Antimicrobial Stewardship in Community Pharmacy

Overview

Acute otitis media (AOM) is the most common indication for antibiotics for Canadian paediatric patients. As the gatekeepers of safe and effective prescription pharmacotherapy, community pharmacists are well positioned to influence and optimize antibiotic use. The purpose of this project is to develop, implement, and evaluate an antimicrobial stewardship program in the community pharmacy setting that aims to optimize antibiotic use for AOM. This nonrandomized pre-post study includes children aged 6 months to 12 years presenting with an antibiotic prescription for AOM at two community pharmacies in Toronto, Ontario. Participants are excluded if they exhibit signs/symptoms of mastoiditis, have an additional indication for systemic antibiotics, or parents/guardians cannot consent in English. The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist. Prescriptions are reviewed and adapted by the pharmacist to optimize congruence with 2016 Canadian Paediatric Society AOM guidelines. The primary outcome is the percentage change in guideline congruence attributable to pharmacist intervention. This study will provide insight into the opportunities and barriers of developing large-scale antimicrobial stewardship programs for community pharmacies.

Full Title of Study: “Moving Antimicrobial Stewardship Into Community Pharmacy: A Pre-post Study of Acute Otitis Media Management”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 15, 2017

Interventions

  • Behavioral: Antimicrobial stewardship
    • The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist.
  • Other: Comparator (no intervention)
    • No active intervention

Arms, Groups and Cohorts

  • Other: Retrospective group
    • Comparator group (pre-intervention)
  • Experimental: Prospective group
    • Study group (post-intervention)

Clinical Trial Outcome Measures

Primary Measures

  • Change in guideline congruence
    • Time Frame: Pre-post study intervention (comparison of two 4-6 month periods)
    • % change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention

Secondary Measures

  • Choice of antibiotic
    • Time Frame: Pre-post study intervention (comparison of two 4-6 month periods)
    • % change in guideline congruence for choice of antibiotic before and after study intervention
  • Antibiotic dosing
    • Time Frame: Pre-post study intervention (comparison of two 4-6 month periods)
    • % change in guideline congruence for antibiotic dose before and after study intervention
  • Antibiotic duration
    • Time Frame: Pre-post study intervention (comparison of two 4-6 month periods)
    • % change in guideline congruence for antibiotic duration before and after study intervention
  • Acceptance of pharmacist recommendations
    • Time Frame: Post-intervention study arm (6 month period after start of intervention)
    • The percentage of pharmacist recommendations that were accepted by prescribers and parents/guardians (descriptive statistic)
  • Balancing measure: resolution of AOM
    • Time Frame: 7-14 days after antibiotics were dispensed
    • The percent of cases with symptom resolution for AOM

Participating in This Clinical Trial

Inclusion Criteria

  • Prescribed systemic oral antibiotic therapy – Antibiotics are indicated for the treatment of acute otitis media (AOM) as reported verbally or in writing by parent/guardian or prescriber Exclusion Criteria:

  • signs/symptoms of mastoiditis – a diagnosis in addition to AOM for which systemic antibiotics are indicated – parents/guardians cannot consent to the study in English

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Toronto
  • Provider of Information About this Clinical Study
    • Principal Investigator: Katherine Koroluk, Principal Investigator – University of Toronto

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