The U.S. drug distribution system ensures that consumers have access to important medications. For some, a doctor’s prescription is required; for others that have a wide margin of safety and that can be used correctly on the basis of information on the medicine’s label, no prescription is required. This two-class system of prescription and nonprescription, or over-the-counter (OTC), medicines is the cornerstone of a scientifically rigorous drug distribution model regulated by the U.S. Food and Drug Administration (FDA).
The U.S. two-class distribution system is fairly unique in the world. Internationally, many nations have a centuries-old pharmacy class system. In these nations, medicines have been available only through pharmacies, effectively creating a pharmacist monopoly on drug distribution. In recent years, however, a number of these national systems have begun to allow greater access to safe and effective medications available without a prescription. Japan, the Netherlands, Denmark, the United Kingdom, Italy, and Argentina all have been part of this trend toward granting consumers increased access to medicines in more outlets beyond pharmacies.
How the U.S. drug distribution system benefits every consumer and household
- OTC medicines are conveniently sold in a number of retail outlets, including those without pharmacies, and are available when you need them. With over 750,000 retail establishments nationwide, the odds are high that both rural and urban consumers can find a treatment for common, everyday conditions, even during weekends or late at night.
- The current two-class system of drug distribution empowers consumers with a widening choice of safe and effective medicinal options at competitive prices. This emphasis on consumer empowerment in matters of healthcare directly serves two of the most fundamental demands of any workable healthcare system: access and affordability.
- The drug distribution system in the United States is a highly regulated safeguard to ensure only those medications that have a wide enough safety margin and that can be safely and effectively used without the help of a healthcare professional are available without a prescription.
What others say
- FDA has historically rejected a third class or transition class of drugs, saying a public health need for a pharmacy- or pharmacist-only class of medicines has not been demonstrated.
- The American Medical Association repeatedly has reaffirmed, as recently as 2012, its support of the present two-class drug distribution system and opposition of an additional class of drugs. A number of other health and consumer organizations also have opposed a third class of drugs in the United States over the years.
- In a 2009 U.S. General Accounting Office report, the agency noted that pharmacist-, infrastructure-, and cost-related issues would have to be addressed before an additional class of pharmacy-only medicines could be established in the U.S., including pharmacists' roles and responsibilities, training, ensuring counseling would be provided, sufficiency of the workforce, data infrastructure, physical infrastructure to ensure consumer privacy in counseling, cost issues (including pharmacist compensation), and pharmacist liability.
- According to a 1995 U.S. General Accounting Office report, "Other countries' experiences do not support a fundamental change in the drug distribution of the United States such as creating an intermediate class of drugs, whether fixed or transition, at this time. The evidence that does exist tends to undermine the contention that major benefits are being obtained in countries with a pharmacist or pharmacy only class."