anti-acne preparations, most of which are of little
safety concern but can produce very substantial
irritation.
However, the effect of a drug on the general
population is only part of the story. The accept-
ability of a drug for market, particularly an OTC
drug without a clinician intermediary, is often
determined by its effect on special populations,
including those patients who are particularly sen-
sitive to its effects. Care should be taken to examine
atypical patients in a study population, as well as
individual adverse reaction reports. Precautions
may be required in the labeling for populations at
particular risk.
The conclusion that a drug is not acceptable for
OTC use based on safety should be reached only
after determining that satisfactory labeling cannot
be developed. The Sponsor must weigh safety and
tolerability against efficacy, both in the general and
special populations. Here the responsibility rests
directly on the Sponsor, because there will be no
other medical professional between the drug and
the patient using it.
Efficacy
Efficacy is a central issue with all pharmaceutical
products. In the context of OTC products, it is
traditional to accept a somewhat lesser degree of
efficacyin order to improve the safety profile. Also,
a lesser standard of efficacy is normally expected
by the patient, because OTC medication tends to be
a first step in therapy. Failure to obtain satisfactory
efficacy typically results in the patient seeking
professional advice, at which point more powerful
treatments can be prescribed. This does not mean,
however, that OTC drugs should not be effective
for the conditions they treat.
Dosage selection
The extent of efficacy will depend considerably on
dosage. In the past, there was an automatic ten-
dency to reduce the dosage to half or less of pre-
scription strength. Today, it is widely realized that
dosage should not be reduced simply as a matter of
course; rather, a considered judgment on optimum
dosage should be made. It is being progressively
appreciated by both the pharmaceutical industry
and the regulatory agencies that inappropriate
reduction of dosage can result in reduced efficacy
with little or no safety and tolerability benefits, thus
leading to needlessly ineffective treatment. The
goal is to provide the lowesteffectivedose. It is
vital to retain medically meaningful efficacy that
will provide patients with satisfying results if self-
treatment is to fulfill its proper role in the medical
care system.14.3 The unique characteristics
of the OTC field from
the Sponsor’s viewpointThe role of the clinician working in the OTC divi-
sion of a major pharmaceutical company is sub-
stantially different from that played in the research
or medical affairs departments dealing with drugs
intended for prescription. One might assume that
OTC work is simpler and less involved than that
related to prescription medications. In many ways,
the opposite is true.
Clinicians overseeing OTC products must be
generalists, requiring a broad expertise in medi-
cine, toxicology and regulatory affairs. The OTC
clinician deals with a vast variety of drugs from
many different areas of medicine, including some
that are little taught in medical school and never
encountered while working as a junior hospital
doctor. This contrasts with research on new chemi-
cal entities, where the clinician generally focuses
on a single therapeutic area, enjoys a large support
staff that provide him/her with in-depth assistance
and uses a limited number of research protocols
and techniques that can be thoroughly mastered. In
contrast, the OTC clinician must be an expert on
smoking cessation one day, gastroenterology the
next and dermatology the next.
The regulations governing OTC medications are
substantially different from those in the prescrip-
tion field, and the OTC clinician is typically more
involved in regulatory matters than his/her non-
OTC colleagues. The OTC clinician must also be182 CH14 THE UNIQUE ROLE OF OVER-THE-COUNTER MEDICINE