5. WHY Pharmacovigilance?
(1)New medicines
-property of pharmaceutical company.
(2)Established treatment
-efficacy,cost,safety are of interest to community.
(3)Clinical trials
-intended for objective demonstration of clinical efficacy.
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6. 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
Why do we need Pharmacovigilance?
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7. • Incomplete information collected during the pre-marketing
phase of drug.
• ADRs are leading cause of morbidity and mortality in both
developing and developed world.
• ADRs were 4th-6th commonest cause of death in the US
in 1994
• It has been suggested that ADRs may cause 5700
deaths per year in UK
• 30-70% ADRs are preventable.
• They increase cost of patient care and loss of patient
confidence in health care system.
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8. 1.HUMANITARIAN CONCERN
-Animal toxicology is often not a good
predictor for human effects .
-Evidence of safety from clinical trials is
insufficient due to some limitations
LIMITATIONS (phase 1-3): limited size ,
narrow population (age &sex specific),
narrow indications (only specific disease),
short duration
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9. 2. SAFE USE OF
MEDICINESit has been suggested that ADRs may cause
5700 deaths per year in UK
3.ADRs ARE
EXPENSIVE4.PROMOTING RATIONAL USE OF MEDICINES
5.ENSURING PUBLIC CONFIDENCE
6.ETHICAL CONCERN
not reporting is serious reaction is unethical
9
10. Pharmacovigilance
Check if the drug on the market fulfill their role in
society.
(1)Alleviating human suffering.
(2)Reduce disease related economic loss.
10
12. Adverse drug reaction(ADR)
(WHO,1992)
“A Response which is noxious and unintended,
and which occurs at doses normally used in
human for the prophylaxis, diagnosis or therapy
of disease or for modification of physiological
function.”
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13. Adverse event
“any unwanted medical occurrence that may present
during treatment with a pharmaceutical product but
which does not necessarily have a casual relationship
with this treatment.”
synonyms :- Adverse experience.
13
20. Because they can….
• Increase health care cost.
• Increase rate of morbidity and mortality.
• Increase length of hospital stay.
• Decrease in health outcome/quality of life.
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21. International scenario
Thalidomide disaster(1961).
WHO international programme for drug monitoring-
1968.
Uppsala monitoring centre.sweden-coordinates the
Pharmacovigilance activity.
www.who-umc.org
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23. Continue…..
in U,K.the committee of safety of medicines(CSM))is
operating it through the yellow card system since
1964.
In united states ,the food & drug
administration(USFDA)has been conducting a
programme since 1954 to monitor ADRs to approved
drug.(med-watch programme).
In the Netherlands Pharmacovigilance started as early
as 1960.
23
24. Continue….
In Canada ADRs to drug products are monitored by
Canadian adverse drug reaction monitoring
programme.
In Australia ADRs reporting has been operated through
the spontaneous reporting system, the central agency,
is adverse drug reaction advisory committee(ADRAC).
New Zealand,
china,singapore,malasia,norway,japan,brazil,
argentina,france,ghana,tanzania.
24
25. 25
METHODS 0F PHARMACOVIGILANCE
1.Individual case safety reports
2.Clinical review of case reports
3.Cohort event monitoring
4.Longitudinal electronic patient records
5.Spontaneous reporting
6.Periodic Safety Update Reports
(PSUR)7.Expedited report
8.Record linkage
26. Why do we need
Pharmacovigilance in India?
India is a vast country with a population of over 1.2 billion
with
Vast ethnic variability.
Difference disease prevenlence patterns.
Practice of difference systems of medicines.
Different socio-economic status.
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27. Pharmacovigilance in India
1986-started the ADR monitoring centre with 12
regional centers.
1997-india joined WHO- ADR monitoring programme.
2004-national Pharmacovigilance programme.
2010-pharmacovigilance programme of India(PVPI).
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28. 1982 &
2010
2008
•ADR monitoring system • India joined WHO-ADR
for India proposed (12 monitoring programme (3
regional centers) centers: AIIMS, KEM,
• JLN)
1989 1997
2004 –
• Pharmacovigilance • National Pharmacovigilance
Programme of India Programme
Pharmacovigilance in India: A Brief History
28
29. PVPI
• Gov of india,with assistance of world bank, has
initiated the national Pharmacovigilance programme.
• This programme coordinated country wide/Initiated by
the central drugs standard control
organization(CDSCO).
• National coordinating center(NCC).
29
30. Continue….
National Pharmacovigilance programme is structured
in a three tier system with two-zonal centers, five
regional centers and 25-peripheral centers.
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34. Working pattern of PVPI
34
Health care professionals
ADRs monitoring
centre/NCC
Data entered in
vigiflow
NCC
WHO Uppsala
MC,sweden
35. Aims & Scope
• 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
35
36. OBJECTIVES/RESPONSIBIL
ITY
To monitor ADRs in Indian population.
To create awareness amongst health care
professionals about the important of ADRs reporting in
India.
To monitor benefit-risk profile of medicines.
Generate independent evidence based
recommendations on the safety of medicines.
Support the CDSCO for formulating safety related
regulatory decisions for medicines.
Communications findings with all key stakeholders.
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37. Goals
Short term goals,
To develop and implement Pharmacovigilance system
in India.
To enroll, initially all MCI approved medical colleges in
the programme covering north,south,east ,west in
India.
To encourage healthcare professionals in the reporting
of adverse reaction in drugs,vaccines,medical devices
and biological products.
Collection of case reports and data.
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38. Long term goals
To expand Pharmacovigilance to all hospitals (Gov.
and private)and centers of public health programme
located across India.
To develop and implement electronic reporting
system(e-reporting).
To develop reporting culture amongst health care
professionals.
To make ADRs reporting mandatory for health
professionals.
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39. VigiFlow is a web-based Individual Case Safety Report
(ICSR) management system that is specially
designed
for
forus
e
by national centre
s
in the WHO Programme
International Drug Monitoring.
VigiFlow 5.1(Released on 14 June
2013)
Subscription for Vigiflow is free in India.
Other tools:
ARISg (mainly used by Drug manufacturer in
Europe)
Argus (mainly used by Drug manufacturer in USA)
Vigibase
ADR Reporting through vigiflow.
39
42. ADRs monitoring centers in
medical college
Collection of ADR report.
Perform follow up with the complainant to check
completeness as per SOPs.
Data entry into vigiflow.
Training/feedback to physicians.
Post Graduate and under graduate training in PV.
42
43. National coordination centre(NCC)
Preparation of SOPs, guidance documents and
training manuals.
Cross-check completeness,casuality assessment as
per SOPs.
Reporting to CDSCO headquarters.
Conduct training workshops of all enrolled centers.
Publications of medicines safety newsletter.
43
44. CDSCO
Take appropriate regulatory decision and actions on
the basis of recommendations of NCC.
Propagation of medicine safety related decisions to
stakeholders.
Collaborations with WHO- Uppsala monitoring centers.
Assess to vigiflow.
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48. What is HIPAA?
Health Insurance Portability and Accountability Act
HIPAA is a Federal Law enacted to:
• Protect the privacy of a patient’s personal and health
information
Provide for the physical and electronic security of
personal health information
Simplify billing and other transactions with Standardized
Code Sets and Transactions
Specify new rights of patients to approve access/use of
their medical information
•
•
•
48
49. c
What is Protected Information?
We must protect an individual’s personal and health
information that
• Is created, received, or maintained by a health care
provider or health plan AND
• Is written, spoken, or electroni
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50. Who Is a “Covered Entity”?
Clearinghouses
Covered Entities (CE)
Health Care
Providers
(who conduct
“transactions”
electronically)
Health Plans
(payors)
Health Care
(data processors)
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51. What is the purpose of HIPPA?
HIPAA stands for Health Insurance Portability
and Accountability Act. President Bill Clinton
signed it in 1996, and it is comprised of five
sections. Health providers and health plans are
legally required to follow this act, which includes
protecting the privacy of health records and
information contained in a patient's file.
Read more: Purpose of HIPAA | eHow.com
http://www.ehow.com/facts_5581110_purpose-hi
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52. What is the difference between privacy
security?
Privacy is securing, protecting and
maintaining the confidentiality of the
patients data.
Vs.
Security is the methods, tools, strategy
and process that is used to ensure the
privacy.
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