Implementation of a method for glucose measurements in community pharmacies

Area of Science:

• Clinical Chemistry
• Point-of-Care Testing
• Pharmaceutical Sciences

Background:

• Patient self-monitoring of blood glucose (SMBG) requires reliable comparison methods.
• Evaluating the analytical quality of glucose measurements in pharmacies is crucial for their role in healthcare.
• General practices are established sites for glucose monitoring, serving as a benchmark for comparison.

Purpose of the Study:

• To implement and validate a glucose measurement method for use as a comparison standard for SMBG.
• To assess if pharmacies can achieve analytical quality in glucose measurements comparable to general practices.
• To investigate the feasibility of using pharmacies for quality control of patient glucose meters.

Main Methods:

• Sixteen pharmacy employees were trained in glucose measurement, quality control, and blood sampling using the HemoCue Glucose 201+ device.
• The HemoCue method was validated through instrument variation assessment, comparison with laboratory methods, internal quality controls, and an external quality assessment scheme.
• Pharmacies' external quality assessment results were compared against those of 359 general practices.

Main Results:

• HemoCue instruments showed low coefficients of variation (1.7-6.1%) and negligible bias at normal glucose levels.
• Internal quality controls demonstrated high precision (1.2-4.5% CV).
• Pharmacies achieved good precision and trueness in external quality assessments, with significantly lower inter-site variation than general practices.

Conclusions:

• With appropriate training and quality assurance systems, pharmacies can provide reliable glucose measurements for controlling patients' glucose meters.
• Pharmacies demonstrated external quality assessment results comparable to, and in some aspects better than, general practices.
• This validates the potential for pharmacies to serve as accessible and accurate sites for glucose monitoring comparison.