Objective: We compared the effectiveness of antibiotic postprescription review and authorization (PPRA) determined by infectious disease (ID) clinical fellows with that of trained general pharmacists.
Methods: We conducted a noninferiority cluster-randomized controlled trial in 6 general medical wards at Siriraj Hospital in Bangkok, Thailand. Three wards were randomly assigned to the intervention (ie, the pharmacist PPRA group), and another 3 wards were assigned to the control (ie, the fellow PPRA group). We enrolled all patients in the study wards who received 1 or more doses of the targeted antibiotics: piperacillin/tazobactam, imipenem/cilastatin, and meropenem. The noninferiority margin was 10% for the favorable clinical response and 1.5 defined daily doses (DDDs) for the targeted antibiotics.
Results: We enrolled 303 patients in the pharmacist PPRA group and 307 patients in the ID fellow PPRA group. The baseline and clinical characteristics were similar in the 2 groups. The difference in the favorable response of patients who received the targeted antibiotics (ie, the pharmacist PPRA group minus the fellow PPRA group) was 5.15% (95% confidence interval [CI], -2.69% to 12.98%); the difference in the DDD of targeted antibiotic use (ie, the pharmacist PPRA group minus the fellow PPRA group) was 0.62 (95% CI, -1.57 to 2.82). We observed no significant difference in the DDD of overall antibiotics, 28-day mortality, 28-day ID-related mortality, favorable microbiological outcome, or antibiotic-associated complications.
Conclusions: We confirmed the noninferiority of pharmacist PPRA in terms of favorable clinical response; however, noninferiority in targeted antibiotic consumption could not be established. Therefore, using trained general pharmacists rather than ID clinical fellows could be an alternative in a resource-limited setting.
Clinical trials registration: clinicaltrials.gov identifier: NCT 01797133.
Trial registration: ClinicalTrials.gov NCT01797133.