KHS ICMR RP 28 March 2011 03 Version

150 Birth Anniversary of Founder Mahamana Pt.
Madan Mohan Malaviya Jee
ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai
March 28,2011
Dr A B Vaidya
March 28,2011
PHARMACOVIGILANCE AN INTEGRAL COMPONENT OF AYURVEDIC PHARMACOEPIDEMIOLOGY
Anand Chaudhary Associate Professor & Regional Coordinator Department of Rasa Shastra & Regional Centre for PVg of Ayurvedic Drugs Faculty of Ayurveda, IMS Banaras Hindu University ,Varanasi E mail- anandayubhu@gmail.com Cell 09452074480
Content
y WHO Guidelines for Pharamacovigilance y Significance of Pharmacovigilance y Ways and means of Pharmacovigilance y National Pharmacovigilance Programme
March 28,2011
World Health Organization

Article 2 To develop, establish and promote international standards with respect to Food Biologicals Pharmaceuticals Similar products
March 28,2011

Article 21 Adopt regulations concerning
y Standards with respect to the safety ,purity and potency y Biologicals, Pharmaceuticals and similar products
Moving in International commerce
March 28,2011

The Erice Declaration 1997
Highest ethical ,professional and scientific standards in protecting and promoting safe use of medicine Framework of values and practice for collection ,analysis and subsequent of drug safety issues
March 28,2011
Point of Concern----Medicines are both, powerful health care instruments and profitable commercial products ..
March 28,2011
Risk -- No medicinal product is entirely or
absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty.
March 28,2011
Basic Documents
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10
Ideal Manuscripts
March 28,2011
11
Pharmacoepidemiology
Pharmacoepidemiology is the study of the
use and effects of drugs on large groups of people.

Pharmacology and Epidemiology
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12
nlighten Endorsement
A K Raut 2011 JAIM Arthritis
March 28,2011
13
Extensive Exploration
Governance Comprehensive
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14
Incursion of Pharmacovigilance in domain of herbal medicines
March 28,2011
15
Misconception
Natural means safe Long use of medicine means safe Traditional medicines means safe
March 28,2011
16
Causative Causes
Globalization

Consumerism Explosion in free trade Self medication
March 28,2011
17
Origin of Concept
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18
Concrete Chronology
Documented
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19
Characterization
Pharmacovigilance is the science and activities related
y Detection y Assessment y Understanding y Prevention of
Adverse effects or Any other possible drug related problems
March 28,2011
20
Extended Enclosure

Herbals Traditional & complementary medicines Blood products Biologicals Medical devices Vaccines
March 28,2011
21
Aim of Pharmacovigilance
To help save lives and improve health By closing the huge gap between the potentials that essentials drugs have to offer and the reality Where medicines are unavailable, unaffordable, unsafe
or improperly used
March 28,2011
22
Rationale Reasons
Potentials of conflict of interest Unethical patient recruitment practices Inadequacy of informed consent Lack of capacity to monitor clinical trials Poor reporting and management of adverse events
March 28,2011
23
Awareness
Alertness Compliance
March 28,2011
24
Recent Resentment
ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai
March 28,2011
25
Decisive Doctrine
Improve patient care and safety
Medicines Medical & Paramedical interventions

Improve public health and safety Medicines
March 28,2011
26
Definitive Details
Assessment of medicine
Benefit, harm, effectiveness and risk of medicines

Promote effective communication
Understanding Education Training
March 28,2011
27
Wisdomnary Vision
March 28,2011
28
Consequential Concerns
Policy makers Regulatory authorities Health care practitioners Legal advisors in health care
March 28,2011
29
Beyond Belief
Wiki leaks CWG 2 G Spectrum Adarsh ISRO
March 28,2011
30
Steadfast Stakeholders

Pharmaceutical industry Editors of medical journals Consumer groups Health economist The concern layperson
March 28,2011
31
Perplexity
For Pharmaceutical Companies ,the Pharmacovigilance is a complex matter. involvement in
March 28,2011
32
Collaborator
March 28,2011
33
Compromise /Pre Mature Action ?

Regulators & Companies
Educators & Prescribers
Journalists &Patients
34
ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai March 28,2011
Logistic Obligations
Drug Information Drug Regulation Rationalization of Drug Use
Integration of PVg
March 28,2011
35
Adorable
Attitude
March 28,2011
36
Appropriate Approach
Who can Report
Any Health care professionals/Providers ASU Doctors Nurse Pharmacist etc
March 28,2011
37
Constituent Criteria
What to report
All suspected adverse reactions Lack of effects Resistance Drug interactions Dependence Abuse
March 28,2011
38
Adverse Drug Reaction

y Noxious- An unexpected therapeutic
response y Nature or severity-NOT y Consistent with domestic labeling y Market authorization y Expected from characteristic of drug
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39
Adverse Event
Serious adverse event is any event that Fatal Life threatening Permanently/significantly disabling Requires or prolongs hospitalization Causes a congenital anomaly
March 28,2011
40
125 Patients 24 Patients experienced ADRs (19%)
(59%) were avoidable
March 28,2011
41
Assured Advantages
Confidentiality Submission and fate of report
March 28,2011
42
Assertive Assessment
y Physiological & Pathological pathways y Medicine prescribed is the medicine received. y Verify onset of suspected ADR y Determine time interval
March 28,2011
43
Accurate Authenticity
Evaluate after discontinuation Analyze the alternative cause Use up -to -date literature Personal experience
March 28,2011
44
Documentation Dominance
Description of problem Date of event Date of this report Relevant test Other relevant patient information Outcomes
March 28,2011
45
Drug Description
Name-INN & brand name Dose , frequency & route Therapy date Batch number Expiration date Reappearance Concomitant
March 28,2011
46
Points of Performance
Reporting Rate Reporting Distribution Reporting Quality Reporting Efficiency
March 28,2011
47
Essential Elements
The primary role of spontaneous reporting is signal generation Number of reporting physician Quantity of information Quality Evidence
CRITICAL MINIMUM NUMBER OF CASE REPORTS FOR A SIGNAL
March 28,2011
48
Move Toward
Signal Testing
S
Signal Suspicion Signal strengthening
49
Work ahead
Perception Process is on ------
March 28,2011
50
National Pharmacovigilance Center

y Collecting and Analyzing case reports of ADRs y Distinguishing signals from background noise y Making regulatory decisions based on strengthened signals y Alerting prescribers, manufacturers and the public to new risks of adverse reactions
March 28,2011
51
Infrastructure Itinerary
National Centre Regional Centers Peripheral Centers
ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai 52 March 28,2011
Future Custodian
ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai
March 28,2011
53
Substantial Salutation
March 28,2011
54
Keep Away From

Spontaneous reporting when Data based on Suspicion Ambiguous Doubtful Wrong
Premature or Erroneous Conclusion
March 28,2011
55
Best Thing xPlease listen to your patient!!!

Pharmacovigilance
March 28,2011
56
Be Vigilant -----
ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai 28,2011 March
57
Special Submission
Safety Sustainability of Medicines
March 28,2011
58
Classical Connotation
Explanation Elucidation
March 28,2011
59
Marvelous Miraculous
Indian Inheritance Authoritative Agenda
March 28,2011
60
Wrapping up
Pharmacovigilance of Ayurvedic Drugs is a Pragmatic Approach for its Proficient Practice.
March 28,2011
61
Conclusion
The ultimate aim of Pharmacovigilance system is that new information be rapidly and effectively incorporated into therapeutic decision making by Physicians in benefit of Patients through Ayurvedic Pharmacoepidemiology .
62
Take Home Message

Wakefulness Long Live Pharmacovigilance
ICMR Workshop for Training in Reverse Pharmacology ,KHS ,Mumbai
March 28,2011
63
Thanks & All Good Wishes ----
March 28,2011
64

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150 Birth Anniversary of Founder Mahamana Pt.

Madan Mohan Malaviya Jee

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

PHARMACOVIGILANCE AN INTEGRAL COMPONENT OF AYURVEDIC PHARMACOEPIDEMIOLOGY

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

World Health Organization

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

World Health Organization

Moving in International commerce

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

World Health Organization

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Risk -- No medicinal product is entirely or

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

use and effects of drugs on large groups of people.

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

 Incursion of Pharmacovigilance in domain of herbal medicines

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Consumerism Explosion in free trade Self medication

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Adverse effects or Any other possible drug related problems

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS, Mumbai

Medicines Medical & Paramedical interventions

Improve public health and safety Medicines

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Benefit, harm, effectiveness and risk of medicines

Understanding Education Training

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Compromise /Pre Mature Action ?

Educators & Prescribers

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai March 28,2011

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Adverse Drug Reaction

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

 125 Patients  24 Patients experienced ADRs (19%)

(59%) were avoidable

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

ICMR Workshop for Training in Reverse Pharmacology ,KHS,Mumbai

Risk -- No medicinal product is entirely or

Incursion of Pharmacovigilance in domain of herbal medicines

125 Patients 24 Patients experienced ADRs (19%)

National Centre Regional Centers Peripheral Centers