availability of topical anti-fungals, it was often
necessary for a woman who had already recog-
nized the symptoms of the disease to call and
arrange a clinician’s appointment. This often took
several days. Delaying treatment caused much
unnecessary suffering and encouraged disease
progression. Many clinicians, recognizing these
difficulties, would prescribe over the phone,
based solely on the woman’s description of symp-
toms. Research has shown that the accuracy of the
clinician’s diagnosis in this setting is no better than
that of the woman herself. This constituted an ideal
situation for the switching of an important class of
drugs from prescription to OTC status. The patient
obtained equally accurate diagnosis and far more
rapid treatment for a disease that is very uncomfor-
table. Severe cases of vaginal candidiasis with
heavy discharge are now much less common.
A second example is in the treatment of the
common cold. Anticold medications have been
available OTC for many years, because of the
compelling need for rapid treatment. A cold
evolves quickly, the entire illness lasting only a
few days. A delay of only a day or two in seeing
the clinician for a prescription may eliminate any
possibility of obtaining effective treatment for half
of the duration of the illness. The prompt avail-
ability of self-medication improves treatment effi-
cacy while reducing costs and enhancing patient
satisfaction with the medical system.
The above factors have combined to greatly
increase public awareness of the importance of
self-medication in the total healthcare scheme.
The Sponsor should recognize the opportunities
for OTC use of medications and the advantages
and pitfalls attendant upon such use. As self-med-
ication becomes a central part of the healthcare
system, the skillful and appropriate movement of
pharmaceuticals from prescription to OTC avail-
ability will increasingly become a vital role of the
Sponsor in optimizing the nation’s health.
14.2 Criteria for OTC use
of medicinesThe criteria by which a drug may be judged as
suitable for self-medication are never absolute.
The capability for OTC drug labeling is always a
matter of careful judgment. The Food and Drug
Administration (FDA) has been progressive in
defining the requirements for OTC use in recent
years. The old tendency to restrict OTC treatment
to conditions of short duration and primarily to
symptomatic therapy is rapidly disappearing. The
suitability of a medication for OTC use is not solely
dependent upon its pharmacologic characteristics.
Appropriatelabeling and advertising of themed-
ication can have a major impact on the extent to
which patients understand its proper use.An OTC
product should be envisioned not just as the drug
itself but as the whole package of drug, labeling,
and advertising, designed to encourage safe and
effective self-medication.With this in mind, sev-
eral vital considerations concern suitability of a
drug for OTC marketing.Self-diagnosis
First of all, and nothing to do with the drug itself,
self-treatment implies self-diagnosis. Only dis-
eases that are self-diagnosable with the assistance
of appropriate labeling can be considered for OTC
treatment.
Fortunately, there are many common conditions
that are indeed self-diagnosable. It should not be
assumed that a diagnosis made by a patient is
necessarily inferior to that made by a clinician.
The patient can actually feel the symptoms as
well as observe the signs of a disease – a real
advantage in the diagnosis of diseases where symp-
toms predominate and signs are few. Of course,
diseases where diagnosis depends on the interpreta-
tion of complicated laboratory tests or sophisticated
imaging techniques are usually best diagnosed by
the clinician and treated only by prescription.
An example of this is headache, where the diag-
nosis rests largely on history and symptoms. The
patient has lived the history and experienced the
symptoms.The clinician has at best adescription of
these symptoms, which a patient may be able to
communicate well or poorly. Even with the most
skillful clinician eliciting the history, there is a
degradationofinformationasit moves frompatient
to clinician. If patients can be educated about the180 CH14 THE UNIQUE ROLE OF OVER-THE-COUNTER MEDICINE