Infection Control & Hospital Epidemiology (2018), 39, 1154–1162 doi:10.1017/ice.2018.198


Original Article


A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows


Pinyo Rattanaumpawan MD, MSCE, PhD1, Prasit Upapan MD2 and Visanu Thamlikitkul MD1


1Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand and 2Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand


Abstract


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


(Received 18 May 2018; accepted 21 July 2018; electronically published August 29, 2018)


Previous antibiotic therapy is a well-known risk factor for the emergence of antimicrobial resistance.1–5 The rational use of antibiotics is key to preventing such emergence.6–9 Results from a recent systematic review and meta-analysis have confirmed sig- nificant benefits of many antimicrobial stewardship program (ASP) strategies; they include empirical therapy according to guidelines, de-escalation therapy, switching from intravenous to oral treatment, therapeutic drug monitoring, using a list of restricted antibiotics, and bedside consultation.10 To reduce antibiotic use in the healthcare setting, the 2016


Infectious Diseases Society of America and Society for Health- care Epidemiology of America guidelines for implementing an antibiotic stewardship program strongly recommend both pre- authorization and prospective audit and feedback strategies.11


Author for correspondence: Pinyo Rattanaumpawan MD, MSCE, PhD, Division of


Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty ofMedicine Siriraj Hospital, Mahidol University, 2 Wanglung Road, Bangkoknoi, Bangkok, 10700, Thailand. E-mail: pinyo.rat@mahidol.ac.th


Cite this article: Rattanaumpawan P, et al. (2018). A noninferiority cluster-


randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows. Infection Control & Hospital Epidemiology 2018, 39, 1154–1162. doi: 10.1017/ice.2018.198


© 2018 by The Society for Healthcare Epidemiology of America. All rights reserved.


Antibiotic postprescription review and authorization imple- mented by infectious disease (ID) specialists has been confirmed as an effective strategy to improve clinical outcomes and to reduce antibiotic consumption and expenditure.12 A recent study revealed that postprescription authorization may have greater impact on decreasing antibiotic consumption than pre- prescription authorization.13 In terms of appropriateness of antibiotic prescriptions, anti-


biotic consumption, and clinical outcomes, an ASP implemented by ID clinical pharmacists under ID faculty supervision was shown to be superior to an ASP implemented by ID clinical fel- lows.14 In some resource-limited countries, including Thailand, the availability of ID clinical pharmacists is very restricted. In such countries, most pharmacists on the ASP team are general pharmacists without any formal ID training. To date, the effec- tiveness of postprescription authorization of antibiotics deter- mined by trained general pharmacists has not been confirmed. Accordingly, we conducted a cluster-randomized controlled


trial to determine the effectiveness of postprescription review and authorization of antibiotics made by ID clinical fellows. We undertook a comparative study of such review and authorization made by trained general pharmacists in terms of important


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