Abstract
Sibutramine products, which were not approved in Japan, but were the most popular anti-obesity agents on-line, were purchased through on-line brokers in 2008. Fiftythree parcels consisted of 9 products were obtained from 32 on-line brokers.
These products are prescription medicines in countries where they are approved, but no brokers informed us of this, or requested prescriptions. Package inserts were written in various foreign languages, including Polish and Turkish, or were absent. An explanatory note in Japanese on dosage and administration accompanied several parcels,but the maximum dose was described as nearly three times that in the proper package insert.
The Japanese Ministry of Health, Labour and Welfare’s guidance to patients wishing to import medicines personally is that they should not import more than one month’s supply. The majority of parcels included more than one month’s supply and the maximum was 10 times this amount. A few parcels failed content uniformity tests. One product had not been approved by any government. After the suspension of market authorization of sibtramine products in Europe and the USA in 2010, several sites continued to offer supplies.
Consumers are individually responsible for personal imports, and poor management by stakeholders puts them at risk. They should be made aware that emerging outlets such as the internet bypass the conventional protection framework, and should take great care.
Internet sales easily cross borders, and international cooperation would be indispensable to improve the situation. Personally imported pharmaceutical parcels to Japan were dispatched from several neighboring countries, including Cambodia, China, Hong Kong, India, and Thailand, and also from the Philippines, USA, and UK. Cooperation with these countries would be indispensable for the control of personal imports to protect Japanese public health.
