Hello, my name is Marta Brooks, and I am a pharmacist and president of a healthcare regulatory consultant communications company located in Ohio. 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." I was prompted to write this article given the current state of risk evaluation and mitigation strategies, or REMS, as I will refer to them as. It's not only a matter of healthcare policy but also patient access to safe and effective medications. It is a timely and relevant topic given the ongoing efforts to improve the implementation and effectiveness of REMS programs, as mandated by the FDA Safety and Innovation Act of 2012, which is actually an extension of the 2007 mandate. Approximately forty percent of all newly approved drugs have some level of safety restrictions, including REMS. So today's REMS is really sort of the flavor du jour of setting the standard for improving the benefit-risk profile of drugs. So what are REMS? They are enforceable instruction plans designed to mitigate the specific risks of specific drugs. Examples of some of those risks include severe liver damage and allergic reactions, just to name a couple. REMS do vary in their scope and complexity depending on the magnitude of the risks that need to be mitigated. Some of the common REMS elements include MedGuides, which have actually been around for a while. And then there are other elements, as you can see from the figure on the screen, there are increasing levels of risk and therefore different elements to address that risk. This is also included in Table 1 within the article. The core...
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Security clearance drug use mitigation Form: What You Should Know
Those with such a security clearance are expected to maintain a drug-free status from that time on. Drug Testing in the U.S. Military The armed forces have been using substance testing as part of their background checks for more than 15 years. Since January 20, 2001, all new applicants have needed to pass a physical exam to receive a security clearance and a current list of exemptions can be found at How To Obtain a Security Clearance Despite Prior Abuse. Drug use can impair a person's judgment and judgment can impair job performance. It can be difficult to obtain clearance when you have criminal records. A criminal record can delay or prevent an individual from obtaining security clearance. What is Considered Illegal in the U.S.? The term “drug abuse” encompasses all drugs, not only marijuana specifically. For example, the marijuana-related crime is not considered illegal if it only involves smoking marijuana. As long as a consistent drug of abuse can be determined, no criminal actions are required. A Drug Intoxication Exception However, it is not uncommon for individuals to find themselves in a situation where they cannot access clearance because the use of marijuana interferes with their ability to conduct work activities for which they currently hold a security clearance. The DEA prohibits the use of marijuana in the workplace at federal facilities, and any drug use that prevents access to classified information may be grounds for requiring a clearance denial. The DEA has issued guidelines that explain who may receive security clearance exemptions for their use of medicinal marijuana while conducting official duties at work. See the following guidelines and examples : A drug abuse exception may be granted to protect public safety if cannabis is being used for treating an illness, and the use is not impairing functioning. To qualify, the authorized use must be for a qualified medical condition for which the individual is medically unable to obtain an exemption from security restrictions. For the purpose of the above exceptions, a qualified medical condition includes a chronic condition that can be reasonably treated as medically tolerable. Examples of the types of severe chronic diseases that may entitle an individual to use marijuana are AIDS, Hepatitis C, Multiple Sclerosis, and cancer.
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