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Clinical Decision Making
Clinical Decision Making
Prescription drugs are prescribed during clinical encounters. Thorough and effective patient-provider communication about the benefits, risks, costs and alternatives to prescription medicines is a vital part of clinical care. The Center supports research and advocacy to identify and overcome barriers to patient-provider communication to improve safe medication use and to maximize adherence.
Comparative Effectiveness
Comparative Effectiveness
For stakeholders to make informed decisions about prescription drug use, they need timely evidence about the comparative effectiveness of therapies and their alternatives, including their risks and benefits. Incomplete evidence contributes to overuse of some therapies, underuse of others and risky prescribing. The Center supports innovative research into these topics.
Global Medicines
Global Medicines
Ensuring adequate access and affordability of prescription medicines poses major and unique challenges for countries around the world. These challenges are particularly salient in emerging economies that account for an increasing proportion of the world's population and pharmaceutical expenditures. Center investigators focus on how public policy can be optimized to maximize global drug availability and access.
Medication Safety
Medication Safety
Some adverse effects of medicines only come to light after medications have been on the market and widely used. Center investigators are working to develop new methods for identifying risk, to predict the likelihood of high-risk medicines or drug combinations and to protect the public from excessive exposure to these products.
Policy Analyses
Policy Analyses
Complex and dynamic policies govern prescription drug regulation. Policymakers face the challenge of maximizing innovation while protecting public health, and developing payment policies that promote evidence-based usage. Center investigators evaluate regulatory policies to provide policymakers with information to continually optimize pharmaceutical regulation.
Prescription Abuse
Prescription Abuse
Prescription drugs provide therapeutic value to millions of Americans. At the same time, rates of prescription drug abuse and overdose deaths are skyrocketing. The annual number of fatal drug overdoses in the United States now surpasses those of motor vehicle deaths. The Center supports innovative research and public advocacy to help stem this epidemic.

CDSE Publications

Our core faculty and staff work diligently to generate high quality and innovative research. Here are some select examples of recent publications, which demonstrate the bredth of projects the Center for Drug Safety and Effectiveness supports. 

  1. Greene, JA, Anderson G, Sharfstein JM. "Role of the FDA in Affordability of Off-Patent Pharmaceuticals." JAMA (2016): 1-2. 
     
  2. Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med.2016;176(2): doi:10.1001/jamainternmed.2015.7193.
     
  3. Sharfstein JM, Pstay BM. Evolution of the Cardiovascular Risk of Naltrexone-Bupropion: A Study Interrupted. JAMA. 2016;315:984-6. doi: 10.1001/jama.2016.1461
     
  4. Green AR, Leff B, Wang Y, Spatz ES, Masoudi FA, Peterson PN, Daugherty SL, Matlock DD. Geriatric Conditions in Patients Undergoing Defibrillator Implantation for Prevention of Sudden Cardiac Death: Prevalence and Impact on Mortality. Circ Cardiovasc Qual Outcomes. 2016 Jan;9(1):23-30. 
     
  5. Hendrix CW, Andrade A, Bumpus NN, Kashuba AD, Marzinke M, Moore A, Anderson PL, Bushman LR, Fuchs E, Wiggins I, Radebaugh C, Prince HA, Bakshi R, Wang R, Richardson P, Shieh E, McKinstry L, Li X, Donnell D. Elharrar V, Mayer K, Patterson KB. Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine after Directly Observed Dosing in Healthy Volunteers to establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retrovir 2016 Jan 32(1):32-43. PMC4692123
     
  6. Sharfstein JM, Charo A. The Promotion of Medical Products in the 21st Century: Off-label Marketing and First Amendment Concerns. JAMA. 2015;314:1795-6. doi: 10.1001/jama.2015.12045
     
  7. Rutkow L, Chang HY, Daubresse M, Webster DW, Stuart EA, Alexander GC. Effect of Florida’s Prescription Drug Monitoring Program and pill mill laws on opioid prescribing and use. JAMA Internal Medicine. 2015;175(10):1642-1649. 
     
  8. Fuchs EJ, Schwartz J, Memon MA, Bakshi RP, Coleman J, Hendrix CW. A Pilot Study to Measure the Distribution and Permeability of a Vaginal HIV Microbicide Gel Vehicle using MRI, SPECT/CT, and Radiolabeled Small Molecule. AIDS Res Hum Retrovir 2015 November 31(11):1109-1115. PMC4651045
     
  9. Li, P., Stuart, E.A, and Allison, D.B.. (2015). Multiple imputation: A flexible tool for handling missing data. Journal of the American Medical Association 314(18): 1966-1967. NIHMS ID: 731701.
     
  10. Chang HY, Zhou M, Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: Population based retrospective cohort study. BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1585 (Published 24 April 2015)
     
  11. Webb-Vargas, Y., Rudolph, K.E., Lenis, D., Murakami, P., and Stuart, E.A. (2015). An imputation-based solution to using mismeasured covariates in propensity score analysis.  Forthcoming in Statistical Methods in Medical Research.  Published online June 3, 2015. PMCID: In progress.  
     
  12. Greene JA, Watkins ES. The vernacular of risk – rethinking direct-to-consumer advertising of pharmaceuticals. NEJM. 2015;373(12):1087-1089. 
     
  13. Green AR, Boyd CM, Rickard J, Gomon R, Leff B. Attitudes of older adults with serious competing health risks toward their implantable cardioverter-defibrillators: A pilot study. BMC Geriatr. 2015 Dec 23;15(1):173. 
     
  14. Leyva F, Fuchs EJ, Bakshi R, Carballo-Dieguez A, Ventuneac A, Yue C, Caffo B, Du Y, Torbenson M, Li L, Mullin G, Lee L, Rohan L, Anton PA, Hendrix CW. Simultaneous evaluation of safety, acceptability, peri-coital kinetics, and ex vivo pharmacodynamics comparing four rectal microbicide vehicle candidates. AIDS Res Hum Retrovir 2015 November 31(11):1089-1097. PMC4651043
     
  15. Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015;314:233-4. doi: 10.1001/jama.2015.7151. 
     
  16. Kanavos P, Ferrario A, Vandoros A, Anderson GF. "Higher US branded drug prices and spending compared to other countries may stem partly from quick uptake of new drugs." Health Affairs 32.4 (2013): 753-761.
     
  17. Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. New England Journal of Medicine. 2015;372:1171-1175. 
     
  18. Rutkow L, Turner L, Lucas E, Hwang C, Alexander GC. Most primary care physicians are aware of prescription drug monitoring programs, but many find the data difficult to access. Health Affairs. 2015;34:484-492. 
     
  19. Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee D-G, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis a randomized trial. Annals of Internal Medicine 2015;162:81-89. 
     
  20. Chang H-YDaubresse MKruszewski SPAlexander GC. Prevalence and treatment of pain in EDs in the United States, 2000 to 2010.American Journal of Emergency Medicine. 2014;32:421-431. 
     
  21. Chen L-Y, Strain EC, Alexandre PK, Alexander GCMojtabai R, Martins SS. Correlates of nonmedical use of stimulants and methamphetamine use in a national sample. Addictive Behaviors 2014; 39: 829-836. 
     
  22.  Daubresse M, Gleason PP, Peng Y, Shah ND, Ritter ST, Alexander GC. Impact of a drug utilization review program on high-risk use of prescription controlled substances. Pharmacoepidemiology and Drug Safety 2014;23:419-427.
     
  23. Baxi SM, Greenblatt RM, Bacchetti P, Scherzer R, Minkoff H, Huang Y, Anastos K, Cohen M, Gange SJ, Young M Shlipak MG, Gandhi M. Common clinical conditions-age, low BMI, ritonavir use, mild renal impairment-affect tenofovir pharmacokinetics in a large cohort of HIV-infected women. AIDS. 2014;28:59-66.
     
  24. He D, Mathews SC, Kalloo AN, Hutfless S. Mining high-dimensional administrative claims data to predict early hospital readmissions. Journal of the American Medical Informatics Association. 2014;21:272-279.
     
  25. Cranston RD, Hoesley C, Carballo-Diéguez A, Hendrix CW, Husnik M, Levy  L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures. AIDS Research and Human Retroviruses. 2014;30:184-189.
     
  26. Akshintala VS, Hutfless SM, Colantuoni E, Kim KJ, Khashab MA, Li T, Elmunzer BJ, Puhan MA, Sinha A, Kamal A, Lennon AM, Okolo PI, Palakurthy MK, Kalloo AN, Singh VK. Systematic review with network meta-analysis: Pharmacological prophylaxis against post-ERCP pancreatitis. Alimentary Pharmacology and Therapeutics. 2014;38:1325-1337.
     
  27. Cobb LK, McAdams-Demarco MA, Huxley RR, Woodward M, Koton S, Coresh J, Anderson CAM. The association of spousal smoking status with the ability to quit smoking: The atherosclerosis risk in communities study. American Journal of Epidemiology. 2014;179:1182-1187.  
     
  28. McAdams-Demarco MA, Grams ME, King E, Desai NM, Segev DL. Sequelae of early hospital readmission after kidney transplantation American Journal of Transplantation 2014;14;397-40.
     
  29. Maynard JW, McAdams-Demarco MA, Law A, Kao L, Gelber AC, Coresh J, Baer AN. Racial differences in gout incidence in a population-based cohort: Atherosclerosis risk in communities study American Journal of Epidemiology 2014;179:576-583 
     
  30. Mojtabai R, Olfson M. National trends in long-term use of antidepressant medications: Results from the US National Health and Nutrition Examination Survey. Journal of Clinical Psychiatry.2014;75:169-177.
     
  31. Takayanagi Y, Spira AP, Roth KB, Gallo JJ, Eaton WW, Mojtabai R. Accuracy of reports of lifetime mental and physical disorders: Results from the baltimore epidemiological catchment area study. JAMA Psychiatry.2014;71:273-280.
     
  32. Carras MC, Mojtabai R, Furr-Holden CD, Eaton W, Cullen BAM. Use of mobile phones, computers and internet among clients of an inner-city community psychiatric clinic. Journal of Psychiatric Practice. 2014;20;94-103.
     
  33. Nakimuli-Mpungu E, Wamala K, Okello J, Alderman S, Odokonyero R, Musisi S, Mojtabai R. Developing a culturally sensitive group support intervention for depression among HIV infected and non-infected Ugandan adults: A qualitative study. Journal of Affective Disorders. 2014;163:10-17.
     
  34. Achenbach CJ, Buchanan AL, Cole SR, Hou L, Mugavero MJ, Crane HM, Moore RD, Haubrich RH, Gopal S, Eron JJ, Hunt PW, Rodriguez B, Mayer K, Saag MS, Kitahata MM. HIV viremia and incidence of non-Hodgkin lymphoma in patients successfully treated with antiretroviral therapy Clinical Infectious Diseases 2014;58:1599-1606
     
  35. Laws MB, Lee Y, Rogers WH, Beach MC, Saha S, Korthuis PT, Sharp V, Cohn J, Moore R, Wilson IB. Provider-Patient Communication About Adherence to Anti-retroviral Regimens Differs by Patient Race and Ethnicity. AIDS and Behavior. 2014. [Epub ahead of print]
     
  36. Shin DW, Cho J, Roter DL, Kim SY, Park JH, Cho B, Eom H-S, Chung J-S, Yang H-K, Park J-H. Attitudinal concordance toward uptake and disclosure of genetic testing for cancer susceptibility in patient-family member dyads Clinical Genetic 2014 [Epub ahead of Print]
     
  37. Guan Y, Roter DL, Huang A, Erby LAH, Chien Y-H, Hwu W-L. Parental discussion of G6PD deficiency and child health: Implications for clinical practice Archives of Disease in Childhood 2014;99:251-255.
     
  38. Cai L, Wu Y, Wilson RF, Segal JB, Kim,MT, Wang Y. Effect of childhood obesity prevention programs on blood pressure: A systematic review and meta-analysis Circulation 2014;129:1832-1839.
     
  39. Romanelli RJ, Wu FM, Gamba R, Mojtabai RSegal JB. Behavioral therapy and serotonin reuptake inhibitor pharmacotherapy in the treatment of obsessive-compulsive disorder: A systematic review and meta-analysis of head-to-head randomized controlled trials Depression and Anxiety 2014[Epub ahead of print]
     
  40. Schmittdiel JA, Adams SR, Segal J, Griffin MR, Roumie CL, Ohnsorg K, Grant RW, O'Connor  PJ. Novel use and utility of integrated electronic health records to assess rates of prediabetes recognition and treatment: Brief report from an integrated electronic health records pilot study Diabetes Care 2014;37:565-568
     
  41. Seal BS, Sullivan SD, Ramsey SD, Shermock KM, Ren J, Kreilick C, Boklage S, Valluri S, Sarma S, Asche CV. Systemic therapy for colorectal cancer: Patterns of chemotherapy and biologic therapy use in nationally representative US claims database. BioDrugs. 2014;28: 229-236.
     
  42. Lee GP, Stuart EA, Ialongo NS, Martins SS. Parental monitoring trajectories and gambling among a longitudinal cohort of urban youth. Addiction. 2014;109:977-985. 
     
  43. Varadhan R, Yao W, Matteini A, Beamer BA, Xue Q-L, Yang H, Manwani B, Reiner A, Jenny N, Parekh N, Fallin M, Newman A, Bandeen-Roche K, Tracy R, Ferrucci L, Walston J. Simple biologically informed inflammatory index of two serum cytokines predicts 10 year all-cause mortality in older adults. Journals of Gerontology. 2014;69:165-173.
     
  44. Weiss CO, Varadhan R, Puhan MA, Vickers A, Bandeen-Roche K, Boyd CM, Kent DM. Multimorbidity and evidence generation. Journal of General Internal Medicine. 2014;29:653-660.

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