i£2*
THE PURDUE
PHARMACIST
PURDUE UNIVERSITY SCHOOL OF PHARMACY AND PHARMACAL SCIENCES
Vol. 62
FALL 1984
No. 1
The Dean's
Column
Adelbert M. Knevel, Ph.D.
Associate Dean
The passage of the Federal Food, Drug
and Cosmetic Act in 1938, and the
Kefauver Ammendments in 1962, did
much to improve the safety and effectiveness of new drugs before their introduction into the market place as therapeutic agents. Prior to approval of a
drug product, the Food and Drug Administration (FDA) requires the drug-
sponsor to submit convincing data from
fchase I, II, and III clinical trials in
^uman subjects showing that the product is a safe and effective therapeutic
agent. Although these clinical trial premarketing studies are of great value, the
matter of safety is not totally resolved
even upon completion of Phase III evaluations. Some reasons given for this
dilemma are: (1) the relatively small
numbers of patients evaluated during
the Phase III studies (2) the conditions
of drug use during the study do not
•reflect the circumstances of general use
after marketing (3) certain patient
groups that are not included in the original studies will ultimately use the drug,
and (4) no mechanism to monitor long
term adverse effects is now in place.
Furthermore, the current voluntary reporting system by which physicians,
pharmacists, and manufacturers can
notify the FDA of adverse drug reactions is simply not sufficient.
The need to establish a monitoring system (Phase IV) which has a more effective reporting program and which includes a wider population of patients
^han those studies in Phase III clinical
■rials is thus quite clear. In addition to
prescription drugs, certain over-the-
counter (OTC) drugs, especially legend
drugs which now have attained OTC
status, require monitoring for adverse
effects.
How can an effective system of postmarketing drug surveillance be established to overcome the shortcomings of
our present system?
Through the efforts of Drs. Holly L.
Mason and Stephen W. Schondelmeyer
of the Department of Pharmacy Practice in our Pharmacy School, a series of
research projects have been proposed
and funded in which selected community pharmacists in Indiana, as well as
other parts of the country, will be asked
to participate in a drug therapy monitoring process. Their project is known
as the CAPS MED (Computer-Assisted-
Pharmacy Surveillance of MEDication)
program. The basic program methodology calls for pharmacists using on-site
computer terminals to enter data directly into a central CAPSMED computer
system. This post-marketing surveillance (PMS) system provides a cost efficient method for study of the effects of
marketed drugs. Although our formal
research-oriented data collecting systems are in operation today, the CAPSMED program addresses many of the
shortcomings of these other systems.
This research study of Drs. Mason and
Schondelmeyer is intended to demonstrate that the community pharmacist
can play a key role in generating information about patient use of, and response to, prescription medication as
customarily prescribed for nonhospital-
ized patients and selective OTC drugs
for the purpose of improving safety in
self-medication. I am confident that
their study will show that the community pharmacist can make a significant
contribution regarding drug safety both
in OTC and prescribed medication.
PERSISTENCE
PAYS OFF: AND
TOM WILSON
CAN PROVE IT!
(Deborah Ann Syferd)
Many pharmacists developed their first
interest in the profession while working
in a pharmacy during high school. Tom
Wilson is one of those people. When he
graduated from high school he was sufficiently intrigued with the profession to
enroll in the University of Cincinnati
College of Pharmacy.
Like many others, he worked his way
through college. At one point a decision
had to be made: continue in college and
be a pharmacist or make some money.
Making money won and he left the college for a sales position with E.R.
Squibb. A year and a half later he joined
Ciba as a salesman in the Fort Wayne
area.
Quite often, the more you learn, the
more you realize you don't know. This
was the situation Tom found himself in
and decided that if he was going to be a
professional, he wanted to be the best he
could be — so he returned to school.
This time he decided to attend the
School of Pharmacy and Pharmacal
Sciences at Purdue University. By this
time he had added a few years to his age
THE PURDUE PHARMACIST will be published three times per year (Spring, Summer. Fall). Subscription price for the three issues is $2.00.
Address all correspondence to The Purdue Pharmacist, School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, IN
47907. Editor: Mary Lea Gora.