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

Abstract

BackgroundPoor 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.Methods and findingsWe 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.ConclusionsThis 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.

Medication adherence during laboratory workup for primary aldosteronism: pilot study

“… 25 – 30 In one large survey, 38 different drugs were screened in 821 random serum samples by LC-MS/MS and 33% of positive hits did not correspond to a known prescription. 31 In another study, 8.3% of hypertensive patients relied on some kind of self-medication according to plasma drug checks yet without reporting this to the clinic. 30 Indeed, the current review literature still neglects self-medication as a relevant topic.…”

Assessment of Patient Medication Adherence, Medical Record Accuracy, and Medication Blood Concentrations for Prescription and Over-the-Counter Medications

“…Analysis using the validated mass spectrometry-based 263-drug serum assay revealed a median number of detected medications per patient of 2.5 (IQR, 1-5) in the residuals cohort, 6 (IQR, [5][6][7][8][9] in the gastroenterology care cohort, and 6 (IQR, 4-7) in the ED care cohort. Inconsistencies between detected and listed medications consisted of both missing medications that were prescribed but not detected and additional medications that were DNP according to the patient EHR.…”

“…More medications were detected in serum samples from the gastroenterology care cohort and ED care cohort (patients seeking treatment) than from the residuals cohort (patients randomly selected), similar to previous results using a smaller assay panel. 7 To discern trends within categories of medications, we compared the overall detection rate among patients in the ED care cohort relative to those in the residuals cohort (eFigure 1 in the Supplement). The detection rates of individual medications were correlated between the 2 large cohorts.…”

“…Recent pilot medication measurement studies have unearthed problematic trends in medication therapy for real-world patients prescribed multiple medications using small, focused medication panels. 7,8 These evidence-based studies of nonadherence, medication record inaccuracies, and subtherapeutic and/or supratherapeutic dosing found costly and potentially dangerous issues affecting both patients and the health care system. 9,10 Measuring all medications using individual assays is impractical: the probability of 2 patients prescribed 5 or more medications being on the same medication regimen is less than 1%.…”

“…11 Technical advances in liquid chromatography-tandem mass spectrometry (LC/MS/MS) technology have made possible the simultaneous measurement of hundreds of analytes in a single complex biological sample, offering a practical way of assessing most prescribed medications in a single test. The ingestion of medications by patients frequently does not match the prescription records, 7,12 and this would be valuable information that can be used to improve medication therapy and safety. If the concentration of each medication in a patient was known, then medication adherence and the discordance between the medications taken and those listed in the patient's health record could be shown at both the individual level and the population level, and it could also be shown which drug interactions, genetic polymorphisms, and environmental factors manifest as altered drug concentrations.…”