Titien Siwi Hartayu

Two components of
Pharmacoepidemiology
1.Pharmaco
2.Epidemiology

1.Pharmacology is the study of the effects of
medicines.
2. Clinical Pharmacology is the study of the
effects of medicines in humans.


Pharmacoepidemiology can be considered,
therefore, to fall within clinical pharmacology.




Clinical pharmacology divided in 2 basic
areas:
Pharmacokinetics
Pharmacodynamics

Pharmacokinetics is the study of the relationship
between the dose administered of a medicine and the
serum or blood level achieved (medicine absorbtion,
distribution, metabolism, and excretion).

Pharmacodynamics is the study of the relationship
between medicine level and medicine effect.
Pharmacoepidemiology VS. Epidemiology
Epidemiology is the study of the distribution and
determinants of diseases in populations.

Epidemiology is divided in 2 basic areas:
1. Infectious diseases
2. chronic diseases



Pharmacoepidemiology
A relatively new applied field
Bridging between clinical pharmacology and
epidemiology
Applies the methods of epidemiology to the content
area of clinical pharmacology.
HISTORICAL
1906 US law: the Pure Food and Drug Act, response to excessive
adulteration and misbranding of the food and medicines available at
that time.
1937 over 100 people died from renal failure as a result of the
marketing of elixir of sulfanilamide disolve in diethylene glycol.
1938 Food, Drug and Cosmetic Act: pre clinical and toxicity testing
was required for the first time, and submit clinical data about safety
to the FDA prior to drug marketing.
Litle attention to adverse drug reaction until 1950: Chloramphenicol
could cause aplastic anaemia.
1952: the first textbook of adverse drug reaction was published. The
AMA council on Pharmacy and Chemistry established the first official
registry of adverse drug effects, to collect cases of drug induced
blood dyscrasias.
1960: FDA began collect reports of ADR.



1961: Thalidomide (mild hypnotic) disaster:
phocomelia-the absence of limbs or parts of limbs
sometimes with the presence instead of flippers.
1962: Kefauver-Harris Amandments strengthened the
requirements for proof of drug safety, requiring
extensive preclinical pharmacologic and toxicologic
testing before a drug could be tested in humans.
1968: the Commitee on Safety of Medicines.

DESI (Drug Efficacy Study Implementation)
conducted by the National Academy of Sciences
National Research Council with support from the FDA:
removal from US market of many ineffective drugs and
drug combination.
1960s: publication of a series of utilization studies,
provide the first descriptive information on how
physicians use drugs, and began a series of
investigations of the frequency of poor prescribing and
determinants of poor prescribing.
1960s

is the begining of the field of
Pharmacoepidemiology
MEDICINE USE & FACTORS
INFLUENCING PRESCRIBING
Defining pharmacoepidemiology and
medicine utilization
Process of pharmacotherapy
Factors influencing prescribing
Aims of Pharmacoepidemiology
To examine and judge pattern of medicine use
To determine how efficacy in clinical trials translates
into effectiveness in the population
To evaluate the extents of risks Adverse medicine
reactions
To evaluate the extents of cost
SCOPES OF
PHARMACOEPIDEMIOLOGY
Medicine utilization
Adverse medicine reactions
Pharmacoeconomics
DEFINING
MEDICINE UTILIZATION
Medicine utilization is defined as the marketing,
distribution, prescription, and use of medicines with
special emphasis on the resulting medical, social, and
economic consequences (WHO, 1997)
FOCUSED MEDICINE
UTILIZATION STUDIES?
To identify problems of medicine utilization
To identify possible causing factors
To identify intervention for improvement
To evaluate intervention strategy
PROCESS OF
PHARMACOTHERAPY
Making of diagnosis and defining patients problem
Defining therapeutic goal
Defining interventions: Medicines & Non medicines
Selecting medicines
Determining dose, route, frequency, and duration of
medicine administration
Writing prescription
Providing information
Monitoring and evaluation
FACTORS INFLUENCING
PRESCRIBING
Levels of knowledge, skills, and competence of
prescribers
Attitude
Information and promotion
Patients demand
Medicine supply and availability
Peers and environmental
Framework for changing medicine
use practices
Purpose and content
There are many different ways to improve medicine use practices. This unit
will expose you to a number of different strategies which have been tried to
improve medicine use, ranging from providing information to restrictive
regulatory measures, and the evidence for or against their effectiveness.
Not all strategies are relevant or feasible in specific area, in specific
program, or for every medicine use problem. However, this session will
enable students to identify and choose among the possible intervention
strategies which might be considered in a given situation.

The case study will also make clear the need for carefully considering each
approachs unintended effects before widespread implementation.






OBJECTIVES
Students will be able to:
1. Identify particular medicine use problems, and place
them in the perspective of the factors underlying
problems in medicine use.
2. Identify any different approaches to improve
problems in medicine use which have been tried in
the past.
3. Understand some of strehgths and weaknesses of
different approaches in terms of demonstrated
effectiveness, cost, and suitability for specific place
contexts and medicine therapy problems.


FACTORS WHICH INFLUENCE MEDICINE USE
Problems in medicine use can be caused by a wide range
of factors, which differ in importance from problem to
problem and from setting to setting. Before trying to
correct any problem in medicine use, it is helpful to
identify which factors are most important in causing
the problem at hand. Unless the proposed
intervention targets the appropriate causes of the
problem, it is unlikely to be successful.

Several categories of factors which
should be considered as possible
causes of a problem in medicine use.
1. Characteristic of providers of care

Lack of knowledge about diagnosis, therapeutics, the
efficacy and risks of particular medicines.
Acquired habits in diagnosis and treatment which may not
reflect what providers actually know, but the patterns of
behaviour they have come to adopt.
Beliefs about illness and medicines such as the increased
power of injections over oral medicines, which also do not
always reflect their level of scientific knowledge.
Personal economic motivations for prescribing or
dispensing particular medicines, for example, medicine
company incentives, dispensing fees, referrals to private
practice, ect.
2. The Summary of Medicine
Utilization Research




Proven Effectiveness:

Face to face education focused on a few
prescribing problems
Structured medicine order forms
Prescription audits/procurement review
plus feedback





Possible Effectiveness:

Essential medicine lists plus education
Standard treatment schedules plus
education
Ineffective:

Printed materials alone
Arbitrary limits on number/quantity of
medicines per prescription
Unfocused education
Essential medicine lists alone
Standard treatment schedules alone

New Medicine Development
In vitro and Pre clinical Toxicity: animal testing
Phase I: Human clinical trials
Phase II and Phase III: Human clinical trials
Phase IV studies: Post marketing surveilance and
medicine use experience

Premarketing Risk Analysis
To detect overt toxicity
To establish dose-response estimation of
pharmacologic and toxic effects
To assess medicine distribution to organ system
To identify metabolic, kinetic, and elimination
pathways
To assess carcinogenic potential
To assess reproductive toxicity and teratogenic
potentials
To direct clinical safety assesssments
Premarketing clinical investigations
Phase I:
Usually in normal volunteers with attention to
pharmacokinetics, metabolism, and both single dose
and dose-range safer
Phase II:
Limited size, closely monitored investigations designed
to assess efficacy and relative safety
Phase III:
Full-scale clinical investigations designed to provide an
assessment of safety, efficacy, optimum dose, and more
precise definition of medicine-related adverse effects

Postmarketing Medicine Evaluation
Phase IV Studies, Postmarketing Surveilance and
Medicine Use Experience
Efficacy
Effectiveness
Safety
Adverse Medicine Reactions
Economic Analysis

PHARMACOECONOMICS
PHARMACOECONOMICS
Economic analysis of Pharmaceuticals

Introduces the concepts of clinical economics
Review some methodologic issues
Dimensions of Economic analysis
Types of analysis:
Cost-identification
Cost minimization
Cost-effectiveness
Cost -utility
Cost-benefit
Viewpoints of analysis
Provider, Payer, Patient, Society
Types of cost
Direct costs: medical and non medical cost
Indirect cost
Intangible cost

Changing a Medicine Use Problem
An Overview of The Process
1. Examine
Measure Existing Practices

Improve diagnosis 2. Diagnose
4. Follow up Identify Specific
Measure changes in outcomes Problems & Causes
Improve intervention
3. Treat
Design & Implement
Interventions