DEA Places Strict Sanctions on Hydrocodone to Crack Down on Opioid Abuse

Katie Eder, Senior Editor
Published Online: Friday, August 22, 2014
Follow Pharmacy_Times:
Drugs that contain hydrocodone will be moved to a more restrictive category of the Controlled Substances Act.

In an effort to curb rampant opioid abuse and addiction, the Drug Enforcement Administration (DEA) is imposing stricter regulatory sanctions on hydrocodone, the most frequently prescribed painkiller in the United States.
“Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart in a statement released Thursday. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
Under the new rule, which will be implemented on October 6, 2014, drugs that contain hydrocodone, such as Vicodin, will be moved from Schedule III of the Controlled Substances Act to the more restrictive Schedule II, where substances with the highest potential for harm and abuse are classified.
Nathaniel Katz, MD, MS, assistant professor of anesthesia at Tufts University School of Medicine, told The New York Times that the move is “substantial” and “a sign of a shift toward more cautious opioid prescribing.”
“This will be an inconvenience to some, but policy is a machete, not a scalpel, and you have to figure out where to use it,” Dr. Katz continued. “I think people will be more helped than harmed.”
According to the Associated Press, the new rule comes more than a decade after the DEA first recommended moving hydrocodone to Schedule II. Although the FDA originally opposed the move, arguing it would burden health care providers and patients, the agency reversed its position last year, recognizing the record growth in opioid-related overdoses.
In the AP story, the advocacy group Physicians for Responsible Opioid Prescribing (PROP) praised the DEA’s action, but criticized the FDA’s inaction throughout the last decade.
“Had FDA responded in a timely and appropriate manner to DEA’s urgent request, thousands of overdose deaths and tens of thousands of cases of opioid addiction might have been prevented,” PROP said.

Related Articles
Tighter hydrocodone regulations meant to reduce opioid abuse are hindering pain patients’ access to the products.
In response to a recent resurgence in fentanyl abuse, the DEA today issued a nationwide alert about the dangers of the drug, describing it as a threat to health and public safety.
Almost all New York pharmacists are prepared to accept only electronic prescriptions for controlled substances, but 94% of prescribers are not prepared to issue them.
Orexo has recently announced that the 8.6-mg/2.1-mg dosage strength of its partial opioid agonist, buprenorphine and naloxone (Zubsolv), is now available in the United States.
Latest Issues
  • photo
    Pharmacy Times
    Health-System Edition
    Directions in Pharmacy
    OTC Guide
    Generic Supplements
  • photo
    Pharmacy Careers
    Specialty Pharmacy Times