Defining medication adherence in individual patients.

Background: The classification of patients as adherent or non-adherent to medications is typically based on an arbitrary threshold for the proportion of prescribed doses taken. Here, we define a patient as pharmacokinetically adherent if the serum drug levels resulting from his/her pattern of medication-taking behavior remained within the therapeutic range.

Methods: We used pharmacokinetic modeling to calculate serum drug levels in patients whose patterns of dosing were recorded by a medication event monitoring system. Medication event monitoring system data were from a previously published study of seven psoriasis patients prescribed 40 mg subcutaneous adalimumab at 14-day intervals for 1 year. Daily serum concentrations of adalimumab were calculated and compared with a known therapeutic threshold.

Results: None of the seven patients took adalimumab precisely every 14 days. Three patients who took adalimumab at intervals of 6-26 days could be classified as pharmacokinetically adherent, because their daily adalimumab serum concentration never fell below the therapeutic threshold. The four other patients, who took adalimumab at intervals of 7-93 days, could be classified as pharmacokinetically non-adherent, because their adalimumab serum concentration fell below the therapeutic threshold on 3.5%-71.3% of days.

Conclusion: Patients with varying patterns of adalimumab dosing could be classified as pharmacokinetically adherent or non-adherent according to whether or not their serum drug concentrations remained within the therapeutic range.