Clin Ther. 2013 Apr 15. pii: S0149-2918(13)00167-7. doi: 10.1016/j.clinthera.2013.03.019. [Epub ahead of print]
Illegal "No Prescription" Internet Access to Narrow Therapeutic Index Drugs.
Source
Institute of Health Law Studies, California Western School of Law, San Diego, California; San Diego Center for Patient Safety, University of California San Diego School of Medicine, San Diego, California; Department of Anesthesiology, University of California San Diego School of Medicine, San Diego, California; Joint Program on Health Policy and Law, University of California San Diego-California Western School of Law, San Diego, California. Electronic address: baliang@alum.mit.edu.
Abstract
BACKGROUND:
Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online "no prescription" Web sites.
OBJECTIVE:
We assessed no prescription online availability of NTI drugs, using an academically published list (core NTI drugs).
METHODS:
Using the Google search term "buy DRUG no prescription," we reviewed the first 5 search result pages for marketing of no prescription NTI drugs. We further assessed if National Association of Boards of Pharmacy (NABP) Not Recommended vendors were marketing NTI drugs. Searches were conducted from November 3, 2012 to January 3, 2013.
RESULTS:
For core NTI drugs, we found 13 of 14 NTI drugs (92%) marketed as available without prescription, all from NABP Not Recommended vendors. On the basis of these initial findings, we expanded our core list to 12 additional NTI drugs; 11 of 12 of these drugs (92%) were available from no prescription Web sites. Overall, 24 of 26 NTI drugs (92%) were illegally marketed as available online without the need for a prescription.
CONCLUSION:
Suspect online NTI drug access from no prescription vendors represents a significant patient safety risk because of potential patient drug switching and risk of counterfeit versions. Further, state health care exchanges with coverage limitations may drive patients to seek formulations online. Food and Drug Administration harmonization with tighter international NTI drug standards should be considered, and aggressive action against suspect online marketers should be a regulatory and public health priority.
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