Drug Evaluation Committee 2005-06 Obligation to Report Adverse Reactions to Over-the-Counter Drugs Adjunctively Used in Conjugation (Part 1)
Related classification: Adverse drug reaction reports
First published: May 2006
Revised publication date: December 2021
Question
In one case, a non-serious adverse event occurred that was not causally related to the investigational drug.
Since the case was treated with an already marketed drug from Company A, the patient was later asked to submit a report requesting a causal relationship between the marketed drug and the adverse event. (This is different from a clinical trial case report.)
I was told that this is part of the drug information gathering that MRs are required to do, and that I would be reprimanded by the regulatory authorities if I did not do so, and that it is also written into the sponsor's SOP. We have not obtained this information yet, but if it is a side effect of our product that should be reported, the medical institution asks us to report it to the MHLW, and the medical institution decides whether to report it or not, but to ask us to submit a report as a matter of course is a secondary use of information obtained through SDV, in other words, it is a leakage to other departments. In other words, I think it would mean that the information obtained through SDV is leaked to other departments. What do you think?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
I will answer based on the assumption that the marketed drugs used in the case in question do not fall under the category of drugs specified in the study protocol (GCP Article 2, Paragraph 9, "investigational drugs") used to evaluate the efficacy and safety of the study drug in the clinical trial.
As you know, information on adverse reactions and adverse events of investigational drugs is collected by clinical trial monitors in accordance with GCP.
On the other hand, with regard to marketed products, the manufacturer and distributor shall endeavor to collect information on proper use of the product in accordance with Article 68-2-5, Paragraph 1 of the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices, and in Article 68-2-5, Paragraph 2 of the same law, medical professionals shall endeavor to cooperate with the collection of information by the manufacturer and distributor. In general, MRs are responsible for this collection.
Normally, MRs are responsible for this collection work, but it is not limited to MRs. It is our understanding that this duty is imposed on all employees of pharmaceutical companies.
We believe that the fact that a clinical trial monitor informs the MR in charge of the company of side effects of Company A's over-the-counter drugs discovered during SDV and that the MR is responsible for collecting information on the company's over-the-counter drugs is not a leakage of information obtained during SDV to other departments and is handled appropriately as a pharmaceutical company. When collecting information on adverse reactions to marketed drugs, it is necessary to use the form prescribed in the procedure, and we would like to request submission of an adverse reaction report separate from the CRF.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the revision of the GCP Ministerial Ordinance (Ordinance of the Ministry of Health, Labour and Welfare No. 155 of August 31, 2020).