Skip to content

CLOSED-LOOP DIGITAL TRACEABILITY OF DOSE BANDING BAGS

European Statement

Production and Compounding

Author(s)

Paola Cristina Cappelletto, Linda Cappellazzo

Why was it done?

Ensure complete digital tracking in closed loop of batches and expiry dates of anticancer drugs prepared in dose banding. Software Medical80© must be able to identify quickly the batches of the drug and solvent used to prepare the bag in dose banding and administered later to a specific patient, following a medical prescription.

What was done?

In 2018, the Pharmacy Unit of Bolzano Hospital introduced automated preparation of fixed-dose anticancer drugs (gemcitabine, paclitaxel, rituximab, pembrolizumab) using Apoteca Chemo© [3]. Until now, the batches prepared have been partially tracked by the Bolzano hospital’s internal software (Indaco©). In 2025, new software called Medical80© was purchased. To digitalize the entire process of prescribing cytostatic drugs by the departments, it was developed a complete batch tracking in closed loop within the Medical80© software including also dose banding preparations. The hospital pharmacist collaborated with the software developers to ensure a safe and complete batch tracking system, in accordance with current regulations [1] and pharmacovigilance requirements [2].

How was it done?

The pharmacist responsible for the galenic area coordinated the activity. Initially, she requested the coding of dose banding preparation within a national database to assign a unique code to each preparation. Specific records for the individual bags prepared in dose banding were then coded, both in the warehouse software and in the prescription and medical record software. The codes automatically assigned by the warehouse program were then entered into Medical80©.

What has been achieved?

This process has enabled to fully track batches and check stock levels directly from the prescription and validation software. Once the batches have been set up, labels were printed and affixed to the bags, and the technician loaded the preparations into Medical80©, recording the batch and expiry date of the starting drug. This information was also recorded and tracked through barcode. At the time of prescription, the bag set up in advance was associated and tracked until administration to the patient.

What next?

Complete tracking from preparing dose-banded bags to delivery to the patient, ensured safe dispensing of the cytostatic drugs. The future goal is to digitalize the load of batches prepared in dose banding using an optical scanner in Medica80©.

UDI-BASED END-TO-END TRACEABILITY: A SMART APPROACH TO MEDICAL DEVICE MANAGEMENT

European Statement

Patient Safety and Quality Assurance

Author(s)

Andrea Piovanelli, Ivan Schimmenti, Enrico Almici, Paola Crosasso, Fabio Genestrone, Elena Toniato

Why was it done?

Medical devices’ traceability is a critical issue in hospital settings due to the high cost of devices and the need to associate item-patient-procedure. Standardized identification systems become fundamental to manage clinical risk, while addressing inefficiencies in inventory management, and minimizing waste from poorly monitored expiration dates. RFID-based solutions have been tested to implement identification and traceability with the promise of automating procedures and facilitating personnel activities, nonetheless their complexity and cost have limited their adoption so far. EU Regulation 2017/745 (MDR) introduced the requirement of native UDI (Unique Device Identifier) codes present on each medical device. As such, it is now possible to implement simple and cost-effective solutions for identification and traceability that do not require specific hardware or tedious relabeling procedures compared to RFID, and exploit 2D data carriers natively present on MDs.

What was done?

To implement a digital, end-to-end traceability system for medical devices using native UDI (Unique Device Identifier) codes, in compliance with EU Regulation 2017/745 (MDR). The objective is to improve patient safety, optimize inventory management, reduce operational costs, and ensure regulatory compliance without the need for relabelling and dedicated personnel.

How was it done?

The proposed solution leverages optical identification technologies and hands-free systems to automate device tracking from hospital entry to patient association. Smart cabinets manage inventory and access control, while smart baskets automatically link devices to patients. An AI-powered platform analyses data across all phases to support stock optimization, automatic reordering, structured reporting, and performance evaluation.

What has been achieved?

The system enables real-time inventory visibility, eliminates manual errors, improves device utilization. Avoiding costly, time-consuming and risky relabeling of MDs with RFID tags lowers implementation costs, minimizing environmental impact. Clinically, it enhances patient safety enabling rapid response to recalls and adverse events. Operationally, it streamlines logistics, reduces staff workload, and improves planning through AI-driven insights.

What next?

The adoption of an end-to-end UDI-based traceability system represents a significant advancement in medical device management. It delivers tangible benefits in terms of economic efficiency, clinical safety, organizational performance, and environmental sustainability. This innovative approach aligns with the digital transformation of healthcare and offers a scalable model for hospitals seeking to modernize their logistics and compliance processes

90% reduction of medication waste by reusing returned medication from medical wards

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Douwe van der Meer, Peder Nygard

Why was it done?

In our hospital 30% of the daily distributed medication for individual patients was not administered. Reasons for not administering were for example lack of need because of patients clinical performance, discontinuation of prescriptions or early discharge. Because of safety concerns, like mix-ups, our standard procedure was to discard all returned medication. This resulted in a waste of about 220.000 pills annually.

What was done?

We reduced medicine waste by 90% by reusing returned medication from our medical wards. With this result we made an important step for our hospital to meet the national sustainability goals in the Dutch ‘Healthcare Green Deal (3.0)’.

How was it done?

Reusing returned medication brings multiple safety concerns. By performing a prospective risk analysis we identified three major risks: mix-ups, expired medication and accepting non-qualitative packages (like slightly opened blisters or incomplete labels). With these risks identified we redefined our distribution process on four key elements: 1) Every medication has a barcode on unit level and if not, is labelled by our team through duplicating the ‘Falsified Medicine Directive’-barcodes to small 2D barcode labels which includes expiration date. 2) All returned medication is checked by a pharmacy employee on major quality aspects. 3) Returned medication is placed in a separate ‘return-box’ in front of the original stock inside the distribution cabinet. 4) Expiration dates are checked more frequently and are checked upon distribution and administration through barcode scanning.

What has been achieved?

The new distribution process was implemented in all of our eight distribution cabinets and resulted in saving 90% of the returned medication; witch amount to 200.000 pills and 70.000 euro savings annually. On average we work with 6 employees daily, who need 15 minutes extra per person per day to process returned medication.

What next?

Our goal is to save all returned medication that meets our quality standards. 5% of the returns that are not reused are medicines not included in the assortments of the specific distribution cabinet, so extra logistic and administrative steps are needed to place them back in the pharmacy stock. We are exploring new ways to make this next step in reducing medication waste further.

Centralised DataMatrix reading for drug authenticity verification

European Statement

Selection, Procurement and Distribution

Author(s)

Leonor Romero, Paloma Lozano, Veronica Canales, Vanesa Dechado, Marta Puebla, Ricardo Villarubia, Isamar Gomez, Estefanía Ramírez, Juan Rodríguez, Belén Soto

Why was it done?

According to Directive 2011/62/EU, one of the measures is the inclusion in the secondary packaging of the drug of a Unique Identifier that allows the recognition of a unitary case at any point in the supply chain until it is dispensed to the patient. Another is the development of a European repository that allows the traceability of medicinal products for human use within the European market. In Spain, in accordance with Article 84.1 of Royal Decree 717/2019 of 5 December 2009, the SNSFarma Node was established as an instrument for technological integration and information exchange with the national repository known as the SEVeM.

What was done?

The logistics company of our hospital aggregates several codes corresponding to the Datamatrix of the individual containers in an electronic file, in order to send the reading automatically to Spanish Medicines Verification System (SEVeM).

How was it done?

The shipment of the drugs and the electronic file will be linked by the Seria Shipping Container Code (SSCC), which will univocally guarantee traceability between the two. The Pharmacy Service staff receive the delivery notes by reading the barcode without the need to scan the Datamatrix of each container.
Since the implementation of this project between July 2023 to September 2023, a total of 61 delivery notes have been registered under the code aggregation system with 27 suppliers involved. The number of packages read was 2151.

What has been achieved?

This project ensures the automatic sending of readings to SEVeM and to facilitate the reception of delivery notes at the Pharmacy Services by barcode reading.
This has allowed pharmacy staff to save time in receiving delivery notes, to improve traceability of batches and expiry dates of medicines, to improve stock control thanks to the confirmation of quantities received and to verify the medicines in accordance with European regulations to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.

What next?

A limitation is the existence of suppliers that are not involved in this project since their delivery is not done through the logistics company. In these cases, the datamatrix reading must be performed on each container individually.

Designing drug packages to support correct barcode scanning and closed loop medication

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Helge Ovesen

Why was it done?

In November 2022 St Olav’s hospital, a large university hospital, introduced electronic prescribing and closed loop medication for more than 700 beds. Oral medications are predominantly available as unit doses, other medications as barcoded packages. After go-live with the bedside scanning, data showed that a large part of the administrations and preparations did not happen with barcode scanning. The hospital needed to understand the reason for this in more detail.

What was done?

A team of pharmacists, nurses and IT personnel have analysed technical reasons why medications are not scanned at the patient’s bedside during administration or when doing preparation in the wards’ medicine room.

How was it done?

The group collected data on all scans that had failed and analyzed the input to the barcode scanner. In addition, the nursing staff lead was consulted to provide more information of the problems with the physical packages for the medication and how that affected the work process of achieving closed loop medication. Products that did not have a printed barcode at all were not included in the analysis.

What has been achieved?

Six different areas were identified when trying to describe the problems with closed loop medication and scanning of medicine:
1. Barcode printed on package but missing product code/GTIN in the system/national drug registry.
2. Barcode printed on package but with wrong implementation of ISO/GS1 encoding.
3. Barcode printed on package but hidden for the user on the package label.
4. Barcode only printed on the outer package that was removed when stored in the medicine room.
5. QR codes with links to training materials or other barcodes confused the nurse and the wrong code was scanned.
6. Barcode printed on package but contrast for the barcode scanning was not good enough (ex. dark vials with black barcodes).
The problems have been shared with drug manufacturers and competent authorities to raise awareness of how drug package design and correct/incorrect use of barcode printing affect implementation of closed loop medication.

What next?

Work together with national drug registries in Norway and drug manufacturers to create a national best practice for barcode printing on drug packages. The work should be coordinated with work on a European level.

DRUG SERIALISATION: ORGANIZATIONAL AND ECONOMICAL IMPACTS FOR HOSPITAL PHARMACIES (submitted in 2019)

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Quentin HIVER, Agathe ROGER, Marine EGOT, Ivan VELLA, Marie-Hélène TYWONIUK

Why was it done?

Community and hospital pharmacists are required to apply the European directive on falsified medicines. In France, we are currently undergoing a transition phase for the progressive generalisation of serialisation. French pharmacies are more or less ahead of schedule for the implementation of decommissioning. In our pharmacy, the decommissioning has been operational since February 2019. After 8 months of practice, we are able to provide data as a basis for work and thinking.

What was done?

Determining and evaluating, by feedback approach, the organisational and economical impacts of drug serialisation for a hospital pharmacy

How was it done?

• Step-by-step description of the supply chain after implementation of decommissioning. • Collection of the man-hours necessary for: decommissioning implementation, software training, routine decommissioning, problem solving. • Census of financial investments

What has been achieved?

After analysis of our supply chain, the reception stage appeared to be the most favorable for decommissioning, in terms of practicality, safety and traceability. Several steps have thus been added at reception: Identification of serialized boxes, manual scan, checking of the decommissioning report and the number of decommissioned boxes, printing of the report. The pharmaceutical time necessary for the decommissioning implementation has been estimated to up to 28 hours. The software training was made in small groups of 2−3 agents, requiring 9 minutes per agent on average. The decommissioning is currently requiring 17 minutes for 100 boxes. Over 8 months, the time necessary for the pharmacists to solve problems linked with serialisation (non-operational Hub, corrupted database, error message at decommissioning…) was estimated to up to 7 hours. The financial investment amounts to 17200 euros (software+ergonomic desk+man-hours at implementation).

What next?

The decommissioning itself doesn’t have a major impact on the pharmacy’s organization. But, ensuring a clear and safe supply chain, to identify which boxes must be decommissioned and which boxes can be dispensed, is time-consuming. It goes through a proper working environment with a forward supply chain and traceability tools. Moreover, the encountered problems were mainly due to computer failures, requiring a performing software with an efficient maintenance. We are currently working on improving the ergonomics of the workstation to avoid the risk of musculoskeletal disorders due to decommissioning.