BTC report garners little industry interest, for now

BTC might as well stand for back to the chalkboard for all the interest the Government Accountability Office’s updated report on a behind-the-counter class of drugs generated among consumer publications or Congress last month. In the week following the release, no consumer dailies covered the event, based on a query through the Nexis search engine, which includes more than 600 American dailies in its database.

And neither of the Congressmen who last year requested the survey—Michigan Democrats John Dingell and Bart Stupak—made a comment on the release. Both Congress leaders and the Department of Health and Human Services typically receive a preview copy of the GAO report approximately one month prior to its public release. To date, neither the HHS’ Food and Drug Administration, which rekindled the BTC debate with a public meeting in November 2007, nor Congress leaders have announced any plans to pursue this issue further.

All that suggests that the debate over a third class of drugs in this country is on the back burner, at least for now, as Congressional leaders and consumers struggle with more immediate concerns, such as how to afford the medicines in today’s two-class drug system.

Part of any lack of interest may have been the absence of any firm conclusions in the report, which specifically examined whether or not a BTC class of drugs would impede or expand access to medicines in this country, and represented an update from a similar report the GAO conducted in 1995.

“The impact of restricted nonprescription drug classes on availability is unclear,” the report stated. “Pharmacist-, infrastructure- and cost-related issues would have to be addressed before a BTC drug class could be established in the United States. For example, ensuring that pharmacists provide BTC counseling and that pharmacies have the infrastructure to protect consumer privacy would be important,” the report concluded. “Issues related to the cost of BTC drugs would also require consideration. For example, the availability of third-party coverage for BTC drugs would affect consumers’ out-of-pocket expenditures and pharmacists’ compensation for providing BTC services would need to be examined.”

Compensation of that pharmacist is a key issue for many of the pharmacy and pharmacist associations that have cautiously embraced a pharmacist-class of drugs. And the GAO report helped frame any future debate around that pharmacist-patient interaction, supporting the contention that pharmacist intervention merits healthcare value, and therefore ought to be duly compensated.

“The time involved for the pharmacist to work with the patient [should] be compensated,” affirmed Harry Hagel, SVP government and professional affairs at the American Pharmacists Association. And it’s not because a reimbursed third-class consultation would create a new revenue stream for the business of pharmacy, but rather that consultation would deliver measurable savings to overall healthcare costs. “We really see the BTC class as a potential to be part of [President Obama’s] health reform process,” Hagel added.

According to the GAO report, proponents of a BTC drug class emphasize the potential savings a BTC class of drugs would deliver as a result of the fewer physician visits and the lower drug prices that might result from such switches.

Opponents argued, the GAO reported, that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs, much like most payers today don’t cover OTC medicines. That argument may have greater merit if the pharmacist consultation is in fact monetized, and the combined cost of the medicine and the pharmacist consultation exceeds the average co-pays for those medicines when they were sold as prescription-only.

“The report was very thorough and well-done,” noted David Spangler, SVP policy and international affairs at the Consumer Healthcare Products Association. “[The GAO] did a lot of thoughtful analysis, [and took] a very hard look at a number of complex issues,” Spangler said. And while the GAO made an understandably apples-to-oranges comparison of BTC formats in other countries, one take-away was clear, Spanger said. “Just because a country has [a] behind-the-counter class, [it] doesn’t automatically lead to wider access to medicines. The picture is mixed.”

That is another key argument proponents of a third-class make, the GAO report noted—BTC medicines would in fact lead to improved public health through increased availability of nonprescription drugs and greater use of pharmacists’ expertise.

“We…think a BTC class, structured properly, has great potential—it can increase access, it can improve patient compliance and it can reduce healthcare costs,” Julie Kahni, VP federal healthcare programs for the National Association of Chain Drug Stores, told Drug Store News. “But if it’s not structured properly, there are a lot of outstanding issues about liability,” Kahni said, adding that a poorly structured BTC class could also, in fact, restrict access.

“An effective and appropriate behind-the-counter class is one that is clinically [based], not enforcement based,” she said, referencing today’s two de facto BTC drugs in the United States: the emergency contraceptive Plan B and pseudoephedrine. “Medicines should be available behind the counter if there is a clear, clinical profile requiring pharmacist intervention.… A class should not be used to enforce age- or quantity-based limits.”