Development and pilot testing of guidelines to monitor high-risk medications in the ambulatory setting

Am J Manag Care. 2010 Jul;16(7):489-96.


Objectives: To develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications among a multispecialty group practice.

Study design: Safety intervention trial.

Methods: We developed guidelines for the laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders used a 2-round Internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on a literature review and local interdisciplinary consensus. To estimate the potential effect of the planned intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008, and July 31, 2008.

Results: Consensus on medications to include in the guidelines was achieved in 2 rounds. Final guidelines included 35 drugs or drug classes and 61 laboratory tests. The prevalence of monitoring ranged from less than 50.0% to greater than 90.0%, with infrequently prescribed drugs having a lower prevalence of recommended testing (P <.001 for new dispensings and P <.01 for chronic dispensings, nonparametric test for trend). When more than 1 test was recommended for a selected medication, monitoring within a medication sometimes differed by greater than 50.0%.

Conclusions: Even among drugs for which there is general consensus that laboratory monitoring is important, the prevalence of monitoring is highly variable. Furthermore, infrequently prescribed medications are at higher risk for poor monitoring.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Ambulatory Care Facilities*
  • Drug Monitoring / methods*
  • Guidelines as Topic*
  • Humans
  • New England
  • Pharmaceutical Preparations* / classification
  • Pilot Projects
  • Safety Management / standards*


  • Pharmaceutical Preparations