Optimization of current pain management strategies is necessary in order to reduce medication risks. Promoting patient and healthcare provider education on pain and pain medications is an essential step in reducing inadequate prescribing behaviors and adverse events. In an effort to raise awareness on medication safety, the FDA has launched the Safe Use Initiative program. The program seeks to identify areas with the greatest amount of preventable harm and help promote new methods and practices to reduce medication risks. Since the establishment of the program, FDA’s Safe Use initiative staff convened a panel of key opinion leaders throughout the medical community to address pain management in older adults (≥65 years of age). The aim of the expert panel was to focus on areas where significant risk occurs and where potential interventions will be feasible, implementable, and lead to substantial impact. The panel suggested one focus could be the use of NSAIDs for pain management in the elderly. 1. Medication Risks Medication use can result in unwanted adverse reactions that can cause injury and even death. It was documented in 2001 that over 4 million people experienced medication adverse events, which was about 1.5 times the rate observed in 1995 [1]. The Institute of Medicine has estimated that 1.5 million preventable adverse events occur every year [2] and up to 50% could have been prevented by the modification of prescribing methods [3, 4]. Certain risks cannot be avoided, and these include unknown risks that do not manifest during the medication development program and unpreventable known side effect risks, which result even if drug administration is executed optimally, that factor in the risk-benefit evaluation during the regulatory review process of innovative medications. Though these risks are of great concern, proper precaution and prescribing methods cannot circumvent or minimize them [5]. FDA’s Safe Use Initiative (SUI) focuses on preventable risks that are significant and amenable to implementable interventions that have potential impact and measurable outcomes. Identifying, describing, and understanding the root cause of significant preventable risks are essential for reducing harm from medications. FDA’s SUI describes four main categories of preventable risks: medication errors, unintended/accidental exposure, intentional misuse/abuse, and drug quality defects [5]. Medication errors can also be broken into subcategories: informational errors in prescribing or by patients/consumers, and procedure and process type errors. Procedure type
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