Drug Information Q&A Q13. What should I do if I notice anything unusual while using a drug?
Answer
Please consult your family doctor or the doctor/pharmacist who prescribed the drug. Some drugs may be dangerous if you stop taking them on your own judgment.
Explanation
Side effects of medicines include a variety of symptoms.
Rashes, itching, and drowsiness are common symptoms, but even OTC drugs, which can be purchased at pharmacies and drugstores without a prescription, can cause a terrible side effect called "Stevens-Johnson syndrome," which can cause inflammation of the skin and mucous membranes. If you experience unusual symptoms, consult your doctor or pharmacist as soon as possible.
It is important to be able to explain the name of the drug you took, the dosage and duration, and what symptoms you experienced.
If you experience side effects that are severe enough to require hospitalization or medical treatment, or if you suffer physical disability, you may be eligible for relief under the "Adverse Drug Reactions Relief Program.
This system was established with subsidies from the Ministry of Health, Labor and Welfare and contributions from pharmaceutical companies, and is managed and administered by the Pharmaceuticals and Medical Devices Agency.
The system is managed and administered by the Pharmaceuticals and Medical Devices Agency (PMDA), an independent administrative agency, and is designed to provide relief from side effects of drugs prescribed at medical institutions or purchased at pharmacies and drugstores that, when used properly, cause side effects that require hospitalization for treatment or result in disability (including death) that severely limits daily life. However, if the side effects of the treatment do not require hospitalization, the patient may be entitled to relief. However, relief is not available if the patient is not hospitalized or if the drug was used in an inappropriate manner.
Also, please note that you cannot receive relief if you are covered by another relief program or if the deadline for claiming relief has passed.
The relief is in the form of monetary relief in the form of "relief benefits (kyusai kufu). Specifically, there are medical expenses to compensate for the cost of treatment, medical allowances to cover expenses other than treatment costs, disability pensions, pensions for bereaved family members, funeral rites fees, etc.
To file a claim, a doctor's certificate, a medication certificate, or a sales certificate from the retailer is required.
Chart/Column
System for Relief from Adverse Effects of Drugs
Source: Website of the Pharmaceuticals and Medical Devices Agency
13｜Consultation for the relief system
Pharmaceuticals and Medical Devices Agency
| Phone | 0120-149-931 (toll-free) |
| Office Hours | 9:00 - 17:00 (except national holidays and year-end and New Year holidays) |
| Home page | https://www.pmda.go.jp/kenkouhigai_camp/index.html |
MINI Column "Pharmaceutical Risk Management Plan" (RMP)
The RMP is a new measure imposed on pharmaceutical companies to further strengthen the assurance of drug safety, and is required for new drugs and biosimilars for which an application for approval is to be submitted from April 2013 onward. The "RMP" is a document that includes a "Drug Safety Monitoring Plan" and a "Risk Minimization Plan" that describes how to reduce the risks of the drug.
The creation of the "RMP" has enabled risk assessment and review to be conducted at all stages of a drug's life cycle, from the development stage and approval review to the post-marketing period.
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