FARMAKOEPIDEMIOLOGI
Pharmaco -Pharmaco -
epidemiology isepidemiology is
the study of thethe study of the
use of and theuse of and the
effects ...
Pharmacoepidemiology
Pharmacology Epidemiology
Pharmacology is the study of the effect of
drugs.
Clinical pharmacology is the study of effect
of drug in humans
clinical ...
1. Descriptive epidemiology describes disease and/or
exposure and may consist of calculating rates, e.g.,
incidence and pr...
Pharmacoepidemiology then can also be defined
as the application of epidemiological methods to
pharmacological issues.
Pha...
Pharmacovigilance is a type of continual
monitoring for unwanted effects and other safety-
related aspects of drugs that a...
DRUG
RISK
BENEFIT
The history of drug regulation parallels the
history of major adverse drug reaction
“disasters”.
Recent data indicate that...
Adverse reaction
Type A
Reactions
tend to be
common
Dose related
Predictable
Less serious
Type B
Reactions tend to be
unco...
Pharmacoepidemiology
versus
Clinical pharmacology
To optimize use of drugs, Clinical Pharmacology specifies
that therapy should be individualized, or tailored to the
needs ...
Clinical Pharmacology
Pharmacocinetic
Pharmacodinamic
Epidemiology
Potential Contributions Of Pharmacoepidemiology
A)Information which supplements the information
available from premarketin...
B) New types of information not available from pre-marketing studies.
1. Discovery of previously undetected adverse and be...
ReaReason to Perform
Pharmacoepidemiology studies
A. RegulatoryA. Regulatory
1.1. RequiredRequired
2.2. To obtain earlir a...
B. Marketing
1. To assist market penetration by dokumenting the
safety of the drug
2. To increase name recognition
3. To a...
C. Legal
In anticipation of future product
liability litigation
D. Clinical
1. Hypothesis testing
a. Problem hypothesized on the basis of drug structure
b. Problem suspected on the basis...
Conclusion
All drugs have adverse effects.
Pharmacoepidemilogy will never succeed in
preventing them. It can only detect t...
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Farmakoepidemiologi3

  1. 1. FARMAKOEPIDEMIOLOGI
  2. 2. Pharmaco -Pharmaco - epidemiology isepidemiology is the study of thethe study of the use of and theuse of and the effects of drugseffects of drugs in large numbersin large numbers of people.of people. What IsWhat Is PharmacoepidemiologyPharmacoepidemiology ??
  3. 3. Pharmacoepidemiology Pharmacology Epidemiology
  4. 4. Pharmacology is the study of the effect of drugs. Clinical pharmacology is the study of effect of drug in humans clinical pharmacology a risk benefit assessment for the effect of drugs in patients Epidemiology can be defined as the study of the distribution and determinants of diseases in populations.
  5. 5. 1. Descriptive epidemiology describes disease and/or exposure and may consist of calculating rates, e.g., incidence and prevalence. Such descriptive studies do not use control groups and can only generate hypotheses, not test them. Studies of drug use would generally fall under descriptive studies. 2. Analytic epidemiology includes two types of studies: observational studies, such as case-control and cohort studies, and experimental studies which would include clinical trials such as randomised clinical trials. The analytic studies compare an exposed group with a control group and are usually designed as hypothesis testing Epidemiological studies can be divided into two main types:
  6. 6. Pharmacoepidemiology then can also be defined as the application of epidemiological methods to pharmacological issues. Pharmacoepidemiology benefits from the methodology developed in general epidemiology and may further develop them for applications of such methodology unique to pharmacoepidemiology. e.g : pharmacovigilance
  7. 7. Pharmacovigilance is a type of continual monitoring for unwanted effects and other safety- related aspects of drugs that are already on the market. In practice, pharmacovigilance refers almost exclusively to the spontaneous reporting systems which allow health care professionals and others to report adverse drug reactions to a central agency. The central agency can then combine reports from many sources to produce a more informative safety profile for the drug product than could be done based on one or a few reports from one or a few health care professionals.
  8. 8. DRUG RISK BENEFIT
  9. 9. The history of drug regulation parallels the history of major adverse drug reaction “disasters”. Recent data indicate that 100000 Americans die each year from Adverse Drug Reactions, and 1.5 million US hospitalizations each year result from Adverse Drug Reactions; yet, 20-70% of Adverse Drug Reactions may be preventable.
  10. 10. Adverse reaction Type A Reactions tend to be common Dose related Predictable Less serious Type B Reactions tend to be uncommon Not related to dose Unpredictable Potential more serious
  11. 11. Pharmacoepidemiology versus Clinical pharmacology
  12. 12. To optimize use of drugs, Clinical Pharmacology specifies that therapy should be individualized, or tailored to the needs of the specific patient at the hand. Doing so requires a prescriber to be aware of the potential beneficial and harmful effects of drugs in question and to know how elements of patient’s clinical status might modify the probability of a good therapeutic outcome. For example consider a patient with a serious infection, serious liver impairment and mild impairment of his or her renal function. In considering whether to use gentamicin treat the infection, it is not sufficient to know that gentamicin has a small probability of causing renal disease. A good clinician should realize that a patient who has impaired liver function is at a greater risk of suffering from this adverse effect than one with normal liver function
  13. 13. Clinical Pharmacology Pharmacocinetic Pharmacodinamic Epidemiology
  14. 14. Potential Contributions Of Pharmacoepidemiology A)Information which supplements the information available from premarketing Studies- better quantitation of the incidence of known adverse and beneficial effects. a. Higher precision. b. In patients not studied prior to marketing e.g. the elderly, children, in pregnant women. c. As modified by other drugs and other illnesses. d. Relative to other drugs used for the same medication.
  15. 15. B) New types of information not available from pre-marketing studies. 1. Discovery of previously undetected adverse and beneficial effects. a. Uncommon effects. b. Delayed effects. 2. Patterns of drug utilization. 3. The effects of drug overdoses. 4. The economic implications of drug use. C) General Contributions of Pharmacoepidemilogy 1. Reassurances about drug safety. 2. Fulfillment of ethical and legal obligations.
  16. 16. ReaReason to Perform Pharmacoepidemiology studies A. RegulatoryA. Regulatory 1.1. RequiredRequired 2.2. To obtain earlir approval for marketingTo obtain earlir approval for marketing 3.3. AAs a response to question by regulatory agency 4. To assist aplication for approval for marketing elseware
  17. 17. B. Marketing 1. To assist market penetration by dokumenting the safety of the drug 2. To increase name recognition 3. To assist in repositioning the drug a. different outcomes e.g quality of life and economic b. Different types of patients e.g the elderly c. New indication d. Less restrictive labeling 4. To protect the drug from accusation about advers effect
  18. 18. C. Legal In anticipation of future product liability litigation
  19. 19. D. Clinical 1. Hypothesis testing a. Problem hypothesized on the basis of drug structure b. Problem suspected on the basis of preclinical or premarketing human data c. Problem suspected on the basis of spontaneous reports d. Need to better quantitative the frequency of adverse effect 3. Hyphotesis generating – need depends on : a. Wheather it is a new chemical entity b. The safety profile of the class C. The relative safety of the drug *ithin its class d. The formulation e. The disease tobe treated, including : • Its duration • Its prevalence • Its severity • wheathe alternative therapies are available
  20. 20. Conclusion All drugs have adverse effects. Pharmacoepidemilogy will never succeed in preventing them. It can only detect them, hopefully early, and thereby educate health care providers and public, which will lead to better medication use. The net results of increased activity in pharmacoepidemilogy will be better for industry and Academia but most importantly, for public’s health.

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