sutures newsletter

PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY September 2014 | Archived Issues

P and T Approvals, Changes for Hydrocodone, Tramadol

Pharmacy Focus

See highlights of the Aug. 5 meeting of the Pharmacy and Therapeutics Committee. Also, the U.S. Drug Enforcement Administration is more strictly controlling hydrocodone combination products, and more details are available about tramadol's new status as a controlled substance.


Mark Your Calendar


Surgery Grand Rounds

Click the "read more" to see information about upcoming Surgery Grand Rounds.


Grand Rounds

Click here to view a schedule of all upcoming grand rounds.


Educational Schedule

Click the PDF link below to see the Department of Surgery's educational schedule.

Educational Schedule - September 2014 (PDF)


Surgery Scheduling

Click the "read more" for hours and contact information for surgery scheduling.

Share Your News

Know an interesting colleague we should profile? A story we should tell? Submit your ideas, meetings and events for consideration.

Click here to submit your news to Sutures

P and T Approvals, Changes for Hydrocodone, Tramadol

Pharmacy Focus

Highlights of the Aug. 5 meeting of the Pharmacy and Therapeutics Committee are summarized in the PDF link below. Also, the U.S. Drug Enforcement Administration (DEA) is more strictly controlling hydrocodone combination products, and more details are available about tramadol's new status as a controlled substance. 

P and T Committee Approvals - Aug. 5, 2014 (PDF)

Hydrocodone Products in Schedule II as of Oct. 6

The DEA is placing all hydrocodone combination products into Schedule II of the Controlled Substances Act. The products have been in Schedule III.

The new, stricter classification takes effect Oct. 6. It applies to medications including Norco, Vicodin, Hycodan and Lortab.

Schedule II prescriptions cannot be transmitted by telephone order. The maximum supply is 30 days per prescriptions, and prescriptions are not refillable. Patients will need a new written prescription from the prescriber for each fill beginning Oct. 6.

Prescriptions must be signed and dated in the prescriber's handwriting to be valid.

Details About Tramadol's Classification as a Controlled Substance

Tramadol has been used as a substitute for other opioids. In 2013, 43.8 million prescriptions for tramadol were dispensed in the United States. Tramadol is a synthetic opioid analgesic used for the management of moderate to moderately severe pain.

Tramadol has traditionally and incorrectly been considered a drug of little abuse potential. Similar to other opioids, it binds µ-opioid receptors while also inhibits norepinephrine and serotonin reuptake.

As of Aug. 18, 2014, the DEA placed tramadol (also known by the brand name Ultram) into Schedule IV of the Controlled Substances Act due to an increase in abuse of tramadol products over the last few years.

Tramadol is extensively metabolized by N- and O-demethylation, glucuronidation or sulfation, and CYP3A4 and CYP2D6:

  • Higher tramadol concentrations in poor metabolizers of CYP2D6
  • Multiple significant drug-drug interactions

Similar to opioid withdrawal, abrupt discontinuation may lead to symptoms such as anxiety, insomnia, sweating and tremors. Tapering tramadol may be prudent to avoid withdrawal symptoms.

For discharge prescription, a prescription written on secure paper or called in to a pharmacist is required before the medication can be dispensed.

The usual dosage range:

Immediate release50-100 mg every 4-6 hours (maximum dose 400 mg/day)
Orally disintegrating tablet50-100 mg every 4-6 hours (maximum dose 400 mg/day)
Extended release100-300 mg once daily (maximum dose 300 mg/day)

 


References

  • Ultram (tramadol) package insert. Raritan, New Jersey: Ortho-McNeil Pharmaceutical Inc.; revised March 2008.
  • Ultram ER (tramadol extended release) package insert. Titusville, New Jersey: Janssen Pharmaceuticals Inc.; revised July 2014.
  • Rybix ODT (tramadol) package insert. Florham Park, New Jersey: Shionogi Inc.; revised August 2011.
  • Schedules of Controlled Substances: Placement of Tramadol into Schedule IV. Drug Enforcement Administration. Federal Register. 2014;79(127):37623-30.

Previously in Sutures:

Tramadol Is Now Managed as a Controlled Substance (Pharmacy Focus, August 2014)