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16 Cards in this Set

  • Front
  • Back
study of the effects of drugs
pharmacology
study of the distribution and determinants of disease in populations
epidemiology
study of the use of and the effects (good and bad) of drugs in populations
pharmacoepidemiology
purpose of pharmacoepidemiology studies (8)
1. describe, explain, control, predict the use and effects of drugs in a defined time, place, and population
2. determine how drug performs in clinical practice (effectiveness, safety)(in certain patient populations i.e. socioeconomic, comorbidities, environment, compliance, etc)
3. frequently used for post-marketing survellance
4. identify rare adverse events or events that occur in "special" populations
5. document new uses of approved drugs
6. determine long term effects of drugs, or effects on ultimate vs intermediate outcomes
7. used by FDA to allow approval of priority drugs in shorter time (on condition of surveillance)
8. used by the FDA to modify product label or approve status
methods used in pharmacoepidemiology (3)
1. Randomized controlled trials
2. observational studies (cohort, case-control, cross-sectional)
3. descriptive studies (drug use, vital statistics, case reports, etc)
Limitations of Pre-Marketing RCTs to detect true ADRs (6)
1. short duration (not long enough to detect ADR)
2. Narrow population (not representative of entire population)
3. Narrow indications
4. limited co-morbidities and co-therapies
5. ADRs that have a significant background incidence in population are even more difficult
6. Small sample size (remember rule of three; for 95% probability to detect ADR, the number of subjects needed to be followed is 3x the incidence of that event)
Relative risk (RR) =
RR = risk of outcome with exposure/ risk of outcome without exposure
Proportion of the risk increase that is thought to be due to the exposure to the factor
attributable risk
The number of people that need to be exposed to the drug for one person to develop the adverse effect
Number needed to harm
Estimates the proportion of cases that could be prevented by eliminating the risk factor in the total population
Population attributable risk (PAR)
Limitations in spontaneous reports (5)
1. causality assessment is difficult
2. subject to under-reporting
3. not possible to calculate incidence rate (unreliable numerator and very limited ability to estimate the denominator)
4. reporting rates vary with the age of the drug, publicity, type of reaction, marketing promotion, local policy, indication for use, and frequency for use)
5. domestic reports should not be lumped with foreign reports or reports from studies
1. The description and analysis of the costs of drug therapy to heath care systems and society
2. A discipline devoted to contrasting the full range of consequences across alternative medical treatments to aid in decision-making under uncertainty
pharmacoeconomic studies
purpose of pharmacoeconomic studies (1)
1. identify, measure, and compare the costs (resources consumed) and the consequences of pharmaceutical products and services (outcomes)
What are pharmacoeconomic studies useful for? (5)
1. Making individual patient treatment decisions
2. Making decisions about formulary management
3. Developing drug-use guidelines
4. Evaluating disease management initiatives
5. Determining the value of existing and proposed pharmaceutical services
Pharmcoeconomic study modeling

Studies are often ____, but can be ___ and can be ____
Studies are often _prospective observational studies___, but can be _retrospective__ and can be __RCTs__
components of a decision tree (5)
1. decision nodes
2. chance nodes
3. branches
4. event probabilities
5. outcomes