- BS Pharmacy, University of Utrecht, Netherlands
- MS PH, University of Washington
- PharmD, University of Utrecht, Netherlands
- PhD, University of Minnesota
Health outcomes research with an emphasis on:
- Active Drug Safety Surveillance methods development
- Therapeutic risk management
- Program evaluation
Abraham G. Hartzema is Professor and Eminent Scholar at the University of Florida in the Department of Pharmaceutical Outcomes & Policy. He is the Perry A. Foote Chair in Health Outcomes Research, and Professor in Epidemiology and Biostatistics in the College of Public Health and the College of Medicine. In the year 2007, he was awarded the University of Florida Foundation Research award.
Dr. Hartzema has widely published on various aspects of prescription drug safety, including several books on Pharmacoepidemiology. His last book is entitled “Pharmacoepidemiology and Therapeutic Risk Management” was published by Harvey Whitney Book Publishers. Co-edited with Hugh Tilson (UNC-Chapel Hill) and Arnold Chan (Harvard University) the book reflects the new therapeutic risk management paradigm as implemented by the US FDA.
He has served on the scientific board of the FIP from 1988-1996; and on editorial boards, including Medical Care, Annals of Pharmacotherapy, Clinical Therapeutics, the International Journal of Pharmacy Practice, Pulmonary Circulation and others. In 2003 he was bestowed fellow status in the International Society on Pharmacoepidemiology. He has been the Chair of Data Safety and Monitoring Boards. He has also served on the University of Florida Graduate Council, and grant review panels for AHRQ, FDA, HealthCanada, DSEN, NASA, NIH, and NIHBL. He currently serves on the United States Pharmacopeia: Nomenclature, Safety and Labeling Expert Committee. He was recently appointed as Senior Advisor to the FDA, Center for Devices and Radiological Health.
Dr. Hartzema’s research funded by the Agency for Healthcare Research and Quality, NIH, the FDA, the Florida Office of Rural Health and several pharmaceutical companies. His theoretical interests are in data mining techniques, developing metrics for the benefit/risk ratio of drugs, methods development for active medical product safety surveillance, and bias calibration in observational methods.
Dr. Hartzema was on faculty leave (2008–2009) in the US Food and Drug Administration’s Immediate Office of the Commissioner working on the Congressional mandated Sentinel Initiative. He also served as a Principle Investigator on the Observational Medical Outcomes Partnership (OMOP), a public-private partnership between the US-FDA, the Foundation of the National Institute of Health and PhRMA. He is currently a participant in the research group Observational Health Data Sciences and Informatics (OHDSI) research program.
Stang P, Ryan P, Hartzema AG, Madigan D, Overhage JM, Welebob E, Reich CG, Scanecchia T. Development and Evaluation of Infrastructure and Analytic Methods for Systematic Drug Safety Surveillance: Lessons and Resources from the Observational Medical Outcomes Partnership. Chapter in Mann’s Pharmacovigilance 3rd edition edited by EB Andrews and N Moore 2013.
Madigan D, Stange PE, Berlin JA, Schuemie M, Overhage M, Suchard MA, Dumochel B, Hartzema AG, Ryan PB. A Systematic Statistical Approach to INtegrating INformation from Observational Studies. Annu. Rev. Sat. Appl. 2014. 1:x-x doi: 10.1146.
Rivera DR, Hartzema AG. Pediatric Exclusivity: Evolving Legislation and Novel Complexities within Pediatric Therapeutic Development. Ann Pharmacother. 2013 Dec. 5 [Epub ahead of print]
Hartzema AG, Chen C. Is fidaxomicin worth the cost? The verdict is still out! Clin Infect Dis. 2014 Feb; 58(4): 604-5. doi: 10.1093/cid/cit774. Epub 2013 Dec 2.
Reply to Simon, Shah, et al, and Hartzema and Chen. Bartsch SM, Umscheid CA, Fishman N, Lee BY. Clin Infect Dis. 2014 Feb;58(4):605-7.
Ryan PB, Schuemie M, Welebob E, Duke J, Valentine S, Hartzema AG. Defining a reference set to support methodological research in drug safety. Drug Safet 2013; 36: Issue 1 Supplement 33-47.
Hartzema AG, Reich C, Ryan PB, Stang P, Madigan D, Welebob E, Overhage JM. Managing Data Quality for a Drug Safety Surveillance System. 2013; 36 Issue1 Supplement 49-58.
Ryan PB, Stang PE, Overhage JM, Suchard MA, Hartzema AG, DuMouchel W, Reich C, Schuemi MJ, Madigan D. A comparison of the empirical performance of methods for a risk identification system. Drug Safety 2013; 36: Issue 1 Supplement 15-25.
Stang PE, Ryan PB, Overhage JM, Schuemie MJ, Hartzema AG, Welebob E. Variation in choice of study design: Findings from the Epidemiology Design Decision Inventory and Evaluation (EDDIE) Survey. Drug safety 2013; 36: Issue 1 Suplement 15-25.
Bird ST, Etminan M, Brophy JM, Hartzema AG, Delaney JA. CMAJ. Risk of acute kidney injury associated with the use of fluoroquinolones. 2013 Jun 3. PMID: 23734036
Madigan D, Ryan PB, Schuemie M, Stang PE, Overhage JM, Hartzema AG, Suchard MA, Dumouchel W, Berlin JA. Am J Epidemiol. Evaluating the Impact of Database Heterogeneity on Observational Study Results. 2013 May 5. PMID: 23648805
Bird ST, Brophy JM, Hartzema AG, Delaney JA, Etminan M. J Urol. Male breast cancer and 5-alpha reductase inhibitors, finasteride and dutasteride. 2013 May 9. doi:pii: S0022-5347(13)04325-5. 10.1016/j.juro.2013.04.132. PMID: 23665270
Bird ST, Delaney JA, Etminan M, Brophy JM, Hartzema AG. J Thromb Haemost. Drospirenone and non-fatal venous thromboembolism: Is there a risk difference by dosage of Ethinyl-Estradiol? 2013 Apr 11. doi: 10.1111/jth.12224. PMID: 23574590
Bird ST, Hartzema AG, Etminan M, Brophy JM, Delaney JA.Polycystic ovary syndrome and combined oral contraceptive use: a comparison of clinical practice in the United States to treatment guidelines. Gynecol Endocrinol. 2013 Apr;29(4):365-9. doi: 10.3109/09513590.2012.743007. Epub 2013 Jan 11. PMID: 23311996
Ryan PB, Madigan D, Stang PE, Marc Overhage J, Racoosin JA, Hartzema AG. Response to comment on empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observation Medical Outcomes Partnership. Stat Med. 2013 Mar 15;32(6):1075-7. doi: 10.1002/sim.5725. PMID: 23413214
Bird ST, Hartzema AG, Brophy JM, Etminan M, Delaney JA. Risk of venous thromboembolism in women with polycystic ovary syndrome: a population-based matched cohort analysis. CMAJ. 2013 Feb 5;185(2):E115-20. doi: 10.1503/cmaj.120677. Epub 2012 Dec 3. PMID: 23209115
Hartzema AG, Racoosin JA, MaCurdy TE, Gibbs JM, Kelman JA. Utilizing Medicare Claims Data for Real-Time Drug Safety Evaluations: Is it Feasible? Pharmacoepidemiology and Drug Safety 2011; 20:
Ryan P, Webelob E, Hartzema AG, Stang P, Overhage JM. Surveying Observational U.S. Data Sources and Characteristics for Drug Safety Needs. Pharmaceutical Medicine 24(4):231-238, 2010.
Stang PE, Ryan PB, Racoosin JA, Overhage JM, Hartzema AG, Reich C, Welebob E, Scarnecchia T, Woodcock J. Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153: 600-606.
Wen X, Meador KJ, DW Loring2 DW, Eisenschenk S, Segal R, PhD, Hartzema, AG. Is Antiepileptic Drug Use Related to Depression and Suicidality Among Patients with Epilepsy? Epilepsy Behav 2010 Sep 27, 2010.
Johnson M, Mills TL, Deleon JM, Hartzema AG, Haddad J. Lives in isolation: stories and struggles of low-income African American women with panic disorder. CNS Neurosci Ther. 2009 Fall;15(3):210-9.
Kauf TL, Coates TD, Huazhi L, Mody-Patel N, Hartzema AG. The cost of health care for children and adults with sickle cell disease. Am J Hematol. 2009 Jun;84(6):323-7.
LaVista JM, Treise DM, Dunbar LN, Ritho J, Hartzema AG, Lottenberg R. Development and evaluation of a patient empowerment video to promote hydroxyurea adoption in sickle cell disease. J Natl Med Assoc. 2009 Mar;101(3):251-7.
Dunbar LN, Coleman Brown L, Rivera DR, Hartzema AG, Lottenberg R. Transfusion practices in the management of sickle cell disease: a survey of Florida hematologists/oncologists. ISRN Hematol. 2012;2012:524513. doi: 10.5402/2012/524513. Epub 2012 Dec 12. PMID: 23316379
Ryan PB, Madigan D, Stang PE, Overhage JM, Racoosin JA, Hartzema AG. Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership. Stat Med. 2012 Dec 30;31(30):4401-15. doi: 10.1002/sim.5620. Epub 2012 Sep 27. PMID: 23015364