Today the US government has begun to make good on a promise to curb the nation’s epidemic of prescription-painkiller abuse.
The US Food and Drug Administration (FDA) announced that doctors and patients will have access to training and educational materials on the risks of abuse and addiction associated with opioids, a class of medications prescribed for severe pain.
In the United States, opioids such as Oxycontin are abused both by patients for whom they’re prescribed and recreational users. They accounted for 14,800 deaths by overdose in 2008 and 15,597 deaths in 2009, according to the Centers for Disease Control and Prevention. Last year, more people died from prescription-opioid overdoses than from heroine and cocaine overdoses combined.
“Prescription-drug abuse is our nation’s fastest-growing drug problem,” said FDA commissioner Margaret Hamburg at a press briefing on the measure. “Today, the FDA is taking the next critical step in risk management.”
The FDA is requiring companies that manufacture long-lasting or extended release opioids to pay for educational materials that teach doctors how to communicate the risk of opioid dependence to patients and how to handle those who’ve become addicted. Between now and March 2013, some 20 companies will develop educational strategies, which must adhere to a blueprint issued by the FDA. A third party will audit the materials to ensure that they are comprehensive and free from bias.
One clear shortcoming of the approach is that opioid prescribers can skip training sessions, and patients might not read pamphlets that health-care providers give them. In other words, it’s mandatory for companies to provide education, but not for people to listen. Hamburg says that the agency expects 60% of the current 320,000 prescribers to attend the training sessions by 2016. “We’d like to see a higher number,” she adds, “and we are working with Congress to explore a way of mandating training.”
Before that happens, the FDA must demonstrate that the training would not add additional burdens to busy healthcare providers, or restrict opioid access to deserving patients. Surveys conducted once the plan is in place should shed light on both of these concerns, Hamburg says.