Understanding of patient compliance with crucial drug regimens has imp
roved markedly since 1986, based on data from two objective methods fo
r monitoring drug dosing by ambulatory patients. Electronic monitoring
records times and dates of drug package use, and chemical markers, in
corporated into drug dosage forms, are assayed in plasma. These method
s remove the camouflage that masks many poor compliers. In contrast, o
ther methods (returned tablet counts, interviews, questionnaires) allo
w patients easily to censor evidence for delayed or omitted doses. The
new methods show many more and larger errors of omission in both tria
ls and practice than previously believed. One patient in about six is
punctually compliant, but a modest majority of patients make errors pr
obably too small to attenuate or otherwise modify the actions of all b
ut the most unforgiving medicines. About a third of patients delay or
omit many prescribed doses, thus attenuating or otherwise modifying th
e actions of all but the most forgiving drugs. One patient in about si
x takes little medicine, though camouflaged as a good complier. Simila
r patterns of delayed and omitted doses prevail, essentially independe
nt of drug, disease, prognosis, or symptoms;Ln summary, patients take
the prescribed dose at intervals longer than prescribed - often by hou
rs, sometimes by days, occasionally by weeks. The clinical and economi
c consequences of these lapses in dosing are unique to the treatment s
ituation and the severity of disease and comorbidity. The new methods
have not yet been applied to androgen-blocking agents, but if the find
ings resemble those with, e.g. tamoxifen in breast cancer, it will dou
btless trigger some rethinking about failed treatment, trial design, a
nd clinical management.