Drug–Drug Interactions: Communicating Post-market Drug Safety Information in the USA

Chapter

Abstract

It has been more than a decade since the withdrawal of a number of drugs from the market as a result of serious adverse events from drug–drug interactions (DDI). Since then, additional research has led to a much better understanding of the mechanisms behind many of these interactions. These advances have made DDI one of the best understood causes of observed adverse drug events. However, to reap the full benefit of all this research, much more could be done to translate this information into a form more useful in clinical care settings. Health-care providers rely on two principal sources – FDA approved product information (i.e., drug product label) and drug interaction databases – to help them prescribe medications safely. Greater standardization of definitions, classifications, and severity assessments of drug interactions would help prescribers to better understand the clinical significance of a particular DDI. Achieving greater standardization will require the continued input and coordination of efforts of important stake holders such as academic scientists, industry, and regulators.

Keywords

Fatigue Stake Clarification 

References

  1. Abarca J, Malone DC, Armstrong EP, Grizzle AJ, Hansten PD, Van Bergen RC, and Lipton RB (2004) Concordance of severity ratings provided in four drug interaction compendia. J Am Pharm Assoc (2003) 44:136–141.CrossRefGoogle Scholar
  2. Aspden P, Wolcott J, Bootman JL, Cronenwett LR, and Committee on Identifying and Preventing Medication Errors (2006) Preventing Medication Errors: Quality Chasm Series. National Academies Press, Washington, DC.Google Scholar
  3. Bigelow JH, Fonkych K, Fung C, and Wang J (2005) Analysis of Healthcare Interventions that Change Patient Trajectories. RAND Health, RAND Corporation, Santa Monica, CA.Google Scholar
  4. Chao SD and Maibach HI (2005) Lack of drug interaction conformity in commonly used drug compendia for selected at-risk dermatologic drugs. Am J Clin Dermatol 6:105–111.CrossRefPubMedGoogle Scholar
  5. Chui MA and Rupp MT (2000) Evaluation of online prospective DUR (drug utilization review) programs in community pharmacy practice. J Manag Care Pharm 6:27–32.Google Scholar
  6. Drazen JM, Rainey J, Begg H, Stith Butler A, and Rapporteurs (2007) Forum on drug discovery, development, and translation, Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary IOM of the National Academies. National Academies Press, Washington, DC.Google Scholar
  7. Ferner RE and Aronson JK (2007) Communicating drug safety. IOM report on adverse drug events. Br Med J 333:143–145.CrossRefGoogle Scholar
  8. Hansten PD and Horn JR (2001) Drug Interactions: Analysis and Management. Facts and Comparisons, St. Louis, MO.Google Scholar
  9. Hillestad R, Bigelow J, Bower A, Girosi F, Meili R, Scoville R, and Taylor R (2005) Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood) 24:1103–1117.CrossRefGoogle Scholar
  10. Mangini RJ (2001) Drug Interaction Facts. Facts and Comparisons, St. Louis, MO.Google Scholar
  11. Moore LL, Minne K, and Moore KB (2001) DRUG-REAX System http:\\http://www.micromedex.com/products/drugreax/
  12. Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M, Chan KA, Platt R, Schech SD, and Ray WA (2000) Contraindicated use of cisapride. The impact of FDA regulatory action. J Am Med Assoc 284:3036–3039.CrossRefGoogle Scholar
  13. Spina JR, Glassman PA, Belperio P, Cader R, Asch S. (2005) Clinical relevance of automated drug alerts from the perspective of medical providers. American Journal of Medical Quality 20(1): 7–14.CrossRefPubMedGoogle Scholar
  14. Terhune C, Epstein K, and Arnst C (2009) The Dubious Promise of Digital Medicine. Business Week, April 23.Google Scholar
  15. Vitry AI (2007) Comparative assessment of four drug interaction compendia. Br J Clin Pharmacol 63:709–714.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.Novartis Pharmaceuticals Corporation (SM)East HanoverUSA
  2. 2.Department of Clinical PharmacologyGlobal Alliance for TB Drug DevelopmentNew YorkUSA

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