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      Dose-to-dose variations with single packages of counterfeit medicines and adulterated dietary supplements as a potential source of false negatives and inaccurate health risk assessments.

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          Abstract

          In this report, we show three examples of how the variability in dose units in single packages of counterfeit medicines and adulterated dietary supplements may contribute to a false negative screening result and inaccurate health risk assessments. We describe a counterfeit Viagra 100mg blister pack and a box of an instant coffee both containing dose units with and without an active pharmaceutical ingredient (API). We also describe a purportedly herbal slimming product with capsules that mutually differed in API and impurities. The adulterated dietary supplements contained sibutramine, benzyl-sibutramine, N-desmethyl-sibutramine (DMS), N,N-didesmethyl-sibutramine (DDMS) and several other related impurities. Counterfeit medicines and adulterated dietary supplements are a health risk because their quality is unreliable. Health risks are even greater when such unreliability extends to fundamental differences between dose units in one package. Because dose-to-dose variability for these products is unpredictable, the confidence interval of a sample size is unknown. Consequently, the analyses of a selection of dose units may not be representative for the package. In the worst case, counterfeit or unauthorised medicines are not recognised as such or a health risk is not identified. In order to reduce erroneous results particular care should be taken when analysing a composite of dose units, when finding no API in a dietary supplement and when finding conformity in a suspect counterfeit medicine.

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          Author and article information

          Journal
          J Pharm Biomed Anal
          Journal of pharmaceutical and biomedical analysis
          Elsevier BV
          1873-264X
          0731-7085
          Feb 2014
          : 89
          Affiliations
          [1 ] National Institute for Public Health and the Environment, Postbox 1, 3721MA, Bilthoven, The Netherlands. Electronic address: bastiaan.venhuis@rivm.nl.
          [2 ] Dutch Customs Laboratory, Postbox 58933, 1040ED, Amsterdam, The Netherlands.
          [3 ] National Institute for Public Health and the Environment, Postbox 1, 3721MA, Bilthoven, The Netherlands.
          Article
          S0731-7085(13)00497-4
          10.1016/j.jpba.2013.10.038
          24291553
          48221079-6b82-4bad-b466-061d407797e9
          History

          UPLC-QTOF-MS/MS,Benzyl-sibutramine,Counterfeit medicines and adulterated dietary supplements,Dose-to-dose variability,Sibutramine analogues

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