Countdown to October 6, 2014: Hydrocodone Containing Product Reclassification
As discussed previously here on the Baer Law Blog, after more than a decade of debate, hydrocodone containing products (HCPs) are being reclassified from Schedule III to the more restrictive Schedule II controlled substances category starting October 6, 2014.
HCPs are the most prescribed drug in the United States, second only to levothyroxine, a thyroid medication commonly sold under the brand name Synthroid or Levoxyl. In 2012, over 135 million prescriptions for HCPs were sold. Levothyroxine was the only other medication to surpass the 100 million prescription mark.
What does the reclassification of HCPs to Schedule II mean for health care providers, specifically pharmacists?
Here are some key points for pharmacists (and other health care providers):
1. Refills are not allowed for prescriptions that are written beginning Monday, October 6, 2014. New Schedule II hard copy prescriptions or certified electronic Schedule II prescriptions should be issued for all HCPs. Pharmacists must use extra due diligence when addressing all HCP prescriptions starting on October 6, 2014, as this will likely be an area of immense focus during future State Board of Pharmacy audits.
2. Prescriptions issued before Monday, October 6, 2014 will not necessarily qualify for refills, so plan on obtaining new prescriptions for HCPs. The new rule allows refills to be issued on prescriptions issued before October 6, 2014, and until April 8, 2015 (i.e., the six-month rule for Schedule III refills), but more strict state specific laws could prevent patients from receiving those refills since some states have proactively published notices that they will treat HCP prescriptions issued before October 6, 2014, in the same manner as prescriptions issued after the new rule’s implementation date. Thus, the more stringent state pharmacy law will govern and the refills for a prescription written prior to October 6, 2014 should not be honored.
3. Schedule II prescriptions cannot be faxed or called in, though some emergency circumstances may apply. Pharmacists are generally prohibited from filling Schedule II prescriptions delivered verbally or via fax, so new hard copy prescriptions will need to be written by providers. An exception is the emergency treatment rule which allows physicians to call in a limited quantity of the medication to cover the emergency period, generally up to seventy-two hours only. Pharmacists are required to report prescribers if the prescribers of emergency Schedule II controlled substance do not provide the pharmacist with a written prescription within seven days.
4. Some non-physician health care professionals (physician assistants or nurse practitioners) may not be able to write prescriptions for Schedule II controlled substances. Pharmacists should verify that the prescribers of HCPs have the appropriate prescriptive authority to issue prescriptions for Schedule II controlled substances. Again, all pharmacists must use due diligence to ensure all prescribers have Schedule II prescriptive authority as this will likely be another area of focus for all State Boards of Pharmacy in the near future.
5. Multiple prescriptions may be issued at one time under certain circumstances. Under the new rule, a patient may receive new prescriptions totaling a 90-day supply if the prescriber, in his or her professional medical opinion and in accordance with medical standards, determines that it is appropriate to see the patient once every three months. However, each prescription must be written with instructions specifically detailing the earliest refill date.
6. Educating all patients on the new HCPs requirements and processes. All health care providers should make sure each patient understands that HCPs cannot be refilled due to the new DEA rule. Pharmacists, however, will likely be the primary educators when patients have questions regarding prior HCP prescription refills and HCP requirements and processes going forward.
While pharmacies have had forty-five days to prepare for the new rule, there is bound to be confusion for the first few days or even weeks after implementation of the new rule. Pharmacists, however, should take extra precautions to ensure that all HCPs are filled under the strict Schedule II controlled substance requirements and any applicable more stringent state laws, if needed.
Contact Baer Law with any questions or issues.