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Hydrocodone-containing products becoming more strictly regulated
e-Reports, Sept. 22, 2014
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Effective Oct. 6, 2014, hydrocodone-containing products (HCPs) will be rescheduled as Schedule II Controlled Substances because of a new federal regulation. This will include HCPs such as Vicodin®, Lortab® and Norco®, formerly classified as Schedule IIIs.

Schedule II drugs are considered to have “high potential for abuse, which may lead to severe psychological or physical dependence.” For that reason, they are more heavily regulated than Schedule IIIs. Here are examples of the changes:

Verbal/phoned orders: Verbal/phoned orders: Not permitted (Except in emergency situations, with emergency doses, which are immediately reduced to writing and delivered to the pharmacy within 7 days. Indiana law limits emergency doses to 48 hours).

Faxing: Not permitted.

Permissible transmission formats:

  • Written on a hard copy, original tamper-resistant prescription pad (See in.gov for state requirements.)
  • E-prescribing (See here for state and federal requirements.)

Refills:

  • Not permitted for Schedule IIs (See “multiple prescriptions” below.)
  • Per the DEA, HCP prescriptions issued before Oct. 6 and authorized to be filled or for refilling may be dispensed if such dispensing occurs before April 8, 2015. However, health insurers may not honor the refills and pharmacies may not be able to refill them due to state law and their internal systems. (The ISMA has requested clarification from Indiana Board of Pharmacy.) Prescribers should be prepared for patients to need a new, written prescription in lieu of a refill.
  • HCP prescriptions written on or after Oct. 6 may not be refilled.

Multiple prescriptions: Permitted to cover up to a 90-day supply, when appropriate. Each prescription still must be “dated as of” and “signed on” the day issued and include written instructions on each prescription indicating the earliest date on which that prescription may be filled. At the end of the 90-day supply, patient must be seen again to receive another prescription. (See www.ismanet.org/go/DEA-multiRx for details.)

Other prescribers: Advance practice nurses and licensed physician assistants may still prescribe HCPs, but must remain consistent with their collaborative/supervisory agreements, respectively.

Other important reminders:

  • Physicians may not delegate their authority to make medical determinations about whether or not to prescribe.
  • Under state and federal law, all prescriptions must be issued for a legitimate medical purpose, in a reasonable quantity and in the usual course of professional practice by either a practitioner who has conducted at least one in-person medical evaluation of the patient or a covering practitioner.
  • Physicians must date and sign prescriptions the day issued.
  • Physicians may not delegate signature authority.

For questions, call the ISMA legal department at (800) 257-4762.

Copyright: Information written and displayed on www.ismanet.org is the property of ISMA and may not be reproduced without expressed written permission of the Indiana State Medical Association.

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