Behind the counter" (BTC) is a category of medications that would not be prescribed but would be distributed by pharmacists only after they inform consumers of the risks and benefits of each particular medication. These drugs literally would be kept behind the counter. Now that the FDA is considering adding this category, many entities have been registering their often-still-evolving opinions on this controversial topic.

A pharmacist group's position

At an FDA public meeting last November, the American Society of Health-System Pharmacists stated their position on medications being considered for BTC status. They said they should:

1. Have a well-established benefit-to-risk ratio and a high safety margin.

2. Have been marketed as a prescription product for a sufficient length of time and been used in sufficient numbers of patients.

3. Have evidence of effectiveness and safety at the dose and regimen recommended for the BTC formulation.

4. Be used to treat a disease, symptom or condition that can be readily detected or diagnosed by the patient or pharmacist.

5. Be associated with measures that can be used to assess the effectiveness of the medication, as well as signs and symptoms of potential toxicity that can be detected and interpreted by the pharmacist or patient.

6. Not be an anti-infective agent for which emergence of resistance is a concern.

They also suggested there would be great usefulness in BTC demonstration projects, along with FDA oversight and systematic data collection. The experiences of these projects would help answer public policy questions.

Pharmacists as "learned intermediaries"

If a BTC category were established, pharmacists likely would be considered "learned intermediaries" between the public and drug manufacturers. They would be responsible for educating consumers about the risks and benefits of those products, as physicians do with prescription medications.

The term "learned intermediary" was first used in 1966 during a suit brought against the producer of chloroquine phosphate for failing to properly warn doctors against severe side effects. The federal court established a hierarchy of responsibility in which pharmaceutical companies have a duty to warn doctors about potential adverse effects. Physicians were to serve as "learned intermediaries," and advise patients appropriately.

What's at stake

Some physician organizations are against pharmacists dispensing a new category of medication. They fear that patients may not always be diagnosed or monitored at the level of care that physicians give patients in traditional settings.

In December, Rebecca J. Patchin, MD, an American Medical Association trustee, told American Medical News, "If a medication requires oversight, it should be available by prescription, and a physician should be involved in prescribing it and monitoring the patient." The AMA testified in opposetion to this classification at an FDA hearing in November.

Steven Crawford, MD, of Oklahoma City, chair of the AAFP Commission on Governmental Advocacy, raised the following crucial point at that same hearing: "The challenge in the BTC proposal is that if there's enough concern that a drug needs to be put behind the counter — and particularly with drugs that need laboratory monitoring, like statins — are we then going to have the pharmacist doing lab work and interpreting lab work?" Crawford continued, "Statins are a chronic long-term therapy, and a physician should be involved in the decisions ... most people don't have just high cholesterol; they also have potential elevated blood pressure, diabetes, plus all other kinds of health issues. I can't imagine a pharmacist doing a Pap smear at the pharmacy or a rectal exam for male prostate cancer screening."

Some members of the OTC industry also have concerns about a new third category of products over which pharmacists would have control. For many years, this industry has enjoyed wide distribution of its products. It opposes renewed interest in a system that would limit distribution of even some of its products to pharmacies.

There are questions as to whether pharmacists really want to be responsible for administering a new class of drugs. According to a recent study, many Canadian pharmacists are unenthusiastic about the prospect, and wonder whether pharmacist oversight of BTC medications would be sufficient.

What's next?

This volatile topic undoubtedly will be vigorously debated over the next few years. Patient safety, economics and turf battles likely will be among the central components of these discussions.