Pharmacoepidemiology

Pharmacoepidemiology

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  Pharmacoepidemiology Dr. P.NainaMohamed Pharmacologist
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  Introduction  Pharmacoepidemiologyis the study of the uses and effects of drugs in large numbers of people. Pharmacoepidemiology Pharmakon - Drug Epi – upon or among Demos – People or district Logos - Study  Pharmacovigilance is an area unique to pharmacoepidemiology and it is a type of continual monitoring of unwanted effects and other safety-related aspects of drugs.
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  Pharmacoepidemiological Research Pharmacoepidemiological studies focus on  Global trends in prescribing  Appropriateness of drug use  Medication adherence  Identification of predictors for medication use Lifestyle effects on drug therapy Special population (Elderly, Pediatric, etc.) drug therapy Drug Interactions  Predictable ADRs  Uncommon and unpredictable ADRs
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  Epidemiologic Study Designs  Case Reports: A case report describes the effects of the drug a single patient experiencing. Case reports are easy and cheap method for generating hypothesis about drug effects.  Case Series: Case series are collection of patients who had single exposure.  Case series are useful in quantifying the incidence of ADRs.  Analyses of secular trends (Ecological Studies): Analysis of data from a single region and examine how it changes over time. They are useful to provide rapid evidence for hypotheses.
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  Epidemiologic Study Designs  Case-control study:  These studies compare cases with disease to controls without disease.  Useful to study multiple possible causes of a single disease.  Useful to study uncommon diseases.  It is easier and faster to conduct Case-control study.  It is less expensive.  Cohort study:  Cohort studies identify subsets of a defined population and follow them over time, looking for differences in their outcome.  They are useful to compare exposed patients to unexposed patients.  Can study multiple outcomes.  Can study uncommon exposures.
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  Epidemiologic Study Designs  Randomized clinical trials (Experimental Studies): In randomized clinical trials, the investigator controls the therapy to be received by each participant. Most convincing design. Most expensive design. It is an artificial design. Logistically most difficult.
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  Reasons to perform Pharmacoepidemiology studies  Regulatory reasons: To obtain earlier approval for marketing  As a response to a question raised by regulatory agency To assist application for marketing elsewhere  Marketing reasons: To assist market penetration by documenting the safety of the drug To increase name recognition To assist repositioning the drug To protect the drug from accusations about adverse effects
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  Reasons to perform Pharmacoepidemiology studies  Legal reasons:  In anticipation of future product liability litigation  Clinical reasons: Hypothesis testing o Problem hypothesized based on the structure of the drug o Problem suspected on the basis of preclinical or premarketing human data o Problem suspected on the basis of spontaneous reports Hypothesis generating (for new chemical entity, etc.)
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  Users of Pharmacoepidemiology  Government agencies & Health care plans: Pharmacoepidemiology research is important for the government agencies like the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS) and Healthcare plans.  Pharmaceutical industries: The pharmaceutical industry want to understand how a drug is prescribed, used and what are all the positive and negative outcomes.  Practitioners: Pharmacoepidemiological studies can help Pharmacists, Physicians, Nurses and other Public health care practitioners to make informed decisions about treatment for patients.
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  Users of Pharmacoepidemiology  Academicians: Academicians often conduct pharmacoepidemiological studies to find answers to practice related questions.  Attorneys: Findings from pharmacoepidemiological studies can be used as evidence that a drug product did or didn’t cause an event.  Consumers and Patients: To learn about safety and effectiveness of drug products, patients and consumers rely on pharmacoepidemiological studies.
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  Role of Pharmacists& other Public Health Practitioners in Pharmacoepidemiology  Pharmacists are considered drug experts and naturally they play an important role in Pharmacoepidemiology.  A pharmacist may identify and report an adverse event to a hospital drug safety committee, Medwatch, or a pharmaceutical company.  Physicians and pharmacists have the highest rate of adverse event reporting among other health care practitioners.  Pharmacists and other health care practitioners may serve on Pharmacy Therapeutic Committee, Patient Safety Committees or other groups deciding health care plans.
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  References  Pharmacoepidemiology,5th Edition Brian L. Strom, Stephen E Kimmel, Sean Hennessy Understanding Pharmacoepidemiology Yi Yang, Donna West-Strum Pharmacoepidemiology Stanley A. Edlavitch http://www.pharmacoepi.org/about/about.cf m