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MEDICATION SAFETY

"Insight" into Drug Quality: Comparison of Simvastatin Tablets from the US and Canada Obtained via the Internet

Associate Professor, Social, Behavioral, and Administrative Sciences, Department of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Kingsville, TX

Eunah Lee, PhD

Applications Scientist, HORIBA Jobin Yvon, Edison, NJ

E Neil Lewis, PhD

Lead Scientist, Analytical Imaging Product and Business Development, Malvern Instruments Ltd., Columbia, MD

Reprints: Dr. Veronin, Department of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, MSC 131, 1010 W. Avenue B, Kingsville, TX 78363, fax 361/593-4303, veronin{at}pharmacy.tamhsc.edu

BACKGROUND: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US.

OBJECTIVE: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product.

METHODS: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis. Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets' internal structures.

RESULTS: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets.

CONCLUSIONS: Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.

Key Words: drug importation, drug quality, Internet pharmacy

Published Online, June 26, 2007. www.theannals.com, DOI 10.1345/aph.1H680

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