Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016

Xu, Yuanjin; Patel, Dhavalkumar Narendrabhai; Ng, Suet-Leng P; Tan, Siew-Har; Toh, Dorothy; Poh, Jalene; Lim, Adena Theen; Chan, Cheng-Leng; Low, Min‐Yong; Koh, Hwee‐Ling

doi:10.3389/fmed.2018.00167

Cited by 22 publications

(10 citation statements)

References 85 publications

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“…Unexpectedly, not a single case of HILI was found in a retrospective study of adverse events due to complementary health products in Singapore from 2010 to 2016; adverse events were reported to the Health Sciences Authority, and analyzed were overall 147,215 adverse event reports suspected to be associated with pharmaceutical products and complementary health products, which included Chinese traditional medicines. 101 These data are at variance with another Singapore study of liver injury associated with CAM-a review of adverse event reports in an Asian community from 2009 to 2014, in which 10 assessable HILI cases provided weak RUCAM scores from 0 to 2 for 9 patients and a score of 5 for 1 patient. 56 In another report from Singapore, RUCAM was used in 15 HILI patients for causality assessment, whereby all cases reportedly fulfilled all RUCAM criteria but individual RUCAM-based causality gradings were not reported.…”

Section: Herbal Product Qualitymentioning

confidence: 81%

Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases

Teschke¹,

Zhu²,

Jing³

2020

Journal of Clinical and Translational Hepatology

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Herb-induced liver injuries (HILI) by traditional herbal medicines are particular challenges in Asian countries, with issues over the best approach to establish causality. The aim of the current analysis was to provide an overview on how causality was assessed in HILI cases from Asian countries and whether the Roussel Uclaf Causality Assessment Method (RUCAM) was the preferred diagnostic algorithm, as shown before in worldwide evaluated cases of drug-induced liver injury (DILI). Using the PubMed database, publications in English language were preferred to allow for reevaluation by peers. Overall 11,160 HILI cases have assessed causality using RUCAM and were published by first authors working in Asian countries. With 21 evaluable reports, most publications came from mainland China, with Hong Kong and Taiwan, followed by Korea (n=15), Singapore (n=2), and Japan (n=1), while other Asian countries were not contributory. Most publications provided case and RUCAM data of good quality. For better presentation of future cases, however, the following recommendations are given: (1) preference of prospective study design with use of the updated RUCAM version; (2) clear separation of HILI cohorts from those of other herbal products or DILI; (3) case series for epidemiology studies should contain many essential data, possibly also as supplementary material; (4) otherwise, preference of single case reports providing individual case data and RUCAM-based causality gradings, and applying liver test threshold values; and (5) publication in English language journals. In conclusion, China and Korea are top in presenting RUCAM-based HILI cases, other Asian countries are encouraged to follow.

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Section: Herbal Product Qualitymentioning

confidence: 81%

Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases

Teschke¹,

Zhu²,

Jing³

2020

Journal of Clinical and Translational Hepatology

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“…Of all the extracted ICSRs, 19.9% ICSRs were related to suspected cutaneous ADRs in the present analysis. Skin-related ADRs are common and contribute a major quantum of ADRs for both modern medicines and complementary health products ( Giardina et al, 2018 ; Xu et al, 2018 ). The lists of modern medicines causing various cutaneous ADRs have been available extensively in the literature and regularly updated through various sources of information that can guide clinicians in being careful while prescribing these drugs.…”

Section: Discussionmentioning

confidence: 99%

Suspected cutaneous adverse drug reactions reported with traditional medicines: analysis of data for United Nations Asia region from WHO VigiBase

Barvaliya¹,

Chetan²,

Chandan³

et al. 2023

Front. Pharmacol.

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Background: Data on traditional medicine-induced cutaneous adverse drug reactions (ADRs) is very scarce. The current secondary analysis based on the WHO database (VigiBase) of individual case safety reports (ICSRs) focuses on the suspected cutaneous ADRs linked to traditional medicines (TMs).Methods: All the ICSRs reported between 1st January 2016 and 30th June 2021 from the UN Asia region in VigiBase where at least one TM was suspected to cause cutaneous ADRs were included in the study. Data regarding demographic details, suspected drug, adverse reaction as per MedDRA term, the seriousness of the reaction, de-challenge, re-challenge, and clinical outcome for suspected cutaneous ADRs associated with TM were obtained from VigiBase and analyzed for frequency of reported events and suspected medicines.Findings: Total 3,523 ICSRs with 5,761 ADRs related to “skin and subcutaneous tissue disorders” were included in the analysis. Amongst these, 6.8% of ICSRs were reported as serious. Pruritus (29.6%), rash (20.3%), urticaria (18.9%), and hyperhidrosis (3.3%) were commonly reported ADRs. Artemisia argyi H.Lév. and Vaniot. (14.9%), Ginkgo biloba L. (5.1%), Vitis vinifera L. (4%), Vitex agnus-castus L. (3.8%), Silybum marianum (L.), Gaertn (3.5%), and Viscus album L. (2.7%) were some commonly suspected TMs for cutaneous ADRs. There were 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported with TMs during the study period. Death was reported in 5 ICSRs.Interpretation: TMs are linked with various cutaneous ADRS ranging from pruritus to toxic epidermal necrolysis which may have serious consequences. TMs listed as suspected offending agents in this analysis, should be kept in mind while dealing with suspected cutaneous ADRs. Clinicians should be more vigilant in detecting and reporting events associated with TMs.

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“…Health products are defined as any substance, preparation, or device intended for use by humans principally or entirely for a health-related purpose. They include pharmaceutical products, complementary health products, cosmetic products and medical devices (Xu et al, 2018) Pharmaceutical products are essential in maintaining human health and are a key factor in all healthcare systems. Global medicine consumption is increasing daily with more emphasis on rational use but the proportion of medicines left unused is still high.…”

Section: Introductionmentioning

confidence: 99%

The Disposal Practices of Unused and Expired Pharmaceutical Products Among Non-Governmental Healthcare Providers in North Eastern Nigeria

Omokhapue,

Folorunso,

Suleiman

2024

AJHSE

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The disposal practices of unused and expired medicines have become a worldwide challenge. Due to the state of insecurity in the North Eastern Nigeria, Non-Governmental Healthcare providers provide healthcare services and medication to populations in distress and are also positioned to possess unused and expired health products. The objective of the study was to evaluate the knowledge, attitude, and practices of Non-Governmental Healthcare providers working in Borno State Nigeria towards handling unused and expired pharmaceuticals. A cross-sectional research design using questionnaires was employed among all Non-Governmental Healthcare providers registered under the Borno State Agency for Coordination of Sustainable Development and Humanitarian Response (BACSDAHR) and all donor agencies implementing health programmes within the state. A total of 43 respondents participated in the study. About 86.0% showed good knowledge of the environmental impact of improper disposal, 95.5% showed a good attitude on disposal of unused and expired medicine, 62.8% exhibited good practices in the handling of unused and expired medicines. A significant association was found between the profession and the disposal practices of unused and expired medicines. Between 80% to 93% of respondents do not know of the availability of any medicine disposal guideline document in their organization. The staff of Non-Governmental Healthcare providers show good knowledge, good attitude as well as good practices on the disposal of unused and expired medicines. The profession of respondents significantly influenced their disposal practices.

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Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016

Cited by 22 publications

References 85 publications

Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases

Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases

Suspected cutaneous adverse drug reactions reported with traditional medicines: analysis of data for United Nations Asia region from WHO VigiBase

The Disposal Practices of Unused and Expired Pharmaceutical Products Among Non-Governmental Healthcare Providers in North Eastern Nigeria

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