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.