Hydrocodone: To reschedule, or not to reschedule?
The issue is gathering momentum on a national level
In January, FDA’s Drug Safety and Risk Management Committee voted 19–10 in favor of moving hydrocodone-containing medications from Schedule III to Schedule II. In March, the Safe Prescribing Act of 2013 was introduced to reclassify hydrocodone-containing drugs to Schedule II. The prospect of rescheduling these medications is stirring up a conversation among clinicians, especially physicians and pain management specialists.
Abuse, misuse, and diversion of controlled substances are competing with poorly controlled pain in legitimate patients. This competition is a public health crisis, according to Mary Lynn McPherson, PharmD, BCPS, CPE, Professor and Vice Chair Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy. Although good arguments exist on both sides, the prospect of reclassifying hydrocodone-containing products “may decrease the drug use but not necessarily the misuse or diversion.” She expressed concern about “the fate of legitimate pain patients.”
Some argue that the unintentional consequence of reclassification would be a decrease in patient access. For patients who live in rural areas, are not mobile, or do not have the means to visit their physician for a prescription, rescheduling could affect their pain management and burden them unduly. Others argue that rescheduling hydrocodone-containing products from Schedule III to Schedule II would curb the misuse, abuse, and diversion of the drug by limiting the number of tablets and capsules of hydrocodone in circulation. Believing that reclassification to limit access would make the problem go away would be “the most simplistic point of view in dealing with the drug diversion,” said Ernest Dole, PharmD, FASHP, BCPS, Clinical Pharmacist at the University of New Mexico Pain Consultation and Treatment Center in Albuquerque, NM.
As the issue gathers momentum on a national level, here’s a look at the experience of pharmacists in New York, where hydrocodone was rescheduled as part of a new state law.
New York’s I-STOP Act
While the proposed legislation in Congress would seem an unimaginably daunting task to enact, the state of New York has lived through that change. The Internet System for Tracking Over-Prescribing (I-STOP) Act was signed into state law by New York’s governor on August 27, 2012, and became effective February 23, 2013. The I-STOP Act included the reclassification of hydrocodone-containing drugs from Schedule III to Schedule II, with several patient waivers. “There was some confusion in the first month,” said Selig Corman, BSPharm, Consultant Pharmacist/Professional Affairs, Pharmacists Society of the State of New York (PSSNY). “All refills were canceled when patients arrived at the pharmacy to pick them up as usual.” Corman added, “After that first month, there were no serious problems, mainly because we had 6 months to get ready for it.”
Another part of the I-STOP Act is the mandatory registration of prescribers for the Prescription Monitoring Program (PMP) that is part of the Health Commerce System operated by the New York State Department of Health. Beginning August 27, 2013, prescribers are required to look up a patient profile through the PMP registry before prescribing any controlled substances. After reviewing PMP for the patient, prescribers who suspect diversion may report the prescription discrepancy or the Bureau of Narcotic Enforcement office. PMP also includes information about addiction treatment programs through the state’s Office of Alcoholism and Substance Abuse Services.
Pharmacists can register through PMP and review a patient’s profile to double-check if any prescriptions seem suspicious. The I-STOP Act “is not just about reducing drug misuse or diversion,” said Craig M. Burridge, MS, CAE, the former PSSNY Executive Director who is now CEO of the South Carolina Pharmacy Association. “It brings patients to seek help and opportunities for rehabilitation,” with $46 million in the budget set aside for that.
Education is vital
Understandably, grasping the various amounts and types of hydrocodone and other opioid products available on the market is difficult. Another issue is the insufficient number of pain specialists and addiction specialists in the United States, according to McPherson. “Educating practitioners about not only how to treat pain but also about how to screen people for potential drug abuse and diversion is important.”
Regardless of whether reclassification of hydrocodone-containing medications becomes reality for everyone, educating prescribers and patients is vital in reducing the misuse, overuse, or diversion of the medications.