To make it harder to get certain prescription drugs illegally, the government is making it harder to get them legally.
A rule from the U.S. Drug Enforcement Agency, which takes effect Monday, reclassifies hydrocodone-based drugs — which include widely prescribed painkillers such as Vicodin and Lortab — into a new, more restrictive category.
The change means that doctors will be allowed to only prescribe the drugs in intervals of 30 days or less, for no longer than 90 days total. If patients need more medication they must visit their doctors for a new prescription, as opposed to the current practice of having refills called in to a pharmacy.
DEA officials say the new rule will more closely regulate hydrocodone-based medications, which are easily converted to street drugs in what has become a national epidemic of prescription drug abuse.
But some worry that the result for patients will be more pain, greater inconvenience and higher costs.
“It’s done with good thoughts, but unfortunately you’re going to have patients who legitimately need their medications who are going to run into barriers,” said Tim Musselman, executive director of the Virginia Pharmacists Association, which opposed the new classification.
Before the rule took effect, patients could have their pills refilled automatically as many as five times, covering up to six months.
Last year, health care providers wrote nearly 128 million prescriptions for hydrocodone-based drugs, making them the most frequently prescribed medications in the United States, according to IMS Health, a global information and technology services company.
However, what is a popular pain reliever for everything from toothaches to wrenched backs is also an easy way for abusers to get high, who sometimes crush the tablets and snort the powder on the way to becoming hooked.
In Western Virginia, police say misuse of prescription painkillers is a major source of crime and addiction.
The region saw 185 deaths from prescription drug overdoses in 2012, the most recent year for which numbers are available from the state medical examiner. Hydrocodone played a role in 77 of the deaths.
“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” DEA Administrator Michele Leonhart said in a written statement when the new rule was announced in August.
In Southwest Virginia and elsewhere, prescription drug abuse has been linked to a rising problem with heroin, which is a cheaper alternative to pills that addicts often turn to when their money runs low.
Authorities say many of the prescription painkillers on the black market get there through doctor shopping, a practice in which abusers go to multiple physicians and feign injury or illness, accumulating a cache of ill-gotten pills.
Against that backdrop, the new rule makes sense to Dr. Trevar Chapmon, a Roanoke physician and board member of the Roanoke Valley Academy of Medicine.
“There’s always a concern that when you start making regulations that have broad effects, you’re going to have some unintended consequences,” Chapmon said. “However, with the problems we have in Southwest Virginia with opioid abuse, and overprescribing, I think it’s a necessary move.”
Still, he acknowledged that “it’s going to be a headache for some patients. It’s going to be a headache for some physicians.”
In a letter to the DEA written when the rule was still under consideration, the Virginia Pharmacists Association wrote that it would “complicate the care of patients that are in need of proper pain management while having little impact on those who abuse the system.”
Among the concerns: Patients will be forced to endure pain while waiting for an doctor’s appointment for a new prescription, some physicians might balk at prescribing hydrocodone after it’s grouped with more potent drugs by the DEA, and lower-income patients will struggle to pay more co-payments and travel costs for additional doctor appointments.
And with an existing shortage of primary care physicians, the new regulations “may cripple an already overtaxed system,” seven national pharmacy associations wrote in a letter to the DEA.
DEA officials counter that the new rule means, at most, that someone who has been seeing their doctor twice a year must now go four times a year to maintain the same regimen of painkillers.
“It’s really a misunderstanding on the doctors’ part if they say, ‘I can’t do this anymore,’ ” said Barbara Carreno, a DEA spokeswoman.
After taking public comments on the proposed rule change and getting support from the Food and Drug Administration, which had previously opposed the move, the DEA moved forward in August after nearly a decade of deliberations.
The change it made was to a part of the Controlled Substance Act that ranks drugs in five categories, or schedules. Schedule I drugs are those that have no federally approved medical use and are considered the most dangerous, such as heroin, LSD and marijuana.
Schedule II drugs include illegal narcotics such as cocaine and methamphetamine, as well as medications with the highest potency and potential for abuse — oxycodone, Dilaudid, Demerol and fentanyl among them.
It is in this category that the new rule puts hydrocodone-based drugs, which previously had been Schedule III drugs. (Pure hydrocodone was already a Schedule II drug, but smaller amounts of hydrocodone mixed with acetaminophen or other non-narcotic ingredients had appeared one level down in the five-schedule list.)
In addition to restricting prescribing practices for hydrocodone-based drugs, their reclassification to Schedule II increases the possible criminal penalties for those convicted of abusing them.
Having hydrocodone-based drugs in the same category as OxyContin, which has been blamed for rampant abuse and addiction in Southwest Virginia, might give some physicians pause.
“It puts the physician in an awkward situation of wanting to treat pain, but not wanting to get in trouble or be labeled as an over-prescriber,” said Dr. Edwin Polverino, president of Primary Care Associates, an independent medical group with offices in Roanoke and Salem.
“You could argue that you are setting up an adversarial relationship with every patient who walks into the office,” he said. “They [physicians] have to look at every patient seeking chronic pain medication as if they are a drug seeker.”
But patients at PCA should not notice any changes under the new rule, Polverino said, because doctors in his practice have been treating hydrocodone-based drugs as if they were in the Schedule II category for the past decade, ever since OxyContin hit the market.
Whether it’s a Schedule II or III, he said, “Every one of us who is conscientious has a little anxiety when we prescribe these drugs.”
