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However, in an earlier phase of this research, we identified a number of historical cases of substandard medicines that would not have been detected by the method [ 5].
As a result, this study could not be designed to evaluate the proportion of real cases of substandard medicines that would be correctly recalled and how many would be missed.
It should also be noted that some clusters that match confirmed cases of substandard medicines also include several reports with other explanations for the suspected product inadequacy and could represent coincidental findings.
The application of the algorithm to VigiBase allowed identification of some cases of substandard medicines; however, some key prerequisites for broad prospective detection of substandard medicines are not currently fulfilled.
In considering the results, one should bear in mind the retrospective nature of our study and the risk that public awareness of cases of substandard medicines might have led to increased rates of reporting of product quality issues, after they were known.
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The fact that substandard care was taken to be the reason for potentially avoidable severe morbidities, while the same type of substandard care could have been also found in cases without adverse outcome posed a great challenge to the verdict [ 27].
There are, however, multiple cases of fake or substandard products purchased through overseas Internet pharmacy sites for personal use (Baert and De Spiegeleer 2010; Khan et al. 2012).
A nationwide shift to caps could result in more cases of negligence and substandard care.
7, 25– 30 These previous studies offer valuable preliminary data, and have in some cases served an important purpose in alerting drug regulatory authorities to cases of falsified and substandard products.
Experience with perinatal audit from high income countries over a number of years has shown that in 30-70% of cases substandard care contributed or caused the death [ 28].
An ongoing Dutch enquiry into term perinatal deaths shows that in 30% of cases substandard care factors are present (Bruinse 2008, personal communication).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com