The trillion-dollar healthcare industry is the perfect breeding ground for turf battles. For decades, such battles have included MDs versus chiropractors, optometrists versus ophthalmologists, "traditional" medicine versus "alternative" medicine, and many, many others.

One of the latest such issues to reemerge on the scene is the subject of so-called "behind the counter" (BTC) drugs. For at least the fourth time, federal regulators are now considering whether pharmacists should be allowed to regularly dispense certain designated medications without a doctor's prescription.

Three times since the 1970s, the FDA has rejected the idea of adding a new BTC class of drugs to existing prescription-only and over-the-counter medication. Agency officials said they're evaluating how — or if — to proceed with this new class of drugs that patients could access without doctors' orders, but only with screening from pharmacy personnel.

Pharmacists in the United States have been organizing to encourage the establishment of a BTC category. Such a category would likely improve their level of respect from the public, as well as their economic standing. Pharmacists have long battled the image, at least among some people, of being mere pill counters. "None of us went into the profession to stand behind a counter and count by fives," says Janet Engle, a former president of the American Pharmacists Association and associate dean of the University of Illinois at Chicago College of Pharmacy, in an article in USA Today last February.

Supporters of this concept feel that a BTC category would both cut medication costs and reduce visits, and therefore fees, to doctors. So, unsurprisingly, the movement is ardently supported by many pharmacist groups, who point to successful programs in place in other countries, such as the United Kingdom and Canada.

It's already here ... sort of

The movement has already resulted in real changes in some pharmacies in the United States. In some states, for instance, non-prescription cold remedies, such as Sudafed, have been moved from store shelves to behind the counter. Pseudoephedrine, their active ingredient, can be ground up to make methamphetamine. Placing such drugs behind the counter enables pharmacists to limit the amount sold and to keep track of buyers.

Pilot programs also have already begun in which some pharmacies offer extensive medication-counseling services, in spaces that resemble physician offices. Patients in these centers also can order certain procedures and lab tests, such as blood cholesterol and blood pressure monitoring. This is done by the pharmacist and does not require physician involvement.

Pharma's possible motive

Keeping drugs prescription-only keeps costs within the realm of the insurance system, allowing drug makers to set prices based on what insurance companies, not individuals, will bear. Patients with health insurance rarely ever see the total bill for their medications, and the actual full prices of those medicines are rarely a factor in their decisions to buy or not buy them.

Once a patent runs out, however, the situation changes, and the FDA becomes the major hurdle to going over the counter. With a patent expiration looming, a pharmaceutical company may profit from a switch to over-the-counter status by regaining control of the market before generic makers can produce and sell the medication.

Let the debates begin

So this topic obviously sets up a few turf battles and philosophical issues. Physicians who currently prescribe medications that would go BTC stand to lose office visits because of the change in policy. Companies that sell over-the-counter products are concerned about introducing yet another category of competing products into pharmacies. Pharmaceutical companies might view this category as a way to extend the life of a medication going off patent. Healthcare advocates and consumer watchdogs will be looking at how this issue will affect the quality of healthcare, as well as the cost of the delivery of that care. Pharmaceutical representatives will be affected by changes in a particular drug's status, and by the increased attention that may have to be given to pharmacists, who would suddenly have more control over medication decisions. Last but not least, something tells me that lawyers will most likely be involved somehow in this scenario.

Next month's column will focus on the specific issues among the players in this forum, including the government, pharmacists, physicians, the pharmaceutical industry and patients.