Evidence based diagnosis of drug-induced pancreatitis: Protocol for a series of reviews related to mechanisms and detection of disease

In the context of the Drug Safety and Effectiveness Network funded by the Canadian Institutes of Health Research (CIHR), Health Canada has identified the need to develop a greater understanding surrounding detection methods to identify drug-induced pancreatitis (DIP), to become more familiar with specific agents with risk of DIP and different hypothesized mechanisms underlying the occurrence of DIP. Interest in these topics is motivated by the desire to establish a firm evidence base to support researchers and manufacturers who may be called upon to collect data in their primary studies to facilitate monitoring for DIP. Establishing such a support will be helpful toward further ensuring patient safety and increased identification of an important harm. This protocol outlines a series of reviews with the aim to address the following research questions: (1) What drugs have been shown to have an association with drug-induced pancreatitis? What level of evidence is available for these associations? (2) What mechanisms of drug-induced pancreatitis have been described in the literature? (3) What are current evidence-informed recommendations regarding diagnosis of DIP? and (4) For two specific drugs identified by our knowledge users from Health Canada (blinatumomab/Blincyto®; ceritinib/Zykadia®) as having a known association with DIP, what evidence suggestive of a potential association was demonstrated historically in the literature, from preclinical studies through to clinical trials? Accepted scoping and systematic review methods will be used to conduct the planned research.