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Time to stop counting the tablets?

T Pullar1, S Kumar, H Tindall

  • 1University Department of Medicine, General Infirmary, Leeds, England.

Clinical Pharmacology and Therapeutics
|August 1, 1989
PubMed
Summary
This summary is machine-generated.

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Return tablet count often overestimates patient compliance. A pharmacologic indicator, like phenobarbital levels, provides a more accurate assessment of medication adherence in clinical studies.

Area of Science:

  • Pharmacology
  • Clinical Research
  • Patient Adherence

Background:

  • Accurate assessment of patient compliance is crucial for reliable clinical study outcomes.
  • Traditional methods like tablet counts may not precisely reflect actual medication intake.

Purpose of the Study:

  • To compare the accuracy of return tablet count versus a pharmacologic indicator (phenobarbital) for assessing patient compliance.
  • To evaluate medication adherence in patients participating in clinical trials.

Main Methods:

  • Assessed compliance in 225 patients across three studies using both return tablet counts and plasma phenobarbital concentrations.
  • Phenobarbital levels were corrected for patient dose and weight and compared to established volunteer values.
  • Follow-up appointments and container returns were also monitored.

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Main Results:

  • While 96% of patients attended follow-up, return tablet counts suggested good compliance (90-109%) in 161 patients.
  • However, 32% of these patients had sub-therapeutic phenobarbital levels, indicating poorer compliance.
  • Significant discrepancies were observed, with tablet counts overestimating adherence, particularly in cases of seemingly excessive or incomplete returns.

Conclusions:

  • Return tablet count is an unreliable method that grossly overestimates patient compliance.
  • Pharmacologic indicators, such as plasma drug concentrations, offer a more objective and accurate measure of medication adherence.
  • Relying solely on tablet counts can lead to erroneous conclusions regarding patient adherence in clinical research.