Developing a framework regarding a complex risk based methodology in the evaluation of hazards associated with medicinal products sourced via the internet.
Counterfeit medicine
Eye drops
Internet pharmacy
Online medicines
Risk assessment
Test purchase
Journal
Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society
ISSN: 1319-0164
Titre abrégé: Saudi Pharm J
Pays: Saudi Arabia
ID NLM: 9705695
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
31
07
2020
accepted:
31
10
2020
entrez:
11
1
2021
pubmed:
12
1
2021
medline:
12
1
2021
Statut:
ppublish
Résumé
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).
Identifiants
pubmed: 33424264
doi: 10.1016/j.jsps.2020.10.018
pii: S1319-0164(20)30260-7
pmc: PMC7783221
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1733-1742Informations de copyright
© 2020 The Authors.
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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