Japan is planning to tighten controls on sales of over-the-counter medicines, in the first major amendment to the Pharmaceutical Affairs Law since 1960.
The proposal, which the Ministry of Health, Labor and Welfare plans to submit shortly to the Diet (parliament) for introduction in 2008, would place OTCs into three categories (A, B and C) to reflect the level of risk associated with their use.
Category A products would be highest-risk, eg, those switched from prescription to OTC status, and these would only be available at pharmacies, where prescriptions are dispensed.
Category B would consist of middle-risk products such as aspirin, which could be sold at both pharmacies and drugstores, as could Category C products, such as vitamins, which represent the lowest risk.
Each product’s ranking would have to be displayed on both its inner and outer packaging.
Currently, the law requires a pharmacist to be on duty at all pharmacies and at drugstores selling stronger OTCs; together, these number around 60,000 businesses. While Japan has 240,000 licensed pharmacists, they tend to be more attracted to careers in hospitals and the pharmaceutical industry, so it is not always possible to fulfil this requirement, reports the Yomiuri Shimbun newspaper. It quotes one drugstore chain official as claiming that, at night, some businesses put an unqualified part-time employee in charge of dispensing.
The amendments would require employees selling medicines to prove their knowledge of the products to the Ministry; stores in which they fail to do so would not be permitted to sell Category A drugs. The Ministry also wants to end the need for drugstores which sell only Category B and C products to have a pharmacist present, and to do away with the current division of drugstores into the 11,000 general retailers which are permitted to sell stronger OTCs, and the 13,000 second-class drug retailers which are not.