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Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa
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, sibutrami...
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| Format: | Thesis |
| Language: | English |
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Division of Forensic Medicine and Toxicology
2018
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| _version_ | 1867614182181961728 |
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| access_status_str | Open Access |
| author | Catterson, Sandra Lynne |
| author2 | Davies, Bronwen |
| author_browse | Catterson, Sandra Lynne Davies, Bronwen |
| author_facet | Davies, Bronwen Catterson, Sandra Lynne |
| author_sort | Catterson, Sandra Lynne |
| collection | Thesis |
| description | 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. |
| format | Thesis |
| id | oai:open.uct.ac.za:11427/27059 |
| institution | University of Cape Town (South Africa) |
| language | eng |
| last_indexed | 2026-06-10T12:47:58.502Z |
| license_str | Not specified — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from UCTD — University of Cape Town Open Access Repository |
| publishDate | 2018 |
| publishDateRange | 2018 |
| publishDateSort | 2018 |
| publisher | Division of Forensic Medicine and Toxicology |
| publisherStr | Division of Forensic Medicine and Toxicology |
| record_format | dspace |
| source_str | UCTD — University of Cape Town Open Access Repository |
| spelling | oai:open.uct.ac.za:11427/27059 Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa Catterson, Sandra Lynne Davies, Bronwen Smith, Peter Aukloo, Kathrina Mendoza Biomedical Forensic Science 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. 2018-01-29T07:23:14Z 2018-01-29T07:23:14Z 2017 Master Thesis Masters MPhil http://hdl.handle.net/11427/27059 eng application/pdf Division of Forensic Medicine and Toxicology Faculty of Health Sciences University of Cape Town |
| spellingShingle | Biomedical Forensic Science Catterson, Sandra Lynne Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa |
| thesis_degree_str | Master's |
| title | Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa |
| title_full | Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa |
| title_fullStr | Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa |
| title_full_unstemmed | Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa |
| title_short | Complementary and alternate medicines: a forensic analysis of the potential adulteration of over-the-counter anorectics and "lifestyle" medicines in South Africa |
| title_sort | complementary and alternate medicines a forensic analysis of the potential adulteration of over the counter anorectics and lifestyle medicines in south africa |
| topic | Biomedical Forensic Science |
| url | http://hdl.handle.net/11427/27059 |
| work_keys_str_mv | AT cattersonsandralynne complementaryandalternatemedicinesaforensicanalysisofthepotentialadulterationofoverthecounteranorecticsandlifestylemedicinesinsouthafrica |