OBJECTIVE: Outpatient drug complications have not been well studied. We sou
ght to assess the incidence and characteristics of outpatient drug complica
tions, identify their clinical and nonclinical correlates, and evaluate the
ir impact on patient satisfaction.
DESIGN: Retrospective chart reviews and patient surveys.
SETTING: Eleven Boston-area ambulatory clinics.
PATIENTS: We randomly selected 2,248 outpatients, 20 to 75 years old.
MEASUREMENTS AND MAIN RESULTS: Among 2,248 patients reporting prescription
drug use, 394 (18%) reported a drug complication. In contrast, chart review
revealed an adverse drug event in only 64 patients (3%). In univariate ana
lyses, significant correlates of patient-reported drug complications were n
umber of medical problems, number of medications, renal disease, failure to
explain side effects before treatment, lower medication compliance, and pr
imary language other than English or Spanish. In multivariate analysis, ind
ependent correlates were number of medical problems (odds ratio [OR] 1.17;
95% confidence interval [95% CI] 1.05 to 1.30), failure to explain side eff
ects (OR 1.65; 95% CI, 1.16 to 2.35), and primary language other than Engli
sh or Spanish (OR 1.40; 95% CI, 1.01 to 1.95). Patient satisfaction was low
er among patients who reported drug complications (P < .0001). In addition,
48% of those reporting drug complications sought medical attention and 49%
experienced worry or discomfort. On chart review, 3 (5%) of the patients w
ith an adverse drug event required hospitalization and 8 (13%) had a docume
nted previous reaction to the causative drug.
CONCLUSIONS: Drug complications in the ambulatory setting were common, alth
ough most were not documented in the medical record. These complications in
creased use of the medical system and correlated with dissatisfaction with
care. Our results indicate a need for better communication about potential
side effects of medications, especially for patients with multiple medical
problems.