If federal health advisers get their desired new restrictions on hydrocodone, the potentially addictive painkiller that has grown into the most widely prescribed drug in the US, access could become very limited. In late January FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 to reclassify hydrocodone-containing compounds, including Vicodin, from Schedule III drugs under the Controlled Substances Act to Schedule II. Panelists who voted for new restrictions hoped it would alert physicians about the potential dangers of abuse of hydrocodone drugs.
Among the differences between the classifications, a Schedule II designation for hydrocodone combination drugs would limit how much a patient can receive in between doctor visits and would require written prescriptions, rather than prescriptions that are faxed or called in by phone. The Drug Enforcement Agency, who requested the FDA meeting, has urged limiting prescriptions to a 90-day supply instead of the current five refills within six months, and for stripping dentists, physician assistants and nurse practitioners of their authority to prescribe the pills, according to Bloomberg. Also, distributors would be required to store the drugs in special vaults.
The proposal—which FDA is not required to follow, though such recommendations are often central in final agency decisions—highlights that while both the parties voting for and against the measures agree opioid abuse is a problem worth tackling, their cohesion ends there.
It was the rampant abuse of Oxycontin that took pain medicine misuse to industrial proportions, notably opiate mills, noted Miroslav Backonja, MD, Medical Director CRI Lifetree in Salt Lake City. “That’s what really brought a bad name to pain medicine.
“One thing that’s really incredible is you have a medication like hydrocodone that was just prescribed here and there that became the most prescribed chemical in the United States,” he added.
That increase has been matched by soaring drug abuse in the US. A study by the Department of Health and Human Services found the rate of pain-reliever dependence grew from 936,000 in 2002 to 1.4 million in 2010 for those aged 12 or older. Further, a report published in July 2012 found that emergency department visits related to hydrocodone totaled 115,739 in 2010, more than double 2004 admissions, according to the Substance Abuse and Mental Health Services Administration. Two members of the House of Representatives plan to reintroduce a bill called the “Pill Mill Crackdown Act,” which also aims to make the medications harder to obtain, according to The Hill.
“The classification of opioids doesn’t stop misuse,” Edward Michna, director of the Pain Trials Center at Brigham and Women’s Hospital in Chestnut Hill, Massachusetts, said during the hearing. “Oxycotin is class II and it’s our most misused.” Instead, he said greater restrictions on hydrocodone might decrease patient access and cause a negative effect on doctors’ willingness to provide needed hydrocodone. The National Community Pharmacists Association has also spoke out against the measure because of the burdens they say it will put on all parties.
“It’s not an innocuous drug, so I think more regulation is necessary,” Dr. Backonja said. “To have open-ended refills on Vicodin … It just doesn’t make sense.”
He said he has shifted more to treating opiate abusers in recent years and has been struck by the ineptitude of the medical profession’s ability to assess people’s risk for developing addiction, and treatment of active drug addicts. He’s seen two extremes with little middle ground: physicians who prescribe the drug carelessly and those who vilify patients who complain on pain and level accusations of drug addiction.
“I work with people who became heroin addicts. The incredible part is how many of them discover they love opioids after just a single prescription of Vicodin for a sprained ankle or tooth extraction,” he said. It was remarkable, he added, when the prescribing physician “wouldn’t take a second and ask the patient, ‘What was the effect of the prescription?’ It’s really missing the opportunity to identify those at risk.
“If you talk to people who end up becoming heroin addicts they will tell you the first time [on opioids] was really like, ‘Wow! This is different!’”
Dr. Backonja believes the drugs can be administered safely, but says physicians need to approach it with the care they might with ailments that have more obvious side effects, such as avoiding infections in a hospital. Better patient care can be achieved by learning better clinical skills.
He says three points need to be raised by doctors: Did the prescription make the patient sick? Did it relieve the pain – did it achieve the goal of prescribing? Did it do anything else – did it make the patient feel funny or high?
“If it’s ‘yes’ then you can open the discussion about being careful with this drug because it can form addiction. If you talk to patients who end up going down the path of drug addiction you learn nobody ever told them anything. But they find themselves in this amazing world that they can’t get out of,” Dr. Backonja said. “I think this is welloverdue.”
“It’s kind of funny that marijuana is vilified as this gateway drug, but if you talk to people who are drug addicts, in terms of heroin abuse, marijuana is like drinking soda or drinking beer,” Dr. Backonja said.