Research in this broad area involves better understanding and improving the safe use of medications and ensuring pharmacies and clinicians serve a prominent role in the development and implementation of policies aimed at improving public health and reducing health disparities. One past project involves an evaluation of the drug safety program implemented by the Food and Drug Administration (FDA), also called Risk Evaluation and Mitigation Strategy (REMS), which require manufacturers to develop REMS to ensure benefits of a drug/biologic product outweighs its risks.
Select Publications:
Guadamuz, J. S., Qato, D. M., & Alexander, G. C. (2020). Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019. JAMA, 324(3), 299-301.
Qato, D. M., Alexander, G. C., Guadamuz, J. S., & Lindau, S. T. (2018). Prevalence of dietary supplement use in US children and adolescents, 2003-2014. JAMA Pediatrics, 172(8), 780-782.
Daubresse, M., Hutfless, S., Kim, Y., Kornfield, R., Qato, D. M., Huang, J., … & Alexander, G. C. (2015). Effect of direct-to-consumer advertising on asthma medication sales and healthcare use. American Journal of Respiratory and Critical Care Medicine, 192(1), 40-46.
Kornfield, R., Alexander, G. C., Qato, D. M., Kim, Y., Hirsch, J. D., & Emery, S. L. (2015). Trends in exposure to televised prescription drug advertising, 2003–2011. American Journal of Preventive Medicine, 48(5), 575-579.
McConeghy, K. W., Bress, A., Qato, D. M., Wing, C., & Nutescu, E. A. (2014). Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 34(6), 561-569.
Qato, D. M., & Alexander, G. C. (2012). Just Because It’s Low Cost Doesn’t Mean It’s Accessible. Journal of General Internal Medicine, 27(10), 1233-1234.
Qato, D. M., & Alexander, G. C. (2011). Improving the Food and Drug Administration’s mandate to ensure postmarketing drug safety. JAMA, 306(14), 1595-1596.
Qato, D. M., Lindau, S. T., Conti, R. M., Schumm, L. P., & Alexander, G. C. (2010). Racial and ethnic disparities in cardiovascular medication use among older adults in the United States. Pharmacoepidemiology and Drug Safety, 19(8), 834-842.
Policy Impact:
HHS-OCR-0945-AA00: 45 C.F.R. § 160 & 164
Proposed Modifications to the HIPAA Privacy Rule To Support, and Remove Barriers to, Coordinated Care and Individual Engagement: HHS is issuing this Notice of Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications address standards that may impede the transition to value-based health care by limiting or discouraging care coordination and case management communications among individuals and covered entities (including hospitals, physicians, and other health care providers, payors, and insurers) or posing other unnecessary burdens. The proposals in this NPRM address these burdens while continuing to protect the privacy and security of individuals’ protected health information. Read the proposed rule in its entirety here.
CMS-4180-P
Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses: U.S Senators serving on the Committee on Finance urges the Department of Health and Human Services (HHS) to reform direct and indirect remuneration (DIR) with respect to pharmacy DIR reforms included in CMS-4180-P. These reforms will provide needed financial relief to pharmacies and beneficiaries. Read the proposed rule in its entirety here.