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H. Nordeng - One of the best experts on this subject based on the ideXlab platform.
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Safety classification of Herbal Medicines used in pregnancy in a multinational study
BMC Complementary and Alternative Medicine, 2016Co-Authors: D. A. Kennedy, A. Lupattelli, G. Koren, H. NordengAbstract:Background The use of Herbal Medicines for health prevention and ailments is an increasing trend worldwide. Women in pregnancy are no exception; the reported prevalence of Herbal medicine use in pregnancy ranges from 1 to 60 %. Despite a common perception of safety, Herbal Medicines may have potent pharmacological actions, and historically, have been used for this reason. Methods A multinational, cross-sectional study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North America, and Australia. This study’s primary aim was to evaluate and classify the Herbal Medicines used according to their safety in pregnancy and, secondly, to investigate risk factors associated with the use of contraindicated Herbal Medicines during pregnancy. Results In total, 29.3 % of the women ( n = 2673) reported the use of Herbal Medicines in pregnancy; of which we were able to identify 126 specific Herbal Medicines used by 2379 women (89.0 %). Twenty seven out of 126 Herbal Medicines were classified as contraindicated in pregnancy, and were used by 476 women (20.0 %). Twenty-eight were classified as safe for use in pregnancy and used by the largest number of women ( n = 1128, 47.4 %). The greatest number was classified as requiring caution in pregnancy; these sixty Herbal Medicines were used by 751 women (31.6 %). Maternal factors associated with the use of contraindicated Herbal Medicines in pregnancy were found to be working in the home, having a university education, not using folic acid, and consuming alcohol. Interestingly, the recommendation to take a contraindicated Herbal medicine was three times more likely to be from a healthcare practitioner (HCP) than an informal source. Conclusion Based on the current literature the majority of women in this study used an Herbal medicine that was classified as safe for use in pregnancy. Women who reported taking a contraindicated herb were more likely to have been recommended it use by an HCP rather than informal source(s), indicating an urgent need for more education among HCPs. The paucity of human studies on Herbal Medicines safety in pregnancy stands in stark contrast to the widespread use of these products among pregnant women.
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safety classification of Herbal Medicines used in pregnancy in a multinational study
BMC Complementary and Alternative Medicine, 2016Co-Authors: D. A. Kennedy, A. Lupattelli, G. Koren, H. NordengAbstract:The use of Herbal Medicines for health prevention and ailments is an increasing trend worldwide. Women in pregnancy are no exception; the reported prevalence of Herbal medicine use in pregnancy ranges from 1 to 60 %. Despite a common perception of safety, Herbal Medicines may have potent pharmacological actions, and historically, have been used for this reason. A multinational, cross-sectional study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North America, and Australia. This study’s primary aim was to evaluate and classify the Herbal Medicines used according to their safety in pregnancy and, secondly, to investigate risk factors associated with the use of contraindicated Herbal Medicines during pregnancy. In total, 29.3 % of the women (n = 2673) reported the use of Herbal Medicines in pregnancy; of which we were able to identify 126 specific Herbal Medicines used by 2379 women (89.0 %). Twenty seven out of 126 Herbal Medicines were classified as contraindicated in pregnancy, and were used by 476 women (20.0 %). Twenty-eight were classified as safe for use in pregnancy and used by the largest number of women (n = 1128, 47.4 %). The greatest number was classified as requiring caution in pregnancy; these sixty Herbal Medicines were used by 751 women (31.6 %). Maternal factors associated with the use of contraindicated Herbal Medicines in pregnancy were found to be working in the home, having a university education, not using folic acid, and consuming alcohol. Interestingly, the recommendation to take a contraindicated Herbal medicine was three times more likely to be from a healthcare practitioner (HCP) than an informal source. Based on the current literature the majority of women in this study used an Herbal medicine that was classified as safe for use in pregnancy. Women who reported taking a contraindicated herb were more likely to have been recommended it use by an HCP rather than informal source(s), indicating an urgent need for more education among HCPs. The paucity of human studies on Herbal Medicines safety in pregnancy stands in stark contrast to the widespread use of these products among pregnant women.
Ismail E Musa - One of the best experts on this subject based on the ideXlab platform.
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Attitude and use of Herbal Medicines among pregnant women in Nigeria
BMC Complementary and Alternative Medicine, 2009Co-Authors: Titilayo O Fakeye, Rasaq Adisa, Ismail E MusaAbstract:Background The use of Herbal Medicines among pregnant women in Nigeria has not been widely studied. Methods Opinion of 595 pregnant women in three geopolitical zones in Nigeria on the use of Herbal Medicines, safety on usage, knowledge of potential effects of Herbal remedies on the fetus and potential benefits or harms that may be derived from combining Herbal remedies with conventional therapies were obtained using a structured questionnaire between September 2007 and March 2008. Descriptive statistics and Fisher's exact tests were used at 95% confidence level to evaluate the data obtained. Level of significance was set at p < 0.05. Results More than two-third of respondents [67.5%] had used Herbal Medicines in crude forms or as pharmaceutical prepackaged dosage forms, with 74.3% preferring self-prepared formulations. Almost 30% who were using Herbal medicine at the time of the study believed that the use of Herbal Medicines during pregnancy is safe. Respondents' reasons for taking Herbal medications were varied and included reasons such as herbs having better efficacy than conventional Medicines [22.4%], herbs being natural, are safer to use during pregnancy than conventional Medicines [21.1%], low efficacy of conventional Medicines [19.7%], easier access to Herbal Medicines [11.2%], traditional and cultural belief in Herbal Medicines to cure many illnesses [12.5%], and comparatively low cost of Herbal Medicines [5.9%]. Over half the respondents, 56.6% did not support combining Herbal Medicines with conventional drugs to forestall drug-herb interaction. About 33.4% respondents believed Herbal Medicines possess no adverse effects while 181 [30.4%] were of the opinion that adverse/side effects of some Herbal Medicines could be dangerous. Marital status, geopolitical zones, and educational qualification of respondents had statistically significant effects on respondents views on side effects of Herbal Medicines [p < 0.05)] while only geopolitical zones and educational qualifications seemed to have influence on respondents' opinion on the harmful effects of Herbal Medicines to the fetus [p < 0.05]. Conclusion The study emphasized the wide spread use of Herbal Medicines by pregnant women in Nigeria highlighting an urgent need for health care practitioners and other health care givers to be aware of this practice and make efforts in obtaining information about herb use during ante-natal care. This will help forestall possible interaction between Herbal and conventional Medicines.
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attitude and use of Herbal Medicines among pregnant women in nigeria
BMC Complementary and Alternative Medicine, 2009Co-Authors: Titilayo O Fakeye, Rasaq Adisa, Ismail E MusaAbstract:The use of Herbal Medicines among pregnant women in Nigeria has not been widely studied. Opinion of 595 pregnant women in three geopolitical zones in Nigeria on the use of Herbal Medicines, safety on usage, knowledge of potential effects of Herbal remedies on the fetus and potential benefits or harms that may be derived from combining Herbal remedies with conventional therapies were obtained using a structured questionnaire between September 2007 and March 2008. Descriptive statistics and Fisher's exact tests were used at 95% confidence level to evaluate the data obtained. Level of significance was set at p < 0.05. More than two-third of respondents [67.5%] had used Herbal Medicines in crude forms or as pharmaceutical prepackaged dosage forms, with 74.3% preferring self-prepared formulations. Almost 30% who were using Herbal medicine at the time of the study believed that the use of Herbal Medicines during pregnancy is safe. Respondents' reasons for taking Herbal medications were varied and included reasons such as herbs having better efficacy than conventional Medicines [22.4%], herbs being natural, are safer to use during pregnancy than conventional Medicines [21.1%], low efficacy of conventional Medicines [19.7%], easier access to Herbal Medicines [11.2%], traditional and cultural belief in Herbal Medicines to cure many illnesses [12.5%], and comparatively low cost of Herbal Medicines [5.9%]. Over half the respondents, 56.6% did not support combining Herbal Medicines with conventional drugs to forestall drug-herb interaction. About 33.4% respondents believed Herbal Medicines possess no adverse effects while 181 [30.4%] were of the opinion that adverse/side effects of some Herbal Medicines could be dangerous. Marital status, geopolitical zones, and educational qualification of respondents had statistically significant effects on respondents views on side effects of Herbal Medicines [p < 0.05)] while only geopolitical zones and educational qualifications seemed to have influence on respondents' opinion on the harmful effects of Herbal Medicines to the fetus [p < 0.05]. The study emphasized the wide spread use of Herbal Medicines by pregnant women in Nigeria highlighting an urgent need for health care practitioners and other health care givers to be aware of this practice and make efforts in obtaining information about herb use during ante-natal care. This will help forestall possible interaction between Herbal and conventional Medicines.
D. A. Kennedy - One of the best experts on this subject based on the ideXlab platform.
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Safety classification of Herbal Medicines used in pregnancy in a multinational study
BMC Complementary and Alternative Medicine, 2016Co-Authors: D. A. Kennedy, A. Lupattelli, G. Koren, H. NordengAbstract:Background The use of Herbal Medicines for health prevention and ailments is an increasing trend worldwide. Women in pregnancy are no exception; the reported prevalence of Herbal medicine use in pregnancy ranges from 1 to 60 %. Despite a common perception of safety, Herbal Medicines may have potent pharmacological actions, and historically, have been used for this reason. Methods A multinational, cross-sectional study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North America, and Australia. This study’s primary aim was to evaluate and classify the Herbal Medicines used according to their safety in pregnancy and, secondly, to investigate risk factors associated with the use of contraindicated Herbal Medicines during pregnancy. Results In total, 29.3 % of the women ( n = 2673) reported the use of Herbal Medicines in pregnancy; of which we were able to identify 126 specific Herbal Medicines used by 2379 women (89.0 %). Twenty seven out of 126 Herbal Medicines were classified as contraindicated in pregnancy, and were used by 476 women (20.0 %). Twenty-eight were classified as safe for use in pregnancy and used by the largest number of women ( n = 1128, 47.4 %). The greatest number was classified as requiring caution in pregnancy; these sixty Herbal Medicines were used by 751 women (31.6 %). Maternal factors associated with the use of contraindicated Herbal Medicines in pregnancy were found to be working in the home, having a university education, not using folic acid, and consuming alcohol. Interestingly, the recommendation to take a contraindicated Herbal medicine was three times more likely to be from a healthcare practitioner (HCP) than an informal source. Conclusion Based on the current literature the majority of women in this study used an Herbal medicine that was classified as safe for use in pregnancy. Women who reported taking a contraindicated herb were more likely to have been recommended it use by an HCP rather than informal source(s), indicating an urgent need for more education among HCPs. The paucity of human studies on Herbal Medicines safety in pregnancy stands in stark contrast to the widespread use of these products among pregnant women.
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safety classification of Herbal Medicines used in pregnancy in a multinational study
BMC Complementary and Alternative Medicine, 2016Co-Authors: D. A. Kennedy, A. Lupattelli, G. Koren, H. NordengAbstract:The use of Herbal Medicines for health prevention and ailments is an increasing trend worldwide. Women in pregnancy are no exception; the reported prevalence of Herbal medicine use in pregnancy ranges from 1 to 60 %. Despite a common perception of safety, Herbal Medicines may have potent pharmacological actions, and historically, have been used for this reason. A multinational, cross-sectional study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North America, and Australia. This study’s primary aim was to evaluate and classify the Herbal Medicines used according to their safety in pregnancy and, secondly, to investigate risk factors associated with the use of contraindicated Herbal Medicines during pregnancy. In total, 29.3 % of the women (n = 2673) reported the use of Herbal Medicines in pregnancy; of which we were able to identify 126 specific Herbal Medicines used by 2379 women (89.0 %). Twenty seven out of 126 Herbal Medicines were classified as contraindicated in pregnancy, and were used by 476 women (20.0 %). Twenty-eight were classified as safe for use in pregnancy and used by the largest number of women (n = 1128, 47.4 %). The greatest number was classified as requiring caution in pregnancy; these sixty Herbal Medicines were used by 751 women (31.6 %). Maternal factors associated with the use of contraindicated Herbal Medicines in pregnancy were found to be working in the home, having a university education, not using folic acid, and consuming alcohol. Interestingly, the recommendation to take a contraindicated Herbal medicine was three times more likely to be from a healthcare practitioner (HCP) than an informal source. Based on the current literature the majority of women in this study used an Herbal medicine that was classified as safe for use in pregnancy. Women who reported taking a contraindicated herb were more likely to have been recommended it use by an HCP rather than informal source(s), indicating an urgent need for more education among HCPs. The paucity of human studies on Herbal Medicines safety in pregnancy stands in stark contrast to the widespread use of these products among pregnant women.
Titilayo O Fakeye - One of the best experts on this subject based on the ideXlab platform.
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Attitude and use of Herbal Medicines among pregnant women in Nigeria
BMC Complementary and Alternative Medicine, 2009Co-Authors: Titilayo O Fakeye, Rasaq Adisa, Ismail E MusaAbstract:Background The use of Herbal Medicines among pregnant women in Nigeria has not been widely studied. Methods Opinion of 595 pregnant women in three geopolitical zones in Nigeria on the use of Herbal Medicines, safety on usage, knowledge of potential effects of Herbal remedies on the fetus and potential benefits or harms that may be derived from combining Herbal remedies with conventional therapies were obtained using a structured questionnaire between September 2007 and March 2008. Descriptive statistics and Fisher's exact tests were used at 95% confidence level to evaluate the data obtained. Level of significance was set at p < 0.05. Results More than two-third of respondents [67.5%] had used Herbal Medicines in crude forms or as pharmaceutical prepackaged dosage forms, with 74.3% preferring self-prepared formulations. Almost 30% who were using Herbal medicine at the time of the study believed that the use of Herbal Medicines during pregnancy is safe. Respondents' reasons for taking Herbal medications were varied and included reasons such as herbs having better efficacy than conventional Medicines [22.4%], herbs being natural, are safer to use during pregnancy than conventional Medicines [21.1%], low efficacy of conventional Medicines [19.7%], easier access to Herbal Medicines [11.2%], traditional and cultural belief in Herbal Medicines to cure many illnesses [12.5%], and comparatively low cost of Herbal Medicines [5.9%]. Over half the respondents, 56.6% did not support combining Herbal Medicines with conventional drugs to forestall drug-herb interaction. About 33.4% respondents believed Herbal Medicines possess no adverse effects while 181 [30.4%] were of the opinion that adverse/side effects of some Herbal Medicines could be dangerous. Marital status, geopolitical zones, and educational qualification of respondents had statistically significant effects on respondents views on side effects of Herbal Medicines [p < 0.05)] while only geopolitical zones and educational qualifications seemed to have influence on respondents' opinion on the harmful effects of Herbal Medicines to the fetus [p < 0.05]. Conclusion The study emphasized the wide spread use of Herbal Medicines by pregnant women in Nigeria highlighting an urgent need for health care practitioners and other health care givers to be aware of this practice and make efforts in obtaining information about herb use during ante-natal care. This will help forestall possible interaction between Herbal and conventional Medicines.
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attitude and use of Herbal Medicines among pregnant women in nigeria
BMC Complementary and Alternative Medicine, 2009Co-Authors: Titilayo O Fakeye, Rasaq Adisa, Ismail E MusaAbstract:The use of Herbal Medicines among pregnant women in Nigeria has not been widely studied. Opinion of 595 pregnant women in three geopolitical zones in Nigeria on the use of Herbal Medicines, safety on usage, knowledge of potential effects of Herbal remedies on the fetus and potential benefits or harms that may be derived from combining Herbal remedies with conventional therapies were obtained using a structured questionnaire between September 2007 and March 2008. Descriptive statistics and Fisher's exact tests were used at 95% confidence level to evaluate the data obtained. Level of significance was set at p < 0.05. More than two-third of respondents [67.5%] had used Herbal Medicines in crude forms or as pharmaceutical prepackaged dosage forms, with 74.3% preferring self-prepared formulations. Almost 30% who were using Herbal medicine at the time of the study believed that the use of Herbal Medicines during pregnancy is safe. Respondents' reasons for taking Herbal medications were varied and included reasons such as herbs having better efficacy than conventional Medicines [22.4%], herbs being natural, are safer to use during pregnancy than conventional Medicines [21.1%], low efficacy of conventional Medicines [19.7%], easier access to Herbal Medicines [11.2%], traditional and cultural belief in Herbal Medicines to cure many illnesses [12.5%], and comparatively low cost of Herbal Medicines [5.9%]. Over half the respondents, 56.6% did not support combining Herbal Medicines with conventional drugs to forestall drug-herb interaction. About 33.4% respondents believed Herbal Medicines possess no adverse effects while 181 [30.4%] were of the opinion that adverse/side effects of some Herbal Medicines could be dangerous. Marital status, geopolitical zones, and educational qualification of respondents had statistically significant effects on respondents views on side effects of Herbal Medicines [p < 0.05)] while only geopolitical zones and educational qualifications seemed to have influence on respondents' opinion on the harmful effects of Herbal Medicines to the fetus [p < 0.05]. The study emphasized the wide spread use of Herbal Medicines by pregnant women in Nigeria highlighting an urgent need for health care practitioners and other health care givers to be aware of this practice and make efforts in obtaining information about herb use during ante-natal care. This will help forestall possible interaction between Herbal and conventional Medicines.
Joanne Barnes - One of the best experts on this subject based on the ideXlab platform.
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Pharmacovigilance of Herbal Medicines
Drug Safety, 2013Co-Authors: Eliana Rodrigues, Joanne BarnesAbstract:Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional Herbal Medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of Herbal Medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional Herbal Medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional Herbal Medicines. Questions on the precise composition of traditional prescriptions or ‘recipes’, their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional Herbal Medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of ‘general’ traditional knowledge on the safety of traditional Herbal Medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance techniques (e.g. causality assessment and data mining) requires field testing.
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Pharmacovigilance of Herbal Medicines
Drug Safety, 2003Co-Authors: Joanne BarnesAbstract:There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for Herbal Medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of Herbal Medicines presents unique challenges in addition to those described for conventional Medicines. Several problems relate to the ways in which Herbal Medicines are named, perceived, sourced, and utilised. Other important challenges arise from the current regulatory framework for Herbal Medicines in the UK. In the UK at present, the Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency’s (CSM/MHRA) ‘yellow card’ scheme for adverse drug reaction (ADR) reporting is the main method of monitoring the safety of Herbal Medicines. Despite recent initiatives to stimulate reporting of suspected ADRs associated with Herbal Medicines, such as extending the scheme to unlicensed Herbal products, and including community pharmacists as recognised reporters, numbers of Herbal ADR reports received by the CSM/MHRA remain relatively low. Under-reporting, an inevitable and important limitation of spontaneous reporting schemes, is likely to be significant for Herbal Medicines, since users typically do not seek professional advice about their use of such products, or report if they experience adverse effects. The Herbal sector in the UK has initiated various spontaneous reporting schemes, based on the yellow card scheme, but targeted mainly at Herbal-medicine practitioners. It is important that these schemes have a link with the CSM/MHRA so that potential signals are not missed. Several other tools used in pharmacovigilance of conventional Medicines, such as prescription-event monitoring, and the use of computerised health-record databases, currently are of no use for evaluating the safety of Herbal and other non-prescription Medicines. Proposed European Union legislation for traditional Herbal medicinal products will require manufacturers of products registered under new national schemes to comply with regulatory provisions on pharmacovigilance. In the longer term, other improvements in safety monitoring of Herbal Medicines may include modifications to existing methodology, patient reporting and greater consideration of pharmacogenetics and pharmacogenomics in optimising the safety of Herbal Medicines.
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pharmacovigilance of Herbal Medicines a uk perspective
Drug Safety, 2003Co-Authors: Joanne BarnesAbstract:There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for Herbal Medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of Herbal Medicines presents unique challenges in addition to those described for conventional Medicines. Several problems relate to the ways in which Herbal Medicines are named, perceived, sourced, and utilised. Other important challenges arise from the current regulatory framework for Herbal Medicines in the UK. In the UK at present, the Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency's (CSM/MHRA) 'yellow card' scheme for adverse drug reaction (ADR) reporting is the main method of monitoring the safety of Herbal Medicines. Despite recent initiatives to stimulate reporting of suspected ADRs associated with Herbal Medicines, such as extending the scheme to unlicensed Herbal products, and including community pharmacists as recognised reporters, numbers of Herbal ADR reports received by the CSM/MHRA remain relatively low. Under-reporting, an inevitable and important limitation of spontaneous reporting schemes, is likely to be significant for Herbal Medicines, since users typically do not seek professional advice about their use of such products, or report if they experience adverse effects. The Herbal sector in the UK has initiated various spontaneous reporting schemes, based on the yellow card scheme, but targeted mainly at Herbal-medicine practitioners. It is important that these schemes have a link with the CSM/MHRA so that potential signals are not missed. Several other tools used in pharmacovigilance of conventional Medicines, such as prescription-event monitoring, and the use of computerised health-record databases, currently are of no use for evaluating the safety of Herbal and other non-prescription Medicines. Proposed European Union legislation for traditional Herbal medicinal products will require manufacturers of products registered under new national schemes to comply with regulatory provisions on pharmacovigilance. In the longer term, other improvements in safety monitoring of Herbal Medicines may include modifications to existing methodology, patient reporting and greater consideration of pharmacogenetics and pharmacogenomics in optimising the safety of Herbal Medicines.