The US Food and Drug Administration (FDA) recently approved a risk assessment and reduction strategy (REMS) for sustained-release and long-acting opioids.
FDA Director Margaret A. Dr. Hamburg said at a press conference that the above measures are taken as an important part of the prevention of the growing abuse, misuse, and overuse of these prescription drugs while ensuring that patients with moderate and severe persistent pain can continue to obtain highly effective analgesic drugs. As expected.
Dr. Hamburg pointed out that this new security measure involving about 30 listed drugs requires drug manufacturers to provide funds for continuing education institutions that develop and provide training, and guarantees to provide FDA-approved training to prescription doctors before March 1, 2013. data. In addition, REMS includes prescribing doctors' patient counseling manuals on the safety and efficacy of medications, an updated single-page patient medication guide, implementation plans, and periodic assessments of the program's impact on the safe use of drugs. The FDA will adjust the plan as necessary based on the assessment report.
According to Dr. John Jenkins, director of the New Drugs Office at the FDA's Center for Drug Evaluation and Research, the reason for focusing on sustained-release and long-acting opioids is because these drugs have special safety issues that need to be seriously addressed. These drugs, including hydromorphone, oxycodone, morphine, oxymorphone, methadone, fentanyl transdermal patches, and buprenorphine transdermal patches, may cause problems even if the prescription is reasonable.
Dr. Jenkins pointed out that the content of prescribing doctor education in REMS includes information on the risks and benefits of opioid treatment for individual patients, rational choice of patients, patient management and monitoring, and patient counseling, as well as potential abuse, misuse and overuse, and evidence verification guidelines. Wait. The up-to-date medication guidelines and patient consultation documents include information on how to safely use, store, and distribute such pain medications, clear guidelines for identifying signs of potential overdose, and recommendations for preventing accidental exposure of family members and visitors.
According to Dr. Hamburg, for the evaluation and verification of the contents of the plan, the FDA has established relevant goals that the manufacturer can expect to reach, including the proportion of doctors who prescribe doctors to complete the training and the evaluation of prescription doctors' knowledge of risk information. However, she claims that it is not mandatory for prescription doctors to participate in educational programs. In addition, the assessment also required an assessment of whether REMS adversely affected patients' access to these drugs. She stressed, "We must ensure that patients with pain can continue to receive these drugs when needed."
The new REMS program is part of the White House’s multi-sectoral collaboration national strategy to address the abuse of prescription drugs in 2011. Dr. Hamburg said that the abuse of prescription drugs is the most rapidly developing drug problem in the United States. In particular, overuse of opioids caused about 15,000 Americans to die in 2008 and increased to nearly 16,000 in 2009. The national plan entitled "Epidemiology: Responding to US Prescription Drug Abuse Crisis" proposes to expand state-based prescription drug monitoring programs, explore convenient, environmentally-friendly recommendations for the disposal of unused drugs, and call for legislative measures to reduce "walking doctors ( Refers to the fact that some patients frequently change doctors)" and "pill workshops."
In the absence of legislative changes, a comprehensive White House plan needs to be implemented, and REMS “is an important and timely step for FDA to supplement prescription training and consumer information,†said the director of the White House National Drug Control Policy Office. Gil Kerlikowske said.
FDA Director Margaret A. Dr. Hamburg said at a press conference that the above measures are taken as an important part of the prevention of the growing abuse, misuse, and overuse of these prescription drugs while ensuring that patients with moderate and severe persistent pain can continue to obtain highly effective analgesic drugs. As expected.
Dr. Hamburg pointed out that this new security measure involving about 30 listed drugs requires drug manufacturers to provide funds for continuing education institutions that develop and provide training, and guarantees to provide FDA-approved training to prescription doctors before March 1, 2013. data. In addition, REMS includes prescribing doctors' patient counseling manuals on the safety and efficacy of medications, an updated single-page patient medication guide, implementation plans, and periodic assessments of the program's impact on the safe use of drugs. The FDA will adjust the plan as necessary based on the assessment report.
According to Dr. John Jenkins, director of the New Drugs Office at the FDA's Center for Drug Evaluation and Research, the reason for focusing on sustained-release and long-acting opioids is because these drugs have special safety issues that need to be seriously addressed. These drugs, including hydromorphone, oxycodone, morphine, oxymorphone, methadone, fentanyl transdermal patches, and buprenorphine transdermal patches, may cause problems even if the prescription is reasonable.
Dr. Jenkins pointed out that the content of prescribing doctor education in REMS includes information on the risks and benefits of opioid treatment for individual patients, rational choice of patients, patient management and monitoring, and patient counseling, as well as potential abuse, misuse and overuse, and evidence verification guidelines. Wait. The up-to-date medication guidelines and patient consultation documents include information on how to safely use, store, and distribute such pain medications, clear guidelines for identifying signs of potential overdose, and recommendations for preventing accidental exposure of family members and visitors.
According to Dr. Hamburg, for the evaluation and verification of the contents of the plan, the FDA has established relevant goals that the manufacturer can expect to reach, including the proportion of doctors who prescribe doctors to complete the training and the evaluation of prescription doctors' knowledge of risk information. However, she claims that it is not mandatory for prescription doctors to participate in educational programs. In addition, the assessment also required an assessment of whether REMS adversely affected patients' access to these drugs. She stressed, "We must ensure that patients with pain can continue to receive these drugs when needed."
The new REMS program is part of the White House’s multi-sectoral collaboration national strategy to address the abuse of prescription drugs in 2011. Dr. Hamburg said that the abuse of prescription drugs is the most rapidly developing drug problem in the United States. In particular, overuse of opioids caused about 15,000 Americans to die in 2008 and increased to nearly 16,000 in 2009. The national plan entitled "Epidemiology: Responding to US Prescription Drug Abuse Crisis" proposes to expand state-based prescription drug monitoring programs, explore convenient, environmentally-friendly recommendations for the disposal of unused drugs, and call for legislative measures to reduce "walking doctors ( Refers to the fact that some patients frequently change doctors)" and "pill workshops."
In the absence of legislative changes, a comprehensive White House plan needs to be implemented, and REMS “is an important and timely step for FDA to supplement prescription training and consumer information,†said the director of the White House National Drug Control Policy Office. Gil Kerlikowske said.
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