Abstract
Today, the increasing number of illicit internet pharmacies is a global phenomenon, however, the size of the online pharmaceutical market is still relatively unknown and the dubious quality of products is questionable and warrants investigation. Descriptive data from this black market channel are derived from studies analyzing the online availability of different medications procured over the internet and their methodology is quite heterogeneous. Our aim was to develop a comprehensive and specific risk assessment for selecting high patient safety risk medications from the online pharmaceutical market. A rapid tool was developed based upon the two quality and safety standard resolutions in pharmaceutical practice, published by the European Directorate for the Quality of Medicines, and was illustrated on eye drops. We developed five dimensions in support of the risk assessment including intrinsic, extrinsic and potential risks of counterfeiting. The five criteria were integrated in a comprehensively weighted risk-scoring format. The probability of procuring the product from the internet was also assessed based on the number of relevant links within the first twenty search engine results and the cost of the products. With the application of the tool a dorzolamide & timolol combination eye drop represented the highest overall patient safety risk score. In consideration of our literature review of the past 20 years, there is no current, standardized methodology to effectively identify pharmaceutical products associated with high patient safety risks. Notably, the fully comprehensive analysis of the internet pharmaceutical market and the test purchase of all online available medicines is unrealistic. Therefore, we developed a method to aid online surveillance researches and targeted international organizational led joint actions against the uncontrolled sale of falsified and substandard medications (e.g.: Operation Pangea).
Highlights
The expanding market of illicit internet pharmacies is a global public health threat with potential negative patient safety consequences in every aspect of our health care system
We define patient safety risk based on the broader perspective of medication errors, since patient safety risk is a risk which may cause or lead to inappropriate medication use and patient harm based on the characteristics of the product itself or the environment while the medication is in the control of the patient or consumer
The proposed dimensions of the framework are suitable for all drug classes, to improve the specificity of the risk assessment, customized sub-dimensions are required in accordance with the evaluated therapeutic categories or selected dosage forms
Summary
The expanding market of illicit internet pharmacies is a global public health threat with potential negative patient safety consequences in every aspect of our health care system. According to the survey of the National Association of Boards of Pharmacy (NABP), in 2017, 95.7% of 11,749 online pharmacies were noncompliant with the U.S legislation and standards (The National Association of Boards of Pharmacy, 2018). The majority of these ‘‘Not Recommended” sites were found to be dispensing prescription-only medicines without a valid prescription (The National Association of Boards of Pharmacy, 2018). In 2016, based on the available industry data (LegitScript), there were 30,000 to 35,000 illicit online pharmacies (Corazza et al, 2014; LegitScript, 2016), and the market was estimated to grow by twenty online vendors daily (LegitScript, 2016)
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