On the right track
July 19, 2017 – Manufacturing and Packing –
Melsungen, 19 July 2017
The quality of trial results depends largely on patient compliance. Patient compliance is affected by a predictable and unpredictable factors. One of these predictable factors is packaging.
ISPE survey
In a survey conducted by ISPE (International Society for Pharmaceutical Engineering) in 2013, subjects of clinical trials were questioned about their experiences when using IMPs (investigational medicinal products). 77% found their medication easy to use. Since the survey was almost exclusively based on responses by US patients, ISPE decided to expand it to the UK, the European Union and Asia. Study findings were published a few months ago. Consistently with the US survey, patients’ opinions about the overall ease of use were both positive in the EU (85%) and in China (88%).
Besides having the opportunity to ask clinical site staff how to use the medicine, packaging such as package inserts or labels was found to be helpful. Patients’ increasing preference for having IMPs delivered directly to their homes (75% in the EU, 78% in China; 78% in US in 2013) clearly shows how significant secondary packaging is. For site personnel, briefing patients on the phone means an effort as opposed to dosing instructions that can be read on the packaging. In addition, all the relevant information is directly and durably attached to the medication and subjects do not necessarily require any technical equipment such as mobile phones or computers to access it.
Comprehensive support
To reproduce all the necessary information in a reader-friendly font size (ISPE recommends 6 to 7 points while the European Commission even considers 9 pt font size as adequate) booklet labels are often used for the purpose of multilingual IMP identification. This being said, only 23% of the European patients surveyed actually saw the booklet label, 45% opened it, 54% were able to view their language and font size was deemed adequate by 71%. 41% of the Chinese subjects saw the booklet label, more than 80% opened it and 75% were able to find their way through it easily.
“The need for comprehensive information is growing. Booklet labels take care of this but ease of use would still appear to need improving”, Anthony Morrow, Business Development Manager Northern Europe at Faubel explains.
This is why Anthony Morrow is in favour of adding clearly visible opening arrows as well as partly rough or rubberized surfaces to booklet labels. Such visual and tactile features draw attention. Moreover, these special surfaces give users a good grip – especially with IMP bottles. Besides blisters, the second most common form of primary packaging used are bottles, according to the ISPE study.
“The specific design of the easy-peel opening section helps when separating the layers of the label. That’s what makes it very easy to open”, says Morrow. Once the label is open, there is a thumb index to facilitate navigation through the booklet. Patients can get to their national language in just one move. Pictograms or QR codes linked to instructions for use videos are to be regarded as text supplements.
Within the clinical trial supply chain, booklet labels do not only allow efficient distribution and safe identification worldwide, but they can also be combined with any measure designed to maximise ease of use in a single product.
Patient centricity
Thanks to these technological advancements, patient’s needs are taking centre stage for Anthony Morrow. “We are on the right track, because patient compliance is continuously improving and the quality of clinical trial results is secured.”
Caption FAUBEL Patient Centricity: There are several features to improve the ease of use.
Your PR contact:
Miriam H¸ther
Communication Manager
Phone: +49 5661 7309-219
Email: m.huether@faubel.de
