FDA Urges Tighter Control for Painkillers

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COLUMBIA - The Food and Drug Administration is proposing new restrictions that would put tighter control on some of the most commonly prescribed narcotic painkillers on the market.

The move follows a decade long debate over whether widely abused drugs should be controlled as strictly as more powerful painkillers such as OxyContin. The proposition specifically targets hydrocodone combination pills, also known as opioids, which combine hydrocodone with less potent painkillers such as acetaminophen or aspirin. These are often sold either as generics or under brand names like Vicodin or Lortab. Doctors use these medications to treat pain from injuries, arthritis, dental extractions, and other problems.

An anonymous source, who experienced spinal fusion in January 2010, said the doctors continuously prescribed pain medications which left her with an addiction. "That's how a lot of people that are addicted find themselves in this situation," she said. "What starts out innocently becomes a problem." She battled a drug addiction for over three years. "If it becomes harder to get a prescription from doctors, people may look for other ways of getting it whether that means through the Internet, Black Market, or on the streets."

The Drug Enforcement Administration (DEA) classifies drugs and their prescribing rules into categories called "Schedules" based on a medication's use and potential for abuse and addition. In the 1970's, drug companies successfully argued to Congress that Vicodin and other similar products should be categorized as Schedule III, which is less restrictive, because the use of over-the-counter drugs like acetaminophen or aspirin in them would reduce their misuse and increase their effectiveness.

Patients can get refills for a Schedule III drug for as long as six months before seeing a doctor again, twice as long as for a Schedule II drug. Also, drugstores face tighter and more costly storage and record-keeping requirements for Schedule II drugs. If the reclassification proposal is accepted, they will be labeled as Schedule II. Other drugs, such as Adderall and morphine, are also in this category.

The change means patients would have to have a written prescription from a doctor and take it to a pharmacy, rather than a prescription submitted over the phone, to access the drugs.

Bill Morrissey, a pharmacist and owner of Kilgore's Pharmacy, said these changes could cause a lot of patient outcry. "Just in our clientele we have many individuals who are homebound whether that's someone who has been in a car accident and has mobility issues or an elderly person," he said. "For them to have to go to the physician every month to obtain that prescription rather than being able to have it called in I think will be a major inconvenience for them and I don't think they'll like that."

Along with changing how doctors prescribe these drugs, there will also be added storage and recordkeeping requirements on pharmacists. In some states, nurse practitioners and other health care professionals who currently have the ability to prescribe drugs containing hydrocodone may no longer be able to do so.

For years, FDA officials had rejected recommendations from the DEA and others for stronger prescribing controls as a method to curb drug abuse, saying the action would create unnecessary hardship for patients. A number of doctors' groups, including the American Medical Association and pharmacy organizations, have continued to fight the measure, referring to the effect on patients. Last year, lobbyists for druggists and chain pharmacies rallied to overturn a measure passed in the Senate that would authorize the types of restrictions that the FDA is now recommending.

"We're getting to the time of year where we have what I call "snowbirds" which are individuals who live in Missouri in the warmer months and maybe go to Florida or Texas for the colder winter months," Morrissey said. "In that instance they have to make arrangements if they're taking a medicine to either find a physician where they're staying or find a way to arrange having a hard copy actually mailed to them. If someone has to travel a lot, lets say overseas for their job, that would present some other issues. If the supply that they can get is smaller and they have to get the prescriptions more often that's going to cut down their window of travel."

Currently, a patient can refill a prescription for these painkillers five times during a six month period before needing a new prescription. The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription.

Concerns remain about the huge number of overdoses involving prescription painkillers during the last decade. According to 2011 congressional testimony from the American Society of Interventional Pain Physicians, roughly 80 percent of the world's pain medications are consumed in the United States. Since 1999, sales of these painkillers in the U.S. have quadrupled along with the number of fatal poisonings due to the drugs. Based on a news report released by the DEA nearly twice as many people abuse prescription drugs as the number of people abusing cocaine, heroin, hallucinogens, and inhalants combined.

Missouri is currently the only state that doesn't have a prescription drug-monitoring program, which would allow doctors and pharmacists to access a database to see clients' prescription history. Morrissey says the program would be beneficial. "In the world that we live in we also live with a little bit of skepticism which is unfortunate for the honest patient," he said. "Because it's such a prevalent problem I think that most practitioners are on guard to try to detect that ahead of time."

The FDA's proposal will be submitted to the Department of Health and Human Services by early December, but the DEA has the final decision on whether to reclassify the drugs.