Visual double-checking alone is insufficient.
Research confirms this.
One might assume that two pairs of eyes are better than one. In reality, it is more nuanced.
A study conducted at the Geneva University Hospitals assessed the actual effectiveness of double visual checks on chemotherapy preparations. The results are unequivocal: the double check detected only 4 errors out of the 7 that occurred, meaning 3 errors slipped through the net.
Even more concerning: 40% of preparations had a deviation greater than 5% from the target dose. The double visual check had no impact on this accuracy.
This is not a matter of competence.
It's a human limitation, intensified by:
However, human error is not a fault. It is a factor to be integrated within the quality system.
The 2023 GMP guidelines are clear: final product control is now mandatory.
The 2023 Good Preparation Practices enhance the requirements for release control. Chapter 6 states that the finished product must be tested before the release of each batch, with full traceability.
The SFPO recommendations for oncological pharmacy go even further:
Analytical monitoring advised for high-risk preparations
Annual qualification of equipment by external service provider
Archiving and traceability at every stage of preparation
Key point
The GPP 2023 specify that 'the release control relies as much as possible on new gravimetric, analytical, or digital technologies,' regardless of the type of preparation.
Dual Verification, HPLC, Video
Each Method Has Its Blind Spots
The assessment
None of these methods alone can certify that the finished product contains the correct molecule, at the correct dosage, in the right solvent — in real-time.
Final Product Analytical Review:
Focusing on What Truly Matters
What if, instead of controlling the process, we directly control the outcome?
This is the principle of release analytical control on the finished product:
This approach introduces a clear final safeguard, independent of human fatigue or attention.
Dose banding or compounded preparations:
same need for control
"We only carry out master preparations, not dose banding."
This is an observation we occasionally come across. It stems from the misconception that analytical control is exclusively for pre-prepared standard doses. The reality is quite the opposite.
Two approaches, one shared safety challenge
Dosing standardisation
Why Compounded Medicines Require Extensive (or Even Greater) Control
Each preparation is a distinct case
In dose banding, the technician consistently performs the same steps for identical doses. This routine fosters procedural consistency. However, in precise compounding, every bag requires its unique concentration, such as 127 mg, 89 mg, 203 mg, and so forth. This scenario involves peak cognitive load, which inherently raises the risk of error.
Tailored calculations increase the number of potential failure points.
Body surface area, adjustment according to renal function, dose reduction... Each calculation presents an opportunity for error. Analytical control validates the final result, regardless of the complexity of the initial calculations.
The double visual check is even less reliable with atypical doses.
The French simulation study (Bonabry et al., 2016) indicates that visual double-checking identifies only 57% of dosing errors. When dealing with 'round' and repetitive figures, the eye might notice aberrations. Comparing against 127.4 mg vs 174.2 mg? Far less likely.
The 2023 BPP guidelines make no distinctions.
The message is clear: release control must rely on analytical technologies for all preparations, not just standardised hospital preparations.
Overview:
Common myths vs reality
Preconceived notion
Analytical control designed for the daily operations of hospital pharmacies
QCRx® has been developed in collaboration with hospital pharmacists to solve a simple equation: better control, without slowing down.
What QCRx® does:
Impact on daily operations:
Dual visual inspection (67% undetected errors¹)
Uncertainty regarding the actual concentration
Time spent on video review
Manual traceability
Objective analytical assessment
Assurance on content
Real-time release
Automated Archiving
What it doesn't require:
No dedicated laboratory
No costly consumables
No specific analytical training (just ours)
No deceleration of the production flow
Whether it's dose banding or compounding: the result remains consistent! Whether you're preparing 50 identical bags of 5-FU in a dose banding or 50 customised bags with varying concentrations, the QCRx® assesses each one individually, providing you with the same assurance: correct molecule, precise dosage, appropriate solvent. All done within the same timeframe!
Already embraced by over 50 institutions
QCRx® is utilised daily across over 55 hospital pharmacies in France and Europe: University Hospitals, Comprehensive Cancer Centres, and private facilities.
"Since we have been using the QCRx®, the error rate for controlled preparations is zero. We release each batch with peace of mind."
Hospital Pharmacist
Martinique University Hospital
Experience it firsthand
A demonstration speaks louder than words.
In 30 minutes, we will show you:
How does QCRx® integrate into your compounding workflow
What it detects (and what a double visual check might miss)
How your colleagues use it daily: as dose banding or as pure magistral preparation
