Pharmacoepidemiology

1. Pharmacoepidemiology Huang, Boji

2. Pharmacoepidemiology is the study of the use of the effects of drugs in large numbers of people. The term pharmacoepidemiology contains two components: "pharmaco" and "epidemiology."

3. The joining of the fields of clinical pharmacology and epidemiology has resulted in the development of a new field: pharmacoepidemiology, the study of the use of and the effects of drugs in large numbers of people.

4. Pharmacoepidemiology applies the methods of epidemiology to the content area of clinical pharmacology.

5. Pharmacoepidemiology encompasses elements of both of these fields, exploring the effects achieved by administering a drug regimen. It does not normally involve or require the measurement of drug levels.

6. Pharmacoepidemiology has become the science underlying postmarketing drug surveillance, studies of drug effects which are performed after a drug has been marketed.

7. In attempting to optimize the use of drugs, one central principle of clinical pharmacology is that therapy should be individualized, or tailored to the needs of the specific patient at hand.

8. Clinical pharmacology is traditionally divided into two basic areas, pharmacokinetics and pharmacodynamics.

9. Together, these two fields allow one to predict the effect one might observe in a patient from administering a certain drug regimen.

10. Specifically, the field of pharmacoepidemiology has primarily concerned itself with the study of adverse drug effects including Type A and Type B reactions.

11. The usual approach to studying adverse drug reactions has been the collection of spontaneous reports of drug-related morbidity or mortality.

12. However, determining causation in case reports of adverse reactions can be problematic, as can attempts to compare the effects of drugs in the same class.

13. This has led academic investigators, industry, FDA, and the legal community to turn to the field of epidemiology.

14. Specifically, studies of adverse effects have been supplemented with studies of adverse events.

15. This marriage of the fields of clinical pharmacology and epidemiology has resulted in the development of a new field: pharmacoepidemiology.

16. Since pharmacoepidemiology is the study of the use of and effects of drugs in large numbers of people, it falls within epidemiology, as well. Epidemiology is also traditionally subdivided into two basic areas.

17. The pharmacoepidemiology field uses the techniques of chronic disease epidemiology to study the use of and the effects of drugs.

18. Although pharmacoepidemiology method application can be useful in performing the clinical trials of drugs which are performed prior to marketing, the major application of these principles is after drug marketing.

19. This has primarily been in the context of post-marketing drug surveillance, although in recent years the interests of pharmacoepidemiologists have broadened.

20. Thus, pharmacoepidemiology is a relatively new applied field, bridging between clinical pharmacology and epidemiology.

21. From clinical pharmacology, pharmacoepidemiology borrows its focus of inquiry. From epidemiology, pharmacoepidemiology borrows its methods of inquiry.

22. In other words, it applies the methods of epidemiology to the content area of clinical pharmacology.

23. In the process, multiple special logistical approaches have been developed and multiple special methodological issues have arisen.