Anesthesia Management: FDA, DEA Crack Down on Hydrocodone-Combo Drugs

The AMA opposes the reclassification of hydrocodone combination products, but placing tighter prescribing rules on drugs such as Vicodin and oxycodone sends a strong message to physicians about the drugs’ high potential for abuse.

The combination of a new federal law placing stricter requirements on prescription drugs containing hydrocodone and a new statement criticizing the effectiveness of long-term use of opioids, such as hydrocodone, for chronic pain may be a one-two punch in the battle to reduce deaths and addictions to these powerful and easily accessed painkillers.

Beginning October 6, hydrocodone combination products (HCPs), such as Vicodin, will be reclassified as schedule II drugs. Vicodin joins methamphetamine, methodone, oxycodone, and others drugs in this classification, which falls under more restrictive prescribing rules because they are all defined as having a “high potential for abuse.”

Hydrocodone by itself is already listed as a schedule II drug. The new law applies to hydrocodone combo drugs that are used to manage pain, which are the most prescribed opioids in the U.S. HCPs are also one of the most abused prescription drugs.

According to the Centers for Disease Control and Prevention, more than half of deaths caused by drug overdoses involved prescription drugs, and 74% of the time, the drug associated with the overdose was an opioid painkiller.

The reclassification of HCPs into the more restrictive class of schedule II controlled substances is a direct result of the overdose deaths left behind in states like West Virginia, which has one of the highest rates of prescription drug overdose.

Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing (PROP), and chief medical officer for Phoenix House, a drug and alcohol addiction organization in 13 states calls the new classification a hard fought victory for patients.

“We are very strongly in support of this change,” says Kolodny. “It’s probably the single most important intervention on the federal level we can do to bring this crisis under control.”

The new rule affects how much and how often HCPs can be prescribed. For example, prescriptions can no longer be called or faxed in by a physician, except in emergency situations that allow for a 72-hour supply. Written prescriptions are required in all cases, even emergencies. Doctors must follow up with a written prescription after the emergency script has been phoned in for fulfillment.

Another effect that will be immediately felt (and complained about) is that prescription refills prior to October 6 may not be honored. There are provisions that allow for refills that were issued prior to the effective date, but the American Medical Association is warning that some insurance companies may not pay for the refills, and that states with stricter schedule II laws may not be able to fill prescriptions written before October 6.

“We’re concerned a patient will show up at a pharmacy with a legitimate prescription and that the pharmacist won’t fill it, and the patient may not be able to get to their doctor immediately to get a written prescription,” says Andrew Gurman, MD, speaker of the AMA’s House of Delegates and an independent orthopedic hand surgeon in Pennsylvania.

“[Prescriptions] are supposed to be honored for six months, but we’re not sure all states will allow that,” says Gurman.

The AMA opposed the change because of unintended consequences such as the scenario Gurman describes. He also says the reclassification of HCPs places a burden on patients if they have to travel to see a physician.

“I am a hand surgeon, and in some cases, I’m the only one for 100 miles,” he says. “This may put me in a situation where I prescribe more pills. I don’t want to do that.”

The reason Gurman believes that he may put more pills in circulation than he’s comfortable with is because of the strict no refill requirement, except in certain circumstances that allow for a physician to write multiple prescriptions that total 90-days.

“My practice is to write a prescription with one refill, so what do I do? Prescribe with no refill or write multiple prescriptions with no refill dates? We’re very concerned about the opioid epidemic in this country, but this rule is an attempt to solve it from the supply side. We favor a multi-pronged approach.”

The AMA believes solving the problem requires funding for the treatment of addiction, patient and physician education, and an increase in what are called “takeback” programs that offer opportunities for people to safely dispose of unused and expired prescription medications.

While PROP and the AMA are on opposite sides of the fence on their support of the reclassification, the American Academy of Neurologyrecently released a position paper on the effectiveness of opioids for chronic pain.

Using opioids to manage pain long term is controversial because the drugs are highly addictive and have been believed to be effective at reducing acute pain. No one disagrees that opioids are addictive, but there is dispute over their long-term effectiveness.

In the paper the AAN released this week, author Gary Franklin, MD, MPH, a research professor of environmental and occupation health sciences at the University of Washington, concluded that “there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction.”

A New England Journal of Medicine study made similar conclusions more than 10 years ago, yet it didn’t curb prescribing patterns. That is what PROP and Zolodny hope this new classification will do.

“The change will be a burden for pharmacists, pharmacies, and some doctors,” says Kolodny.

“The paperwork to track it is very burdensome. It’s also a headache for the physician. Opioids are an essential class of medicine for end of life care and they’re very good for acute pain for a few days, but the incorrect scheduling has led to massive overprescribing. We have to prevent new people from getting addicted. It sends a strong message to the medical community to rein it in.”