Pharmacoepidemiology... Pharmacovigilan e

M pharm ppt

1. Pharmacoepidemiology Submitted By : Jamdade Sonali Lala. Submitted To: Prof. Bang Ma’am. M Pharm 1 st Year Pharmacology ( pharmacology department) Sudhakar Rao Naik institute of pharmacy pusad

2. introduction pharmacoepidemiology is the study of the uses and effects of drugs in large numbers of people pharmacoepidemiology often called PE may be defined as all fields in the medical science that act as as bridge that connects pharmacology and epidemiology to provide valuable information about the effectiveness of any drug against any special or rare disease, use as well as adverse effect of any drug entity, by simply performing the study over 500 to 3000 clinical patients/volunteers. the word pharmacoepidemiology is made up of two different terms i.e. pharmacology and epidemiology, where pharmacology in simple words defined as the study of drugs while epidemiology may be defined as the branch of medical science that deals with the study of causes, distribution, and prevention/control of any disease.

3. pharmacoepidemiology uses clinical epidemiology methods mainly to focus on the clinical patients to know the following: response of drug concerning duration. Effectiveness of any drug substance. Effect of genetic variation on the effects of the drug. Possible adverse drug reactions. drug interaction.

4. Scope of pharmacoepidemiology pharmacoepidemiology may be defined as a field where epidemiology methods are used to search and deal with one special of disease or illness that may have occurred because of ingestion, application, or administration of pharmaceuticals to humans. The PE finds a scope in the regulation of drugs, for example: pharmacoepidemiology identifies the market for any drug substance, as we know in PE we study disease and to cure disease we need drugs hence PE finds a scope in increasing the demand for drugs the pe finds scope in variation, renewal and reclassification of any drug substance. for example, PE evaluate the benefits of the drug and it also provides valuable information about the possible risks that can occur due to that drug, hence based on information the drug can be reclassified and the indication of the drug will be renewed.

5. Pharmacoepidemiologic 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, Paediatric, etc.) drug therapy >Drug Interactions Predictable ADRs Uncommon and unpredictable ADRs Epidemiologic Study Designs Case Reports: A case report describes the effects Of the drugs single patient experiencing. Case reports are an easy and cheap method for generating hypotheses about drug effects. Case Series: Case series are collections 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 for providing rapid evidence for hypotheses

6. case-control study: these studies compare cases with the 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 the 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. And can study multiple outcomes. can study uncommon exposures.

7. 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. at is an artificial design. a- ogistically most difficult 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 in repositioning the drug to protect the drug from accusations about adverse effect

8. legal reasons: in anticipation of future product liability litigation clinical reasons: hypothesis testing problem hypothesized based on the structure of the drug o problem suspected based on preclinical or premarketing human data o problem suspected based on spontaneous reports hypothesis-generating (for new chemical entity, etc.) Application of pharmacoepidemiology government agencies & health care plans: pharmacoepidemiology research is important for 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 wants to understand how a drug is prescribed and used and what are all the positive and negative outcomes.

9. practitioners: pharmacoepidemiologic studies can help pharmacists, physicians, nurses, and other public health care practitioners to make informed decisions about treatment for patients. academicians: academicians often conduct pharmacoepidemiologic studies to find answers to practice-related questions. attorneys: findings from pharmacoepidemiologic studies can be used as evidence that a drug product did or didn't cause an event. consumers and patients: to learn about the safety and effectiveness of drug products, patients and consumers rely on pharmacoepidemiologic studies

10. 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 healthcare practitioners pharmacists and other health care practitioners may serve on pharmacy therapeutic committees, patient safety committees, or other groups deciding health care plans.

11. references pharmacoepidemiology, 5th editio brian l. Strom, Stephen E. Kimmel, Sean Hennessy understanding pharmacoepidemiology yi yang, donna west-strum pharmacoepidemiology stanley a. Ravitch http ://www.pharmacoepi.org/about/about.cfm