The national pharmacovigilance program for Ayurveda, Siddha and Unani drugs: Current status

Baghel, Madhav Singh

doi:10.4103/0974-7788.76779

Cited by 12 publications

(10 citation statements)

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“…At present, this system is based on eight regional and 30 peripheral centres for pharmacovigilance. 28,29 China and the Republic of Korea have not found it necessary to develop such an …”

Section: Discussionmentioning

confidence: 99%

Adverse events attributed to traditional Korean medical practices: 1999–2010

Shin

Jeong

Lee

et al. 2013

Bull. World Health Organ.

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“…At present, this system is based on eight regional and 30 peripheral centres for pharmacovigilance. 28,29 China and the Republic of Korea have not found it necessary to develop such an …”

Section: Discussionmentioning

confidence: 99%

Adverse events attributed to traditional Korean medical practices: 1999–2010

Shin

Jeong

Lee

et al. 2013

Bull. World Health Organ.

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“…Modern pharmacovigilance has become differentiated to accommodate special product groups, including herbal [ 11 ] and other MPs used in whole medical systems (WMPs) [ 7 , 13 , 43 ]. Of these WMPs, some (e.g., those used traditionally in China [ 43 ] and on the Indian subcontinent [ 13 ]) were historically produced for local use. In modern times, industrial scale production developed without the rigorous quality control of modern drug manufacturing, and in many countries these WMPs are regulated as food or food supplements or are imported for use without any regulation.…”

Section: Introductionmentioning

confidence: 99%

Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network

Hamre

Glockmann

Heckenbach

et al. 2017

Drugs - Real World Outcomes

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BackgroundThere is a need for data on the clinical safety of anthroposophic medicinal products (AMPs).ObjectivesThe main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.MethodsEvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. All physicians documented ADRs of Grades III–IV and serious ADRs, seven ‘prescriber physicians’ also documented non-serious ADRs of any intensity. Patients were eligible for this analysis if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit.ResultsA total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. Among patients of prescriber physicians, ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. In subgroup analyses according to age, specific AMPs or AMP groups, dosage forms, and concentrations (altogether 11 groups), the highest ADR frequency was 0.290% of prescriptions (for one specific AMP). Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.ConclusionIn this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.Electronic supplementary materialThe online version of this article (doi:10.1007/s40801-017-0118-5) contains supplementary material, which is available to authorized users.

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“…For this purpose, the reporting format designed by the National Pharmacovigilance Resource Centre for Ayurveda, Siddha and Unani Drugs (NPRC-ASU) could be used. This format is very comprehensive and designed based on the conventional ADR reporting and the need of Ayurveda [32].…”

Section: The Effective Utilization Of Phar-macovigilance In Ayurvedamentioning

confidence: 99%

“…The department of AYUSH, Govt. of India, has also been requested to instruct the drug licensing authorities to include pharmacovigilance aspect as one of the criteria for approving a new drug [32].…”

Section: National Pharmacovigilance Re-source Centre Of Asu Drugsmentioning

confidence: 99%

Pharmacovigilance in Ayurveda – Concept and Regulations

Samal

2018

CPPM

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Background: The Indian system of medicine has its origin in India and has been practiced since centuries in India and its neighbouring South East Asian countries. Mostly the practice of this system of medicine is believed to be the safest form of therapy, however, incidences of adverse drug reactions owing to the consumption of traditional drugs led to the origin of pharmacovigilance of Ayurvedic drugs. The Concept of Pharmacovigilance: Pharmacovigilance is the science of detection, understanding, assessment and prevention of adverse drug reactions and related untoward effects. Concepts and Regulations of Pharmacovigilance in Ayurveda: Given the current scenario of the usage of the traditional and alternative medicine at a global scale, it becomes imperative to ensure the safety of the patients consuming these medications. This makes the science of pharmacovigilance, a significant domain in the field of medicine and public health as well. Nevertheless, the adverse drug reaction of traditional Ayurvedic medicine may range from trivial effects to serious fatal outcomes leading to the death of a patient. Furthermore, the application of the principles of pharmacovigilance in the realm of Ayurveda is a challenging job owing to several of the inherent characteristic features associated with such a science. Albeit recent researches are based on in-vivo and/or in-vitro trials of many herbal preparations, however, the science of Ayurveda is the science of ages and is transmitted from generation to generation. During the recent past considering the significance of pharmacovigilance in Ayurveda and other indigenous systems of medicine, a national pharmacovigilance unit of ASU (Ayurveda, Unani and Siddha) systems of medicine has been initiated at Gujrat Ayurveda University in the year 2008.

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The national pharmacovigilance program for Ayurveda, Siddha and Unani drugs: Current status

Cited by 12 publications

References 0 publications

Adverse events attributed to traditional Korean medical practices: 1999–2010

Adverse events attributed to traditional Korean medical practices: 1999–2010

Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network

Pharmacovigilance in Ayurveda – Concept and Regulations

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