Objective versus subjective assessment of oral medication adherence in pediatric inflammatory bowel disease.

BACKGROUND

The objective was to examine the prevalence and frequency of oral medication nonadherence using a multimethod assessment approach consisting of objective, subjective, and biological data in adolescents with inflammatory bowel disease (IBD).

METHODS

Medication adherence was assessed via pill counts, patient/parent interview, and 6-thioguanine nucleotide (6-TGN)/6-methylmercaptopurine nucleotide (6-MMPN) metabolite bioassay in 42 adolescents with IBD. Pediatric gastroenterologists provided disease severity assessments.

RESULTS

The objective nonadherence prevalence was 64% for 6-MP/azathioprine (AZA) and 88% for 5-aminosalicylate (5-ASA) medications, whereas subjective nonadherence prevalence was 10% for 6-MP/AZA and 2% for 5-ASA. The objective nonadherence frequency was 38% for 6-MP/AZA and 49% for 5-ASA medications, and subjective nonadherence frequency was 6% for 6-MP/AZA and 3% for 5-ASA. The bioassay data revealed that only 14% of patients had therapeutic 6-TGN levels.

CONCLUSIONS

The results indicate that objectively measured medication nonadherence prevalence is consistent with that observed in other pediatric chronic illness populations, and that objective nonadherence frequency is considerable, with 40%-50% of doses missed by patients. Subjective assessments appeared to overestimate adherence. Bioassay adherence data, while compromised by pharmacokinetic variation, might be useful as a cursory screener for nonadherence with follow-up objective assessment. Nonadherence in 1 medication might also indicate nonadherence in other medications. Clinical implications and future research directions are provided.