information content entity operational classification statement Mathias Brochhausen A risk classification that suggests specific management criteria for a specific patient context. An information content entity that is about some risk management (http://purl.obolibrary.org/obo/ERO_0000715) that has as a specified input an instance of a potential drug-drug interaction (http://purl.obolibrary.org/obo/DIDEO_00000000). Risk assessment based upon clinical management of drug interactions rather than clinical significance alone. Example using ORCA (see below for more about ORCA): Warfarin - NSAIDs The NSAIDs is topical diclofenac: Recommended Action: No special precautions The NSAID is NOT topical diclofenac but the patient is concomitantly taking a proton pump inhibitor or misoprostol: Recommended Action: Assess risk and take action if necessary The NSAID is NOT topical diclofenac, the patient is NOT concomitantly taking a proton pump inhibitor or misoprostol, and the patient has one or more of the following risk factors: History of upper gastrointestinal bleeding (UGIB) or peptic ulcer or age > 65 years old Recommended Action: Use only if benefit outweighs risk Concomitantly taking systemic corticosteroids, aldosterone antagonists, or high dose or multiple NSAID Recommended Action: Use only if benefit outweighs risk Example Operational Classification Criteria: Avoid Combination (Risk of combination outweighs benefit) Usually Avoid Combination (Use only under special circumstances) - Interactions for which there are clearly preferable alternatives for one or both drugs. - Interactions to avoid by using an alternative drug or other therapy unless the benefit is judged to outweigh the increased risk. Minimize Risk (Assess risk and take one or more of the following actions if needed) - Consider alternatives: Alternatives may be available that are less likely to interact. - Circumvent: Take action to minimize the interaction (without avoiding combination). Monitor: Early detection can minimize the risk of an adverse