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hospital patients will receive a blood transfusion. Relatively few people, in comparison, receive a bone marrow transplant or a bone implant. In contrast, an area that has grown significantly in the past 10-15 years is cell and gene therapies, and these often have special requirements that mean a mistake in the labelling could be fatal.
If correct labelling is important in day-to-day medical practice, then it is even more so in phase 2 or 3 clinical trials, where the possibilities for error are multiplied. The cell- or gene-based product has to pass through several different stages, from apheresis collection through transportation to delivery and infusion, and at each stage mistakes could be made that could put clinical trial subjects at risk. Apheresis centres, for example, often collect source material products for many different clinical trial sponsors or manufacturers, many of whom have different labelling requirements. En route, the product may cross multiple borders and jurisdictions, and frequently a cold chain has to be maintained across the entire journey.
Before a standard labelling system was developed, the methods adopted for labelling products were inconsistent and prone to error. Different organisations used different ways of recording the same information. For example, hematopoietic progenitor cells might be identified by a patient’s name and date of birth, or by their hospital ID number, creating potential for confusion and misidentification once the product had left the hospital. Sometimes, labels were handwritten, meaning poor legibility or missing information could add to the problem.
Accuracy, security and traceability In 1994, the newly formed ICCBBA introduced a labelling standard, ISBT 128, as a method for labelling blood products. The letters in ISBT 128 stand for International Society of Blood Transfusion, and as a new standard it was comprehensive, mandating standardised terminology for each piece of information on the labels of MPHOs. Every product that conforms to the standard must have the product information encoded in a barcode. But the label must also contain information readable by eye, such as the patient’s name and product description, to reduce the risk of error when products from multiple sources are used. This is particularly useful, says
Szczepiorkowski, in countries where there may be no technological means of reading the barcode. ISBT 128 aims to ensure that information critical to patient safety can pass through the supply chain accurately, securely and in a manner ensuring the product can be traced. As an example, if a recipient experiences an adverse event from an MPHO, other products from the same source can be quickly identified and quarantined.
Clinical Trials Insight /
www.worldpharmaceuticals.net
Standardised terminology for cell therapy
Although the new standard worked well, the landscape of clinical products began to change in the late 1990s. ICCBBA responded by continuing to refine and develop ISBT 128, using technical advisory groups (TAGs) made up of experts to make sure that the standard could adapt to user requirements.
One of the most significant developments has been the growth in MPHOs, and by the turn of the century, some facilities realised that ISBT 128 had the potential to be adapted for use with cellular products. A huge multi-organisational effort spanning multiple countries was required to make the necessary changes, which in 2007 culminated in a standardised terminology for use in cell therapy products.
The new standard had to take account of the importance of maintaining low temperatures, because when certain biological material is transported, any break in the cold chain could have serious adverse consequences. It did this through a new product description database that included three elements: classes (broad descriptions such as cord blood); modifiers, which describe the state of the product (such as “cryopreserved” or “thawed”); and attributes – the elements that make it possible to uniquely identify the product. A mandatory attribute, known as Core Conditions, enables the recording of the storage temperature, which can range from ambient room temperature through to complete immersion in liquid nitrogen.
A later development involved the creation of a Global Registration Identifier for Donors (GRID), in response to a serious error in 2013, when a patient was given the wrong bone marrow transplant because two registries had used the same identifier for two different donors. The standard has been an undoubted success. It has been adopted in 80 countries – typically by independent accreditation organisations rather than
Every product that conforms to the ISBT 128 standard must have the product information encoded in a barcode.
40
million
The number of products that are labelled with ISBT 128 every year.
National Library of Medicine 37
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Shutterstock.com
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