Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)

Study Overview
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Brief Summary
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The main purpose of this study is to see if patients with the flu would receive oseltamivir treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and to see if there is any difference in the effect of treatment on flu symptoms and overall health. Another reason for doing the study is to see how accurately pharmacists can diagnose the flu as compared to physicians. Viruses that are exposed to antiviral medications (like oseltamivir) sometimes develop a resistance to the medication. This means that the medication is no longer as effective in treating the symptoms caused by the virus. The development of viral resistance to oseltamivir will also be followed in this study.

Official Title
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Comparison of Time From Symptom Onset to Oseltamivir Access When Oseltamivir is Prescribed by Pharmacists vs. Physicians and the Impact on Symptoms, Oseltamivir Resistance, and Patient Safety

Conditions
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Influenza

Intervention / Treatment
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* Drug: Oseltamivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Group 1 Male and female subjects ≥ 18 years of age presenting at the pharmacy with a current prescription for oseltamivir (75 mg capsule BID for 5 days as per the Canadian label) for the treatment of their own current influenza symptoms Willingness to undergo 2 nasal swab procedures Willingness to participate in the study as evidenced by a written and signed Informed Consent Form Inclusion Criteria Group 2 Male and female subjects ≥ 18 years of age presenting at the pharmacy with indicative clinical symptoms/signs of uncomplicated acute illness due to influenza infection that started within a maximum of 2 days prior to the visit to the pharmacy (see Appendix A: FACTSS Influenza Diagnostic Tool) Suitable for oseltamivir treatment at a dose of 75 mg BID (see Appendix B: Algorithm for Determining Suitability of Pharmacist Prescribing of Oseltamivir) Willingness to undergo 2 nasal swab procedures Willingness to pay for (if not covered by insurance) and receive treatment with oseltamivir Willingness to participate in the study as evidenced by a written and signed Informed Consent Form Exclusion Criteria Group 1 Subjects who have been prescribed any other formulation (i.e., oral suspension) or dose regimen of oseltamivir, or any other antiviral medication for the treatment of influenza Individuals presenting at the pharmacy with an oseltamivir prescription who themselves do not currently have a diagnosis of influenza (e.g., individuals filling a prescription for someone else who is currently infected with influenza; individuals filling a prescription that they or someone else will use for prevention of influenza infection or for treatment of a future influenza infection) Subjects who have received an oseltamivir prescription from a physician participating in the study Subjects for whom the oseltamivir prescription is not filled for any reason Subjects who, in the opinion of research personnel, will not comply with the study procedures Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members Exclusion Criteria Group 2 Subjects who have already started treatment with an antiviral medication for their current influenza symptoms Subjects for whom the oseltamivir prescription is not filled for any reason Subjects who, in the opinion of the investigator, are not suitable for the study for clinical or other reasons (e.g., the patient requires hospitalisation or will not be able to comply with study procedures) Staff in the pharmacy or the primary care clinic who are involved in the study, and their family members

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with Oseltamivir Prescription<br>Patients arriving at the pharmacy with a prescription for Oseltamivir | Drug: Oseltamivir<br>* Oseltamivir 75 mg BID<br>* Other names: Tamiflu;|
| Experimental: Patients with signs, symptoms of flu<br>Patients arriving at the pharmacy with signs, symptoms of flu that the pharmacist diagnoses as having flu and being suitable for pharmacist prescribing of Oseltamivir according to an algorithm. | Drug: Oseltamivir<br>* Oseltamivir 75 mg BID<br>* Other names: Tamiflu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from symptom onset to Oseltamivir access |  | Confirmed at Visit 1, Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) of Influenza Clinical Diagnosis |  | Confirmed at Visit 1, Day 1 | 
| Oseltamivir Resistance |  | Confirmed at Visit 1, Day 1 and Visit 2, Day 5 | 
| Influenza Signs and Symptoms |  | Collected from Day 1 to Day 5 | 
| Adverse Events |  | Collected over 21 days |