News
Frances Correa/IMNG Medical Media
Winifred Landis, temporary member of the advisory committee and pharmacist with CVS/Caremark Pharmacy.
Winifred A. Landis, R.Ph., a pharmacist in Lafayette, Ind., said that the recommendation for rescheduling was "a knee jerk reaction" and that when prescribed and used appropriately, hydrocodone combination products should remain as schedule III drugs. "Those who are addiction-seeking will find other medications that are available, whether it’s clonazepam, alprazolam, or hydrocodone, and at the same time we’re going to reduce access for those who really need the medication for pain."
Almost all (99%) of hydrocodone used in the world is in the United States, where hydrocodone combination products are the most widely prescribed products: In 2011, there were about 131 million prescriptions for the combination hydrocodone analgesic products, for 47 million people, compared with 34.6 million for oxycodone combination drugs prescribed for 15.1 million patients, according to national prescription data cited by the FDA. About 40% of the hydrocodone combination analgesics are prescribed by primary care practitioners.
Because of indiscriminate prescribing, rogue pain clinics, leftovers in medication cabinets, and other sources, "there’s so much hydrocodone on the street it’s getting into the wrong hands," Joseph Rannazzisi, the deputy assistant administrator in the Drug Enforcement Administration’s office of diversion control, said at the meeting. He described these drugs as a gateway drug to harder drugs for teenagers, who tend to combine it with benzodiazepines and muscle relaxants.
The FDA’s analysis of the national data indicates that hydrocodone products are widely abused. High school students are more likely to abuse hydrocodone products than oxycodone products, because there are so many more hydrocodone prescriptions and wider availability of leftover drugs in homes. However, hydrocodone combination products have lower abuse ratios than oxycodone combination products, according to the FDA reviewers, who acknowledged that calculating accurate abuse ratios is complicated
Panelists strongly recommended close study of the impact of the scheduling change on prescribing practices, abuse, and diversion. There should be a transition period in the rescheduling process so patients with appropriate needs for the drug and prescribers can adjust to the tighter regulations and avoid losing access to the drug abruptly.
Currently, there are 81 products that contain up to 10 mg of hydrocodone per dosage unit with acetaminophen or ibuprofen, and 12 cough suppressant products that contain up to 10 mg of hydrocodone per dosage unit, with chlorpheniramine, homatropine, or pseudoephedrine, according to the FDA. Hydrocodone alone is a schedule II drug, but there is no single-ingredient hydrocodone product available. In December another FDA advisory panel voted against approval of an extended-release, single-ingredient hydrocodone formulation, largely because of what they considered an enormous potential for abuse once it became available.
Parents and other family members of people who had committed suicide or died of overdoses related to hydrocodone products also testified at the meeting, including several who had testified a month earlier at the meeting on the extended-release hydrocodone product, calling for tighter controls on the drug.
Dr. Olbrisch, Dr. Morrato, Dr. Kaboli, Dr. Nelson, Dr. Mendelson, and Ms. Landis are committee members. The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. While a panelist may be given a waiver, none were granted at this meeting.