Now, New York State has reclassified hydrocodone products into the controlled substance schedule II (C-II) category, effective on February 23, 2013.7 As is the case with other C-II narcotics, no refills are allowed on hydrocodone products. In addition, tramadol and all combinations of tramadol were moved to schedule C-IV status. In New York, prescriptions for tramadol (or other C-III through C-V medications) cannot be filled beyond six months of the date the prescription was written, nor can they be refilled more than five times. All New York State laws and regulations for a schedule IV controlled substance are to be followed.
The FDA has been meeting regularly to discuss the issue of rescheduling hydrocodone, and perhaps other opioids or opioid-like agents. In addition, the FDA issued a draft guidance on abuse-deterrent opioids in January 2013.8 This guidance is for manufacturers who hope to develop new opioid formulations. The draft guidance includes information on requirements for new agents in order to prevent abuse and misuse. The FDA hopes that this will encourage manufacturers to continue to produce opioids, but with abuse-deterrent formulations to decrease the prescription drug abuse problem.
Other solutions to tackling the prescription drug abuse epidemic include effective risk mitigation and evaluation strategy (REMS) programs for high-risk agents, proper medication disposal programs, better training of healthcare providers (e.g., prescribers and dispensers of opioids) to raise awareness of this problem, as well as educating parents, young people, and patients. In addition, law enforcement agencies are needed to help decrease drug diversion and abuse by shutting down “pill mills” and identifying and prosecuting other behaviors that enable prescription drug abuse.
Some believe that, if federal laws are changed to be similar to New York State law, many patients with chronic, nonmalignant pain who use opioids will have difficulty obtaining their medications.
Drug Safety
Galloway et al reported an increased risk of shingles and skin and soft tissue infections (SSSIs) in patients treated with tumor necrosis factor (TNF)–α inhibitors.9 A serious infection was defined as resulting in a hospitalization, requiring intravenous antibiotics, or causing death. Any postoperative infections occurring within 30 days of surgery were excluded. The researchers evaluated data from the British Society for Rheumatology Biologics Register, a prospective observation cohort study created in 2001, which enrolls all United Kingdom patients with RA that are prescribed an anti-TNF therapy. In the current evaluation, only treatment with adalimumab, etanercept, and infliximab were evaluated. Biologic anti–TNF therapy–treated patients were compared to a cohort of RA patients receiving nonbiological disease-modifying antirheumatic drugs (nbDMARD). All patients were biologic naive at study entry. Follow-up patient information was obtained every six months via a postal questionnaire from the patient and their treating rheumatology group. Shingles and SSSI were analyzed separately.
