Introduction to Pharmacoepidemiology, Maribel Salas - International ...

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Pharmacoepidemiology. Definition Discipline that study the frequency and distribution of health and disease as a result of the use and effects (beneficial and adverse) of drugs in human populations. Aims: Describe Explain Control Predict Uses and effects of drugs in a defined time, space and population Pharmacoepidemiology and Other Disciplines Pharmacology Medicine Cellular and Molecular Biology Biochemistry Clinical Epidemiology Physiology Pharmacogenetics and Microbiology Pharmacogenomics Epidemiology Clinical Pharmacology Pathology Genetics Immunology Toxicology Outcomes Research PHARMACOECONOMICS Social Sciences Economics Health Economics Psychology •Marketing •Policy Sociology Others PHARMACOEPIDEMIOLOGY Clinical Psychology Clinical Pharmacology & PE What are the differences between Clinical Pharmacology and Pharmacoepidemiology?
What Research Questions Are Answered by PE? What is the effect of “X” drug on “Y” outcome? What are the most common uses/adverse events of “X” drugs? How Why Where When do “X” drugs are used in “Z” population? STUDIES IN VITRO AND IN VIVO ANIMAL TESTING •SHORT TERM •LONG TERM Questions answered in this phase •Is the substance biologically active? •Is it safe? Phases of Drug Development PHASE I Who? Healthy volunteers, small number Why? Safety, biological effects, pharmacokinetics profile, dosage range, duration of action and drug interactions By Whom? Clinical Pharmacologists PHASE II Who? Selected patients (up to 300 patients) Why? Therapeutic efficacy, dose range, kinetics, metabolism By Whom? Clinical pharmacologists, clinical investigators PHASE III Who? Large sample of selected patients (500- 3000 patients) Why? Safety and efficacy By Whom? Clinical pharmacologists, clinical investigators and pharmacoepidemiologists PHASE IV Who? Patients given drug for therapy Why? Adverse reactionslabeling changes, patterns of drug utilization, additional indications discovered, pricing negotiations, marketing By Whom? Pharmacoepidemiologists and all physicians Areas: Pharmacovigilance Pharmacoeconomics 1-5 years (µ=2.6 yr) Preclinical 2-10 years (µ=5.6 yr) Variable Clinical Postmarketing Surveillance Kaitlin KI, et al. J Clin Pharmacol 1987;27:542-548; Young FE, et al. JAMA1988; 259:2267-2270 Why Is Postmarketing Surveillance Needed? Frequently RCT use placebo as comparators to establish the efficacy of a drug. Efficacy, toxicity and cost of new drugs usually are not compared with alternative agents. Effectiveness data are limited, if any.
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