Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016
The objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP) submitted to the Health Sciences Authority (HSA) of Singapore for the period 2010–2016 to identify various trends and signals for pharmacovigilance purposes. A t...
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Frontiers Media S.A.
2018-06-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fmed.2018.00167/full |
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| author | Yimin Xu Yimin Xu Dhavalkumar N. Patel Suet-Leng P. Ng Siew-Har Tan Dorothy Toh Jalene Poh Adena Theen Lim Cheng-Leng Chan Cheng-Leng Chan Min-Yong Low Hwee-Ling Koh |
| author_facet | Yimin Xu Yimin Xu Dhavalkumar N. Patel Suet-Leng P. Ng Siew-Har Tan Dorothy Toh Jalene Poh Adena Theen Lim Cheng-Leng Chan Cheng-Leng Chan Min-Yong Low Hwee-Ling Koh |
| author_sort | Yimin Xu |
| collection | DOAJ |
| description | The objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP) submitted to the Health Sciences Authority (HSA) of Singapore for the period 2010–2016 to identify various trends and signals for pharmacovigilance purposes. A total of 147,215 adverse event reports suspected to be associated with pharmaceutical products and CHP were received by HSA between 2010 and 2016. Of these, 143,191 (97.3%) were associated with chemical drugs, 1,807 (1.2%) with vaccines, 1,324 (0.9%) with biological drugs (biologics), and 893 (0.6%) with CHP. The number of adverse event reports associated with Chinese Proprietary Medicine, other complementary medicine and health supplements are presented. Eight hundred and ninety three adverse event reports associated with CHP in the 7-year period have been successfully collated and analyzed. In agreement with other studies, adverse events related to the “skin and appendages disorders” were the most commonly reported. Most of the cases involved dermal allergies (e.g., rashes) associated with the use of glucosamine products and most of the adulterated products were associated with the illegal addition of undeclared drugs for pain relief. Dexamethasone, chlorpheniramine, and piroxicam were the most common adulterants detected. Reporting suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The findings from this study help to create greater awareness on the health risks, albeit low, when consuming CHP and dispelling the common misconception that “natural” means “safe.” In particular, healthcare professionals and the general public should be aware of potential adulteration of CHP. The analysis of spontaneously reported adverse events is an important surveillance system in monitoring the safety of CHP and helps in the understanding of the risk associated with the use of such products. Greater collaboration and communication between healthcare professionals, regulators, patients, manufacturers, researchers, and the general public are important to ensure the quality and safety of CHP. |
| first_indexed | 2024-12-10T12:34:57Z |
| format | Article |
| id | doaj.art-04daa284d139474e915a9ce142bdbb16 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-12-10T12:34:57Z |
| publishDate | 2018-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-04daa284d139474e915a9ce142bdbb162022-12-22T01:48:40ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2018-06-01510.3389/fmed.2018.00167368951Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016Yimin Xu0Yimin Xu1Dhavalkumar N. Patel2Suet-Leng P. Ng3Siew-Har Tan4Dorothy Toh5Jalene Poh6Adena Theen Lim7Cheng-Leng Chan8Cheng-Leng Chan9Min-Yong Low10Hwee-Ling Koh11Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore, SingaporeApplied Sciences Group, Pharmaceutical Division, Health Sciences Authority, Singapore, SingaporeDepartment of Pharmacy, Faculty of Science, National University of Singapore, Singapore, SingaporeVigilance, Compliance and Enforcement Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, SingaporeVigilance, Compliance and Enforcement Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, SingaporeVigilance, Compliance and Enforcement Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, SingaporeVigilance, Compliance and Enforcement Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, SingaporeVigilance, Compliance and Enforcement Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, SingaporeDepartment of Pharmacy, Faculty of Science, National University of Singapore, Singapore, SingaporeVigilance, Compliance and Enforcement Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, SingaporeApplied Sciences Group, Pharmaceutical Division, Health Sciences Authority, Singapore, SingaporeDepartment of Pharmacy, Faculty of Science, National University of Singapore, Singapore, SingaporeThe objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP) submitted to the Health Sciences Authority (HSA) of Singapore for the period 2010–2016 to identify various trends and signals for pharmacovigilance purposes. A total of 147,215 adverse event reports suspected to be associated with pharmaceutical products and CHP were received by HSA between 2010 and 2016. Of these, 143,191 (97.3%) were associated with chemical drugs, 1,807 (1.2%) with vaccines, 1,324 (0.9%) with biological drugs (biologics), and 893 (0.6%) with CHP. The number of adverse event reports associated with Chinese Proprietary Medicine, other complementary medicine and health supplements are presented. Eight hundred and ninety three adverse event reports associated with CHP in the 7-year period have been successfully collated and analyzed. In agreement with other studies, adverse events related to the “skin and appendages disorders” were the most commonly reported. Most of the cases involved dermal allergies (e.g., rashes) associated with the use of glucosamine products and most of the adulterated products were associated with the illegal addition of undeclared drugs for pain relief. Dexamethasone, chlorpheniramine, and piroxicam were the most common adulterants detected. Reporting suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The findings from this study help to create greater awareness on the health risks, albeit low, when consuming CHP and dispelling the common misconception that “natural” means “safe.” In particular, healthcare professionals and the general public should be aware of potential adulteration of CHP. The analysis of spontaneously reported adverse events is an important surveillance system in monitoring the safety of CHP and helps in the understanding of the risk associated with the use of such products. Greater collaboration and communication between healthcare professionals, regulators, patients, manufacturers, researchers, and the general public are important to ensure the quality and safety of CHP.https://www.frontiersin.org/article/10.3389/fmed.2018.00167/fullcomplementary health productsadverse eventspharmacovigilanceglucosamineadulterants |
| spellingShingle | Yimin Xu Yimin Xu Dhavalkumar N. Patel Suet-Leng P. Ng Siew-Har Tan Dorothy Toh Jalene Poh Adena Theen Lim Cheng-Leng Chan Cheng-Leng Chan Min-Yong Low Hwee-Ling Koh Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 Frontiers in Medicine complementary health products adverse events pharmacovigilance glucosamine adulterants |
| title | Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 |
| title_full | Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 |
| title_fullStr | Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 |
| title_full_unstemmed | Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 |
| title_short | Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 |
| title_sort | retrospective study of reported adverse events due to complementary health products in singapore from 2010 to 2016 |
| topic | complementary health products adverse events pharmacovigilance glucosamine adulterants |
| url | https://www.frontiersin.org/article/10.3389/fmed.2018.00167/full |
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