Pharmacoepidemiology

Pharmacoepidemiology is a subspeciality of epidemiology involving the evaluation of drug/pharmaceutical safety and benefits among large populations. Although pharmacoepidemiology has traditionally focused on the adverse effects of drugs, food/nutriceuticals, or medical devices, it can also be used to provide information on the beneficial effects of such agents as well. In addition to identifying adverse events, one of the key objectives of pharmacoepidemiology is to identify reasons that may explain the adverse events. These questions can include:

• Are the events dose related? 
• Does the pharmaceutical interact with other medications or substances to promote adverse events? 
• Are there high-risk subpopulations or pertinent lifestyle factors that can be identified as being related to the event? 
• Are drugs being used differently than originally intended?

Pharmacoepidemiologic studies provide "real world" assessments of potential short-term and long-term adverse drug events in the general population with a wide range of health status and demographic characteristics and with a much longer follow-up period than clinical trials, which evaluate initial drug efficacy and safety. Pharmacoepidemiology relies on the same study designs (cohort, case control, case-crossover, case-cohort studies), analytical methods, and statistical modeling as other branches of epidemiology. The field also offers unique challenges in controlling for confounding factors, addressing the limitations of health care databases, obtaining accurate assessment of drug exposure and use, and accounting for potential selection bias concerns.

Exponent’s staff of Ph.D. and Master’s level epidemiologists, statisticians, clinicians, and clinical toxicologists provide the expertise needed for the conduct and evaluation of pharmacoepidemiologic studies. Our health scientists have extensive experience in the following areas of epidemiology that are relevant to pharmacoepidemiology:

Exponent staff have provided pharmcoepidemiologic consulting services on numerous projects. Some examples include: 

• Cardiovascular risk among women using dietary supplements 
• Liver failure risks among users of anticonvulsants 
• Clinical and economic impacts on asthma and COPD of a new respiratory bronchodilator 
• Costs associated with complications after cataract surgery 
• Effectiveness of adding omega-3 supplements to diet 
• Projection of future needs, clinical trends, and economic impact for knee and hip replacement surgery 
• Assessment of potential patient population size for proposed orphan drug application and filing of Pediatric Investigation Plan 
• Epidemiologic evaluation of factors influencing patterns of care in chemotherapy treatment for common female cancers 
• Descriptive epidemiologic characterization of various childhood bone disorders for assessment of population in need of treatment for these rare childhood diseases 
• Epidemiologic characterizations of rare blood disorders in the general population

Our epidemiologists and statisticians have published extensively on methodological issues of epidemiologic research and on numerous health care, medical device, and pharmaceutical topics. We provide timely, multidisciplinary, comprehensive research expertise across all aspects of pharmacoepidemiology and pharmaceutical product safety evaluation.