Pharmacovigilance is the science of monitoring the effects of pharmaceutical products after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions. Herbal medicines are traditionally viewed as safe due to their natural origins, but reports have shown several herbs can cause adverse reactions. Systematic pharmacovigilance of herbal medicines is needed to build a reliable understanding of their safety and inform guidelines for their safe use. Problems encountered include herbs containing undeclared drug ingredients, misidentification of plant species, and interactions between herbs and conventional drugs.

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

4. Pharmacovigilance in India: A Brief
History

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.

23. ADR REPORTING

24. Why report ADRs?
 To prevent drug-induced human
suffering
• To avoid financial risks associated with
unexpected risks

25. Reports
from
Participating
Hospitals
Reports
from
Private
Practitioners
Report
from
Drug Mfr.
Traders/
Outlets
Reports
on
Clinical
Investiga-
tions
Reports
from
Regulatory
Authorities
Reports
from
Int’l
ADR
Centers
BFAD ADR UNIT
NADRAC WHO Collaborating Center
Director - BFAD
Secretary of
Health - DOH
ADR Monitoring System

26. REPORTING SCHEME
NADRAC
(Trend Analysis)
CASE
Reporter Fills Out a Form
Hospital
Therapeutic Committees
ADRMP Office
(Central Database) WHO
WHO

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.

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).

32. Pharmacist

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.

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