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
Bibliographic record
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 antibiotics without a prescription. From these websites, we successfully placed 27 orders, received 11 packages, and collected 1373 antibiotic product samples. Visual inspection resulted in all product packaging consisting of pill packs or blister packs and some concerning indicators of potential poor quality, falsification, and improper dispensing. Though all samples had the presence of stated active pharmaceutical ingredient, 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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".