Opioids

6 things you need to know about hydrocodone reclassification

If you prescribe hydrocodone combination products, prescribing these medications to the patients who need them to alleviate pain just became more complicated. A new rule from the Drug Enforcement Administration (DEA) taking effect Oct. 6 reclassifies these drugs as Schedule II controlled substances, prohibiting refills and establishing other restrictions that will require major changes to prescribing practices.

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These are the six key points you need to know so you can take appropriate action over the next few weeks:

  • Refills aren’t allowed for prescriptions that are written beginning Oct. 6. Be prepared to issue new hard-copy or electronic prescriptions for patients. Note that eScripts can only be used if state law permits and the prescriber is certified to ePrescribe Schedule II substances. Pharmacies also must be certified to accept eScripts for controlled substances.
  • Prescriptions issued before Oct. 6 won’t necessarily qualify for refills; plan to issue new ones. Although the DEA rule allows refills of prescriptions issued before Oct. 6 until April 8, 2015, other factors could prevent patients from getting those refills. Several states have published notices that they will treat hydrocodone combination product prescriptions issued before Oct. 6 in the same way they will handle prescriptions issued after the rule’s implementation date. In addition, any state laws that are more stringent than the DEA rule will govern refills. Meanwhile, some pharmacy quality and safety processes may not allow refills for prescriptions issued before Oct. 6, and some health insurers will not pay for those refills.
  • Prescriptions can’t be called in or faxed. Make sure to plan ahead for any patients who may need refills. The new rule prohibits pharmacies from filling prescriptions delivered over the phone or via fax, so you’ll need to issue written scripts. The only exception to this rule is emergency treatment, which would allow physicians to call in a limited quantity of the medication to cover the emergency period only. Pharmacies are required to report prescribers to the DEA if they make such a request and do not give the pharmacy a written prescription within seven days.
  • Allied health professionals might not be able to write prescriptions for these drugs going forward. Check your state’s restrictions around Schedule II substances to confirm whether any non-physician members of your team who have prescriptive authority will be able to continue issuing prescriptions for hydrocodone combination products. You may need to modify your collaborative practice agreements accordingly.
  • Multiple prescriptions may be issued at one time under certain circumstances. The new rule does allow a patient to receive prescriptions that would total a 90-day supply, if the prescriber has determined it is appropriate to see the patient only once every 90 days. Each prescription must include written instructions that specify the earliest date it may be filled. In addition to sound medical judgment and established medical standards, make sure to base your practice’s policy on issuing multiple prescriptions on relevant federal and state laws.
  • Patients should be notified of the new requirements and processes. Make sure your patients understand that their new prescriptions will not be refilled and are aware of the procedures they will need to follow going forward.

Download a printable fact sheet (log in) containing this information as well as details about how the new rule will impact patients and pharmacists for a convenient office reference or handout.

“The AMA is strongly committed to combating prescription drug abuse and diversion while at the same time preserving patient access to medically necessary treatments for pain,” AMA President Robert M. Wah, MD, said in a news release. “This new fact sheet explains how new regulatory changes impact both physicians and pharmacists, which will help ensure patients continue having access to the care they need under the new federal rule.”

The AMA and other groups have warned the DEA about the potential unintended consequences of reclassifying hydrocodone combination products since the agency made the proposal early last year. Eliminating phoned-in prescriptions and refills could make it difficult for some patients to get the pain relief they need, especially patients in nursing homes and those with persistent pain and disabilities.

Visit the AMA’s Web page on combating prescription drug abuse and diversion under “federal agency and administration activities” to learn more about this advocacy work.