Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa

dc.contributor.advisorDavies, Bronwenen_ZA
dc.contributor.advisorSmith, Peteren_ZA
dc.contributor.advisorAukloo, Kathrina Mendozaen_ZA
dc.contributor.authorCatterson, Sandra Lynneen_ZA
dc.date.accessioned2018-01-29T07:23:14Z
dc.date.available2018-01-29T07:23:14Z
dc.date.issued2017en_ZA
dc.description.abstractBackground: Complementary and Alternate Medicines (CAMs) in South Africa are not yet subjected to the same rigorous testing required for allopathic (prescription) medication, yet they are freely available as over-the-counter medicines. Past research has shown the presence of a banned drug, sibutramine in natural anorectics and a schedule 6 prescription drug, sildenafil, found in natural erectile dysfunction preparations. Methods: Initially, 26 exhibits (18 erectile dysfunction medicines and 8 anorectics) were screened for active pharmaceutical ingredients using high performance liquid chromatography tandem mass spectrometry. An AB SCIEX 3200 TRAP® linear ion-trap quadrupole mass spectrometer was used to detect and subsequently quantitate these active pharmaceutical ingredients using a targeted multiple reaction monitoring mode. Samples were extracted with 50% v/v methanol in water. A method for the quantitation of sildenafil was subsequently partially validated. The intra- and inter-assay precisions were evaluated and the linearity of the method was investigated in the range of 20 ng/mL to 2000 ng/mL. The method was then successfully applied to a random selection of CAMs. A random sample (n=61) of erectile dysfunction CAMs were selected for quantitation from two different clusters. Cluster 1 comprised of supermarkets and cluster 2 of pharmacies. Results: The validation method for sildenafil showed that the limit of detection was 1.09 ng/mL and the limit of quantitation was 20 ng/mL. The correlation co-efficient and bias were less than 20%. Initial screening of the 26 exhibits indicated that sildenafil was present in 12 of the 18 samples tested and sibutramine in 6 of the 8 anorectics. Of the later 61 exhibits tested, 43 tested positive for sildenafil. The mass of sildenafil per sample ranged from 1.09 ng/mL to 123.7 mg/sample. Conclusion: The lack of label content, regulation and legislation exposes the consumer to the risk of consuming an active pharmaceutical ingredient which may very likely have an adverse effect on their health. There is a need to raise public awareness to the potential dangers of unregulated CAMs, encourage doctors to become more aware of their patients' consumption of CAMs and to motivate the Medicines Control Council to follow through with their deadlines for the regulation of CAMs.en_ZA
dc.identifier.apacitationCatterson, S. L. (2017). <i>Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa</i>. (Thesis). University of Cape Town ,Faculty of Health Sciences ,Division of Forensic Medicine and Toxicology. Retrieved from http://hdl.handle.net/11427/27059en_ZA
dc.identifier.chicagocitationCatterson, Sandra Lynne. <i>"Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa."</i> Thesis., University of Cape Town ,Faculty of Health Sciences ,Division of Forensic Medicine and Toxicology, 2017. http://hdl.handle.net/11427/27059en_ZA
dc.identifier.citationCatterson, S. 2017. Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa. University of Cape Town.en_ZA
dc.identifier.ris TY - Thesis / Dissertation AU - Catterson, Sandra Lynne AB - Background: Complementary and Alternate Medicines (CAMs) in South Africa are not yet subjected to the same rigorous testing required for allopathic (prescription) medication, yet they are freely available as over-the-counter medicines. Past research has shown the presence of a banned drug, sibutramine in natural anorectics and a schedule 6 prescription drug, sildenafil, found in natural erectile dysfunction preparations. Methods: Initially, 26 exhibits (18 erectile dysfunction medicines and 8 anorectics) were screened for active pharmaceutical ingredients using high performance liquid chromatography tandem mass spectrometry. An AB SCIEX 3200 TRAP® linear ion-trap quadrupole mass spectrometer was used to detect and subsequently quantitate these active pharmaceutical ingredients using a targeted multiple reaction monitoring mode. Samples were extracted with 50% v/v methanol in water. A method for the quantitation of sildenafil was subsequently partially validated. The intra- and inter-assay precisions were evaluated and the linearity of the method was investigated in the range of 20 ng/mL to 2000 ng/mL. The method was then successfully applied to a random selection of CAMs. A random sample (n=61) of erectile dysfunction CAMs were selected for quantitation from two different clusters. Cluster 1 comprised of supermarkets and cluster 2 of pharmacies. Results: The validation method for sildenafil showed that the limit of detection was 1.09 ng/mL and the limit of quantitation was 20 ng/mL. The correlation co-efficient and bias were less than 20%. Initial screening of the 26 exhibits indicated that sildenafil was present in 12 of the 18 samples tested and sibutramine in 6 of the 8 anorectics. Of the later 61 exhibits tested, 43 tested positive for sildenafil. The mass of sildenafil per sample ranged from 1.09 ng/mL to 123.7 mg/sample. Conclusion: The lack of label content, regulation and legislation exposes the consumer to the risk of consuming an active pharmaceutical ingredient which may very likely have an adverse effect on their health. There is a need to raise public awareness to the potential dangers of unregulated CAMs, encourage doctors to become more aware of their patients' consumption of CAMs and to motivate the Medicines Control Council to follow through with their deadlines for the regulation of CAMs. DA - 2017 DB - OpenUCT DP - University of Cape Town LK - https://open.uct.ac.za PB - University of Cape Town PY - 2017 T1 - Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa TI - Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa UR - http://hdl.handle.net/11427/27059 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/27059
dc.identifier.vancouvercitationCatterson SL. Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa. [Thesis]. University of Cape Town ,Faculty of Health Sciences ,Division of Forensic Medicine and Toxicology, 2017 [cited yyyy month dd]. Available from: http://hdl.handle.net/11427/27059en_ZA
dc.language.isoengen_ZA
dc.publisher.departmentDivision of Forensic Medicine and Toxicologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.subject.otherBiomedical Forensic Scienceen_ZA
dc.titleComplementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africaen_ZA
dc.typeMaster Thesis
dc.type.qualificationlevelMasters
dc.type.qualificationnameMPhilen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceThesisen_ZA
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