Packaging
FDA guidance around the reporting of clinical trial safety, published in September 2021, did not cover labelling.
A needle in a haystack
Draft guidance around the reporting of clinical trial safety issues in the US was published by the FDA in September 2021, but it did not cover labelling. A spokesperson for FDA told Clinical Trials Insight that there were no immediate plans to introduce guidance on labelling. Only the World Health Organisation could produce global guidelines, says Grissinger, but he doubts that will happen as it has other priorities at present.
“With trials being conducted in multiple countries, study drugs often have labels that would work for many different countries, so they contain many pages (the label is often a multiple-page/multiple-language leaflet attached to a container), and the information can be hard to find.”
Cynthia Tanguay
He highlights the common use of bottle containers for medication instead of boxes or packets for clinical trials, as a problem, as everything depends on the label to ensure the patient takes the correct dose. It is easier to ensure the right dose is taken if the tablets are in ‘unit- dose’ packets, which can help to identify how many should be taken each time. Sometimes drugs are supplied in multiple vials, he says, which is “asking for trouble”, as it could lead to an overdose. “Atrociously small” font sizes on labels, and the over-use of numbers to identify details such as the
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patient’s name and the dose, are serious issues, adds Grissinger.
The ISMP itself has highlighted a list of concerns in its regular newsletters, which include the issues Grissinger describes, as well as others. Some investigational drugs come without an expiration date because it may change during a trial. They ask participants to call an interactive voice response system, which is time consuming, the ISMP says, and in some cases drugs are being used beyond the expiry date.
It is a “low priority” for some trial sponsors to ensure they are using safe labelling, the ISMP says, and this is also the case when outside companies run the trials for sponsor companies. Clinical sites are advised by the ISMP to return or destroy any drugs that arrive without labelling. Another examination of investigational drug labelling published by the National Center for Biotechnology Information in the US, (The Near- Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors), also found that there was often poor use of large font sizes for the print, which would make it easier to read, and the text was not spaced well on the label. Regulations in some countries prevented a reduction in the amount of information on a label, the researchers found. They recommend a more ‘patient-centric’ approach to labelling so that clarity of information provided to patients is as clear as possible. They say the industry needs to start laying down these conditions now as a foundation for the future. Perhaps, ensuring that the patient is always the prime consideration at every stage of a clinical trial, is a principle worth sticking to. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Burlingham/
Shutterstock.com
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