On Sept.10, the Food and Drug Administration announced a new labeling system for prescription painkillers in an effort to deter abuse. Health care providers and patients will soon be faced with this updated labeling in the near future. Douglas Throckmorton, M.D., a deputy director in the Center for Drug Evaluation and Research at the FDA, stated, “These actions are part of the FDA’s efforts to make opioids as safe as possible for those who need them.”
Opioids are high strength painkillers and the abuse of these painkillers has been on the rise for many years. The new rules indicate that high strength painkillers can only be used if the patient has severe pain around the clock. If the patient only has moderate pain, the FDA stated that the patient be given other, less addictive options. The labeling language dictates that patients in pain need to be evaluated for a demonstration of pain if other treatments are inadequate, rather than the traditional pain scale.
As part of the new labeling adjustment, manufacturers of opioids must revise patient handouts that come with the prescription. They must indicate the risks involved with taking this high level of narcotic. The Opioid Rick Evaluation and Mitigation Strategy (REMS) will also be revised after the changes are finalized. The REMS requires manufacturers to make educational courses for health care professionals who prescribe these drugs available. The courses teach risk and safety practices when prescribing and using these medications.
Throckmorton then adds, “By improving information about the risks of opioid pain relievers and by clarifying the populations for whom the benefits outweigh the risks, we aim to improve the safe and appropriate use of these products.”
Overall, these changes may put a huge dent in the more highly addictive opioids, but dependency won’t disappear overnight. Perhaps more drastic actions need to be taken to deal with a major problem that dwells within the underbelly of modern day society. It’s America’s skeleton in the closet. With 70 percent of Americans on some form of prescription drug, it’s obviously a much more serious threat than any other drug. After all, we, for the most part, obtain these powerful drugs legally in the name of science. More regulation is key to helping America overcome this cloaked sickness.