Drug Evaluation Committee 2014-23 Necessity of prescribing investigational drugs by investigators
Related classification: Other
First published: October 2014
Question
I have a question regarding question No. 2004-11. In response to this question, the Pharmaceutical Manufacturers Association of Japan (PMAJ) states, "When prescribing a drug, it is necessary to examine the patient (Article 20 of the Medical Practitioners Act), but since it is the principal investigator who examines the subject, it is not possible to prescribe an investigational drug. This is stated as follows.
First of all, an investigational drug is considered to be an unapproved drug, not a drug/medicine (except when an already approved drug is an investigational drug), but does it necessarily need to be prescribed by a physician? I understand that a medical examination is necessary to prescribe a drug, and that only a physician can perform such an examination.
In IVRS/IWRS, the instructions for dispensing a specific investigational drug are given when the subject registers at the hospital (and the ID of the drug to be delivered to the subject is determined at this point, I believe). Generally, the investigator prescribes the investigational drug, and from there, the investigational drug manager dispenses the drug.
We would like to know why it is not acceptable for the investigator, sub-investigator or collaborator to check (not prescribe, but check) the investigational drug listed on the registration form and only dispense the drug by the investigational drug manager.
The reason for my question is that we received feedback from the sponsor during an audit that the only record of prescribing is a clinical trial worksheet, and that the investigator is the one who writes the worksheet, and that the prescribing is done by the physician (at the site in question), (At the facility in question, the physician signed the worksheet after final confirmation, so there was no problem.)
We wondered if the term "prescribing" could be applied to the investigational drug itself. We also wondered if the same ID would be used for the registration form, medical record (prescription record), and investigational drug control chart (dispensing record), which would cause discrepancies and lead to incorrect prescribing and dispensing. We also thought that it would be smarter if we only needed to check the ID record, since the investigational drug delivered to the subject is already determined at the time of registration.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since investigational drugs are still under research with insufficient knowledge of efficacy and safety, they must be administered to subjects more carefully than ethical drugs that have been approved as medicines. Therefore, it is necessary to make a decision on whether or not to administer the drug to the subject based on a consultation by the investigator or subinvestigator. Prescribing is a medication instruction based on this decision, so this procedure is essential and must be recorded.
On the other hand, "assignment" of an investigational drug ID to a subject by IVRS, etc. is different from prescribing and can be performed by a collaborator.