PE 5 Flashcards
What is clinical pharmacology?
Comprises all aspects of the scientific study of medicinal drugs in humans.
Its overall objective is to provide the knowledge base needed to ensure rational drug therapy.
What is pharmacotherapeutics?
The application of the principles of clinical pharmacology to rational prescribing, the conduct of clinical trials, and the assessment of outcomes during real-life clinical practice.
What does pharmacoepidemiology involve?
The application of epidemiologic methods to the subject matter of clinical pharmacology.
How does clinical pharmacology differ from pharmacoepidemiology?
Clinical pharmacology explains the response to drugs in individuals, while pharmacoepidemiology measures and explains variability in drug treatment outcomes in populations.
What factors can affect drug response variability?
- Genetic determinants
- Effects of adaptive responses
- Effects of age
- Effects of disease states
- Pharmacodynamic drug-drug interactions
List the pharmacokinetic factors affecting drug response variability.
- Variations in drug absorption
- Variation in systemic distribution of drugs
- Variation in drug elimination
- Variation in drug metabolism
What role does human behavior play in pharmacoepidemiology?
Human behavior represents a greater source of variability in patterns of drug exposure.
What influences prescribing practices?
- The illness
- The doctor
- The patient
- The doctor-patient interaction
- Drug costs and availability
- Perceived and actual benefits and risks of treatment
- Pharmaceutical company promotional activities
True or False: Doctors’ decisions to prescribe are influenced by patient demand.
True
What are some economic influences on prescribing practices?
- Patients’ ability to pay for their medicines
- Promotional activities of the pharmaceutical industry
What are some factors affecting patient compliance?
- Disease
- Symptoms
- Drugs
What are the risks of conducting a pharmacoepidemiology study?
- Identifying an adverse outcome as associated with a drug when it is not
- Providing false reassurances about a drug’s safety
How can risks in pharmacoepidemiology studies be minimized?
- Appropriate study designs
- Skilled researchers
- Responsible interpretation of results
What are the categories of benefits from pharmacoepidemiology studies?
- Regulatory
- Marketing
- Legal
- Clinical
What are the regulatory reasons for performing pharmacoepidemiology studies?
- Required before drug approval
- To obtain earlier approval
- Response to regulatory agency questions
- Assist in marketing approval elsewhere
What defines the safety versus risk of a drug?
Judgement about the degree of safety, acceptability of risk, and tolerability of the risk.
What factors affect the acceptability of risks?
- Features of the adverse outcome
- Characteristics of the exposure
- Perceptions of the evaluator
What features of an adverse outcome influence its tolerability?
- Severity
- Reversibility
- Frequency
- Immediate versus delayed effects
- Known with certainty or not
How does the nature of the exposure affect risk acceptability?
- Essential versus optional
- Presence versus absence
- Availability of alternatives
What is the importance of perceptions in evaluating risks?
Perceptions of authorities and individuals can significantly influence the decision-making process regarding risk acceptability.
What is a key conclusion regarding the decision to conduct pharmacoepidemiology studies?
It involves weighing the costs and risks of a therapy against its benefits.
