New Drugs and Drug News: The 411 and Implications for Palliative Care (FR477)

Abstract

•List new drugs approved by the FDA in 2016. For each drug the participant will be able to describe the approved indication, unapproved uses of the medication, common adverse effects and drug interactions.•Describe the burden-to-benefit ratio and the role of the medication in caring for patients with advanced illness for each new relevant medication approved in 2016.•Analyze important drug alerts and their relevance to drug therapies commonly used in hospice and palliative care patients. Up to 100 new drugs and dosage formulations are approved every year by the Food and Drug Administration (FDA). Some of these are new molecular entities, while others are new formulations, new indications, generic drug approvals or labeling revisions. Even if a drug is a “new” molecular entity, it may not be “improved” over molecular entities already commercially available. In caring for patients with advanced illnesses, practitioners must make prudent drug therapy choices. Part of this decision-making process is a careful assessment of the burden-to-benefit ratio, including the financial burden of using each medication. This concurrent session is a follow-up to previous year's very popular update on new drugs. For relevant drugs approved in 2016, participants will learn about the FDA-approved indication for using the medication, unapproved uses of the medication (particularly as it applies to palliative care patients), if it is a controlled substance and the schedule (if appropriate), adverse effects, major drug interactions, dosing, and financial implications of drug procurement and monitoring if relevant. Participants will learn what “NDA Chemical Type” (e.g., new molecular entity, formulation, manufacturer, indication or OTC switch), and “Review Classification” (priority, or standard review; orphan drug status) was assigned by the FDA. If available, participants will also learn the “new drug comparison rating” (1-5, 5 highest in terms of drug importance). Most importantly, the participant will learn about the role of the new agent in caring for patients with advanced illnesses, and how this medication compares with medications already available. Public health advisories and drug-related alerts pertinent to end of life care will also be discussed, and their impact on caring for palliative care patients. Inappropriate use of medications in hospice or palliative care may result in suboptimal symptom management. This is a session that every health care professional needs to attend!