is volume dependent, and volume is limited by
pricing. For this reason, most of the work done to
date with electronic monitoring of compliance has
been in the clinical trials arena, where per-patient
costs are high and the premium is on the yield of
reliable information. One hopeful sign that the
‘chicken–egg’ impasse is beginning to break is
the emergence of four companies in the past year
competing in theprovision ofmonitored packaging
for solid dosage forms. Another hopeful sign is the
adoption of the ‘forgiving drug’ logic in pharma-
ceutical promotion by several firms.
An informative bit of related history is the devel-
opment of glucometers for use in the management of
insulin-dependent diabetes mellitus (IDDM). As
glucometers began to appear in the early 1980s,
they held the promise of making a marked improve-
ment in the quality of metabolic regulation in IDDM,
supplemented by measurements of glycosylated
hemoglobin. Yet use of these new methods required
patients to shift from a singledaily injection of mixed
short- and long-acting insulins to multiple finger-
sticks per day for glucometry plus multiple injections
per day of short-acting insulin. Moreover, the cost of
glucometry-guided insulinadministration approxi-
mately trebled the costs of care for IDDM. What
drove the market in this direction was the promise
that improved metabolic control would make a major
reduction in the risk of the many long-term compli-
cations of IDDM: blindness, renal failure, peripheral
nerve disorders and atherosclerosis, all leading to
excessive morbidity and premature death. Definitive
proof of that promisewas not forthcoming until 1993,
with the publication of a meta-analysis and two
randomized, controlled trial of the two modes of
managing IDDM.
A noteworthy aspect of IDDM management is
that a new professional entity, the ‘diabetes educa-
tor’, emerged to help patients grapple with the
veritable flood of metabolic data generated by
glucometry, in relation to patients’ particular levels
of diet and exercise. Neither physicians nor phar-
macists rose to the occasion to confront the new
data and guide patients to use this new information
in their daily lives. It is an object lesson in how
emerging technologies can force changes in pro-
fessional arrangements, when the professionals
involved resist change.
27.15 What is the relevance
of compliance in daily
practice?About one-third of patients appear to underdose to
an extent that is likely, for most drugs, to be clini-
cally relevant. About 50% of the patients comply
well enough, if not perfectly, to get full benefits of
the prescribed treatment. Only one patient in about
six is strictly punctual. How much compliance is
enough is a key question in order to secure full
therapeutic benefit.
A striking finding from post-1987 research on
compliance is that poor or partial compliance occur
to a remarkably similar extent across many fields of
chronic pharmacotherapy, irrespective of disease
severity. A compelling example is the consensus
among organ transplantation experts that poor
compliance with immune suppression regimens is
a leading cause of transplant rejection (Didlake
et al., 1988; Rovelliet al., 1989; De Geestet al.,
1998; Nevinset al., 2001).
Diagnostic confusion and hospital admission are
the direct consequences of poor or partial compli-
ance with medically crucial prescribed drug regi-
mens. The associated economic problems have, for
most part, not yet been quantified, although some
initial efforts have been made (Urquhart, 1999).
Here, it is important to re-emphasize that the
clinical signs of overdosing are often recognizable,
but the clinical signs of underdosing – which is far
more common – are usually misinterpreted as
worsened disease, with ensuing lack of responsive-
ness to the pharmaceutical in question.27.16 What should interactive
packaging offer to improve
patient compliance?It is clear that patients have individual preferences
and needs, and so will decide what fits them best:
audible, visible alerts, integrated or not with the
phone system. Technology is available to meet
foreseeable preferences. It seems highly unlikely
that a single type of electronically monitored
packaging will accommodate the whole range of368 CH27 PATIENT COMPLIANCE: PHARMIONICS, A NEW DISCIPLINE