“Pharmacy Care” OTC Category Considered By APhA Task Force

A new category of "pharmacy care" drugs could broaden access to certain over-the-counter drugs, according to the American Pharmacists Association.

The designation of a new subset of OTC medications could be an intermediate step, short of establishing a "third class" of drugs at the regulatory level, designed to encourage more Rx-to-OTC switches and enhance the pharmacist's role in consumer healthcare, APhA says.

In light of switches and with future candidates on the horizon, APhA convened a task force in August to "develop recommendations for incorporating additional OTC products into pharmacy practice."

APhA describes the new classification, dubbed "pharmacy care OTCs," as "a sub-category of non-prescription medicines available only in pharmacies," according to an Oct. 28 report on the meeting.

By convening the task force, the trade association is "exploring the concept of enhancing the role of the pharmacy" in the sale of OTCs used to treat "chronic, asymptomatic conditions, or other conditions where consumers would benefit from additional interaction with their pharmacist."

The task force is soliciting comments on the subject from interested parties through Dec. 1. The group will consider recommendations before issuing a final report in early 2005.

The group includes practicing pharmacists and managers of independent and chain pharmacies (Walgreens, Target), as well as representatives from managed care organizations (Kaiser Permanente, Wellpoint), trade associations (the National Association of Chain Drug Stores) and academia.

Wellpoint Health Networks' Chief Pharmacy Officer Robert Seidman, who spearheaded Wellpoint's petition asking FDA to force switches of certain non-sedating antihistamines, is a member of the task force.

The task force's mission is to define the pharmacy care OTC category and its guiding principles. The report describes preliminary recommendations on the training and education of pharmacists and staff, consumer access to pharmacy personnel, product placement and support services such as in-pharmacy point-of-care testing.

Products in the category "should demonstrate a proven health benefit" and be accompanied by available guidelines for patient identification and risk assessment, the report states.

Pharmacists should be able to identify consumers who should use the OTC, as well as those who should be referred to another health care professional, the report states.

Pharmacists and staff should be educated and trained about the product and its appropriate population for use, keeping in mind risks, monitoring and follow-up, the report adds. Moreover, education on the proposed category should be provided to consumers through media and marketing.

Additionally, product placement, promotion, workflow and staffing patterns "should support direct interaction with the pharmacist," the report suggests. Marketing devices, including print ads and shelf talkers, should direct consumers with questions to the pharmacist.

Appointment systems "should be considered if the product requires lengthy consultations or if the pharmacy environment is not always conducive to consumer/pharmacist interaction," the report states.

Documentation of pharmacy care OTC use in patient profiles is encouraged in order to screen drug/drug interactions, protect against drug/disease contraindications and monitor outcomes, the report claims.

A "third class" of pharmacy-restricted drugs has reemerged as a controversial topic in wake of the Rx-to-OTC switches of Schering-Plough's Claritin and Procter & Gamble's Prilosec OTC .

The possibility of an expanded role for pharmacists has accompanied discussion of switches in other therapeutic categories, such as cholesterol-lowering statins.

FDA's Nonprescription/Endocrinologic Drugs Advisory Committees are expected to discuss an OTC statin switch at a Jan. 13-14, 2005 meeting (¹ (Also see "NDAC/Endocrinologic Drug Joint Panel Meeting Likely To Focus On Statins" - Pink Sheet, 25 Oct, 2004.), p. 4).