The FDA launched an educational program to reduce the abuse of long-lasting opioid pain drugs. This launch took place on 19th April 2011, inspite of the fact that the advisory panel had a strong "no" vote for the same.
This program is basically for the companies that make opioid pain drugs. It educates doctors and patients of effectively using the drugs and to reduce the risk involved due to addictive drugs.
The advisory panel had voted in July 2010 and rejected the plan, recommending effective actions required for opioids usage. In a news release the FDA said that "they had arrived at a conclusion that there were safety issues related to the extended release and long-acting opioids that were important to be resolved. And will provide step by step educational program to the prescribers of extended-release and long-acting opioids."
The FDA's, REMS (Risk evaluation and mitigation strategy)plan goes one step further in the package insert. REMS has a medication guide and a plan included in it to inform the risk involved for both doctors and patients using these drugs.
In case of long-acting opioids, REMS educates its patients to keep their drugs or prescription away from the abusers, which in turn helps doctors to give the prescription properly to their patients. However, any further education required by the doctors will be voluntary for their plan.
There will be no formal or special training for the doctors to prescribe opioid drugs for pain. In fact,FDA is requesting Congress to pass legislation that would require the doctors to complusorily get a Drug Enforcement Administration number to prescribe controlled drugs.
The Advisory Panel has supported this legislation very strongly.
Following are the well-known brands drugs listed under the new plan :
Avinza
Butrans
Dolophine
Duragesic
Embeda
Exalgo
Kadian Capsules
MS Contin
Opana ER
Oramorph
OxyContin
Palladone
Generic Drugs that are covered are:
· Fentanyl extended-release transdermal system
· Methadone (all versions)
· Morphine extended-release tablets
· Oxycodone extended-release tablets
The joint efforts of the departments of Justice, Health and Human Services, Veterans Affairs, and Defense have bought this plan into action. This effort helps to reduce prescription drug abuse at bay and also helps to keep prescription drugs from being diverted from patients to leisure users.
CV34 4EW
This program is basically for the companies that make opioid pain drugs. It educates doctors and patients of effectively using the drugs and to reduce the risk involved due to addictive drugs.
The advisory panel had voted in July 2010 and rejected the plan, recommending effective actions required for opioids usage. In a news release the FDA said that "they had arrived at a conclusion that there were safety issues related to the extended release and long-acting opioids that were important to be resolved. And will provide step by step educational program to the prescribers of extended-release and long-acting opioids."
The FDA's, REMS (Risk evaluation and mitigation strategy)plan goes one step further in the package insert. REMS has a medication guide and a plan included in it to inform the risk involved for both doctors and patients using these drugs.
In case of long-acting opioids, REMS educates its patients to keep their drugs or prescription away from the abusers, which in turn helps doctors to give the prescription properly to their patients. However, any further education required by the doctors will be voluntary for their plan.
There will be no formal or special training for the doctors to prescribe opioid drugs for pain. In fact,FDA is requesting Congress to pass legislation that would require the doctors to complusorily get a Drug Enforcement Administration number to prescribe controlled drugs.
The Advisory Panel has supported this legislation very strongly.
Following are the well-known brands drugs listed under the new plan :
Avinza
Butrans
Dolophine
Duragesic
Embeda
Exalgo
Kadian Capsules
MS Contin
Opana ER
Oramorph
OxyContin
Palladone
Generic Drugs that are covered are:
· Fentanyl extended-release transdermal system
· Methadone (all versions)
· Morphine extended-release tablets
· Oxycodone extended-release tablets
The joint efforts of the departments of Justice, Health and Human Services, Veterans Affairs, and Defense have bought this plan into action. This effort helps to reduce prescription drug abuse at bay and also helps to keep prescription drugs from being diverted from patients to leisure users.
CV34 4EW
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