Pharmacoepidemiology and Safety Services
Pharmacoepidemiology and Safety Sciences focuses on the use of epidemiological methods in the study of uses and effects of drugs in human populations. This specialization concentrates on assessment of drug utilization, understanding of potential risks and benefits of drugs after their approval, and evaluation of the quality of medication use and medication use systems.
This specialization provides students with the knowledge and skills set to conceive, design, and conduct studies related to pharmacoepidemiology and drug safety. It offers a strong methodological focus on the application of observational research methods in phase IV studies and other related applications of translational clinical sciences.
Scientific expertise in Pharmacoepidemiology and Safety Sciences includes:
- Content knowledge related to drug safety, pharmacovigilance, comparative effectiveness, drug utilization, risk management, and quality assessment and improvement of medication use.
- Technical expertise in epidemiologic methods, measurement issues specific to drugs, clinical services, diagnosis and associated determinants, and statistical analysis of large healthcare datasets.
For further information about Pharmacoepidemiology and Safety Sciences, please visit the following sites:
What can students do when they have the degree (careers)?
MS Degree – Pharmacoepidemiology and Safety Sciences
An MS degree, with a concentration in pharmacoepidemiology, provides individuals with the credentials to serve as an entry- or mid-level research associates in contract research organizations, academic and clinical research units, pharmaceutical companies, and government organizations. Typically, these individuals work under limited direction as part of a multi-disciplinary research group. Examples of such positions include research associates, program managers, and health scientists.
For individuals with a clinical background who oscillate between a more research-oriented or clinical specialization (e.g., residency), the MS degree offers the opportunity to explore a research career while maintaining clinical involvement.
Ph.D. Degree – Pharmacoepidemiology and Safety Sciences
A Ph.D. degree, with a concentration in Pharmacoepidemiology and Safety Sciences, provides individuals with the credentials to develop and direct clinical research units in universities, pharmaceutical companies and contract research organizations, and government organizations. Successful graduates have a range of technical and disciplinary competencies in research design, measurement, inferential statistics, the communication of research results, the evaluation of research, research ethics, healthcare delivery and the medication use system, the drug product, and behavioral issues surrounding medication use. Specialization in Pharmacoepidemiology and Safety Sciences enables individuals to conduct and evaluate phase IV (e.g., drug safety or comparative effectiveness) and drug utilization studies, develop pharmacovigilance programs and participate in regulatory and public policy initiatives that affect the use of medications in society.
What prerequisites do I need to have? (student profiles)
Individuals interested in pursuing a specialization in Pharmacoepidemiology and Safety Sciences include:
- Practicing clinicians with a desire to conduct pharmacoepidemiological research or develop a research program in patient safety.
- Individuals working in research settings (e.g., academic, pharmaceutical, or government organizations dealing with drug evaluations or quality improvement/assessment) who wish to formalize and extend their training to advance their careers in these settings;
- Recent graduates in the health sciences who desire a research career;
- Individuals with previous training in epidemiology or related research methods who would like to advance and focus their training on pharmaceutical research.
Applicants with a non-clinical but strong methodological background such as formal training in epidemiology may wish to pursue this degree to specialize in the evaluation of pharmaceuticals.
How does training at UF look like? (curriculum)
Graduate training in Pharmacoepidemiology includes two cores: didactic course work and independent research experience. Students are expected to join a research team during their first year of study and get involved in the design and conduct of Pharmacoepidemiologic and drug safety studies. Typically, students will start their first independent research project in the second half of their first year of study. Students have access to SAS online learning modules, and many complete their SAS Certification during their training at UF.
What ongoing research is at UF in this area? (ongoing research and publications)
Pediatric Pharmacoepidemiology (Almut Winterstein)
The pediatric infectious disease pharmacoepidemiology research program includes a variety of treatment indications, primarily in upper and lower respiratory disease. Ongoing studies include the prophylaxis of respiratory syncytial virus infections, treatment of NTM infections in cystic fibrosis, treatment of otitis media and antibiotic safety issues related to ototoxicity.
This program is centered on children and adults eligible for Medicaid benefits, which covers close to 50% of all youth in the United States. Healthcare utilization data is extracted from more than 50 million individuals, from 29 US states, from the Centers for Medicaid and Medicare Services (CMS) Medicaid Extract Files (MAX). MAX is linked in part to vital statistics birth and death certificates, and disease specific registry data. The program is funded through grants from CMS and AHCA. For examples publications in pediatric infectious disease Pharmacoepidemiology, please see here.
Geriatric Pharmacoepidemiology (Josh Brown & Jenny Wei)
The geriatric pharmacoepidemiology research program has centered on safety, effectiveness, and quality of medication use in elderly patients with chronic conditions. Ongoing studies include quality of pain treatment in Alzheimer’s disease, high-risk use of prescription opioids in Medicare population, and the long-term benefits of randomized controlled trials (RCTs) focusing on benefits of physical activity interventions.
This program is centered on older adults eligible for Medicare benefits in the United States, with a great emphasis on individuals living in nursing homes and older adults with physical mobility disorders. Healthcare and prescription utilization data are extracted from more than 2.9 million individuals per year from the Centers for Medicaid and Medicare Services (CMS) and 8-10 million individuals with commercial insurance in the Truven Health Analytics database. Medicare data are linked in part to federal Nursing Home Minimum Data Set, death certificates, national survey data, and RCT data. The program is funded by grants from NIH/NIA. For examples publications in Geriatric Pharmacoepidemiology, please see here (Josh Brown & Jenny Wei)
Psychiatric Pharmacoepidemiology (Rene Soria-Saucedo, Almut Winterstein, & Jenny Wei)
The psychiatric disease pharmacoepidemiology research program has centered on comparative studies (psychotropics’ safety and effectiveness), and medication utilization (prescription patterns and issues around overuse, underuse, and misuse) and medication therapy outcomes (hospitalizations, adherence). Ongoing studies include the comparative safety and effectiveness of treatments for attention-deficit/hyperactivity disorder, the epidemiology of psychotropic polypharmacy in adults and adolescents, inappropriate psychotropic use in older adults, and measurement of residual confounding in psychotropic adherence.
The program is focused on older adults for Medicare benefits, as well as children and adults eligible for Medicaid benefits using state and national healthcare utilization data (a 5% Medicare sample and Medicaid Extract Files (MAX) from CMS). MAX data are linked in part to vital statistics birth and death certificates and driving performance data from the Florida Division of Motor Vehicles. The Medicare data are linked to Nursing Home Minimum Data Set and national survey data. The program is funded by AHRQ, AHCA, and NIH/NIA. For examples of publications in psychotropic Pharmacoepidemiology, please see here
Spatial pharmacoepidemiology (Hong Xiao, Rene Soria-Saucedo)
It focuses on the description and analysis of geographic variations in utilization of health services and disease outcomes affected by social determinants of health in addition to genetic or biological risk factors. In other word, we investigate whether geography serves as an effect modifier in health outcomes.
Disease states studied include cancers (breast, prostate, oral and oropharyngeal). Florida Cancer Data System (state cancer registry data) has been the major data source. Variations in access to care due to race and geography have been investigated in relation to health outcomes. Also, variations of quality of care indicators (e.g. star ratings) between hospitals and geographic areas. Ongoing work aims to examine geographic variations in pharmacotherapy (i.e. opioids, psychotropics) use and outcomes, as well as use of immune checkpoint inhibitors in cancer patients and outcomes. For examples of publications in Spatial Pharmacoepidemiology, please see here.
Pharmaceutical Predictive Analytics (Almut Winterstein, Rene Soria-Saucedo)
It focuses on combining technology and statistics to search massive amounts of information and reveal behavioral trends, identify “at high-risk” patients accurately, and enhance personalized medicine. This information not only has the power to increase patient satisfaction and quality-of-life outcomes, but also being strategic on curbing costs and reduce overall need for acute and costlier health interventions.
The program is currently focused on two main projects using electronic medical records: a) the development of a complexity score that identifies hospitalized patients “at high risk” for preventable adverse events. This project allows ranking a predicted score amenable to pharmacist intervention. The predictive score for hypoglycemia is already fully operational in Shands; b) a predicting algorithm to identify patients “at risk” of being readmitted to psychiatric inpatient facilities. For examples of publications in predictive analytics, please see here
Are there other resources where I can read about this area? (other resources)
- International Society for Pharmacoepidemiology (ISPE)
- FDA’s Center for Drug Evaluation and Research (CDER)
- European Network for Centres for Pharmacoepidemiology and Pharmacovigilance (http://www.encepp.eu/)
Pharmacoepidemiology at UF