JMIR Publications

ABSTRACT

Background:

Antimicrobial resistance is a significant global public health threat. However, the impact of sourcing of potentially substandard and falsified antibiotics via the Internet remains understudied, particularly in the context of access to and quality of essential 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:

Identify and characterize “no prescription” online pharmacies selling five essential antibiotics and assess the quality characteristics of samples though controlled test buys.

Methods:

We first utilized structured search queries associated with the international nonproprietary names of Amoxicillin, Azithromycin, Amoxicillin/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 visual inspection of packaging and contents for risk evaluation. Antibiotics were then analyzed using untargeted mass spectrometry through UHPLC-ESI-MS/MS. Semi-quantitative results were used to determine if the claimed API was present and molecular networking was used to analyze MS/MS data to detect drug analogs as well as possible adulterants and contaminants.

Results:

109 unique websites were identified that actively advertised direct-to-consumer sale of antibiotics without a prescription. From these websites, we successfully placed 27 orders, received 11 packages, and collected 1,373 antibiotic product samples. Visual inspection resulted in all product packaging consisting of pill pack or blister packs and some concerning indicators of potential poor quality, falsification, and improper dispensing. Though all samples had presence of stated API, molecular networking revealed a number of drug analogs of unknown identity, as well as known impurities and contaminants.

Conclusions:

Our study used a multifactor approach including web surveillance, test purchasing, and analytical chemistry to assess risk factors associated with purchasing antibiotics online. Results provide evidence of possible safety risks, including substandard packaging and shipment, falsification of product information and markings, detection of undeclared chemicals, high variability of quality across samples, and payment for orders being defrauded. Beyond immediate patient safety risks, these falsified and substandard products could exacerbate the ongoing public health threat of antimicrobial resistance by circulating substandard product to patients.