On Thursday, the meals and Drug Administration (FDA) suggested tighter controls how doctors prescribe common, widely-use narcotic painkillers containing the narcotic hydrocodone, which makes them controlled as strictly as powerful painkillers for example OxyContin.
In announcing its recommendations, the FDA said hello had become “increasingly worried about the abuse and misuse of opioid products, that have sadly reached epidemic proportions in certain parts of america.”
Janet Woodcock, who heads the FDA’s center for drug evaluation and research, said that the company expects to submit its formal recommendation later this season that reclassify painkillers containing hydrocodone as “Schedule II” medications, an upgrade using their current “Schedule III” classification.
“We are announcing the agency’s intent to recommend to HHS (Health and Human Services) that hydrocodone combination products ought to be reclassified to a different and much more restrictive schedule,” she said inside a statement.
“This determination comes after a thorough and cautious of extensive scientific literature, review of countless public comments around the issue and many public meetings, during which we received input from the number of stakeholders, including patients, health care providers, outside experts and other government entities.”
The change will come following the Drug Enforcement Administration (DEA) requested just this type of relocate 2009. According to federal data, doctors wrote over 130 million prescriptions for hydrocodone-containing drugs for about 47 million patients in 2011.
Created in a collaboration between the FDA and also the DEA, the scheduling system ranks drugs based on their medical use, potential for abuse and international agreements, among other factors.
If hydrocodone-containing drugs would become Schedule II substances, they’d officially be looked at having among the highest potentials for abuse and addiction of legally prescribed medications. Other Schedule II substances include morphine, the attention-deficit hyperactivity disorder (ADHD) medications Adderall and Ritalin and cocaine C when used as a topical anesthetic to treat cancer.
Prescription drugs are responsible for about 75 percent of drug overdose deaths in america. Based on federal statistics, the number of deaths from prescription narcotic painkillers has quadrupled since 1999. With drugs containing hydrocodone representing about 70 % of opioid prescriptions, and their current status like a Schedule III substance, abuse has skyrocketed, experts have said.
In a job interview with The New York Times, Woodcock said FDA officials have considered the way the new rules might affect patients. However, she said that the result on public health brought on by the abuse of these drugs has created a watershed moment.
“These are very difficult trade-offs that our society needs to make,” she said. “The reason we approve these drugs is perfect for people in pain. But we can’t disregard the epidemic on the other side.”
The new regulations would cut the availability of the drug an individual receives with no new prescription in half to 90 days. Under current regulation, a patient can refill a prescription for hydrocodone-containing drugs five times over a six-month period before needing a new prescription. Previous studies have found that most patients use such medications for just 14 days.