The United Kingdom. Italy and Australia have an intermediary drug classification between prescription and nonprescription drugs. Is the United States ready to add a new behind-the-counter (BTC) drug classification, too?
Like over-the-counter, or nonprescription drugs, a BTC category of drugs would be available without a doctor's prescription, but consumers would be required to consult with a pharmacist in order to purchase BTC medications.
The Academy of Managed Care Pharmacy thinks its time. "The establishment of a behind-the-counter (BTC) class of drugs would optimize care for patients by facilitating access to medications which require the intervention of a health care practitioner to judge appropriateness of a specific medication for a condition which a patient has self-identified," according to the AMCP.
The Food and Drug Administration (FDA) has been exploring the feasibility of a BTC designation since 2007, when it held a public meeting to explore its implications.
A U.S. Government Accountability Office (GAO) 2009 analysis of the BTC issue identified the pros and cons:
"Proponents of a BTC drug class suggest it would lead to improved public health through increased availability of nonprescription drugs and greater use of pharmacists' expertise. Opponents are concerned that a BTC drug class might become the default for drugs switching from prescription to nonprescription status, thus reducing consumers' access to drugs that would otherwise have become available OTC, and argue that pharmacists might not be able to provide high quality BTC services. Proponents of a BTC drug class point to potentially reduced costs through a decrease in the number of physician visits and a decline in drug prices that might result from switches of drugs from prescription to nonprescription status. However, opponents argue that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs."
The ability of pharmacists to provide patient counseling, adequate pharmacy infrastructure and insurance coverage for BTC drugs would all have to be addressed before a BTC drug class could be established in the United States, according to the GAO.
A BTC designation would greatly impact the training that pharmacists receive. "Depending on the medication being dispensed and on the condition being treated, pharmacists may need additional training to differentiate diseases treated by proposed BTC drugs in order to accurately identify those that are treatable by BTC drugs and those that are more serious and require referral to appropriate health care professionals for additional medication attention," according to the Academy of Managed Care Pharmacy.