Outcomes of Urinary Tract Infection Management by Pharmacists: RxOUTMAP

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RxOUTMAP tracks and quantifies the impact of pharmacist management of patients with uncomplicated urinary tract infections.

Background Urinary tract infection (UTI) is one of the most common indications for which antibacterial agents are initiated. It is also the 8th most common reason for ambulatory clinic visits and the 5th most common reason for emergency department visits in Canada. 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 antibacterials. 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. The scope of practice of pharmacists in New Brunswick has recently been expanded to include prescribing for uncomplicated urinary tract infections. 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.

Study Objective To track and quantify the impact of pharmacist management of patients with uncomplicated urinary tract infections.
Study Design Prospective registry
Participants Any adult (19 years of age or older) patient presenting to a pharmacy in New Brunswick with symptoms suggestive of UTI and who provides written, informed consent to have their data collected. Any patient with complicated UTI or symptoms suggestive of pyelonephritis or systemic illness will be documented, but excluded from the registry and referred to their physician. Patients who present with a prescription for antibiotics for UTI from a physician are still eligible for participation as long as their UTI is considered uncomplicated (or if determined to be asymptomatic bacteriuria). Prophylaxis of UTI will be excluded. Recruitment: Pharmacists will identify and recruit patients that present in one of two ways. The first is when patients present without a prescription; and the second is when patients present with a prescription from another healthcare provider. A public relations campaign already underway from the New Brunswick Pharmacists’ Association will also help to raise awareness of pharmacists’ availability to manage UTIs.
  • All patients will receive a baseline assessment, which will include a thorough medication history (including allergies and recent antimicrobials)
  • Pharmacists will have The assessment and management of urinary tract infections in adults: A pharmacist’s guide, published in the Canadian Pharmacists Journal, and the New Brunswick Health Authorities Anti-Infective Stewardship Committee’s Treatment of Adult Urinary Tract Infections made available to them as additional resources.
  • Patient education will be central to the intervention and will include education on what to expect, as well as instructions to come back if symptoms are not improving or worsening after 3 days.
  • Pharmacists will practice to their full scope, which may include prescribing
    of antibacterials, ordering labs, and systematic patient follow-up.
  • Patients’ physicians will be informed of all assessments and treatments provided by the pharmacist.
  • Data will be collected via a secure web-based portal, which will be designed and maintained by EPICORE Centre, University of Alberta.
  • Pharmacists will conduct a follow-up visit (which may be via telephone) at 2 weeks after initial presentation. At this follow-up, pharmacists will assess for resolution of symptoms, adverse reactions, and adherence to the treatment regimen. Assessment and outcome data will be captured by standardized questions built into the web-based registry. Other follow-up visits will be conducted, as deemed necessary. All follow-up visits will be collected in the study database.
Outcomes Primary Outcome:

The primary outcome will be clinical cure at 2 weeks

Secondary Outcome:

The secondary outcomes will include medications used, number and nature of pharmacist interventions, followups 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. Patient satisfaction will be collected using a survey that has been used previously to gauge satisfaction in other general pharmacist prescribing activities with slight modification.

Feasibility UTIs are common in the general population. Because of the unpleasant symptoms and potential complications associated with UTIs, timely access to care is important to patients and our healthcare system. The accessibility of community pharmacists (in terms of not needing an appointment and longer business hours) means that patients will likely embrace this service. In addition, the issue of appropriate use of antibacterials (antimicrobial stewardship) is an important public health concern, which can be addressed by pharmacists’ application of evidence-based practice guidelines. Pharmacists will be interested in participating because of the reporting functions of the database. They can print individual patient summaries (to cut/paste into their clinic letters or other documentation requirements), and generate a report showing their impact in UTI patients (which helps to justify their positions). Initial data on UTI treatment by pharmacists in New Brunswick suggest that approximately 150 patients were treated per month in 40 pharmacies. Therefore, we feel that recruitment of 750 patients in 8 months is feasible.
What This Study Adds At the local level, the generation of provider-specific reports will help pharmacists to show their impact on UTIs (important for justification of their advanced scope of practice and remuneration). This registry may also encourage more pharmacists to get involved in providing clinical services to patients with UTIs. Our design of the registry will facilitate implementation of best practices in UTI management. This study will also evaluate the appropriate use of antibacterials for UTI management. This has important public health implications with regard to the misuse of antibacterials and concern over antibacterial resistance – much of which can be prevented/minimized with judicious use of antibacterials (such as not using antibacterials for asymptomatic bacteriuria and following guideline recommendations when antibacterials are indicated). From a health-system perspective, this registry will help to quantify the impact of pharmacist-managed UTIs. This information will demonstrate the uptake, patient satisfaction, and outcomes of pharmacist-managed UTIs. These data will be crucially important for justification of remuneration and further expansion of pharmacists’ scope of practice in New Brunswick and beyond.
Additional Resources
Publications and Guidelines
Video (Patient Perspective)
Video (Information for Health Professionals)