Pharmacy in Public Health:

Epidemiology

Course, date, etc. info

 Learning Objectives
• Explain how epidemiology is used in public
health
• List the different types of epidemiology
studies and give an example of a study design
used for each type
• Given an epidemiological measure of disease,
explain what it means
• Given data about a disease in a population,
calculate prevalence, incidence, relative risk,
and/or odds ratio
 Introduction
• Epidemiology is the study of disease in a
population; it is considered the science of
public health
• Studies the determinants and distribution of disease
• Assumes disease does NOT occur at random
• If causes can be identified, disease may be prevented
• It is a collection of study designs and methods
for calculating disease rates
• Pharmacoepidemiology is a subset that
focuses on medication-related disease
Key Assumption: Exposure-then-Disease

Figure 10.2
 EXAMPLE
Using the death rates given below, what can you
say about premature death risk in the population?
Death Rates from a Single Cause by Gender, Age, & Economic Status
SES: Male Female

Child Adult Child Adult

High 0% 67% 0% 3%

Medium 0% 92% 0% 14%

Low 73% 84% 55% 54%

Unknown --N/A--- 78% --N/A--- 13%

Adapted from Simonoff, 1997

 Roles for Epi in Public Health
• Monitor health of a population
• Respond to emerging public health problems
• Promote research and use of evidence-based
interventions
• Evaluate effectiveness of a program
• Develop public health policy and law
• Set funding priorities for research and
intervention programs
 Understanding an Outbreak
• Epidemiology is used to better understand a
disease outbreak by answering these
questions
– What is it?
– How big is the outbreak?
– Who is affected by the disease?
– Where is the disease occurring?
– When does the disease occur?
– Why does the disease occur?
 Measures of Disease Frequency
• Prevalence (total number of cases)
• Incidence (number of new cases)
• Mortality (number of deaths)

• EXAMPLE: In the past month, Town A

reported five new cases of HIV/AIDS. This
brings the total number of HIV/AIDS cases this
year to 26. In Town B, there were 10 new
cases and over 100 total cases during the
same time periods.
 Prevalence rates
• Need an indication of how the number of cases
relates to the population
• Prevalence rate
• Total number of cases during a specified time period
divided by the population count
 Calculating a Prevalence Rate
EXAMPLE
Five new cases of HIV/AIDS were reported. This brings the total number
of active HIV/AIDS cases this year (2006) to 56; total population is
100,000 and population at risk if HIV/AIDS is 20,000

Prevalence rate calculation:

Prevalence rate (P) = 56 active HIV/AIDS cases /100,000 total population
P = 56 per 100,000 (in 2006)

Prevalence rates are increased by:

An increase in the number of new cases (↑ incidence)
A reduction in deaths due to disease (↓ mortality)
New treatments that prolong life but not cure the disease
Prevalence rates are decreased by:
Reduced number of new cases
Increased number of cures
 Cumulative Incidence rates
• Incidence rates
• Cumulative incidence rate (number of new cases in a
specified time period divided by number of population
that is at risk of the disease)
Incidence Rates / Incidence Density
• Incidence Rates
• Incidence rate or density (number of new cases in a
specified time period divided by the total number of
person-time when at risk)
 Comparing Incidence Rates
EXAMPLE: Five new cases of HIV/AIDS were reported. This brings
the total number of HIV/AIDS cases this year to 56; total population is
100,000 and population at risk of HIV/AIDS is 20,000.
Suppose the actual time at risk for any one individual is estimated at
183 days per year (= 0.5 years per individual).

Cumulative Incidence Rate calculation for one year:

Use 5 new cases and 20,000 at-risk individuals
CI = 5/20,000 (=25/100,000)

Incidence Rate calculation for person-years:

Use 5 new cases in numerator;
Adjust denominator: 20,000p x 0.5y/p = 10,000 person-years
IR = 5/10,000 (=50/100,000)
Example: Calculation of annual Incidence Density for
suspected medication-related hyperthyroidism cases
for the Clinic

Total population at the start of the year was 200

There were 16 new cases of medication-related hyperthyroidism

No new patients were admitted, but 10 patients left during the year:
5 left at 3 months (0.25year) = 5 persons x 0.25years = 1.25person-years
3 left at 6 months (0.5year) = 3 persons x 0.5years = 1.5 person-years
2 left at 9 months (0.75 years)=2 persons x 0.75years = 1.5 person-years
Person-years for patients leaving the clinic: 4.25 person-years

190 stay all 12 months (1year) = 190 persons x 1year = 190 person-years

Total person-years for denominator is 190 + 4.25 = 194.25

Incidence Density = 16 / 194.25 = 8.24%

Figure 10.6
 Study Designs

• There are three main categories of

epidemiology studies
– Descriptive
– Analytical
– Interventional

• Potential disease risks are often identified in

descriptive studies then studied in analytical
and interventional designs
 Descriptive Study Designs
• There are three types of study designs
1. Case report (or case series)
2. Cross-sectional
3. Correlational

• They differ in these ways:

– Ability to tie cause to effect
– Ability to allow comparisons across time or with
other groups
 Summary of Descriptive Designs
Cross-
Characteristic Case Correlate Section
• Individual-level data XXX --- XXX
• Population-level data --- XXX ---
• Links cause-effect XX --- X
• Timeline measured XXX --- ---
• Allows comparisons to --- XXX XXX
other groups
• Observational XXX XXX XXX
• Experimental --- --- ---
 Analytic Study Designs
• These designs must be able to:
• Establish that exposure preceded disease
• Determine if risk factor is necessary and/or sufficient
• Determine if risk factor is a direct or indirect cause
• Rule out confounding factors
• Eliminate or reduce systematic bias

• Two basic types:

1. Cohort
2. Case control
 Cohort Study
• Use two groups of subjects
– Subjects selected on basis of exposure status
• Exposed
• Not exposed
• May be prospective or retrospective
• Seeks to determine whether an exposure
affects the likelihood that a person will get the
disease
• Results usually reported as Relative Risk
 Calculating Relative Risk using a 2x2 Table

A ratio of percent of exposed individuals who get the disease

compared to percent of not-exposed people who get the disease

Figure 10.8
 EXAMPLE - Calculating Relative Risk

Disease No Disease
Exposed 300 200
Not Exposed 150 350

RR = a/(a+c) ÷(c/(c+d) = 300/450 ÷ 150/500

= 2.23
Interpreting results:

RR >1; exposure increases risk of disease

RR=1; no difference due to exposure
RR<1; exposure is protective and reduces risk of disease

or

When 95% CI includes a “1” then no difference in risk is seen

(such as 95% CI of 0.55 – 3.6)
Figure 10.8
 Case Control Study
• Use two groups of subjects
– Subjects selected on basis of disease status
• Disease
• No Disease
• Retrospective only
• Seeks to determine whether a person with the
disease was more likely exposed to the risk
factor than someone without the disease
• Results usually reported as odds ratios
 Calculating an Odds Ratio (Cross-Products Ratio)

A ratio of the probabilities diseased individuals were/were not exposed

is compared to the ratio of probabilities that disease-free people
were/were not exposed

Figure 10.10
 EXAMPLE - Calculating Odds Ratio

Disease No Disease
Exposed 300 200
Not Exposed 150 350

OR = (a/c) ÷(b/d) = (300/150)÷ (200/350) = 2/0.5714

= 3.5
Interpreting results:

OR >1; person with disease was more likely exposed

OR=1; no difference in exposure likelihood
OR<1; person with disease was less likely exposed

or

When 95% CI includes a “1” then no difference in likelihood of exposure

(such as 95% CI of 0.25 – 2.7)
Figure 10.8
 Interventional Study Designs
• Use same approach as experimental design
• Random assignment to study arms
• Researcher controls the exposure

• Indirect method for learning more about a

disease
• Used to test the effects of removing risk factors or
adding protective factors on subsequent disease
development
• Never used to directly test whether an exposure causes
a disease
 Summary
• Epidemiology is the scientific tool used in public
health to describe disease behavior and
distribution within a population;
• Measures of disease frequency include
prevalence, incidence, and mortality rates;
• Study designs are used to establish exposure-
to-disease associations and timelines, and
• Pharmacoepidemiology is the application of
these methods to study adverse events after a
medication is approved.
 Case Example
• The following slides are optional
Handwritten prescription and label placed on
prescription vial

Figure 10.1
 Population level data for Clinic Patients with
medication-related Hyperthyroidism for current year
(n=16) and the previous year
Characteristics: THIS YEAR LAST YEAR

(% or mean)

Total hypothyroid patient population 200 195

Subset of population with hyperthyroidism due to medication 16 4

Gender (%) 4 (25%) male 1 (25%) male

12 (75%) female 3 (75%) female

Age, years (mean ± std dev) 46 (±14) 44 (±12)

Years since diagnosis (mean ± std dev) 15 (± 22) 14 (±24)

ICD-9-CM code 244.9 (%) 16 (100%) 4 (100%)

Average l-thyroxine dose (mean ± std dev) 38mcg (± 10mcg) 45mcg (±18mcg)

Months on current dose (mean ± std dev) 15 (± 56) 14 (±53)

Months since most recent symptoms appeared (mean ± std dev) 1.5 (± 0.04) 3 (±4.5)

Table 10.1
Cross-Sectional Survey of Patients with medication-
related Hyperthyroidism for one year (n=16)
Characteristics: TOTAL
Gender (%) 4 (25%) male 12 (75%) female

Age, years (mean ± std dev) 46 (±14)

Years since diagnosis (mean ± std dev) 18 (± 29)
Average l-thyroxine dose (mean ± std dev) 32mcg (± 16mcg)
Months on current dose (mean ± std dev) 18 (± 64)
Months since most recent symptoms appeared (mean ± std dev) 1 (± 0.34)

Pharmacies used during past year Rx corner 12 (75%)

(can list more than one) Chain Scripts 4 (25%)
Clinic pharmacy 8 (50%)
VA mail order 1 (7%)
Brand name of medication Synthroid® 4 (25%)
Levo-throid® 4 (25%)
levo-thyroxine (GenX brand) 8 (50%)
Usual number of days in prescription (mean ± std dev) 30 (± 2)

Self-reported compliance 28 (± 3)
(mean days/ month took dose ± std dev)
Medical Lab where T4 / TSH analyzed MML 16 (100%)

Table 10.2
Sample of Case Report Data for five of the 16 clinic
patients with medication-related hyperthyroidsim
Characteristics: CF LA CW HT HC

Gender F F M F M

Age 62 23 43 13 37

Date of diagnosis 02/1988 04/08 11/1997 05/04 02/09

Current l-thyroxine dose 25mcg 25mcg 50mcg 25mcg 25mcg

Pharmacy filling last prescription Rx Corner Rx Corner Rx Corner Rx Corner Rx Corner

Brand of l-thyroxine last dispensed GenX GenX GenX GenX GenX

Date last prescription filled prior to onset of Jan 29 Feb 1 Jan 24 Jan 29 Jan 25

hyperthyroidism symptoms

Date hyperthyroidism symptoms appeared Feb 2 Feb 5 Jan 29 Feb 4 Jan 30

Table 10.3
Relative Risk from Cohort Study of Medication Errors

Figure 10.9
Odds Ratios from Case-Control Study of Med Errors

Figure 10.11