ISPE (www.ispe.org) has developed industry guidance to help companies conducting global clinical trials standardize booklet labels. Available for purchase on the group’s Web site (http://www.ispe.org/ispe-good-practice-guides/booklet-labels), the ISPE Good Practice Guide: Booklet Labels was developed to help train clinical trial personnel on proper booklet label use.
“ISPE is pleased to introduce its first Guide to support standardization of booklet labeling requirements globally,” said ISPE President and CEO Nancy S. Berg, in a statement. “Companies involved in clinical trials now have a resource that provides guidance on how to design and structure a booklet label and how to standardize the use and application of booklet labels for global clinical trials. By following the recommendations presented in the Guide, companies can feel confident that their booklet label strategy is supported by a scientific, risk-based methodology and that patients will receive accurate, complete, and compliant instructions in their local language.”
ISPE was particularly interested in “standardizing label information, proper use of the booklet label, ensuring compliance with applicable country regulations and enhancing site and patient understanding and compliance with label instructions,” explains Michael A. Arnold, R.Ph., senior director strategic relationships and investigational products business process owner at Pfizer, who served as mentor to the Guide task team.
“Labels are an important component of a clinical trial supply package,” he explains. “Among other information, they are a source of communication to the study sites and patients regarding proper use and storage of the product. Most people are used to seeing a single label on their medication provided by the local pharmacist. In clinical trial materials (CTM), we need to provide investigational product information to patients around the world and in multiple languages. The booklet label allows the pharmaceutical industry to prepare large volumes of required supplies efficiently and cost effectively. Benchmarking showed clearly that the pharmaceutical industry uses booklet labels in several different ways and standardization could be of value for investigators, patients, and global regulatory authorities.”
Standardization could also help promote patient compliance. “It is important to understand that in the clinical study space, label purpose and content is often very different than what most patients see when receiving a medication from their local pharmacy,” says Arnold. “In clinical studies, by nature of study design, the placebo and active components of a study look identical and are not discernible to the investigator, study personnel, or the patient. Therefore, label information is extremely critical, and any improvement or simplification of its use can lead to greater accuracy in dispensing and overall patient compliance. Important label attributes include: container identification, patient identification (patient number), storage instructions, dosing instructions and, where appropriate, emergency contact information. Each country-specific label must meet applicable country regulations, and for the most part, these are not standardized and can lead to potential compliance errors as well.”
ISPE also sees potential to increase operational efficiency. “Operational efficiency is important for a number of reasons, which can include containing costs, timely preparation of supplies to ensure no interruption in patient supply, compliance with applicable local regulations, and simplification of patient use and ultimately enhancing patient medication compliance,” explains Arnold.
It could also reduce relabeling. “Labels are very high on the list of reasons for audit citations,” says Arnold. “The purpose of this guide is to take the learnings and feedback from regulatory inspectors and industry experts and develop a guide that will minimize the chance of these issues reoccurring and to drive toward a more optimal, business-efficient, patient-focused and regulatory-compliant process within our industry. I think the authors and contributors of this guide have produced a very valuable document for our industry.”
During development of the guidance, “feedback was obtained from a number of pharmaceutical companies who routinely conduct clinical trials and have received study site feedback,” he says. “An inspector from European MHRA also provided some experiential feedback as well. Obtaining direct feedback from patients is complicated due to legal and confidentiality requirements.”
Lori Robinson of Robinson Printing (Temecula, CA), which prints clinical trial labeling but was not involved in development of the guidance, says that “My first reaction is that standardized instructions is a very good thing. I would imagine doctors, nurses, and patients would appreciate being able to immediately find product information because every IFU [instructions for use] looks similar. The standardization of product instructions can only improve their effectiveness.”