Drug Evaluation Committee 2009-20 Product Name Mention (Basic Therapeutic Drug) on the Poster for Recruitment of Test Subjects
Related classification: Other
Initial release date: January 2010
Revised publication date: March 2021
Question
We believe that advertisements in medical institutions are subject to various restrictions under the Medical Service Act, the Pharmaceuticals and Medical Devices Act, etc. Please tell us whether it is acceptable to mention the product name of a basic therapeutic drug on a poster (for in-hospital display) for the recruitment of test subjects.
In a study to confirm the add-on effect of an investigational drug, the draft poster provided by the sponsor for recruiting subjects includes the condition of participation: "patients being treated with XX drug*1". Since it is difficult for patients to understand "XX drug" (the name of the drug group), we would like to include the trade name of the drug that is used in the hospital.
- Example of description (1)
- "Those who are being treated with XX drugs*1 such as △△△△*2, □□□□*2, ××××*2, etc."
- Example (2)
- Patients under treatment with △△△*2, □□□*2, or ×××*2"
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1Names of drug groups such as histamine H2-receptor antagonists, ACE inhibitors, sulfonyl chloride antihypertensives, etc.
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2.All are trade names
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We believe that the content of information provided when recruiting subjects should be written in terms and sentences that are easy for subjects to understand, in accordance with the contents of the clinical trial protocol. If the term "XX drug" listed as one of the criteria for participation in a clinical trial (eligibility criteria) is difficult to understand, it would be acceptable to add a specific example of the trade name prescribed in the hospital as an explanation of the term. Although it is prohibited to advertise ethical drugs to the general public, in this case, it is not a problem because the purpose of the advertisement is not to advertise the drug but to advertise a clinical trial, and the location of the advertisement is in a hospital, targeting only in-patients. When adding additional product names, please be careful not to make it appear as excessive drug advertising.
For example,
For example, "You are being treated with XX drug *1. 1: "XXX drugs*1 are prescribed at this hospital.
Reason for revision of opinion
Minor changes have been made to the description in accordance with the name change from the Pharmaceutical Affairs Law to the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Drugs.