1) Herbal medicines are widely used globally but can cause adverse drug reactions. Pharmacovigilance, or monitoring the safety of medicines, is important for herbal drugs.
2) Challenges in herbal pharmacovigilance include regulation, quality control, and recording identities due to chemical complexity of herbs. Adverse reactions must be reported using forms submitted to regulatory authorities.
3) The WHO established guidelines for herbal pharmacovigilance to build safety information and protect public health. Improved monitoring can restore confidence in herbal medicines.
INDIAN SYSTEM OF MEDICINE, UNIT2, MPHARM PCG SEM2 Naturopathy Yoga and Aromatherapy practices
Naturopathy Introduction, basic principles and treatment modalities.
Yoga - Introduction and Streams of Yoga. Asanas, Pranayama, Meditations and Relaxation techniques
Aromatherapy - Introduction, aroma oils for common problems, carrier oils.
Ethnobotany and Ethnopharmacology-Approaches of Traditional Medicine Studies, Traditional use & management of medicinal plants in Asian countries, Application of Ethnobotany to community conservation and medicinal plant resource management
WHO guidelines on herbal drug monitoringKaustav Dey
This presentation points out the various guidelines laid out by World health organization for safe & effective way of monitoring of Herbal Medicine in a pharmacovigilance setting
Herbal medicines have gained lot of popularity, however the side effects associated have been neglected due to lack of knowledge and belief. Hence the Pharmacovigilance of herbal drugs needs to be addressed by educating the common people though campaigns.
Immobilization is "the imprisonment of an enzyme in a distinct phase that allows exchange with, but is separated from the bulk phase in which the substrate, effector or inhibitor molecules are dispersed and monitored"
Plants are natural sources of valuable secondary metabolites used in pharmaceuticals, agrochemicals, the food industry, etc.
There is an increasing demand to obtain these metabolites through more productive plant tissue applications and cell culture methods.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
INDIAN SYSTEM OF MEDICINE, UNIT2, MPHARM PCG SEM2 Naturopathy Yoga and Aromatherapy practices
Naturopathy Introduction, basic principles and treatment modalities.
Yoga - Introduction and Streams of Yoga. Asanas, Pranayama, Meditations and Relaxation techniques
Aromatherapy - Introduction, aroma oils for common problems, carrier oils.
Ethnobotany and Ethnopharmacology-Approaches of Traditional Medicine Studies, Traditional use & management of medicinal plants in Asian countries, Application of Ethnobotany to community conservation and medicinal plant resource management
WHO guidelines on herbal drug monitoringKaustav Dey
This presentation points out the various guidelines laid out by World health organization for safe & effective way of monitoring of Herbal Medicine in a pharmacovigilance setting
Herbal medicines have gained lot of popularity, however the side effects associated have been neglected due to lack of knowledge and belief. Hence the Pharmacovigilance of herbal drugs needs to be addressed by educating the common people though campaigns.
Immobilization is "the imprisonment of an enzyme in a distinct phase that allows exchange with, but is separated from the bulk phase in which the substrate, effector or inhibitor molecules are dispersed and monitored"
Plants are natural sources of valuable secondary metabolites used in pharmaceuticals, agrochemicals, the food industry, etc.
There is an increasing demand to obtain these metabolites through more productive plant tissue applications and cell culture methods.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
Adulteration and Deterioration: Introduction, Types of
Adulteration/ Substitution of Herbal drugs, Causes and Measures
of Adulteration, Sampling Procedures, Determination of Foreign
Matter, DNA Finger printing techniques in identification of drugs of
natural origin, detection of heavy metals, pesticide residues, phytotoxin, microbial contamination in herbs and their
formulations.
Toxicity and Regulations: Herbals vs
Conventional drugs, Efficacy of Herbal medicine products, Validation of herbal therapies, Pharmacodynamic and
Pharmacokinetic issues.
The process of initiation and development of an organ is called organogenesis.
In-plant tissue culture, inducing organogenesis is an important way to regenerate plants from the culture.
The process of formation of an embryo is called embryogenesis.
Embryogenesis starts from a single embryogenic cell, which can be a zygote (the product of the fusion of an egg and a sperm during fertilization),
Embryogenesis from an undifferentiated callus cell is termed Somatic Embryogenesis.
INDUSTRIAL PHARMACOGNOSTICAL TECHNOLOGY
Herbal drug industry: Infrastructure of herbal drug industry
involved in production of standardized extracts and various
dosage forms. Current challenges in upgrading and
modernization of herbal formulations. Entrepreneurship
Development, Project selection, project report, technical
knowledge, Capital venture, plant design, layout and construction.
Pilot plant scale –up techniques, case studies of herbal extracts.
Formulation and production management of herbals.
70-80% of people worldwide rely chiefly on traditional, largely herbal, medicines.
The global demand for herbal medicine is not only large but growing.
Various technologies- adopted for enhancing bioactive molecules in medicinal plants.
Biotechnological tools are important for the multiplication and genetic enhancement of medicinal plants.
In vitro regeneration and genetic transformation are the Techniques adopted.
The importance of medicinal plants in the treatment of a variety of human ailments man has been dependent on the higher plants as a source of food and medicine.
การวิเคราะห์ฤทธิ์ต้านอนุมูลอิสระที่ระยะต่างกันในกล้วยเล็บมือนาง
Analysis of Antioxidant Activity at Different Stage in Musa (AA group) ‘Kluai Leb Mu Nang’
อดิศร จำรูญ
Adulteration and Deterioration: Introduction, Types of
Adulteration/ Substitution of Herbal drugs, Causes and Measures
of Adulteration, Sampling Procedures, Determination of Foreign
Matter, DNA Finger printing techniques in identification of drugs of
natural origin, detection of heavy metals, pesticide residues, phytotoxin, microbial contamination in herbs and their
formulations.
Toxicity and Regulations: Herbals vs
Conventional drugs, Efficacy of Herbal medicine products, Validation of herbal therapies, Pharmacodynamic and
Pharmacokinetic issues.
The process of initiation and development of an organ is called organogenesis.
In-plant tissue culture, inducing organogenesis is an important way to regenerate plants from the culture.
The process of formation of an embryo is called embryogenesis.
Embryogenesis starts from a single embryogenic cell, which can be a zygote (the product of the fusion of an egg and a sperm during fertilization),
Embryogenesis from an undifferentiated callus cell is termed Somatic Embryogenesis.
INDUSTRIAL PHARMACOGNOSTICAL TECHNOLOGY
Herbal drug industry: Infrastructure of herbal drug industry
involved in production of standardized extracts and various
dosage forms. Current challenges in upgrading and
modernization of herbal formulations. Entrepreneurship
Development, Project selection, project report, technical
knowledge, Capital venture, plant design, layout and construction.
Pilot plant scale –up techniques, case studies of herbal extracts.
Formulation and production management of herbals.
70-80% of people worldwide rely chiefly on traditional, largely herbal, medicines.
The global demand for herbal medicine is not only large but growing.
Various technologies- adopted for enhancing bioactive molecules in medicinal plants.
Biotechnological tools are important for the multiplication and genetic enhancement of medicinal plants.
In vitro regeneration and genetic transformation are the Techniques adopted.
The importance of medicinal plants in the treatment of a variety of human ailments man has been dependent on the higher plants as a source of food and medicine.
การวิเคราะห์ฤทธิ์ต้านอนุมูลอิสระที่ระยะต่างกันในกล้วยเล็บมือนาง
Analysis of Antioxidant Activity at Different Stage in Musa (AA group) ‘Kluai Leb Mu Nang’
อดิศร จำรูญ
This is an Engg Biotechnology project based on medicinal plant i.e singapore cherry or jamaican cherry tree (scientific name Muntingia calabure ), we did in 2013 in GMIT college Davangere, karanataka, India. i have complete project detail what we did..,
An antioxidant is a molecule capable of inhibiting the oxidation of other molecules.
Oxidation reactions can form free radicals and these start chain reactions that damage cells .
Antioxidants terminate these chain reactions by removing free radical intermediates and inhibit other oxidation reactions
Following file comprises of information about interactions taking place between herbs-drug, herbs-herbs, it also highlights some of the cases of clinical laboratory test interactions taking place due to use of herbal medicines.
The term “medicinal plant” include various types of plants used in herbalism ("herbology" or "herbal medicine"). It is the use of plants for medicinal purposes, and the study of such uses.
The word “herb” has been derived from the Latin word, “herba” and an old French word “herbe”. Now a days, herb refers to any part of the plant like fruit, seed, stem, bark, flower, leaf, stigma or a root, as well as a non-woody plant. Earlier, the term “herb” was only applied to non-woody plants, including those that come from trees and shrubs. These medicinal plants are also used as food, flavonoid, medicine or perfume and also in certain spiritual activities.
Plants have been used for medicinal purposes long before prehistoric period. Ancient Unani manuscripts Egyptian papyrus and Chinese writings described the use of herbs. Evidence exist that Unani Hakims, Indian Vaids and European and Mediterranean cultures were using herbs for over 4000 years as medicine. Indigenous cultures such as Rome, Egypt, Iran, Africa and America used herbs in their healing rituals, while other developed traditional medical systems such as Unani, Ayurveda and Chinese Medicine in which herbal therapies were used systematically.
Herbal supplements: what you should know about it?Ahmed Nouri
introduction to herbal products, how to use it, what you should know about it for easy and safe use by public
a lecture prepared by a clinical pharmacist
Ayurveda Versus Allopathic Treatment - Ayurvedic medicine For Kidney CareKARMA AYURVEDA
As Ayurveda concentrates on the starting reason to cure the influenced zone and related arrangement of our body, you'll likewise need to keep up a sound way of life and control what you devour to get the most out of the treatment.
Then again allopathic medicine is an articulation authored to allude to standard therapeutic utilization of pharmacologically dynamic operators or drugs and physical mediations, for example, surgery to treat or stifle manifestations of disease
Asthma solutions and inhalers, for example, fluticasone cause throat disturbances, upper respiratory tract diseases, cerebral pain, roughness of voice, parasitic contaminations of oral cavity and thrush. These ordinary medicines likewise result in diseases of ear, nose and throat when utilized as a part of kids. While, ayurvedic medicine never causes these symptoms.
The distinction amongst Ayurveda and Allopathy is principally in light of three attributes.
(1) Ayurveda relies upon a progressive structure as opposed to a trial approach in allopathy.
(2) Ayurveda adopts a philosophical strategy in light of the Vedas to wellbeing while Allopathy concentrates on logical clinical trials making utilization of all measures that have ended up being of significant worth in treatment of disease.
3) In Ayurveda the emphasis is on counteractive action of disease and to discover the main driver to bring the body once again into adjust instead of the attention on regarding side effects with mediations as in Allopathic medicine.
The human genome project, which has been under way for several years now, represents an attempt to build a complete genetic profile of the human race. Already researchers claim to have identified the gene responsible for a number of abnormalities, from cystic fibrosis to, most recently, aggression. Should this be regarded as an exciting enterprise that deserves the support of therapists of all persuasions? Or is it an extreme expression of hubris, a hazardous undertaking with unforeseeable and possibly disastrous consequences for human health and liberty. The result of this misperception is that, inevitably, genetic mapping will lead to genetic manipulation – indeed that is the avowed aim of geneticists. Whatever the good intentions of researchers, the medical -industrial establishment a tacit alliance of doctors, drug companies ,insurance, and other interested parties, influenced to varying degrees by consideration of money or power –will ensure that the pressures on ‘genetic defectives’ to undergo therapy will be irresistible. This will give rise to a society where the individual will relinquish all control over his or her own health, and where virtually everyone, from gestation onward, will become a “patient” under the control of the medical- industrial complex.
What does all this have to do with Phytotherapy(Herbal Medicine)? The natural therapies-among which the phytotherapy, in global terms, is paramount-in general reflect the philosophical view that nature in totality , is the expression of a universal harmony and equilibrium , the rupture of which gives rise to numerous ill effects, among them environmental devastation in the biosphere and ill-health in the individual.
Phytotherapy, by contrast, aims not to cure disease by a technological fix, but to bring about a restoration of homoeostasis through remedies that assist , but stop short of violence to, the organism’s intrinsic healing powers.
The eminent French doctor J.C Lapaz maintains that 90% of both common and serious illnesses could be treated with phytotherapy.It is therefore the lecturer believe that widening the scope of natural medicine in this way presents as worthy as a challenge to science as the human genome project, and one whose success would be crowned with immeasurably greater benefits to humanity and prevention of diseases.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
1. Towards safety of herbal medication
Prepared by : Miss Mariyan Patel
Asst.Prof Indukaka Ipcowala College of Pharmacy
2. "Pharmacovigilance” =( Pharmakon -drug ) + (Vigilance- to
watch)
The science and activities relating to the detection,
evaluation, understanding and prevention of
adverse drug reactions or any other drug-related
problems
3. • To improve patient care & safety in relation to
medicines & all medical & para-medical
interventions
Patient
Care
• To improve public health & safety in relation to
the use of medicines
Public
Health
Risk Benefit
Assessment
• To contribute to the assessment of benefit, harm,
effectiveness and risk of medicines
• To promote understanding, clinical training &
effective communication to health professionals
& the public
Communication
AIMS & SCOPE
5. NEED FOR PHARMACOVIGILANCE
Humanitarian concern
ADR May cause sudden death
Promoting rational use of medicines
and adherence
Ethics:To know of something that is
harmful to another person who does not know,
and not telling, is unethical.
ADRs: 4th Leading Cause of Death
6. Adverse Drug Reactions (ADRs)
Any response to a drug which is
noxious and unintended and
which occurs at doses used in
man for prophylaxis,
diagnosis or therapy
Six Classifications of ADR
Type A
Type B
Type C
Type D
Type E
Type F
(Augmented)
(Bizarre)
(Continuous)
(Delayed)
(Ending of Use)
(Failure of Efficacy)
7. 78,095
56,231
4,667
*
1
4
7
C
E
2
5
8
%
3
6
/
9
0
+
=
STATISTICS
5% of adults are allergic to one or more medications
6 – 10% of ADRs result from a drug allergy
3% of hospital admissions are due to ADRs
28% of ADRs are preventable
Drugs associated with ADRs: 29% analgesics, 10%
sedatives, 9% antibiotics, and 7% antipsychotics.
PGH: Antibiotics (35%), anti-TB meds (34%),
anticonvulsants and ASA/NSAIDS (10% each)
8. Herbalism
•Herbalism ("herbology" or "herbal medicine") is use of
plants for medicinal purposes, and the study of such use.
•Plants have been the basis for
medical treatments through much
of human history, and such
traditional medicine is still widely
practiced today.
•The World Health Organization
estimates that 80 % of the population
of some Asian and African countries
presently use herbal medicine for some
aspect of primary health care.
9. •The use of herbal remedies is more prevalent in
patients with chronic diseases such
as cancer, diabetes, asthma and end-stage renal
disease.
•Multiple factors such as gender, age, ethnicity,
education and social class are also shown to have
association with prevalence of herbal remedies use.
Prevalence of use
10. In India the herbal remedy is so popular that the
government of India has created a separate
department—AYUSH—under the Ministry of
Health & Family Welfare. The National Medicinal
Plants Board was also established in 2000 by the
Indian government in order to deal with the herbal
medical system.
11. Herbal preparations
•Herbal teas, or tisanes, are the resultant liquid of extracting herbs into
water, though they are made in a few different ways.
•Infusions are hot water extracts of herbs, such aschamomile or mint,
through steeping.
• Decoctions are the long-term boiled extracts, usually of harder
substances like roots or bark.
• Maceration is the old infusion of plants with high mucilage-content,
such as sage, thyme, etc.
•Tinctures are alcoholic extracts of herbs, which are generally stronger
than herbal teas. Usually obtained by combining 100% pure with the
herb.
• Extracts include liquid extracts, dry extracts, and nebulisates. Liquid
extracts are liquids with a lower ethanol % than tinctures. Dry extracts
are extracts of plant material that are evaporated into a dry mass.
12. Safety
•A number of herbs are thought to be likely to cause adverse effects.
Datura stramonium is a highly
effective treatment for asthma
symptoms when smoked, because it
contains atropine, which acts as an
antispasmodic in the lungs. However,
datura is also an extremely powerful
hallucinogen and overdoses of the
tropane alkaloids in it can result in
hospitalization or death.
13. Examples of highly toxic herbs include:
•Poison hemlock and nightshade. They are not marketed to the public as
herbs, because the risks are well known, partly due to a long and colorful
history in Europe, associated with "sorcery", "magic" and intrigue.
•A case of major potassium depletion has been attributed to chronic licorice
ingestion., and consequently professional herbalists avoid the use of licorice
• Black cohosh has been implicated in a case of liver failure.
•Examples of herbs where a high degree of confidence of a risk long term
adverse effects can be asserted include ginseng, which is unpopular among
herbalists for this reason, the endangered herb goldenseal, milk thistle, senna,
against which herbalists generally advise and rarely use, aloe vera juice,
buckthorn bark and berry, cascara sagrada bark, saw palmetto, valerian, kava,
which is banned in the European Union, St. John's wort, Khat, Betel nut, the
restricted herb Ephedra, and Guarana.
14. Herbal Pharmacovigilance
Some unwanted reactions due to herbs can be :
(i) side effects (usually detectable by pharmacodynamics and
often predictable)
(ii) reactions occurring as a result of overdose, over duration,
tolerance, dependence-addiction (detectable either by
pharmacodynamics or pharmacovigilance)
(iii) hypersensitivity, allergic and idiosyncratic reactions
(detectable by pharmacovigilance),
(iv) mid-term and long-term toxic effects including liver, renal,
cardiac and neurotoxicity also genotoxicity and teratogenicity
(detectable by in vitro and in vivo toxicological studies or by
pharmacovigilance).
15. The safety of herbal medicines has
become an issue for the regulatory
authorities, as serious effects have
been reported, including
hepatotoxicity, renal failure and
allergic reactions
The World Health Organisation,
recognising the growing importance
of the use of herbal medicines
worldwide developed guidelines for
the monitoring of herbal safety
within the existing
pharmacovigilance framework.
Herbal medicines are
traditionally considered
harmless since these belong to
natural sources. However, this is
not true as there are several case
reports of adverse reactions of
herbal drugs mentioned in
published literature.
Systematic pharmacovigilance is
essential to build up reliable
information on the safety of herbal
medicines for the development of
appropriate guidelines for safe
effective use.
16. Herbs with suspected or known adverse effects
HERBALDRUGS ADVERSEEFFECTS
Ginkgo biloba Bleeding
St. John's wort Gastrointestinal disturbances,
allergicreactions, fatigue,
dizziness,confusion, dry
mouth,photosensitivity
Ephedra (Ma Huang) Hypertension, insomnia,
arrhythmia,nervousness, tremor,
headache,seizure, cerebrovascular
event,myocardial infarction, kidney
stones.
Kava(
Pipermethysticum)
Sedation, oral and lingual
dyskinesia,torticollis, oculogyric
crisis,exacerbation of Parkinson's
disease,painful twisting movements of
thetrunk, rash
17. Herbs with Adverse Drug Interactions
Herb Drug Adverse Effects
Ginkgo biloba Drugs like Aspirin,
warfarin, ticlopidine,
clopidogrel,
dipyridamole, garlic,
vitamin E
With aspirin -retards
aspirin absorption
Psyllium seed Coumarin derivates Retards absorption of
drug
Ephedra Caffeine,
decongestants,
stimulants
May be additive in
nature
Feverfew Aspirin Additive effects
18. Problems encountered with the use of herbal
medicines and products.
•Some herbal products were found to contain 0.1 to 0.3 mg of
betamethasone per capsule after some patients developed corticosteroid-
like side effects.
•Owing to misidentification of the medicinal plant species, plant materials
containing aristolochic acid were used for manufacturing herbal products,
which caused severe kidney failure in patients in several countries.
•Reports have been received by drug safety monitoring agencies of
prolonged prothrombin times, increased coagulation time, subcutaneous
hematomas, and intracranial hemorrhage associated with the use of Ginkgo
biloba.
•One of the most well-known traditionally used herbal medicines caused
severe, sometimes fatal cases of interstitial pneumonia, when used in
conjunction with interferon.
19. List of the unapproved Ayurvedic
medicinal products
•Karela tablets, produced by Shriji Herbal Products, India
•Karela capsules, produced by Himalaya Drug, India
•Karela capsules, produced by Charantia, UK (specifically
batch #12011)
•Maha Sudarshan Churna powder, produced by Zandu Pharmaceuticals, Mumbai, India
•Maha Sudarshan Churna powder, D and K Pharmacy, Bhavnagar, India
•Maha Sudarshan Churna powder, produced by Chhatrisha, Lalpur, India
•Maha Sudarshan Churna powder, produced by Dabur India, New Delhi, India
•Safi liquid, produced by Hamdard-WAKF-Pakistan
•Safi liquid, produced by Hamdard-WAKF-India
•Yograj Guggul tablets, produced by Zandu Pharmaceuticals, Mumbai, India
•Sudarshan tablets, produced by Zandu Pharmaceuticals, Mumbai, India
•Shilajit capsules, produced by Dabur India, New Delhi, India
20. Importance of Herbal Pharmacovigilance
SOME COUNTRIES ACCEPT TRADITIONAL, EXPERIENCE BASED EVIDENCE WHILE
OTHERS CONSIDER HERBAL REMEDIES AS DANGEROUS OR OF QUESTIONABLE
VALUE. MEDICINAL HERBS AS POTENTIAL SOURCE OF THERAPEUTICS AIDS HAS
ATTAINED A SIGNIFICANT ROLE IN HEALTH CARE SYSTEM ALL OVER THE WORLD
FOR HUMAN BEINGS NOT ONLY IN THE DISEASED CONDITION BUT ALSO AS
POTENTIAL MATERIAL FOR MAINTAINING PROPER HEALTH
A MAJOR FACTOR IMPEDING THE DEVELOPMENT OF THE MEDICINAL PLANT
BASED INDUSTRIES IN DEVELOPING COUNTRIES HAS BEEN THE LACK OF
INFORMATION ON THE SOCIAL AND ECONOMIC BENEFITS THAT COULD BE
DERIVED FROM THE INDUSTRIAL UTILIZATION OF MEDICINAL PLANTS.
THE MONITORING THE SAFETY OF HERBAL MEDICINAL PRODUCTS, IN THE
MARKET OR IN THE PIPELINE, WILL DEFINITELY GO A LONG WAY IN RESTORING
THE CONFIDENCE OF THEIR SAFETY
21. CHALLENGES IN MONITORING THE SAFETY OF
HERBAL MEDICINES:
Regulation
Quality assurance and control
Safety monitoring of herbal
medicines
Recording and coding the identity
of herbal medicines
22. Specific challenges
Unlike synthetic medicines, herbal medicines are typically
chemically rich and complex products and not isolated single
compounds.
A number of factors can influence the qualitative and quantitative
chemical profile including:
• Geographical origin – climate, soil, photoperiod.
• Genotype.
• Parts of the plant – leaves, stems, root, root bark, etc.
• Harvesting time (year, season, time of day) and conditions.
• Storage, processing, extraction.
• Combinations of herbs and/or processing of the combined herbs
as medicines.
27. How do we report ADRs?
STEP 1 : Fill out the RED ALERT CARDS
PGH FORM # P – 60170
PGH ADVERSE DRUG SURVEILLANCE
ALERT CARD
(Clip this on chart front cover)
Name of patient:___________________________________
Ward & Bed No.:__________________________________
Name of suspect drug:______________________________
Manufacturer:_____________________________________
Lot/ Code No.:__________ (Retain empty vial or container)
Describe the reaction:_______________________________
_________________________________________________
_________________________________________________
Reporter: _________________________________________
(Please Print)
PLEASE NOTIFY: CENTRAL BLOCK PHARMACY
Loc. 3163 / 3170
28. How do we report ADRs?
STEP 2: Complete the ADR REPORT FORM
The Resident - in - charge of
the patient shall
complete the
necessary report of ADR
circumstances.
29.
30.
31. HOW DO WE REPORT ADRS?
STEP 3: Submit the red alert card and the
ADR report form to the Central Block
Pharmacy for proper referral.
STEP 4: The Pharmacy will then compile the
reports for review of the ADR Subcommittee
and submission to the Bureau of Food and
Drugs (BFAD).
33. The WHO international drug monitoring program
Under the WHO International Drug Monitoring Program, national
pharmacovigilance centers designated by the competent health
authorities are responsible for the collection, processing, and evaluation
of case reports of suspected adverse reactions supplied by health care
professionals (mainly spontaneous reporting by physicians of reactions
associated with the use of prescribed medicines). The Program is
described in two publications: Safety monitoring of medicinal products:
guidelines for setting up and running a pharmacovigilance center.
34.
35. CONCLUSION
This project aims to provide a comprehensive and critical
overview of the current state of pharmacovigilance activities for
herbal medicines at the national and global levels. It will explore
in depth the challenges that pharmacovigilance of herbal
medicines presents, consider relevant emerging issues and what
steps could and should be taken to improve safety monitoring
for herbal medicines in the future
