Patient Organization Collaboration Promotion Committee Held the 3rd Patient Organization Advisory Board

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The 3rd Patient Organizations Advisory Board (March 27, 2019): How information on pharmaceutical products should and should not be provided

1. Guidelines on activities for providing sales information on ethical drugs

Mr. Takamasa Horio of the Monitoring, Guidance and Narcotics Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, gave a lecture on the "Guidelines on Activities to Provide Information on the Sale of Ethical Drugs" (hereinafter referred to as the "Guidelines"), focusing on how information should be provided to patients.

Purpose of the Guidelines

Issues on Providing Information to Patients

There are two legal issues regarding the provision of information to patients: first, whether media seminars and disease awareness advertisements fall under the category of "advertisements to the public"; and second, the issue of providing information on "unapproved and off-label drugs. The second is "the issue of providing information on unapproved and off-label drugs."
The first "prohibition of advertisements to the general public" is based on Article 67 of the Law Concerning Assurance of Quality, Efficacy and Safety of Drugs, Medical Devices and Other Related Matters (Pharmaceutical Marketing Law), which states, "For special diseases such as cancer, sarcoma, leukemia, The "advertising of designated drugs for the general public is prohibited. In addition, advertising to the general public of ethical drugs for diseases other than cancer, sarcoma, and leukemia is prohibited under the "Appropriate Advertising Standards. The background to the prohibition of public advertisements of ethical drugs in the form of notices is the thalidomide incident. The use of thalidomide, a sleeping pill, expanded due to advertisements claiming that the drug was "completely non-toxic" and "safe for pregnant women," and this led to the spread of side effects such as teratogenicity. In response to this incident, the issue of ensuring safety became an issue, and in 1967, the Basic Guidelines for the Approval of the Manufacture of Pharmaceuticals were issued, which stipulate that "advertising of ethical drugs to the general public shall be prohibited.
The second issue, "how to provide information on unapproved and off-label drugs," requires clarification of the relationship with Article 68 of the Pharmaceutical Affairs Law, which stipulates that "general advertising of pre-approved drugs is prohibited.
Based on these regulations, companies have been cautious about providing information to patients. However, while all of these regulations prohibit "advertisements," they do not prohibit the "provision of information that does not constitute an advertisement. Therefore, this guideline describes what "provision of information on unapproved or off-label drugs that does not fall under the category of advertising" means. In addition to the conditions for providing information on unapproved and off-label drugs, such as that the content of the information provided must be in line with the required content, the guidelines also include conditions for ensuring proper use.
In the future, we would like to learn from patient groups and healthcare professionals about the actual status of information provision to patients, and after gaining an understanding of what patients want in terms of information provision, we will continue to consider how information should be provided to patients.

2. Thinking about the provision of drug information

Next, Ms. Tomiko Tawaraki, President of the Council for the Appropriate Use of Drugs (RAD-AR Council), gave a lecture titled "Considering the Provision of Drug Information.

Activities of the RAD-AR Council

For better information provision activities

Currently, the Internet is flooded with a variety of medical information, and measures to help patients find truly useful and correct information are an urgent issue. on March 28, 2018, six organizations jointly released a joint statement "For the correct understanding of information on health, medicine and pharmaceuticals" The statement is available on our website. In addition, the "Drug Bookmark" website we are creating saw its monthly views rise to nearly 12 million in 2018, more than three times the number of views in the previous year. This is due to a change in Google's search formula in October 2017, whereby sites considered more appropriate are now displayed at the top of the list.
The Ministry of Health, Labor, and Welfare (MHLW), in its "Roundtable Conference on Promoting Good Medical Practice," has recommended that reliable medical information be provided in an easy-to-read format. In addition, a research group of the Japan Agency for Medical Research and Development (AMED) is also working on an initiative to build a reliable medical information website. We are currently studying how we can address this issue. For example, the "Bookmark of Drugs" website is accessed 12 million times a month, so we are considering whether it would be possible to make the "Bookmark of Drugs" website a portal site and provide links to related sites so that those who access the site can obtain relevant information. We are also considering educating people on simple checking methods to identify appropriate and inappropriate information, etc.
In the past, when safety information on a certain drug was issued, an alert for the drug in question was posted for patients on the website of a patient organization before the next day's morning paper. I was very impressed with the explanation, which was very easy to understand and understandable. This is one example of how we can work together with patient groups to improve our information provision activities.

3. Question and answer session

A lively question-and-answer session on the lecture ensued.

1) Patients should have access to information sources other than pharmaceutical companies

Advisor's comments:
Even if guidelines regulate information provision activities from companies to patients, patients are currently in a situation where they can freely obtain information from corporate shareholder meetings, overseas conferences, and literature. What are your thoughts on imposing such regulations only on pharmaceutical companies, despite the fact that there is an environment in which information can be obtained from other sources?

Mr. Horio's comment:
We are not prohibiting all information-providing activities, but those that fall under the category of advertising. However, we are aware of the problem that the current lack of clarity on the extents of information that falls under the category of advertising may be atrophying activities to provide information to patients, and we have developed these guidelines to clearly indicate the boundaries of what information can be provided so that appropriate information can reach patients.

2) Information provided by patient groups

Advisor's comments:
When attending overseas academic conferences (e.g., American Society of Clinical Oncology (ASCO)), there are booths of patient groups at the entrance, and patient groups work with companies to provide information to patients. However, at Japanese academic societies, patient groups are not allowed to enter and cannot obtain pipeline and clinical trial information. Is it not possible for patient groups to conduct information provision activities for patients together with companies in Japan?

Mr. Horio's comment:
Based on your comment that there are situations where patients cannot get information at exhibition booths at conferences, we have presented a Q&A on providing information to patients who come to exhibition booths to study in 2018. We hope to continue to address the issue by presenting the correct approach from the administration where misunderstandings are occurring.

3) Providing information on unapproved and off-label drugs

Advisor's comments:
In the future, when genomic medicine starts in earnest in Japan, patients will undergo genomic testing, and even if there are therapeutic drugs available as a result of the testing, most of them will probably be unapproved or off-label drugs. Won't this cause anxiety among patients, who may not be able to obtain information on therapeutic drugs directly from pharmaceutical companies?

Mr. Horio's comment:
The idea of the guideline is that information within the scope requested can be provided by companies as long as it is accurate information based on scientific and objective evidence. We would like to present the concept from the administration to ensure that information on pharmaceutical products is appropriately provided to patients.

4) Providing appropriate information on over-the-counter drugs and the role of pharmacists

Advisor's Comments:
Dr. Kenji Taira, a physician in Kyoto, has created a free paper called "Kusuri Hayamicho," which summarizes the ingredients of OTC cold remedies and antipyretic analgesics, includes a picture of the package and QR code, and is distributed to medical institutions nationwide. Even if each individual institution is making excellent efforts, if the activities are not shared and the amount of information increases, patients will not know where to access the information. In the future, we need a "lead" who can organize such activities.

4. General discussion

The participants exchanged opinions from various perspectives on "information that patients want.

1) Public disclosure of names of investigational sites

If the sites where clinical trials are conducted are not disclosed, it is impossible for patients to investigate and participate in clinical trials on their own.

Advisor's comment:
ClinicalTrials.gov and other information that patients can access is increasing, but I feel very uncomfortable that Japanese people have to look up foreign English sites (ClinicalTrials.gov) to find information on clinical trials in Japan. Also, ClinicalTrials.gov does not always list the name of the site. We would like to see information on clinical trials in Japan published in Japanese, especially including the name of the facility.
In the U.S., patient groups have ClinicalTrials.gov accounts, and they even determine the distance from the facility based on the address of the patients they consult with and connect them to the appropriate clinical trial site.

The Pharmaceutical Manufacturers Association commented:
I think companies are positive about the release of clinical trial information, as they have notified us that they will be releasing clinical trial information in Japanese in 2018. Currently, we can identify the name of the facility from the investigational review board (IRB) information, and we would like to correct any company that refuses to disclose the name of the facility.

2) Use of generic names in public lectures and 3 requirements for advertising

If neither the product name nor the generic name can be disclosed at public meetings, patients will not be able to learn about the latest treatments.

Comment from the Pharmaceutical Manufacturers Association:
The current thinking is that the rule is that we cannot even give generic names to patients who are not taking the drug in question. However, times are changing, and we feel that it is strange that we cannot discuss therapeutic drugs at public lectures. The point that Mr. Horio of the Ministry of Health, Labor, and Welfare explained, "Provision of information upon request does not fall under the three requirements for advertising," is important. However, these guidelines have changed the thinking that companies need to be proactive in providing information in response to requests from patients.

3) Use of materials prepared by pharmaceutical companies

Even if pharmaceutical companies create easy-to-understand materials, if they cannot provide them directly to patients, patients will not be able to obtain useful information.

Mr. Tawaraki's comments:
As part of our efforts to connect the "Drugs for Patients" website to various types of information, we are considering the possibility of including information on materials such as guidance notes and disease information for patients that are produced by companies. When we consulted with the Ministry of Health, Labour and Welfare's Surveillance Guidance and Narcotics Control Division regarding this matter, they pointed out that the Council should establish a system to appropriately determine what information to post on the website. We understand that there is no problem with providing company-produced materials directly to patients as long as it is done in an appropriate manner.

Advisor's comments:
For five years from 2003, COML assisted with a model patient information room project at the National Hospital Organization Osaka Medical Center. This was very popular with the patients.

Comments from the Pharmaceutical Manufacturers Association:
While the booklets produced by companies are very popular at the national intractable disease consultation support centers, we also hear that they are having a hard time collecting the booklets. We would like to conduct activities to make information more accessible to patients in order to improve their health literacy.

Closing Remarks

Finally, Mr. Yoshinaga, the chairperson of the committee, made closing remarks.
He said, "Unlike the previous Advisory Board, this time we were able to have discussions with people from various perspectives. I would like to thank the participants for their active discussions on the actual situation and issues in the field. Our future activities became clearer with the keywords of "what we can do for information provision" and "collaboration for drug discovery. The Heisei era has come to an end, and a new era will begin in May. I hope that today's discussion will lead to a bright future for all of you.

Patient Groups Collaboration Promotion Committee Mamiko Yoshida

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