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 departmentAYUSHunder 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 Intl 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.
29. 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).
30. Pharmacist
31. 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.
32. 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