Magic Bullet Gone Astray: Medications and the Internet

Veronin, Michael A.; Youan, Bi‐Botti C.

doi:10.1126/science.1097355

Cited by 40 publications

(21 citation statements)

References 3 publications

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“…However, the findings in this report support results with previously published work [Westenberger et al 2005;Veronin and Youan, 2004], and further studies are warranted to identify trends in accessibility and health risks for these types of drug products sold on the Internet.…”

Section: Limitations Of the Studysupporting

confidence: 89%

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

Veronin

Nutan

Dodla³

2014

Therapeutic Advances in Drug Safety

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Background: The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. Objective: The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. Methods: A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using highperformance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Results: Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Conclusions: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet.

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Section: Limitations Of the Studysupporting

confidence: 89%

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

Veronin

Nutan

Dodla³

2014

Therapeutic Advances in Drug Safety

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“…The rise of an unregulated global market of drugs may increase the risk of the spread of counterfeit medicines, coming from States where drug production is not submitted to the same quality control as in US, Canada and Europe (Veronin 2004). The World Health Organization has declared that "medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases" (WHO 2006).…”

Section: Introductionmentioning

confidence: 99%

Marketing and pricing strategies of online pharmacies

et al. 2009

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“…It has been stated that this ability to purchase medications directly from a website poses the greatest risk of drug adverse effects by bypassing the traditional “visit to the physician and a review by a pharmacist” [20], and this observation may be expanded to included issues of packaging and labeling. Consumers who order drugs from the Internet do not have sufficient access to information and advice at the point of ordering and on delivery to make informed decisions about their safe and appropriate use [21]. Again, substandard packaging and labeling may compound this risk.…”

Section: Discussionmentioning

confidence: 99%

Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

Veronin¹

2011

J Med Internet Res

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BackgroundFor patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging.ObjectiveThe study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging.MethodsDuring March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States.ResultsOf the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms.ConclusionsResults suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, ...

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Magic Bullet Gone Astray: Medications and the Internet

Cited by 40 publications

References 3 publications

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

Marketing and pricing strategies of online pharmacies

Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

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