontaneous reporting with formal epidemiological studies.
What is a major strength of PEM?
It provides both a numerator and a denominator for analysis.
What is a limitation of PEM regarding data collection?
Only 50%-70% of the green forms are returned.
What are hypothesis-generating methods in pharmacovigilance?
Systematic methods used to identify patterns of events associated with medication use.
What are hypothesis-testing methods in pharmacovigilance?
- Case-Control and Case-Crossover Studies
- Cohort Studies
- Randomized Controlled Trials
What criteria must be met for new drug approval?
- Good quality
- Effective
- Safe for proposed purposes
What are some ethical concerns in clinical trials?
- Conflict of interest
- Unethical patient recruitment
- Inadequate informed consent
What is a neglected aspect of drug safety monitoring?
Detection of drug interactions.
What are the public concerns regarding pharmaceutical advertising?
It may adversely affect medical practice and clinical research.
How does the Internet impact prescription drug safety?
It allows buying and selling prescription drugs without controls.
What is the regulatory status of herbal products?
Regulation varies significantly from country to country.
