DEA Classifies Tramadol as a Schedule IV Controlled Substance

Krystle Vermes
Published Online: Thursday, August 21, 2014
Follow Pharmacy_Times:
As of August 18, 2014, the Drug Enforcement Administration (DEA) has officially placed tramadol, a centrally acting opioid analgesic, into schedule IV of the Controlled Substances Act.
 
In the past, it was widely believed that tramadol had a better safety profile than other opioid analgesics. Now that the drug has been deemed a Schedule IV substance, however, health care professionals may be less likely to prescribe it to patients for pain.
 
Within the first 2 years of the drug’s approval for use in the United States, between 2 to 3 patients out of every 100,000 were abusing tramadol, experts found. Researchers also discovered that patients were susceptible to suffering from opioid-like withdrawal symptoms after stopping tramadol treatment. In fact, 40% of the adverse effects associated with tramadol are linked to discontinuation of the painkiller.
 
In 2010 alone, more than 16,000 visits to the emergency room were documented as resulting from the use of tramadol for non-medial purposes.
 
This past June, the United Kingdom decided to place tramadol under strict restrictions. Several states have been implementing laws of their own to schedule tramadol as a controlled substance. As a result, the level of exposure to the drug has dropped in those areas.
 
Now that the DEA has stepped in, there is potential for the amount of tramadol exposure to decrease across the nation as a whole.
 
“As confirmed by the association, current distributors of tramadol are DEA registrants with existing controlled substance storage that complies with DEA regulations,” the agency explained in its declaration. “The DEA understands that handlers of tramadol may need to make modifications to their current security procedures for compliance. These modifications necessary for security compliance will be a 1-time modification to provide for the appropriate storage, revision of operating procedures, training of staff, and amendments to suspicious order monitoring systems to include customer verifications.”
Related Articles
Prescription opioid dispensing and overdoses decreased after abuse-deterrent oxycodone hit the market and propoxyphene left it.
Deaths related to oxycodone overdose dropped 25% in Florida after the state adopted a Prescription Drug Monitoring Program to track controlled substance dispensing.
The FDA today expanded the indication of Allergan’s onabotulinumtoxinA (Botox), allowing the drug to be used for the treatment of upper limb spasticity in adults.
In addition to relieving pain, acetaminophen may cause patients to experience less intense emotional responses.
Latest Issues
  • photo
    Pharmacy Times
    photo
    Health-System Edition
    photo
    Directions in Pharmacy
    photo
    OTC Guide
    photo
    Generic Supplements
  • photo
    Pharmacy Careers
    photo
    Specialty Pharmacy Times
    photo
    Generic
$auto_registration$