At Sumitomo Dainippon Pharma, the safety of the patients who use our products is our top priority. To ensure safety, we incorporate the dosage forms and indications that best meet patients' needs from the initial planning stages of development. In addition, we have adopted a special printing method that prints the name and dosage over each dose on the PTP sheet to make our products more distinguishable and prevent errors when individual doses are separated from the sheet.
At Sumitomo Dainippon Pharma, the entire clinical trial process from planning to execution, reporting, and the submission of applications to authorities has in the past been undertaken by the same division. In fiscal 2012, however, we restructured our organization to establish a Clinical Operations Department as the department in charge of overseeing clinical trials and a Clinical Research Department to handle planning, reporting and the submission of applications to authorities. This division of responsibilities is common outside of Japan, and the purpose of the restructuring was to make Sumitomo Dainippon Pharma clinical trial procedures more compatible for global coordination and collaboration, as well as further enhance the skills of our clinical team by promoting greater specialization. Striving to build a global business base that comprehensively meets the diverse range of patient needs, we will continue to sharpen our expertise and provide exceptionally reliable data.
Informed consent is defined as "the voluntarily given agreement (consent) on the part of the patient who will be participating based on a proper understanding of and agreement with a complete explanation from a physician or other medical professional of the patient's illness and the treatment strategy" when a patient is to participate in clinical trials or receive medical care.
Since clinical trials are conducted during the intermediate stages of confirming the efficacy and safety of drug candidate substances, it is particularly important that the informed consent of a patient is based on sufficient data and a careful explanation of all that is involved. In order to help patients decide whether or not to participate, we compile a wide range of data that covers the state of clinical trials in Japan and overseas, as well as the possible outcomes indicated by clinical findings, so that it can be presented in a manner that is easy for the patient to understand.
While packaging and labeling designs are subject to many restrictions, displaying certain product information is mandatory, as well. Given these limitations, the design of more than one company's product packaging and labels may look alike, and this confusion has become a contributing factor in pharmaceutical product mix-ups.
At Sumitomo Dainippon Pharma, the packaging and labeling team of the Manufacturing Management Department heads our efforts to respond to the needs of both medical institutions and customers by improving packaging and label designs to prevent medical errors. We focus particularly closely on making sure that our packaging and labels are easily distinguished from other products since serious problems can arise when pharmaceuticals are taken incorrectly. Although we check in advance to ensure that our product names and package designs are not similar to products already on the market, we take immediate action to rectify the situation when our products are mistaken for others despite these efforts. We work with the company marketing the other product to modify product names and designs so that they are easily distinguishable from one another.
In fiscal 2012, we went even further, introducing the industry's first laser printing to our manufacturing line in order to print the product name on the top of the cap of bottles containing our tablets. Since most medical institutions store these bottles in drawers, having the product name printed on the cap, as well as on the bottle, makes the products easier to identify and remove. In the past, we had affixed removable labels to the sides of the bottles, and employees at these medical institutions would then move the labels to the caps themselves. Having the name printed on the cap before the product ships saves medical staff time and trouble.
We have also taken steps to improve our PTP sheets to make them easier for the patients to use.
Manufacturing Management Department
We have a number of initiatives based on three key phrases each starting with the letter S: safe operations, security in product quality, and stable supplies.
Of these, our highest priority project at the Sumitomo Dainippon Pharma Group has been strengthening our production capacity to ensure stable supplies for the global marketing of LATUDA®, an atypical antipsychotic. Our efforts on this important issue made it possible to submit our application in February 2013 for the Suzuka Plant to export this product to the US. With this, the Suzuka Plant would join our partner in Japan (an outside contract manufacturer) and the US plant already supplying this medication, which will give us three manufacturing bases for LATUDA®. This is a major step forward in establishing a global development structure for stable supplies as we market this drug in a larger and larger area.
Moving forward, we will continue to take the steps necessary to fulfill our "3S" policy at the global level.