New regulations will be issued to strengthen control over opium analgesics
New regulations will be issued to strengthen control over opium analgesics The Federal Food and Drug Administration (FDA) announced new safety regulations for powerful analgesics on the 9th, requiring the production of 30...
The Federal Food and Drug Administration (FDA) announced new safety regulations for powerful analgesics on the 9th. , requiring pharmaceutical companies that produce 30 types of long-acting opioid analgesics to train doctors and other medical personnel to safely prescribe these drugs and explain the dangers of these drugs to patients, so as to reduce the misuse and abuse of drugs and avoid the deaths of tens of thousands of people every year.
This type of drugs includes various forms of morphine, methadone and oxycodone, such as OxyContin from Purdue Pharmaceuticals, Druagesic patches from J&J, Embeda from Pfizer, etc. The FDA has issued many prescribing warnings on painkillers in recent years, but they have been ineffective. Improper use of these drugs resulted in 425,000 emergency room visits and 15,600 deaths in 2009. The FDA's new rule requires drug companies to provide two to three hours of training to prescribers. The training program must be sponsored by a company that provides ongoing education to medical professionals, and must not be sponsored by the drug company. These training programs must be provided by March 2013 and will be inspected by FDA regulators. The agency hopes that within three years, at least 60% of the nation's 320,000 prescribers will be trained.
The FDA also stipulates that drug manufacturers must provide patients with safety pamphlets explaining the dangers of such drugs and how to seek emergency treatment after overdose. The FDA has spent more than three years working with industry and health care professionals to develop a risk management plan for this class of drugs. Opioid painkillers have natural narcotic effects and are often prescribed to people already taking painkillers, including cancer patients, to treat severe pain. The FDA is targeting drugs that release drugs over a long period of time to achieve long-term pain relief, but when doctors prescribe them improperly and patients abuse them as stimulants, these powerful drugs can pose serious risks. The FDA reports that many doctors also prescribe this type of painkiller to migraine sufferers, although the drug is not approved by the FDA for the treatment of migraines. In addition, patients sometimes chew the medicine, which is meant to be swallowed, and overdose.
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