PE 1 Flashcards
What is the definition of pharmacoepidemiology?
Pharmacoepidemiology is the study of the use of and the effects of drugs in large numbers of people.
What are the two components of the term ‘pharmacoepidemiology’?
‘Pharmaco’ and ‘epidemiology’.
What is pharmacology?
Pharmacology is the study of the effects of drugs.
What is clinical pharmacology?
Clinical pharmacology is the study of effects of drugs in humans.
What is epidemiology?
Epidemiology is the study of the distribution and determinants of disease in populations.
When was the Pure Food and Drug Act passed?
1906
What event led to the passing of the Food, Drug, and Cosmetic Act in 1938?
Over 100 people died from renal failure caused by sulfanilimide elixir dissolved in diethylene glycol.
What significant discovery was made in the early 1950s regarding chloramphenicol?
Chloramphenicol could cause aplastic anemia.
What was published in 1952 related to adverse drug reactions?
The first textbook of adverse drug reactions.
What was established by the AMA Council on Pharmacy and Chemistry in 1952?
The first official registry of adverse drug effects.
What was the thalidomide disaster?
A dramatic increase in the frequency of phocomelia due to in utero exposure to thalidomide.
What did epidemiologic studies establish regarding thalidomide?
Its cause was in utero exposure to thalidomide.
What was established in the UK in 1968 in response to drug safety concerns?
The Committee on Safety of Medicines.
What did the mid-1960s see regarding drug utilization studies?
The publication of studies providing descriptive information on how physicians use drugs.
What are the phases of the drug approval process?
- Phase I
- Phase II
- Phase III
What is the primary goal of Phase I testing?
To determine the metabolism of the drug and a safe dosage range in humans.
Who generally conducts Phase II testing?
Clinical pharmacologists.
What is the focus of Phase II testing?
To obtain more information on pharmacokinetics, common adverse reactions, and initial efficacy.
What is the main purpose of Phase III testing?
To rigorously evaluate a drug’s efficacy and provide more information on its toxicity.
What is a requirement for Phase III studies to meet FDA standards?
At least one randomized clinical trial needs to be conducted in the US.
What is the difference between premarketing and post-marketing studies?
Premarketing studies assess drug safety before market release; post-marketing studies monitor long-term effects and patterns.
What kind of information do pharmacoepidemiological studies provide?
- Information on patients not studied prior to marketing
- Discovery of previously undetected effects
- Patterns of drug utilization
- Economic implications of drug use
Fill in the blank: Pharmacoepidemiology can reassure about drug _______.
safety
True or False: Pharmacoepidemiology only studies the adverse effects of drugs.
False.
What are some applications of pharmacoepidemiology?
- Monitor the use and effects of medicines
- Measure the occurrence of diseases
- Study the natural history of diseases
- Measure characteristics of patients with and without specific diseases
