Pharmacoepidemiology

Definition and scope

Kanav Khera Lecturer Dept of Pharmacy Practice

Definition and scope:

Pharmacoepidemiology: Study of the use

and the effect of medicine in large number of people. OR Pharmacoepidemiology can be defined as the study of the therapeutic effect(s), risk and use of drugs, usually in large populations, using epidemiological methods and/or reasoning.

Epidemiology:
Epidemiology Study of the relationships

between diseases or any other biological phenomenon and various factors (e.g. lifestyle, environment or social setting, individual traits, etc.) which can influence their frequency, distribution and evolution.
Descriptive epidemiology, in which the

objective is to describe a population (e.g. drug utilization studies), Analytic epidemiology, in which the objective is to study the associations (causal or otherwise) that can exist, within a population, between the occurrence of an event and a given characteristic

 Pharmacoepidemiology: Bridging b/w

clinical pharmacology and epidemiology Application of the principles of epidemiology to drug effect and drug use Better assessment of risk/benefit balance for the use of any particular drug in any particular patient Focus: Clinical Pharmacology: Drug effect in Individual Patient Drug Utilization: Drug usage pattern and appropriateness of drug use in groups Pharmacoepidemiology: Relation between drug exposure and health outcomes in

Adverse reactions
Type A reactions: reactions tend to be common, dose-

related, predictable, and less serious. They can usually be treated by simply reducing the dose of the drug.
They tend to occur in individuals who have one of three

characteristics. First, the individuals may have received more of a drug than is customarily required.
Second, they may have received a conventional amount

of the drug, but they may metabolize or excrete the drug unusually slowly, leading to drug levels that are too high.
Third, they may have normal drug levels, but for some

reason are overly sensitive to them.

 Type B reactions: tend to be uncommon, not

related to dose, unpredictable, and potentially more serious.

They usually require cessation of the drug. They

may be due to what are known as hypersensitivity reactions or immunologic reactions.

Alternatively, Type B reactions may be some

other idiosyncratic reaction to the drug, either due to some inherited susceptibility (e.g., glucose-6-phosphate dehydrogenase deficiency) or due to some other mechanism.
Regardless, Type B reactions are the more

difficult to predict or even detect, and represent the major focus of many pharmacoepidemiology

Origin and Evolution of Pharmacoepidemiology

Pharmacotherapy 20th century

Use of drug inc-----ADR inc

1961 Maternal use of Thalidomide with

malformations (Limb reduction) in offspring -----Focus of detection , prevention and management of ADR--------- It began the era of Pharmacoepidemiology
To Identify ADR----spontaneous reporting and

surveillance programs created e.g Grey baby syndrome with chloramphenicol \

Birth defect with Isotretetinoin

 Drug re-introduce : when drug have unique benefit

and risk can be managed E.g Isotretinoin, cancer drugs etc. Drug utilization : Define as marketing , distribution , prescription and use of drug in a society with special emphasis on the resulting medical, social and economic consequences Drug utilization review ( DUR): define as authorized , structural and continuing program that review, analysis and interprets pattern of drug use against predetermined standards
DUR studies focus on drugs and Aim of these

studies is to evaluate the appropriateness of the therapy using approved criteria and to develop

Aim of Pharmacoepidemiology
Signal Generation: Most commonly

associated with ADR but also use to detect new applications E.g Minoxidil 1st indicated for hypertension but case report (signal generation) soon identified it causes hirsutism in a number of patients, side effect was investigated and now it is marketed for purpose mainly stimulation of hair growth
Risk Quantification: of ADR often require

large sample size

Hypothesis testing:
Require the use of comparison group to

determine whether there are difference in variable of interest (risk factor, trait, characteristic, drug exposed, or clinical conditions)
Statistic method are used to assess whether the

observed difference could have occur by chance alone

Conclusions about relation b/w exposure to a

drug and clinical event thus based on the ability to reject the null hypothesis, postulating that

Reasons to perform pharmacoepidemiology studies

Application of Pharmacoepidemiology
Estimation of risk of drug use

Use in patient counseling

Formulation of public health policy decision Formulation of therapeutic guidelines and

discovery of new indications Facilitation of pharmaco-economic evaluation

Pharmacoepidemiology in Practice
The basic idea of pharmacoepidemiology is to

measure the source, diffusion, use, and effects of drugs in a population and to determine the frequency and distribution of drug use outcomes in that population

The focus of this type of research includes

(1) what is being used (an assessment of

specific drugs being used in certain situations)

(2) how it is being used (an assessment of the

patterns of use, including how much, where and when, and by whom); and
(3) why it is being used (an assessment of the

reasons for drug-taking behaviors and the functions that drugs serve in society).

World Health Organization

WHO focuses its pharmacoepidemiological efforts on

ensuring the quality, safety, and efficacy of drugs and their use in specific populations and studies are performed to :
(1) Describe current patterns of drug use in specific

patient populations (2) Determine changes in drug use over time (3) Measure the effects of information, education, promotional activities, media accounts, and price on drug use (4) Detect inappropriate drug use and associated problems

Research methods used most often by pharmacoepidemiologists

Cross-sectional study: a prevalence survey of

health and illness in the population at one point in time Case-control study, a retrospective analysis comparing subjects with the condition (cases) to those without it (controls) with respect to possible risk or causative factors Cohort study, an incidence study that follows a population free of health problems over time, examining subsequent development of problems and factors associated with them. Clinical trials, an experimental approach that tests the value of a new treatment or intervention

Sources of Data on Drug Use

Institutional record systems and

databases drug utilization studies hospital-based medical audits (inpatient)

System wide databases institutionally based reviews (outpatient) health insurance groups and third-party

payers pharmaceutical organizations commercial vendors of marketing studies

 National databases
government-sponsored studies essential drug lists and inventory data

pharmacoepidemiological surveillance

systems
Field data records of drug dispensers, sellers, and

distributors drug-taking behaviors of individuals and small groups

Experimental data

Problem Solving with Pharmacoepidemiology Medical drug use

Beneficial effects of drug therapy Risks (e.g., adverse reactions, side effects) of

drug therapy Inappropriate prescribing behaviours Patient noncompliance Irrational self-medication practices Poor drug use outcomes Cost-effectiveness of drug therapy

Nonmedical drug use

Social-recreational drug use and associated

problems Acute incidents of drug toxicities (e.g., overdoses) Chemical dependencies Outbreaks and sources of drug epidemics