Beginning October 2014, all hydrocodone combination products will be reclassified and more strictly regulated. We sat down with Robert Hutchison Jr., Pharm. D., and John Bowman, M.S. Pharm., both faculty members at the Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy, to learn more about this reclassification and what it means to us as consumers.

Q: What products are we talking about?

A: According to the Texas Pain Advocacy Committee, pain is the most common reason that Texans access the health care system; and hydrocodone products and combination hydrocodone and acetaminophen products are among the most prescribed products in the U.S. As such, there are several hundred brands and generic products affected by this change.

Hydrocodone combination products contain hydrocodone, an opioid pain reliever and cough suppressant, in combination with other medications. Some combination products, such as Lortab®, Lorcet®, Norco®, and Vicodin®, contain hydrocodone and acetaminophen and are used to treat pain. Some combination products, like CodiCLEAR DH, contain hydrocodone and guaifenesin and are used to treat coughing associated with colds and flu.

Q: What are hydrocodone products now classified as?

A: The U.S. Drug Enforcement Agency (DEA), responding to the 2012 Food and Drug Administration Safety and Innovation Act, reclassified hydrocodone combination medications from Schedule III to Schedule II.   Schedule III drugs are defined as drugs with moderate to low potential for abuse, whereas Schedule II drugs are defined as drugs with a high potential for abuse. The move, announced in a federal notice this month, comes more than a decade after the DEA first recommended reclassifying hydrocodone due to its risks for abuse and addiction.

Q: I have a prescription for hydrocodone, what should I do?

A: Only prescriptions issued before Oct. 6 and authorized for refills may be dispensed, as long as such dispensing occurs before April 8, 2015. After Oct 6, the ruling allows a practitioner to issue multiple Schedule II prescriptions to provide up to a 90-day supply of medication. In addition, no verbal or faxed prescriptions will be allowed. Prescriptions may not be refilled without visiting with the health care professional first.

It is worth mentioning that individuals who use hydrocodone and other analgesics in the class called opioids are many times not seen by the prescriber for long periods. Seeing the health care professional for ongoing pain and monitoring analgesic effects provides for better care and helps prevent diversion.

Q: When will this ruling take effect?

A: The rule was published on Aug. 22 and becomes effective 45 days after this date.

Robert Hutchison Jr., Pharm.D., associate professor of pharmacy practice for the Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy, published several studies in pain management research, and also serves on the Texas Pain Advocacy and Information Network’s multidisciplinary committee. 

John Bowman, M.S., Pharm.D., associate professor of pharmacy practice for the Texas A&M Rangel College of Pharmacy, has been a practicing pharmacist since 1976, served on a chronic pain team, and served as a hospice pharmacist in pain relief. He also serves on the Regional Health Awareness Board representing the Coastal Bend area. 

— Cheri Shipman

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