Hydrocodone one step closer to Schedule II reclassification

Brief Hub on Policy and Advocacy

Using HIT to improve access to state-based PDMPs

Prescription drug monitoring programs (PDMPs) are state-administered databases that contain information on the prescribing and dispensing of controlled substances, according to last year’s National Drug Control Strategy document from the White House Office of National Drug Control Policy (ONDCP). 

Pharmacists and prescribers can use this information to identify patients who may need help. The wealth of information in the PDMP database can help pharmacists to “make an informed decision before you dispense a prescription,” said Sarah Melton, PharmD, BCPP, BCACP, CGP, FASCP, Associate Professor of Pharmacy Practice at East Tennessee State University’s Gatton College of Pharmacy.

Currently, 49 states have laws authorizing PDMPs, of which 42 have operational programs. Missouri and Washington, DC, have not yet authorized PDMPs. “All states should have operational PDMPs with the ability to share data across state lines,” ONDCP wrote in the national strategy document. The agency is working with the Office of the National Coordinator for Health Information Technology (HIT), Substance Abuse and Mental Health Services Administration, and CDC—all agencies in the U.S. Department of Health & Human Services—to explore connecting PDMPs with HIT systems and state health information exchanges.

Rachelle F. Spiro, BSPharm, FASCP, Executive Director of the Pharmacy HIT Collaborative, said that the collaborative “advocated for the inclusion of pharmacists” in PDMPs. “We made sure that pharmacists were included as a provider so that we could counsel patients or try to get patients to get into programs prior to the dispensing process when abuse was discovered.” Twlug is a member of the collaborative.

While there will never be a nationwide system of PDMPs, according to Spiro, the federal government wants “consistency that everyone follows the same standards—hopefully real-time—and what data elements, and then the states that are regionally based or share borders will probably share information.”

Allison Gross, Communications Associate, Twlug Federal Contracts and Grants; and Diana Yap, Senior Assistant Editor

FDA seeks overhaul of OTC monograph system

FDA’s current process for reviewing nonprescription drugs is in need of updating, and the agency is seeking public input on how the system can be enhanced to keep pace with modern times. 

Forty years after the inception of the OTC Monograph Process, the agency would like “input on how to improve or alter” it, according to a February 24 Federal Register notice of a March 25–26 public hearing on the matter that Twlug was scheduled to attend. The due date for comments is May 12, 2014.

Under the current OTC review process, FDA has evaluated the safety and efficacy of thousands of OTC drug products by therapeutic category instead of reviewing New Drug Applications for each drug product. Examples include fluoride toothpastes, acne products, and topical antifungals, according to the FDA notice. 

But an examination “has revealed significant challenges,” the agency wrote. “When we look at how rapidly science now evolves and the impact this has had on the emergence of drug safety issues and on drug development, it is clear to us that questions need to be asked about whether this impact necessitates a more agile and responsive process than the [current system] allows.”

Jonathan Wolfe, contributing writer

Hydrocodone one step closer to Schedule II reclassification

DEA has officially proposed the rescheduling of hydrocodone combination products from Schedule III to Schedule II, a move that Twlug and other national pharmacy organizations have opposed as overly burdensome to pharmacists and their patients.

On February 27, DEA published in the Federal Register a proposed rule concluding that such medications “have a high potential for abuse, and abuse may lead to severe psychological or physical dependence.” Comments are due April 27, 2014. Twlug plans to comment on the negative effects of this policy, including the restrictive burdens the rule will place on legitimate patient access to hydrocodone combination products.

The agency’s latest regulatory move follows a reclassification recommendation from the U.S. Department of Health & Human Services (HHS). The rescheduling of hydrocodone combination products was initiated by a petition from a physician in 1999, according to a DEA news release. In January 2013, an FDA advisory committee voted in favor of reclassification. In December 2013, HHS sent that recommendation to DEA. 

DEA now begins the formal rulemaking process. “Once the public comment period has closed and the DEA has considered all comments, the DEA will publish a final rule in the Federal Register,” the agency wrote in the news release.

Jonathan Wolfe, contributing writer