Development of a Novel Assays for Severe Adverse Drug Reactions and Establishment of a Drug Safety Laboratory Service Facility
Patient Safety and Quality of Care
TRANSFORMATION: Currently possible serious Adverse Drug Reactions (ADRs) are managed by avoidance, with patients using less effective or more costly drugs. The Drug Safety Laboratory (DSL) is a unique resource for clinicians and patients to evaluate possible ADRs to determine which drugs can be used and which should be avoided. ADOPTABILITY: The DSL has been developed as a provincial and potentially national resource. We have conducted a pilot project demonstrating the feasibility of evaluating patients from Toronto and have extended this pilot to include institutions from as far away as Brazil. OUTCOMES: We have developed protocols for assessment of patients locally or from distant centres and have used them in pilot projects for proof of concept and to enhance clinical care. In collaboration with the Ivey Business School we have developed a business plan and have developed a website to enable interactions with distant centres.
ADRs are common & important complications of therapy occurring in at least 5% of courses of therapy costing approximately $15B/yr & the 4th commonest cause of death in Canada. Diagnosis of serious ADRs is essentially clinical resulting in the use of less effective & costly drugs. Goal is to establish a DSL for timely and evidence-driven assessments for patients across Ont. We have used our expertise in pharmacology & cell biology to develop assays for diagnosis of serious ADRs with a special focus on drug hypersensitivity. In addition to developing these assays we modified to enable them to be conducted using blood samples obtained from patients in distant centres. By developing these assays and protocols for obtaining & shipping blood we have developed collaborations with other centres to establish the feasibility of distant evaluation of possible ADRs. Conducting a series of pilot studies demonstrated feasibility of our approach for commonly used drugs including antibiotic anticonvulsants & chemotherapy. We studied assays with blood from patients from sites including Toronto Kitchener-Waterloo Netherlands & Brazil. Another example was a pilot cohort of 12 patients on the Renal Transplant Service locally. All 12 were believed to have had ADRs to sulfonamides & would be unable to take sulfonamide prophylaxis post-transplant putting them at high risk for infection. Testing in the DSL showed that 3 were at risk for serious sulfonamide ADRs but 9 were not and 5 of the 9 have gone on to successful transplantation using sulfonamide prophylaxis. Patients can be evaluated for serious ADRs using a centralized resource that enables expertise to be shared across the province & which can improve patient care. Continue to develop new assays to evaluate an expanding list of drugs as well as to evaluate different patterns of ADRs.