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Views Total views. Actions Shares. Embeds 0 No embeds. No notes for slide. Pharmacoepidemiology 1. Textbook of Pharmacoepidemiology. Study designs available for PE studies 4. Reasons to perform these studies 5. Sources of PE data 6. Molecular Pharmacoepidemiology 7. Bioethical issues 8. Pharmionics 9. Special applications of PE Analysis of secular trends and case-control studies- useful to explore these associations If study question warrants investment and can tolerate the delay until results become available, then cohort studies and RCTs - can be used to assess these associations more definitively.
Thus, the decision to conduct a PE study can be viewed as similar to the regulatory decision about whether to approve a drug for marketing or the clinical decision about whether to prescribe a drug. Global Drug surveillance Case- control surveillance Prescription event monitoring Automated databases A spontaneous report is a clinical observation that originates outside of a formal study.
Voluntary reporting by health care professionals or consumers Mandatory reportingof AEs by manufacturers as required by law and regulation. Restricted use or distribution of the drug Name or packaging changes In addition, there were published reports in literature.
Drugs previously available on prescription being approved for OTC sales In CCS, multiple case-control studies are conducted simultaneously in order to monitor the effects of prescription and OTC medications and dietary supplements e. CCS relies on self-reports of medication and dietary supplement use Potentially important confounders Over-the-counter drugs As CCS obtains data on many exposures and many outcomes, it has capacity to discover unsuspected associations.
Allows for assessment of whether genetic polymorphisms modify the effect of a medication or supplement on the risk of the illness. It is one form of pharmacovigilance and is complementary to spontaneous reporting of suspected ADRs Disease incidence data Ad hoc case-control studies Registry data Pharmacy based postmarketing surveillance studies Molecular PE- focuses on effects of genetics on clinical outcomes from medication use Evaluating how these SNPs alter disease outcomes Assessing impact of gene-drug and gene-gene interactions on disease risk Cost-effectiveness of such approaches must be justifiable given the additional costs of genetic testing in clinical care Ethical, legal and social implications of genetic testing must be considered and addressed Idiosyncratic side effects in susceptible patients based on genotyping eg.
Carriers of HLA B in use of abacavir….. Cost of drugs is not limited to their purchase price Includes the cost of preparation, administration, monitoring for and treating side effects,etc… In addition to differences in efficacy and safety, differences in efficiency or effectiveness of the agent in actual clinical practice compared to its cost distinguish drugs from one another.
Economic data from Phase III studies are used to support initial pricing of new therapies and are used in professional educational activities by pharmaceutical firms Post marketing economic studies are used to compare new therapies with existing ones and also to confirm the initial Phase III economic assessments of the product. HRQOL has become an established outcome measure in clinical research Or in some cases, they may procure it but may take none or only a few doses. Patient may commence taking the medicine but, execute the prescribed dose regimen poorly Essence of eMEM is to imbed into the drug package microcircuitry that is connected to one or more micro-switches which detect when the maneuvers occur that are needed to remove a dose of drug from the package Microcircuitry enters the time of occurrence of each medication event and stores the information in its memory for later transfer to the computer which analyses the data.
To omit a single dose Miss two sequential doses, miss 3 sequential doses, so on… Pharmaceutical product developers can use such natural experiment early in drug development, before recommended dosing regimen and pricing has been set. This can avoid the adverse economic consequences of postmarketing , post pricing reduction in actually used doses.
Early discontinuation of medications- Halts the drug action, and thus the beneficial effects that the drug may have induced up to the point of discontinuation Wastes whatever costs were incurred in tests and other maneuvers to prepare the patient to start taking the drug in question.
Evaluating and improving physician prescribing Drug Utilization Review Special methodologic issues in PE studies of Vaccine Study PE studies of Devices Studies of Drug-induced birth defects
Pharmacoepidemiology, 4th Edition