New DEA Rules Aim to Balance Risks, Benefits of Prescription Painkillers

Prescription painkillers have been objects of increasing concern in recent years, blamed by the Centers for Disease Control and Prevention for a national epidemic of drug abuse. But starting next month, it will be more difficult to access certain pain medicines — thanks to a rule being implemented by the Drug Enforcement Administration.

The agency is taking aim at pain relievers that combine hydrocodone with other analgesics, such as Vicodin. Hydrocodone is currently the most commonly prescribed drug in the country. The move comes as Congress and the Food and Drug Administration try to address abuse of opioid pain relievers that often are obtained legally but then diverted for unapproved use.

Some pain management groups representing patients with chronic conditions and debilitating diseases are concerned lawmakers and officials will overreact and block access to needed treatments.

“It’s a complex problem, and a simple solution that just says, ‘Reduce the supply of medications,’ is not the answer,” said Bob Twillman, director of policy and advocacy for the American Academy of Pain Management. “You’re not only reducing the supply for those who use them inappropriately, but also for those in need.”

Groups such as Twillman’s have been less vocal in the prescription drug abuse debate, although some have raised concerns in public comments to the DEA or in messages to Congress.

“There are those who think we need to crack down even more, and there is a large number of people, but perhaps a less vocal group, that feel like that’s not the case,” said Helen N. Turner, president of the American Society for Pain Management Nursing and a pediatric clinical nurse specialist.

A Unique Challenge

Unlike combating illegal drugs such as heroin, the biggest challenge in reducing opioid abuse is stopping the diversion of drugs obtained legally, according to a Congressional Research Service report released earlier this year.

In October, the DEA will move the products to the more restrictive Schedule II class, meaning pharmacists cannot refill prescriptions, doctors must provide written prescriptions and manufacturers must store the drugs in electronically monitored safes. It also means illegal traffickers would face harsher penalties.

Although the DEA’s move is intended to make it harder to abuse painkillers, some pain management groups are worried it will cause more hardship for patients. People will have to see a doctor every time they need a refill or seek immediate care in the emergency room, both of which cost time and money.

“Millions have used hydrocodone for years and it has been effective in relieving their pain,” said Lynn Webster, a physician and former president of the American Academy of Pain Medicine. “This change in scheduling will threaten their ability to have access to their medicine.”

Certain nurses who had previously been able to prescribe drugs such as Vicodin will no longer be able to once the products are moved to Schedule II, which means some people will have to find new doctors, and physicians could become overwhelmed by new patients.

There is also mounting concern that physicians will have to prescribe painkillers in larger quantities to compensate for the new restrictions on refills. Andrew Gurman, an orthopaedic hand surgeon and speaker of the House of Delegates for the American Medical Association, pointed out that some of his patients have to travel two hours to see him. He said the rescheduling rules will force him to change the way he prescribes those medications.

“Ultimately, that puts more pills out in circulation,” he said. “There are some instances in which the new rule will have its desired effect, but I think there are some unintended consequences, too.”

The Growing Epidemic

The CRS report estimates that 6.8 million people currently abuse prescription drugs, with 4.9 million abusing pain relievers and 15,000 dying every year from pain pill overdoses — more than from heroin and cocaine combined. Those rates have been steadily climbing over the past decade, according to the Substance Abuse and Mental Health Services Administration.

The epidemic has been partly linked to a push by the medical community in the 1990s to more aggressively treat pain. Stephen Patrick, a neonatologist and assistant professor of pediatrics and health policy at Vanderbilt University, said, “We’ve made pain the fifth vital sign,” which he attributes to the uptick in overprescribing.

Last year, the FDA approved a controversial and powerful new painkiller, Zohydro ER. But backlash over the product has heightened awareness of the prescription drug abuse epidemic. Some anti-addiction groups called for the resignation of FDA Commissioner Margaret Hamburg over the drug’s approval, while many lawmakers urged its withdrawal from the market.

“The perception is that these opioid painkillers are safe and effective, but the way they’re currently being used is causing harm throughout our health system,” said Patrick, who has specialized in helping infants who are born addicted to opioid painkillers. “We need policies that target them. I think the response of making them more restrictive is a good step.”

Searching for Solutions

Lawmakers have introduced a wide range of bills to address the prescription drug abuse epidemic. Some legislation (HR 672, S 348) would set training requirements for those prescribing methadone and other opioids; one measure (HR 4709) would alter the process for revoking or suspending registrations for controlled substances; and another (S 1277) would establish a commission to review and recommend federal initiatives to reduce prescription drug abuse and diversion rates.

The FDA has already made safety labeling changes, encouraged the development of drugs to treat opioid overdoses and recommended rescheduling for certain drugs. FDA spokesman Jeff Ventura said another area the agency plans to target — which pain management groups and lawmakers should be able to coalesce around — is the development of more tamper-resistant and abuse-deterrent drugs.

Rep. William Keating, D-Mass., introduced a bill (HR 486) last February that encourages companies to create tamper-resistant formulations for commonly abused painkillers. Such medications aren’t as rewarding for abusers, because they lose their effectiveness when crushed, snorted or injected.

However, Twillman said half the people who abuse prescription drugs swallow them, so it is not a slam-dunk solution.

Pain management groups point to a variety of other ways to help solve the problem, including better patient storage of medications, greater treatment of substance abuse disorders, more monitoring of electronic health records in order to prevent “doctor shopping” and enhanced education for physicians prescribing opioids.

Turner agreed there are many other steps that can be taken instead of just rescheduling or reducing the supply of certain pain relievers. “I think there are lots of tools needed,  . . .  instead of just putting a Band-Aid on the problem,” she said.