Initiatives for Patients and Consumers
Increasing Product Reliability
A Global-Standard Regulatory Compliance and Quality Assurance System
Chugai works hard to supply high-quality medicines and pharmaceuticals of superior efficacy and safety to healthcare providers around the world, and strives to ensure timely and accurate delivery of quality information on the proper use of its products.
Chugai’s fundamental views on reliability assurance are stated in the policy for regulatory compliance and quality assurance, and in the product lifecycle regulatory compliance and quality assurance system. This policy and system are based on our Mission Statement, which encompasses the Chugai Group’s mission, Core Values, and Envisioned Future, and on the Chugai BCG, which outline our code of conduct.
Regulatory Compliance and Quality Assurance System
Policy for Regulatory Compliance and Quality Assurance
The policy for regulatory compliance and quality assurance places specific emphasis on the following four points for ensuring reliability throughout the product lifecycle.
- (1) product quality
- (2) product information quality
- (3) business process quality
- (4) staff suitability
Under the policy for regulatory compliance and quality assurance, Chugai also works to ensure product reliability on a global basis.
Post-Marketing All-Case Surveillance
Since April 2013, pharmaceutical companies in Japan have been required to prepare a risk management plan (RMP) comprising a pharmacovigilance plan and a risk minimization plan to better understand the safety profile and to mitigate risks of medicines. The RMP is prepared with the objectives of ensuring safety after the drug is on the market, evaluating benefits and risks, and contributing to improvement of safety measures based on those evaluations. Drugs for which applications for approval were filed after the enforcement of the ministerial ordinance are disclosed on the website of the Ministry of Health, Labour and Welfare.
At Chugai, the RMP represents our commitment to safety for patients and healthcare providers. Leveraging our extensive experience accumulated in the sale of oncology and biotechnology products, ahead of our competitors we formulated and began implementing RMP measures for nine products in 2012 (as of October 2015).
We have enhanced safety-related functions to ensure the smooth execution of RMPs. For example, we have introduced an electronic data capture (EDC) system to expedite the collection of safety information. We have also built a system to quickly detect safety-related signals from the safety information collected. In evaluating safety information, we have strengthened our analytical capabilities based on an epidemiological perspective. We also have medical doctors with extensive clinical experience on staff assigned exclusively to our Drug Safety Division, enabling us to conduct highly specialized evaluations. This allows us to quickly and accurately determine the need for new safety measures, and means that we have in place the systems and processes for rapidly executing them.
In addition, we provide information on product-specific side effects to professional societies and healthcare providers. Through those healthcare providers, we also reach patients by providing them with pamphlets on adverse reactions and disclosing similar information through the Chugai website. Chugai has established a specialized group to ensure that this kind of information is released in a timely manner. These and other efforts lead to more sensitive treatment environments for patients at high risk of adverse reactions, and a steady reduction in the occurrence of adverse reactions and increased severity.
In Europe, where RMP guidance is already in effect, we have established alliances through our partnership with Roche to make RMPs globally consistent.
There is also a growing move to gather information not only on adverse events but also on post-marketing benefits to evaluate the risk/benefit balance. Assessing this balance in an appropriate and timely manner will enable us to consistently provide patients with truly valuable information on drugs, which in turn will help us to earn deeper trust from patients and healthcare providers.
Chugai will continue to properly evaluate pharmaceutical risk based on scientific evidence, continuously implement safety measures to minimize this risk, and work to promote the appropriate use of medicines.
Handling of Inquiries by the Medical Information Department
A shift from the traditional model of physician-managed care to one of patient-managed care is now being advocated, and in providing drug information, pharmaceutical companies are increasingly expected to respond to varied and wide-ranging needs for everything from the most basic to highly specialized information. As a result, the medicine consultation departments of pharmaceutical companies are assuming an increasingly important role in promoting the appropriate use of drugs while taking individual patient and healthcare provider needs into consideration.
Chugai’s Medical Information Dept. supplies patients, their families, healthcare providers, pharmaceutical wholesalers and medical representatives with information on our pharmaceuticals in response to inquiries via telephone, e-mail and other routes. The center acts as an open point of contact for Chugai, providing prompt and accurate explanations that make even highly specialized information easy to understand.
Medical Information Dept. received approximately 60,000 inquiries in 2015, on a par with the previous year. About 70 percent of the inquiries came from pharmacists in hospitals or community pharmacies. By drug category, anti-influenza agents accounted for about 15 percent of all inquiries. The center also received many inquiries concerning anticancer agents, osteoporosis treatments, anti-thyroid agents, humanized anti-human IL-6 receptor monoclonal antibody for treatment, and long-acting erythropoietin-stimulating agents.
The staff at the center will continue working together to enhance customer satisfaction with a patient-oriented philosophy.
Number of Inquiries Received
Inquiries by Treatment Area (2015)
Contributing to Patient-Centered Healthcare
Conducting Support Activities for Patients
Employees participated as volunteers.
Relay for Life Japan (RFLJ)
Relay for Life Japan
The Relay for Life is an awareness support campaign that forges ties in the fight against cancer. A 24-hour walk-a-thon, in which cancer patients, their families and supporters compete as relay teams, was held in 47 locations throughout Japan in 2015. Chugai employees have participated as volunteers in the Relay for Life since 2007. In 2015, a total of 648 employees participated in “Team Chugai” at 27 locations nationwide. 2,261 people participated in the breast cancer version of the virtual reality 3D Adventure Experience at 22 venues nationwide, part of our disease awareness activities. As “Team Chugai” members described the display, users looked into a viewer to find video explaining who should go for cancer screening and what cancer cells look like, gaining an understanding of the importance of early discovery and treatment of breast cancer through a positive, fun experience.
NPO Shuhei Ogita Fund Supporting Patients with Lymphatic Malformations
For 25 years, Chugai has worked with the nonprofit organization the Shuhei Ogita Fund (http://www.fund-ogita.org/) to provide an agent for treating lymphangiomas*1 free of charge to children around the world suffering from this rare disease.
In 1986, Dr. Shuhei Ogita, a pediatric surgeon at the Kyoto Prefectural University of Medicine, had great success in treating lymphangiomas, which previously could only be treated through extremely complex surgery, using a targeted drug treatment method known as OK-432. To provide this treatment to children overseas, he established the “Little Carlos Fund,”*2, which was later renamed the “Shuhei Ogita Fund” in honor of Dr. Ogita’s work and to carry on his will. This fund helps to make treatment available to children around the world who suffer from this disease, regardless of their local medical circumstances or financial difficulties.
*1 A rare disease in which lymphatic fluid abnormally pools in the lymphatic vessels. In many cases it is found at birth. Unlike cancer, lymphatic malformations are benign, but can retard a child’s development, and occasionally the cysts compress the respiratory tract and become life-threatening.
*2 In 1992, Dr. Ogita learned that the family of little Carlos, a 14-month-old child living in Mexico, was attempting to raise money for the cost of traveling to Japan for OK-432 treatment, and established the fund to help them.
Chugai Academy for Advanced Oncology Holds International Forum 2015
IAAO 2015, a CHAAO event
The International Academy for Advanced Oncology (IAAO) 2015, the largest event of the Chugai Academy for Advanced Oncology (CHAAO)*3, took place in Tokyo in July 2015. The theme of this sixth annual forum was “Forefront of Oncology Care: Discovery, Development and HTA.” Thirteen influential oncologists working at the forefront of their field gave lectures on cutting-edge cancer therapies, which were followed by fervent discussions. In addition to cancer immunotherapy, an area in which expectations have continued to increase over the past couple of years, the issue of cancer cell epigenetics was also brought up, a topic the importance of which has become clear in recent years. The Japanese oncologists who participated in this event praised it as extremely informative and meaningful. CHAAO is in its sixth year, and is making steady progress. In addition to the core international forum, it also co-hosts the Focus Symposium on topics in global cancer research and treatment; supports academic and research societies in basic research that will lead to future cancer research and treatments; and has established the JCA-CHAAO Award presented at the annual meeting of the Japanese Cancer Association.
Forum for Japan Cancer Patients (FFJCP)
It also supports sound, innovative advocacy efforts by cancer patient groups, and since 2013 has worked to support patient groups as part of the goal of achieving patient-centered healthcare. In February of this year, the Forum for Japan Cancer Patients (FFJCP) held its first meeting in Tokyo. The conference featured the participation of 41 domestic organizations and 73 attendees, who learned about one another’s activities and deepened their interaction. Three individuals from cancer patient organizations in the U.S. were also invited to lecture about advocacy activities overseas, leading to a lively discussion. Seven representatives from Japanese patient groups participated in the International Experience Exchange for Patient Organizations (IEEPO), held in Munich in March and attended by more than 100 representatives of patient groups worldwide. Through these and other programs, CHAAO will continue its efforts to help raise cancer treatment in Japan to a world-class level.
*3. Founded in October 2009 to contribute to the establishment and advancement of infrastructure for cancer treatment in Japan. To bring cancer treatment in Japan to a world-class level, CHAAO promotes deeper academic exchange between the world’s top specialists in oncology, and healthcare professionals who play a leading role in cutting-edge research and treatment of cancer in Japan.
Supporting Researchers from Asia
The Tokyo Biochemical Research Foundation (TBRF)
Chugai conducts an international joint fellowship program through the Tokyo Biochemical Research Foundation (TBRF).
Established in 1960, the TBRF received approval as a public interest incorporated foundation from the Cabinet Office on September 1, 2010, and marked its 50th anniversary on December 1 the same year. Chugai provides support for one of the TBRF’s core grant functions, an international joint research fellowship program inviting young postdoctoral researchers from Asia to Japan to conduct joint research at universities and scientific research institutions for one to two years. Since this program was launched in 1995, it has supported 84 researchers from 17 Asian countries and regions.
At the 19th TBRF Party held in March 2015, 13 young researchers invited to attend from India, Indonesia, South Korea, Bangladesh and Myanmar presented the results of their research.
Chugai will continue to enhance and develop this program to promote medical and pharmaceutical research in Asia centered on Japan, and help to raise the level of basic research related to drug therapy and discovery of new drugs.
(Refer to this page for more information on the Tokyo Biochemical Research Foundation: http://www.tokyobrf.or.jp/english/)