What goes into a clinical drug label? If you’re a sponsor developing labels for a clinical drug, the process can at times be convoluted. After all, labels provide a multitude of information, so important, that it could influence the way the trial is run.
When looking at the elements of clinical drug label, recipients can often expect to find:
- Directions on how to take the medication properly, according to the protocol;
- Terminology understood by subjects;
- Storage condition (e.g. keep refrigerated at 2oC- 8oC);
- Key numbers or codes on the labels, which can include protocol numbers, patient numbers, med ID numbers, and bottle sequence numbers, etc;
- Sponsor company information, regulatory information, quantities, content, expiration/retest dates etc. and;
- Tear-off portion for the subject records.
As you can see, producing a label is much more than providing the name of the drug, directions for usage, and an expiry date. As trials for one drug can be carried out on various sites around the world, the label must account for several different languages. If the translated label provides information that is inaccurate that could lead to delays, costing time and money. Hence the need for developing labels that are user-friendly and easy to understand.
In that regard, George Omburo, VP, Clinical and Product Development, Derma Sciences, says there’s a strong case for simplifying the language used on drug labels.
"In clinical trials, standardising the language used on drug labels would avoid miscommunication and confusion," said Omburo.
Where things get particularly complex, he says, is when companies are required to list manufacturing and expiry dates. For new clinical drugs, Omburo argues it is difficult to establish expiry dates as little is known about the product itself. When a new drug is discovered, it has no history, meaning sponsors don’t fully understand its stability or its safety and efficacy.
"There needs to be more flexibility on this issue," Omburo said. "A new chemical entity shouldn’t have expiry dates because there are too many unknowns. As long as the drug is still viable based on stability data that is being acquired and given to the sites that should be OK."
Omburo hopes there comes a time where clinical drug labels don’t carry an expiry date, despite not knowing the full extent of the drug’s efficacy. These differences, he says,need to be harmonised in order to move forward.
While drug labels are typically are customised to the patient, problems start to arise when individual countries demand clinical drugs be labelled in line with their government requirements.
"Countries want labels to be customised to meet their laws. In the grand scheme of things, it’s not feasible. For a sponsor, that is severely limiting," Omburo said.
He went on to explain that if, for instance, a sponsor wants to conduct a 10,000 patient study across 100 countries, the timeline and effort needed to customise a label for each country would be "horrendous". Such a demand would require the sponsor to be competent in each country’s regulatory requirements, which would be unrealistic.
"If the sponsor is a small company that competency cannot be built," Omburo said.
One thing that has helped mitigate the problems surrounding drug labelling is the multilingual booklet label. Booklet labels are used for international trials where each page provides label requirements in different languages to cater to relevant countries. The additional index page is crucial as it aids the patient to find their specific page while the cover page provides variable information.
Ultimately, Omburo said a universal agreement is needed to label global supplies efficiently. "If you’re labelling a drug for clinical trials, we must agree on: the name of the medicine, its protocol number, its safety instructions, how to apply it liberally, how to store it and so forth."
Although multilingual booklet labelling has helped somewhat, Omburo argues there needs to be an agreement on technical terms, such as unit of temperature (oF and oC). What’s more, an agreement is needed on managing drug expiration while the trial is ongoing; that means, establishing the expiry date, the re-test date, and the date of manufacture. The ultimate goal of one label – with translations included – would go a long way in making sure trials around the world begin without delays.