Drug Distribution in the United
The U.S. drug distribution model is a two-class system of
prescription and over-the-counter (OTC) medicines, 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, 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.
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 consumers need them.
With more than 750,000 retail establishments nationwide, both rural and urban
consumers have access 24/7 to treatments for common, everyday conditions.
- The current two-class system of drug distribution empowers consumers with a
widening choice of safe and effective self-care 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
- The drug distribution system in the U.S. 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.
Background on a Third Class of Drugs
- FDA has
historically rejected a third class or transition class of drugs, saying a
public health need for a pharmacy-only class of medicines has not been
- 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 U.S. over the years.
- In a 2009 U.S. General
Accounting Office report, the agency several 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."