by ICONESOn the ground
A workload that never lets up
Peaks in activity, staff turnover, often understaffed teams: the pressure is constant, and vigilance wears down over the hours.
Why check the finished product? Because behind every IV bag, there is a patient.
You can follow a protocol perfectly and still obtain a non-compliant product. Only analysis of the finished product reveals it.
40 %of preparations deviated by more than 5% from the target dose, with or without visual double-checking (simulation, HUG Geneva)
The challenge
Every preparation involves patient safety. And daily life in hospital pharmacies leaves little room for error.
Flow
Ever-tighter deadlines
Uncertain supplies, just-in-time production, a patient waiting after the medical go-ahead: every minute counts, and so does every IV bag.
Risk
A persistent risk of error
Fatigue, urgency, imperfect communication: even with double-checking or in-process control, all it takes is for the gaps to line up for an error to get through.
Several publications show that double-checking does not eliminate all errors, and that workload and fatigue increase the risk. See the sources
Visual double-checking
Two pairs of eyes are not enough. Studies confirm it.
3 errors out of 7went unnoticed by visual double-checking, simulation at Geneva University Hospitals
Double-checkingvisual
● error detected● error not detected
At Geneva University Hospitals, eleven operators prepared syringes under real working conditions, using marker products instead of cytotoxics. Visual double-checking detected only 4 of the 7 dose errors made. 40% of preparations deviated by more than 5% from the target dose, and double-checking made no difference.
That is 57% of dose errors spotted. Only weighing detected them all, without making doses any more accurate (Carrez et al., J Oncol Pharm Pract, 2017).
See the sources →Deviations measured in manual preparationNine published measurements, from 0.03% to 7.74% depending on the threshold and method used+
Several teams have measured these deviations, either by weighing each step during preparation or by analyzing the finished IV bag. Depending on the threshold used, up to 7.7% of preparations show a dose deviation. Visual double-checking does not correct them: in the Geneva study, it did not improve dose accuracy.
| What was measured | Rate | Preparations | Measured by | Study |
|---|---|---|---|---|
| Wrong drug scanned | 0,03 % | 15 843 | Barcode, during preparation | Reece et al., 2016 |
| Molecule not confirmed by analysis | 0,35 % | 5 742 | UV-Raman, finished IV bag | Nardella et al., 2016 |
| Deviation of more than 4% when weighing the syringe | 5,03 % | 15 843 | Weighing, during preparation | Reece et al., 2016 |
| Dose deviation of more than 10% | 2,25 % | 759 060 | Weighing, during preparation | Terkola et al., 2017 |
| Dose deviation of more than 15% | 7,74 % | 4 458 | HPLC, finished IV bag | Delmas et al., 2009 |
| Dose deviation of more than 15% | 1,52 % | 5 742 | UV-Raman, finished IV bag | Nardella et al., 2016 |
| Dose deviation of more than 15% | 0,20 % | 69 663 | FIA and HPLC, finished IV bag | Delis, Vigneron et al., 2015 |
| Dose deviation of more than 20% | 0,7 % | 7 382 | HPLC, finished IV bag | Castagne et al., 2011 |
| Dose deviation of more than 20% | 0,71 % | 759 060 | Weighing, during preparation | Terkola et al., 2017 |
Summary presented at GERPAC 2026 (Merienne and Carrez), checked against the original publications where accessible. Weighing studies measure deviations during preparation, before correction; analytical studies measure the finished IV bag. See the sources →
The alternatives
Solutions exist. But each one involves a compromise.
Conventional analytical control · HPLC
Accurate, but slow and demanding
- A very accurate analytical reference
- One method per molecule, late results
- Dedicated laboratory and qualified operators
In-process gravimetric control
Accurate on dose, indirect on molecule
- Checks the quantity, weighing after weighing
- Molecule verified only by scanning the vial
- Even with a scan, the vial can still be mixed up
In-process video control
Traceable, but blind to the finished product
- Every action traced
- Does not check the contents of the IV bag
- Hours of recordings to review
Robotic automation
Automated, but under supervision
- Reproducible actions
- Constant supervision
- A programming error repeats
In practice, none of these approaches on its own removes the risk of error on the finished product.
And in your hospital pharmacy?
Ask for a personalized assessment: based on these studies, we estimate with you the errors your controls may let through.
Dose banding or compounding
“We only do compounding.” That is precisely where analytical control matters most.
Each compounded dose is unique and each calculation is individualized: the risk of concentration error is higher. The QCRx® suits both approaches.
The comparison in 8 criteriaDose banding and pure compounding, side by side+
| Criterion | Dose banding | Pure compounding |
|---|---|---|
| Principle | Doses standardized in bands (±5 to 10% of the theoretical dose) | Dose personalized for each patient, calculated on body surface area |
| Preparation | Can be prepared in advance, in batches | Prepared on demand, for immediate use |
| Risk of molecule error | Present | Present |
| Risk of concentration error | Present, but limited by fixed doses | Higher: each dose is unique, each calculation is individualized |
| Routine effect | Yes, the same doses recur | No, variability is constant |
| BPP 2023 | Controls defined by risk analysis, release by a pharmacist | Controls defined by risk analysis, release by a pharmacist |
| SFPO, recommendation no. 17 | A traced check for every preparation | A traced check for every preparation |
| QCRx® suitable | Yes | Yes |
BPP 2023 compliance
When traceability becomes automatic. Compliance becomes a by-product of the check.
Your regulations
Canada: NAPRA Model Standards
The NAPRA Model Standards for hazardous sterile preparations require compounding personnel to verify each stage and the final preparation. The QCRx® helps you meet this requirement by analysing the finished preparation itself: drug, dose and diluent. Read the NAPRA standards
BPP 2023, chapter 4: real traceability
Each batch must have a complete record making it possible to reconstruct all operations. For controls, it contains:
- The dated and signed results of the controls performed
- The conclusions of the physico-chemical controls
- The identification of operators
- The record of any anomalies and incidents
- The release decision, with the pharmacist's date, name and signature
Retention: at least 1 year after the batch expiry date, or 10 years if the data are used for the traceability of the register.
“Release testing should rely as much as possible on new gravimetric, analytical or digital technologies.”
Chapter 6 and SFPO recommendations
A preparation is released only once its quality has been judged satisfactory, by decision of a pharmacist, following a strategy based on risk analysis (points 6.2, 6.69 and 6.70). The SFPO goes further for oncology pharmacy:
- A traced check for every preparation, aiming to replace visual double-checking with analytical, gravimetric or digital methods (no. 17)
- Release testing under pharmaceutical responsibility (no. 19)
- Annual qualification of equipment, ideally by a company independent of the supplier (no. 4)
| BPP 2023 requirement | What the QCRx® does, with every analysis |
|---|---|
| Dated and signed results | Automatic time-stamping and operator identification |
| Physico-chemical controls | Spectroscopic analysis: molecule, concentration, solvent |
| Control conclusions | Automatic verdict: compliant or non-compliant |
| Operator identification | User login traced for every action |
| Record of anomalies | Alerts and recording of non-conformities |
| Long-term archiving | Data retained and exportable for audit |
Zero re-entryResults are pushed directly into the hospital information system. No copying, no transcription errors.
Zero interpretationThe verdict is automatic. No subjective judgement to document.
Audit-readyThe inspector wants to see a batch record? A few clicks are enough to export the history.
Without automated control
- Batch record filled in by hand
- Control results re-entered
- Pharmacist's paper signature
- Manual searches for audits
- Risk of transcription error
With the QCRx®
- Records generated automatically
- Sent directly to the prescribing software
- Traced electronic validation
- Instant export of the history
- Raw data, cannot be modified
BPP 2023Good Preparation Practices (ANSM), in particular chapters 4 and 6
SFPO recommendationsAdaptation of resources in oncology pharmacy, 2nd edition, July 2019
HAS and certificationCriteria for controlling the medication circuit
The QCRx® is an analytical control tool, not document management software. It generates control data that meet the requirements; integrating them into your overall quality system remains your responsibility.
Sources and further information+
- A systematic review found insufficient evidence that double-checking reduces administration errors compared with a single check (Koyama et al., BMJ Qual Saf, 2020).
- Geneva University Hospitals (Carrez et al., 2017): in a simulation under real working conditions (marker products, 438 syringes), visual double-checking detected only 4 of 7 dose errors and did not improve dose accuracy.
- In-process video systems improve traceability, but do not measure the final concentration of the preparation.
- Several studies link occupational fatigue to an increase in medication errors; a meta-analysis estimates that nearly one pharmacist in two is affected by burnout (48%, Teoh et al., Value in Health, 2022).
- HPLC offers high accuracy but requires a dedicated laboratory, qualified operators and one method per molecule. Method development is long and tedious (Bazin et al., Int J Pharm, 2015).
- Even robotic automation can amplify an error if programming or supervision fails (UCSF, San Francisco, 2013: the pharmacy robot faithfully prepared 38 and a half tablets instead of one, from a wrongly entered prescription).
- SFPO recommendations: patient waiting time of less than one hour after medical validation (no. 12), preparation sessions of no more than 2 hours at a stretch (no. 10).
- ANSM. Good Preparation Practices. Decision of 21 July 2023 (in French).
- SFPO. Recommendations: adaptation of resources related to oncology pharmacy, 2nd edition. July 2019.
- Merienne and Carrez. “Sitting of the GERPAC court: the trial of analytical control”. 29th GERPAC European congress, Hyères, 2026. Summary of the studies below.
- Delmas A. et al. Quantitative and qualitative control of cytotoxic preparations by HPLC-UV in a centralized parenteral preparations unit. J Pharm Biomed Anal. 2009;49(5):1213-1220.
- Nardella F. et al. A UV-Raman spectrometry method for quality control of anticancer preparations: results after 18 months of implementation in hospital pharmacy. Int J Pharm. 2016;499(1):343-350.
- Delis B., Vigneron J. et al. Contrôle analytique des préparations cytotoxiques : bilan de 7 ans d'activité et perspectives. Pharm Hosp Clin. 2015;50(2):233-242.
- Castagne V. et al. Cytotoxics compounded sterile preparation control by HPLC during a 16-month assessment in a French university hospital. J Oncol Pharm Pract. 2011;17(3):191-196.
- Reece K.M. et al. Implementation and evaluation of a gravimetric i.v. workflow software system in an oncology ambulatory care pharmacy. Am J Health-Syst Pharm. 2016;73(3):165-173.
- Terkola R. et al. Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact. J Clin Pharm Ther. 2017;42(4):446-453.
- Carrez L. et al. Reliability of chemotherapy preparation processes: evaluating independent double-checking and computer-assisted gravimetric control. J Oncol Pharm Pract. 2017;23(2):83-92.
- Koyama A.K. et al. Effectiveness of double checking to reduce medication administration errors: a systematic review. BMJ Qual Saf. 2020;29(7):595-603.
- Bazin C. et al. Comparative analysis of methods for real-time analytical control of chemotherapies preparations. Int J Pharm. 2015;494:329-336.
- Cataldi A. et al. Alertness of in-process controls: feedback on two production errors. CHI Poissy-Saint-Germain-en-Laye, GERPAC 2022.
- Viault M. et al. Feedback: is it useful to watch all DrugCam® videos before delivery? CH de Niort, GERPAC 2022.
- Cho H.N. et al. Implementation and evaluation of APOTECAchemo in a community cancer center: a comparative study of robotic versus manual antineoplastic preparation. J Pharm Technol. 2024;40(6):269-276.