It’s going to be more difficult to refill prescriptions for the most popular painkillers starting Monday, when new federal rules move products with hydrocodone into a stricter drug class reserved for the most dangerous and addictive substances.

In approving the change, the Drug Enforcement Administration cited the 7 million Americans who abuse prescription drugs and the 100,000 overdose deaths from painkillers in the last decade. Hydrocodone combinations, including Vicodin, Lortab and Norco, now account for more prescriptions than any other drug, with more than 130 million filled each year.

Proponents of the new rules believe many prescriptions go to younger people for recreational use because they are less likely to suffer from arthritis or other chronic pain conditions. Painkiller overdoses have overtaken car crashes as a cause of death for Americans ages 35 to 54.

But many doctors, pharmacists and patients say the rule change effectively punishes people suffering from pain conditions because a small minority of the population abuses the drugs. The changes will be most burdensome for patients with cancer, disabilities and those who live in rural areas or in nursing homes, advocates say.

“For some patients who are legitimately using hydrocodone products for pain, this will be more challenging for them,” said Amy Tiemeier, associate professor at St. Louis College of Pharmacy. “For physicians, the hassle will make them think twice about whether it’s really necessary to prescribe this drug or maybe they should prescribe something else that has less addiction potential.”

NEW LIMITS

The changes mean:

• Prescriptions for hydrocodone combination painkillers can only contain a 30-day supply.
• No refills will be allowed.
• Each prescription must be handwritten by a doctor, not called in or faxed to a pharmacy.
• Only doctors can write the prescriptions, not nurse practitioners, physician assistants or other midlevel providers.
• “This is going to have a big impact on our practice,” said Dr. Robert Swarm, chief of pain management at Washington University. “Every time you prescribe a medication, the doctor has to sign a piece of paper, and the patient has to get to the pharmacist. In a lot of situations, that’s difficult to put together.”

Previously, doctors could prescribe a 30-day supply of hydrocodone combination drugs with up to five refills. Under the new classification, there is some flexibility for postdating prescriptions to allow for a 90-day supply, and doctors may be able to call in emergency short-term prescriptions for an injury or other acute need. But pharmacies don’t have to agree to those concessions, doctors said.

“The spirit of (the new rule) is every time the medicine is dispensed, the doctor is supposed to make a conscious review of the case and a decision to write a new prescription,” Swarm said.

That could lead to more emergency room visits or an even bigger black market for people seeking painkillers. And patients who decide to self-medicate with over-the-counter drugs run the risk of liver damage from taking too much.

Now there won’t be many options for prescription painkillers in the less-restrictive classifications. Tylenol with codeine won’t be as tightly controlled, but the drug’s effects are more variable and potentially more risky compared to hydrocodone products, Swarm said.

PATIENT BURDEN

The tighter restrictions place a logistical and financial burden on patients with cancer and those with limited mobility by requiring more frequent doctor and pharmacy visits, patient advocates said.

“It’s a quality of life issue for patients with cancer,” said Keysha Brooks-Coley, director of federal relations for the American Cancer Society’s Cancer Action Network. “Patients will have more difficulty in accessing these types of drugs that they need. Patients deal with pain even when they finish treatment.”

Before the 1990s, chronic pain was not widely recognized as a legitimate medical condition, and doctors were more stingy with prescriptions of narcotics. Improved advocacy and research led to the idea of pain management as both a medical and quality of life issue for many patients with chronic health conditions. Laws governing narcotics became less restrictive, particularly for long-term use. But at the same time, prescription painkiller addictions and overdose deaths soared.

Now the medical community is again questioning the need for addictive pain medicines. In a new position statement, the American Academy of Neurology took a hard stance against the use of the drugs for many patients.

“The risk of death, overdose, addiction or serious side effects with prescription opioids outweigh the benefits in chronic, noncancer conditions such as headache, fibromyalgia and chronic low back pain,” reads the group’s statement.

The group cited research showing that half the patients who take the drugs for three months will still be on them in five years, and said there is no evidence that the drugs are effective at maintaining pain relief in the long term. The nonprofit National Safety Council is now telling doctors to recommend ibuprofen, an anti-inflammatory medicine, over prescription pain relievers in what it considers a safer and more effective choice.

When the government solicited public comments for the rule change, just over half were supportive. Most of those opposed were pharmacists and patients who use the drugs. Many pharmacists supported less-drastic changes to combat abuse, including improvements to electronic monitoring programs. Missouri is the only state that doesn’t track prescriptions; tracking allows pharmacists to identify doctors and patients who abuse the system.

The National Fibromyalgia and Chronic Pain Association commented that the new rule will have unintended consequences because “the sheer number of people affected by addiction is much smaller in comparison to the number of people suffering with life-altering, disabling, serious chronic pain who need access to pain relief.”

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