Medication adherence, medical record accuracy, and medication exposure in real-world patients using comprehensive medication monitoring

• Published in: PloS one Vol. 12; no. 9; p. e0185471
• Main Authors: Ryan, Timothy P., Morrison, Ryan D., Sutherland, Jeffrey J., Milne, Stephen B., Ryan, Kendall A., Daniels, J. Scott, Misra-Hebert, Anita, Hicks, J. Kevin, Vogan, Eric, Teng, Kathryn, Daly, Thomas M.
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 28.09.2017; Public Library of Science (PLoS)
• Subjects: Adhesion; Adults; Biology and Life Sciences; Blood; Chromatography; Chronic illnesses; Clinical trials; Cohort Studies; Diabetes; Drug Monitoring - methods; Drug Prescriptions; Drug therapy; Drugs; Electronic Health Records; Exposure; Female; Genetics; Health services; Hospitals; Humans; Laboratories; Liquid chromatography; Male; Management; Mass spectrometry; Mass spectroscopy; Medical records; Medical Records - statistics & numerical data; Medication adherence; Medication Adherence - statistics & numerical data; Medicine; Medicine and Health Sciences; Methods; Middle Aged; Optimization; Patient compliance; Patients; Polypharmacy; Prescription drugs; Therapy; Variability; United States; Cleveland Ohio; Ohio; United States > US; Tennessee
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0185471

Poor adherence to medication regimens and medical record inconsistencies result in incomplete knowledge of medication therapy in polypharmacy patients. By quantitatively identifying medications in the blood of patients and reconciling detected medications with the medical record, we have defined the severity of this knowledge gap and created a path toward optimizing medication therapy. We validated a liquid chromatography-tandem mass spectrometry assay to detect and/or quantify 38 medications across a broad range of chronic diseases to obtain a comprehensive survey of patient adherence, medical record accuracy, and exposure variability in two patient populations. In a retrospectively tested 821-patient cohort representing U.S. adults, we found that 46% of medications assessed were detected in patients as prescribed in the medical record. Of the remaining medications, 23% were detected, but not listed in the medical record while 30% were prescribed to patients, but not detected in blood. To determine how often each detected medication fell within literature-derived reference ranges when taken as prescribed, we prospectively enrolled a cohort of 151 treatment-regimen adherent patients. In this cohort, we found that 53% of medications that were taken as prescribed, as determined using patient self-reporting, were not within the blood reference range. Of the medications not in range, 83% were below and 17% above the lower and upper range limits, respectively. Only 32% of out-of-range medications could be attributed to short oral half-lives, leaving extensive exposure variability to result from patient behavior, undefined drug interactions, genetics, and other characteristics that can affect medication exposure. This is the first study to assess compliance, medical record accuracy, and exposure as determinants of real-world treatment and response. Variation in medication detection and exposure is greater than previously demonstrated, illustrating the scope of current therapy issues and opening avenues that warrant further investigation to optimize medication therapy.