548. Exam 1
Define pharmacoepidemiology as it relates to pharmacy and public health - answer-
Pharmacoepidemiology = the study of the use and effects of drugs in large numbers of
people
-Goals to study = drug prescribing and utilization (appropriate vs. misuse), adherence,
predictors of med use or misuse, safety and ADEs (post clinical trials)
Define the following: adverse event, adverse drug reaction/effect, and medication error -
answer-Adverse Event (AE) = untoward medical occurrence not necessarily related to a
drug
-Adverse Drug Reaction (ADR) = harm or occurrence directly linked to a drug, may or
may not be dose dependent
-Medication Error = *preventable* event leading to harm or inappropriate use
Identify limitations of clinical trials - answer-Small sample sizes
-some groups may be excluded
-short duration
-controlled therapy
What important new opportunities does post-marketing surveillance offer? - answer-
potentially millions of patients taking the drug
-patients with multiple diseases, multiple other drugs, and risk factors
-first time to observe the more rare ADEs
-seeing how the drug works in the real world
Phase 4 clinical trials are optional surveillance that is sometimes required by the FDA,
what are other surveillance studies? - answercase-control studies, cohort studies, etc.
Identify 2 limitations of spontaneous adverse event reporting - answer-don't see it in the
slides
-maybe lack of reporting? lots of barriers
-
What can happen as a result of phase 4 post-marketing surveillance? - answer-"Dear
Dr" warning letters
-Black Box Warnings
-Withdrawal from market
Describe the need for pharmacoepidemiology in US health care system - answer-
payers want cost-effective therapies
-clinical trials will never be able to address all the issues, need real world data and
observational studies
,-polypharmacy, multiple chronic meds, more expensive meds, and med errors require
optimal drug therapy
-Help evaluate patient safety (ADRs, DDIs, pre-disposing factors), effectiveness, and
economic effectiveness
-Important Users = government agencies, health care payers, pharma,
prescribers/practitioners, researchers, attorneys, patients/consumers,
global/international users
Explain how health care databases have facilitated the growth of the
pharmacoepidemiology discipline - answer-Able to use secondary data sources for
information --> medical transactions (insurance claims), EMR/EHR, pharmacy
transactions, health surveys, etc.
-Easier to collect information for analysis
Explain how the leading causes of death have changed over the last 100 years -
answer-used to be a lot more infections that caused death 100 years ago
-changed to more chronic diseases and cancer
-changes resulted from immunizations, improvements in nutrition, sanitation, and
medications
Causality Criteria - answer1. Temporal (timing)
2. Strength of Association = Association ratios (RR,OR) are very high
3. Dose-Response = more exposure leads to more disease or outcome
4. Replication = is it found in different studies/populations
5. Plausability = Does it make biological sense?
6. Alternative Explanations = have alternatives been ruled out?
7. Cessation of Exposure = does stopping the exposure lead to less disease/outcome?
8. Consistent = supported by other findings
9. Specificity = does exposure cause only one disease?
Types of research questions for pharmacoepidemiology? - answer-patterns of drug use,
who is using what?
-patient safety = ADEs, drug-induced events, DDIs, pre-disposing factors
-Effectiveness = comparative (drug A vs. B), predisposing characteristics
-Economic effectiveness
Important users of pharmacoepidemiology - answer-government agencies
-healthcare payers
-Pharma (rx outcomes are critical to product use, marketing, and ADEs)
-Prescribers & Practitioners
-Research & Academics
-Attorneys
-Patients/Consumers
-Global/International Users
, What are rates? - answer-a frequency of an event in a population at risk (PAR) in a time
period
-4 parts = numerator, denominator, time period, and multiplier
-time period is usually 1 year
-usually multiplied --> per 1,000, per 10,000, etc.
-Disease Rate = # of cases / Population at Risk
Ratios vs. Proportions - answer-Ratios --> numerator and denominator are NOT related,
can range from 0 to infinity
-Proportions --> numerator and denominator ARE related, can range from 0-100% (or 0-
1), a part of a whole
Understand and calculate incidence of a disease - answer-Incidence = the number of
new cases in a PAR per time period, used for studying *causes of disease*, tells us the
risk of something happening
-Cumulative Incidence = measures # of new cases in a PAR per time period,
denominator is observed for the duration of follow up, appropriate when you don't lose a
lot to follow up
-Incidence Rate = # of new cases in a time period / total patient vs. time observations at
risk during time period (?) --> incidence at one point in time or over a specific time
period
Understand and calculate prevalence of a disease - answer-Prevalence = number of
existing cases in a population, used to assess resources
-population = at risk and not at risk
-Point prevalence (a snapshot) = # of people w/ disease at a specific time / # of people
in population at that specific time
-Period prevalence = # of people with disease during a time period / # of people in
population during that time period
Discuss the application of incidence and prevalence of diseases in
pharmacoepidemiology - answer-Incidence tells us the risk of something happening,
and is useful for measuring causes of disease and evaluating treatments/interventions
-Prevalence is used to assess resources and disease burden
-as incidence increases, prevalence increases (assuming mortality rate is unchanged)
-as the disease duration increases, prevalence increases
-Diseases with a high mortality rare will always have a low prevalence, regardless of
incidence
Crude Mortality Rate - answerCrude Mortality Rate = # of deaths (all cause) during
some time period / # in population during the same time period (*1000)
-Does not control for age
-May be misleading so its like never used
Define pharmacoepidemiology as it relates to pharmacy and public health - answer-
Pharmacoepidemiology = the study of the use and effects of drugs in large numbers of
people
-Goals to study = drug prescribing and utilization (appropriate vs. misuse), adherence,
predictors of med use or misuse, safety and ADEs (post clinical trials)
Define the following: adverse event, adverse drug reaction/effect, and medication error -
answer-Adverse Event (AE) = untoward medical occurrence not necessarily related to a
drug
-Adverse Drug Reaction (ADR) = harm or occurrence directly linked to a drug, may or
may not be dose dependent
-Medication Error = *preventable* event leading to harm or inappropriate use
Identify limitations of clinical trials - answer-Small sample sizes
-some groups may be excluded
-short duration
-controlled therapy
What important new opportunities does post-marketing surveillance offer? - answer-
potentially millions of patients taking the drug
-patients with multiple diseases, multiple other drugs, and risk factors
-first time to observe the more rare ADEs
-seeing how the drug works in the real world
Phase 4 clinical trials are optional surveillance that is sometimes required by the FDA,
what are other surveillance studies? - answercase-control studies, cohort studies, etc.
Identify 2 limitations of spontaneous adverse event reporting - answer-don't see it in the
slides
-maybe lack of reporting? lots of barriers
-
What can happen as a result of phase 4 post-marketing surveillance? - answer-"Dear
Dr" warning letters
-Black Box Warnings
-Withdrawal from market
Describe the need for pharmacoepidemiology in US health care system - answer-
payers want cost-effective therapies
-clinical trials will never be able to address all the issues, need real world data and
observational studies
,-polypharmacy, multiple chronic meds, more expensive meds, and med errors require
optimal drug therapy
-Help evaluate patient safety (ADRs, DDIs, pre-disposing factors), effectiveness, and
economic effectiveness
-Important Users = government agencies, health care payers, pharma,
prescribers/practitioners, researchers, attorneys, patients/consumers,
global/international users
Explain how health care databases have facilitated the growth of the
pharmacoepidemiology discipline - answer-Able to use secondary data sources for
information --> medical transactions (insurance claims), EMR/EHR, pharmacy
transactions, health surveys, etc.
-Easier to collect information for analysis
Explain how the leading causes of death have changed over the last 100 years -
answer-used to be a lot more infections that caused death 100 years ago
-changed to more chronic diseases and cancer
-changes resulted from immunizations, improvements in nutrition, sanitation, and
medications
Causality Criteria - answer1. Temporal (timing)
2. Strength of Association = Association ratios (RR,OR) are very high
3. Dose-Response = more exposure leads to more disease or outcome
4. Replication = is it found in different studies/populations
5. Plausability = Does it make biological sense?
6. Alternative Explanations = have alternatives been ruled out?
7. Cessation of Exposure = does stopping the exposure lead to less disease/outcome?
8. Consistent = supported by other findings
9. Specificity = does exposure cause only one disease?
Types of research questions for pharmacoepidemiology? - answer-patterns of drug use,
who is using what?
-patient safety = ADEs, drug-induced events, DDIs, pre-disposing factors
-Effectiveness = comparative (drug A vs. B), predisposing characteristics
-Economic effectiveness
Important users of pharmacoepidemiology - answer-government agencies
-healthcare payers
-Pharma (rx outcomes are critical to product use, marketing, and ADEs)
-Prescribers & Practitioners
-Research & Academics
-Attorneys
-Patients/Consumers
-Global/International Users
, What are rates? - answer-a frequency of an event in a population at risk (PAR) in a time
period
-4 parts = numerator, denominator, time period, and multiplier
-time period is usually 1 year
-usually multiplied --> per 1,000, per 10,000, etc.
-Disease Rate = # of cases / Population at Risk
Ratios vs. Proportions - answer-Ratios --> numerator and denominator are NOT related,
can range from 0 to infinity
-Proportions --> numerator and denominator ARE related, can range from 0-100% (or 0-
1), a part of a whole
Understand and calculate incidence of a disease - answer-Incidence = the number of
new cases in a PAR per time period, used for studying *causes of disease*, tells us the
risk of something happening
-Cumulative Incidence = measures # of new cases in a PAR per time period,
denominator is observed for the duration of follow up, appropriate when you don't lose a
lot to follow up
-Incidence Rate = # of new cases in a time period / total patient vs. time observations at
risk during time period (?) --> incidence at one point in time or over a specific time
period
Understand and calculate prevalence of a disease - answer-Prevalence = number of
existing cases in a population, used to assess resources
-population = at risk and not at risk
-Point prevalence (a snapshot) = # of people w/ disease at a specific time / # of people
in population at that specific time
-Period prevalence = # of people with disease during a time period / # of people in
population during that time period
Discuss the application of incidence and prevalence of diseases in
pharmacoepidemiology - answer-Incidence tells us the risk of something happening,
and is useful for measuring causes of disease and evaluating treatments/interventions
-Prevalence is used to assess resources and disease burden
-as incidence increases, prevalence increases (assuming mortality rate is unchanged)
-as the disease duration increases, prevalence increases
-Diseases with a high mortality rare will always have a low prevalence, regardless of
incidence
Crude Mortality Rate - answerCrude Mortality Rate = # of deaths (all cause) during
some time period / # in population during the same time period (*1000)
-Does not control for age
-May be misleading so its like never used
