Will FDA classify hydrocodone as Schedule III, Schedule II, or somewhere in between?
Up Front in Depth
Hydrocodone may be going the way of oxycodone, joining the latter on the Food and Drug Administration's Schedule II list of drugs. FDA’s Drug Safety and Risk Management Advisory Committee has voted 19 to 10 in favor of the reclassification. FDA rejected a similar request for reclassification in 2008.
Changes in prescribing process
According to the Drug Enforcement Administration, hydrocodone is the most frequently prescribed opiate in the United States, with more than 139 million prescriptions for hydrocodone-containing products dispensed in 2010 and more than 36 million dispensed in the first quarter of 2011.
If FDA adopts reclassification, hydrocodone fills would require an original, physician-signed, hard-copy prescription - an inconvenience for patients, who would have to pick up a prescription at their doctor’s office and bring it to a pharmacy - that may be filled only one at a time.
Under Schedule III, the present classification for hydrocodone, physicians can phone or fax in a prescription, which may be refilled up to five times without a doctor visit.
An exception to Schedule II regulations is emergency prescriptions; physicians are permitted to phone in a prescription for a three-day dose. The short-term prescription, however, needs to be replaced by a signed, hard-copy prescription.
One concern has been voiced by Ronna Hauser, vice president, regulatory affairs, National Community Pharmacists Association (NCPA), who said that a Schedule II classification might hold up prescriptions for those in real need.
Lynn Webster, MD, president-elect, American Academy of Pain Medicine, said that if FDA accepts the Advisory Committee’s recommendation, it will be more difficult for physicians to prescribe hydrocodone.
“Having to submit a written prescription instead of calling may force physicians to prescribe an alternative Schedule III drug, one less effective and potent,” Webster said.
However, Webster acknowledged, stricter rules are likely to make less of the drug available for diversion and nonmedical use.
A medical necessity
On the other hand, David Kloth, MD, board director, American Society of Interventional Pain Physicians (ASIPP), strongly supported the reclassification, saying, “We have to rein in hydrocodone’s use with the help of the government.” In his opinion, hydrocodone is just as potent as oxycodone.
In addition, Kloth told Drug Topics, hydrocodone is often compounded with acetaminophen, the protracted use of which can cause liver damage.
In his practice in Danbury, Conn., Kloth sees patients on hydrocodone at least every two months, at which time he conducts urine tests and monitors use. He allows most of his patients one refill before they must come in to see him.
While Kloth is not “antimedication,” he said, he knows it is important to maintain a balance between ensuring that those who need hydrocodone have access and those who are predisposed to addiction do not. He said prescribers need to be vigilant about identifying a potential abuser right away, monitoring continually and prescribing appropriate doses.
Between II and III
Not convinced that moving hydrocodone to Schedule II will achieve the desired effect, Webster recommended creating a drug classification that falls between Schedules II and III, in which the first prescription may be called in but refill requirements would follow Schedule II regulations.
Jeffrey Fudin, BS, PharmD, FCCP, adjunct associate professor of pharmacy practice at Albany College of Pharmacy and Health Services, has also proposed a compromise to Schedule II classification - one that would allow refills one at a time, capping them at five in a six-month period, which would give physicians sufficient time to study patient outcomes before making any changes.
Although FDA has not yet approved the reclassification, New York State put it on the books this past February. The change prohibits automatic refills and requires physicians to send prescriptions electronically.
More prescriber education
Although Fudin hasn’t taken a vehement stand on either side of the issue, he feels strongly that pain management education is insufficient.
He recommended that prescribers hone their patient-monitoring skills, improve their ability to interpret drug-screening results, and type their patients by risk stratification - smokers, sexual abusers, and alcoholics are among those at high risk for abuse - if they are going to be taking pain medication for any length of time.
Expressing its views on the issue of balance between appropriate access and potential misuse, abuse, and diversion of hydrocodone in a recent letter to the FDA Advisory Committee, the National Community Pharmacists Association (NCPA) recommended prescriber education, drug-monitoring programs, increased use of e-prescribing for controlled substances, safe drug disposal, and the dispensing by mail of limited quantities of controlled substances.
Mark Holtsman, PharmD, is co-director of inpatient pain services, University of California at Davis Medical Center. He advocates for instruction on effective pain-management practices - how to look for symptoms, analyze patient behaviors, detect potential misuse, and refer patients to appropriate treatment centers.
Holtsman has directed his criticism toward the distribution channel for analgesics, noting a lack of security that prevents some drugs from ever reaching a pharmacy and lands them instead in the hands of nonmedical users.
“Most physicians will adapt to changes if they keep patients safer,” Webster concluded.
Mari Edlin is a healthcare writer based in Sonoma, Calif.