Author(s)

Y Fardo, J Verdier, F Al Shoukr, A Maget, E Verrechia, G Rondelot, S Ben Mahmoud

Why was it done?

An optimisation of an in vitro labelling protocol for red blood cells (RBCs) with technetium-99m (Tc-99m) for the detection of gastrointestinal bleeding was carried out. The initiative aimed to improve a reference protocol that did not achieve the expected labelling yields under local working conditions. By systematically testing several modifications to the protocol parameters, the variables influencing labelling efficiency were identified, and adjusted conditions were defined to obtain satisfactory and reproducible yields.

What was done?

The implementation of existing reference protocols regularly resulted in labelling yields below expected values around 50–60% instead of more than 85%, which limited diagnostic reliability. The objective was to identify the key variables that significantly affected yield, with the aim of optimising the protocol parameters to achieve higher and more consistent results suitable for routine hospital practice

How was it done?

The standard in vitro RBC labelling CNHIM procedure was used as the baseline. Forty-one experimental runs were performed, testing variations in pyrophosphate dilution, centrifugation forces, and agitation times. The resulting labelling yields were recorded and analysed by multiple linear regression to quantify the impact of each parameter on the overall efficiency.

What has been achieved?

Statistical analysis indicated that decreasing both pyrophosphate concentration and centrifugation force during the washing step of unbound Tc-99m significantly improved the yield (+37.0% and +17.2%, respectively). The other tested parameters showed no significant effect. The optimised protocol, diluting reconstituted pyrophosphate at 1:400 and applying a centrifugation force of 700 g during separation steps, consistently achieved labelling yields above 95%.

What next?

This initiative demonstrates that a simplified and reproducible labelling protocol can improve efficiency and reliability in the detection of gastrointestinal bleeding, without increasing procedural complexity. These findings could be easily applied in other hospital laboratories using in vitro RBC labelling.

Author(s)

David Ackermann
Dr. Judith Thiesen
Prof. Dr. Irene Krämer

Why was it done?

Recently we started batchwise preparation of 10 mL prefilled syringes (PFS) containing different active substances and concentrations using APOTECAsyringe. The syringes are automatically filled, capped, and labeled. However, layout and formatting of the inline printed labels (only black printing) needed improvement to avoid look-alike errors. Moreover, readability of PFS labels is compromised, since labels are wrapped around the syringes. Good labeling is absolutely necessary when norepinephrine (NE) 10 µg/ml, norepinephrine (NE) 100 µg/ml, and epinephrine (E) 100 µg/ml PFS are delivered in a set of three to be used in emergency cases. Erroneous identification of the PFS can have serious consequences for patients.

What was done?

Based on the national guideline and the international standard (ISO 26825) we decided to go for color-coded labeling and Tall Man lettering to maximize the difference between the two similar drug names. For E and NE the recommended label color is pink, on E labels the drug name is printed in pink on black background. Measures to enhance the readability of the labels were limited by the predefined size of the label and a scarce label assistant in the software.

How was it done?

Drug names and concentrations were printed in bold letters on the best visible part of the PFS label. The Tall Man lettering chosen was NORepinephrin and EPINEPHrin. To ease the identification of the two different NE concentrations, for NE 10 µg/mL a darker pink label was chosen and for NE 100 µg/mL the concentration was underscored. On E labels, the recommended black background was printed as bar beyond the drug name.

What has been achieved?

An optimized printing image of inline printed labels for pharmacy prepared NE and E PFS was successfully developed. The optimized labeling enhances readability of the PFS labels and contributes to reduced error rates in emergency cases.

What next?

Three months after implementation of the optimized PFS labels a survey among users is planned to evaluate the need for further optimization.

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Author(s)

Mª Antonia Meroño-Saura, María López-Morte, Taida Rodríguez-Martínez, Pilar Pacheco-López, Consuelo García-Motos

Why was it done?

The publication of the NIOSH list and its application by INSHT in Spain has changed the concept of “Hazardous drug” in terms of its handling and administration, as well as personnel training involved in its management.

What was done?

The main objective is to label every drug considered “Hazardous” and to review the medication included in the Emergency Department kit in a tertiary hospital.

How was it done?

Literature about Hazardous drugs was reviewed. All the drugs included in the Emergency Department kit belonging were identified and classified according to their level published in the NIOSH list. A kit’s review was carried out on site, as well as a Hazardous drugs’ categorisation by adequate labels.

What has been achieved?

6 out of 239 drugs included in the emergency kit were labelled as Hazardous drugs, and could be found in 9 different presentations. Regarding its risk level according to the NIOSH list; chloramphenicol, risperidone and all different presentations of phenytoin were classified as level 2. Acenocoumarol, colchicine/dicycloverine and all different presentations of valproic acid were classified as level 3.
The following incidents were detected;
– Lack of identification: 8 out of the total number of drugs presented identification errors.
– Location error: 4 out of the total number of drugs were not well located.
– Photosensitive: 56 out of the total drugs were photosensitive, of which 11 were not correctly identified or stored.
– Expired drugs: 12 drugs, whose total stock was 399 units. 51 out of the total amount were expired.
After this review, the following measures were carried out:
– Orange labelling for Hazardous drugs’ identification, regardless of their risk level.
– Misidentified drugs were re-labelled, and those that were misplaced were placed in their assigned spot.
– Photosensitive drugs were correctly identified by blue labels and properly preserved.
– Expired drugs were withdrawn.

What next?

Simplifying Hazardous drugs’ identification by a categorisation following a colour code could lead to a safer manipulation by the professionals. During the review of the kit, several incidents were detected and sorted out, which avoided possible medication-related errors. Therefore, it is necessary to establish several control measures in emergency kits in order to avoid errors and improve the safety in the use of drugs.

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Author(s)

Kirsten Lykke Vorbeck

Why was it done?

When preparing treatments for blinded clinical trials it is very important to make sure that it is not possible to distinguish between the active and the placebo dose, as this may lead to unblinding of the treatment and thus jeopardise the results of the trial.

What was done?

The purpose was to find solutions for how to handle active and placebo drugs in the production system CATO to ensure they would end up being identical when prepared.

How was it done?

Before preparing a drug using CATO the drug must be registered in the system with all of its data. It is not possible to have two different sets of data for one drug. CATO records detailed documentation of what is being done during preparation and it is not possible to pretend to pick one drug and then grab another instead. Also, the label is printed automatically so it will show exactly what was prepared. We decide on a common name for the active/placebo and register both of these in the system under that name so that they will be prepared in exactly the same way and appear identical on the label but are still distinguishable in the batch documentation. We name the drug ‘Protocol name Active substance/placebo’ and register the stock of both active drug and the sodium chloride solution that is used as placebo under that name. We will also stock vials of NaCl for this purpose next to the drug it is being placebo for, and NaCl can be prepared pretending it has the density of the drug. CATO will think they are the same drug but they have been registered with their very different batch numbers, maybe with a NaCl after the number of that, so it is always possible to see what was actually being prepared.

What has been achieved?

Our doses of active and placebo are indistinguishable. Labels are the same and, for example, withdrawal into a syringe and insertion of a needle into the port of the infusion bag will be done in the same way.

What next?

These very simple routines can be used anywhere for the preparation with CATO and possibly also with other systems.