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CDA 06-300 – HSR&D Study

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CDA 06-300
Building Evidence for Explicit Drug Therapy Monitoring Strategies
Brian C. Sauer PhD
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, UT
Funding Period: January 2008 - December 2012

BACKGROUND/RATIONALE:
Ineffective drug-therapy monitoring is a leading cause of adverse drug events (ADEs). Various drug-monitoring strategies have been developed through expert consensus. However, there is a lack of empirical evidence to guide monitoring decisions. The problem of scant evidence is compounded by the lack of established methods for comparing drug-monitoring strategies.

OBJECTIVE(S):
Aim 1: Examine serum-potassium monitoring practices in veterans who receive inhibitors of the renin-angiotensin-aldosterone system.
Aim 2: Assess the effect of adherence to recommended monitoring strategies on occurrence of severe- hyperkalemia.
Aim 3: Identify improved laboratory testing strategies for veterans who receive inhibitors of the renin-angiotensin-aldosterone system.

METHODS:
National VA DSS NDE data and vitals will be used to assess Aims 1 and 2. Simulation is being used to evaluate the causal inference analytic techniques.

FINDINGS/RESULTS:
Not yet available.

IMPACT:
Many drug therapies require safety monitoring. Little evidence exists to support guidance for risk specific monitoring recommendations. The findings from this study are expected to provide evidence for optimal monitoring of RAAS therapies. The approach developed for evaluating and optimizing RAAS therapies can be applied to develop evidence based monitoring strategies for other drug therapies. I plan to work with PBM VA MEDSafe and the OQP to disseminate our research findings and monitoring strategies.

We are developing methods to improve the transparency, reproducibility and credibility of VHA database research. The implications are huge for a learning healthcare system such as the VA.

PUBLICATIONS:

Journal Articles

  1. Sauer BC, Brookhart MA, Roy J, VanderWeele T. A review of covariate selection for non-experimental comparative effectiveness research. Pharmacoepidemiology and drug safety. 2013 Nov 1; 22(11):1139-45.
  2. Johnson EM, Lanier WA, Merrill RM, Crook J, Porucznik CA, Rolfs RT, Sauer B. Unintentional prescription opioid-related overdose deaths: description of decedents by next of kin or best contact, Utah, 2008-2009. Journal of general internal medicine. 2013 Apr 1; 28(4):522-9.
  3. Johnson ES, Bartman BA, Briesacher BA, Fleming NS, Gerhard T, Kornegay CJ, Nourjah P, Sauer B, Schumock GT, Sedrakyan A, Stürmer T, West SL, Schneeweiss S. The incident user design in comparative effectiveness research. Pharmacoepidemiology and drug safety. 2013 Jan 1; 22(1):1-6.
  4. Sauer BC, Hepler CD. Application of system-level root cause analysis for drug quality and safety problems: a case study. Research in social & administrative pharmacy : RSAP. 2013 Jan 1; 9(1):49-59.
  5. Nelson RE, Nebeker JR, Sauer BC, LaFleur J. Factors associated with screening or treatment initiation among male United States veterans at risk for osteoporosis fracture. Bone. 2012 Apr 1; 50(4):983-8.
  6. Hall GC, Sauer B, Bourke A, Brown JS, Reynolds MW, Casale RL. Guidelines for good database selection and use in pharmacoepidemiology research. Pharmacoepidemiology and drug safety. 2012 Jan 1; 21(1):1-10.
  7. Cannon GW, Mikuls TR, Hayden CL, Ying J, Curtis JR, Reimold AM, Caplan L, Kerr GS, Richards JS, Johnson DS, Sauer BC. Merging Veterans Affairs rheumatoid arthritis registry and pharmacy data to assess methotrexate adherence and disease activity in clinical practice. Arthritis care & research. 2011 Dec 1; 63(12):1680-90.
  8. LaFleur J, Nelson RE, Sauer BC, Nebeker JR. Overestimation of the effects of adherence on outcomes: a case study in healthy user bias and hypertension. Heart (British Cardiac Society). 2011 Nov 1; 97(22):1862-9.
  9. Porucznik CA, Johnson EM, Sauer B, Crook J, Rolfs RT. Studying adverse events related to prescription opioids: the Utah experience. Pain medicine (Malden, Mass.). 2011 Jun 1; 12 Suppl 2:S16-25.
  10. Sauer BC. Adult Use of Prescription Opioid Pain Medications—Utah, 2008. JAMA. 2010 Jan 1; 303(14):1359-1361.
  11. Rubin MA, Mayer J, Greene T, Sauer BC, Hota B, Trick W, Jernigan JA, Samore MH. An agent-based model for evaluating surveillance methods for catheter-related bloodstream infection. AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium. 2008 Nov 6; 631-5.
  12. Porucznik, Sauer, Sims, Rolfs. Non-Illicit Drug Poisoning Deaths in Utah 1999-2004: How are legitimate prescriptions involved? American journal of epidemiology. 2008 Jun 1; 167:S120.
  13. Rupper RW, Bair BD, Sauer BC, Nebeker JR, Shinogle J, Samore M. Out-of-pocket pharmacy expenditures for veterans under medicare part D. Medical care. 2007 Oct 1; 45(10 Supl 2):S77-80.
  14. Samore MH, Shen S, Greene T, Stoddard G, Sauer B, Shinogle J, Nebeker J, Harbarth S. A simulation-based evaluation of methods to estimate the impact of an adverse event on hospital length of stay. Medical care. 2007 Oct 1; 45(10 Supl 2):S108-15.
  15. Sauer BC, Hepler CD, Cherney B, Williamson J. Computerized indicators of potential drug-related emergency department and hospital admissions. The American journal of managed care. 2007 Jan 1; 13(1):29-35.
  16. Ried LD, Tueth MJ, Taylor MD, Sauer BC, Lopez LM, Pepine CJ. Depressive symptoms in coronary artery disease patients after hypertension treatment. The Annals of pharmacotherapy. 2006 Apr 1; 40(4):597-604.
  17. Smith WD, Winterstein AG, Johns T, Rosenberg E, Sauer BC. Causes of hyperglycemia and hypoglycemia in adult inpatients. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists. 2005 Apr 1; 62(7):714-9.
  18. Winterstein AG, Sauer BC, Hepler CD, Poole C. Preventable drug-related hospital admissions. The Annals of pharmacotherapy. 2002 Jul 1; 36(7-8):1238-48.
Journal Other

  1. Sauer BC. Physician specialty and opioid prescribing in the Utah controlled substance database, 2005-2009. [Abstract]. Pain medicine (Malden, Mass.). 2012 Feb 1.
  2. Cannon GW, Sauer BC, Hayden C, Reimold AM, Hooker R, Kerr GS, Richards JS, Caplan L, Johnson DS, Mikulus TR. Utilization of VA Pharmacy Benefits Management Data and the VA Rheumatoid Arthritis Database to Demonstrate Reduced Disease Activity in Rheumatoid Arthritis Patients Adherent with Methotrexate. [Abstract]. Arthritis + Rheuma.. 2009 Jan 1; 60(9):Supp.
Book Chapters

  1. Sauer BC, Vanderweele TJ. Supplement 2: The Use of Directed Acyclic Graphs on Non-experimental Comparative Effectiveness Research. In: Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, editors. Developing a Protocol for Observational Comparative Effectiveness Research: A Users Guide. Rockville, MD: Agency for HealthCare Research and Quality; 2013. Supplement 2. 1-5 p.
  2. Sauer BC, Brookhart MA, Roy JA, Vanderweele TJ. Covariate Selection. In: Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, editors. Developing a Protocol for Observational Comparative Effectiveness Research: A Users Guide. Rockville, MD: Agency for Healthcare Research and Quality; 2013. Chapter 7. 93-108 p.
  3. Sauer BC, VanderWeele T. Supplement 2 Use of Directed Acyclic Graphs. In: Dreyer N, Velentgas P, Nourjah P, Smith S, Torchia M, editors. Developing an Observational CER Protocol: A User’s Guide. Rockville, MD: Agency for Healthcare Research and Quality; 2013. S2. 177-183 p.
Center Products

  1. Sauer BC, He T, Nebeker JR. SAS® Tools for Transparent and Reproducible Research: Medication History Estimator. 2013 May 1; 2013(169).
Conference Presentations

  1. Rubin MA, Redd AM, Sauer BC. An automated electronic rule for predicting methicillin-resistant staphylococcus aureus (MRSA) carriage upon hospital admission at VA medical centers (VAMC) nationwide. Paper presented at: ID Week: A Joint Meeting of IDSA, SHEA, HIVMA, and PIDS; 2012 Oct 17; San Diego, CA.
  2. DuVall SL, Sauer BC. Using Advanced Healthcare Data Analytics to Identify and Characterize Central Venous Catheterization Episodes Via Electronic Health Records in the Veterans Affairs. Paper presented at: Pharmacoepidemiology and Therapeutic Risk Management Annual International Conference; 2012 Aug 25; Barcelona, Spain.
  3. Sauer BC. Transparent, Reproducible and Reusable Research in Pharmacoepidemiology. Paper presented at: Pharmacoepidemiology and Therapeutic Risk Management Annual International Conference; 2012 Aug 23; Barcelona, Spain.
  4. Sauer BC, DuVall SL. Development of a Modified RxRisk Score. Poster session presented at: International Society for Pharmacoeconomics and Outcomes Research Annual Meeting; 2012 Jun 4; Washington, DC.
  5. Porucznik, Sauer, Sims, Rolfs. Non-Illicit Drug Poisoning Deaths in Utah 1999-2004: How are legitimate prescriptions involved? Presented at: Society for Epidemiologic Research Annual Meeting; 2008 Jun 26; Chicago, IL.


DRA: Health Systems
DRE: Treatment - Observational
Keywords: none
MeSH Terms: none

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