FDA panel recommends tighter controls, rescheduling as Schedule II
LEXINGTON, Ky. (Feb. 18, 2013) — In January, an advisory panel of the Food and Drug Administration recommended tighter controls and greater scrutiny be placed on hydrocodone, one of the most widely abused pain medications in the United States, by reclassifying it from Schedule III to the more restrictive Schedule II.
Hydrocodone, an opioid painkiller (often combined with non-opioid analgesics and sold under various trade names, including Vicodin and Lortab) is the single most commonly prescribed medication in the United States, with more than 120 million prescriptions last year. It is also one of the most commonly diverted drugs.
Abuse of prescription pain pills, including those containing hydrocodone, has become a serious public health and law enforcement problem, particularly in rural, low-income areas — and notably in Eastern and Central Kentucky.
Sharon Walsh, director of the University of Kentucky’s Center on Drug and Alcohol Research, gave expert testimony at the meeting that led to the up-scheduling recommendation.
Walsh, a professor in the UK College of Medicine with appointments in Behavioral Science, Psychiatry, and Pharmacology and Pharmaceutical Sciences, is a researcher specializing in substance dependence disorders, including opioid abuse. She has led pharmacological studies focused on developing new medications for the treatment of opioid use disorders, as well as improving the utility, safety and application of existing medications. She has also conducted studies evaluating opioids and related compounds for the potential to be abused.
“The FDA invited me as an outside expert to summarize the available human data on the pharmacological profile of hydrocodone,” Walsh said. “We had conducted two of the critical studies here at UK that characterized hydrocodone when taken orally, and also when used intravenously, by comparing it to other common opioids with high abuse potential, such as oxycodone, morphine and hydromorphone.”
Those studies showed that hydrocodone was virtually indistinguishable from other opioids placed in Schedule II. These findings were in contrast to the information originally used in the 1970s when the decision was made to place hydrocodone combination products into Schedule III.
Walsh was initially appointed to the FDA as a special government employee in 2008. She has served as a consultant on various advisory committees. More recently, she has been invited by the FDA to speak as an outside expert to inform committee deliberations by presenting data on opioid pharmacology in humans.
The January meeting, of the FDA Advisory Committee on Drug Safety and Risk Management, was convened because the federal Drug Enforcement Administration had petitioned the FDA for a public hearing on up-scheduling hydrocodone combination products to Schedule II.
Drugs placed in Schedule II have more stringent requirements for prescriptions and controls over supply. One difference is that a Schedule II prescription must have a paper prescription written by the physician, which means a visit to the doctor’s office, and cannot be “called in” by phone, Walsh explained.
Schedule II prescriptions are also usually written for only a maximum 30-day supply. Currently, hydrocodone prescriptions may be written with up to a six-month supply. This would mean more visits to the doctor would be required for those requiring long-term treatment.
By making the controls more restrictive, it is very likely that the absolute numbers of prescriptions will be reduced, Walsh says.
“Just last month, we heard at a meeting in Frankfort that prescriptions for hydrocodone had already declined secondary to the introduction of House Bill 1, which enforces the use of the KASPER (Kentucky All Schedule Prescription Electronic Reporting) prescription monitoring program for hydrocodone combination products,” she said.
Epidemiological studies reveal that rates of abuse, drug dependence treatment admissions and overdose deaths increase proportionately with sales. It is likely, Walsh says, that decreasing availability will have a positive impact on rates of abuse of hydrocodone. However, there are also potential drawbacks to consider.
“The downside is that patients who have a legitimate need for these products for pain relief may have a more difficult time accessing them,” Walsh said. “In some states, mid-level providers, such as physician assistants and nurse practitioners, may be licensed to prescribe Schedule III agents but not Schedule II. Thus, if the change were enacted, some providers who could previously prescribe for their patients would be unable to do so.”
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