Multifactor Quality and Safety Analysis of Antimicrobial Drugs Sold by Online Pharmacies That Do Not Require a Prescription: Multiphase Observational, Content Analysis, and Product Evaluation Study
Abstract
Background: Antimicrobial resistance is a significant global public health threat. However, the impact of sourcing potentially substandard and falsified antibiotics via the internet remains understudied, particularly in the context of access to and quality of common antibiotics. In response, this study conducted a multifactor quality and safety analysis of antibiotics sold and purchased via online pharmacies that did not require a prescription.
Objective: The aim of this paper is to identify and characterize "no prescription" online pharmacies selling 5 common antibiotics and to assess the quality characteristics of samples through controlled test buys.
Methods: We first used structured search queries associated with the international nonproprietary names of amoxicillin, azithromycin, amoxicillin and clavulanic acid, cephalexin, and ciprofloxacin to detect and characterize online pharmacies offering the sale of antibiotics without a prescription. Next, we conducted controlled test buys of antibiotics and conducted a visual inspection of packaging and contents for risk evaluation. Antibiotics were then analyzed using untargeted mass spectrometry (MS). MS data were used to determine if the claimed active pharmaceutical ingredient was present, and molecular networking was used to analyze MS data to detect drug analogs as well as possible adulterants and contaminants.
Results: A total of 109 unique websites were identified that actively advertised direct-to-consumer sale of…
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