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【MHLW】Interim plan for switch OTC drugs – pharmacists play important roles

2020年12月15日 (火)

On the 2nd of Dec, at the “meeting of evaluation for application of prescription drugs to guidance-mandatory/non-prescription drugs”, the Ministry of Health, Labor and Welfare (MHLW) proposed the interim plan to evaluate a need for switch drugs and discuss effectively and efficiently. For guidance-mandatory/non-prescription drugs, pharmacists should play important roles such as compliance instruction, selection of drug, and follow-up, and some drugs to treat allergic rhinitis and others whose symptoms users can judge by themselves were mentioned as possible switch OTC drugs. The MHLW will finalize the interim plan at the meeting on 24th of Dec.

The interim plan aims to summarize the issues discussed at this meeting and to evaluate a need for switch OTC drugs and discuss effectively and efficiency. Based on the discussion on the draft, the interim plan describing issues and tasks was specified.

In the interim plan, the responsibility of the stakeholders was determined since prescription drugs will be marketed at pharmacies by being applied to switch OTC drugs. Whereas prescription drugs are to be assessed/prescribed and controlled by physicians, non-prescription drugs are to be controlled by users or pharmacists. It was specified that pharmacists would also play important roles in compliance instructions for users and selection of drug.

In addition, the people use would be demanded to have responsibilities with regards to communicating personal information including symptoms and compliance to pharmacists accurately and selecting a drug by themselves.

Possible switch OTC drugs had to be those that do not need selection and/or dose adjustment by physician depending user’s condition and/or change. Any drugs to treat conditions whose symptoms users can judge and that can be used properly for a short-term period at their discretion are candidate, for example, drugs to treat allergic rhinitis, analgesics, and those to treat irritable bowel syndrome (IBS).

At the meeting on this day, how to communicate information between pharmacists and physicians to promote switch OTC drugs was discussed. Etsuko Ogata member (Vice-president, Japan Woman’s Pharmaceutical Association) mentioned that laboratory data should be shared between physicians and pharmacists. She said, “Sharing laboratory data as materials other than prescriptions, we can know patient’s condition and judge whether to use non-prescription drugs or consult with physicians at hospital again, so I hope sharing of laboratory data to be incorporated in the interim plan”.

The chair, Hiroshi Kasanuki (Senior research professor, Waseda University), pointed out that, “It is important to create an environment where stakeholders can cooperate to promote switch OTC drugs”. In addition, he also commented on sharing of laboratory data, “It can be an example for resolving issues on switch OTC drugs”.


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