Public health concerns for anti-obesity medicines imported for personal use through the internet: a cross-sectional study

Abstract

Objective: To explore the circulation of anti-obesity medicines via the internet and their quality.

Design: Cross-sectional study.

Setting: Internet pharmacies and pharmaceutical suppliers accessible from Japan.

Participants: Anti-obesity medicines were purchased using relevant keywords on Japanese Google search engine. Blogs and advertisement-only sites were excluded.

Primary and secondary outcome measures: The authenticity of the samples was investigated in collaboration with the manufacturers of the samples and medicine regulatory authorities. Quality of the samples was assessed by pharmacopoeial analyses using high-performance liquid chromatography.

Results: 82 samples were purchased from 36 internet sites. Approximately half of the sites did not mention a physical address, and 45% of the samples did not contain a package insert. A variety of custom declarations were made for the shipments of the samples: personal health items, supplement, medicines, general merchandise, tea and others. Among 82 samples, 52 samples were analysed to check their pharmacopoeial quality. Authenticity responses were received from only five of 20 manufacturing companies. According to the pharmacopoeial analyses and authenticity investigation, three of the samples were identified as counterfeits and did not contain any active ingredients. Two of these samples were confirmed as counterfeits by the manufacturer of the authentic products. The manufacturer of the other sample did not respond to our request for an authenticity check even after several communication attempts. These counterfeit cases have been reported at the rapid alert system of Western Pacific Region of the WHO.

Conclusions: Many counterfeit and unapproved anti-obesity medicines may be easily bypassing regulatory checks during shipping and are widely circulated through the internet. Regulatory authorities should take measures to prevent these medicines from entering countries to safeguard their citizens.

Figure 1

Chromatograms (A–D) of the reference standard of orlistat and counterfeit samples.

Figure 2

Front of blister: (A) genuine sample, (B) counterfeit sample, (C) manufacturing date of counterfeit sample (MFD 02-2011), and (D) expiration date of counterfeit sample (EXP 02-2011).

Figure 3

Reverse side of blister: (A) logo of genuine sample and (B) logo of counterfeit sample.