Outcomes of Urinary Tract Infection Management by Pharmacists
Outcomes of Urinary Tract Infection Management by Pharmacists
Pharmacists in some Canadian jurisdictions have recently been granted the ability to
 prescribe for uncomplicated urinary tract infections (UTIs). Therefore, the purpose of this
 study is to assess the impact that community pharmacists can have on the management of UTIs.

 Pharmacists will identify potential study participants (patients) when they either present
 with symptoms of a UTI (such as difficulty or painful urination, increased frequency or
 urgency of urination) without a prescription for an antibiotic from another health care
 provider, or when they present with a prescription for an antibiotic from another health care
 provider to treat a UTI. For patients who consent to participate in the study, the pharmacist
 will screen for eligibility and assess for appropriateness of treatment.

 If the patient does not already have a prescription for an antibiotic from another health
 care provider, the pharmacist will prescribe this for them if they meet certain criteria. If
 they do already have a prescription from another health care provider, the pharmacist will
 assess the appropriateness of the prescription and work with the patient to potentially
 change it to make it more appropriate, if necessary. If the pharmacist identifies any
 complicating factors that require a physician's assessment, the patient will be referred to
 their physician. The enrolled patients will also have a 2-week follow-up to assess for
 resolution of symptoms, unintended effects, and adherence to the treatment regimen. All data
 will be collected in a web-based registry that will maintain the patient's confidentiality
 outside of the pharmacy (i.e. patient initials, date of birth, and study identification (ID)
 number will be the only patient identifiers collected by the researchers). A patient
 satisfaction survey will also be administered via email.
UTIs produce symptoms that may be unpleasant and distressing for patients and have the
 potential to lead to complications. It is also commonly misdiagnosed and treated
 inappropriately, resulting in unnecessary antimicrobial exposure and increased potential for
 adverse effects (including secondary infections, such as Clostridium difficile), as well as
 the selection of resistant pathogens. The incidence of UTI in women is 12% annually, with 50%
 of women reporting to have had a UTI by 32 years of age. Recurrence of infection occurs in
 25% of women within 6 months of the first UTI, and this rate increases when more than one
 prior UTI has been experienced. In the elderly, the prevalence of asymptomatic bacteriuria
 (ASB) increases, with up to 20% of women at the age of 75 or older affected and up to 50% of
 institutionalized, non-catheterized elderly women affected, a finding that often results in
 the overuse of antibiotics. With bacterial resistance on the rise and a limited pipeline of
 antibacterials with novel mechanisms of action, antimicrobial stewardship has become
 imperative to maintain the effectiveness of available antimicrobials. Pharmacists are
 accessible primary care professionals that are well-positioned to take on a larger role in
 the management of medical conditions, including UTIs, and have an important role to play in
 antimicrobial stewardship. Therefore, it would be of great value to quantify the real-world
 impact of pharmacists providing care to patients with UTI, and then disseminate this
 information to inform best practice and policy change.

 Design: prospective web-based registry Setting: ~40 community pharmacies in New Brunswick,
 Canada Patients: Any adult patient presenting to a pharmacy with symptoms suggestive of
 urinary tract infection (UTI) and assessed to be uncomplicated; or those presenting with a
 prescription for antibiotics from another healthcare provider for a UTI that are assessed to
 be uncomplicated or asymptomatic bacteriuria.

 Intervention: Pharmacists will assess symptoms and prescribe antibiotics or perform
 prescription adaptation or therapeutic substitution, as necessary. They will also discontinue
 antibiotics for asymptomatic bacteriuria in cases where treatment is unnecessary. Follow-up
 will occur at 2 weeks to assess for clinical cure, as well as adverse reactions, adherence to
 the treatment regimen, early recurrence of infection, and other outcomes. Additional
 follow-up will occur as needed, and will also be captured in the registry.

 Outcomes: The primary outcome will be clinical cure at 2 weeks. Secondary outcomes will
 include medications used, number and nature of pharmacist interventions, follow-ups
 conducted, patient adherence to initial recommendations and follow up, adverse events,
 treatment failures (including reasons for; such as adherence, delay in accessing care, missed
 baseline complicating factors, presence of a resistant organism, and complications such as
 pyelonephritis), and patient satisfaction.

 Quality assurance: Data will be collected via a secure web-based portal. Data quality will be
 monitored by EPICORE Centre, University of Alberta, and site audits will be performed
 periodically.

 Analytical plan: Most outcomes will be descriptive in nature. Target sample size of 750
 patients over 8 months; this is a bit more than necessary for the primary outcome, but the
 intention is to also have enough power for analyses of some of the secondary outcomes.
Inclusion Criteria:

 -  Patients presenting without a prescription for antibacterials from another health care
 practitioner with symptoms of urinary tract infection that is found to be
 uncomplicated. Or patients presenting with a prescription for an antibacterial from
 another health care practitioner that is found to either have uncomplicated urinary
 tract infection or asymptomatic bacteriuria.

 Exclusion Criteria:

 -  Patients with complicated urinary tract infections or symptoms suggestive of
 pyelonephritis or systemic illness.