Epoetin alfa drug use evaluation using a software system - Lessons learned

Objective: To assess the utility of using a computer software program to de termine whether epoetin alfa therapy drug use evaluation (DUE) criteria wer e met. Study design: Computer software was designed to allow pharmacists to enter patient data such as haematocrit results and iron stores into a database. D UE data were collected upon entry into the study (through medical record re view), at 6 months and at 12 months after enrollment for both the treatment and control groups (see Interventions section). The analyses of the 6- and 12-month DUE process and outcome criteria were conducted through an automa ted algorithm that was part of the software. The DUE evaluation was collect ed as part of a randomised, prospective, controlled study conducted at 32 s ites across the US. Interventions: At least 1 pharmacist at each study site completed a 4-day t raining session on end-stage renal disease and haemodialysis treatment, pri nciples of anaemia management, use of an epoetin alfa software program, and review of specific DUE criteria. The treatment group consisted of patients managed by a trained pharmacist working in collaboration with a nephrologi st being responsible for monitoring, evaluating and recommending epoetin al fa dosage regimens for patients. The control group consisted of patients fo r whom pharmacists monitored and collected haematocrit data but did not rec ommend therapy to the nephrologists. Main outcome measures and results! There were no statistically significant differences between patients in both the treatment and control groups with regard to the DUE results. However, the study demonstrated that computer da tabases can assist in determining whether specific DUE criteria have been m et at multiple patient care sites. The computer software applied the same c onsistent methodology across a broad range of hospital practice sites and t hus may have minimised investigator bias or site to site variations in crit eria application. Conclusions: Future DUE software algorithms should allow investigators/phar macists to adjust important parameters such as the criterion threshold, tim e period of monitoring, ability to code 'excused' gaps in data and flexibil ity to modify criterion parameters.