Background/Purpose : A large proportion of patients with rheumatologic diseases are now being treated with biologic therapies. Estimates of the use of biologics in patients with rheumatoid arthritis (RA), for example, now range from 30-40%. While biologics improve disease outcomes, they also increase the risk of infections, autoimmunity, and possibly malignancy. Screening for these conditions, as well as completion of routine vaccinations, has shown to decrease complication rates. Despite these benefits, compliance with current guideline recommendations tends to be low in practice. Development of The Ottawa Biologic Safety & Screening Tool (OBSST) is a quality initiative at The Ottawa Hospital with the objective to increase compliance with guideline recommendations and ultimately improve patient safety. The Ottawa Hospital is an academic teaching hospital in Ontario, Canada with 1,122 beds, facilitating 1.155 million ambulatory care visits each year. Our rheumatology clinic serves more than 880 patients using biologic therapies.

Methods: A chart review of randomly selected patients (n=50) who started a biologic treatment at our centre from 2011 to 2013 revealed baseline rates of compliance with guidelines. American College of Rheumatology and Canadian Rheumatology Association Guidelines for treatment of rheumatoid arthritis were used to determine screening goals (Singh et al, 2012; Bombardier et al, 2011-2012). The OBSST was then developed using a Nominal Group Technique, and implemented by a multidisciplinary team. OBSST is a checklist reviewing 1) patient characteristics which may preclude the use of certain biologics, 2) recommended laboratory and imaging screening, and 3) vaccination counselling. After one year of OBSST use, a chart review of randomly selected patients (n=50) initiating biologic therapy from October 2015 to September 2016 was completed. Descriptive statistics are reported for pre- and post- implementation rates.

Results: Following implementation of the OBSST, rates of documented Hepatitis B serology increased significantly from 50% to 94% (25/50 to 47/50 patients, P<0.0001). Hepatitis C serology documentation showed similar rates of improvement, from 46% to 98% (23/50 to 49/50 patients, P<0.0001). Prior to the implementation of OBSST, the rate of documented vaccination counselling was low; 6% of patients (3/50) had documented counselling regarding influenza, herpes zoster, and pneumococcal vaccines. With the OBSST, vaccination counselling increased to 98% (49/50, P<0.0001) for influenza, 96% (48/50, P=0.0003) for herpes zoster, and 94% (47/50, P<0.0001) for pneumococcal vaccines. Screening rates for tuberculosis with a TB skin test and chest X-ray were relatively high at baseline. Rates increased with OBSST but not reach statistical significance.

Conclusion: The Ottawa Biologics Safety & Screening Tool, administered by a multidisciplinary team, led to significantly increased rates of recommended screening and vaccine counselling of patients starting biologic therapies. Use of a standardized tool, combined with a team approach, may be beneficial in aligning institutional practices with current guideline recommendations when initiating biologics.