Squaring off

by Tim Covington, Pharm.D.

Yes, it is time for a pharmacist-only third class of drugs. The reason? Recent issues regarding direct consumer access to nonprescription versions of pseudoephedrine, levonorgestrel 0.75 mg (Plan B, Women's Capital Corp./Barr), and the "statin" lovastatin are making the case for a pharmacist-only third class of drugs.

A third class of drugs would not require a prescription or physician office visit but would restrict distribution to pharmacies. A behind-the-counter, R.Ph.-only third class of drugs could and should mandate pharmacist oversight to ensure safe, appropriate, and effective use of drugs placed in that category.

Drugs so designated would be readily accessible to consumers. Countless consumers enter and exit a community pharmacy every week. Drugs that could be assigned to a pharmacist-only third class might include selected drugs currently Rx-only (e.g., lovastatin) and selected drugs that are currently over-the-counter but can be sold at or through any U.S. retail or mail-order outlet or any Internet site in spite of justifiable concerns regarding safe and appropriate use (e.g., pseudoephedrine).

The current two-drug (Rx or OTC) classification system in the United States is rigid and static. It does not reflect substantial technical, professional, scientific, social, cultural, economic, and other marketplace and societal changes that have occurred over the past 50 years. The United States lags behind most developed countries of the world, as it is one of the very few that does not restrict access to certain drugs to R.Ph.s or pharmacies. The pharmacy-only designation alone would not seem to adequately serve the public interest. Any third-class drug designation should be R.Ph.-only and involve the pharmacist in predetermined activities that foster safe and appropriate drug use.

The three major issues in health care today remain access to care, quality of care, and cost of care. An R.Ph.-only third class of drugs would address all three critical issues. Having the pharmacist intervene as a learned intermediary and gatekeeper in ensuring optimal clinical outcomes and safe and appropriate use of a small number of designated drugs would pay substantial public health dividends.

Self-serving special interest groups and their lobbying enterprises have argued for years that an R.Ph.-only third class of drugs is anticompetitive and would create a "pharmacists's monopoly." Restricting Rx drug distribution through licensed pharmacies serves our nation well and has not created public access problems or antitrust issues. Congress seems to have succumbed to the influence of powerful special interests, as no significant Congressional initiative to create a pharmacist-only third class of drugs in the public interest has ever surfaced for public discourse.

In certain situations, public access to powerful drug therapies is not adequately served by the current black-or-white, two-dimensional, Rx-only or OTC system in this country. Many shades of gray exist in the drug selection, use, and monitoring process that are not optimally addressed by the two-category classification system.

All drugs are powerful chemical entities with well-defined pharmacology and toxicology. The Drug Facts label has contributed significantly to more appropriate OTC use; however, the OTC Drug Facts label content and format are relatively brief and can, in no way, address all necessary considerations in drug use.

This is due to the near infinite considerations relative to comorbidities and polypharmacy (e.g., contraindications, warnings, adverse effects, drug-drug interactions, administration and dosage considerations) and special considerations in special populations (e.g., smokers, elderly, pediatric, pregnancy). Integrated thought, application of therapeutic logic, and clinical judgment that go far beyond package labeling are frequently required to minimize risk while optimizing the benefit of drug therapy.

America's pharmacists are well trained but substantially underutilized in drug selection, use, and monitoring and in the overall disease management process. That situation is changing with medication therapy management (MTM) services under Medicare Part D and pharmacist-physician collaborative practice agreements.

For decades the focus of the pharmacy profession was on drug distribution of both Rx and OTC drugs. However, the professionalization of pharmacy over the past 30 to 40 years has created tens of thousands of pharmacy practitioners who are highly qualified to work with physicians and other health professionals in the clinical management of drug therapy. The R.Ph. is the only health professional who receives in-depth, formal education and training in nonprescription drug therapy. The pharmacist is intellectually qualified and strategically placed in the community to manage utilization of a designated pharmacist-only third class of drugs.

by Linda A. Suydam, D.P.A.

No, our current two-class system successfully empowers and protects consumers.

The American public demands drugs that are safe and effective and manufactured to a high standard and needs the information to use them responsibly. When a "learned intermediary" is necessary, a drug carries a prescription. When a medicine has a high margin of safety and when clear directions for safe and effective use can be written to ensure consumer comprehension, the Food & Drug Administration may grant it over-the-counter status.

This two-class drug istribution system works. A drug's classification—whether prescription or OTC—is determined on a case-by-case, science-driven basis. This rigorous approach is also dynamic. As new data emerge and research is conducted, a drug's marketing status can change. In fact, almost 80 ingredients, dosages, or indications have made the switch from prescription to nonprescription status in the past 30 years. The result is that consumers have increased options and are more empowered to safely take a more active role in their own health care.

This movement toward consumer empowerment seems to be expanding in other countries. Argentina, Denmark, Japan, the Netherlands, and the United Kingdom have all been part of a slow, yet definite, trend toward granting consumers greater access to medications through providing drug availability in more outlets.

In fact, the General Accountability Office examined other nations' experience with a third class of drugs, or pharmacy class, in 1995. In its final report to Congress, GAO concluded that "the evidence ... tends to undermine the contention that major benefits are being obtained in countries with a pharmacist- or pharmacy-only class."

The benefits of the two-class system in the United States are unmistakable. This system ensures that consumers have convenient access to medicines deemed safe enough to be used without a prescription. While prescription drugs are restricted to approximately 55,000 pharmacies across the country, nonprescription medicines can be sold in more than 750,000 retail establishments. This means that, day or night, even rural consumers with no easy access to a pharmacy need not face barriers to finding the healthcare products they need.

What's more, while pharmacy school enrollments are currently trending upwards, there is still a severe pharmacist shortage in the United States. According to a 2000 report to Congress by the Health Resources & Services Administration, there are only about 71 pharmacists per 100,000 people in the United States. While HRSA estimates that the number of active pharmacists will grow this decade, the demands on pharmacists' days also are growing at a rapid rate.

Pharmacists are filling more prescriptions, and likely will fill far more as the baby boomer generation continues to age. The administrative work required by third-party payers also is occupying a substantial portion of R.Ph.s' time. That workload is further multiplied in some states that have required pharmacists to place certain OTC cold medicines behind pharmacy counters in an attempt to hamper criminals' ability to illegally divert these products for the manufacture of the illicit street drug methamphetamine.

Pharmacists are indeed the most informed healthcare practitioners when it comes to drugs, and surveys repeatedly demonstrate that consumers hold their pharmacists in high regard. Our organization, the Consumer Healthcare Products Association, firmly believes pharmacists can make valuable contributions when it comes to drug selection or helping counsel consumers on possible drug interactions.

With the great variety of OTC products on the market and the likelihood that these safe and essential medications will become even more complex in the future, more effort should be made to facilitate dialogue between consumers and pharmacists, rather than to pursue a lengthy Congressional process to change the U.S. drug distribution system to an approach with no proven benefits.