Counterfeit medicines: report of a cross-sectional retrospective study in Iran.

OBJECTIVES

To gain insight into the pharmaceutical grey market in Iran by reviewing inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, Ministry of Health and Medical Education, and to define the counterfeit pharmaceutical pattern in Iran.

STUDY DESIGN

Cross-sectional retrospective study.

METHODS

In total, 382 inspection files of pharmaceutical counterfeit cases between 2007 and 2008 were reviewed. A database was constructed in Microsoft Access, and all cases of counterfeit medicines together with the details recorded in the files were entered. A primary list of all items in all files was produced (n = 7910), and this contained 716 different counterfeit medicines. This article reports the analysis of these 716 items and the outcome. Subsequently, the list of items was further filtered, and a final working list of 100 items was selected for further analysis. Drug samples of the working list were collected and checked against a modified version of the 'Checklist for the visual inspection of medicines to identify suspicious drug products' of the US Pharmacopeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting Taskforce). Details of items in the working list recorded in the checklist were then entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel.

RESULTS

Of the 716 items, 64.5% were supplements, 10.2% were analgesics, 7.8% were hormones and 3.2% were antihistamines. Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genito-urinary systems, and drugs used for cardiovascular disease and diabetes represented 1-2% of items, and other drug groups accounted for <1% of the 716 counterfeit medicines. Drugs used in professional settings accounted for 20% and drugs used in non-professional settings accounted for 15% of the 716 items. Selected items were checked against the World Health Organization's visual checking tool, and the following observations were made: 15.8% showed mismatch between the label and the container, 7.9% showed the incorrect manufacturer's name and address, 82.9% showed existence or a different view of the logo and hologram of the product, and 18.4% used poor-quality paper for the insert. In 73.7% of products checked, the ink of the packaging or inserts was not smudge-proof.

CONCLUSION

Results from this study have been utilized by the Deputy Ministry for Food and Drugs in Iran and the outcome was a faster registration and market authorization of supplements compared with other pharmaceutical products. Inter- and intra-section collaboration, active vigilance and conducting educational programs at different levels would reduce the risk of counterfeit medicines and protect public health.