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Pharmacoepidemiology Part 1 Merged Compressed
Pharmacoepidemiology Part 1 Merged Compressed
College of Pharmacy
MODULE 3
PHARMACOEPIDEMIOLOGY
PART 1 OF 2
WEEK 2 (DAY 2 OF 6)
NOTES
Introduction to
1 Pharmacoepidemiology
Pharmacoepidemiology
f) logos
“It is the study of the use of and the
I ←
effects of drugs in large numbers of
people.”
Strom, 2006
Pharmacoepidemiology
phase 1 given in a healthy volunteer, the studies usually test new drugs for the first time
in a small group of people to evaluate a safe dosage range and identify the side effects.
Phase 2 first trials in patients is a phase 2 study so that these treatments that have been
found to be safe in phase one but no need a larger group of human subjects to monitor
for any adverse effects
Phase 3 these are for larger or multicenter trials they are perform like any experimental
study according to a very strict methodology following previously defined inclusion and
exclusion criteria. for the phase 3 studies they are conducted on a larger populations and
in different regions and countries and are often the step right before a new treatment is
been approved by the fda.
discovery and preclinical trials
- so discovery this is drug discovery know where we conduct experimental research coming from the different plant or animal sources and of course, we all know that the first testing
is should be on animals or also known as animal trial or in laboratory trial
*in vivo using animal subjects like for example albino mice, rats and rabbits
*in vitro using mga equipments or apparatuses in our laboratory setting
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However, clinical trials are limited…
Insufficiencies of Clinical Trials
polymedicated patients)
• Too often concerned with median ages (excluding very
young or old subjects)
• Too narrow (respecting very restrictive and well-defined
indications)
• Too brief (including for example patients treated for only a few
months for a chronic disease)
PHASE 4
Pharmacoepidemiology
Pharmacoepidemiology
• It is defined as the study in real conditions and in
large populations of use, effectiveness and risks of
drugs
• Also known as post-marketing surveillance of
drugs or Phase IV clinical trials
Difference of Pharmacoepidemiology
2 from Clinical Pharmacology and
Epidemiology
Clinical
Epidemiology Pharmacology
↳
study of distribution
the
and determinants of
disease in a population
Pharmacoepidemiology
of
study of utilization and effects
-
kinetics .
body
→
drug -
LADNER
action
dynamics
-
drug
→
body
-
mech .
of
Pharmacoepidemiology vs.
Clinical Pharmacology
Pharmacoepidemiology encompasses elements of
both of these fields, exploring the effects achieved by
administering a drug regimen.
Pharmacoepidemiology can be used to shed light on
the pharmacokinetics of a drug, such as exploring
whether aminophylline is more likely to cause nausea
when administered to a patient simultaneously taking
cimetidine. However, to date this is a relatively
unusual application of the field.
Pharmacoepidemiology vs.
Epidemiology
Epidemiology is the study of the distribution and
determinants of diseases in populations.
Since pharmacoepidemiology is the study of the use
of and effects of drugs in large numbers of people, it
obviously falls within epidemiology as well.
Pharmacoepidemiology vs.
Epidemiology
Epidemiology is also traditionally subdivided into two
basic areas. The field began as the study of infectious
diseases in large populations, i.e., epidemics. More
recently, it has also been concerned with the study of
chronic diseases.
The field of pharmacoepidemiology uses the
techniques of chronic disease epidemiology to study
the use of and the effects of drugs.
Pharmacoepidemiology vs.
Epidemiology
Although application of the methods of
pharmacoepidemiology can be useful in performing
the clinical trials of drugs that are performed before
marketing, the major application of these principles is
after drug marketing.
This has primarily been in the context of post-
marketing drug surveillance, although in recent years
the interests of pharmacoepidemiologists have
broadened considerably.
END OFMODULE 3
PART 1
OUR LADY OF FATIMA UNIVERSITY
College of Pharmacy
MODULE 3
PHARMACOEPIDEMIOLOGY
PART 2 OF 2
WEEK 2 (DAY 4 OF 6)
NOTES
Potential Contributions of
3 Pharmacoepidemiology
Potential Contributions of
Pharmacoepidemiology
1. Provides information which supplements the
information available from premarketing studies—
better quantitation of the incidence of known
adverse and beneficial effects:
a. Higher precision How close
b. In patients not studied prior to marketing, e.g., the
elderly, children, pregnant women
c. As modified by other drugs and other illnesses
d. Relative to other drugs used for the same indication
Potential Contributions of
Pharmacoepidemiology
2. Provides new types of information not available
from premarketing studies: clinical trial
a. Discovery of previously undetected adverse and
beneficial effects
listed in ADR: minimal
• Uncommon effects -
not
or
Applications of
4 Pharmacoepidemiology
Application Fields of
Pharmacoepidemiology
Pharmacoepidemiology, by supplementing and
expanding data from clinical trials, develops three
main areas of interest.
A. Prescription and drug consumption studies EPD MS
B. Study of drug effectiveness pharma vigilance report
-
- s Foa
abuse dependence
{
2) Social i. A .pt attitude b.
tic non adherence
-
drug
D. unavailability of drug
minimization
3) chthonical A. cost
-
-
B cost benefit
c . it effectiveness
D . " utility
Study of Drug Effectiveness
L measurable
Study of Drug Effectiveness
a
C Review
.
control study
b b) systematic
-
. case
C .
Ease reports
2) Experimental study
a randomized control study
RQ
.
b .
population level.
TRUE or FALSE:
False 1. Clinical trials can detect adverse effects that are
uncommon, delayed, and unique to high risk
population.
False 2. effects in large numbers of people.
Clinical pharmacology is the study of drug
Pop Quiz
C 1. POVERTY
A 2. GENETICS
C 3. EDUCATION
B 4. TOXIC AGENTS
A 5. BEHAVIORS
II. INDICATORS OF HEALTH
UNIT 4.1: DETERMINANTS OF HEALTH
INDICATORS OF HEALTH
a. Life expectancy
b. Infant mortality rate
c. Mortality rate/ maternal mortality rate
d. Morbidity
e. Incidence of disease
Indicators of health
A. LIFE EXPECTANCY
PERSON-ENVIRONMENT INTERACTION
- central to the ecological approach to health and
involves:
a. Positive interactions with environment that improve
health
b. Negative interactions with environment that are
detrimental to health and results to illness
Determinants of health:
Individual level
Physical Genetic susceptibility to breast cancer
Immunity protects against specific diseases
Low level of physical fitness increases likelihood of
back injury
Increase in the amount of body fat increases the
risk of developing disease
Socioeconomic Poverty has been identified as GREATEST SINGLE
status KILLER
Lack of economic resources
¥
1. CLIMATE CHANGE
2. HEALTH INSURANCE
3. VIOLENCE
4. PRIMARY CARE
A 5. CHILD ABUSE
DETERMINANTS OF HEALTH
UNIT 4.1: DETERMINANTS OF HEALTH
A. HEREDITY
A. HEREDITY
¨ THE PHYSICAL AND MENTAL TRAITS OF EVERY
HUMAN; TO SOME EXTENT IS DETERMINED BY
GENES.
mutations in multiple genes like the multifactorial inheritance disorder a combination of gene
mutations and environmental factors or damage to chromosomes or changes in the number or
structure of interior chromosomes the structure that carry the gene.
GENES AND HUMAN DISEASES
1. GENES AND CHROMOSOMAL DISEASES
¤ DOWN SYNDROME – TYPE OF MENTAL RETARDATION
CAUSED BY EXTRA GENETIC MATERIAL IN
CHROMOSOME 21. THIS CAN BE DUE TO A PROCESS
CALLED NONDISJUNCTION, IN WHICH GENETIC
MATERIAL FAIL TO SEPARATE.
n CHARACTERISTICS: DECREASED MUSCLE TONE, FLAT FACE,
EYES SLANTING UP, IRREGULAR SHAPED EARS, ABILITY TO
EXTEND JOINTS BEYOND THE USUAL, LARGE SPACE
BETWEEN THE BIG TOE AND ITS NEIGHBORING TOE,
LARGE TONGUE RELATIVE TO THE MOUTH, ETC.
other name, trisomy 21 i have 47 chromosome -
21 -
- 3
normal : 4.6
GENES AND HUMAN DISEASES
2. MONOGENIC DISEASES - RESULTS IN
MODIFICATION OF A SINGLE GENE OCCURING IN
ALL CELLS OF THE BODY.
¨ THREE CATEGORIES:
¤ DOMINANT – INVOLVES DAMAGE TO ONLY ONE
GENE COPY
¤ RECESSIVE – OCCURS DUE TO DAMAGES IN BOTH
COPIES OF GENE
¤ X-LINKED – LINKED TO DEFECTIVE GENES ON THE X
CHROMOSOMES (SEX CHROMOSOMES)
-
Y linked
- -
¤ INFANTILETAY-SACHS DISEASE
¤ LATE ONSET TAYS-SACHS DISEASE (CHRONIC GM2-
GANGLIOSIDOSIS)
GENES AND HUMAN DISEASES
F. FRAGILE X SYNDROME
¨ CAUSED BY A FRAGLE SITE AT THE END OF THE
RETARDATION
GENES AND HUMAN DISEASES
G. HUNTINGTON S DISEASE
¨ DEGENERATIVE BRAIN DISORDER, IN WHICH
Behavior
¨ IMMUNIZATION
¨ FAMILY PLANNING
¨ CHILD REARING
VEGETARIAN)
¨ SOCIAL VALUES (STATUS OF WOMEN)
so according to study for infants born to caucasian mothers with fewer than 12 years of
schooling or 2.4 times more likely to die before their first birthday then infants born to
mothers with 16 or more years of education including african, american, hispanic, american
indian and asian or pacific islander infants this is according to the study of NCHS.
another study conducted in the us and says that higher levels of education are associated with
better health or lower mortality.
and another is the high scoop of perry preschool project indicate beneficial outcomes even in
adolescence and adulthood such as your teenage pregnancy lower rates of high school
dropouts and better earnings and employment prospects which may independently improve
health chances.
C. SOCIO ECONOMIC
3. OCCUPATION/ EMPLOYMENT
¨ STATE OF BEING EMPLOYED IN PRODUCTIVE
2) Education
9) occupation / Employment
4) Political system
D. PSYCHOSOCIAL
D. PSYCHOSOCIAL
¨ ENCOMPASSES THE MENTAL, EMOTIONAL, SOCIAL
AND SPIRITUAL DIMENSIONS OF WHAT IT MEANS
TO BE HEALTHY.
¨ IT IS THE RESULT OF COMPLEX INTERACTION
BETWEEN A PERSON S HISTORY AND HIS OR HER
THOUGHTS ABOUT AND INTERPRETATIONS.
¤ MENTAL (THINKING)
¤ SOCIAL (RELATING)
¤ SPIRITUAL (BEING)
¤ EMOTIONAL (FEELING)
psychosocial is pertains the influence of social factors on an individual's mind or behavior
and to the interrelation of behavioral and social factor that is according to oxford dictionary
Erikson's
stages of
psychosocial
development
D. PSYCHOSOCIAL
¨ PSYCHOSOCIAL DETERMINANTS
¨ GOAL FRUSTRATIONS,
¨ NEGATIVE LIFE EVENTS,
¨ UNEMPLOYMENT,
¨ STRESS,
¨ BEREAVEMENT,
¨ HARDINESS
D. PSYCHOSOCIAL
¨ TYPES OF DISEASES CAUSED BY PSYCHOSOCIAL
FACTORS:
¤ GASTROINTESTINAL DISORDER
¤ COMMON COLD
¤ CARDIOVASCULAR DISEASE
¤ CANCER
¤ LYMPHOCYTE FUNCTION
¤ PHYSICAL ILLNESS
D. PSYCHOSOCIAL
¨ STRESS
¤ CAUSES: STUDY, WORK, AND RELATIONSHIPS
¤ LEADS TO: ANXIETY, INSECURITY, LOW SELF ESTEEM,
SOCIAL ISOLATION, LACK OF CONTROL
¤ ALL WHICH AFFECTS HEALTH
THREATS.
D. PSYCHOSOCIAL
3. SELF EFFICACY AND SELF ESTEEM
¤ PROBLEM SOLVING
¤ EVALUATING DECISIONS
¤ DEFINING AND ADHERING PERSONAL VALUES
¨ CHEMICAL
¨ PHYSICAL
¨ BIOLOGICAL
AIR POLLUTION VULNERABLE
GROUPS
¨ LARGEST ENVIRONMENTAL HEALTH RISK
¨ MILLIONS OF DEATH
¤ ELDERLY
¤ CHILDREN
¤ CHRONIC LUNG
¤ HEART DISEASE
OUTDOOR AIR POLLUTION
NATURAL HUMAN
(BIOGENIC) (ANTHROPOGENIC)
POLLEN INDUSTRY
BUSHFIRE BURNING
FOSSIL FUEL
MOTOR
DUST VEHICLE
ANTHROPOGENIC
SO2 Pb O3
SULFUR DIOXIDE LEAD OZONE
• BURNING OF • METAL AND ORE • SUNàCHEMICALS
SULFUR PROCESSING • NATURALLY
CONTAINING • CAR EXHAUST OCCURING
FUELS processing car exhaust amounting OZONE à
• POWER PLANT of 10 microgram per dl in children PROTECTIVE
can cause low intellectual
• REFINERIES capacity, hyperactivity and for
BARRIER
organizational skills They cause Release of inflammatory
they are released into the air it may be markers or ozone induced asthma
converted into sulfuric acid and wherein the airway hyperactivity
sulfuric trioxide they cause a burning and neutrophilia.
sensation in the nose and throat
difficulty in breathing and asthma
attacks in susceptible individuals
INDOOR AIR POLLUTION
¨ INADEQUATE VENTILATION
¨ HEAT HUMIDITY
¨ SOLID FUELS
¨ COOKING
¨ HEATING
¨ TOBACCO SMOKE most common exogenous cause
¨ PESTICIDES
¨ BUILDING MATERIALS
¨ ASBESTOS
¨ CLEANING PRODUCTS
Environmental Pollution
¨ Air pollution
¤ Sulfur dioxide,
¤ Carbon monoxide,
¤ Ozone- ozone that accumulates in the lower atmosphere
(ground-level ozone) is one of the most pernicious air
pollutants
¤ Nitrogen dioxide,
¤ Lead
¤ Particulate matter
asthma or emphysema.
¨ Ozone-induced asthma is associated with airway
hyper-reactivity and neutrophilia
Sulfur Dioxide
¨ Sulfur dioxide is produced by power plants burning
coal and oil, from copper smelting, and as a
byproduct of paper mills.
¨ Released into the air, it may be converted into
death.
Tobacco
¨ Exposure to environmental tobacco smoke (passive
smoke inhalation) is also associated with some of the
same detrimental effects that result from active
smoking. It is estimated that the relative risk of lung
cancer in nonsmokers exposed to environmental
smoke is about 1.3 times higher than that of
nonsmokers who are not exposed to smoke.
HEALTH EFFECTS
¨ SHORT TERM
¨ LONG TERM
¨ MINOR EFFECTS
¨ CRITERIA OF POLLUTANTS
OIL SPILLS
DEATH TO FISH
CHEMICAL POLLUTION
Chemical Pollution
¨ Chemical Pollution . Industrial and agricultural
chemicals leached from the land enter water in
great amounts and in forms that are resistant to
biodegradation.
¨ Excessive nitrates from agricultural fertilizers
¨ DISEASES
¨ DESTRUCTION OF ECOSYSTEM
PREVENTION OF WATER POLLUTION
NATURAL
• HURRICANES
CAUSES
• URBANIZATION
MANMADE
• INDUSTRIAL WASTE
• MINING
• AGRICULTURAL WASTE
¨ PLANTING OF TREES
GENERATION
¨ MINIMISED THE USE OF CHEMICAL FERTILIZER AND
PESTICIDES
POP QUIZ
¨ ENUMERATE THE ENVIRONMENTAL FACTORS
¨ ENUMERATE THE AIR POLLUTANTS AND WATER
POLLUTANTS
F. CRISES AND DISASTERS
F. CRISES AND DISASTER
¨ DISASTER – CALAMITY, CATASTROPHE,
EMERGENCIES OR CRISIS
¨ A SUDDEN CALAMITOUS EVENT THAT CAUSES
TERRORISM
F. CRISES AND DISASTER
¨ 10 DEADLIEST NATURAL DISASTERS IN 2018
1.INDONESIA: EARTHQUAKE & TSUNAMI (SEPT. DEATHS: 2, 783)
2. INDONESIA: EARTHQUAKE (JULY DEATHS: 468)
3. INDONESIA: TSUNAMI (DEC. DEATHS: 430)
4. GUATEMALA: VOLCANIC ERUPTION (DEATHS: 425)
5. INDIA: FLOODS (DEATHS: 361)
6. JAPAN: FLOODS (DEATHS: 220)
7. NIGERIA: FLOODS (DEATHS: 200)
8. PAKISTAN: HEAT WAVE (DEATHS: 180)
9. NORTH KOREA: FLOODS (DEATHS: 151)
10. PAPUA NEW GUINEA: EARTHQUAKE (DEATHS: 145)
POP QUIZ
A. NATURAL
B. BIOLOGICAL
C. TECHNOLOGICAL
D. SOCIETAL
B 1. COVID 19
D 2. TERRORISM
A 3. FLOOD
C 4. CHEMICAL SUBSTANCE
A 5. TSUNAMI
G. ACCESIBILITY TO HEALTH CARE
G. HEALTH SERVICES
¨ HEALTH AND FAMILY WELFARE COVER A WIDE
SPECTRUM OF PERSONAL AND COMMUNITY
SERVICES FOR TREATMENT OF DISEASES,
PREVENTION OF ILLNESS AND PROMOTION OF
HEALTH.
¨ THE PURPOSE OF HEALTH SERVICES IS TO
IMPROVE THE HEALTH STATUS OF THE
POPULATION
G. HEALTH SERVICES
¨ BOTH ACCESS TO HEALTH SERVICES AND THE
QUALITY OF HEALTH SERVICES CAN IMPACT
HEALTH.
¤ MALARIA
G. HEALTH SERVICES
2. PATIENT PATHWAYS
¨ PERSONAL HEALTH SERVICES ARE PROVIDED BY
RISK MANAGEMENT?
¨ GIVE THE BARRIERS IN ACCESSING HEALTH
ge Access
-
H. EDUCATION
H. EDUCATION
¨ EDUCATION IS THE SECOND MAJOR
INFLUENCING FACTOR IN AFFECTING THE HEALTH
OF THE POPULATION
¨ THE WORLD MAP OF ILLITERACY CLOSELY
¤ HIGHER EDUCATION