FDA Proposing New Controls on Most Commonly Abused Opioids

Opioids are synthetic pain relievers and Americans take more of them than anyone else in the world. The United States represents only five percent of the world’s population and yet we consume 80 percent of the world’s opioid painkillers, with national use quadrupling since 1999. Now the Food and Drug Administration (FDA) is attempting to curb that problem by making the pills harder to get.

Hydrocodone is one of the pain relievers currently in the FDA’s sights. Most of the Hydrocodone prescribed here in the U.S. is cut with acetaminophen, the key ingredient in Tylenol. It’s also one of the most often abused prescription drugs. The FDA would like to see this form of Hydrocodone re-categorized so that it would be more difficult to get.

The Drug Enforcement Agency (DEA) categorizes medications and drugs according to a schedule. There are five schedules under which drugs are placed according to several specific descriptors, including whether or not a drug has an established medical use, whether it holds potential for abuse and how high the risk for addiction. Drugs with high abuse and addiction risks are more tightly controlled.

Today, Hydrocodone with acetaminophen is Schedule III but the FDA would like to move it to Schedule II, meaning doctors could no longer phone in prescriptions for the drug to the pharmacy, with patients instead needing a handwritten prescription.

The rescheduling would also eliminate automatic refills so patients would need to see the doctor for a new prescription. Pure Hydrocodone is already listed under Schedule II. The FDA proposal, which is due before the Department of Health and Human Services in December, only affects the mixed form of the drug, frequently sold under the brand name Vicodin.

Most doctors follow recommended guidelines when prescribing pain relievers to their patients. Doctors want to control patient pain because doing so helps speed up healing. It’s possible that doctors would circumvent imposed restrictions by prescribing a larger number of pills initially. That’s why, in addition to the tighter controls on patient access, some are suggesting a reexamination of prescription guidelines.

Former President Bill Clinton, during an on-camera interview, suggested that Americans have developed a culture of dependency wherein expectations about pain control are inflated. The disproportionate amount of pain medication being taken by Americans suggests that he may be correct as it’s a habit with dire consequences.

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The Pain of Addiction

Vicodin addiction often starts innocently enough. Most people start taking Vicodin or other pain medications after surgery or an injury. But then they can’t stop. They need more to get the same pain relief. They start doctor shopping to get more pills. And the cycle continues until it takes over their lives.