Development and validation of the PAIR (Pharmacotherapy Assessment in Chronic Renal Disease) criteria to assess medication safety and use issues in patients with CKD.

BACKGROUND: Explicit criteria for judging medication safety and use issues in patients with chronic kidney disease (CKD) are lacking. STUDY DESIGN: Quality improvement report. SETTING & PARTICIPANTS: Nephrologists (n = 4), primary care physicians (n = 2), hospital pharmacists with expertise in nephrology (n = 4), and community pharmacists (n = 2). The PAIR (Pharmacotherapy Assessment in Chronic Renal Disease) criteria were applied retrospectively to 90 patients with CKD in a randomized study. QUALITY IMPROVEMENT PLAN: Development of an explicit set of criteria to enable rapid and systematic detection of drug-related problems (DRPs). Using a RAND method, experts judged the clinical significance of DRPs and the appropriateness of a community pharmacist intervention. The PAIR criteria include 50 DRPs grouped into 6 categories. OUTCOMES: DRPs detected using the PAIR criteria compared with implicit clinical judgment by nephrology pharmacists. MEASUREMENTS: Prevalence of DRPs and reliability, validity, and responsiveness of the PAIR criteria. RESULTS: A mean of 2.5 DRPs/patient (95% CI, 2.0-3.1) was identified based on the PAIR criteria compared with 3.9 DRPs/patient (95% CI, 3.4-4.5) based on clinical judgment of nephrology pharmacists. Inter-rater reliability coefficients (κ) by PAIR category varied from 0.80-1.00, with an intraclass correlation coefficient (ICC) of 0.93 (95% CI, 0.89-0.95) for total DRPs per patient. Test-retest reliability coefficients by category varied from 0.74-1.00, with an ICC of 0.91 (95% CI, 0.82-0.96) for total DRPs per patient. During the study, the mean number of DRPs per patient did not change significantly when assessed using the PAIR criteria and clinical judgment. LIMITATION: The prevalence of PAIR DRPs may be underestimated due to the retrospective nature of the validation. CONCLUSION: The prevalence of DRPs requiring the intervention of community pharmacists is high in patients with CKD. The PAIR criteria are reliable, but their responsiveness remains to be shown.