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Issue Background

Rescheduling Hydrocodone

SPPAN Position

SPPAN recognizes that hydrocodone-containing combination products may be over-prescribed, especially in the treatment of acute pain. There are several reasons for this, including inadequate prescriber education about pain management; a paucity of resources for providing other, non-pharmacological, types of pain care; inadequate reimbursement for integrative pain care; and cultural attitudes that focus on seeking immediate and total relief from pain by virtue of taking a medication. We are concerned about the consequences of this rescheduling and are closely monitoring the situation so that we can advocate effectively for people living with high impact pain, and their providers.

Coming soon: A survey written to assess challenges encountered during the first 100 days after hydrocodone rescheduling.  This survey is for people with pain who use affected medications, and will allow us to gather helpful information so we can advocate appropriately for improved access to care.  Please check back in the coming days for a link to this survey.

On October 6, 2014, hydrocodone was moved from a Schedule III medication to a more tightly restricted Schedule II opioid medication. This means that prescriptions for these drugs now:

  1. Require a written prescription, and may not be phoned or faxed to the pharmacy (except in very limited areas where secure electronic transmission of prescriptions is possible);
  2. May not be automatically refilled by the pharmacy; and
  3. Are subject to more stringent security rules in pharmacies.

You may view the new rules in the Federal Register here and read the DEA's statement here.

More Background:

On Friday, January 25, 2013, the US Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee voted 19-10 to recommend that FDA move pain medications containing hydrocodone in combination with other medications (most commonly known as Vicodin, Lortab, or Norco) from Schedule III to Schedule II under the Controlled Substances Act. This vote was the culmination of action that began in 1999, when a citizens’ petition was filed with the US Drug Enforcement Administration (DEA) requesting that such a move be made. The FDA has decided to follow the committee’s recommendation—and as stated above, this was official on October 6, 2014.

Stricter regulations and increased oversight from DEA regarding opioid medications have changed both how doctors prescribe this medication for their chronic pain patients, and the role of pharmacists in this equation. While pharmacists have had “corresponding responsibility” related to the prescribing and dispensing of controlled substances since 1971, this concept has been highlighted in the past few years in the light of DEA sanctions requiring pharmacy chains to pay millions of dollars for failure to monitor the number of controlled substances filled.

SPPAN advocates for effective methods to address the complex—and tragic—societal problems resulting from the misuse, abuse, and diversion of controlled substances.  However, as with any complex issue, there is no obvious or clear answer.  We do believe, however, that with this schedule change now limiting access to these medications to deter illegal activities, the DEA and law enforcement agencies need to understand the resulting unintended, negative consequences to people with chronic pain legitimately seeking pain relief.   This is where advocacy efforts are essential!  SPPAN is working in collaboration with other organizations to aggregate data regarding the calls and emails from people with pain with access problems in order to gain a better understanding of the breadth of the issues and specific challenges, both across the country and locally.

With the official change from the DEA, all states are now required to comply with the federal policy.  SPPAN will continue to monitor state level legislation related to this issue, such as the “scope of practice” bills allowing practitioners the ability to prescribe Schedule II in states where they previously weren’t able to do so.  We also strongly advocate for patients and their providers to discuss the importance of safe use, storage, and disposal of controlled substances prescribed for pain.  It is essential that everyone does their part to address public safety.

Resources:

Pain and the Politics of Hydrocodone, by Stephen Ziegler, PhD, JD, Painview, Vol. 10, No. 1, Spring 2014 (link coming soon)

Rescheduling Hydrocodone article (LIVESTRONG)

Statement on Zohydro (4/14/14; American Academy of Pain Management)

Moving hydrocodone-containing combination products into Schedule II means we will somehow need to accommodate an additional 26 million new prescriptions and associated office visits into our already-overburdened healthcare system.