The U.S. Drug Enforcement Agency recently published a rule that places a more-restrictive classification on hydrocodone combination products, or HCPs. These products are now being reclassified from the more-permissive Schedule III to the more-restrictive Schedule II category.
The rule will take effect Monday, October 6.
We caught up with Andy Boothe, Director of Pharmacy, Ochsner Baton Rouge, to see just what this is all about:
What are HCPs? Hydrocodone Containing Products
What does this reclassification mean and why is it happening? Hydrocodone products are the most widely prescribed and widely abused on the market. Before the reclassification, prescriptions for HCPs were valid for one year and could be written with available refills. After the reclassification, prescriptions for HCPs may be written for up to a 90 day supply, are only valid for six months from the issue date, and may not be refilled. Patients will have to get a new prescription each time.
Prescriptions issued prior to October 6, 2014 may be refilled as written but will become invalid on April 8, 2015. Prescriptions issued on or after October 6, 2014 will be subject to the new restrictions.
Why? – The debate over the classification of HCPs has gone on for 15 years. Because of the rise in opioid addiction and the related emergency room visits and deaths, it was determined that it is an issue of public safety.
Why is it important to put particular drugs into more-restrictive categories? Typically, the category assigned corresponds to the potential for abuse.
Why are some entities opposed to this change? The change will create additional burdens on providers and patients. Since no refills are allowed for Schedule II medications, patients with chronic needs will have to request a new prescription each time. This will also create additional burden for the providers and staffs to process these additional requests. The more stringent controls on manufacturers, distributers, pharmacies, and providers will also increase the costs of managing HCPs.
Can we anticipate this same type of change with other drugs in the future? At this point, I do not know of any other medications being considered for a change.