The continued availability of OTC dextromethorphan depends on convincing safety experts that less restrictive measures than scheduling DXM as a controlled substance will sufficiently reduce abuse.

FDA will ask the Drug Safety and Risk Management Advisory Committee at a meeting Sept. 14 to recommend whether to schedule DXM under the Controlled Substances Act - a move that would eliminate OTC access to the drug.

The request comes at the behest of the Drug Enforcement Agency as a potential way to stop teenagers from "robo-tripping" - a term inspired by the hallucinatory effects of excessive doses of DXM, an ingredient in more than 100 cough and cold medicines, including Pfizer's Robitussin (¹ Also see "FDA Risk Panel DXM Meeting Raises Stakes on Age Restriction Movement" - Pink Sheet, 10 May, 2010.).

The committee will base its scheduling recommendation on whether the pharmacology and epidemiology data sufficiently demonstrate that DXM has abuse potential and, if so, if a particular population is at risk for abuse, according to briefing documents FDA released Aug. 30 (see ² Also see "Extent Of DXM Abuse May Not Support Scheduling" - Pink Sheet, 6 September, 2010. ).

FDA will also ask the committee to discuss how effectively the Consumer Healthcare Products Association's education efforts reduce DXM abuse, and how the committee would modify the program.

The agency also asks what other measures could reduce DXM abuse and misuse and how these efforts would affect the drug's availability and patient care, according to meeting materials.

The committee's recommendations are non-binding, but FDA and DEA will consider them when deciding whether to schedule DXM as a controlled substance.

A Tough Sell

Convincing the committee to spare DXM from becoming a scheduled drug based only on the efficacy of CHPA's education campaign could be a tough sell. FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research in background materials for the meeting include a scathing review of the DXM educational materials on CHPA's main website.

According to the reviewers, educational material about dextromethorphan on CHPA's website is not easy to locate, is marketed insufficiently, does not target all affected audiences and is not user-friendly.

Reviewers looked at CHPA's Dextromethorphan and Stopping Cough Medicine Abuse webpage, which is part of the trade group's main website.

The webpage is part of "an awareness campaign to alert parents and educators about the potential misuse and intentional abuse of over-the-counter cough and cold medicines that contain dextromethorphan by teenagers and young adults," the reviewers note.

They criticize the "limited distribution or 'marketing' of the website," arguing "a parent or educator would have to seek out information about cough medicine abuse and then hope they stumble upon the website in their search."

The reviewers also complain that the website is "very busy" and DXM material "is sporadic" and not in a designated location. They argue users could "become frustrated," "lost" and "give up searching."

Finally, they complain the website targets only parents and educators, but should target tweens and young adults as well because "as teenagers get older, peer influence becomes a greater influence on adolescent substance abuse than parental influence."

The reviewers suggest CHPA create a webpage designated specifically for DXM educational materials that is identified clearly, easily accessible and includes multifaceted educational resources targeted at a variety of audiences.

Education Campaign Goes Beyond Website

The "educational efforts extend far beyond CHPA's website," said spokeswoman Elizabeth Funderburk.

She noted CHPA already has a designated website on DXM abuse - stopmedicineabuse.org - but FDA looked at the group's main website, used mainly by members.

Stopmedicineabuse.org "also has a function to spread the word, connect with StopMedicineAbuse on Facebook, or follow us on Twitter," Funderburk said.

"We also have a consumer destination on WebMD to bring information to parents about cough medicine abuse, and a teen focused peer to peer site (DXMstories.com) that provides information on the health risks of dextromethorphan abuse and showcases real-life testimonials from teens who have abused - and from their parents," she added.

CHPA organized these strategies, and others, into a four-phase "dextromethorphan abuse mitigation plan," that the trade group outlines in background materials submitted for the upcoming meeting.

Phase one, which began in 2003, involved gathering data about the extent of DXM abuse.

In the second phase, CHPA reached out to parents, caregivers and teens to raise awareness and reduce abuse. This phase included placing a sticker on cough medicines warning about teen abuse, creating the Five Moms Campaign, public service announcements, town hall meetings and downloadable educational materials for school nurses (³ 'The Tan Sheet' Oct. 26, 2009 and ⁴ Also see "CHPA’s “Five Moms” Uses Web To Lead Latest Public Service Campaign" - Pink Sheet, 14 May, 2007.).

The third phase identified what motivates abusers and laid the foundation for the fourth and final phase, which is planned to launch in 2010 and will "target at-risk teens' perceptions and attitudes, bringing all the learnings and programming together from the previous phases," according to CHPA.

This phase will include a website targeted at older teens and include videos of peers dissuading each other from trying DXM that the trade group hopes will "go viral." The website also will be "optimized ... to reach sensation-seeking teens as they are 'researching' possible drugs to abuse," CHPA says.

Since CHPA and others launched education campaigns seven years ago, the self-reported DXM abuse rates by grade-schoolers has stayed relatively flat, said Steve Pasierb, president and CEO of the Partnership for a Drug-Free America.

Targeted Online Campaigns Deliver

Pasierb noted that targeted online education campaigns are the best way to discourage young adults from abusing DXM because they often seek information about cough medicine abuse online before trying it.

He added that a national advertising campaign would be inappropriate because DXM abuse is "a relatively small behavior in contrast to other drug abuse and you don't want to end up promoting it" to people who did not know about it.

Education May Not Be Enough

Not everyone agrees that education is enough to stop DXM abuse - no matter how extensive and well-targeted a campaign may be.

Education in general is a "low level" and "not long lasting" strategy to curb intentional misuse of a drug, said Allen Vaida, executive VP at the Institute for Safe Medication Practices. Vaida is a permanent member of DSaRM advisory committee and plans on serving at the Sept. 14 meeting (⁵ Also see "Wolfe Absence May Have Disarming Effect On DXM Safety Panel" - Pink Sheet, 30 August, 2010.).

He noted in an interview before he received the background materials that "education campaigns are necessary [and] effective if you keep repeating them, but are more effective if you can match them with higher level strategies," such as limiting the quantity of the drug available in containers or restricting sales to behind the counter.

Vaida voted to restrict pack sizes of acetaminophen products available OTC at the advisory committee meeting in June 2009 that considered the liver toxicity and safety of the analgesic. Three other existing permanent members of DSaRM voted similarly (⁶ Also see "Lower Acetaminophen Doses Recommended Despite Cost Impact, Lack Of Data" - Pink Sheet, 6 July, 2009.).

The committee likely will discuss similar restrictions to complement education efforts in response to FDA's request for additional measures that could further reduce abuse and misuse of DXM. Such measures could spare the drug from controlled scheduling.

One such measure CHPA lobbies for is restricting the age of consumers who can buy DXM containing OTC products legally. Limiting sales to older consumers could make it more difficult for young adults to obtain and misuse the ingredient.

Legislation Sens. Dick Durbin, D-Ill., and Chuck Grassley, R-Iowa, proposed in 2009 to restrict the sale of DXM-containing products to consumers 18 years and older has remained stuck in the Judiciary Committee.

CHPA also supports restricting the sale of bulk DXM to manufacturers, pharmacists and researchers.

A bill Rep. Fred Upton, R-Mich., introduced to restrict the sale of bulk DXM moved out of the House to the Senate in April 2009, but has not moved from Senate Health, Education, Labor and Pensions committee (⁷ Also see "DXM Distribution Legislation Clears House And Moves To Senate Again" - Pink Sheet, 6 April, 2009.).

Vaida acknowledged such measures likely would be more effective than education alone.

- Elizabeth Crawford ( ⁸ e.crawford@elsevier.com )

FDA Panel To Weigh DXM Education, Sales Restrictions Against Scheduling

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