Minnesota Board of Pharmacy - Minnesota State Legislature

There are two primary reasons why it became evident during the 19 th century that the profession of
pharmacy needed to be regulated. First, ever more powerful drugs were being either isolated from
natural sources or chemically synthesized. These drugs, while offering better treatment options than
previously available medicinals, also caused significant adverse drug events (ADE) if not properly
prepared and dispensed. Second, the latter half of the 19 th century saw the widespread marketing of
“patent medicines” which were promoted by often unscrupulous sellers as “cure-alls” – good for
treating everything from a cold to cancer. In reality, the vast majority of these products contained some
combination of just three drugs – cocaine, heroin and alcohol. Rather than curing patients, the patent
medicines often caused them to become drug addicts or to die.
The need for pharmacists to be both formally trained and regulated became apparent at roughly the
same time. Consequently, the University of Minnesota established a College of Pharmacy in 1892 that
initiated a program consisting of two years of professional studies leading to the doctor of pharmacy
degree. The educational requirements have increased over the years so that current graduates must
complete a minimum of six years of study to earn the doctor of pharmacy degree. As mentioned above,
the Legislature created the Minnesota Board of Pharmacy in 1885, empowering the Board to regulate
both the practice of pharmacy and the distribution of drugs and poisons. The Legislature recognized
that the public needed protection from adulterated, misbranded, and illicit drugs, and from incompetent,
unethical, illegal or unprofessional conduct on the part of pharmacists.
The same basic reasons for regulating the practice of pharmacy and the distribution of drugs continue
to this day. Many pharmaceuticals that are dispensed today are even more powerful and potentially
dangerous than the drugs that were developed in the late 19 th century. According to the report
Preventing Medication Errors, released by the Institute of Medicine in 2006, “in any given week four
out of every five U.S. adults will use prescription medicines, over-the-counter drugs, or dietary
supplements of some sort, and nearly one-third of adults will take five or more different medications”.
The report estimates that “there are at least 1.5 million preventable adverse drug events that occur in
the United States each year”, many of which are attributable to the dispensing of drugs by pharmacists.
The report estimates that, in addition to the suffering and even death that ADEs cause, they cost the
country billions of dollars per year. It is safe to assume that if the boards of pharmacy that exist in each
of the fifty states did not regulate the practice of pharmacy, even more ADEs would occur.
Similarly, the unscrupulous sale of drugs also continues, albeit in a different manner from what
occurred in the late 19 th century. During the 1980’s, certain prescription drug marketing practices,
while being in some ways beneficial, also introduced pricing differentials that contributed to the
diversion of large quantities of pharmaceuticals into a secondary grey market. These practices included
the distribution of free drug samples, the distribution of coupons that could be used to purchase drugs
at reduced cost, and the sale of deeply discounted drugs to hospitals and other health care entities. The
resulting grey market provided a means through which mislabeled, adulterated, expired, subpotent and
counterfeit drugs were able to enter the nation's drug distribution system. As a result, Congress passed
the Prescription Drug Marketing Act (PDMA) of 1987, which President Ronald Reagan signed into law
on April 22, 1988. When signing the bill, President Reagan remarked that he supported “the expressed
goal of this legislation, which is to reduce potential public health risks that may result from the
distribution of mislabeled, subpotent, counterfeit, or adulterated prescription drugs in the secondary
source market, the so-called diversion market”. One provision of the PDMA requires all drug
wholesalers to be licensed and regulated by the states, in accordance with guidelines prescribed by the
Act. Most states, including Minnesota, have designated pharmacy boards to license drug wholesalers.
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