As in any other profession, we find that certain trends and protocols are followed to serve certain purposes. However, when these are already exhausted, the spirit of the time dictates the need to provide more effective strategies. Strategies that still serve still specific purposes, but are more targeted towards a goal that is serving a desired end that facilitates the flow of operation, and at the same time, are quality assured. As for the how of it, we start to study the drawbacks of the previous system and put into consideration all these drawbacks. After careful analysis of these we start implementing new alternatives that would take the place of older systems and present new more efficient ones that are globally compatible.
Within the age of Technologic Revolution, and following the fast pace of development, we are compelled to think and present suitable alternatives. Zooming closer into our profession, after careful analysis and consideration, we reach the conclusion that the booklet label should not be the only solution to creating flexibility around global studies. Going further into detail, we offer a new way to label our supplies. As we discuss the suggested method in this article we will discover that we can label our supplies in a manner that will prove to be in compliance with global regulatory requirements. Furthermore, as the article unfolds, potential Heath Authorities inspectors concerns will be addressed. There are several reasons that lead to the idea of coming up with this innovation.
Let us shed some light on these reasons and discuss them one by one so we can comprehend the necessity of reaching that solution.
First, globally speaking, we find that, as we all know, a challenge or competition (avoiding the word conflict!), is arising among participating countries concerning their position in the booklet label. We find that most of the countries tend to prefer to be located in the first page of the booklet label, or in the base label. Why? Because placing it there makes it is easier for the patient to view. The risk of losing pages from the booklet ought to be put into consideration as the patient consequently might not be able to see them. So, we sense the pressure from these countries and this influences the decision as to where they would like to be located in the booklet label.
Second, dealing with the issue from the side of the Health Authorities, inquiries started to arise. These inquiries were concerning the risk the patient is exposed to in case their page is lost. The patient is trying to handle a 20-25 page booklet - needless to say that these pages might even get more in number based on the nature of the study and how many more countries would be participating. In order to get the information the patient needs, he/she has to go through numerous pages to finally reach what they are looking for. The process is long and tedious; both issuing the booklet from one side and also handling it from the patient side. Worthy of notice is that the cost of the booklet label compared to a single panel label would be much higher. In addition, the lead-time for a booklet compared to a single panel label presents a considerable difference.
Third, and equally important, we study the issue from the side of the clinical groups. 90% of the time the clinical groups are not ready to supply a complete list of the countries participating in the study. So we either delay the beginning of the study altogether or start the study with the first one or two countries available at the time, which will increase the waste factor.
Another potential situation that might occur is the desire to add more countries after the study is started and that will require us to either revise the booklet label to include these countries or to repackage including a new booklet for these new countries added. Other scenarios might crop up; for example, one of the participating countries requesting a change of text on the label due to a change in their regulations or due to any errors that were not caught at the time of booklet approval.
The study may have two booklet labels at the same time. For example, the first one is 25 pages and the second booklet, after adding the new countries, may be 29 pages. It will be very hard (almost impossible) to keep all the countries' positions the same in the booklet labels (i.e each country stays on the same page, even though we have increased the number of pages due to the preference of some countries to be on the base label. In this case, we reach the conclusion that there would be a gap in performance. The operation of this procedure in this manner does not actually form a compatible system that would be totally relied on. The flow of performance is interrupted by several factors that would be a hindrance to the implementation of an effective, more efficient and quality assured operation to ensure patient safety.
Based on the previously mentioned discussion we found out that necessity is the mother of invention. We had to come up with a new form of label presentation. This new presentation would be packaging our supplies using a single panel label. However, the single panel label would still yield to the traditional manner. In this sense, it would be split in two halves. One would be base label coding panel carrying the USA (English) requirements. The other (JIT applied part) would include regulatory requirements for each country participating and local regulations translated into the local language to comply with Annex 13.
Furthermore, the study of each country can start independently from the rest of the participating countries. All of these countries' specific labels will be governed and monitored by the IXRS and the CRO system to ensure compliance.
In a nut shell, following the above method, the drug inventory would be flexible to go anywhere, to any country, at any time. The process this way is definitely facilitated to a much greater extent without taking the pains of issuing a booklet that could create confusion and be a burden on both the manufacturer and the patient. From the clinical point of view, this enables us more flexibility to add any new country at any time. Moreover, we can start the study for any newly added country within 2/3 weeks in the most.
So, what is really required to improve the process is not to package a single panel label operation for each single country but to improve the process and develop a new way for packaging and utilizing the JIT operation in the best way possible. In other words, dividing the clinical supplies label into two halves as previously explained is a good solution. This way we will cut the lead time line from 3-4 months into a week or maybe even less. The lead timeline to print booklet labels would not be required.
We hope that in this article the need for the label presentation innovation is clarified. The discussion presented makes it crystal clear why this move was a necessity. As mentioned in the opening idea, we have to move forward to fulfill what is needed to reach the optimum level required for a smooth, accurately implemented, and quality assured performance.