Third Class of Drugs

Third Class Of Drugs

In the United States, all pharmaceutical products: from Advil to Zoloft, are sold either as over-the-counter remedies or as prescription drugs. Over-the-counter remedies like Advil, aspirin, and Tylenol, can be purchased by any consumer at any store that chooses to sell them. Therefore, an eight-year-old can go into a convenience store and buy a bottle of aspirin. On the other hand, if an eighty-year-old man wanted to try Viagra, he would need to consult a physician and retrieve a prescription, and from there he would need to buy the drug from a licensed pharmacist. The two-class division evolved from a series of acts and resolutions passed in conjunction with the Food and Drug Administration (FDA). The most significant landmark in the creation of a specific prescription-only class of drugs was the Durham-Humphrey Amendment, passed in 1951. The Amendment, which revised a 1938 congressional act called the Federal Food, Drug and Cosmetic Act, defined a specific class of drugs that could only be sold under the care of a practicing physician. The Durham-Humphrey Amendment revolutionized the pharmaceutical industry and the profession of pharmacist: "for the first time physicians rather than patients were the target of sales and marketing efforts by pharmaceutical manufacturers," (Hoffman). Since the passing of the Durham-Humphrey Amendment in 1951, products the FDA deemed safe are available over-the-counter, without a prescription. More potent products, those with potentially adverse side effects or increased risk of overdose, can only be obtained through a physician. The role of the pharmacist was to offer consultation but not prescription; the pharmacist procured and distributed the medicines that doctors prescribed to their patients.

In conjunction with other FDA regulations, the Amendment contributed to public health and safety and prevented the unlawful labeling and marketing of potentially dangerous products. The Amendment also clarified the roles of physician and pharmacist, with the former having more control over the choices that patients made regarding their health care and the latter being more specifically trained in medical chemistry. However, the role of the pharmacist is set to change. Because of their advanced specialty, "clinical pharmacists are now performing tasks that previously were the exclusive domain of physicians," (Hoffman "Indispensable"). Part of the shift in consciousness is due to discussions over whether or not to create a third class of drugs in addition to prescription and non-prescription. The third class of drugs would be sold without a doctor's prescription but only through consultation with a licensed clinical pharmacist. Only pharmacies could sell products in the third class; they would not be available over the counter at convenience stores or grocery stores. Theoretically, drugs in the third class would rank somewhere in between over-the-counter and prescription drugs in terms of safety: they would be products the FDA deems safe enough to be sold without a prescription but not so safe as to be freely available to the undiscerning or uneducated consumer. The third class of drugs could be either a permanent class of drugs that are only sold by pharmacists, or it could be a transitional class. If the third class was transitional, it would include those products that were still under review by the FDA and the pharmaceutical industry. When the products are deemed safe, they would ostensibly be moved into the over-the-counter class of products.

Pharmacists and their professional organizations generally favor the idea of the third class of drugs because it would confer onto their profession greater responsibility and therefore, increased revenues for professional pharmacists and for retail pharmacies. Groups like the American Pharmaceutical Association and the National Association Boards of Pharmacy (NABP) also claim that consumers already self-medicate using over-the-counter remedies and claim that many over the counter remedies are not as safe as consumers are led to believe: "Many people are under the impression that OTC medications are safe since 'the government' has seen fit to make them available to the general public. As pharmacists, we know the naivete of that belief, as well as the dangers inherent in many of the products sold indiscriminately in so many outlets," (Labbe). The third class of drugs would therefore encourage patients and consumers to take advantage of the professional services of pharmacists, who do not usually charge for consultation. Pharmacists therefore note that consumers would save enormous amounts of money with a third class of drugs: "Granting pharmacists control over a specific group of prescription medications might serve to improve care in a cost-effective manner," (Labbe). Many patients can easily treat minor ailments by simply consulting with a pharmacist rather than visiting a physician.

Moreover, pharmacists would not be taking the place of the physician but would be able to offer consumers educated guidance regarding side effects and treatment options. The third class of drugs affords more control to the consumer and strips some power from the medical community. However, pharmacists would still refer patients to physicians whenever necessary, such as when contraindications or other concerns might be a problem. Pharmacist groups also avow that there would be "little negative impact on corporate profit margins or on physician ability to provide medical care," (Labbe). The third class of drugs, also known as "pharmacist only" drugs has been in effect in many other nations, including Canada and most European Union nations. In fact, according to the United States General Accounting Office (GAO), "the classification of drugs in the United States into one of two classes, prescription or nonprescription, is unique," (Chan 2).

Although pharmacists paint a rosy picture of the third class of drugs, the concept is met with major mistrust and disapproval by most major regulatory bodies, including the FDA, the United States Justice Department, and the American Medical Association (AMA). A report by the GAO called "Value of a Pharmacist-Controlled Class Has Yet to be Demonstrated" is based partly on research into the third class system in other countries. According to the report, "Little evidence supports the establishment of a pharmacy or pharmacist class of drugs in the United States as either a fixed or transition class," (3). The AMA opposes the third class of drugs because of the potential for loss of revenue for doctors. If patients with minor ailments consult their pharmacists about their health care options, the number of visits to physicians would be significantly reduced. Furthermore, the pharmaceutical industry would market their third class of drugs to pharmacies and pharmacists more than to practicing physicians, which could also entail loss of revenue for medical doctors.