Mr. Eckel is professor and director ofthe Office of Practice Developmentand Education at the School ofPharmacy, University of North Carolinaat Chapel Hill.
After years of debate, could wefinally see the emergence of anew category of behind-thecounter(BTC) drugs?
The idea of a drug category that wouldbe available to patients with pharmacistadvice but without a prescription is gainingsupport. Notably, the FDA's positionhas shifted. For years, the agency maintainedthat it lacked the authority to designatedrugs for BTC access without legislativechanges. The agency's 2006 decisionto assign BTC status to levonorgestrel(Plan B) suggested just theopposite, however, and the FDA's recenthearings reflect its interest in applyingBTC status more broadly.
BTC systems have been operating successfullyfor years in several countries,including the United Kingdom andCanada. Medications already beingoffered abroad on this basis includesome of those being discussed for potentialBTC status here, such as drugs forchronic conditions like high cholesterol.
In this country, a BTC category couldbenefit patients by providing easieraccess to some drugs, along with themedical guidance needed to ensure safety.It also could benefit our profession,not least by helping us expand our roleas medication advisers.
Of course, BTC remains controversial.An argument still exists about whetherpatients need expert counseling to helpthem manage chronic conditions, orwhether they should simply be able toobtain drugs over the counter.
I feel that the pharmacist's role with BTCmedications could be viewed as confirminga patient's self-diagnosis—ruling outthe possibility that the diagnosis is incorrect—and then providing a treatment planto address the patient's condition.
The Asheville Project has confirmedthat pharmacist intervention can beextremely effective at improving outcomesfor various chronic disease states.This could substantially cut the nation'shealth care costs, because chronic diseasesaccount for many billions of dollarsin health care spending every year, andmuch of the cost is due to inappropriatetreatment of those diseases.
Another question about the introductionof a BTC category is whether allpharmacists are ready to step into thisnew role. Clearly, we are well-trained andadequately prepared to counsel patients.Many of us are so preoccupied with fillingprescriptions, however, that we havenot yet adjusted to the idea of advisoryroles that involve higher visibility andgreater interaction with the public. Tomake this transition feasible, we need topush for adequate reimbursement forthe time we spend counseling patients.
Establishment of a BTC category couldhelp us provide the right drugs to millionsof people suffering from chronic diseases.We should support efforts to makethis a reality.