OTC-like Drugs Should be Classified as OTC Drugs ― It is essential to return from medical drugs to the starting point of prescription drugs ―

This paper focuses on the issue of OTC-like drugs, which are key to curbing the cost of public medical insurance benefits. Drugs are broadly categorized into those that require a doctor's prescription and those that do not, namely OTC drugs (over-the-counter drugs). The need for a prescription should be determined on the basis of risk, and in fact, in various countries, governments classify high-risk drugs as drugs that require a prescription, and lowrisk drugs as OTC drugs. The term OTC-like drug is used to mean a drug that is similar in nature to an OTC drug in terms of factors such as effect and risk, but that normally requires a prescription.

The product group called OTC-like drugs has arisen because the standard for determining the need for prescriptions in Japan is actually a double standard, with one standard for prescription drugs and another for medical drugs, and because medical drugs have become the main focus despite not originally being the target of the standards. Whether a drug is a prescription drug is determined by the level of risk, and only high-risk drugs are classified as prescription drugs, and a prescription is required to purchase them. However, even lowrisk drugs that are not classified as prescription drugs are not automatically made available without a prescription in Japan, and if one has been classified as a medical drug pursuant to an application by the manufacturer, a prescription is normally required to purchase it, and it is covered by public medical insurance. In Japan at present, drugs other than medical drugs are considered to be OTC drugs.

There are four main problems with drugs that are similar in nature to OTC drugs being covered by public medical insurance and normally requiring a prescription. The first is that they impede self-medication. Patients who visit a medical institution (hospital or clinic) and are prescribed OTC-like drugs pay less out of pocket for drugs than if they purchased OTC drugs directly from a pharmacy. In other words, self-medication is more expensive. The second stems from the first, and is that it puts pressure on medical insurance finances. According to estimates prepared for this paper, OTC-like drugs account for 2.3%, or 1.0 trillion yen, of the 45 trillion yen in national medical expenditure (FY2021). The third is that it undermines the fairness of the health insurance system. A system whereby health insurance covers the drug costs of those who immediately go to a medical institution and are prescribed OTC-like drugs even if they only have mild symptoms cannot be described as fair. The fourth is that it makes it difficult for patients to purchase OTC-like drugs directly at pharmacies, which can be seen as a disadvantage for patients. Above all, many OTC-like drugs are more cost-effective than OTC drugs.

In light of the above, the classification of medical drugs should be abolished and drugs other than prescription drugs should be classified as OTC drugs. This could be expected to solve the above-mentioned problems. However, concerns could also be expected to arise, such as higher drug costs due to doctors prescribing substitutes that are covered by public medical insurance benefits, poorer access to drugs for patients due to increased out-of-pocket payments, and improper use due to reduced physician involvement. These concerns can be addressed through, for example, monitoring and guidance for doctor's prescriptions, the provision of exceptional insurance benefits in the case of serious illnesses, and ensuring that pharmacists provide thorough guidance to patients.

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