Pharmacovigilance

1. PHARMACOVIGILANCE
&
PHARMACIST- AN ADRs
REPORTER
Gaurav Chhabra
Pharmacist, Northern Railway
Central Hospital, New Delhi
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Gaurav Chhabra, NRCH, NDLS

2. TITLES
 INTRODUCTION
 AN HISTORICAL OVERVIEW OVER PHARMACOVIGILANCE
 NEED OF PHARMACOVIGILANCE
 PURPOSE OF PHARMACOVIGILANCE
 PHARMACOVILANCE PROGRAMME OF INDIA
 ADRs MONITORING CENTERS
 PHARMACOVIGILANCE PROCESS IN HEALTH CARE SYSTEM
 REPORTING OF ADRs, ADRs REPORTING IN INDIA &
SUSPECTED ADRs REPORTING FORM
 PHARMACIST- AN ADRs REPORTER
 CONCLUSION
 REFERENCES
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3. INTRODUCTION
PHARMACOVIGILANCE
Pharmaco + Vigilance
(Medicines) (To Watch)
According to WHO-:
 Science and activities relating to the detection, assessment,
understanding and prevention of adverse effects and any other drug
related problems.
 This applies throughout the life cycle of a medicine equally to the pre-
approval stage as to the post approval.
 Adverse drug reaction (ADR): “A response to a medicine which is
noxious and unintended, and which occurs at doses normally used in
human”
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Gaurav Chhabra, NRCH, NDLS

4. AN HISTORICAL OVERVIEW OVER
PHARMACOVIGILANCE
Gaurav Chhabra, NRCH, NDLS
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In 1961, A Big Development happened in pharmacovigilance due to the
tragedy of Thalidomide. Congenital malformation in babies was observed
when prescribed to pregnant woman.

5. Some adverse effects are not predictable from pre-clinical studies
(Animal studies during drug discovery).
Phase I, II, III: limited size of the population,
• Narrow population (age & sex specific – Children, elderly, pregnant are
excluded),
• Short duration of study(Pressure from various groups to reduce time to
approval)
• Participants are closely monitored with clinical supervision
• Detection of rare adverse event is difficult
• Detection of Drug-food interaction and Drug- Drug interaction is not
possible
• Detection of Long term adverse effects are not possible.
•Due to all above problems ADR remain an important cause of
morbidity and mortality
NEED OF
PHARMACOVIGILANCE
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Gaurav Chhabra, NRCH, NDLS

6. Globally about 5% of all deaths may be caused by pharmaceuticals.
Globally about 6.5% hospital admission were related to ADR’s.
ADR related cost to the country exceeds the cost of medications
themselves.
ADR are preventable in large scale (at least in 50 %) but in some
cases new approaches are needed.
NEED OF
PHARMACOVIGILANCE
(Conti….)
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Gaurav Chhabra, NRCH, NDLS

7. THE PURPOSE OF
PHARMACOVIGILANCE
The main purpose/ practice of pharmacovigilance in health care
system is to improve the patient’s safety and enhance patient
care in terms of the use medicines, including paramedical
interventions.
Contribute to the assessment of uses, side-effects, harm,
effectiveness and risk of medicines.
Encouraging the safe, rational and more effective (including
cost-effective) use of various medicines.
Promote education, understanding and clinical training in
pharmacovigilance and its effective availability to the public.
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Gaurav Chhabra, NRCH, NDLS

8. THE PURPOSE OF
PHARMACOVIGILANCE
(Conti….)
Efficient assessment of the risk-benefit profile of medicines. Ban
and withdrawal of drugs from the market if the risks (ADRs) are more
than the benefits of a particular drug.
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9.  A nation-wide pharmacovigilance programme was started in July,
2010 by the Central Drugs Standard Control Organisation (CDSCO),
New Delhi, under the aegis of Ministry of Health & Family Welfare
Government of India in AIIMS, New Delhi.
 In April, 2011 shifted from AIIMS, New Delhi to the Indian
Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.). (NCC-PvPI)
 From July, 2017 IPC, NCC-PvPI became a WHO Collaborating
Centre for Pharmacovigilance in Public Health Programmes &
Regulatory services.
PHARMACOVILANCE
PROGRAMME OF INDIA
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Gaurav Chhabra, NRCH, NDLS

10. Gaurav Chhabra, NRCH, NDLS
ADRs MONITORING CENTERS
(AMCs)
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11. PHARMACOVIGILANCE PROCESS
IN HEALTH CARE SYSTEM
Pharmcovigilance is to be seen as the process of-
1) Collection and reporting of ADRs.
2) Monitoring and causality assessment
3) Researching
4) Evaluating information from heath care providers for the
purposes of understanding and preventing Drug-related
problems.
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Gaurav Chhabra, NRCH, NDLS

12. REPORTING OF ADRs
ADR reporting can be done by-
 Healthcare professionals
 Clinician/ Physician/ Doctor
 Dentist
 Pharmacist
 Nurse
 Patient
4 Minimum criteria for reporting of ADRs-
1. A Patient / Medicine consumer
2. A suspected ADR
3. A suspected Drug
4. A Reporter
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Gaurav Chhabra, NRCH, NDLS

13. Gaurav Chhabra, NRCH, NDLS
ADVERSE DRUG REACTIONS REPORTING IN INDIA

14. Gaurav Chhabra, NRCH, NDLS
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15. SUSPECTED ADRs REPORTING
FORM
(Conti…)
Gaurav Chhabra, NRCH, NDLS
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16. Gaurav Chhabra, NRCH, NDLS
SUSPECTED ADRs REPORTING
FORM
(Conti…)
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17. SUSPECTED ADRs REPORTING
FORM
(Conti…)
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Gaurav Chhabra, NRCH, NDLS

18. Pharmacist- An ADRs reporter
(Need of Pharmacist in Reporting of ADRs)
 An Important part of health care system, so the reporting
of ADRs are moral responsibility of a Pharmacist.
 Qualified in prescription reading, therefore can monitor
and determine drug related problems; thus maintain safe use
of medicines..
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Gaurav Chhabra, NRCH, NDLS

19. Pharmacist- An ADRs reporter
(Need of Pharmacist in Reporting of ADRs)
(Conti…)
 Up to date knowledge of side effects and adverse
reactions of different drugs.
 Educated and aware of drug dosage and drug-drug
interactions, contraindications.
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20.  Pharmacist–Patient relationship-
A good patient–pharmacist relation allows patients to talk
openly without hesitation about the ADRs with pharmacist
during drug treatment.
Pharmacist- An ADRs reporter
(Need of Pharmacist in Reporting of ADRs)
(Conti…)
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Gaurav Chhabra, NRCH, NDLS

21. CONCLUSION
 Pharmacovigilance basically targets safety of medicine and
prevent from the irrational use of medicines.
 The vision of Pharmacovigilace Programme of India (PVPI) is to
improve patient safety and by reporting and monitoring of drug
safety and thereby reducing the risk associated with the use of
medicines.
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Gaurav Chhabra, NRCH, NDLS

22. CONCLUSION
(Conti…)
Pharmacists play crucial roles in health systems in
maintaining the rational and safe use of medicines by their
contribution in reporting of ADRs since they are specifically
trained in the field of pharma and health care sector.
Effective use of pharmacist workforce will improve the outcome
of the pharmacotherapy as well as decrease global health costs.
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23. REFERENCES
 Gupta SK ”Textbook of Pharmacovigilance” Jaypee brothers medical publishers (P)Ltd, New Delhi
2011.
 Mann RD, Andrews EB, Pharmacovigilance John Wiley & Sons Ltd, Chichester, 2002.
 Katzung BG (Eds.): Basics and Clinical Pharmacology: 10th edition.: McGraw- Hill, Boston, 2007.
 Rang HP, Dale MM, Ritter JM, Moore PK: Pharmacology: 5th edition.: Churchill Livingstone,
Edinburg, 2003.
 Biswas P Pharmacovigilance in Asia Journal of Pharmacology and Pharmacotherapeutics |
December 2013 | Vol 4 | Supplement 1.
 www.who.int/medicines/areas/quality_safety/safety.../definitions
 www.Who-umc.org.
 www.fda.gov
 www.ich.org/products/guidelines.
 www.ema.europa.eu
 "Central Drugs Standard Control Organization". Cdsco.nic.in
 "Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India".
Ipc.gov.in
 dbtbiosafety.nic.in/act/schedule_y.pdf
 Hale Z. Toklu1 and Edward Mensah “Why do we need pharmacists in pharmacovigilance systems?”
Online Journal of Public Health Informatics, 2016.
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24. THANK YOU
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Gaurav Chhabra, NRCH, NDLS