Antimicrobial Stewardship in Community Pharmacy

Study Overview
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Brief Summary
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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.

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

Conditions
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Otitis Media

Intervention / Treatment
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* Behavioral: Antimicrobial stewardship
* Other: Comparator (no intervention)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-post intervention study model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Retrospective group<br>Comparator group (pre-intervention) | Other: Comparator (no intervention)<br>* No active intervention<br>|
| Experimental: Prospective group<br>Study group (post-intervention) | Behavioral: Antimicrobial stewardship<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antimicrobial stewardship, pharmacies, community pharmacy services, anti-infective agents, drug utilization