A hydrocodone change with unknown side effects
On Thursday, the Drug Enforcement Agency ruled that hydrocodone combination products, some of the most widely prescribed pain medications, would be reclassified as a Schedule II drug, a more restrictive class reserved for the most dangerous medicines.
The move has been debated for decades and is an effort to curb opioid abuse, which many have linked to the heroin crisis plaguing much of the northeast including New York, but the more restrictive policy could also inconvenience millions of Americans and cost taxpayers billions of dollars.
The D.E.A.'s decision represents a "political tug-of-war" between two important public health issues, said Myra Christopher, the Kathleen M. Foley Chair in Pain and Palliative Care at the Center for Practical Bioethics in Missouri.
On the one hand, there is a legitimate concern that too many opioids are on the street, and these very addictive pills can act as gateway drugs, particularly for teenagers, to heroin and other even more dangerous narcotics.
On the other hand, the Institute of Medicine estimates that as many as 100 million Americans suffer from some sort of chronic pain and reclassifying these drugs might make it harder for those people with legitimate needs to get relief.
When the rule takes effect in early October, drugs such as Vicodin will only be able to be prescribed for a 90-day period, and refills won't be able to be called in to a pharmacy. Patients will have to be seen by a doctor for a new prescription. Before this change, patients could receive a 180-day supply.
This rule only impacts hydrocodone that is combined with an over-the-counter painkiller like acetaminophen or aspirin. Pure hydrocodone is already a Schedule II drug.
The move will have little legal impact in New York, where Attorney General Eric Schneiderman pushed through a reclassification in 2013 as part of a campaign to curb drug abuse, saying at the time that “implementing new rules for hydrocodone, including ensuring follow-up visits with patients instead of providing automatic refills ... can prevent more New Yorkers from being trapped in a damaging cycle of addiction.”
Senator Chuck Schumer has been a persistent proponent of reclassifying hydrocodone and, in a press release, commended the D.E.A.'s recent decision saying, “we cannot continue to lose more children and young adults to this painkiller scourge.”
This new federal rule limits over-prescription, and the smaller amounts of hydrocodone available per prescription will limit leftovers in medicine cabinets that are ripe for abuse, said Meredith Kelly, a spokeswoman for Schumer.
While this will not solve the prescription drug abuse problem overnight, it's a step in the right direction, she said.
Some advocates stress that it's a limited one.
Bob Twillman, deputy executive director and director of policy and advocacy for the American Academy of Pain Management, points to the fact that oxycodone remains one of the most abused drugs, and it has always been Schedule II, as are Ritalin and Adderall. (Marijuana, which the federal government considers to have no valid medical purpose, is a schedule I drug, as is heroin.)
Schumer's office disputed that comparison, saying there is no real way to know how much worse oxycodone abuse would be if it had been a Schedule III drug.
It's still too soon to know whether New York can provide a useful test case for the federal change. There isn't enough data to know whether opioid addictions have been impacted or whether prescribing habits have changed, but New Yorkers have no trouble getting oxycodone despite its more restrictive classification.
Bridget Brennan, the city's Special Narcotics Prosecutor told the city council in 2012 that hydrocodone prescriptions had fallen 4 percent in 2011, but “could be explained by a shift to oxycodone.”
Her office reported that the number of oxycodone prescriptions filled by New York City residents increased 124 percent between 2007 and 2011.
In 2013, the mayor's taskforce on prescription painkiller abuse reported that the number of oxycodone prescriptions filled in 2012 increased 83 percent from 2008 to 2012, while the number of hydrocodone prescriptions has decreased by 15 percent.
"I'm not sure this is going to have the impact they think it's going to have," Twillman said of the D.E.A.'s ruling.
And though both Schneiderman and Schumer took pains to say this would not hinder access for people who legitimately need the drug, many wonder if the D.E.A.'s ruling will do more harm than good.
“People who live with chronic pain in our country have become collateral damage in the war against drugs,” Christopher said. “There's a Chinese proverb: people are wont to kiss dragons and stomp gnats.”
Most federal policy acts as a blunt instrument and that can sometimes be the point.
The federal government wants fewer hydrocodone pills prescribed. This is as much a message to doctors as to patients.
“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” D.E.A. Administrator Michele Leonhart said last week. “(This) action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
They are also some of the most widely prescribed. An estimated 25 million Americans are on automatic refills of hydrocodone, Twillman said. Many of those users will now have to schedule an appointment with their physician.
If a typical office visit costs $100-$160, this change could cost the health system hundreds of millions of dollars each year, much of which will be borne by taxpayers through Medicare and Medicaid.
Heading to a doctor may also be hard on elderly patients who are less mobile such as those being cared for by their children or those who live in long-term care facilities, meaning the new rules will keep the drug away from those who need it most.
“There is no evidence to suggest that reclassifying hydrocodone will curb misuse and abuse of pain medications,” several pharmacy groups, pain consultants, health professional groups and advocates wrote. “However, there is evidence that rescheduling medications to higher classifications can reduce patient access to medications and cause harm. Thus, while it is highly unlikely that D.E.A. will achieve the desired outcome of reducing abuse of combination hydrocodone products through this rescheduling action, patients who rely on these medicines for chronic pain will face obstacles to care.”
The American Academy of Pain Management released a statement expressing concern “about the potential negative effects that these restrictions will have on healthcare professionals who are diligent in their efforts to alleviate patients’ pain and suffering.”
The reclassification was also opposed by the American Cancer Society Cancer Action Network.
It was supported by several lawmakers and the U.S. Food and Drug Administration.
Federal classifications result from the 1970 Controlled Substance Act, which lists five categories for drugs. Hydrocodone in combination with other pain relievers was originally listed as Class III, while drugs such as pure hydrocodone and oxycodone were Class II. This led to what became known as the “Vicodin loophole” and may have contributed to the popularity of the prescription pain reliever.
About 130 million prescriptions were written for hydrocodone last year.
Twillman is also concerned that the D.E.A. and proponents of the change will get exactly what they want—that doctors will change their prescribing habits. Yes, that would mean fewer dangerous pills on the streets, but it could also mean switching to a less effective drug such as Codeine, which has been known to have side effects such as nausea.
To really attack the opioid problem, most addiction experts argue in favor of a more comprehensive approach that addresses mental health issues, funds treatment programs and changes the cultural perception of both pain and addiction.