prescribed therapy, and, if necessary, adjust for
variable exposure to the test drug.
Phase IV
More robust outcomes studies because of an opti-
mized degree of forgiveness for the more common
errors in dosing.
Commercial use
Seamless transition to proven programs that
enhance patients’ persistence with their use of
product meant for indefinitely long use for higher
revenues, lower marketing costs and much higher
profits (Delmaset al., 2003; Eastellet al., 2003;
Vrijenset al., 2003).
27.8 Compliance standards
for analyzing real-time
compliance dataFor the analysis of the observation period, the data
saved in the electronic monitors are transferred via
a communicator to a personal computer or to a
secure website. With few commands, the patient’s
medication history can be visualized on the PC
screen and then printed as a compliance report.
The compliance report
The central part of the compliance report is a
quantitative and qualitative evaluation of the real-
time compliance data.
Calendar plot
The calendar plot shows the number of daily dose
units taken by the patient as illustrated in a monthly
calendar.
Thisformofillustrationfacilitatestheassignment
of the drug intake to certain days, for example,
the last days before the consultation (recognition
of white-coat compliance) or weekend compliance
(recognition of drug holidays). Moreover, account
can be taken of the patient’s regimen behavior when
evaluating reported effects and adverse effects.
An exact analysis of the temporal relationship
between separate applications is given in the
‘chronology diagram’.Chronology
The chronology diagram shows the dose units
applied in a graph with a system of coordinates.
The abscissa shows the observation period in days,
the ordinate the hours of the day from 0:00 to 24:00 h.
Every point in the diagram represents an application
of the medication. Thetimeinterval between the
doses corresponds to the regularity of the applica-
tions and permits an easier evaluation of the treat-
ment result and also of adverse effects of the
prescribed medication.Therapeutic coverage
The therapeutic coverage is the percentage of time
during which the patient had a therapeutically ade-
quate effect of medication in the observation per-
iod, based on the interplay between the drug’s
measured duration of therapeutically effective
action, after a last-taken dose and the patient’s
dosing history (Urquhart, 2000).
A useful consideration is captured in the
term ‘forgiveness’, which relates to a given phar-
maceutical product’s ability to continue to
provide therapeutic drug action in the face of
the most common errors in dosing. Forgiveness is
specifically defined as the post-dose duration of
therapeutically effective drug actionminus the
recommended interval between doses. Obviously,
when an interval between doses exceeds the drug’s
post-dose duration of action, there begins an
accumulation of ‘uncovered hours’, during which
drug action is inadequate. Therapeutic coverage
is the percentage of a period of observation
during which therapeutic action of the drug was
maintained.27.8 COMPLIANCE STANDARDS FOR ANALYZING REAL-TIME COMPLIANCE DATA 361