FDA reconsiders training requirements for painkillers ;
The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers such as OxyContin should be required to take courses safety training, according to federal documents released Friday.
A panel of FDA advisers will meet next week to review plans risk management launched almost four years ago to reduce misuse and abuse of painkillers long-acting, potent opioid drugs in the center of a national wave of abuse and death.
Under current risk management programs, drug manufacturers voluntary fund training for doctors on how to prescribe their drugs safely. However, many experts, including a former FDA advisory panel said that these measures are not sufficient and that the doctor’s training should be mandatory.
The FDA says its own conclusions “mixed show results that make it difficult to draw conclusions about the program’s success,” according to information documents published on the Internet.
The FDA will present its findings through a two-day meeting that begins next Tuesday, then ask your panel of security experts outside what changes should be made to improve the plans. the panel’s advice is not binding.
In the past year, government authorities have launched a series of measures to reduce deaths from painkillers, including new rules of federal prescribing Centers for Disease Control and Prevention and state measures restricting and track prescribing opioids.
prescription opioid overdose have increased steadily for more than a decade, reaching almost 19,000 in 2014, the highest number recorded. Total opioid overdose that year exceeded 28,600 when combined with heroin, many abusers to change after being hooked on painkillers.
The FDA first proposed its risk management plan in 2010, before the CDC had formally identified opioid overdose as a national epidemic.
While advocates of public health urged the agency to implement the measures at all painkillers, the FDA decided to limit its action to painkillers long acting as OxyContin and Opana, due to its high levels of ingredients drug. The risk management measures do not apply to the most commonly used opioids like Vicodin and Percocet.
FDA initial ideas to improve safety include mandatory certification for physicians and a national registry to track patients taking the drugs. But the industry pushed back. Pharmaceutical and panels of pain that funds argued that certification would be too onerous for physicians, leaving many patients undertreated. And the patient groups said the records would unfairly stigmatize those who rely on painkillers to treat long-term pain.
FDA final plans were ultimately much softer than its initial proposals instance. Patients will receive pharmacy brochures about the risks of opioid drug manufacturers and optional funded medical training .
own panel of outside advisers to the FDA rejected the proposal by a vote of 25-10, saying that the steps not doing enough to curb the misuse and abuse. At that time, FDA officials said the risk plans were designed to address the inappropriate use of drugs of abuse, not deliberate.
In July 2012, the FDA launched plans risk, essentially unchanged.
In his book of instructions Friday, the FDA again recalls that although admits that require doctors to take training courses before renewing their registration with the prescription of the Drug Enforcement Administration. Only physicians registered with the DEA may prescribe opioids. However, the FDA notes that this requirement to put in place require action by Congress.
The FDA has its own authority to require specialized training for certain drugs, but says such measures “impose significant burdens on the system of health care and reduce patient access.”
This article was originally published on medicalxpress, Read the original article
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