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Directive puts traceability in the spotlight

Published: 11 January 2012 - Heather Ramsden

Consumer protection and increasing health and safety concerns have become central in the pharmaceutical supply chain due to the need to track medicines moving from manufacturer to dispensing pharmacy, says Barry McMahon, pharmaceutical applications specialist at Zetes Ireland

In February, the European Parliament voted to ammend the 2001/83/EC Falsified Medicines Directive concerning the threat of falsified medicinal products for human use. Once enforced, this Directive will ensure all prescription medicine products sold across Europe are uniquely identifiable and can be traced throughout the supply chain.

The falsification of medicine refers to any medical product with a false representation of identity, source or history. For medicinal product manufacturers, this means a legal requirement to apply safety features which make it possible for wholesale distributors, to uniquely identify and verify the authenticity of individual packs, ensuring external packaging has not been tampered with. The Directive will extend from finished medicines to active substances within two years.

This development is significant as many manufacturers are outsourcing their logistics operations to specialist third party logistics providers or introducing Direct to Pharmacy supply practices in an effort to reduce costs.

Various solutions are already in use to enable manufacturers to achieve compliance with the new Directive cost effectively. High-speed print and apply marking systems are available that allow secure identification and serialisation of the secondary packaging of medicines and medical goods at the production line. Several international manufacturers have implemented a serialised print and apply labelling system ahead of the Directive being passed which works across multiple production lines.

There is an opportunity for the pharma industry to learn from the food and fast moving consumer goods sectors (FMCG) to achieve faster, more accurate order preparation with advanced stock picking strategies, greater shipment accuracy, improved product quality and greater safety through better cold chain management. The increased visibility such systems deliver will also improve customer intimacy levels by allowing a greater understanding of consumption patterns.

Proven stock picking strategies

Manufacturers need to supply pharmacies with the right order often at short notice. Pharmaceutical wholesalers/ distributors and logistics companies can very quickly optimise order preparation processes by applying the voice directed picking techniques adopted by food retailers in particular. ‘Pick to voice’ as it is also known, has been proven to cut costs and improve operational efficiency by up to 40 per cent. It is also possible to combine voice picking with manual or automated scanning systems to eliminate pre-despatch verification.

CERP, a French/Belgian pharmaceutical distributor uses voice picking ensuring speed of delivery. CERP’s system, has allowed CERP to adopt a just-in-time operational mode for pharmacy deliveries. A pharmacist placing an order in the morning expects to receive it on the same day or overnight for afternoon orders. Zetes’ system supports hundreds of operators across the country and uses the MCL-Voice recognition engine with Motorola MC3190 terminals.

The voice picking system helps reduce labour costs and time taken for orders to be shipped. As the warehouse operator picks items within each pharmacy order in response to spoken instructions from the voice picking system, each product selected is also individually scanned using a wearable ring scanner to capture the Datamatrix code. This step ensures batch references and expiry dates are recorded for each item, useful in the event of a product recall.

Accuracy and visibility

Next generation automatic shipment verification solutions like Visidot from Zetes use image-based technology to ensure that the right medicines are sent to the right pharmacy or hospital. Already employed by food and beverage manufacturers, they can ensure 100 per cent accuracy of shipped pallets. Using this technique it is also straightforward to inspect items when preparing boxes or crates, manage returns from pharmacies and create a log of all unique identifiers on crates and cartons in order to maintain a record of products shipped.

Ensuring medicine quality

RFID technology offers advantages for cold chain management and ensures certain medicines such as vaccines and antibiotics are stored at a constant temperature along the supply chain. In a temperature-controlled environment, the entire operation is only as strong as its weakest link, with every negative impact having a cumulative effect on product quality, including point of sale. Using special RFID tags, it is possible maintain optimal product quality from production to the time they are dispensed to patients.

Pan European system

Implementing the Directive properly will also require the co-operation of all stakeholders. Indeed the detailed notes emphasise the collective responsibility of all stakeholders within the pharmaceutical supply chain to inform the competent authority if any medicinal products are suspected of being falsified, irrespective of whether those products were distributed by legal or illegal means. In practice, we believe it will be necessary to create a pan-European system with the support of manufacturers to assign and store unique numbers for all products. Having data in a central repository like this will mean product serial numbers can be checked against the items having been previously dispensed to prevent the possibility of counterfeiting but will require a significant increase in data volumes stored between partners. Incoming legislation to increase patient safety clearly creates a challenge for the entire industry but rather than simply representing additional unnecessary ‘red tape’, offers a number of real benefits.

Industry Connections: Zetes


 
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