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Video instructions and help with filling out and completing security clearance drug use mitigation
Hello my name is Marta Brooks and I am a pharmacist and president of a health care regulatory consultant he communications company located in between Ohio pro in communications thank you so much for taking a few minutes of your time to view this video encapsulating my special article that is upcoming in the mayo clinic proceedings entitled mitigating safety risks of drugs with a focus on opioids our risk evaluation and mitigation strategies the answer I was prompted to write this article given the current state of risk evaluation and mitigation strategies or realms as I will refer to them as it's not only a matter of healthcare policy but patient access to safe and effective medications it is a timely topic and relevant given the ongoing efforts to improve the implementation the effectiveness of rome's programs as mandated by the FDA safety and innovation Act of 2021 which is actually an extension of the 2012-2021 mandate approximately forty percent of all newly approved drugs have some level of safety restrictions including Rams so today's REMS is really sort of the flavor du jour of setting the standard for improving the benefit risk profile of rams drugs so what are runs they are enforceable instruction plans designed to mitigate the specific risks of specific drugs examples of some of those risks include severe liver damage allergic reactions and those are just a couple of examples Rams do vary in their scope and complexity depending on the magnitude of the risks that are need to be mitigated some of the common REMS elements include med guides which have actually been around for a while and then there are other elements and as you can see from the figure on the screen there's increasing levels of risk and therefore different elements to address that risk and this is also included in table 1 within the article the core issue is whether this latest attempt at mitigating safety risk is achieving its intended outcomes ie mitigating risk of effective medications or are there unintended consequences such as creating an extra burden on the health care system and providers as well as perhaps limiting access to medications for patients the approved shared grounds for extended release and long-acting opioid analgesics is or earlham ramesses I will refer to it provides an excellent lens to which to examine the issues arguably the opioids are one of the compelling reasons that we've moved to Rams and the non-medical use of opioids can really trace some of its roots at least back to the approval of in 1996 where we saw an explosion of the illicit availability and abuse of opioid narcotics the figure that's now on your screen is showing the consequences of this available in the sense that there is a dramatic rise in overdose deaths since 1999 from opioid analgesics if we fast forward to present day with the approval of Zohydro we are we have that being the first.