Pharmacist Prescribing for UTI: The Burning Question of Self Diagnosis

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1 for UTI: The Burning Question of Self Diagnosis Overview Review Pharmacist prescribing in Saskatchewan Discuss current management / diagnosis of UTI Appraise the literature for safe and accurate diagnosis of uncomplicated UTI Justify the role for pharmacist prescribing for UTI Case examples Casey Phillips, BSP, PharmD student Feb. 27, 2013 Why is pharmacist prescribing important? For patients For other health care practitioners For pharmacists March 3, 2010 Announcement for expanded authority pharmacist prescribing Level 1 of enhanced prescribing authority for minor, self limiting and self diagnosed ailments Development of the Minor Ailment Guidelines Criteria for Minor Ailment Conditions Can be reliably self diagnosed by patient Self limiting condition Lab tests are not required for diagnosis Treatment will not mask underlying conditions Medical and medication histories can reliably differentiate more serious conditions Only minimal or short term follow up needed Criteria for prescription drugs suitable for pharmacist prescribing for patient minor ailments Has an official indication for the self care condition Has valid evidence of efficacy for the self care condition Has wide safety margin Not subject to abuse Dosage regimen for treatment of self care conditions is not complicated 1

2 Components of Minor Ailment Guidelines Baseline prescribing criteria Assessment of signs and symptoms Ruling out a differential Diagnosis Consideration for referral Point of care treatment Monitoring and follow up Why is this important? Urinary tract infections (UTIs) remain one of the most common reasons patients in the community seek medical attention and are prescribed an antibiotic. Most outpatients presenting with a UTI are premenopausal women with some studies reporting as many as 50% of women having a UTI by age 30. Mazzulli T. Diagnosis and management of simple and complicated urinary tract infections (UTIs). Canadian Journal of Urology 2012: 19(supp1): How should we manage uncomplicated UTI? Clinical Diagnosis of each UTI episode is supported by symptoms of dysuria, frequency, urgency, hematuria, back pain, self diagnosis of UTI, nocturia, costo vertebral tenderness and the absence of vaginal discharge or irritation (Level 1, Grade A recommendation). How should we manage uncomplicated UTI? Despite published guidelines for the optimal selection of an antimicrobial agent and duration of therapy, studies demonstrate a wide variation in prescribing practices Causes of complicated UTI may be ruled out on history and physical exam (Level 3, Grade C). Culture and sensitivity analysis when symptomatic and in 2 weeks from sensitivity adjusted treatment (Level 4, Grade C). Dason S, et al. Guidelines for the diagnosis and magnagement of recurrent urinary tract infection in women. CUAJ 2011; 5(5): International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update by the Infectious Disease Society of America and the European Society for Microbiology and Infectious Diseases. How should we manage uncomplicated UTI? There is wide variation in how physicians manage acute uncomplicated cystitis. In one study, physicians proposed 82 different treatment regimens. McIsaac WJ, et al. The Impact of Empirical Management of Acute Cystitis on Potential reasons for variability Definitions: Complicated vs. Uncomplicated Recurrent vs. Reinfection vs. Relapse Diagnostic criteria Symptom based vs. Laboratory confirmation Treatment approaches Empiric vs. Targeted vs. Self treatment Local resistance patterns 2

3 Can be reliably self diagnosed by patient Clinical Question Can pharmacists safely and accurately assess for the presence of uncomplicated UTI to provide appropriate antibiotic treatment? Lab tests are not required for diagnosis Treatment will not mask underlying conditions Choosing the correct patient years old Uncomplicated History of previously diagnosed UTI Pharmacist assessment for symptoms of UTI Ruling out of alternative diagnoses Search Strategy Medline and PubMed search for articles from 2000 to the present using search terms: urinary tract infection; pharmacist prescribing; self diagnosis; diagnosis; treatment A second search was performed using Google Scholar to identify additional literature Of the literature identified, two trials and one meta analysis were chosen to answer the clinical question McIsaac WJ, et al. The Impact of Empirical Management of Acute Cystits on P I/C N=231 women (aged 16+) presenting to family physicians offices with symptoms of cystitis Physicians completed a standardized physical assessment, dipstick testing, and urine culture; standard care was then provided. The results of standard care and the 3 UTI strategies for empiric antibiotic treatment were applied retrospectively to culture data for positive UTI (positive cultures were deemed a definitive UTI) O antibiotic prescriptions urine culture use sensitivity of each strategy standard care and the 3 UTI strategies Evidence for diagnosis based on symptoms McIsaac WJ, et al. The Impact of Empirical Management of Acute Cystits on P I/C O Age range of years History of UTI in 58.5% of patients Presenting with symptoms for which UTI was a possible diagnosis Assessment, dipstick, and culture Retrospective application of 3 treatment strategies: 1. Stamm and Hooton empiric tx without cultures (sx/pyuria) 2. Group Health Cooperative telephone abx or office treatment for symptomatic patients 3. Protocol Steering Committee BCMA tx classic symptoms With standard care, physicians prescribed abx to 80.9% (186) pt s, of which 39.8% were culture negative. Retrospective analysis of 2 of the empiric strategies resulted in similar negative cultures / inappropriate use (41.4% and 40.6%). Classic symptoms and pyuria decreased unnecessary abx use (26.2%), but also resulted in less women with confirmed UTI receiving tx. 3

4 McIsaac WJ, et al. The Impact of Empirical Management of Acute Cystits on Empiric management can reduce the number of unnecessary urine cultures but results in high levels of unnecessary antibiotic use. Authors identified four core findings that could quickly and accurately identify UTI: symptoms for 1 day, dysuria, positive leukocyte or positive nitrite (3 = 84%; 4=100%): these factors may be applied to a simple decision rule for appropriate treatment. BL Patients in the study do not reflect our target tx group Follow up study: McIsaac WJ, et al. Validation of a Decision Aid to Assist Physicians in Reducing Unnecessary Antibiotic Drug Use for Acute Cystitis. Arch Intern Med 2007; 167(2): Gupta K, et al. Patient Initiated Treatment of Uncomplicated Recurrent Urinary Tract Infections in Young Women. Ann Intern Med 2001; 135:9 16 P I/C O N=172 women aged 18+ experiencing 2 or more UTIs in 12 months Exclusion pregnancy, hypertension, diabetes, or renal disease Following self diagnosis of UTI on the basis of symptoms (from previous UTIs), self initiated therapy with a 3 day course of ofloxacin or levofloxacin. Participants also taught how to obtain pre tx urine specimen. Follow up after each treatment event was done by phone and office visits 88 participants self diagnosed 172 UTIs. Lab evaluation showed a uropathogen in 84% of cases [95%CI 77 90%] (definitive UTI), sterile pyuria in 11% of cases [CI 6 16%] (probable UTI), and no pyuria or bacteriuria in 5% of cases [CI 1 10%]. Of the cases confirmed by culture, clinical and microbiological cure occurred in 92% [CI 89 95%] and 96% [CI 93 99%] of patients respectively. Characteristic Data # Data % Mean age (range), y Ethnicity White Black 3 2 Asian or Pacific Islander Other 12 7 Education High School Graduate 4 2 Some college College graduate Graduate school Previous UTI > History of pyelonephritis History of STD Gupta K, et al. Patient Initiated Treatment of Uncomplicated Recurrent Urinary Tract Infections in Young Women. Ann Intern Med 2001; 135:9 16 Authors conclude that self diagnosis was possible in 84 94% of cases (depending on definitive vs. probable UTI diagnosis). Self diagnosis and self start therapy presents an effective and safe treatment option for patients with recurrent, uncomplicated UTI. Additionally, patient satisfaction was very high in this trial; pt s felt comfortable with self diagnosis, allows for earlier tx, shortens the course of symptoms, and allows earlier resumption of daily activities. BL The patients in the trial by Gupta and colleagues best represent our target population: age, history of UTI, lack of history for complicated UTI, ability to self diagnose based on symptoms. Bent S, et al. Does This Woman Have an Acute Uncomplicated Urinary Tract Infection? JAMA 2002; 287(20): Study Search Meta analysis and review of articles on the accuracy or precision of history or physical exam for diagnosing acute uncomplicated UTI in women. Medline search for articles from with search terms including urinary tract infection, diagnostic tests, physical examination, and sensitivity and specificity. Studies were included if they contained original data on the accuracy or precision of the history and/or physical exam in diagnosing uncomplicated UTI in healthy women. Studies were excluded if they evaluated infants, children, or adolescents, pregnant women, nursing home patients, or patients with complicated UTI. Bent S, et al. Does This Woman Have an Acute Uncomplicated Urinary Tract Infection? JAMA 2002; 287(20): Study Selection Results BL 9 studies were included of the 464 identified; 6 studies reported on accuracy of 1 or more sx in diagnosis of UTI 2 studies reported on physical exam signs (low quality) 1 study reported on the accuracy of self diagnosis In women who present with 1 or more symptoms of UTI, probability of infection is approximately 50%. Specific combinations of symptoms (dysuria, frequency, no vaginal discharge or irritation) raise the probability of UTI to more than 90%, effectively ruling in UTI on history alone. A combination of core symptoms with ruling out alternate symptoms may reliably diagnose UTI without need for physical exam or laboratory confirmation 4

5 Summary of Evidence McIsaac Empiric antibiotic treatment may result in high levels of unnecessary antibiotic use. Core symptoms including urine dipstick testing may improve point of care diagnosis. Gupta Self diagnosis and initiation of therapy provides a safe and effective treatment option for uncomplicated UTI. Symptoms identified from a previous UTI provide an accurate basis for future diagnosis. Bent A combination of core symptoms may be used to reliably diagnose uncomplicated UTI. Physical exam and urine dipstick results do not appreciably improve diagnostic ability. Baseline prescribing criteria Assessment of signs and symptoms Ruling out a differential Diagnosis Consideration for referral Point of care treatment Monitoring and follow up Signs and Symptoms Core symptoms of UTI ( 3 of): Dysuria painful voiding Frequency frequent voiding of urine Urgency the urge to void immediately Hematuria presence of blood in the urine Suprapubic pain Foul smelling or cloudy urine Absence of vaginal discharge or irritation Differential Diagnosis Complicated UTI Pyelonephritis Sexually Transmitted Infection When to Refer? Does patient fit prescribing criteria? Risk factors for complicated UTI Signs/symptoms of pyelonephritis S/Sx and RF for Sexually Transmitted Infection Case #1 35 year old female Presents to your community pharmacy complaining of dysuria, frequency, and urgency; she denies experiencing any vaginal discharge or irritation. She is well known to you and you are aware she has had a previously diagnosed UTI (approximately one year ago, treated for 3 days with ciprofloxacin). Her past medical history is unremarkable except for the previous UTI. She is not on any chronic medications and has no allergies. 5

6 Case #2 27 year old female Presents to your community pharmacy complaining of dysuria and urgency. Additionally, she complains of nausea, fever, and severe throbbing back pain. She does not have a prior documented history of UTI at your pharmacy. You are able to see she doesn t have any chronic medical history but is on oral contraception. Case #3 55 year old female Presents to your pharmacy describing symptoms of dysuria, frequency, and urgency. Additionally, she denies any vaginal irritation or discharge. She describes her symptoms as being exactly the same as her last UTI. She is well known to your pharmacy including having a past history of multiple UTI s, most recently 6 months ago. Past medical history is significant for: Diabetes x 15 years Metformin 1G BID Rheumatoid Arthritis x 5 years Prednisone 15mg OD + Leflunomide 20mg OD She does not have any overt renal dysfunction she is aware of. Summary Saskatchewan pharmacists are prescribing for minor ailments Current diagnosis and management of UTI shows wide variability in practice Literature supports the diagnosis of uncomplicated UTI based on symptomology in women with a previous diagnosis of UTI Pharmacist prescribing for uncomplicated UTI may increase access to care and alleviate the burden on other health care practitioners Conclusion Can pharmacists safely and accurately assess for the presence of uncomplicated UTI to provide appropriate antibiotic treatment? Yes; by focusing specific patient parameters, using effective assessment, and ruling out alternative diagnoses, pharmacists may safely and accurately assess for uncomplicated UTI. Questions? 6